Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-118189 · Präparat HOS-094775

Metabolism and nutrition anorexia Common disorders Psychiatric disorders insomnia Common Nervous system disorders headache, dizziness, dysgeusia Very common Cardiac disorders tachycardia Very common palpitations Common Vascular disorders flushing, hypotension Very common Respiratory, thoracic, and cough, dyspnoea Very common mediastinal disorders

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-118190 · Präparat HOS-094775

nasal congestion Common Gastrointestinal disorders nausea, dyspepsia, diarrhoea Very common vomiting, abdominal pain Common upper, dry mouth, gastritis, abdominal distention Skin and subcutaneous tissue rash Very common disorders erythema, hyperhidrosis, night Common sweats, pruritus Musculoskeletal and arthralgia, myalgia Very common connective tissue disorders pain in extremity, back pain Common General disorders and injection site granuloma, Very common administration site conditions fatigue, pyrexia, injection site erythema, feeling hot, injection site reaction, injection site pruritus, influenza like illness, chills, injection site inflammation, injection site pain injection site urticaria, injection Common site bruising, injection site rash, injection site swelling, asthenia, chest pain

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-118191 · Präparat HOS-094775

8 Other oncology (advanced tumour) studies

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-118192 · Präparat HOS-094775

Ceplene and low dose IL-2 have been investigated in other clinical studies at different doses (1 mg histamine dihydrochloride twice a day) and with different dose regimens of low-dose IL-2 and interferon-alfa. The following adverse reactions, not listed above, were at least possibly related to the study medicine:

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-118193 · Präparat HOS-094775

System organ class Adverse reaction Frequency Blood and lymphatic system anaemia Common disorders Endocrine disorders hypothyroidism Common Metabolism and nutrition decreased appetite Very common disorders dehydration Common Psychiatric disorders anxiety Very common depression Common Nervous system disorders paraesthesia Common Ear and labyrinth disorders vertigo Common Vascular disorders hot flush Common Respiratory, thoracic, and wheezing Common mediastinal disorders Gastrointestinal disorders constipation, abdominal Common distention, stomatitis Skin and subcutaneous tissue dry skin Very common disorders General disorders and malaise, oedema peripheral Very common administration site conditions injection site fibrosis, pain Common Investigations weight decreased Very common

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-118194 · Präparat HOS-094775

Reporting of suspected adverse reactions

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

Nebenwirkungen · Ceplene

Ceplene 0.5 mg/0.5 mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-118195 · Präparat HOS-094775

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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

Wechselwirkungen · Ibandronic Acid Teva

Ibandronic Acid Teva 150 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 17

HOS-212588 · Präparat HOS-154930

H2 blockers or proton pump inhibitors Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively. Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): histamine (HOS-088516)

Wechselwirkungen · Triumeq

Triumeq 50 mg/600 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-129263 · Präparat HOS-096703

11 Antimycobacterials Rifampicin/Dolutegravir Dolutegravir ↓ The dose of dolutegravir is 50 mg twice AUC ↓ 54% daily when co-administered with Cmax ↓ 43% rifampicin. As Triumeq is a fixed dose Cτ ↓ 72% tablet, an additional 50 mg tablet of (induction of UGT1A1 dolutegravir should be administered, and CYP3A enzymes) approximately 12 hours after Triumeq for the duration of the rifampicin co- administration (a separate preparation of dolutegravir is available for this dose adjustment, see section 4.2). Rifabutin Dolutegravir ↔ No dose adjustment is necessary. AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes) Anticonvulsants Carbamazepine/Dolutegravir Dolutegravir ↓ The recommended dose of dolutegravir AUC ↓ 49% is 50 mg twice daily when co- Cmax ↓ 33% administered with carbamazepine. As Cτ ↓ 73% Triumeq is a fixed dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Triumeq for the duration of the carbamazepine co-administration (a separate preparation of dolutegravir is available for this dose adjustment, see section 4.2). Phenobarbital/Dolutegravir Dolutegravir↓ The recommended dose of dolutegravir Phenytoin/Dolutegravir (Not studied, decrease is 50 mg twice daily when co- Oxcarbazepine/Dolutegravir expected due to induction administered with these metabolic of UGT1A1 and CYP3A inducers. As Triumeq is a fixed dose enzymes, a similar tablet, an additional 50 mg tablet of reduction in exposure as dolutegravir should be administered, observed with approximately 12 hours after Triumeq carbamazepine is for the duration of the co-administration expected) with these metabolic inducers (a separate preparation of dolutegravir is available for this dose adjustment, see section 4.2). Antihistamines (histamine H2 receptor antagonists) Ranitidine Interaction not studied. No dose adjustment necessary.

