Connettivina plus - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Hyaluronic acid (hyaluronic acid sodium salt), Silver sulfadiazine

0.2% + 1% Cream
2 mg + 40 mg impregnated gauze
4 mg + 80 mg impregnated gauze
12 mg + 240 mg impregnated gauze

The package inserts of Connettivina plus are available for the packs:
  • 0.2% + 1% Cream, 2 mg + 40 mg impregnated gauze, 4 mg + 80 mg impregnated gauze, 12 mg + 240 mg impregnated gauze
  • Connettivina Plus 2 mg + 40 mg impregnated gauze, Connettivina Plus 4 mg + 80 mg impregnated gauze, Connettivina Plus 12 mg + 240 mg impregnated gauze

Why is Connettivina plus used? What is it for?

Connettivina Plus 2 mg / g + 10 mg / g cream contains two active ingredients: hyaluronic acid, sodium salt and silver sulfadiazine, and belongs to a class of medicines called healing and disinfectants.

Hyaluronic acid is a substance naturally produced by our body, capable of stimulating the formation of collagen and connective tissue, increasing the elasticity of the tissues and ensuring optimal skin hydration. The local supply of hyaluronic acid determines acceleration of the wound healing process.

The silver sulfadiazine is an active ingredient belonging to the family of sulfonamide antibiotics, it is able to block the replication mechanisms and thus counteract the formation of infections.

Connettivina Plus 2 mg / g + 10 mg / g cream is indicated for the prevention and local (topical) treatment of hard-to-heal wounds (sores), injuries that usually form in the lower limbs due to blood circulation disorders ( varicose ulcers) and burns.

Thanks to the complementary action of the two active ingredients, Connettivina Plus prevents the recurrence of the infection (secondary infection) and promotes wound healing.

Contraindications When Connettivina plus should not be used

Do not use Connettivina Plus:

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Precautions for use What you need to know before taking Connettivina plus

Talk to your doctor or pharmacist before using Connettivina Plus if:

  • have had a hypersensitivity reaction (allergic reaction) after taking sulfonamides;
  • have severe liver problems (liver failure);
  • have severe kidney problems (kidney failure);
  • if you are pregnant or breastfeeding.

Interactions Which drugs or foods can modify the effect of Connettivina plus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pay particular attention when using Connettivina Plus together with proteolytic enzymes for local use, as their action could be prevented by the components present in the cream.

Warnings It is important to know that:

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 or pharmacist for advice before using this medicine.

Connettivina Plus should not be used during pregnancy or breastfeeding unless, in the opinion of the doctor, its use is not essential. In this case, Connettivina Plus should only be used under the direct supervision of the doctor.

Driving and using machines

Connettivina Plus does not affect the ability to drive or use machines.

Dose, Method and Time of Administration How to use Connettivina plus: Posology

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Apply an even layer of cream 2-3mm thick to the lesion, 1 or 2 times a day. Do not stop the treatment until the lesion has completely healed.

Consult your doctor if symptoms persist after a short period of treatment, or at any time if they get worse.

If you forget to use Connettivina Plus

If you have forgotten to apply the cream, do so as soon as you remember. Then continue the application according to the usual scheme.

If you stop using Connettivina Plus

The application of the cream should continue without interruption, until the lesion is completely healed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken an overdose of Connettivina plus

In case of accidental use of an excessive dose of Connettivina Plus, notify your doctor immediately or go to the nearest hospital. There are no known cases of overdose due to the use of an excessive quantity of Connettivina Plus.

Side Effects What are the side effects of Connettivina plus

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Non-serious, local reactions have rarely been observed.

Since Connettivina Plus only crosses the deeper layers of the skin in negligible quantities (percutaneous absorption), no undesirable effects have ever been reported due to the presence of active ingredients in the circulation (systemic effects).

However, following the application of Connettivina Plus on large areas of the skin, you may experience the side effects that are usually observed with the oral administration of sulfonamide-based medicines (class of drugs to which sulfadiazine belongs). or injective (systemic routes) such as:

  • severe kidney problems (kidney failure);
  • inflammation of the liver as a reaction to certain substances to which one is exposed (toxic hepatitis);
  • reduction in the number of white blood cells (agranulocytosis and leukopenia) and platelets (thrombocytopenia) circulating in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.it/it/responsabili.

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month.

The expiry date indicated refers to the medicine in intact packaging, correctly stored.

Store below 30 ° C.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other_information "> Other information

What Connettivina Plus contains

  • The active ingredients are: hyaluronic acid, sodium salt and silver sulfadiazine. 1 g of cream contains 2 mg of hyaluronic acid sodium salt and 10 mg of silver sulfadizine.
  • The other components are: polyethylene glycol 400 monostearate, decyl ester of oleic acid, emulsifying wax, glycerol, 70% sorbitol solution, purified water.

