Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Gegenanzeigen · Norvir
Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 4
HOS-086138 · Präparat HOS-083284
Concomitant medicinal product levels increased or decreased
1-Adrenoreceptor Alfuzosin Increased plasma concentrations of alfuzosin
Antagonist which may lead to severe hypotension (see
section 4.5).
Analgesics Pethidine, Increased plasma concentrations of
propoxyphene norpethidine and propoxyphene. Thereby,
increasing the risk of serious respiratory
depression or haematologic abnormalities, or
other serious adverse effects from these agents.
Antianginal Ranolazine Increased plasma concentrations of ranolazine
which may increase the potential for serious
and/or life-threatening reactions (see section
4.5).
Anticancer Neratinib Increased plasma concentrations of neratinib
which may increase the potential for serious
and/or life-threatening reactions including
hepatotoxicity (see section 4.5).
Venetoclax Increased plasma concentrations of venetoclax.
Increased risk of tumor lysis syndrome at the
dose initiation and during the dose-titration
phase (see section 4.5).
Antiarrhythmics Amiodarone, bepridil, Increased plasma concentrations of amiodarone,
dronedarone, bepridil, dronedarone, encainide, flecanide,
encainide, flecanide, propafenone, quinidine. Thereby, increasing the
propafenone, quinidine risk of arrhythmias or other serious adverse
reactions from these agents.
Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid
and ritonavir.
Anti-gout Colchicine Potential for serious and/or life-threatening
reactions in patients with renal and/or hepatic
impairment (see sections 4.4 and 4.5).
Antihistamines Astemizole, Increased plasma concentrations of astemizole
terfenadine and terfenadine. Thereby, increasing the risk of
serious arrhythmias from these agents.
Antipsychotics/ Lurasidone Increased plasma concentrations of lurasidone
Neuroleptics which may increase the potential for serious
and/or life-threatening reactions (see section
4.5).
Clozapine, pimozide Increased plasma concentrations of clozapine
and pimozide. Thereby, increasing the risk of
serious haematologic abnormalities, or other
serious adverse effects from these agents.
Quetiapine Increased plasma concentrations of quetiapine
which may lead to coma. The concomitant
administration with quetiapine is
contraindicated (see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): propoxyphene (HOS-086140) quetiapine (HOS-086150) encainide (HOS-086145) alfuzosin (HOS-086139) propafenone (HOS-084530) dronedarone (HOS-086144) fusidic acid (HOS-086146) bepridil (HOS-085612) quinidine (HOS-085593) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) clozapine (HOS-086149) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141)
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Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage f9fe97979894eedcce9660008265f9fc818cdb3984974bb2555b6c5e5869e4e5 · Zeichen 902–5292 im Abschnitt
Gegenanzeigen · Norvir
Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35–36
HOS-086388 · Präparat HOS-083284
35
Analgesics Pethidine, Increased plasma concentrations of
propoxyphene norpethidine and propoxyphene. Thereby,
increasing the risk of serious respiratory
depression or haematologic abnormalities, or
other serious adverse effects from these agents.
Antianginal Ranolazine Increased plasma concentrations of ranolazine
which may increase the potential for serious
and/or life-threatening reactions (see section
4.5).
Anticancer Neratinib Increased plasma concentrations of neratinib
which may increase the potential for serious
and/or life-threatening reactions including
hepatotoxicity (see section 4.5).
Venetoclax Increased plasma concentrations of venetoclax.
Increased risk of tumor lysis syndrome at the
dose initiation and during the dose-titration
phase (see section 4.5).
Antiarrhythmics Amiodarone, bepridil, Increased plasma concentrations of amiodarone,
dronedarone, bepridil, dronedarone, encainide, flecainide,
encainide, flecainide, propafenone, quinidine. Thereby, increasing
propafenone, quinidine the risk of arrhythmias or other serious adverse
effects from these agents.
Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid
and ritonavir.
Antihistamines Astemizole, Increased plasma concentrations of astemizole
terfenadine and terfenadine. Thereby, increasing the risk of
serious arrhythmias from these agents.
Anti-gout Colchicine Potential for serious and/or life-threatening
reactions in patients with renal and/or hepatic
impairment (see sections 4.4 and 4.5).
Antipsychotics/ Lurasidone Increased plasma concentrations of lurasidone
Neuroleptics which may increase the potential for serious
and/or life-threatening reactions (see section
4.5).
