Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Apomorphine hydrochloride 5 mg/mL
Max Health Limited
Apomorphine hydrochloride 5 mg/mL
5 mg/mL
Solution for infusion
Active: Apomorphine hydrochloride 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium metabisulfite Water for injection
Prescription
Macfarlan Smith Ltd
Apomorphine is indicated to reduce the number and severity of 'off' phases in patients with Parkinson's Disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with Apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during 'on' phases.
Package - Contents - Shelf Life: Vial, glass, Type 1 with bromobutyl rubber stopper and aluminium cap 20 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 7 days opened stored at or below 25°C protect from light
2016-01-06
Page 1 of 12 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Apomorphine, solution for infusion, 5 mg/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL contains 5 mg apomorphine hydrochloride hemihydrate. Each 20 mL vial contains 100 mg apomorphine hydrochloride hemihydrate. Excipients with known effect: Sodium metabisulfite 1 mg per mL Contains sodium 3.3 mg per mL. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear and practically colourless solution, pH 2.6 – 4.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Apomorphine solution for infusion is indicated to reduce the number and severity of ‘off’ phases in patients with Parkinson’s disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ‘on’ phases. 4.2 DOSE AND METHOD OF ADMINISTRATION The optimal dosage of apomorphine solution for infusion has to be determined on an individual patient basis. Hospital admission under appropriate specialist supervision is advised when establishing a patient’s therapeutic regime. It is essential that the patient is established on the antiemetic domperidone for at least 48 - 72 hours prior to initiation of therapy. Apomorphine solution for infusion (5 mg/ mL) is intended for use as a continuous subcutaneous (SC) infusion with suitable pumps/syringe drivers. THERE IS NO NEED TO DILUTE APOMORPHINE SOLUTION FOR INFUSION PRIOR TO USE. Contains no antimicrobial agent. Apomorphine solution for infusion is for single use in one patient only. For microbial reasons, once opened the contents of the container should be used for infusion immediately. The infusion site should be changed every 12 hours. Any unused solution should be discarded. Page 2 of 12 Apomorphine solution for infusion must not be used via the intravenous route. PATIENT SELECTION: For patients in whom conventional therapy has fail Soma hati kamili