Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Viread

Viread 163 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 53–54

HOS-110611 · Präparat HOS-093385

53  Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, Cmin concerning (dose in mg) co-administration with 245 mg tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma (400 mg/100 mg q.d.) + AUC: ↔ concentrations of tenofovir Atazanavir/Ritonavir Cmax: ↔ resulting from (300 mg q.d./100 mg q.d.) + co-administration of tenofovir Emtricitabine/Tenofovir GS-3310072: disoproxil, disoproxil AUC: ↔ sofosbuvir/velpatasvir and (200 mg/245 mg q.d.) Cmax: ↔ atazanavir/ritonavir may Cmin: ↑ 42% increase adverse reactions related to tenofovir disoproxil, Velpatasvir: including renal disorders. The AUC: ↑ 142% safety of tenofovir disoproxil Cmax: ↑ 55% when used with Cmin: ↑ 301% sofosbuvir/velpatasvir and a pharmacokinetic enhancer Atazanavir: (e.g. ritonavir or cobicistat) AUC: ↔ has not been established. Cmax: ↔ Cmin: ↑ 39% The combination should be used with caution with Ritonavir: frequent renal monitoring (see AUC: ↔ section 4.4). Cmax: ↔ Cmin: ↑ 29%

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 204 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 88

HOS-110683 · Präparat HOS-093385

Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, Cmin concerning (dose in mg) co-administration with 245 mg tenofovir disoproxil ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir Atazanavir: No dose adjustment is (300 q.d./100 q.d.) AUC: ↓ 25% recommended. The increased Cmax: ↓ 28% exposure of tenofovir could Cmin: ↓ 26% potentiate tenofovir- Tenofovir: associated adverse events, AUC: ↑ 37% including renal disorders. Cmax: ↑ 34% Renal function should be Cmin: ↑ 29% closely monitored (see section 4.4). Lopinavir/Ritonavir Lopinavir/ritonavir: No dose adjustment is (400 b.i.d./100 b.i.d.) No significant effect on lopinavir/ritonavir recommended. The increased PK parameters. exposure of tenofovir could Tenofovir: potentiate tenofovir- AUC: ↑ 32% associated adverse events, Cmax: ↔ including renal disorders. Cmin: ↑ 51% Renal function should be closely monitored (see section 4.4). Darunavir/Ritonavir Darunavir: No dose adjustment is (300/100 b.i.d.) No significant effect on darunavir/ritonavir recommended. The increased PK parameters. exposure of tenofovir could Tenofovir: potentiate tenofovir- AUC: ↑ 22% associated adverse events, Cmin: ↑ 37% including renal disorders. Renal function should be closely monitored (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): tenofovir (HOS-088083) lopinavir (HOS-086269) atazanavir (HOS-086180) protease (HOS-085623) darunavir (HOS-086181) ritonavir (HOS-084521)

Wechselwirkungen · Viread

Viread 204 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 89–90

HOS-110686 · Präparat HOS-093385

89  Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, Cmin concerning (dose in mg) co-administration with 245 mg tenofovir disoproxil Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma (90 mg/400 mg q.d.) + AUC: ↑ 96% concentrations of tenofovir Atazanavir/Ritonavir Cmax: ↑ 68% resulting from (300 mg q.d./100 mg q.d.) + Cmin: ↑ 118% co-administration of tenofovir Emtricitabine/Tenofovir disoproxil, disoproxil Sofosbuvir: ledipasvir/sofosbuvir and (200 mg/245 mg q.d.)1 AUC: ↔ atazanavir/ritonavir may Cmax: ↔ increase adverse reactions related to tenofovir disoproxil, GS-3310072: including renal disorders. The AUC: ↔ safety of tenofovir disoproxil Cmax: ↔ when used with Cmin: ↑ 42% ledipasvir/sofosbuvir and a pharmacokinetic enhancer Atazanavir: (e.g. ritonavir or cobicistat) AUC: ↔ has not been established. Cmax: ↔ Cmin: ↑ 63% The combination should be used with caution with Ritonavir: frequent renal monitoring, if AUC: ↔ other alternatives are not Cmax: ↔ available (see section 4.4). Cmin: ↑ 45%

