APO-GO

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

APOMORPHINE HYDROCHLORIDE

Tilgængelig fra:

ABIC MARKETING LTD, ISRAEL

ATC-kode:

N04BC07

Lægemiddelform:

SOLUTION FOR INJECTION / INFUSION

Sammensætning:

APOMORPHINE HYDROCHLORIDE 10 MG/ML

Indgivelsesvej:

S.C

Recept type:

Required

Fremstillet af:

BRITANNIA PHARMACEUTICALS LTD, UK

Terapeutisk gruppe:

APOMORPHINE

Terapeutisk område:

APOMORPHINE

Terapeutiske indikationer:

Treatment of motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medication.

Autorisation dato:

2023-05-31

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Produktets egenskaber

APO-GO-Ampoules-SPC-Notification-3-2021 - Clean
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion
_ * ABBREVIATED TO _APO-GO_ IN THE TEXT _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg apomorphine hydrochloride
2 ml contains 20 mg apomorphine hydrochloride
5 ml contains 50 mg apomorphine hydrochloride
Excipient(s) with known effect:
Sodium metabisulphite 1mg per ml
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless or almost colourless, practically free from visible
particles.
pH 3.0-4.0.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment
of
motor
fluctuations
(“on-off”
phenomena)
in
patients
with
Parkinson's disease which are not sufficiently controlled by oral
anti-Parkinson
medication.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Selection of patients suitable for APO-go injections: _
Patients selected for treatment with APO-go should be able to
recognise the
onset of their ‘off’ symptoms and be capable of injecting
themselves or else
have a responsible carer able to inject for them when required.
Patients treated with apomorphine will usually need to start
domperidone at least two
days prior to initiation of therapy. The domperidone dose should be
titrated to the
lowest effective dose and discontinued as soon as possible.
Before the decision to initiate domperidone and apomorphine treatment,
risk
factors
for QT
interval prolongation
in
the
individual patient should be
carefully assessed to ensure that the benefit outweighs the risk (see
Section
4.4).
Refer to the domperidone prescribing information for recommended
domperidone
dosage information.
Apomorphine should be initiated in the controlled environment of a
specialist
clinic. The patient should be supervised by a physician experienced in
the
APO-GO-Ampoules-SPC-Notification-3-2021 - Clean
2
treatment
of
Parkinson’s
disease (e.g., neurologist). The patient’s tre