Silvadev cream for external use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

silver sulfadiazine

Available from:

Arpimed LLC

ATC code:

D06BA01

INN (International Name):

silver sulfadiazine

Dosage:

10mg/g

Pharmaceutical form:

cream for external use

Units in package:

aluminum tube 40g

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-01-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SILVADEV 1% CREAM FOR TOPICAL USE
1. BRAND NAME – Silvadev INTERNATIONAL NON-PROPERTY NAME – Silver sulfadiazine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Silvadev, 1% cream contains:
_ACTIVE INGREDIENT: _Silver sulfadiazine - 10 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
A white cream, odorless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Silvadev cream is indicated for the prophylaxis and treatment of
infection in burn wounds.
Silvadev cream may also be used as an aid to the short-term treatment
of infection in leg ulcers
and pressure sores, and as an aid to the prophylaxis of infection in
skin graft donor sites and
extensive abrasions.
Silvadev cream is also indicated for the conservative management of
finger-tip injuries where
pulp, nail loss and/or partial loss of the distal phalanx has
occurred.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be applied topically.
BURNS:
The burn wound should be cleaned and Silvadev cream applied over all
the affected areas to a
depth of 3-5mm.
This application is best achieved with a sterile gloved hand and/or
sterile spatula. Where
necessary, the cream should be re-applied to any area from which it
has been removed by patient
activity.
In burns, Silvadev cream should be re-applied at least every 24 hours,
or more frequently if the
volume of exudate is large.
HAND BURNS:
Silvadev cream can be applied to the burn and the whole hand enclosed
in a clear plastic bag or
glove, which is then closed at the wrist.
The patient should be encouraged to move the hand and fingers. The
dressing should be changed
when an excessive amount of exudate has accumulated in the bag.
LEG ULCERS/PRESSURE SORES:
The cavity of the ulcer should be filled with Silvadev Cream to a
depth of at least 3-5mm. As
Silvadev Cream can cause maceration of normal skin on prolonged
contact, care should be taken
to prevent spread onto non-ulcerated areas.
Application of Silvadev Cream should be followed by an absorbent