Clozapine, pimozide Increased plasma concentrations of clozapine
and pimozide. Thereby, increasing the risk of
serious haematologic abnormalities, or other
serious adverse effects from these agents.
Quetiapine Increased plasma concentrations of quetiapine
which may lead to coma. The concomitant
administration with quetiapine is
contraindicated (see section 4.5).
Ergot Derivatives Dihydroergotamine, Increased plasma concentrations of ergot
ergonovine, derivatives leading to acute ergot toxicity,
ergotamine, including vasospasm and ischaemia.
methylergonovine
GI motility agent Cisapride Increased plasma concentrations of cisapride.
Thereby, increasing the risk of serious
arrhythmias from this agent.
Lipid-modifying agents
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): propoxyphene (HOS-086140) quetiapine (HOS-086150) encainide (HOS-086145) methylergonovine (HOS-086155) propafenone (HOS-084530) dronedarone (HOS-086144) cisapride (HOS-085610) fusidic acid (HOS-086146) flecainide (HOS-086203) bepridil (HOS-085612) quinidine (HOS-085593) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) clozapine (HOS-086149) ergotamine (HOS-086154) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) ergonovine (HOS-086153) dihydroergotamine (HOS-086152)
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Wechselwirkungen · Norvir
Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 13
HOS-086202 · Präparat HOS-083284
Antiarrthymics
Amiodarone, bepridil, dronedarone, Ritonavir co-administration is likely to result in increased plasma concentrations of
encainide, flecainide, propafenone, amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, and
quinidine quinidine and is therefore contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): encainide (HOS-086145) propafenone (HOS-084530) dronedarone (HOS-086144) flecainide (HOS-086203) bepridil (HOS-085612) quinidine (HOS-085593) amiodarone (HOS-085596)
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Wechselwirkungen · Norvir
Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 45
HOS-086412 · Präparat HOS-083284
Antiarrthymics
Amiodarone, bepridil, dronedarone, Ritonavir co-administration is likely to result in increased plasma concentrations of
encainide, flecainide, propafenone, amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, and quinidine and
quinidine is therefore contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): encainide (HOS-086145) propafenone (HOS-084530) dronedarone (HOS-086144) flecainide (HOS-086203) bepridil (HOS-085612) quinidine (HOS-085593) amiodarone (HOS-085596)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 7be5a56d7eb28c6b0b362a7de5830a5d2ee65bd16f89e27afb151c7f671bb104 · Zeichen 13898–14249 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 5
HOS-108791 · Präparat HOS-093083
Concomitant medicinal product levels increased
Alpha1-adrenoreceptor Alfuzosin Increased plasma concentrations of
antagonist alfuzosin which may lead to severe
hypotension. The concomitant
administration with alfuzosin is
contraindicated (see section 4.5).
Antianginal Ranolazine Increased plasma concentrations of
ranolazine which may increase the
potential for serious and/or life-
threatening reactions (see section 4.5).
Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of
amiodarone and dronedarone. Thereby,
increasing the risk of arrhythmias or
other serious adverse reactions (see
section 4.5).
Antibiotic Fusidic Acid Increased plasma concentrations of
fusidic acid. The concomitant
administration with fusidic acid is
contraindicated in dermatological
infections (see section 4.5).
Anticancer Neratinib Increased plasma concentrations of
neratinib which may increase the
potential for serious and/or
life-threatening reactions (see section
4.5).
Venetoclax Increased plasma concentrations of
venetoclax. Increased risk of tumor lysis
syndrome at the dose initiation and
during the ramp-up phase (see section
4.5).
Anti-gout Colchicine Increased plasma concentrations of
colchicine. Potential for serious and/or
life-threatening reactions in patients with
renal and/or hepatic impairment (see
sections 4.4 and 4.5).
Antihistamines Astemizole, terfenadine Increased plasma concentrations of
astemizole and terfenadine. Thereby,
increasing the risk of serious
arrhythmias from these agents (see
section 4.5).
Antipsychotics/ Lurasidone Increased plasma concentrations of
Neuroleptics lurasidone which may increase the
potential for serious and/or life-
threatening reactions (see section 4.5).
