Connettivina Plus 0.2% + 1% 25 g cream

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

INDICATIONS

Local treatment of mild wounds. Local treatment of 1st and 2nd degree burns

ACTIVE INGREDIENTS

CONNECTIVITY PLUS 2 mg/g + 10 mg/g cream 1 g of cream contains 2 mg of hyaluronic acid sodium salt and 10 mg of silver sulfadiazine. CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauzes Each 10x10 cm gauze is impregnated with 4 g of cream containing 2 mg of hyaluronic acid sodium salt and 40 mg of silver sulfadiazine. CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauzes Each 10x20 cm gauze is impregnated with 8 g of cream containing 4 mg of hyaluronic acid sodium salt and 80 mg of silver sulfadiazine. CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauzes Each 20x30 cm gauze is impregnated with 24 g of cream containing 12 mg of hyaluronic acid sodium salt and 240 mg of silver sulfadiazine. For the full list of excipients, see section 6.1.

EXCIPIENTS

CONNETTIVIN PLUS 2 mg/g + 10 mg/g cream Polyethylene glycol 400 monostearate – oleic acid decyl ester – emulsifying wax – glycerol – sorbitol solution 70% – purified water CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauzes CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauzes CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauzes Polyethylene glycol 4000 – glycerol – purified water

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substances and other closely chemically related substances or to any of the excipients listed in paragraph 6.1.

DOSAGE

CONNETTIVINA PLUS 2 mg/g + 10 mg/g cream: spread a uniform layer of cream 2–3 mm thick over the entire site of the lesion, once or twice a day. CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauzes CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauzes CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauzes: Apply one or more medicated gauzes two or more times a day depending on the extent of the lesions. Before applying CONNETTIVINA PLUS, the affected areas must be cleaned preferably with sterile physiological solution (NaCl 0.9%) and disinfected using antiseptics preferably containing povidone iodine or chlorhexidine. If necessary, surgical cleaning must be carried out. In the treatment of burns, cleaning of the lesions is preferable to be carried out only with water or sterile physiological solution, avoiding disinfection with antiseptic agents before applying Connettivina PLUS cream or impregnated gauze. After cleansing the injured parts, spread a uniform layer of cream 2 or 3 mm thick or apply impregnated gauze. The application must continue as long as there is a possibility of infection and until complete healing.

CONSERVATION

Store below 30°C.

WARNINGS

CONNETTIVINA PLUS must be used with caution in subjects who have shown previous allergies to sulphonamides and in the presence of hepatic or renal insufficiency.

INTERACTIONS

Local proteolytic enzymes, applied simultaneously with CONNETTIVINA PLUS, can be inactivated by the presence of silver ions. Do not use simultaneously with disinfectants containing quaternary ammonium salts as hyaluronic acid may precipitate in their presence.

SIDE EFFECTS

After the application of CONNETTIVINA PLUS, local reactions (pain, burning, itching) may occur, even of an allergic nature. Since the systemic administration of sulphonamides can cause adverse reactions such as renal failure, toxic hepatitis, agranulocytosis, thrombocytopenia and leukopenia, it cannot be excluded that the local treatment of large parts of the body with CONNETTIVINA PLUS may give rise to side effects typical of sulphonamides administered systemicallyReporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

There are no known cases of overdose.

PREGNANCY AND BREASTFEEDING

In the absence of data on the effects of the medicine on the fetus, CONNETTIVINA PLUS must not be used during pregnancy and breastfeeding unless the doctor considers that the therapeutic benefits outweigh the possible risks.

EFFECTS ON DRIVING ABILITY

CONNETTIVINA PLUS does not alter the ability to drive or use machinery.