Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 4

HOS-108788 · Präparat HOS-093083

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 4

HOS-108789 · Präparat HOS-093083

Severe hepatic insufficiency.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 4–5

HOS-108790 · Präparat HOS-093083

Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A. Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events. These medicinal products include: 4 Medicinal product Medicinal products within Rationale class class

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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)

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 5–6

HOS-108805 · Präparat HOS-093083

5  Quetiapine Increased plasma concentrations of quetiapine which may lead to coma. The concomitant administration with quetiapine is contraindicated (see section 4.5). Ergot alkaloids Dihydroergotamine, ergonovine, Increased plasma concentrations of ergot ergotamine, methylergonovine derivatives leading to acute ergot toxicity, including vasospasm and ischaemia (see section 4.5). GI motility agent Cisapride Increased plasma concentrations of cisapride. Thereby, increasing the risk of serious arrhythmias from this agent (see section 4.5). Hepatitis C virus Elbasvir/grazoprevir Increased risk of alanine transaminase direct acting antivirals (ALT) elevations (see section 4.5). 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): quetiapine (HOS-086150) elbasvir (HOS-108814) methylergonovine (HOS-086155) cisapride (HOS-085610) hepatitis C virus (HOS-108813) ergot alkaloids (HOS-108807) lead (HOS-085592) grazoprevir (HOS-108815) ergotamine (HOS-086154) ergonovine (HOS-086153) dihydroergotamine (HOS-086152) alanine (HOS-088949)

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 6

HOS-108817 · Präparat HOS-093083

HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of Inhibitors lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5). Microsomal Lomitapide Increased plasma concentrations of triglyceride transfer lomitapide (see section 4.5). protein (MTTP) inhibitor Phosphodiesterase Avanafil Increased plasma concentrations of (PDE5) inhibitors avanafil (see sections 4.4 and 4.5). Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5) Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. For caution on parenterally administered midazolam, see section 4.5. Lopinavir/ritonavir medicinal product level decreased Herbal products St. John’s wort Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) midazolam (HOS-086167) vardenafil (HOS-086163)

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 6–7

HOS-108826 · Präparat HOS-093083

6 Kaletra oral solution is contraindicated in children below the age of 14 days, pregnant women, patients with hepatic or renal failure and patients treated with disulfiram or metronidazole due to the potential risk of toxicity from the excipient propylene glycol (see section 4.4).

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): metronidazole (HOS-085182) propylene glycol (HOS-108829) disulfiram (HOS-108827)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42

HOS-108983 · Präparat HOS-093083

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42

HOS-108984 · Präparat HOS-093083

Severe hepatic insufficiency.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42

HOS-108985 · Präparat HOS-093083

Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A. Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events. These medicinal products include:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42

HOS-108986 · Präparat HOS-093083

Medicinal product Medicinal products within Rationale class class

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42–43

HOS-108988 · Präparat HOS-093083

42 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). Quetiapine Increased plasma concentrations of quetiapine which may lead to coma. The concomitant administration with quetiapine is contraindicated (see section 4.5). Ergot alkaloids Dihydroergotamine, ergonovine, Increased plasma concentrations of ergotamine, methylergonovine ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia (see section 4.5). GI motility agent Cisapride Increased plasma concentrations of cisapride. Thereby, increasing the risk of serious arrhythmias from this agent (see section 4.5). Hepatitis C virus Elbasvir/grazoprevir Increased risk of alanine transaminase direct acting antivirals (ALT) elevations (see section 4.5). 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): quetiapine (HOS-086150) elbasvir (HOS-108814) methylergonovine (HOS-086155) cisapride (HOS-085610) hepatitis C virus (HOS-108813) ergot alkaloids (HOS-108807) lead (HOS-085592) grazoprevir (HOS-108815) pimozide (HOS-085600) astemizole (HOS-085608) ergotamine (HOS-086154) terfenadine (HOS-085607) lurasidone (HOS-086148) ergonovine (HOS-086153) dihydroergotamine (HOS-086152) alanine (HOS-088949)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 43

HOS-108989 · Präparat HOS-093083

HMG Co-A Lovastatin, simvastatin Increased plasma concentrations of Reductase Inhibitors lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5). Microsomal Lomitapide Increased plasma concentrations of triglyceride transfer lomitapide (see section 4.5). protein (MTTP) inhibitor Phosphodiesterase Avanafil Increased plasma concentrations of (PDE5) inhibitors avanafil (see sections 4.4 and 4.5) Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) vardenafil (HOS-086163)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 43–44

HOS-108990 · Präparat HOS-093083

43  Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. For caution on parenterally administered midazolam, see section 4.5. Lopinavir/ritonavir medicinal product level decreased Herbal products St. John’s wort Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (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): triazolam (HOS-086168) midazolam (HOS-086167)

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77

HOS-109057 · Präparat HOS-093083

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77

HOS-109058 · Präparat HOS-093083

Severe hepatic insufficiency.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77

HOS-109059 · Präparat HOS-093083

Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A. Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events. These medicinal products include:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77

HOS-109060 · Präparat HOS-093083

Medicinal product Medicinal products within Rationale class class

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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)