Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 5

HOS-214225 · Präparat HOS-155296

Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 5

HOS-214226 · Präparat HOS-155296

Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 5–6

HOS-214227 · Präparat HOS-155296

5 Table 1: Adverse reactions reported for SANCUSO System Organ Class Adverse reaction Frequency Immune system disorder Hypersensitivity reactions Not known Metabolism and nutrition Decreased appetite Uncommon disorders Nervous system disorders Headache Uncommon Dystonia Rare Dyskinesia Rare Serotonin syndrome Unknown Ear and labyrinth disorders Vertigo Uncommon Vascular disorders Flushing Uncommon Gastrointestinal disorders Constipation Common Dry mouth, nausea, retching Uncommon Hepatobiliary disorders Alanine aminotransferase Uncommon increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased Musculoskeletal and connective Arthralgia Uncommon tissue disorders General disorders and Generalised oedema Uncommon administration site conditions Application site irritation* Uncommon Application site reactions** Unknown * Application site irritation includes: Application site pruritus and Skin irritation (Spontaneous reports) **Application site reactions includes: Application site erythema, Application site rash, Application site pain, Application site hypersensitivity, Application site vesicles, Application site burn, Application site urticaria and Application site discolouration.

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6

HOS-214228 · Präparat HOS-155296

Description of selected adverse reactions Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO.

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6

HOS-214229 · Präparat HOS-155296

Serotonin Syndrome There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Noradrenaline (norepinephrine) Reuptake Inhibitors (SNRIs)). There have also been reports of possible drug-drug interactions between buprenorphine/Opioids and serotonergic medicinal products leading to serotonin syndrome (see section 4.5). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6

HOS-214230 · Präparat HOS-155296

Class effects Class effects for granisetron seen with other formulations (oral and intravenous) include the following:

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6

HOS-214231 · Präparat HOS-155296

- Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6

HOS-214232 · Präparat HOS-155296

Reporting of suspected adverse reactions

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

Nebenwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.8 · PDF-Seite 6–7

HOS-214233 · Präparat HOS-155296

6 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 · Adempas

Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-129049 · Präparat HOS-096659

Riociguat and its main metabolite are strong inhibitors of CYP1A1 in vitro. Therefore, clinically relevant drug-drug interactions with co-treatment which are significantly cleared by CYP1A1-mediated biotransformation, such as erlotinib or granisetron cannot be ruled out.

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): granisetron (HOS-086051) erlotinib (HOS-113527)

Wechselwirkungen · Adempas

Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.5 · PDF-Seite 32

HOS-129089 · Präparat HOS-096659

Riociguat and its main metabolite are strong inhibitors of CYP1A1 in vitro. Therefore, clinically relevant drug-drug interactions with co-treatment which are significantly cleared by CYP1A1-mediated biotransformation, such as erlotinib or granisetron cannot be ruled out.

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): granisetron (HOS-086051) erlotinib (HOS-113527)

Wechselwirkungen · Busulfan Fresenius Kabi

Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 7

HOS-129997 · Präparat HOS-096825

Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4). The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan. No evidence of an induction effect of phenytoin has been seen on busulfan data. A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics. In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin. The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis. No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.

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): granisetron (HOS-086051) lorazepam (HOS-085981) diazepam (HOS-085904) clonazepam (HOS-116372) ondansetron (HOS-086052) phenytoin (HOS-084531)

Wechselwirkungen · Farydak

Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12

HOS-130465 · Präparat HOS-096923

Prolongation of QT interval Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other substances that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil and pimozide) is not recommended. Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (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): sotalol (HOS-085597) methadone (HOS-086198) granisetron (HOS-086051) bepridil (HOS-085612) halofantrine (HOS-085606) quinidine (HOS-085593) tropisetron (HOS-130469) disopyramide (HOS-085595) procainamide (HOS-086617) clarithromycin (HOS-084517) panobinostat (HOS-130447) pimozide (HOS-085600) moxifloxacin (HOS-085604) amiodarone (HOS-085596) dolasetron (HOS-112533) ondansetron (HOS-086052) chloroquine (HOS-109138)