Connettivina Plus
ItalyTable of Contents
Package leaflet: Information for the user
Connettivina Plus 2 mg + 40 mg impregnated gauzes, 4 mg + 80 mg impregnated gauzes, 12 mg + 240 mg impregnated gauzes
Sodium hyaluronate + silver sulfadiazine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.
Contents of this leaflet:
- What Connettivina Plus is and what it is used for
- What you need to know before using Connettivina Plus
- How to use Connettivina Plus
- Possible side effects
- How to store Connettivina Plus
- Contents of the pack and other information
1. What Connettivina Plus is and what it is used for
Connettivina Plus impregnated gauzes contain two active substances: sodium hyaluronate and silver sulfadiazine, and belong to a class of medicinal products known as healing and disinfectant agents.
Hyaluronic acid is a substance naturally produced by our body. Local administration of hyaluronic acid facilitates the healing process of lesions.
Silver sulfadiazine is an active ingredient belonging to the sulphonamide antibiotic family and is capable of inhibiting bacterial replication mechanisms, thereby preventing the development of infections.
Connettivina Plus impregnated gauzes are indicated for the local treatment of pressure ulcers at an early stage (before the skin breaks down) and for the treatment of mild burns (first- and second-degree burns).
2. What you need to know before using Connettivina Plus
Do not use Connettivina Plus:
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Connettivina Plus if:
you have previously experienced a hypersensitivity reaction (allergic reaction) after taking sulfonamides;
you have severe liver problems (hepatic insufficiency);
you have severe kidney problems (renal insufficiency);
you are pregnant or breastfeeding.
Other medicines and Connettivina Plus
Inform 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 locally applied proteolytic enzymes,
as their activity may be inhibited by the components present in the dressings.
Do not use disinfectants containing quaternary ammonium salts simultaneously.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Connettivina Plus must not be used during pregnancy or breastfeeding unless your doctor considers the therapeutic benefits to outweigh the potential risks. In such cases, Connettivina Plus should be used only under direct medical supervision.
Driving and using machines
Connettivina Plus does not affect the ability to drive vehicles or operate machinery.
Connettivina Plus impregnated dressings contain polyethylene glycol 4000. It may cause skin irritation.
3. How to use Connettivina Plus
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply one or more Connettivina Plus dressings, depending on the size of the area to be treated, two or more times a day.
Before applying CONNETTIVINA PLUS, the affected areas must be cleaned, preferably with sterile physiological solution (NaCl 0.9%) and disinfected using antiseptics, preferably those containing povidone-iodine or chlorhexidine. If deemed necessary by the physician, surgical debridement should be performed.
In the treatment of burns, wound cleaning should preferably be carried out with water or sterile physiological solution alone, avoiding disinfection with antiseptic agents before applying Connettivina PLUS.
Do not stop treatment until the lesion is completely healed.
Consult your doctor if symptoms persist after a short period of treatment, or at any time if they worsen.
If you use more Connettivina Plus than you should
In case of accidental overdose with Connettivina Plus, immediately inform your doctor or go to the nearest hospital.
No cases of overdose due to excessive use of Connettivina Plus have been reported.
If you forget to use Connettivina Plus
If you have forgotten to apply the dressing, do so as soon as you remember. Then continue applying it according to the usual schedule.
If you stop using Connettivina Plus
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
After application of CONNETTIVINA PLUS dressings, local reactions (pain, burning, itching), including allergic reactions, may occur.
Following application of Connettivina Plus to extensive areas of skin, you may experience adverse reactions usually observed with systemic administration (oral or injectable routes) of sulfonamide-containing medicines (the drug class to which sulfadiazine belongs), such as:
- severe kidney problems (renal failure);
- liver inflammation due to exposure to certain substances (toxic hepatitis);
- reduction in the number of circulating white blood cells (agranulocytosis and leukopenia) and platelets (thrombocytopenia).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: http://www.agenziafarmaco.it/it/responsabili .
By reporting adverse reactions, you can help provide further information on the safety of this medicine.
5. How to store Connettivina Plus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine kept in its original, unopened packaging and stored correctly.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Connettivina Plus contains
Connettivina Plus 2 mg + 40 mg impregnated gauzes
The active substances are sodium hyaluronate and silver sulfadiazine.
Each gauze is impregnated with 4 g of cream containing 2 mg of hyaluronic acid and 40 mg of silver sulfadiazine.
The other components are: polyethylene glycol 4000, glycerol, purified water.
Connettivina Plus 4 mg + 80 mg impregnated gauzes
The active substances are sodium hyaluronate and silver sulfadiazine.
Each gauze is impregnated with 8 g of cream containing 4 mg of hyaluronic acid and 80 mg of silver sulfadiazine.
The other components are: polyethylene glycol 4000, glycerol, purified water.
