Silvederma Cream 1g/100g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SULFADIAZINE SILVER

Available from:

Laboratorio Aldo-Union S.L. Baronesa de Malda 73, 08950 Esplugues de Llobregat, Barcelona, Spain

ATC code:

D06BA01

INN (International Name):

SULFADIAZINE SILVER 1 g

Pharmaceutical form:

CREAM

Composition:

SULFADIAZINE SILVER 1 g

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SILVEDERMA CREAM
SILVER SULFADIAZINE
COMPOSITION:
Each 100 grams of SILVEDERMA cream contains 1 g of micronized silver
sulfadiazine and
excipients (Cetostearyl alcohol, paraffin white soft, isopropyl
myristate, propylene glycol,
polyoxyl 40 stearate, sorbitan oleate, methylparaben and purified
water), s.q.
MANUFACTURER RESPONSIBLE:
Laboratorio ALDO-UNIÓN, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat
BARCELONA - SPAIN
INDICATIONS:
Topical
antibacterial.
Preventive
and
healing
of
infections
caused
by
Pseudomonas
and
Staphylococcus in all kind of injuries and ulcers, and especially in
burns.
APPLICATION AND USUAL DOSAGE:
Application in grave and extensive burns: the cream should be applied
to the burnt area after the
cleansing and debridement of the wound, usually once a day, wearing a
sterile glove, to a
thickness of 1 mm, making sure that all interstices and crevices of
the irregular burnt surface are
treated. Silver sulfadiazine should be applied more frequently to
burnt areas from which the
cream might be removed by any involuntary movement of the patient. The
therapy should be
continued until a satisfactory healing has been achieved or until the
burnt area is ready for
grafting.
Dressings are unnecessary but covering it with fine mesh gauze and
bandage will be more
convenient for the majority of the patients. It is advisable
hydrotherapy and mechanical
debridement in patients with third-degree burns.
DIRECTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION:
See “Dosage” section.
The tube has a seal whose opening is carried out following the
instructions of the drawing:
Unscrew cap from tube
Insert the cap and make it coincide
Rotate it until head comes off
with the jagged head of the tube
CONTRAINDICATIONS:
The therapy with sulphonamide is usually contraindicated in premature
babies and in newborns
of less than two months, since it can cause kernicterus.
Because of these theoretical reasons, it is better not to use silver
sulfadiazine in patients
sensitive to sul

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
Silvederma Cream 1g/100g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 100 g of cream contains 1 g of silver sulfadiazine (D.C.I.)
3.
PHARMACEUTICAL FORM:
Cream for topical use.
4.
CLINICAL DATA:
4.1.
THERAPEUTIC INDICATIONS:
Topical antibacterial. Preventive and healing of infections caused by
Pseudomonas and
Staphylococcus in all kind of injuries and ulcers, and especially in
burns.
4.2.
ADMINISTRATION AND DOSAGE:
For topical administration.
Method of application in serious and extensive burns:
Once the wound has been cleansed and debrided, SILVEDERMA cream is
applied wearing sterile
gloves normally once or twice a day, covering all the burnt area to a
thickness of approximately 1
to 3 mm, taking care to cover with cream all the interstices of the
wound. Silver sulfadiazine
should be applied more frequently to burnt areas from which the cream
might be removed by
involuntary movement of the patient.
The therapy is continued until a satisfactory healing is achieved or
until the burnt sites are ready
for grafting. Dressings can be applied over the cream, but it is not
necessary.
Hydrotherapy and mechanical debridement are recommended, especially
in patients with third-
degree burns.
Page 2 of 7
The drug should not be withdrawn from the therapeutic regimen as long
as the possibility of
infection exists, except if a significant adverse reaction occurs.
4.3.
CONTRAINDICATIONS:
SILVEDERMA cream is contraindicated in patients who are hypersensitive
to sulphonamides or
to any other ingredient in the preparation.
The therapy with sulphonamides is known to be contraindicated in
premature infants or newborn
infants of less than two months of age, since it may favour the
possible appearance of kernicterus
Silver sulfadiazine shouldn’t be used in sulphonamide-sensitive
patients or pregnant women
probably due to theoretical reasons. However, due to the serious risk
of sepsis in severe burns, its
use in such patients should be determined ind