Sofar Sofargen 1% Cream To Heal Wounds Burns And Sores 120g

NAME
SOFARGEN 1% CREAM

PHARMACOTHERAPEUTIC CATEGORY
Topical chemotherapy drugs.

ACTIVE PRINCIPLES
Micronized silver sulfadiazine.

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

INDICATIONS
Local antibacterial prophylaxis and treatment of infections in II and III degree burns; local antibacterial treatment of varicose ulcers and infected bedsores and in general of dermatological affections infected or susceptible to superinfections.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; since sulfonamides may increase the risk of neonatal jaundice, the drug 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 the medicine 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 the drug must continue without interruption, once or twice a day, as long as there is the possibility of infection and until complete healing, both in spontaneous and surgical repairs. Each time the dressing is renewed, thoroughly cleanse the wounds with water or physiological solution by means of douching or sponging. Take care to promptly reapply the cream on surfaces from which it has been inadvertently removed. In other cases, varicose ulcers, pressure sores, wounds and dermatological affections susceptible to infection, cleanse the injured part where necessary and apply a layer of cream 2-3 mm thick, 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, carry out 20-30 cm portions of a bandage of adequate length, spread an abundant layer of cream on it, rewind the impregnated part, unwind another 20-30 cm and repeat the operation until the whole length of the bandage has been fully impregnated, then apply the required bandage.

STORAGE
Store below 30 degrees C. The product should be used within 6 months of first opening the container.

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

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

SIDE EFFECTS
A few cases of transient leukopenia (0.4%), rare local disturbances (pain and burning) and rare local allergic reactions (0.3%) have been reported. The classic undesirable effects of systemically administered sulfonamides cannot be ruled out when treating large parts of the body. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
As there are no exhaustive experimental data on the possible effects of the drug on the fetus, the drug should not be used during pregnancy and lactation unless, in the opinion of the doctor, its use is indispensable and essential for the pregnant woman.