NEUROBLOC Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
NeuroBloc 5000 U/ml solution for injection.
2. Qualitative and quantitative composition
Each ml contains 5000 U Botulinum Toxin Type B. Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B. Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B. Each 2.0 ml vial contains 10,000 U Botulinum ...
3. Pharmaceutical form
Solution for injection. Clear and colourless to light yellow solution.
4.1. Therapeutic indications
NeuroBloc is indicated for the treatment of cervical dystonia (torticollis) in adults.
4.2. Posology and method of administration
NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins. Restricted to hospital use only. Posology ...
4.3. Contraindications
Individuals with known neuromuscular diseases (e.g. amyotrophic lateral sclerosis or peripheral neuropathy) or known neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome) ...
4.4. Special warnings and precautions for use
NeuroBloc is recommended for intramuscular administration only. The safety of NeuroBloc outside the approved indication has not been established. This warning includes use in children and in any other ...
4.5. Interaction with other medicinal products and other forms of interaction
The effect of administering different botulinum neurotoxin serotypes concurrently is unknown. However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type ...
4.6. Fertility, pregnancy and lactation
Pregnancy Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development. The potential risk for humans is unknown. NeuroBloc should not be used during ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Neurobloc may impair the ability to drive or operate machinery in case of adverse reactions such as muscle weakness ...
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions associated with NeuroBloc treatment were dry mouth, dysphagia, dyspepsia, and injection site pain. Adverse reactions related to ...
4.9. Overdose
Cases of overdose (some with signs of systemic toxicity) have been reported. In the event of an overdose, general medical supportive measures should be instituted. Doses of up to 15,000 U have infrequently ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> muscle relaxant, peripherally acting agents <b>ATC code:</b> M03AX01 Mechanism of action NeuroBloc is a neuromuscular blocking agent. The mechanism of action of NeuroBloc ...
5.2. Pharmacokinetic properties
NeuroBloc injected intramuscularly produces localised muscle weakness by chemical denervation. Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic ...
5.3. Preclinical safety data
Single dose pharmacology studies in cynomolgus monkeys have shown no effects other than the anticipated dose-dependent paralysis of injected muscles, together with some diffusion of toxin at high doses ...
6.1. List of excipients
Disodium succinate Sodium chloride Human serum albumin Hydrochloric acid (for pH adjustment) Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
5 years, as packaged for sale. Use immediately if diluted (see section 4.2 and section 6.6). From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial ...
6.4. Special precautions for storage
Store in a refrigerator at 2°C-8°C. Do not freeze. Keep the container in the outer carton in order to protect from light. Within its shelf-life, the product may be removed from the refrigerator for a single ...
6.5. Nature and contents of container
0.5 ml, 1 ml or 2 ml solution in a 3.5 ml Type I glass vial, with siliconised butyl rubber stoppers oversealed by aluminium crimped caps. Pack size of 1.
6.6. Special precautions for disposal and other handling
NeuroBloc is provided in vials for single use only. The medicinal product is ready to use and no reconstitution is required. Do not shake. To allow division of the total dose between several injections, ...
7. Marketing authorization holder
Sloan Pharma S.à.r.l., 33, Rue du Puits Romain, 8070 Bertrange, Luxembourg
8. Marketing authorization number(s)
EU/1/00/166/001 – 2500 U EU/1/00/166/002 – 5000 U EU/1/00/166/003 – 10,000 U
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
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