SOFARGEN CREMA 120G 1%

SOFARGEN 1% CREMA

active ingredients

SOFARGEN 1% cream contains 1 g of micronized silver Sulfadiazine. Excipients with known effects: stearilic alcohol, propilenglycole, methyl p–oxybenzoate. For the full list of excipients, see paragraph 6.1

Excellent

Stearilic alcohol; mixed isopropyl; propilenglycol; polyethylenecolmonostearate; polyoxyethylenesorbitanmonolaurate; methyl–p–oxybenzoate; distilled water.

Therapeutic indications

Local antibacterial prophylaxis and treatment of infections in the case of burns of II and III degree; local antibacterial treatment of varicose ulcers and infected decubitate wounds and typically infected dermatological diseases or susceptible to superinfections.

Contraindications

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

Population

Sofargen burns should be applied as early as possible. After a quick detersion of the injured parts, immediately lay on the burned surfaces a uniform layer of cream of 2 or 3 mm thick. The cream can be applied either directly on the lesions, possibly with the help of a sterile glove, or previously laid on a sterile gauze. Sofargen's application must continue without interruption, once or twice a day, as long as there is a possibility of infection and until complete scarring, both in spontaneous repairs and in surgical repairs. To each renewal of the dressing carefully cleanse the wounds with water or physiological solution by means of showers or sponges. Take care to quickly reapply the cream on the surfaces from which it was inadvertently removed. In other cases, varicose ulcers, decubitate sores, wounds and dermatological affections susceptible to infection, deterrence where necessary the injured part and apply a layer of 2–3 mm thick cream, following the same criterion described for the treatment of burns. The injury must always be kept completely covered by the medicine. If you need a leglet type dressing, take 20–30 cm of a bandage of adequate length, lay a thick layer of cream, rewind the impregnated part, carry out another 20–30 cm and repeat the operation until the entire length of the bandage has been completely impregnated, then practice the required bandage.

Conservation

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

Warnings

Sofargen must be applied with caution in the presence of liver or kidney failure. The use of Sofargen can be risky in people with manifest glucose deficit–6–phosphate dehydrogenase, as haemolytic phenomena may occur. Prolonged use of the product can lead to awareness-raising. In this case it is necessary to stop the treatment and take appropriate therapeutic measures. Equally said in case of super infection with resistant microorganisms. In the treatment of burns of an extensive part of the body, serum sulfamidic concentrations can reach therapeutic concentrations in the adult. Therefore in these patients it would be appropriate to control such serum levels, kidney function, the presence of any sulfamidic crystals in the urine and liver function, interrupting therapy in case liver and/or kidney function were compromised. Moreover, since propylene glycol, present as excipient in the composition, can determine hyperosmolality when the product is applied on vast burnt areas, it must be periodically controlled sierica omolality and, if necessary, the treatment must be stopped.

Interactions

Local protein enzymes, applied simultaneously to Sofargen, may be inactivated by the presence of silver ions.

Effects

Some cases of transient leucopenia were reported (0.4%), rare local disorders (sweet and burning) and rare local allergic reactions (0.3%). It is not possible to exclude the classic side effects of systemic sulfamidics in case of extensive body parts treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Not highlighted in literature any overdose symptoms.

There is no extensive experimental data on the effects of the drug on the fetus, Sofargen should not be used during pregnancy and lactating unless, according to the doctor, its use is essential and essential for the pregnant woman (see 4.3).

Source: Farmadati