Active ingredients: Hyaluronic acid (hyaluronic acid sodium salt)
0.2% Cream
0.2% Gel
2 mg Impregnated gauze
4 mg Impregnated gauze
12 mg Impregnated gauze
200 mg / 100 ml Cutaneous spray, solution
Why is Connettivina used? What is it for?
CONNETTIVINA is a healing agent used for the treatment of wounds and skin ulcerations.
Why is it used
CONNETTIVINA stimulates skin repair and regeneration, accelerating the healing of abrasions, bruises, superficial wounds, burns, minor burns and breast fissures.
CONNETTIVINA is also indicated in localized skin irritations caused by physical agents such as sun, cold, wind, diaper redness, irritation and dehydration resulting from radiotherapy treatments.
CONNETTIVINA can also be used as an adjuvant in the treatment of skin ulcers of vascular origin and slow-healing wounds such as bedsores.
Contraindications When Connettivina should not be used
Hypersensitivity to components or other closely related substances from a chemical point of view.
When it can be used only after consulting your doctor
For the use of CONNETTIVINA it is not necessary to consult a doctor.
What to do during pregnancy and breastfeeding
CONNETTIVINA can be used during pregnancy and breastfeeding.
Precautions for use What you need to know before taking Connettivina
Before applying CONNETTIVINA clean and disinfect the area to be treated.
Interactions Which drugs or foods can modify the effect of Connettivina
No phenomena of interaction between CONNETTIVINA and antibiotics or other local treatments have ever been reported.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
The use of the product, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to stop the treatment and contact your doctor. The product does not interfere with the ability to drive and use machines.
Dose, Method and Time of Administration How to use Connettivina: Posology
How many
Skin spray, solution; Cream; Gel: treat the lesion 2-3 times a day, applying the amount of product necessary to evenly cover the entire affected area.
Impregnated gauze: apply one or more gauze depending on the extent of the area to be treated, changing it / s 2-3 times a day.
WARNING: do not exceed the indicated doses without medical advice.
When and for how long
ATTENTION: use only for short periods of treatment. If the problem persists, consult your doctor.
Like
Before applying CONNETTIVINA, thoroughly cleanse and disinfect the lesion.
Cream and Gel: evenly distribute the amount necessary to cover the lesion with the help of a sterile gauze in the case of an open wound.
Impregnated gauze: take it out of the bag, simply touching one end, apply it to the lesion and cover with a suitable bandage.
Skin spray, solution: dispense the solution evenly over the lesion.
Overdose What to do if you have taken an overdose of Connettivina
There have never been any reports of intoxication due to an overdose of CONNETTIVINA.
The product is for external use only. In case of accidental ingestion of an excessive dose of CONNETTIVINA, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Connettivina
No systemic side effects associated with CONNETTIVINA have ever been reported. Reactions of a local type, always of modest entity, have been reported sporadically, which resolved spontaneously. The use of the product, especially if prolonged, can give rise to sensitization phenomena.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
However, when they do occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the Undesirable Effects report form, available at the pharmacy (form B).
Expiry and Retention
The expiry date indicated on the package refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach of children.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
Composition
CONNETTIVINA 0.2% Cream. Active ingredient: hyaluronic acid sodium salt 2 mg / g
Excipients: polyethylene glycol 400 monostearate, decyl ester of oleic acid, emulsifying wax, glycerol, 70% sorbitol solution, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium dehydroacetate, flavor (Dalin PH), purified water.
CONNECTIVIN 0.2% Gel. Active ingredient: hyaluronic acid sodium salt 2 mg / g (60 mg per 30 g tube)
Excipients: 70% non crystallizable sorbitol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium dehydroacetate, carbomer 940, sodium hydroxide, purified water
CONNETTIVINA 2 mg Impregnated gauze. Each gauze (10x10 cm) is impregnated with 4 g of cream containing:
Active ingredient: hyaluronic acid sodium salt 2 mg. Excipients: glycerol, polyethylene glycol 4000, purified water
CONNETTIVINA 4 mg Impregnated gauze. Each gauze (10x20 cm) is impregnated with 8 g of cream containing:
Active ingredient: hyaluronic acid sodium salt 4 mg. Excipients: glycerol, polyethylene glycol 4000, purified water
CONNETTIVINA 12 mg Impregnated gauze. Each gauze (20x30 cm) is impregnated with 24 g of cream containing:
Active ingredient: hyaluronic acid sodium salt 12 mg. Excipients: glycerol, polyethylene glycol 4000, purified water
CONNETTIVINA 200 mg / 100 ml Cutaneous spray, solution.
