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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

BOTOX Powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

BOTOX 100 Allergan Units. Powder for solution for injection.

Qualitative and quantitative composition

Botulinum toxin* type A, 100 Allergan Units/vial. * from Clostridium botulinum Botulinum toxin units are not interchangeable from one product to another. For a full list of excipients, see section 6.1. ...

Pharmaceutical form

Powder for solution for injection. BOTOX product appears as a thin white deposit that may be difficult to see on the base of the vial.

Therapeutic indications

BOTOX is indicated for: Neurologic disorders: treatment of focal spasticity, including:dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age ...

Posology and method of administration

Posology Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan Units are different from other botulinum toxin preparations. Elderly patients Dosages for ...

Contraindications

known hypersensitivity to botulinum toxin type A or to any of the excipients listed in section 6.1; presence of infection at the proposed injection site(s). For the management of bladder disorders: urinary ...

Special warnings and precautions for use

The recommended dosages and frequencies of administration of BOTOX should not be exceeded due to the potential for overdose, exaggerated muscle weakness, distant spread of toxin and the formation of neutralising ...

Interaction with other medicinal products and other forms of interaction

Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics or spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of botulinum toxin type A in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3). The potential risk for humans is unknown. ...

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 may cause asthenia, muscle weakness, somnolence, dizziness and visual disturbance, which could affect ...

Undesirable effects

General In controlled clinical trials adverse events considered by the investigators to be related to BOTOX were reported in 35% of the patients with blepharospasm, 28% with cervical dystonia, 17% with ...

Overdose

Overdose of BOTOX is a relative term and depends upon dose, site of injection, and underlying tissue properties. No cases of systemic toxicity resulting from accidental injection of BOTOX have been observed. ...

Pharmacodynamic properties

ATC class: M03AX01 and D11AX The active constituent in BOTOX is a protein complex derived from Clostridium botulinum. The protein consists of type A neurotoxin and several other proteins. Under physiological ...

Pharmacokinetic properties

General characteristics of the active substance Classical absorption, distribution, biotransformation and elimination studies on the active substance have not been performed due to the extreme toxicity ...

Preclinical safety data

Non-clinical data based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity reveal no special hazard for humans other than exaggerated pharmacological effects predictable ...

List of excipients

Human albumin Sodium chloride

Incompatibilities

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

Shelf life

Shelf life: 3 years. After reconstitution, stability has been demonstrated for 24 hours at 2°C–8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...

Special precautions for storage

Store in a refrigerator (2°C-8°C), or store in a freezer (-5°C to -20°C). For storage conditions of the reconstituted medicinal product see section 6.3.

Nature and contents of container

Clear glass vial, with rubber stopper and tamper-proof aluminium seal, containing white powder for solution for injection. Pack size: Carton comprising one 100 Allergan Unit vial and package leaflet. ...

Special precautions for disposal and other handling

Reconstitution BOTOX is reconstituted prior to use with sterile unpreserved normal saline (0.9% sodium chloride for injection). It is good practice to perform vial reconstitution and syringe preparation ...

Marketing authorization holder

Allergan Limited, Marlow International, The Parkway, Marlow, Bucks SL7 1YL, UK

Marketing authorization number(s)

PL 00426/0074

Date of first authorization / renewal of the authorization

17 May 1994

Date of revision of the text

07/03/2019

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