GRANTRYL Solution for injection Ref.[51215] Active ingredients: Granisetron

As GRANTRYL may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of GRANTRYL. The maximum dose of GRANTRYL to be administered over 24 hours should not exceed 9 mg (120 µg/kg).

GRANTRYL may be associated with dysrhythmias or ECG abnormalities. This may have clinical significance in patients with pre-existing dysrhythmias or cardiac conduction disorders and/or patients with concomitant electrolyte disturbances, or in patients who are being treated with antidysrhythmic medicines, beta-blockers and medicines that prolong the QT-interval.

Cases of myocardial ischemia have been reported in patients treated with granisetron. In some patients, especially in the case of intravenous administration, symptoms appeared immediately after administration of granisetron. Patients should be alerted to the signs and symptoms of myocardial ischaemia.

Hepatic enzyme induction with phenobarbital resulted in an increase in total plasma clearance of intravenous GRANTRYL of approximately one-quarter. GRANTRYL may be coadministered with benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with anti-emetic treatments. No apparent interaction with emetogenic cancer chemotherapies has been shown. No specific interaction studies have been conducted in anaesthetised patients, but GRANTRYL may be administered with commonly used anaesthetic and analgesic agents. In addition, in vitro human microsomal studies have shown that the cytochrome P450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by granisetron.

The use of GRANTRYL during pregnancy and lactation is contra-indicated as safety and efficacy have not been established (see CONTRA-INDICATIONS)

GRANTRYL may cause somnolence and transient visual disturbances. Patients should be advised not to drive or handle machinery if these side effects occur.

The following side effects may occur with use of GRANTRYL:

Infections and infestations

Frequency not known: Infection, urinary tract infection

Blood and lymphatic system disorders

Frequency not known: Anaemia, leukocytosis

Immune system disorders

Less frequent: Hypersensitivity reactions, including skin rashes and anaphylaxis.

Psychiatric disorders

Less frequent: Anxiety, insomnia, somnolence.

Nervous system disorders

Less frequent: Headache, dizziness, seizures, oculogyric crisis.

Eye disorders

Frequency not known: Transient visual disturbances such as blurred vision.

Cardiac disorders

Less frequent: Angina pectoris, dysrhythmias, atrial fibrillation, chest pain, fainting, tachycardia, bradycardia, ECG abnormalities, QTprolongation.

Frequency unknown: myocardial ischemia (see section 4.4)

Vascular disorders

Less frequent: Hypertension, hypotension, flushes.

Gastrointestinal disorders

Frequent: Abdominal pain, constipation, diarrhoea, hiccups

Less frequent: Dyspepsia, unusual taste in mouth.

Musculoskeletal disorders

Frequency not known: Dystonia and dyskinesia

Hepato-biliary disorders

Less frequent: A rise in hepatic transaminases.

General disorders and administration site disorders

Frequent: Asthenia/fatigue

Less frequent: Fever, injection site reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care provders are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8

Acino Pharma (Pty) Ltd: E-mail: drugsafety_za@acino.swiss Tel: 060 998 7896

By reporting side effects, you can help provide more information on the safety of GRANTRYL.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.