Celestoderm-V cream with Garamycin cream

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)

Available from:

Schering-Plough Labo N.V.

ATC code:

D07CC01

INN (International Name):

betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)

Dosage:

1mg/g+ 1mg/g

Pharmaceutical form:

cream

Units in package:

aluminium tube 30g

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-08-04

Summary of Product characteristics

[Organon] Proprietary
SUMMARY OF PRODUCT CHARACTERISTICS
2
[Organon] Proprietary
1.
NAME OF THE MEDICINAL PRODUCT
CELESTODERM-V
®
WITH GARAMYCIN
®
INTERNATIONAL NONPROPRIETARY NAME: betamethasone and antibiotics.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains
_active ingredients: _1 g of cream contains 1,220 mg betamethasone
valerate equivalent to 1 mg
of betamethasone and gentamicin sulfate equivalent to 1 mg (1000 I.U.)
of gentamicin.
_excipients_: white soft paraffin, cetostearylalcohol, liquid
paraffin, macrogol cetostearyl ether,
sodium dihydrogen phosphate dihydrate, chlorocresol, phosphoric acid,
sodium hydroxide/
phosphoric acid, purified water.
3.
PHARMACEUTICAL FORM
Cream.
DESCRIPTION: homogeneous, white to off-white soft cream without
foreign inclusions
PHARMACOTHERAPEUTIC GROUP.
Corticosteroids, dermatological preparations. Corticosteroids,
combinations with antibiotics.
ATC code: D07С C01.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION(S)
Treatment of skin diseases requiring treatment with a potent
glucocorticoid in the presence
of superinfection with gentamicin-susceptible organisms
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Cream is applied 2-3 times daily. The frequency may be reduced as the
condition improves.
Method of administration:
A thin film of Cream should be applied to the affected areas of skin.
The method of
administration should be adjusted to the skin type and stage of the
disease.
Cream is recommended in particular for greasy skin, weeping, itching,
burning and seborrheic
skin diseases, in acute stage.
Duration of use:
The duration of treatment with cream should not exceed 7-10 days (7
days in
children)
because of the gentamicin content.
As soon as medically confirmed that combined therapy is no longer
necessary (i.e., either a
dermatosis requiring a strong-acting glucocorticoid or a
superinfection with gentamicin-
susceptible organisms is no longer present), treatment should be
continued on the basis of
single-agent therapy with a glucocorticoid (p