SILVEROL CREAM

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

SULPHADIAZINE SILVER

Prieinama:

TEVA ISRAEL LTD

ATC kodas:

D06BA01

Vaisto forma:

CREAM

Sudėtis:

SULPHADIAZINE SILVER 1 %

Vartojimo būdas:

DERMAL

Recepto tipas:

Required

Pagaminta:

TEVA ISRAEL LTD, ISRAEL

Farmakoterapinė grupė:

SILVER SULFADIAZINE

Gydymo sritis:

SILVER SULFADIAZINE

Terapinės indikacijos:

Treatment of infected burn wounds, leg ulcers and pressure sores.

Leidimo data:

2021-10-31

Pakuotės lapelis

PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Silverol
®
Cream
Skin cream
Composition
Silver Sulfadiazine 1%
in a water-soluble base.
For information regarding inactive ingredients
and allergens in the medicine, see “Important
information about some of the ingredients of the
medicine” in section 2 and “Additional information”
in section 6.
Read the entire leaflet carefully before using the
medicine. This leaflet contains concise information
about the medicine. If you have additional
questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for your
treatment. Do not pass it on to others. It may
harm them even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
A topical antimicrobial preparation for treatment
of burns, infected pressure ulcers and infected
leg ulcers.
Therapeutic class: antibacterial of the
sulfonamides group.
2. BEFORE USING THE MEDICINE
Do not use this medicine:
•
If you are sensitive (allergic) to the active
ingredient, silver sulfadiazine, or to any of
the other ingredients this medicine contains,
such as cetostearyl alcohol or propylene
glycol (see section 6 “Additional information”)
•
If you are sensitive to medicines that contain
sulfonamides
•
If you are pregnant or breastfeeding
•
In premature or newborn infants during the
first few months of their lives
Special warnings regarding the use of the
medicine
Before treatment with Silverol Cream, inform
the doctor, pharmacist or nurse if:
-
You are suffering from kidney or liver problems
-
You have glucose-6-phosphate dehydrogenase
(G6PD) deficiency
-
You are taking medicines prescribed by your
doctor for treatment of epilepsy or diabetes
-
You are using a biological medicine for the
removal of dead tissue from a leg ulcer or a sore
Upon using sulfadiazine, rashes that may be life-
threatening have been reported (Stevens-Johnson
syndrome, toxic ep

Prekės savybės

Silverol Cream SPC Notification 11-2023
Summary of Product Characteristics
Silverol Cream
Dermal cream
1.
NAME OF THE MEDICINAL PRODUCT
Silverol Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition
_Active Ingredient _
Silver Sulfadiazine
1%
Excipients with known effect:
Propylene glycol, cetostearyl alcohol.
For a full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Dermal cream.
White to slightly grey-white or pinkish-white.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Antimicrobial preparation for local treatment of burns, infected
pressure sores and leg
ulcers.
4.2
Posology and method of administration
Silverol should be applied in a layer approximately 3-5 mm thick with
a sterile, gloved
hand or spatula, to completely cover the burn area. Ordinarily,
blisters are not opened,
but loose tissue is generally removed prior to application.
After application of Silverol, the wound should either be left exposed
or covered with a
fine mesh gauze and an elastic mesh bandage.
The exposure method is preferable in some patients (such as children)
and for certain
parts of the body (face, genitalia, etc.). When the wound is exposed,
Silverol should be
reapplied at about 12-hour intervals, or more frequently if the
medication is rubbed off
on the bedding. When dressings are used, they should be changed daily
or on alternate
days. Use of dressings serves to press the medication firmly against
the wound, helps
keep the area moist, reduces evaporative water loss and prevents
drying/caking of the
medication.
Silverol dressings can usually be left in place for about 48 hours
during the first 2 weeks
post burn. Subsequently, necrotic tissue undergoes proteolytic
decomposition, producing
considerable exudate which dilutes the drug and necessitates more
frequent dressing
changes. When feasible, patients should be bathed daily as an aid in
debridement. A
whirlpool bath is particularly helpful, but patients may be bathed in
bed or in a shower.
Silverol Cream SPC Notification 11-2023
With Silverol treat