Sofargen 1% 120g cream

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Prophylaxis and local antibacterial treatment of infections in case of 2nd and 3rd degree burns; local antibacterial treatment of varicose ulcers and infected bedsores and in general of dermatological conditions that are infected or susceptible to superinfections.

ACTIVE INGREDIENTS

SOFARGEN 1% cream contains 1 g of micronized silver sulfadiazine. Excipients with known effects: stearyl alcohol, propylene glycol, methyl p-oxybenzoate. For the full list of excipients, see section 6.1

EXCIPIENTS

Stearyl alcohol; isopropyl myristate; propylene glycol; polyethylene glycol monostearate; polyoxyethylene sorbitan monolaurate; methyl–p–oxybenzoate; distilled water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients. Since sulphonamides may increase the risk of neonatal jaundice, Sofargen should not be used in women at the end of pregnancy, in premature babies and in newborns in the first months of life.

DOSAGE

In burns Sofargen should be applied as early as possible. After a quick cleansing of the injured parts, immediately spread a uniform layer of cream 2 or 3 mm thick on the burnt surfaces. The cream can be applied either directly to the lesions, possibly with the help of a sterile glove, or previously spread on sterile gauze. The application of Sofargen must continue without interruption, once or twice a day, as long as there is a possibility of infection and until complete healing, both in spontaneous and surgical repairs. At each renewal of the dressing, carefully cleanse the wounds with water or physiological solution by showering or sponging. Take care to promptly reapply the cream on surfaces from which it has been inadvertently removed. In other cases, varicose ulcers, bedsores, wounds and dermatological conditions susceptible to infection, cleanse the injured part where necessary and apply a layer of cream 2-3 mm thick, following the same criterion described for the treatment of burns. The lesion must always be kept completely covered by the medicine. If a knee-high type dressing is needed, unwrap 20-30 cm portions of a bandage of adequate length, spread a generous layer of cream, rewrap the impregnated part, unwrap another 20-30 cm and repeat the operation until the entire length of the bandage has been completely impregnated, then apply the required bandage.

CONSERVATION

Store at temperatures below 30° C. The product must be used within 6 months of first opening the container.

WARNINGS

Sofargen should be applied with caution in the presence of hepatic or renal insufficiency. The use of Sofargen may be risky in subjects with manifest glucose-6-phosphate dehydrogenase deficiency, as hemolytic phenomena may occur. Prolonged use of the product may give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and adopt suitable therapeutic measures. The same applies in case of superinfection by resistant microorganisms. In the treatment of burns of a large part of the body, serum concentrations of sulphonamide can reach therapeutic levels in adults. Therefore, in these patients it would be advisable to monitor these serum levels, renal function, the presence of any sulphonamide crystals in the urine and liver function, interrupting therapy if liver and/or renal function is compromised. Furthermore, given that propylene glycol, present as an excipient in the composition, can cause hyperosmolality when the product is applied to large burn areas, serum osmolality must be periodically checked and, if necessary, the treatment must be interrupted.

INTERACTIONS

Local proteolytic enzymes, applied simultaneously with Sofargen, can be inactivated by the presence of silver ions.

SIDE EFFECTS

Some cases of transient leukopenia (0.4%), rare local disorders (pain and burning) and rare local allergic reactions (0.3%) have been reported. The classic side effects of systemically administered sulphonamides cannot be excluded when treating large parts of the body. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

No symptoms of overdose have been highlighted in the literature.

PREGNANCY AND BREASTFEEDING

Since there is no exhaustive experimental data on the possible effects of the drug on the fetus, Sofargen should not be used during pregnancy and breastfeeding unless, in the opinion of the doctor, its use is indispensable and essential for the pregnant woman (see 4.3).

EFFECTS ON DRIVING ABILITY

Sofargen does not affect the ability to drive or use machines.