Pimozide Increased plasma concentrations of
pimozide. Thereby, increasing the risk
of serious haematologic abnormalities,
or other serious adverse effects from this
agent (see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 3af5f7da19ec49492414676af6b40d10b1389f87518dc00840ff964623d97870 · Zeichen 617–4755 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42
HOS-108987 · Präparat HOS-093083
Concomitant medicinal product levels increased
Alpha1- Alfuzosin Increased plasma concentrations of
adrenoreceptor alfuzosin which may lead to severe
antagonist hypotension. The concomitant
administration with alfuzosin is
contraindicated (see section 4.5).
Antianginal Ranolazine Increased plasma concentrations of
ranolazine which may increase the
potential for serious and/or life-
threatening reactions (see section 4.5).
Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of
amiodarone and dronedarone. Thereby,
increasing the risk of arrhythmias or
other serious adverse reactions (see
section 4.5).
Antibiotic Fusidic Acid Increased plasma concentrations of
fusidic acid. The concomitant
administration with fusidic acid is
contraindicated in dermatological
infections (see section 4.5).
Anticancer Neratinib Increased plasma concentrations of
neratinib which may increase the
potential for serious and/or
life-threatening reactions (see section
4.5).
Venetoclax Increased plasma concentrations of
venetoclax. Increased risk of tumor
lysis syndrome at the dose initiation
and during the ramp-up phase (see
section 4.5).
Anti-gout Colchicine Increased plasma concentrations of
colchicine. Potential for serious and/or
life-threatening reactions in patients
with renal and/or hepatic impairment
(see sections 4.4 and 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) colchicine (HOS-086147) amiodarone (HOS-085596) ranolazine (HOS-086141)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 9293fe9ecfe32956533c5b772cc23612b4a6e3a500aeb3b328481fd78b786272 · Zeichen 583–3923 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77
HOS-109061 · Präparat HOS-093083
Concomitant medicinal product levels increased
Alpha1-adrenoreceptor Alfuzosin Increased plasma concentrations of
antagonist alfuzosin which may lead to severe
hypotension. The concomitant
administration with alfuzosin is
contraindicated (see section 4.5).
Antianginal Ranolazine Increased plasma concentrations of
ranolazine which may increase the
potential for serious and/or life-
threatening reactions (see section 4.5).
Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of
amiodarone and dronedarone. Thereby,
increasing the risk of arrhythmias or other
serious adverse reactions (see section 4.5).
Antibiotic Fusidic Acid Increased plasma concentrations of fusidic
acid. The concomitant administration with
fusidic acid is contraindicated in
dermatological infections (see section
4.5).
Anticancer Neratinib Increased plasma concentrations of
neratinib which may increase the potential
for serious and/or life-threatening
reactions (see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) lead (HOS-085592) amiodarone (HOS-085596) ranolazine (HOS-086141)
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Wechselwirkungen · Kaletra
Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 12–13
HOS-108863 · Präparat HOS-093083
12
CYP3A4 inhibition by concomitantly administered with
lopinavir/ritonavir. Kaletra.
Antianginal
Ranolazine Due to CYP3A inhibition by The concomitant administration of
lopinavir/ritonavir, concentrations Kaletra and ranolazine is
of ranolazine are expected to contraindicated (see section 4.3).
increase.
Antiarrhythmics
Amiodarone, Dronedarone Amiodarone, Dronedarone: Concomitant administration of
Concentrations may be increased Kaletra and amiodarone or
due to CYP3A4 inhibition by dronedarone is contraindicated (see
lopinavir/ritonavir. section 4.3) as the risk of
arrhythmias or other serious
adverse reactions may be
increased.
Digoxin Digoxin: Caution is warranted and
Plasma concentrations may be therapeutic drug monitoring of
increased due to P-glycoprotein digoxin concentrations, if
inhibition by lopinavir/ritonavir. available, is recommended in case
The increased digoxin level may of co-administration of Kaletra and
lessen over time as P-gp digoxin. Particular caution should
induction develops. be used when prescribing Kaletra
in patients taking digoxin as the
acute inhibitory effect of ritonavir
on P-gp is expected to significantly
increase digoxin levels. Initiation
of digoxin in patients already
taking Kaletra is likely to result in
lower than expected increases of
digoxin concentrations.
Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and
Lidocaine, and Quinidine Quinidine: therapeutic drug concentration
Concentrations may be increased monitoring is recommended when
when co-administered with available.
lopinavir/ritonavir.
