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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: APO-go AMPOULES 10mg/ml Solution for Injection or Infusion (2012)

Εκδότης

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

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 ...

Pharmaceutical form

Solution for Injection or Infusion. Clear, colourless or almost colourless, practically free from visible ...

Therapeutic indications

Treatment of motor fluctuations (“on-off” phenomena) in patients with Parkinsons disease which are not ...

Posology and method of administration

Selection of Patients suitable for APO-go injections Patients selected for treatment with APO-go should ...

Contraindications

In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency. Apomorphine ...

Special warnings and precautions for use

Apomorphine HCl should be given with caution to patients with renal, pulmonary or cardiovascular disease ...

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 ...

Pregnancy and lactation

There is no experience of apomorphine usage in pregnant women. Animal reproduction studies do not indicate ...

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 ...

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) ...

Overdose

There is little clinical experience of overdose with apomorphine by this route of administration. Symptoms ...

Pharmacodynamic properties

Pharmacotherapeutic group: Dopamine agonists ATC Classification: N04B C07 Apomorphine is a direct stimulant ...

Pharmacokinetic properties

After subcutaneous injection of apomorphine its fate can be described by a two-compartment model, with ...

Preclinical safety data

Repeat dose subcutaneous toxicity studies reveal no special hazard for humans, beyond the information ...

List of excipients

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

Incompatibilities

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

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 ...

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. ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.