BETACAP Cutaneous solution (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Betacap Scalp Application.
2. Qualitative and quantitative composition
Betamethasone (as valerate) 0.1% w/w. For excipients see section 6.1.
3. Pharmaceutical form
Cutaneous solution. Transparent, slightly gelled, emollient, scalp application.
4.1. Therapeutic indications
For the topical treatment of dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis, which are unresponsive to less potent corticosteroids.
4.2. Posology and method of administration
For adults, including the elderly, and children over the age of one year: Betacap Scalp Application should be applied sparingly to the scalp night and morning until improvement is noticeable. It may then ...
4.3. Contraindications
Not to be used where there is bacterial, fungal or viral infection of the scalp. Not to be used in cases of sensitivity to any of the ingredients. Not to be used in children under the age of one year. ...
4.4. Special warnings and precautions for use
Keep away from the eyes. Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally. Long-term continuous topical therapy should be avoided where possible, ...
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, prolonged use ...
4.9. Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation treatment with Betacap Scalp Application ...
5.1. Pharmacodynamic properties
<b>ATC code:</b> D07AC Corticosteroids, potent (group III) Betamethasone (as valerate) is a well-established example of a corticosteroid which is used in dermatological therapy in pharmacological doses ...
5.2. Pharmacokinetic properties
For clinical usage, the betamethasone valerate is presented as a slightly thickened evaporative solution which allows drug availability over the affected area, whilst reducing the propensity to spread ...
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in this SPC.
6.1. List of excipients
Macrogolglycerol cocoates (a water dispersible derivative of coconut oil) Isopropyl alcohol Carbomer Sodium hydroxide Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Protect from light. Return bottle to carton between use.
6.5. Nature and contents of container
30 ml and 100 ml polyethylene squeeze bottle with integral nozzle/applicator for convenient direct application to the scalp through the hair, and tamper-evident replaceable cap.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK
8. Marketing authorization number(s)
PL 00173/0149
9. Date of first authorization / renewal of the authorization
13 January 1994 / 22 June 2004
10. Date of revision of the text
10 SEPTEMBER 2021
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