Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 15

HOS-086232 · Präparat HOS-083284

Anticoagulants Dabigatran etexilate Serum concentrations may be increased due to P-gp inhibition by ritonavir. Clinical Edoxaban monitoring and/or dose reduction of the direct oral anticoagulants (DOAC) should be considered when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with 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): edoxaban (HOS-086234) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 47

HOS-086430 · Präparat HOS-083284

Anticoagulants Dabigatran etexilate Serum concentrations may be increased due to P-gp inhibition by ritonavir. Clinical Edoxaban monitoring and/or dose reduction of the direct oral anticoagulants (DOAC) should be considered when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with 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): edoxaban (HOS-086234) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 15–16

HOS-108886 · Präparat HOS-093083

15 Dabigatran etexilate, Dabigatran etexilate, Clinical monitoring and/or dose Edoxaban Edoxaban: reduction of the direct oral Serum concentrations may be anticoagulants (DOAC) should be increased due to P-gp inhibition considered when a DOAC by lopinavir/ritonavir. transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with Kaletra. Anticonvulsants Phenytoin Phenytoin: Caution should be exercised in Steady-state concentrations was administering phenytoin with moderately decreased due to Kaletra. CYP2C9 and CYP2C19 induction by lopinavir/ritonavir. Phenytoin levels should be monitored when co-administering Lopinavir: with Kaletra. Concentrations are decreased due to CYP3A induction by When co-administered with phenytoin. phenytoin, an increase of Kaletra dosage may be envisaged. Dose adjustment has not been evaluated in clinical practice. Carbamazepine and Carbamazepine: Caution should be exercised in Phenobarbital Serum concentrations may be administering carbamazepine or increased due to CYP3A phenobarbital with Kaletra. inhibition by lopinavir/ritonavir. Carbamazepine and phenobarbital Lopinavir: levels should be monitored when Concentrations may be decreased co-administering with Kaletra. due to CYP3A induction by carbamazepine and phenobarbital. When co-administered with carbamazepine or phenobarbital, an increase of Kaletra dosage may be envisaged. Dose adjustment has not been evaluated in clinical practice

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) edoxaban (HOS-086234) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 52

HOS-109010 · Präparat HOS-093083

For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions). Patients should be closely monitored for signs related to venetoclax toxicities. Anticoagulants Warfarin Warfarin: It is recommended that INR Concentrations may be affected (international normalised ratio) be when co-administered with monitored. lopinavir/ritonavir due to CYP2C9 induction. Rivaroxaban Rivaroxaban: Co-administration of rivaroxaban and AUC: ↑ 153% Kaletra may increase rivaroxaban (Ritonavir 600 mg twice Cmax: ↑ 55% exposure which may increase the risk daily) Due to CYP3A and P-gp of bleeding. inhibition by lopinavir/ritonavir. The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4). Dabigatran etexilate, Dabigatran etexilate, Clinical monitoring and/or dose Edoxaban Edoxaban: reduction of the direct oral Serum concentrations may be anticoagulants (DOAC) should be increased due to Pgp inhibition by considered when a DOAC lopinavir/ritonavir. transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with Kaletra. Anticonvulsants Phenytoin Phenytoin: Caution should be exercised in Steady-state concentrations was administering phenytoin with Kaletra. moderately decreased due to Phenytoin levels should be monitored CYP2C9 and CYP2C19 induction when co-administering with Kaletra. by lopinavir/ritonavir. When co-administered with phenytoin, an increase of Kaletra Lopinavir: dosage may be envisaged. Dose Concentrations are decreased due adjustment has not been evaluated in to CYP3A induction by clinical practice. phenytoin.

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): venetoclax (HOS-086143) rivaroxaban (HOS-086236) edoxaban (HOS-086234) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531) warfarin (HOS-085950)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 87–88

