APO GO PEN 10 MGML

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

APOMORPHINE HYDROCHLORIDE

Tilgjengelig fra:

TEVA ISRAEL LTD

ATC-kode:

N04BC07

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

APOMORPHINE HYDROCHLORIDE 10 MG/ML

Administreringsrute:

S.C

Resept typen:

Required

Produsert av:

BRITANNIA PHARMACEUTICALS LTD, UK

Terapeutisk gruppe:

APOMORPHINE

Terapeutisk område:

APOMORPHINE

Indikasjoner:

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

Autorisasjon dato:

2022-06-30

Informasjon til brukeren

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Preparatomtale

APO-GO-Pen-SPC-Notification-3-2021-Clean
1
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
APO-go PEN 10 mg/ml Solution for Injection *
* _ ABBREVIATED TO APO-GO_
_®_
_ PEN IN THE TEXT _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg apomorphine hydrochloride.
Each 3 ml PEN contains 30 mg apomorphine hydrochloride.
Excipient(s) with known effect
Sodium bisulphite 0.93 mg per ml.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, practically colourless, odourless and free from
visible particles.
pH = 2.5 to 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
treatment of Parkinson’s
disease (e.g. neurologist). The patient’s treatment with levodopa,
with or without dopamine
agonists, should be optimised before starting A