Finished product reference

Silver Sulfadiazine / Egf

Cream · Topical · 1 %/0.001 % · 15 g

List code
51673
Pharmacologic class
Topical antibacterial with growth factor (silver sulfadiazine + recombinant human epidermal growth factor)

What it is and how it works

Silver sulfadiazine releases silver ions that act on bacterial cell membranes and cell walls, giving broad activity against Gram-positive and Gram-negative organisms (including Pseudomonas) and some yeasts. Recombinant human epidermal growth factor (EGF) stimulates proliferation and migration of keratinocytes and fibroblasts, promoting re-epithelialisation.

Indications

Prevention and treatment of infection in burns and promotion of healing of burn wounds and other superficial wounds.

Dosage and administration (summary)

Applied topically to the cleaned wound in a layer about 1–2 mm thick, usually once or twice daily, with or without a dressing, as directed by the treating physician.

Contraindications

Hypersensitivity to sulfonamides or to any component; pregnancy at term, premature infants and neonates in the first months of life (risk of kernicterus).

Warnings and precautions

Systemic absorption from large burns can cause sulfonamide adverse effects, including leucopenia, skin reactions and, in G6PD deficiency, haemolysis; monitor blood counts and renal and hepatic function with extensive use. Argyria and skin discolouration may occur. Avoid use on malignant or suspected malignant lesions because of the growth-factor component.

Pregnancy

Avoid in pregnancy, especially near term, unless the burn area is small and benefit outweighs risk.

Storage and supply

Store below 25 °C, or refrigerated if specified by the manufacturer; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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