HOS-109085 · Präparat HOS-093083

87 Rivaroxaban Rivaroxaban: Co-administration of rivaroxaban AUC: ↑ 153% and Kaletra may increase (Ritonavir 600 mg twice Cmax: ↑ 55% rivaroxaban exposure which may daily) Due to CYP3A and P-gp increase the risk of bleeding. inhibition by lopinavir/ritonavir. The use of rivaroxaban is not recommended in patients receiving concomitant treatment with Kaletra (see section 4.4). Dabigatran etexilate, Dabigatran etexilate, Clinical monitoring and/or dose Edoxaban Edoxaban: reduction of the direct oral Serum concentrations may be anticoagulants (DOAC) should be increased due to Pgp inhibition by considered when a DOAC lopinavir/ritonavir. transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with Kaletra. Anticonvulsants Phenytoin Phenytoin: Caution should be exercised in Steady-state concentrations was administering phenytoin with moderately decreased due to Kaletra. CYP2C9 and CYP2C19 induction Phenytoin levels should be by lopinavir/ritonavir. monitored when co-administering with Kaletra. Lopinavir: When co-administered with Concentrations are decreased due phenytoin, an increase of Kaletra to CYP3A induction by dosage may be envisaged. Dose phenytoin. adjustment has not been evaluated in clinical practice. Kaletra must not be administered once daily in combination with phenytoin. Carbamazepine and Carbamazepine: Caution should be exercised in Phenobarbital Serum concentrations may be administering carbamazepine or increased due to CYP3A phenobarbital with Kaletra. inhibition by lopinavir/ritonavir. Carbamazepine and phenobarbital levels should be monitored when Lopinavir: co-administering with Kaletra. Concentrations may be decreased When co-administered with due to CYP3A induction by carbamazepine or phenobarbital, an carbamazepine and phenobarbital. increase of Kaletra dosage may be envisaged. Dose adjustment has not been evaluated in clinical practice. Kaletra must not be administered once daily in combination with carbamazepine and phenobarbital. Lamotrigine and Lamotrigine: Patients should be monitored Valproate AUC: ↓ 50% closely for a decreased VPA effect Cmax: ↓ 46% when Kaletra and valproic acid or Cmin: ↓ 56% valproate are given concomitantly.

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): lamotrigine (HOS-086242) valproate (HOS-085955) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) rivaroxaban (HOS-086236) edoxaban (HOS-086234) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 10–11

HOS-116330 · Präparat HOS-094447

10 Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).

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): digoxin (HOS-086172) ritonavir (HOS-084521) bosentan (HOS-086291) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 15–16

HOS-116363 · Präparat HOS-094447

15 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. Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir: Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose dose: reduction of the DOAC should be dabigatran AUC ↑ 72% considered when a DOAC dabigatran Cmax ↑ 64% transported by P-gp but not metabolised by CYP3A4, darunavir/ritonavir 800/100 mg once including dabigatran etexilate and daily: edoxaban, is co-administered with dabigatran AUC ↑ 18% PREZISTA/rtv. dabigatran Cmax ↑ 22% Darunavir/cobicistat: darunavir/cobicistat 800/150 mg single Clinical monitoring and dose dose: reduction is required when a dabigatran AUC ↑ 164% DOAC transported by P-gp but not dabigatran Cmax ↑ 164% metabolised by CYP3A4, including dabigatran etexilate and darunavir/cobicistat 800/150 mg once edoxaban, is co-administered with daily: PREZISTA/cobi. dabigatran AUC ↑ 88% dabigatran Cmax ↑ 99% Ticagrelor Concomitant administration of Based on theoretical considerations, boosted PREZISTA with ticagrelor co-administration of boosted PREZISTA is contraindicated (see section 4.3). with ticagrelor may increase concentrations of ticagrelor (CYP3A and/or P-glycoprotein inhibition). Clopidogrel Co-administration of clopidogrel Not studied. Co-administration of with boosted PREZISTA is not clopidogrel with boosted PREZISTA is recommended. Use of other expected to decrease clopidogrel active antiplatelets not affected by CYP metabolite plasma concentration, which inhibition or induction (e.g. may reduce the antiplatelet activity of prasugrel) is recommended. clopidogrel. Warfarin Not studied. Warfarin concentrations may It is recommended that the be affected when co-administered with international normalised ratio boosted PREZISTA. (INR) be monitored when warfarin is combined with boosted PREZISTA.

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): ticagrelor (HOS-112065) cobicistat (HOS-088111) dabigatran (HOS-112096) rivaroxaban (HOS-086236) lead (HOS-085592) clopidogrel (HOS-087927) clarithromycin (HOS-084517) edoxaban (HOS-086234) apixaban (HOS-112091) prasugrel (HOS-112066) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233) warfarin (HOS-085950)

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 53

HOS-116505 · Präparat HOS-094447

Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).