Antibiotics
Clarithromycin Clarithromycin: For patients with renal impairment
Moderate increases in (CrCL < 30 ml/min) dose reduction
clarithromycin AUC are expected of clarithromycin should be
due to CYP3A inhibition by considered (see section 4.4).
lopinavir/ritonavir. Caution should be exercised in
administering clarithromycin with
Kaletra to patients with impaired
hepatic or renal function.
Anticancer agents and kinase inhibitors
Abemaciclib Serum concentrations may be Co-administration of abemaciclib
increased due to CYP3A and Kaletra should be avoided. If
inhibition by ritonavir. this co-administration is judged
unavoidable, refer to the
abemaciclib SmPC for dosage
adjustment recommendations.
Monitor for ADRs related to
abemaciclib.
Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may
strong CYP3A4 inducer and this result in potential loss of
may lead to a decreased exposure virological response.
of lopinavir/ritonavir.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) apalutamide (HOS-086212) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) lead (HOS-085592) clarithromycin (HOS-084517) amiodarone (HOS-085596) ranolazine (HOS-086141)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 2a6dc58dcb1aed961671098b7774afc6ab5284838d7c3becb73533d81f884e22 · Zeichen 9077–14069 im Abschnitt
Wechselwirkungen · Kaletra
Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 49–50
HOS-109006 · Präparat HOS-093083
49
Antiarrhythmics
Amiodarone, Amiodarone, Dronedarone: Concomitant administration of
Dronedarone Concentrations may be increased Kaletra and amiodarone or
due to CYP3A4 inhibition by dronedarone is contraindicated (see
lopinavir/ritonavir. section 4.3) as the risk of arrhythmias
or other serious adverse reactions
may be increased.
Digoxin Digoxin: Caution is warranted and therapeutic
Plasma concentrations may be drug monitoring of digoxin
increased due to P-glycoprotein concentrations, if available, is
inhibition by lopinavir/ritonavir. recommended in case of
The increased digoxin level may co-administration of Kaletra and
lessen over time as P-gp digoxin. Particular caution should be
induction develops. used when prescribing Kaletra in
patients taking digoxin as the acute
inhibitory effect of ritonavir on P-gp
is expected to significantly increase
digoxin levels. Initiation of digoxin
in patients already taking Kaletra is
likely to result in lower than expected
increases of digoxin concentrations.
Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and therapeutic
Lidocaine, and Quinidine: drug concentration monitoring is
Quinidine Concentrations may be increased recommended when available.
when co-administered with
lopinavir/ritonavir.
Antibiotics
Clarithromycin Clarithromycin: For patients with renal impairment
Moderate increases in (CrCL < 30 ml/min) dose reduction
clarithromycin AUC are expected of clarithromycin should be
due to CYP3A inhibition by considered (see section 4.4). Caution
lopinavir/ritonavir. should be exercised in administering
clarithromycin with Kaletra to
patients with impaired hepatic or
renal function.
Anticancer agents and kinase inhibitors
Abemaciclib Serum concentrations may be Co-administration of abemaciclib
increased due to CYP3A and Kaletra should be avoided. If
inhibition by ritonavir. this co-administration is judged
unavoidable, refer to the abemaciclib
SmPC for dosage adjustment
recommendations. Monitor for
ADRs related to abemaciclib.
Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may
strong CYP3A4 inducer and this result in potential loss of virological
may lead to a decreased exposure response.
of lopinavir/ritonavir. In addition, co-administration of
apalutamide and Kaletra may lead to
Serum concentrations of serious adverse events including
apalutamide may be increased due seizure due to higher apalutamide
to CYP3A inhibition by levels. Concomitant use of Kaletra
lopinavir/ritonavir. with apalutamide is not
recommended.
Afatinib Afatinib: Caution should be exercised in
AUC: ↑ administering afatinib with Kaletra.
(Ritonavir 200 mg twice Cmax: ↑ Refer to the afatinib SmPC for
daily)
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) apalutamide (HOS-086212) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) lead (HOS-085592) afatinib (HOS-086207) clarithromycin (HOS-084517) amiodarone (HOS-085596)
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Wechselwirkungen · Kaletra
Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 84–85
HOS-109080 · Präparat HOS-093083
84
Fentanyl Fentanyl: Careful monitoring of adverse
Increased risk of side-effects effects (notably respiratory
(respiratory depression, sedation) depression but also sedation) is
due to higher plasma recommended when fentanyl is
concentrations because of concomitantly administered with
CYP3A4 inhibition by Kaletra.
lopinavir/ritonavir.
