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APO-go AMPOULES Solution for Injection or Infusion (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Genus Pharmaceuticals
Διεύθυνση :
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
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Δωρεάν εγγραφή

Name of the medicinal product

APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion.

Qualitative and quantitative composition

1ml contains 10mg apomorphine hydrochloride 2ml contains 20mg apomorphine hydrochloride 5ml contains 50mg apomorphine hydrochloride Excipient: Sodium metabisulphite (E223) 1mg per ml For a full list of ...

Pharmaceutical form

Solution for Injection or Infusion. Clear, colourless or almost colourless, practically free from visible particles pH 3.0-4.0

Therapeutic indications

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

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 ...

Contraindications

In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency. Apomorphine HCl treatment must not be administered to patients who have an on response to levodopa which ...

Special warnings and precautions for use

Apomorphine HCl should be given with caution to patients with renal, pulmonary or cardiovascular disease and persons prone to nausea and vomiting. Extra caution is recommended during initiation of therapy ...

Interaction with other medicinal products and other forms of interaction

Patients selected for treatment with apomorphine HCl are almost certain to be taking concomitant medications for their Parkinsons disease. In the initial stages of apomorphine HCl therapy, the patient ...

Pregnancy and lactation

There is no experience of apomorphine usage in pregnant women. Animal reproduction studies do not indicate any teratogenic effects, but doses given to rats which are toxic to the mother can lead to failure ...

Effects on ability to drive and use machines

Apomorphine HCl has minor or moderate influence on the ability to drive and use machines. Patients being treated with apomorphine and presenting with somnolence and/or sudden sleep episodes must be informed ...

Undesirable effects

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and lymphatic ...

Overdose

There is little clinical experience of overdose with apomorphine by this route of administration. Symptoms of overdose may be treated empirically as suggested below:- Excessive emesis may be treated with ...

Pharmacodynamic properties

Pharmacotherapeutic group: Dopamine agonists ATC Classification: N04B C07 Apomorphine is a direct stimulant of dopamine receptors and while possessing both D1 and D2 receptor agonist properties does not ...

Pharmacokinetic properties

After subcutaneous injection of apomorphine its fate can be described by a two-compartment model, with a distribution half-life of 5 (±1.1) minutes and an elimination half-life of 33 (±3.9) minutes. Clinical ...

Preclinical safety data

Repeat dose subcutaneous toxicity studies reveal no special hazard for humans, beyond the information included in other sections of the SmPC. In vitro genotoxicity studies demonstrated mutagenic and clastogenic ...

List of excipients

Sodium metabisulphite (E223) Hydrochloric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

3 years. Once opened, use immediately. Discard any unused contents.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Type I glass ampoules containing 2ml Solution for Injection or Infusion, in packs of 5 ampoules. Type I glass ampoules containing 5ml Solution for Injection or Infusion, in packs of 5 ampoules. The ampoules ...

Special precautions for disposal and other handling

Do not use if the solution has turned green. The solution should be inspected visually prior to use. Only clear and colourless solutions should be used. For single use only. Any unused solution should ...

Marketing authorization holder

Genus Pharmaceuticals Limited Park View House 65 London Road Newbury Berkshire RG14 1JN United Kingdom

Marketing authorization number(s)

PL 06831/0245 PA 1496/2/1

Date of first authorization / renewal of the authorization

January 2000 / January 2010

Date of revision of the text

May 2012