MIRVASO Gel (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Mirvaso 3 mg/g gel.
Qualitative and quantitative composition
One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate. Excipient(s) with known effect: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene ...
Pharmaceutical form
Gel. White to light yellow opaque aqueous gel.
Therapeutic indications
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Posology and method of administration
Posology One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present. The maximum daily recommended dose is 1 g of gel in total weight, which corresponds ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children aged less than 2 years. Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline ...
Special warnings and precautions for use
Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds. In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued. ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of brimonidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...
Effects on ability to drive and use machines
Mirvaso has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies. They ...
Overdose
Overdoses after oral use of other alpha<sub>2</sub>-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other dermatological preparations, Other dermatologicals <b>ATC code:</b> D11AX21 Mechanism of action Brimonidine is a highly selective alpha<sub>2</sub>-adrenergic receptor ...
Pharmacokinetic properties
Absorption The absorption of brimonidine from Mirvaso was evaluated in a clinical study in 24 adult subjects with facial erythema of rosacea. All enrolled subjects received a single-day ocular administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Carbomer Methylparahydroxybenzoate (E218) Phenoxyethanol Glycerol Titanium dioxide Propylene glycol (E1520) Sodium hydroxide Purified water
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage condition. Store below 30°C and do not freeze.
Nature and contents of container
<u>Tube of 2g:</u> Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polyethylene (PE) child resistant closure <u>Tube ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Galderma International, Tour Europlaza, 20 avenue André Prothin – La Défense 4, La Défense Cedex 92927, France
Marketing authorization number(s)
Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004 EU/1/13/904/005 EU/1/13/904/006 Polyethylene (PE)/ Polyethylene (PE)/Copolymer/Aluminium (Al)/Polyethylene ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 February 2014 Date of latest renewal: 22 November 2018
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