Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 3

HOS-086133 · Präparat HOS-083284

Hypersensitivity to the active substance 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 · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 3

HOS-086134 · Präparat HOS-083284

Ritonavir should not be given to patients with decompensated liver disease.

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

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 3

HOS-086135 · Präparat HOS-083284

In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations. The enzyme-modulating effect of ritonavir may be dose dependent (see section 5.1). The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit

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

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 3–4

HOS-086136 · Präparat HOS-083284

3 metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects:

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

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 4

HOS-086137 · Präparat HOS-083284

Medicinal Product Medicinal Products Rationale Class within Class

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

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): encainide (HOS-086145) propafenone (HOS-084530) quinidine (HOS-085593) fusidic acid (HOS-086146) colchicine (HOS-086147) astemizole (HOS-085608) terfenadine (HOS-085607) lurasidone (HOS-086148) clozapine (HOS-086149) pimozide (HOS-085600) quetiapine (HOS-086150) bepridil (HOS-085612) dronedarone (HOS-086144) alfuzosin (HOS-086139) lead (HOS-085592) propoxyphene (HOS-086140) ranolazine (HOS-086141) neratinib (HOS-086142) venetoclax (HOS-086143) amiodarone (HOS-085596)

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 4–5

HOS-086151 · Präparat HOS-083284

4  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): dihydroergotamine (HOS-086152) ergonovine (HOS-086153) ergotamine (HOS-086154) methylergonovine (HOS-086155) cisapride (HOS-085610)

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-086156 · Präparat HOS-083284

HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of lovastatin Inhibitors and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (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) simvastatin (HOS-086158)

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-086159 · Präparat HOS-083284

Microsomal Lomitapide Increased plasma concentrations of lomitapide triglyceride transfer (see section 4.5). protein (MTTP) inhibitor PDE5 inhibitors Avanafil Increased plasma concentrations of avanafil (see section 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 section 4.4. and 4.5). Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate, estazolam, flurazepam, diazepam, estazolam, flurazepam, oral oral midazolam and midazolam and triazolam. Thereby, increasing triazolam the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, 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): lomitapide (HOS-086160) avanafil (HOS-086161) sildenafil (HOS-086162) vardenafil (HOS-086163) clorazepate (HOS-086164) diazepam (HOS-085904) estazolam (HOS-086165) flurazepam (HOS-086166) midazolam (HOS-086167) triazolam (HOS-086168)

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-086169 · Präparat HOS-083284

Ritonavir medicinal product level decreased Herbal Preparation 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 ritonavir (see section 4.5).

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

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35

HOS-086383 · Präparat HOS-083284

Hypersensitivity to the active substance 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 · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35

HOS-086384 · Präparat HOS-083284

Ritonavir should not be given to patients with decompensated liver disease.

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

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35

HOS-086385 · Präparat HOS-083284

In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations. The enzyme-modulating effect of ritonavir may be dose dependent (see section 5.1). The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects:

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

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35

HOS-086386 · Präparat HOS-083284

Medicinal Product Medicinal Products Rationale Class within Class

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

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35

HOS-086387 · 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).

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) lead (HOS-085592)

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): lead (HOS-085592) dihydroergotamine (HOS-086152) ergonovine (HOS-086153) ergotamine (HOS-086154) methylergonovine (HOS-086155) cisapride (HOS-085610) quinidine (HOS-085593) fusidic acid (HOS-086146) astemizole (HOS-085608) terfenadine (HOS-085607) colchicine (HOS-086147) lurasidone (HOS-086148) clozapine (HOS-086149) pimozide (HOS-085600) quetiapine (HOS-086150) propoxyphene (HOS-086140) ranolazine (HOS-086141) neratinib (HOS-086142) venetoclax (HOS-086143) amiodarone (HOS-085596) bepridil (HOS-085612) dronedarone (HOS-086144) encainide (HOS-086145) flecainide (HOS-086203) propafenone (HOS-084530)

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 36–37

HOS-086389 · Präparat HOS-083284

36  HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of lovastatin Inhibitors and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (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) simvastatin (HOS-086158)

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 37

HOS-086390 · Präparat HOS-083284

Microsomal Lomitapide Increased plasma concentrations of lomitapide triglyceride transfer (see section 4.5). protein (MTTP) inhibitor PDE5 inhibitor Avanafil Increased plasma concentrations of avanafil (see section 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 section 4.4. and 4.5). Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate, estazolam, flurazepam, diazepam, estazolam, flurazepam, oral oral midazolam and midazolam and triazolam. Thereby, increasing triazolam the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, see section 4.5.). Ritonavir medicinal product level decreased Herbal Preparation 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 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): flurazepam (HOS-086166) midazolam (HOS-086167) triazolam (HOS-086168) lomitapide (HOS-086160) avanafil (HOS-086161) sildenafil (HOS-086162) vardenafil (HOS-086163) clorazepate (HOS-086164) diazepam (HOS-085904) estazolam (HOS-086165)

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 9–10

HOS-086170 · Präparat HOS-083284

Ritonavir has a high affinity for several cytochrome P450 (CYP) isoforms and may inhibit oxidation with the following ranked order: CYP3A4 > CYP2D6. Co-administration of ritonavir and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse effects. For selected 9 medicinal products (e.g. alprazolam) the inhibitory effects of ritonavir on CYP3A4 may decrease over time. Ritonavir also has a high affinity for P-glycoprotein and may inhibit this transporter. The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (e.g. digoxin and fexofenadine-see table “Ritonavir effects on non-antiretroviral medicinal products” below). Ritonavir may induce glucuronidation and oxidation by CYP1A2, CYP2C8, CYP2C9 and CYP2C19 thereby increasing the biotransformation of some medicinal products metabolised by these pathways, and may result in decreased systemic exposure to such medicinal products, which could decease or shorten their therapeutic effect.

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): alprazolam (HOS-086171) protease (HOS-085623) digoxin (HOS-086172)

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 10

HOS-086173 · Präparat HOS-083284

Important information regarding medicinal product interactions when ritonavir is used as a pharmacokinetic enhancer is also contained in the SmPC of the co-administered protease inhibitor.

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): protease (HOS-085623)