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) hepatitis C virus (HOS-108813) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 204 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 93–94

HOS-110701 · Präparat HOS-093385

93  Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, Cmin concerning (dose in mg) co-administration with 245 mg tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma (400 mg/100 mg q.d.) + AUC: ↔ concentrations of tenofovir Atazanavir/Ritonavir Cmax: ↔ resulting from (300 mg q.d./100 mg q.d.) + co-administration of tenofovir Emtricitabine/Tenofovir GS-3310072: disoproxil, disoproxil AUC: ↔ sofosbuvir/velpatasvir and (200 mg/245 mg q.d.) Cmax: ↔ atazanavir/ritonavir may Cmin: ↑ 42% increase adverse reactions related to tenofovir disoproxil, Velpatasvir: including renal disorders. The AUC: ↑ 142% safety of tenofovir disoproxil Cmax: ↑ 55% when used with Cmin: ↑ 301% sofosbuvir/velpatasvir and a pharmacokinetic enhancer Atazanavir: (e.g. ritonavir or cobicistat) AUC: ↔ has not been established. Cmax: ↔ Cmin: ↑ 39% The combination should be used with caution with Ritonavir: frequent renal monitoring (see AUC: ↔ section 4.4). Cmax: ↔ Cmin: ↑ 29%

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 130

HOS-110773 · Präparat HOS-093385

Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, concerning (dose in mg) Cmin co-administration with 245 mg tenofovir disoproxil ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir Atazanavir: No dose adjustment is (300 q.d./100 q.d.) AUC: ↓ 25% recommended. The increased Cmax: ↓ 28% exposure of tenofovir could Cmin: ↓ 26% potentiate Tenofovir: tenofovir-associated adverse AUC: ↑ 37% events, including renal Cmax: ↑ 34% disorders. Renal function Cmin: ↑ 29% should be closely monitored (see section 4.4). Lopinavir/Ritonavir Lopinavir/ritonavir: No dose adjustment is (400 b.i.d./100 b.i.d.) No significant effect on lopinavir/ritonavir recommended. The increased PK parameters. exposure of tenofovir could Tenofovir: potentiate AUC: ↑ 32% tenofovir-associated adverse Cmax: ↔ events, including renal Cmin: ↑ 51% disorders. Renal function should be closely monitored (see section 4.4). Darunavir/Ritonavir Darunavir: No dose adjustment is (300/100 b.i.d.) No significant effect on darunavir/ritonavir recommended. The increased PK parameters. exposure of tenofovir could Tenofovir: potentiate AUC: ↑ 22% tenofovir-associated adverse Cmin: ↑ 37% events, including renal disorders. Renal function should be closely monitored (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): tenofovir (HOS-088083) lopinavir (HOS-086269) atazanavir (HOS-086180) protease (HOS-085623) darunavir (HOS-086181) ritonavir (HOS-084521)

Wechselwirkungen · Viread

Viread 245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 131–132

HOS-110776 · Präparat HOS-093385

131  Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, concerning (dose in mg) Cmin co-administration with 245 mg tenofovir disoproxil Entecavir AUC: ↔ No clinically significant Cmax: ↔ pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir. Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma (90 mg/400 mg q.d.) + AUC: ↑ 96% concentrations of tenofovir Atazanavir/Ritonavir Cmax: ↑ 68% resulting from (300 mg q.d./100 mg q.d.) + Cmin: ↑ 118% co-administration of tenofovir Emtricitabine/Tenofovir disoproxil, disoproxil Sofosbuvir: ledipasvir/sofosbuvir and (200 mg/245 mg q.d.)1 AUC: ↔ atazanavir/ritonavir may Cmax: ↔ increase adverse reactions related to tenofovir disoproxil, GS-3310072: including renal disorders. The AUC: ↔ safety of tenofovir disoproxil Cmax: ↔ when used with Cmin: ↑ 42% ledipasvir/sofosbuvir and a pharmacokinetic enhancer Atazanavir: (e.g. ritonavir or cobicistat) AUC: ↔ has not been established. Cmax: ↔ Cmin: ↑ 63% The combination should be used with caution with Ritonavir: frequent renal monitoring, if AUC: ↔ other alternatives are not Cmax: ↔ available (see section 4.4). Cmin: ↑ 45%

