FASTUM Gel (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
FASTUM 2.5% GEL.
2. Qualitative and quantitative composition
100gr of gel contain: Ketoprofen 2.50g. <u>Excipients with known effect:</u> Citral, Citronellols, Coumarin, Farnesol, Geraniol, d-Limonene and Linalool. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Gel for topical use.
4.1. Therapeutic indications
This medicinal product is indicated in adults and adolescents over 12 years of age only. Local treatment of painful disorders of the osteo-articular and muscular system of rheumatic or traumatic origin: ...
4.2. Posology and method of administration
Posology Apply a thin layer of gel once or twice daily onto the area of affected skin, gently massaging to help absorption.
4.3. Contraindications
Fastum gel must not be administered in the following cases: Hypersensitivity to Ketoprofen or to any of the excipients listed in section 6.1. Hypersensitivity to ketoprofen, or aspirin or other non-steroidal ...
4.4. Special warnings and precautions for use
Hands should be washed thoroughly after each application of the product. Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application ...
4.5. Interaction with other medicinal products and other forms of interaction
Interactions are unlikely as serum concentrations following topical administration are low. However, a close monitoring of patients treated with coumarins is recommended.
4.6. Fertility, pregnancy and lactation
Pregnancy During the first and second trimester In mice and rats, there is no evidence of teratogenic or embryotoxicity. In the rabbit, slight embryotoxicity likely related to maternal toxicity has been ...
4.7. Effects on ability to drive and use machines
Fastum has negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
There have been reports of localised skin reactions which may subsequently spread beyond the application area. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or ...
4.9. Overdose
Overdose is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic category:</b> non-steroid anti-inflammatory drug for topical use <b>ATC code:</b> MO2AA10 Ketoprofen, in a suitable excipient formulation, reaches the site of inflammation by transcutaneous ...
5.2. Pharmacokinetic properties
Following oral administration of a single dose, maximum blood concentrations are reached within 2 hours. Plasma half-life of ketoprofen varies from 1 hour to 3 hours; plasma protein binding is 60-90%. ...
5.3. Preclinical safety data
In animal trials no embryopathic effects have been found, while there is no epidemiological evidence of the safety of ketoprofen in human pregnancy. Pre-clinical and clinical studies on Fastum gel have ...
6.1. List of excipients
<u>Fastum gel contains:</u> Purified water Carbomer Ethanol Triethanolamine Neroli fragrance (containing Citral, Citronellols, Farnesol, Gerianol, d-Limonene and Linalool) Lavandin fragrance (containing ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Tube: 60 months. Dispenser: 36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Soft aluminium tube, treated inside with non – toxic epoxy vamish. Dispenser: rigid polypropylene dispenser containing 100g gel. Tube of 50g and 100g. Dispenser of 100g. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
Opening the tube of soft aluminium: unscrew cap and perforate the aluminium diaphragm with the point of inverted cap. Using the dispenser for the first time, press the top of the dispenser several times ...
7. Marketing authorization holder
A. Menarini Industrie Farmaceutiche Riunite srl, Via Sette Santi 3, 50131 Firenze, Italy
8. Marketing authorization number(s)
13370
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 04.06.1991
10. Date of revision of the text
09/2021
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