Connettivina Plus 12 mg + 240 mg impregnated gauzes
The active substances are sodium hyaluronate and silver sulfadiazine.
Each gauze is impregnated with 24 g of cream containing 12 mg of hyaluronic acid and 240 mg of silver sulfadiazine.
The other components are: polyethylene glycol 4000, glycerol, purified water.
Description of the appearance of Connettivina Plus and package contents
Connettivina Plus 2 mg + 40 mg impregnated gauzes
Each package contains 10 impregnated gauzes of 10x10 cm, individually enclosed in sealed aluminum-paper-polyethylene pouches.
Connettivina Plus 4 mg + 80 mg impregnated gauzes
Each package contains 10 impregnated gauzes of 10x20 cm, individually enclosed in sealed aluminum-paper-polyethylene pouches.
Connettivina Plus 12 mg + 240 mg impregnated gauzes
Each package contains 5 impregnated gauzes of 20x30 cm, individually enclosed in sealed aluminum-paper-polyethylene pouches.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Package leaflet: Information for the user
Connettivina Plus 2 mg/g + 10 mg/g cream
Sodium hyaluronate + silver sulfadiazine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.
Contents of this leaflet:
- What Connettivina Plus is and what it is used for
- What you need to know before using Connettivina Plus
- How to use Connettivina Plus
- Possible side effects
- How to store Connettivina Plus
- Package contents and other information
1. What Connettivina Plus is and what it is used for
Connettivina Plus 2 mg/g + 10 mg/g cream contains two active substances: sodium hyaluronate and silver sulfadiazine, and belongs to a class of medicines known as healing and antiseptic agents.
Hyaluronic acid is a substance naturally produced by the human body. Local application of hyaluronic acid supports the healing process of skin lesions.
Silver sulfadiazine is an active ingredient belonging to the family of sulfonamide antibiotics, capable of inhibiting bacterial replication and thereby preventing the development of infections.
Connettivina Plus 2 mg/g + 10 mg/g cream is indicated for the local treatment of early-stage pressure ulcers (before skin breakdown occurs) and for the treatment of mild-degree burns (first- and second-degree burns).
2. What you need to know before using Connettivina Plus
Do not use Connettivina Plus:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Connettivina Plus if:
you have previously experienced hypersensitivity reactions (allergic reactions) after taking sulfonamides;
you have severe liver problems (hepatic insufficiency);
you have severe kidney problems (renal insufficiency);
you are pregnant or breastfeeding.
Other medicines and Connettivina Plus
Inform 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 topical use, as their action may be inhibited by the components present in the cream.
Do not use disinfectants containing quaternary ammonium salts simultaneously.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Connettivina Plus must not be used during pregnancy or breastfeeding unless your doctor considers the therapeutic benefits to outweigh the potential risks. In such cases, Connettivina Plus must be used only under the direct supervision of your doctor.
Driving and using machines
Connettivina Plus does not affect the ability to drive or operate machinery.
Connettivina Plus cream contains polyethylene glycol 400 monostearate. It may cause skin irritation.
4. How to use Connettivina Plus
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply an even layer of cream 2–3 mm thick to the affected area, 1 or 2 times daily.
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 deemed necessary by the doctor, surgical debridement should be performed.
In the treatment of burns, wound cleaning should preferably be carried out with water or sterile physiological solution alone, avoiding disinfection with antiseptic agents before application of Connettivina Plus.
Do not stop 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 worsen.
If you use more Connettivina Plus than you should
In case of accidental overdose with Connettivina Plus, immediately inform your doctor or go to the nearest hospital.
No cases of overdose due to excessive use of Connettivina Plus are known.
If you forget to use Connettivina Plus
If you forget to apply the cream, do so as soon as you remember. Then continue applying it according to the usual schedule.
If you stop using Connettivina Plus
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
After application of CONNETTIVINA PLUS, local reactions (pain, burning, itching), including allergic reactions, may occur.
Following application of Connettivina Plus to large areas of skin, you may experience side effects typically observed with systemic administration (oral or injectable) of sulfonamide medicines (the class of drugs to which sulfadiazine belongs), such as:
- serious kidney problems (renal failure);
- liver inflammation due to exposure to certain substances (toxic hepatitis);
- reduced number of circulating white blood cells (agranulocytosis and leukopenia) and platelets (thrombocytopenia).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address: http://www.agenziafarmaco.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Connettivina Plus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine stored in its original intact packaging and kept under proper storage conditions.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
7. Package contents and other information
What Connettivina Plus contains
The active substances are: sodium hyaluronate and silver sulfadiazine.
1 g of cream contains 2 mg of sodium hyaluronate and 10 mg of silver sulfadiazine.
The other components are: polyethylene glycol 400 monostearate, decyl oleate, emulsifying wax, glycerol, sorbitol 70% 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 supplied in a 25 g aluminium tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Manufacturers
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Zeta Farmaceutici S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)