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) entecavir (HOS-088124) hepatitis C virus (HOS-108813) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 135–136

HOS-110792 · Präparat HOS-093385

135  Medicinal product by Effects on drug levels Recommendation therapeutic areas Mean percent change in AUC, Cmax, concerning (dose in mg) Cmin co-administration with 245 mg tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma (400 mg/100 mg q.d.) + AUC: ↔ concentrations of tenofovir Atazanavir/Ritonavir Cmax: ↔ resulting from (300 mg q.d./100 mg q.d.) + co-administration of tenofovir Emtricitabine/Tenofovir GS-3310072: disoproxil, disoproxil AUC: ↔ sofosbuvir/velpatasvir and (200 mg/245 mg q.d.) Cmax: ↔ atazanavir/ritonavir may Cmin: ↑ 42% increase adverse reactions related to tenofovir disoproxil, Velpatasvir: including renal disorders. The AUC: ↑ 142% safety of tenofovir disoproxil Cmax: ↑ 55% when used with Cmin: ↑ 301% sofosbuvir/velpatasvir and a pharmacokinetic enhancer Atazanavir: (e.g. ritonavir or cobicistat) AUC: ↔ has not been established. Cmax: ↔ Cmin: ↑ 39% The combination should be used with caution with Ritonavir: frequent renal monitoring (see AUC: ↔ section 4.4). Cmax: ↔ Cmin: ↑ 29%

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 173

HOS-110864 · Präparat HOS-093385

Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir Atazanavir: No dose adjustment is (300 q.d./100 q.d.) AUC: ↓ 25% recommended. The increased Cmax: ↓ 28% exposure of tenofovir could Cmin: ↓ 26% potentiate tenofovir-associated Tenofovir: adverse events, including renal AUC: ↑ 37% disorders. Renal function should Cmax: ↑ 34% be closely monitored Cmin: ↑ 29% (see section 4.4). Lopinavir/Ritonavir Lopinavir/ritonavir: No dose adjustment is (400 b.i.d./100 b.i.d.) No significant effect on recommended. The increased lopinavir/ritonavir PK exposure of tenofovir could parameters. potentiate tenofovir-associated Tenofovir: adverse events, including renal AUC: ↑ 32% disorders. Renal function should Cmax: ↔ be closely monitored Cmin: ↑ 51% (see section 4.4). Darunavir/Ritonavir Darunavir: No dose adjustment is (300/100 b.i.d.) No significant effect on recommended. The increased darunavir/ritonavir PK exposure of tenofovir could parameters. potentiate tenofovir-associated Tenofovir: adverse events, including renal AUC: ↑ 22% disorders. Renal function should Cmin: ↑ 37% be closely monitored (see section 4.4). NRTIs Didanosine Co-administration of tenofovir Co-administration of tenofovir disoproxil and didanosine results disoproxil and didanosine is not in a 40-60% increase in systemic recommended (see section 4.4). exposure to didanosine. Increased systemic exposure to didanosine may increase didanosine related adverse reactions. Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported. Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine. A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.

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): tenofovir (HOS-088083) lopinavir (HOS-086269) atazanavir (HOS-086180) protease (HOS-085623) didanosine (HOS-085836) darunavir (HOS-086181) ritonavir (HOS-084521)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 173–174

HOS-110865 · Präparat HOS-093385

173  Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Adefovir dipivoxil AUC: ↔ Tenofovir disoproxil should not be Cmax: ↔ administered concurrently with adefovir dipivoxil (see section 4.4). Entecavir AUC: ↔ No clinically significant Cmax: ↔ pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir. Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma concentrations (90 mg/400 mg q.d.) + AUC: ↑ 96% of tenofovir resulting from Atazanavir/Ritonavir Cmax: ↑ 68% co-administration of tenofovir (300 mg q.d./100 mg q.d.) + Cmin: ↑ 118% disoproxil, ledipasvir/sofosbuvir Emtricitabine/Tenofovir disoproxil and atazanavir/ritonavir may (200 mg/245 mg q.d.)1 Sofosbuvir: increase adverse reactions related AUC: ↔ to tenofovir disoproxil, including Cmax: ↔ renal disorders. The safety of tenofovir disoproxil when used GS-3310072: with ledipasvir/sofosbuvir and a AUC: ↔ pharmacokinetic enhancer (e.g. Cmax: ↔ ritonavir or cobicistat) has not Cmin: ↑ 42% been established.

