Apomorphine

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Apomorphine hydrochloride 5 mg/mL

Dostupné z:

Max Health Limited

INN (Medzinárodný Name):

Apomorphine hydrochloride 5 mg/mL

Dávkovanie:

5 mg/mL

Forma lieku:

Solution for infusion

Zloženie:

Active: Apomorphine hydrochloride 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium metabisulfite Water for injection

Typ predpisu:

Prescription

Výrobca:

Macfarlan Smith Ltd

Terapeutické indikácie:

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.

Prehľad produktov:

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

Dátum Autorizácia:

2016-01-06

Súhrn charakteristických

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