Active ingredient: hyaluronic acid sodium salt 2 mg / ml (40 mg per 20 ml bottle). Excipients: sodium chloride, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.
How it looks
CONNETTIVINA comes in different forms for external use:
Cream: 15g tube and 100g tube
Gel: 30 g tube.
2 mg Impregnated gauzes: 10 sterile impregnated gauzes 10x10 cm for cutaneous use.
4 mg Impregnated gauzes: 10 sterile impregnated gauzes 10x20 cm for cutaneous use.
12 mg Impregnated gauzes: 5 sterile impregnated gauzes 20x30 cm for cutaneous use.
Skin spray, solution: Nebulizer bottle containing 20 ml of solution.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
CONNECTIVINE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
CONNETTIVINA 200 mg / 100 mL Cutaneous spray, solution
100 mL of solution contain:
Hyaluronic acid sodium salt 200 mg
CONNETTIVINA 0.2% Cream
100 g of cream contain:
Hyaluronic acid sodium salt 200 mg
CONNETTIVINA 2 mg Impregnated gauze
A 10x10 cm gauze is impregnated with 4 g of cream containing:
Hyaluronic acid sodium salt 2 mg
CONNETTIVINA 4 mg Impregnated gauze
A 10x20 cm gauze is impregnated with 8 g of cream containing: P
Hyaluronic acid sodium salt 4 mg
CONNETTIVINA 12 mg Impregnated gauze
A 20x30 cm gauze is impregnated with 24 g of cream containing:
Hyaluronic acid sodium salt 12 mg
CONNECTIVIN 0.2% Gel
100 g of gel contain:
Hyaluronic acid sodium salt 200 mg
CONNETTIVINA 0.2% Skin foam
One foam bottle contains 47 g of solution and 3 g of propellant gas.
100 g of solution contain:
Hyaluronic acid sodium salt 200 mg
03.0 PHARMACEUTICAL FORM
Skin spray, solution
Cream
Impregnated gauze
Gel
Skin foam
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
CONNETTIVINA stimulates skin repair and regeneration, accelerating the healing of abrasions, bruises, superficial wounds, burns, minor burns and breast fissures.
CONNETTIVINA is also indicated in localized skin irritations caused by physical agents such as sun, cold, wind, diaper redness, irritation and dehydration resulting from radiotherapy treatments.
CONNETTIVINA can also be used as an adjuvant in the treatment of skin ulcers of vascular origin and slow-healing wounds such as bedsores.
04.2 Posology and method of administration
CONNETTIVINA 200 mg / 100 mL Skin spray, solution, CONNETTIVINA 0.2% Cream, CONNETTIVINA 0.2% Gel and CONNETTIVINA 0.2% Skin foam: 2-3 applications per day, evenly covering the entire affected area.
CONNETTIVINA 2 mg Impregnated gauze, CONNETTIVINA 4 mg Impregnated gauze and CONNETTIVINA 12 mg Impregnated gauze: apply 1 or more impregnated gauze depending on the extent of the area to be treated, changing it 2-3 times a day. Then cover the gauze with appropriate bandage.
04.3 Contraindications
Hypersensitivity to the components of the product and to other closely related substances from a chemical point of view.
04.4 Special warnings and appropriate precautions for use
Before each topical application it is recommended to cleanse and disinfect the area to be treated.
The use of the product, especially if prolonged, can give rise to sensitization phenomena. If this happens it is necessary to interrupt the treatment and institute a suitable therapy.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
The association of hyaluronic acid with antibiotics and other local treatments has never given rise to interaction phenomena.
04.6 Pregnancy and lactation
The drug can be used during pregnancy and breastfeeding.
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, no systemic adverse reactions have ever been reported. Reactions of a local type, always of moderate severity, were reported sporadically and resolved spontaneously.
04.9 Overdose
Manifestations of intoxication from overdose of CONNETTIVINA are excluded.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Hyaluronic acid conditions the physiological process of cellular events essential to the tissue repair process. Its local contribution creates the optimal conditions for the migration and proliferation of the cells responsible for the formation of new tissue and stimulates the phagocytic activity of macrophages.