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): digoxin (HOS-086172) ritonavir (HOS-084521) bosentan (HOS-086291) dabigatran etexilate (HOS-086233)

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 57–58

HOS-116518 · Präparat HOS-094447

57  Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir: Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose dose: reduction of the DOAC should be dabigatran AUC ↑ 72% considered when a DOAC dabigatran Cmax ↑ 64% transported by P-gp but not metabolised by CYP3A4, darunavir/ritonavir 800/100 mg once including dabigatran etexilate and daily: edoxaban, is co-administered with dabigatran AUC ↑ 18% PREZISTA/rtv. dabigatran Cmax ↑ 22%

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): dabigatran (HOS-112096) edoxaban (HOS-086234) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 92

HOS-116593 · Präparat HOS-094447

Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).

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): digoxin (HOS-086172) ritonavir (HOS-084521) bosentan (HOS-086291) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 97–98

HOS-116609 · Präparat HOS-094447

97  Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir: Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose dose: reduction of the DOAC should be dabigatran AUC ↑ 72% considered when a DOAC dabigatran Cmax ↑ 64% transported by P-gp but not metabolised by CYP3A4, darunavir/ritonavir 800/100 mg once including dabigatran etexilate and daily: edoxaban, is co-administered with dabigatran AUC ↑ 18% PREZISTA/rtv. dabigatran Cmax ↑ 22% Darunavir/cobicistat: darunavir/cobicistat 800/150 mg single Clinical monitoring and dose dose: reduction is required when a dabigatran AUC ↑ 164% DOAC transported by P-gp but not dabigatran Cmax ↑ 164% metabolised by CYP3A4, including dabigatran etexilate and darunavir/cobicistat 800/150 mg once edoxaban, is co-administered with daily: PREZISTA/cobi. dabigatran AUC ↑ 88% dabigatran Cmax ↑ 99% Ticagrelor Based on theoretical considerations, Concomitant administration of co-administration of boosted PREZISTA boosted PREZISTA with ticagrelor with ticagrelor may increase is contraindicated (see section 4.3). concentrations of ticagrelor (CYP3A and/or P-glycoprotein inhibition). Clopidogrel Not studied. Co-administration of Co-administration of clopidogrel clopidogrel with boosted PREZISTA is with boosted PREZISTA is not expected to decrease clopidogrel active recommended. Use of other metabolite plasma concentration, which antiplatelets not affected by CYP may reduce the antiplatelet activity of inhibition or induction (e.g. clopidogrel prasugrel) is recommended. Warfarin Not studied. Warfarin concentrations may It is recommended that the be affected when co-administered with international normalised ratio boosted PREZISTA. (INR) be monitored when warfarin is combined with boosted PREZISTA. ANTICONVULSANTS Phenobarbital Not studied. Phenobarbital and phenytoin PREZISTA co-administered with Phenytoin are expected to decrease plasma low dose ritonavir should not be concentrations of darunavir and its used in combination with these pharmacoenhancer. medicines. (induction of CYP450 enzymes) The use of these medicines with PREZISTA/cobicistat is 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): ticagrelor (HOS-112065) phenobarbital (HOS-085617) cobicistat (HOS-088111) dabigatran (HOS-112096) clopidogrel (HOS-087927) edoxaban (HOS-086234) prasugrel (HOS-112066) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531) warfarin (HOS-085950)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-118455 · Präparat HOS-094825

Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors. In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2). Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc. In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics. Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM). However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo. It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.

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) trimethoprim (HOS-085184) digoxin (HOS-086172) lamivudine (HOS-085829) zidovudine (HOS-085837) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Celsentri

CELSENTRI 20 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 34

HOS-118500 · Präparat HOS-094825

Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors. In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2). Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc. In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics. Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM). However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo. It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.

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) trimethoprim (HOS-085184) digoxin (HOS-086172) lamivudine (HOS-085829) zidovudine (HOS-085837) dabigatran etexilate (HOS-086233)

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)

Gegenanzeigen · Pradaxa

Pradaxa 110 mg hard capsules · Abschnitt 4.3 · PDF-Seite 38

HOS-118700 · 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

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

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)

Gegenanzeigen · Pradaxa

Pradaxa 150 mg hard capsules · Abschnitt 4.3 · PDF-Seite 78

HOS-118788 · 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

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

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)

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

HOS-118874 · Präparat HOS-094855

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • 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

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

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)