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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: BOTOX 50 Units (2012)

Εκδότης

Εκδότης Allergan Ltd
Διεύθυνση Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
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Περιεχόμενα

Name of the medicinal product

BOTOX. 50 Allergan Units. Powder for solution for injection.

Qualitative and quantitative composition

Botulinum toxin* type A, 50 Allergan units/vial. * from Clostridium botulinum Botulinum toxin units are ...

Pharmaceutical form

Powder for solution for injection.

Therapeutic indications

BOTOX is indicated for: the symptomatic relief of blepharospasm, hemifacial spasm and idiopathic cervical ...

Posology and method of administration

Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan ...

Contraindications

Known hypersensitivity to botulinum toxin type A or to any of the excipients; Presence of infection at ...

Special warnings and precautions for use

The relevant anatomy, and any alterations to the anatomy due to prior surgical procedures, must be understood ...

Interaction with other medicinal products and other forms of interaction

Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics or spectinomycin, ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of botulinum toxin type A in pregnant women. Studies ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, BOTOX ...

Undesirable effects

a) General Based on controlled clinical trial data patients would be expected to experience an adverse ...

Overdose

Overdose of BOTOX is a relative term and depends upon dose, site of injection, and underlying tissue ...

Pharmacodynamic properties

ATC class M03AX01 and ATC class D11AX. The active constituent in BOTOX is a protein complex derived from ...

Pharmacokinetic properties

a) General characteristics of the active substance Classical absorption, distribution, biotransformation ...

Preclinical safety data

Non-clinical data based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity ...

List of excipients

Human albumin Sodium chloride

Incompatibilities

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

Shelf life

3 years. After reconstitution, stability has been demonstrated for 24 hours at 2°C – 8°C. From a microbiological ...

Special precautions for storage

Store in a refrigerator (2°C-8°C), or store in a freezer (at or below -5°C). For storage conditions of ...

Nature and contents of container

Clear glass vial, with rubber stopper and tamper-proof aluminium seal, containing white powder for solution ...

Special precautions for disposal and other handling

Reconstitution BOTOX is reconstituted prior to use with sterile 9 mg/ml (0.9%) preservative-free sodium ...

Marketing authorization holder

Allergan Ltd. Marlow International The Parkway, Marlow Bucks, SL7 1YL UK

Marketing authorization number(s)

PL 00426/0118

Date of first authorization / renewal of the authorization

21/09/2007

Date of revision of the text

24/09/2012
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.