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) rifabutin (HOS-086262) histamine (HOS-088516) ranitidine (HOS-085660) oxcarbazepine (HOS-110224) phenytoin (HOS-084531)

Wechselwirkungen · Triumeq

Triumeq 5 mg/60 mg/30 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 49

HOS-129358 · Präparat HOS-096703

Phenobarbital/Dolutegravir Dolutegravir↓ The recommended dose of dolutegravir Phenytoin/Dolutegravir (Not studied, decrease should be adjusted when co- Oxcarbazepine/Dolutegravir expected due to induction administered with these metabolic of UGT1A1 and CYP3A inducers. enzymes, a similar reduction in exposure as Dosing recommendations are provided observed with in Table 2 (see section 4.2) carbamazepine is expected) Antihistamines (histamine H2 receptor antagonists) Ranitidine Interaction not studied. No dose adjustment necessary.

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) histamine (HOS-088516) ranitidine (HOS-085660) oxcarbazepine (HOS-110224) phenytoin (HOS-084531)

Wechselwirkungen · Talzenna

Talzenna 0.1 mg hard capsules Talzenna 0.25 mg hard capsules Talzenna 0.35 mg hard capsules Talzenna 0.5 mg hard capsules Talzenna 1 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-140581 · Präparat HOS-098546

Effect of acid-reducing agents Population PK analysis indicates that co-administration of acid-reducing agents including proton pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid-reducing agents had no significant impact on the absorption of talazoparib.

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): histamine (HOS-088516)

Wechselwirkungen · Dovato

Dovato 50 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-142836 · Präparat HOS-098886

(organic cation transporter inhibition) Antimycobacterials Rifampicin/Dolutegravir Dolutegravir  The recommended dose of dolutegravir AUC  54% is 50 mg twice daily when Cmax  43% co-administered with rifampicin. As C  72% Dovato is a fixed-dose tablet, an (induction of UGT1A1 additional 50 mg tablet of dolutegravir and CYP3A enzymes) should be administered, approximately 12 hours after Dovato for the duration of the rifampicin co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2). Rifabutin/Dolutegravir Dolutegravir  No dose adjustment is necessary. AUC  5% Cmax  16% Cτ  30% (induction of UGT1A1 and CYP3A enzymes) Anticonvulsants Carbamazepine/Dolutegravir Dolutegravir  The recommended dose of dolutegravir AUC  49% is 50 mg twice daily when Cmax  33% co-administered with these metabolic C  73% inducers. As Dovato is a fixed-dose tablet, an additional 50 mg tablet of Phenobarbital/Dolutegravir Dolutegravir  dolutegravir should be administered, Phenytoin/Dolutegravir (Not studied, decrease approximately 12 hours after Dovato for Oxcarbazepine/Dolutegravir expected due to induction the duration of the co-administration of UGT1A1 and CYP3A with these metabolic inducers (a separate enzymes, a similar formulation of dolutegravir is available reduction in exposure as for this dose adjustment, see section observed with 4.2). carbamazepine is expected). Antihistamines (histamine H2 receptor antagonists) Ranitidine Interaction not studied. No dosage adjustment necessary.

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) rifabutin (HOS-086262) histamine (HOS-088516) ranitidine (HOS-085660) oxcarbazepine (HOS-110224) phenytoin (HOS-084531)

Wechselwirkungen · Ozawade

Ozawade 4.5 mg film-coated tablets Ozawade 18 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-144403 · Präparat HOS-099178

Tri or tetracyclic antidepressants with anti-histaminic H1-receptor properties (e.g. imipramine, clomipramine, mirtazapine) may impair the efficacy of pitolisant because they may decrease the effect of endogenous histamine released in brain by the treatment and alternative should be used.

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): imipramine (HOS-085907) histamine (HOS-088516) clomipramine (HOS-085906) mirtazapine (HOS-144406)