Celestoderm-V with Garamycin ointment

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

betamethasone (betamethasone valerate), gentamicin (gentamicin sulfate)

Beschikbaar vanaf:

Organon Heist B.V.

ATC-code:

D07CC01

INN (Algemene Internationale Benaming):

betamethasone (betamethasone valerate), gentamicin (gentamicin sulfate)

Dosering:

1mg/g+ 1mg/g

farmaceutische vorm:

ointment

Eenheden in pakket:

30g aluminium tube

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2023-12-21

Productkenmerken

[Organon] Proprietary
SUMMARY OF PRODUCT CHARACTERISTICS
[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 ointment contains
_active ingredients:_ 1,000 mg betamethasone as betamethasone valerate
1,220 mg and gentamicin
1,000 mg (1000 IU) as gentamicin sulfate.
_excipients_: white soft paraffin, mineral oil.
3.
PHARMACEUTICAL FORM
Ointment.
DESCRIPTION:_ _homogeneous, off-white to light yellow ointment without
foreign inclusions.
PHARMACOTHERAPEUTIC GROUP
Corticosteroids, dermatological preparations. Corticosteroids,
combinations with antibiotics.
ATC code: D07С C01.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION(S)
Ointment is indicated for the treatment of skin diseases which require
the use of potent
corticosteroids in the presence of superinfection with
gentamicin-susceptible organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Ointment is applied 2-3 times daily, once daily in children. The
frequency may be reduced as
the condition improves.
Method of administration
A thin film of the Ointment should be applied to the affected areas of
skin. The treated area of
skin should not exceed 10 % of the body surface area.
Ointment should be used in children only for a short period of time
and on small areas.
Increased caution is generally required when treating children with
corticoid products, as the
skin of a child may absorb more of the glucocorticoid than adult skin.
Occlusive dressings should not be used with the product because of the
possible risk of
absorption of betamethasone valerate.
Ointment is indicated for use on dry, scaling and horny skin.
Duration of use:
The duration of treatment with Ointment 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
supe