Antianginal
Ranolazine Due to CYP3A inhibition by The concomitant administration of
lopinavir/ritonavir, concentrations Kaletra and ranolazine is
of ranolazine are expected to contraindicated (see section 4.3).
increase.
Antiarrhythmics
Amiodarone, Amiodarone, Dronedarone: Concomitant administration of
Dronedarone Concentrations may be increased Kaletra and amiodarone or
due to CYP3A4 inhibition by dronedarone is contraindicated (see
lopinavir/ritonavir. section 4.3) as the risk of
arrhythmias or other serious adverse
reactions may be increased.
Digoxin Digoxin: Caution is warranted and
Plasma concentrations may be therapeutic drug monitoring of
increased due to P-glycoprotein digoxin concentrations, if available,
inhibition by lopinavir/ritonavir. is recommended in case of
The increased digoxin level may co-administration of Kaletra and
lessen over time as P-gp digoxin. Particular caution should
induction develops. be used when prescribing Kaletra in
patients taking digoxin as the acute
inhibitory effect of ritonavir on
P-gp is expected to significantly
increase digoxin levels. Initiation
of digoxin in patients already taking
Kaletra is likely to result in lower
than expected increases of digoxin
concentrations.
Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and
Lidocaine, and Quinidine: therapeutic drug concentration
Quinidine Concentrations may be increased monitoring is recommended when
when co-administered with available.
lopinavir/ritonavir.
Antibiotics
Clarithromycin Clarithromycin: For patients with renal impairment
Moderate increases in (CrCL < 30 ml/min) dose reduction
clarithromycin AUC are expected of clarithromycin should be
due to CYP3A inhibition by considered (see section 4.4).
lopinavir/ritonavir. Caution should be exercised in
administering clarithromycin with
Kaletra to patients with impaired
hepatic or renal function.
Anticancer agents and kinase inhibitors
Abemaciclib Serum concentrations may be Co-administration of abemaciclib
increased due to CYP3A and Kaletra should be avoided. If
inhibition by ritonavir. this co-administration is judged
unavoidable, refer to the
abemaciclib SmPC for dosage
adjustment recommendations.
Monitor for ADRs related to
abemaciclib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) clarithromycin (HOS-084517) fentanyl (HOS-086196) amiodarone (HOS-085596) ranolazine (HOS-086141)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 441e910c1e6908f1a8725254649dcb0f97fdc57cf122c18523aa47225be733b2 · Zeichen 9035–13902 im Abschnitt
Gegenanzeigen · Prezista
PREZISTA 100 mg/ml oral suspension · Abschnitt 4.3 · PDF-Seite 6
HOS-116288 · Präparat HOS-094447
Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that
are highly dependent on CYP3A for clearance, which results in increased exposure to the
co-administered medicinal product. Therefore, concomitant treatment with such medicinal products
for which elevated plasma concentrations are associated with serious and/or life-threatening events is
contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active
substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine
- astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine)
- elbasvir/grazoprevir
- cisapride
- dapoxetine
- domperidone
- naloxegol
- lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
- triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil
- simvastatin, lovastatin, lomitapide (see section 4.5)
- ticagrelor (see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) cobicistat (HOS-088111) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage e2536d703754b5f39bebb9603c70a8d8759f7198e0666cec1af181c80f42d82c · Zeichen 1442–2753 im Abschnitt
Gegenanzeigen · Prezista
PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 49
HOS-116497 · Präparat HOS-094447
Co-administration of PREZISTA with low dose ritonavir, with active substances that are highly
dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with
serious and/or life-threatening events. These active substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine
- astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine)
- elbasvir/grazoprevir
- cisapride
- dapoxetine
- domperidone
- naloxegol
- lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
- triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil
- simvastatin, lovastatin and lomitapide (see section 4.5)
- ticagrelor (see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 6a604bfa742092630f592a37246ad3ddd261ae7ceba904108fadd195ca4e43c8 · Zeichen 481–1534 im Abschnitt
Gegenanzeigen · Prezista
PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 87
HOS-116580 · Präparat HOS-094447
Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that
are highly dependent on CYP3A for clearance, which results in increased exposure to the
co-administered medicinal product. Therefore, concomitant treatment with such medicinal products
for which elevated plasma concentrations are associated with serious and/or life-threatening events is
contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active
substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine
- astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine)
- elbasvir/grazoprevir
- cisapride
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) cobicistat (HOS-088111) bepridil (HOS-085612) quinidine (HOS-085593) grazoprevir (HOS-108815) ivabradine (HOS-109426) colchicine (HOS-086147) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) ranolazine (HOS-086141) dihydroergotamine (HOS-086152)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 986882b0b712a9a949916f43fb05836de98ea933859327e753cd9346903445da · Zeichen 1383–2254 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 15
HOS-116362 · Präparat HOS-094447
Amiodarone Co-administration of boosted
Bepridil PREZISTA and amiodarone,
Dronedarone bepridil, dronedarone, ivabradine,
Ivabradine quinidine, or ranolazine is
Quinidine contraindicated (see section 4.3).
