SOOLANTRA Cream (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Soolantra 10 mg/g cream.
Qualitative and quantitative composition
One gram of cream contains 10 mg of ivermectin. Excipient(s) with known effect: One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl alcohol, 2 mg of methyl parahydroxybenzoate (E218), 1 ...
Pharmaceutical form
Cream. White to pale yellow hydrophilic cream.
Therapeutic indications
Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients.
Posology and method of administration
Posology One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The treatment course may be repeated. In case of no improvement after 3 months, the treatment ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Soolantra has not been studied in patients with renal or hepatic impairment. The medicinal product contains: cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis), ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed (see section 5.2 for Biotransformation). Concomitant use of Soolantra with other topical or systemic medicinal products for the treatment of rosacea has not been ...
Fertility, pregnancy and lactation
Pregnancy There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits ...
Effects on ability to drive and use machines
Soolantra 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 skin burning sensation, skin irritation, pruritus and dry skin, all occurring in 1% or less of patients treated with the medicinal ...
Overdose
There are no reports of overdosage with Soolantra. In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatological preparations, other dermatologicals ATC code: D11AX22 Mechanism of action Ivermectin is a member of the avermectin class. Avermectin has anti-inflammatory ...
Pharmacokinetic properties
Absorption The absorption of ivermectin from Soolantra was evaluated in a clinical trial in adult subjects with severe papulopustular rosacea under maximal use conditions. At steady state (after 2 weeks ...
Preclinical safety data
Repeat-dose studies up to 9 months via dermal application of ivermectin 10 mg/g cream in minipigs have not shown toxic effects or local toxicity at systemic exposure levels comparable to clinical exposure. ...
List of excipients
Glycerol Isopropyl palmitate Carbomer Dimeticone Disodium edetate Citric acid monohydrate Cetyl alcohol Stearyl alcohol Macrogol cetostearyl ether Sorbitan stearate Methyl parahydroxybenzoate (E218) Propyl ...
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening: use within 6 months.
Special precautions for storage
This medicinal product does not require any special storage condition.
Nature and contents of container
Polyethylene (PE)/Aluminium (Al)/ Polyethylene (PE) laminated plastic white tubes with: A white high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure for the 15 g, 30 g, ...
Special precautions for disposal and other handling
Mitigation measures should be taken in order to prevent or reduce contamination, in particular the aquatic media. Any unused medicinal product or waste material should be disposed of in accordance with ...
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
Marketing authorization number(s)
PL 10590/0063
Date of first authorization / renewal of the authorization
17/04/2015
Date of revision of the text
6<sup>th</sup> April 2018
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