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): tenofovir (HOS-088083) adefovir dipivoxil (HOS-110478) atazanavir (HOS-086180) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) entecavir (HOS-088124) hepatitis C virus (HOS-108813) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 174

HOS-110866 · Präparat HOS-093385

Atazanavir: The combination should be used AUC: ↔ with caution with frequent renal Cmax: ↔ monitoring, if other alternatives Cmin: ↑ 63% are not available (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): atazanavir (HOS-086180)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 177–178

HOS-110883 · Präparat HOS-093385

177  Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma concentrations (400 mg/100 mg q.d.) + AUC: ↔ of tenofovir resulting from Atazanavir/Ritonavir Cmax: ↔ co-administration of tenofovir (300 mg q.d./100 mg q.d.) + disoproxil, sofosbuvir/velpatasvir Emtricitabine/Tenofovir disoproxil GS-3310072: and atazanavir/ritonavir may (200 mg/245 mg q.d.) AUC: ↔ increase adverse reactions related Cmax: ↔ to tenofovir disoproxil, including Cmin: ↑ 42% renal disorders. The safety of tenofovir disoproxil when used Velpatasvir: with sofosbuvir/velpatasvir and a AUC: ↑ 142% pharmacokinetic enhancer (e.g. Cmax: ↑ 55% ritonavir or cobicistat) has not Cmin: ↑ 301% been established.

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): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Wechselwirkungen · Viread

Viread 33 mg/g granules · Abschnitt 4.5 · PDF-Seite 178

HOS-110884 · Präparat HOS-093385

Atazanavir: The combination should be used AUC: ↔ with caution with frequent renal Cmax: ↔ monitoring (see section 4.4). Cmin: ↑ 39%

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): atazanavir (HOS-086180)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112040 · Präparat HOS-093615

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 · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112041 · Präparat HOS-093615

REYATAZ is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2). REYATAZ with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4, and 5.2).

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): ritonavir (HOS-084521)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112042 · Präparat HOS-093615

Co-administration with simvastatin or lovastatin (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 · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112043 · Präparat HOS-093615

Combination of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5). For co-administration of sildenafil for the treatment of erectile dysfunction 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): sildenafil (HOS-086162)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112044 · Präparat HOS-093615

Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), lomitapide, and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (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): quetiapine (HOS-086150) alfuzosin (HOS-086139) methylergonovine (HOS-086155) cisapride (HOS-085610) lomitapide (HOS-086160) bepridil (HOS-085612) quinidine (HOS-085593) ergot alkaloids (HOS-108807) pimozide (HOS-085600) astemizole (HOS-085608) ergotamine (HOS-086154) terfenadine (HOS-085607) lurasidone (HOS-086148) ergonovine (HOS-086153) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112045 · Präparat HOS-093615

Co-administration with medicinal products that are strong inducers of CYP3A4 due to the potential for loss of therapeutic effect and development of possible resistance (e.g., rifampicin, St. John's wort, apalutamide, encorafenib, ivosidenib, carbamazepine, phenobarbital and phenytoin) (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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) apalutamide (HOS-086212) encorafenib (HOS-086222) ivosidenib (HOS-112046) phenytoin (HOS-084531)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112047 · Präparat HOS-093615

Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed-dose combination (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): elbasvir (HOS-108814) grazoprevir (HOS-108815)

Gegenanzeigen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-112048 · Präparat HOS-093615

Co-administration with glecaprevir/pibrentasvir fixed-dose combination (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): pibrentasvir (HOS-086298) glecaprevir (HOS-086297)