Ranolazine
Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow
0.4 mg single dose digoxin Cmin ND therapeutic index, it is
digoxin Cmax ↑ 29% recommended that the lowest
(↑ digoxin from probable inhibition of possible dose of digoxin should
P-gp) initially be prescribed in case
digoxin is given to patients on
boosted PREZISTA therapy. The
digoxin dose should be carefully
titrated to obtain the desired
clinical effect while assessing the
overall clinical state of the subject.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) ivabradine (HOS-109426) amiodarone (HOS-085596) ranolazine (HOS-086141)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 0fca4263d4f5bc605a5ae9a42506a92581e4e87603747a8b6bef8d6ab34c7cfa · Zeichen 27581–29261 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 57
HOS-116517 · Präparat HOS-094447
Amiodarone PREZISTA co-administered with
Bepridil low dose ritonavir and
Dronedarone amiodarone, bepridil, dronedarone,
Ivabradine ivabradine, quinidine, or
Quinidine ranolazine is contraindicated (see
Ranolazine section 4.3).
Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow
0.4 mg single dose digoxin Cmin ND therapeutic index, it is
digoxin Cmax ↑ 29% recommended that the lowest
(↑ digoxin from probable inhibition of possible dose of digoxin should
P-gp) initially be prescribed in case
digoxin is given to patients on
darunavir/ritonavir therapy. The
digoxin dose should be carefully
titrated to obtain the desired
clinical effect while assessing the
overall clinical state of the subject.
ANTIBIOTIC
Clarithromycin clarithromycin AUC ↑ 57% Caution should be exercised when
500 mg twice daily
clarithromycin Cmin ↑ 174% clarithromycin is combined with
clarithromycin Cmax ↑ 26% PREZISTA co-administered with
#
darunavir AUC ↓ 13% low dose ritonavir.
#
darunavir Cmin ↑ 1%
# For patients with renal impairment
darunavir Cmax ↓ 17%
the Summary of Product
14-OH-clarithromycin concentrations
Characteristics for clarithromycin
were not detectable when combined with
should be consulted for the
PREZISTA/ritonavir.
recommended dose.
(↑ clarithromycin from CYP3A inhibition
and possible P-gp inhibition)
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR
Apixaban Not studied. Co-administration of The use of boosted PREZISTA
Rivaroxaban boosted PREZISTA with these with a direct oral anticoagulant
anticoagulants may increase (DOAC) that is metabolised by
concentrations of the anticoagulant. CYP3A4 and transported by P-gp
(CYP3A and/or P-gp inhibition) is not recommended as this may
lead to an increased bleeding risk.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) rivaroxaban (HOS-086236) lead (HOS-085592) clarithromycin (HOS-084517) apixaban (HOS-112091) ivabradine (HOS-109426) ritonavir (HOS-084521) amiodarone (HOS-085596) ranolazine (HOS-086141)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 227bb2dae3a2a6739ad7d75460b7010eb52122480b556e1f4afdf1e753dc6670 · Zeichen 21078–24599 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 97
HOS-116608 · Präparat HOS-094447
Amiodarone Co-administration of boosted
Bepridil PREZISTA and amiodarone,
Dronedarone bepridil, dronedarone, ivabradine,
Ivabradine quinidine, or ranolazine is
Quinidine contraindicated (see section 4.3).
