ALLUZIENCE Solution for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
Alluzience, 200 Speywood units/mL, solution for injection.
2. Qualitative and quantitative composition
<em>Clostridium botulinum</em> toxin type A haemagglutinin complex 200 Speywood units/ml Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Speywood units are ...
3. Pharmaceutical form
Solution for injection. Clear, colourless solution.
4.1. Therapeutic indications
Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, ...
4.2. Posology and method of administration
Posology Botulinum toxin product units differ depending on the medicinal products. Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Speywood units are different ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1. Presence of infection at the proposed injection sites. Presence of myasthenia gravis, Eaton Lambert Syndrome ...
4.4. Special warnings and precautions for use
Care should be taken to ensure that Alluzience is not injected into a blood vessel. Injection of Alluzienceis not recommended in patients with a history of dysphagia and aspiration. Adverse reactions possibly ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant treatment with Alluzience and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) should only be used with caution since the effect of botulinum ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are only limited data from the use of botulinum toxin type A in pregnant women. Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity ...
4.7. Effects on ability to drive and use machines
Alluzience has a minor or moderate influence on the ability to drive and use machines. There is a potential risk of localised muscle weakness or visual disturbances linked with the use of this medicinal ...
4.8. Undesirable effects
Summary of the safety profile A majority of adverse reactions reported with Alluzience in clinical trials were of mild to moderate intensity and reversible. The most frequently reported adverse reactions ...
4.9. Overdose
Excessive doses of botulinum toxin may produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other muscle relaxants, peripherally acting agents <b>ATC code:</b> M03AX01 Mechanism of action The primary pharmacodynamic effect of botulinum toxin type A is chemical ...
5.2. Pharmacokinetic properties
Alluzience is not expected to be present in the peripheral blood at measurable levels following intramuscular injection at the recommended dose. Pharmacokinetic studies have therefore not been performed. ...
5.3. Preclinical safety data
In reproductive studies in rats and rabbits, severe maternal toxicity associated with implantation losses was observed at high doses. At doses corresponding to 60 to 100 times the human recommended dose ...
6.1. List of excipients
L-histidine Sucrose Sodium chloride Polysorbate 80 Hydrochloric acid for pH adjustment Water for Injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
12 months.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep vials in the outer carton in order to protect from light. Once opened, the product should be used immediately.
6.5. Nature and contents of container
<u>Nature of container/closure:</u> Type 1 glass vial, butyl rubber closure and aluminum overseal with a polypropylene flip-off top. <u>Contents of container:</u> Each vial contains 125 Speywood units ...
6.6. Special precautions for disposal and other handling
Immediately after treatment of the patient, any residual Alluzience which may be present in either vial or syringe should be inactivated with dilute hypochlorite solution (1% available chlorine). Spillage ...
7. Marketing authorization holder
Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
8. Marketing authorization number(s)
PA1613/004/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 10<sup>th</sup> September 2021
10. Date of revision of the text
November 2022
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