Sofargen 1% 30g cream

Sofargen 1% 30 g cream is a topical antibiotic cream , formulated to offer effective protection against bacterial skin infections. Thanks to the presence of micronized silver sulfadiazine , Sofargen cream is indicated for the prophylaxis and local antibacterial treatment in the case of second and third degree burns , varicose ulcers , infected bedsores and, in general, for all skin lesions and dermatological conditions that are infected or at risk of superinfection .

Its formulation, enriched with stearyl alcohol, propylene glycol and methyl p-hydroxybenzoate , guarantees a healing action and optimal skin care , promoting tissue regeneration and preventing infections. Sofargen 1% cream is easy to apply and creates a protective barrier that helps keep the lesion covered and protected, reducing the risk of bacterial contamination.

Ideal as a burn cream and wound cream , Sofargen is a local antibacterial reference for the topical treatment of skin infections . Its effectiveness makes it a valuable ally in the prevention of bacterial infections and in the management of bedsores , varicose ulcers and other dermatological problems that require rapid and targeted action.

Trust Sofargen cream for safe, effective and proven quality dermatological care , designed to promote healing and protect the skin in any situation of infectious risk.

ACTIVE INGREDIENTS

Active ingredients contained in Sofargen 1% 30g cream - What is the active ingredient in Sofargen 1% 30g cream?

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

EXCIPIENTS

Composition of Sofargen 1 % 30 g cream - What does Sofargen 1 % 30 g cream contain?

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

DIRECTIONS

Therapeutic indications Sofargen 1 % 30 g cream - Why is Sofargen 1 % 30 g cream used? What is it used for?

Prophylaxis and local antibacterial treatment of infections in cases of second and third degree burns; local antibacterial treatment of varicose ulcers and infected bedsores and in general of infected dermatological conditions or those susceptible to superinfections.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Sofargen 1 % 30 g cream - When should Sofargen 1 % 30 g cream not be used?

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 neonates in the first months of life.

DOSAGE

Quantity and method of taking Sofargen 1% 30g cream - How to take Sofargen 1% 30g cream?

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 burned surfaces. The cream can be applied either directly on the lesions, possibly with the help of a sterile glove, or previously spread on a 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 change of dressing, thoroughly clean the wounds with water or saline solution by showering or sponging. Take care to promptly reapply the cream to the 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 2–3 mm thick layer of cream, following the same criteria described for the treatment of burns. The lesion must always be kept completely covered by the medication. If a knee-high dressing is required, unroll 20–30 cm portions of a bandage of adequate length, spread a generous layer of cream over them, reroll the soaked part, unroll another 20–30 cm and repeat the operation until the entire length of the bandage has been completely soaked, then apply the required bandage.

CONSERVATION

Storage Sofargen 1% 30g cream - How to store Sofargen 1% 30g cream?

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

WARNINGS

Warnings Sofargen 1 % 30 g cream - About Sofargen 1 % 30 g cream it is important to know that:

Sofargen should be used 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, since haemolytic phenomena may occur. Prolonged use of the product may give rise to sensitization phenomena. In this case, treatment should be interrupted and appropriate therapeutic measures should be adopted. The same applies in the case of superinfection by resistant microorganisms. In the treatment of burns of a large part of the body, serum concentrations of sulphonamides may 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 kidney function are compromised. Furthermore, since propylene glycol, present as an excipient in the composition, can determine hyperosmolality when the product is applied to large burned areas, serum osmolality must be periodically checked and, if necessary, treatment must be interrupted.

INTERACTIONS

Interactions Sofargen 1 % 30 g cream - Which medicines or foods can modify the effect of Sofargen 1 % 30 g cream?

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

SIDE EFFECTS

Like all medicines, Sofargen 1 % 30 g cream can cause side effects - What are the side effects of Sofargen 1 % 30 g cream?

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 in case of treatment of large parts of the body. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation 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

Overdose Sofargen 1% 30g cream - What are the risks of Sofargen 1% 30g cream in case of overdose?

No symptoms of overdose have been highlighted in the literature.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Sofargen 1% 30g cream.

Since there are 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).

DRIVING AND USE OF MACHINERY

Take Sofargen 1% 30g cream before driving or using machines - Does Sofargen 1% 30g cream affect driving or using machines?

Sofargen does not alter the ability to drive vehicles or use machines.