Ranolazine
Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow
0.4 mg single dose digoxin Cmin ND therapeutic index, it is
digoxin Cmax ↑ 29% recommended that the lowest
(↑ digoxin from probable inhibition of possible dose of digoxin should
P-gp) initially be prescribed in case
digoxin is given to patients on
boosted PREZISTA therapy. The
digoxin dose should be carefully
titrated to obtain the desired
clinical effect while assessing the
overall clinical state of the subject.
ANTIBIOTIC
Clarithromycin clarithromycin AUC ↑ 57% Caution should be exercised when
500 mg twice daily
clarithromycin Cmin ↑ 174% clarithromycin is combined with
clarithromycin Cmax ↑ 26% boosted PREZISTA.
#
darunavir AUC ↓ 13%
#
darunavir Cmin ↑ 1% For patients with renal impairment
# the Summary of Product
darunavir Cmax ↓ 17%
Characteristics for clarithromycin
14-OH-clarithromycin concentrations
should be consulted for the
were not detectable when combined with
recommended dose.
PREZISTA/ritonavir.
(↑ clarithromycin from CYP3A inhibition
and possible P-gp inhibition)
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR
Apixaban Not studied. Co-administration of The use of boosted PREZISTA
Rivaroxaban boosted PREZISTA with these with a direct oral anticoagulant
anticoagulants may increase (DOAC) that is metabolised by
concentrations of the anticoagulant. CYP3A4 and transported by P-gp
(CYP3A and/or P-gp inhibition) is not recommended as this may
lead to an increased bleeding risk.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) rivaroxaban (HOS-086236) lead (HOS-085592) clarithromycin (HOS-084517) apixaban (HOS-112091) ivabradine (HOS-109426) ritonavir (HOS-084521) amiodarone (HOS-085596) ranolazine (HOS-086141)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage d32b19556a6cce04cd413a7b7e735b8fbe64621522b345e338c67799d622d39b · Zeichen 27793–31178 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.3 · PDF-Seite 6
HOS-118621 · Präparat HOS-094855
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Severe renal impairment (CrCL < 30 mL/min) in adult patients
• eGFR < 50 mL/min/1.73 m2 in paediatric patients
• Active clinically significant bleeding
• Lesion or condition, if considered a significant risk factor for major bleeding. This may include
current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
6
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 58c4826e564b5c5b7f1abc93ec498be4215981e3fc8a5222c2a54f71816b01c4 · Zeichen 0–1751 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 110 mg hard capsules · Abschnitt 4.3 · PDF-Seite 38–39
HOS-118701 · Präparat HOS-094855
38
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage ec2e999673d5b90adcb3018232692e9cba05e46844ff8f9fe74dad3d32d8172e · Zeichen 520–1753 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 150 mg hard capsules · Abschnitt 4.3 · PDF-Seite 78–79
HOS-118789 · Präparat HOS-094855
78
bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses
necessary to maintain an open central venous or arterial catheter or when UFH is given during
catheter ablation for atrial fibrillation (see section 4.5)
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 30c550ec0ab8ef152af1fe03e09c53747fb57851a2196eef5c1b464bb4db5f2f · Zeichen 520–1753 im Abschnitt
Gegenanzeigen · Pradaxa
Pradaxa 20 mg coated granules Pradaxa 30 mg coated granules Pradaxa 40 mg coated granules Pradaxa 50 mg coated granules Pradaxa 110 mg coated granules Pradaxa 150 mg coated granules · Abschnitt 4.3 · PDF-Seite 113–114
HOS-118875 · Präparat HOS-094855
113
intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous
malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low
molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc),
oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
These are switching anticoagulant therapy (see section 4.2) or when UFH is given at doses
necessary to maintain an open central venous or arterial catheter (see section 4.5).
• Hepatic impairment or liver disease expected to have any impact on survival
• Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole,
cyclosporine, itraconazole, dronedarone and the fixed-dose combination
glecaprevir/pibrentasvir (see section 4.5)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) fondaparinux (HOS-110096) glecaprevir (HOS-086297) heparin (HOS-086930) rivaroxaban (HOS-086236) itraconazole (HOS-084516) apixaban (HOS-112091) cyclosporine (HOS-084512) enoxaparin (HOS-118623) dalteparin (HOS-118624) warfarin (HOS-085950)
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