Apomine

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Apomorphine hydrochloride hemihydrate 10 mg/mL;  

Pieejams no:

Pfizer New Zealand Limited

SNN (starptautisko nepatentēto nosaukumu):

Apomorphine hydrochloride hemihydrate 10 mg/mL

Deva:

10 mg/mL

Zāļu forma:

Solution for injection

Kompozīcija:

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

Vienības iepakojumā:

Ampoule, glass, 5 x 1ml, 5 mL

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Sanofi Chimie

Ārstēšanas norādes:

Apomine™ 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 Apomine™ Injection should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during 'on' phases.

Produktu pārskats:

Package - Contents - Shelf Life: Ampoule, glass, 1ml - 5 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorizācija datums:

1993-02-08

Produkta apraksts

Version 5.0
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
Apomine
10 mg/mL
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Apomine™
Injection
is
a
sterile
solution
containing
10
mg/mL
of
apomorphine
hydrochloride.
Sodium
metabisulfite
1
mg/mL
is
included
in
the
formulation
as
an
antioxidant.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Sodium metabisulfite 1 mg/mL
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The pH of the injection is 3.0 to 4.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Apomine™ 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 Apomine™ 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
Apomine™
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
Apomine™
Version 5.0
Page 2 of 10
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
Apomine™ Injection to be used effectively. Adult patients through
all age
ranges
have
been
successfully
managed
with
apomorphine
injections.
Apomine™
Injection is not recommended in
children and adolescents up to 18 years of age.
Elderly patients, in appropriate circumstances, can be successfully
managed with Apomine™
Injection.
The practical steps described below should be follo