Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SILVER SULPHADIAZINE
IMEKS PHARMA SDN. BHD.
SILVER SULPHADIAZINE
25gm mcg/mL; 25gm mcg/mL; 50 gm mcg/mL
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SILVERDERM CREAM ® Silver Sulphadiazine (1g/100g) 1 WHAT IS IN THE LEAFLET 1. What Silverderm Cream is used for 2. How Silverderm Cream works 3. Before you use Silverderm Cream 4. How to use Silverderm Cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Silverderm Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SILVERDERM CREAM IS USED FOR Silverderm Cream is used: • To prevent and treat infection in burn wounds • As an aid to the short-term treatment in other skin conditions, such as leg ulcers • As an aid to prevent infection in skin grafting. HOW SILVERDERM CREAM WORKS Silver sulphadiazine has broad antimicrobial activity against Gram-positive and Gram- negative bacteria. It works by killing bacteria or stopping their growth. BEFORE YOU USE SILVERDERM CREAM_ _ - _When you must not use it_ • Hypersensitive to silver sulphadiazine, other sulphonamides or any of the other ingredients in the preparation such as cetyl alcohol and propylene glycol. • Pregnant women approaching or at term • Premature infants • Newborn infants during the first 2 months of life. - _Before you start to use it _ Please tell your doctor: • If you have kidney or liver problem • If you have extensive burns • If you have glucose-6-phosphate dehydrogenase (G6PD) deficiency Absorption of propylene glycol which is contained in Silverderm Cream may interfere with some laboratory test results. _If you are not sure whether you should start _ _taking this product, consult your doctor._ - _Taking other medicines _ As the silver content of silver sulphadiazine may inactivate topical proteolytic enzymes and debriding agents (a type of medicine used externally to clean and treat wounds), their concomitant use may be inappropriate. The effects of oral hypoglycaemic agents (anti-diabetic medication) and phenytoin (anticonvulsant medication) may be potentiated when large areas of burns are treated. Tell your Läs hela dokumentet
SILVERDERM CREAM Contains silver sulfadiazine 1.0% w/w. DESCRIPTION A white cream. PROPERTIES S ilver sulfadiazine has broad antimicrobial activity against Gram-positive and Gram-negative bacteria including _ Pseudomonas aeruginosa_ and some yeast and fungi. Silver sulfadiazine acts upon the cell membrane and cell wall and its activity is not antagonised by aminobenzoic acid (_p_-aminobenzoic acid). Silver sulfadiazine does not appear to be absorbed, but when in contact with wound exudates, it reacts with sodium chloride, sulfydryl groups and proteins, resulting in the release of sulfadiazine. When applied to second-degree burns particularly, si lver sulfadiazine may be systemically absorbed from the site of application. Concentrations in blood of 10 to 20 micrograms (mcg) per ml have been reported although higher concentrations may be achieved when extensive areas of the body are treated. INDICATIONS F or prevention and treatment of infection in burn wounds. It has also been used as an aid to the short- term treatment in other skin conditions, such as leg ulcers where infections may prevent healing and as an aid to prophylaxis of infection in skin grafting. CONTRAINDICATIONS _S_ _ILVERDERM CREAM_ is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation such as cetyl alcohol and propylene glycol. Sulphonamide therapy is known to increase the p ossibility of kernicterus and because of that _SILVERDERM CREAM_ should not be used on pregnant women approaching or at term, on premature infants or on newborn infants during the first 2 months of life. SIDE EFFECTS / ADVERSE REACTIONS Fre quently reported adverse reactions include burning, skin photosensitivity, pruritus, skin rash and brown-grey skin discolouration. When silver sulfadiazine is applied to extensive areas of th e body surface, or over prolonged periods, sulfadiazine may be absorbed systemically and may produce argyria and adverse reactions characteristic of the sulphonamides. Some of th Läs hela dokumentet