05.2 Pharmacokinetic properties
After systemic administration, hyaluronic acid is rapidly distributed (plasma half-life about 10 ") and efficiently metabolized in the liver. Following topical application, very modest plasma levels of hyaluronic acid are found: this demonstrates poor percutaneous absorption and maximum permanence of the drug at the site where it must carry out the therapeutic action.
05.3 Preclinical safety data
Acute, subacute, chronic toxicity and reproductive toxicity studies performed on various animal species did not show hyaluronic acid toxicity (LD50> 200 mg / kg in rats and mice).
The drug also proved to be devoid of mutagenic and antigenic power and endowed with excellent local tolerability.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
CONNETTIVINA 200 mg / 100 mL Cutaneous spray, solution:
Sodium chloride, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.
CONNETTIVINA 0.2% Cream:
Polyethylene glycol 400 monostearate, decyl ester of oleic acid, emulsifying wax, glycerol, sorbitol solution 70%, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate - sodium dehydroacetate, flavor (Dalin PH), purified water.
CONNETTIVINA 2 mg impregnated gauze, CONNETTIVINA 4 mg impregnated gauze, CONNETTIVINA 12 mg impregnated gauze:
Glycerol, polyethylene glycol 4000, purified water.
CONNECTIVIN 0.2% Gel:
70% non crystallizable sorbitol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium dehydroacetate, carbomer 940, sodium hydroxide, purified water.
CONNETTIVINA 0.2% Skin foam:
Polysorbate 80, propylene glycol, polyvinylpyrrolidone, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium dehydroacetate, purified water. Propellant gas: isobutane-propane.
06.2 Incompatibility
Up to now there are no known phenomena of incompatibility of CONNETTIVINA.
06.3 Period of validity
CONNETTIVINA 200 mg / 100 mL Cutaneous spray, solution: 60 months.
CONNETTIVINA0,2% Cream, CONNETTIVINA 2 mg Impregnated gauze, CONNETTIVINA 4 mg Impregnated gauze, CONNETTIVINA 12 mg Impregnated gauze: 36 months.
CONNETTIVINA 0.2% Gel, CONNETTIVINA 0.2% Skin foam: 24 months.
The validity indicated refers to the product in intact and correctly stored packaging.
06.4 Special precautions for storage
Skin spray, solution, cream and impregnated gauzes: do not store above 30 ° C.
Skin gel and foam: do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Nebulizer bottle: type I amber glass, with plastic nebulizer closed with polyethylene cap.
Cream: aluminum tube.
Impregnated gauze: single sealed envelope of paper-aluminum-polythene.
Gel: aluminum tube
Skin foam: aluminum cylinder lined internally with epoxy-phenolic resin and valve in plastic material with aluminum seam
CONNETTIVINA 200 mg / 100 mL Cutaneous spray, solution: 1 vial. 20 mL
CONNETTIVINA 0.2% Cream: 15 g tube
CONNETTIVINA2 mg Impregnated gauzes: 10 gauze 10x10 cm
CONNETTIVINA4 mg Impregnated gauze: 10 gauze 10X20 cm
CONNETTIVINA 12 mg Impregnated gauzes: 5 20x30 cm gauzes
CONNECTIVIN 0.2% Gel: 30 g tube
CONNETTIVINA 0.2% Skin foam: 50 g bottle
06.6 Instructions for use and handling
Impregnated gauze: take the gauze from the envelope by simply touching one end, apply it to the lesion and cover with a suitable bandage.
Skin foam: shake before use.
07.0 MARKETING AUTHORIZATION HOLDER
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 0.2% A.I.C. Cream 019875044
CONNETTIVINA 200 mg / 100 mL Cutaneous spray, A.I.C. 019875069
CONNETTIVINA2 mg Impregnated gauzes 10x10 cm A.I.C. 019875057
CONNETTIVINA 4 mg Impregnated gauzes 10x20 cm A.I.C. 019875071
CONNETTIVINA 12 mg Impregnated gauzes 20x30 cm A.I.C. 019875083
CONNECTIVIN 0.2% Gel A.I.C. 019875095
CONNETTIVINA 0.2% Skin foam A.I.C. 019875107
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Cream: 09.06.1971 / 01.06.2000
Skin spray: 26.08.1969 / 01.06.2000
Gauzes 10x10 cm: 23.12.1980 / 01.06.2000
Gauze cm 10x20 and cm 20x30: 13.06.2000
Skin Gel and Foam: 28.05.2001
10.0 DATE OF REVISION OF THE TEXT
28/05/2001