Description of the appearance of Connettivina Plus and contents of the pack

Connettivina Plus 2 mg / g + 10 mg / g is a cream contained in a 25 g aluminum tube.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Connettivina plus is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

CONNETTIVINA PLUS 0.2% + 1% cream

CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauze

CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauze

CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauze

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Active principles

Hyaluronic acid sodium salt

Sulfadiazine argentica

CONNETTIVINA PLUS 0.2% + 1% cream

100 g of cream contain:

Hyaluronic acid sodium salt 200 mg

Silver sulfadiazine 1.00 g

CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauze

Each 10x10 cm gauze is soaked with 4 g of cream

CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauze

Each 10x20 cm gauze is soaked with 8 g of cream

CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauze

Each 20x30 cm gauze is soaked with 24 g of cream of the following percentage composition:

Hyaluronic acid sodium salt 50 mg

Silver sulfadiazine 1.00 g

03.0 PHARMACEUTICAL FORM -

Cream - impregnated gauze

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Prophylaxis and local treatment of sores, varicose ulcers and burns.

04.2 Posology and method of administration -

CONNETTIVINA PLUS 0.2% + 1% cream:

spread a uniform 2-3 mm thick layer of cream over the entire site of the lesion, once or twice a day.

CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauze

CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauze

CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauze

apply one or more medicated gauze two or more times a day depending on the extent of the lesions.

The application must continue without interruption, until complete healing.

04.3 Contraindications -

Hypersensitivity to product components or other closely related substances from a chemical point of view.

04.4 Special warnings and appropriate precautions for use -

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

04.5 Interactions with other medicinal products and other forms of interaction -

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

04.6 Pregnancy and breastfeeding -

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

04.7 Effects on ability to drive and use machines -

The drug does not affect the ability to drive and use machines.

04.8 Undesirable effects -

Following the application of CONNETTIVINA PLUS, modest local reactions may rarely occur.

No reports of systemic adverse reactions have ever been received, in fact the percutaneous absorption of CONNETTIVINAPLUS is negligible. However, since the systemic administration of sulfonamides can cause adverse reactions such as renal failure, toxic hepatitis, agranulocytosis, thrombocytopenia and leukopenia, it cannot be exclude that the treatment of large parts of the body with CONNETTIVINA PLUS may give rise to the classic side effects of sulfonamides administered systemically.

04.9 Overdose -

There are no known cases of overdose.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

CONNETTIVINA PLUS is an "association of hyaluronic acid and silver sulfadiazine. Hyaluronic acid is an acidic mucopolysaccharide which constitutes over 50% of the basic substance of the dermis; it is also found in high concentrations in the vitreous humor, in the synovial fluid, in the umbilical cord and in the bone cartilage. The local supply of hyaluronic acid determines the acceleration of the wound healing process.

Silver sulfadiazine has a remarkable antibacterial activity on many gram positive and gram negative germs and on many species of fungi. Its activity on Pseudomonas aeruginosa and Enterobacter pyogenes is remarkable, which are the microorganisms most frequently found in infected wounds and burns.

Thanks to the complementary action of the two active components, CONNETTIVINA PLUS prevents secondary infection and promotes wound healing.

05.2 "Pharmacokinetic properties -

Topical absorption of hyaluronic acid and silver sulfadiazine is clinically insignificant. Plasma levels of sulfadiazine are well below the threshold for systemic risks.

After skin application of a therapeutic dose of CONNETTIVINA PLUS, only 1% of the quantity of sulfonamide absorbed after oral administration of a therapeutic dose of sulphadiazine is absorbed on average.

05.3 Preclinical safety data -

The DL50 - os and i.p. in rats and mice hyaluronic acid is> 200 mg / kg.

The LD50-os in mice of sulfadiazine is> 10,000 mg / kg.

Chronic toxicity studies of hyaluronic acid, performed on various species of animals, did not show toxicity.

Long-term administration of sulfadiazine resulted in nephrotoxicity only at very high oral doses.

No interferences of any kind are established between the active constituents of CONNETTIVINA PLUS with regard to any toxic effects.

The association proved to be devoid of antigenic power and endowed with excellent local tolerability.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

CONNETTIVINA PLUS 0.2% + 1% cream

Polyethylene glycol 400 monostearate - decyl ester of oleic acid - emulsifying wax - glycerol - sorbitol solution 70% - purified water

CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauze

CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauze

CONNETTIVINA PLUS 12 mg + 240 mg impregnated gauze

Polyethylene glycol 4000 - glycerol - purified water

06.2 Incompatibility "-

There are no known incompatibilities.

06.3 Period of validity "-

The product is stable for 36 months when unopened.

06.4 Special precautions for storage -

Do not store above 30 ° C.

06.5 Nature of the immediate packaging and contents of the package -

Cream: 25 g aluminum tube

Impregnated gauze: single sealed bag of paper & 45; aluminum-polythene

Box of 10 impregnated gauze 10x10 cm

Box of 10 impregnated gauze 10x20 cm

Box of 5 impregnated gauze 20x30 cm

06.6 Instructions for use and handling -

No particular.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

FIDIA Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3 / A - 35031 Abano Terme (PD) - Tax Code n 00204260285

08.0 MARKETING AUTHORIZATION NUMBER -

CONNETTIVINA PLUS 0.2% + 1% cream: A.I.C. 028440030

CONNETTIVINA PLUS 2 mg + 40 mg impregnated gauze: A.I.C. 028440079

CONNETTIVINA PLUS 4 mg + 80 mg impregnated gauze: A.I.C. 028440055

CONNETTIVINAPLUS 12 mg + 240 mg impregnated gauze: A.I.C. 028440067

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

15/11/1999

10.0 DATE OF REVISION OF THE TEXT -

13/06/2000

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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