Altergen 15 hyaluronic acid impregnated gauze wounds IBSA 02441020

ALTERGEN * 15 IMPREGNATED GUARANTEES

Therapeutic indications

Local treatment of sores, varicose ulcers and burns.

Dosage and method of use

Dosage . ALTERGEN 0.2% + 1% cream: Spread a uniform 2-3 mm thick layer of cream over the entire site of the lesion, 1 or 2 times a day. ALTERGEN 2 mg + 40 mg impregnated gauze: Apply 1 or more impregnated gauze 2 or more times a day depending on the extent of the lesions. The application must continue without interruption, until complete healing. Method of administration : Cutaneous use.

Contraindications

Individual hypersensitivity to silver sulfadiazine or to any of the excipients listed in section 6.1. Pregnancy and breastfeeding. Premature babies and infants in the first months of life.

Side effects

ALTERGEN is generally well tolerated. When treating large parts of the body with ALTERGEN, the classic side effects of systemically administered sulfonamides cannot be excluded, such as: - renal failure, - toxic hepatitis, - agranulocytosis, - thrombocytopenia, - leukopenia, - skin rashes. Reporting of suspected adverse reactions . Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.

Special warnings

ALTERGEN should be used with caution in people who have had allergies to sulfonamides or who suffer from hepatic or renal insufficiency. Using ALTERGEN for a long time and / or on large parts of the body increases the risk of systemic effects. In such cases it is recommended to check the number of leukocytes. Important information about some of the ingredients : ALTERGEN 0.2% + 1% cream contains sodium lauryl sulfate. Sodium lauryl sulfate can cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

Pregnancy and breastfeeding

As there are no exhaustive experimental data on the possible side effects of the drug on the fetus, ALTERGEN should not be used during pregnancy and breastfeeding unless, in the opinion of the doctor, its use is essential.

Expiry and retention

Do not store above 25 ° C.

Interactions with other drugs

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

Overdose

There are no known cases of overdose.

Active principles

ALTERGEN 0.2% + 1% cream. 100 g of cream contain hyaluronic acid sodium salt 0.20 g and silver sulfadiazine 1.00 g. Excipient with known effect: 100 g of cream contain up to 0.1 g of sodium lauryl sulfate ALTERGEN 2 mg + 40 mg impregnated gauze Each gauze is soaked with 4 g of cream with the following percentage composition: hyaluronic acid sodium salt 0.05 % and silver sulphadiazine 1.00% For a full list of excipients, see section 6.1.

Excipients

ALTERGEN 0.2% + 1% cream: polyethylene glycol 400 monostearate, decyl ester of oleic acid, emulsifying wax *, glycerol, sorbitol solution 70%, purified water. * the emulsifying wax contains sodium lauryl sulfate. ALTERGEN 2 mg + 40 mg impregnated gauze: polyethylene glycol 4000, glycerol, purified water.