Movapo

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Apomorphine hydrochloride hemihydrate 10 mg/mL;  

Предлага се от:

CARSL Consulting

INN (Международно Name):

Apomorphine hydrochloride hemihydrate 10 mg/mL

дозиране:

10 mg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Apomorphine hydrochloride hemihydrate 10 mg/mL   Excipient: Hydrochloric acid Sodium hydroxide Sodium metabisulfite Water for injection

Вид предписание :

Prescription

Произведено от:

Sanofi Chimie

Терапевтични показания:

Latest Regulatory Activity

Каталог на резюме:

Package - Contents - Shelf Life: Ampoule, glass, 5 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Дата Оторизация:

1993-02-08

Данни за продукта

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
MOVAPO
®
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Apomorphine hydrochloride 10 mg/mL injection solution
3 PHARMACEUTICAL FORM
MOVAPO Injection is a clear, colourless or almost colourless sterile
solution for injection,
practically free from visible particles with a pH of 3.0 – 4.0.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
MOVAPO
Injection 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 MOVAPO
Injection 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 MOVAPO
Injection 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.
PATIENT SELECTION
For patients in whom conventional therapy has failed, MOVAPO
Injections
are
only considered
to be suitable for Parkinson’s disease patients capable of
recognising and
anticipating
‘off’
phases in motor performance. Patients must be capable and motivated
for MOVAPO
Injection
to be used effectively. Adult patients through all age ranges have
been successfully managed
with
apomorphine
injections. MOVAPO
Injection
is
not
recommended
in
children
and
adolescents up
to
18 years of
age (see section 4.3).
The elderly are well represented in the population of patients with
Parkinson’s disease and
constitute a high proportion of those studied in clinical trials of
apomorphine. The management
of elderly patients treated with apomorphine has not differed from
that of younger patients,
except
for
the
extra
caution
on
commencing
therapy,
because
of
the
risk
of
postural
hypo