КЕТРИФАРМ 0.015% + 0.15% Топическое решение

Содержание инструкции

1. CETRIFARM 1.5% + 15% concentrate for cutaneous solution
   1. What is CETRIFARM and what is it used for
   2. What you need to know before using CETRIFARM
   3. How to use CETRIFARM
   4. Possible side effects
   5. How to store CETRIFARM
   6. Contents of the pack and other information
2. CETRIFARM 0.015%+0.15% cutaneous solution in single-dose container
   1. What is CETRIFARM and what is it used for
   2. What you need to know before using CETRIFARM
   3. How to use CETRIFARM
   4. Possible side effects
   5. How to store CETRIFARM
   6. Contents of the pack and other information

CETRIFARM 1.5% + 15% concentrate for cutaneous solution

Chlorhexidine gluconate and cetrimide

Read this leaflet carefully before using this medicine as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after a few days.

Contents of this leaflet:

• 1. What CETRIFARM is and what it is used for
• 2. What you need to know before you use CETRIFARM
• 3. How to use CETRIFARM
• 4. Possible side effects
• 5. How to store CETRIFARM
• 6. Contents of the pack and other information

1. What is CETRIFARM and what is it used for

CETRIFARM contains two active ingredients, chlorhexidine gluconate and cetrimide, which belong
to a group of medicines called antiseptics and disinfectants that reduce or block the growth of
bacteria.
CETRIFARM is indicated for cleaning and disinfecting:

• the skin, both intact and in the presence of superficial wounds of small size
• the external genitalia in obstetrics, gynecology and urology.

Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using CETRIFARM

Do not use CETRIFARM

• if you are allergic to chlorhexidine, cetrimide or any of the other ingredients of this medicine (listed in section 6);
• for disinfecting mucous membranes of the body, for example to perform washes and irrigations.

Warnings and precautions
Consult your doctor or pharmacist before using CETRIFARM.
This medicine must only be applied to the skin (external use).
Do not apply this medicine to the eyes or ear.
Furthermore, it is recommended to avoid contact with the brain or with the membranes that cover the
brain (meninges).
CETRIFARM must not be ingested, as serious consequences, including
death, may occur.
Avoid applying CETRIFARM under a non-breathable (occlusive) bandage.
After applying this medicine to the skin, do not expose yourself to the sun.
Do not use this medicine for prolonged treatments, as if you use CETRIFARM for a long
time, allergic reactions (hypersensitivity reactions) may occur. In this case,
stop treatment and consult your doctor who will establish a suitable therapy.

Children
CETRIFARM
may cause chemical burns in newborns, especially those born prematurely.

Other medicines and CETRIFARM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
During treatment with CETRIFARM, it is recommended to avoid using other similar medicines
(disinfectants or detergents).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
You can use this medicine if you are pregnant and if you are breastfeeding.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

3. How to use CETRIFARM

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The product must be used only diluted in water, as follows:

• external cleaning and disinfection in gynaecology, obstetrics and urology:20 ml of solution in 2 litres of water;
• disinfection of intact skin:20 ml of solution in 500 ml of water;
• disinfection and cleaning of superficial wounds of small size:20 ml of solution in 1 litre of water.

After appropriate dilution, dab the skin with cotton wool soaked in the medicine.
If necessary, repeat the application up to a maximum of 4-5 times a day.
Do not exceed the recommended doses.

If you use more CETRIFARM than you should
No cases of overdose have been reported under normal conditions of use.
Accidental ingestion of this medicine may cause symptoms such as: nausea, vomiting, difficulty
breathing (dyspnea), bluish discoloration of the skin due to lack of oxygen (cyanosis),
suffocation (asphyxia) due to blockage of the respiratory muscles, lowering of blood
pressure (hypotension), deep state of unconsciousness (coma).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• burning or irritation of the skin (intolerance). These effects generally do not require changes to treatment;
• idiosyncratic reactions (abnormal reactions to the medicine);
• burns (chemical burns) in newborns (frequency not known).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store CETRIFARM

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 packaging after
“Expiry”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C in the original packaging to protect the product
from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CETRIFARM contains

• The active ingredients are chlorhexidine gluconate and cetrimide. 100 g of solution contain 1.5 g of chlorhexidine gluconate and 15 g of cetrimide.
• The other ingredients are: isopropyl alcohol, purified water.

Description of the appearance of CETRIFARM and contents of the pack
Pack: 1 bottle of 1 litre.

Marketing authorisation holder and manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy

CETRIFARM 0.015%+0.15% cutaneous solution in single-dose container

Chlorhexidine gluconate and cetrimide

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days.

Contents of this leaflet:

• 1. What CETRIFARM is and what it is used for
• 2. What you need to know before using CETRIFARM
• 3. How to use CETRIFARM
• 4. Possible side effects
• 5. How to store CETRIFARM
• 6. Contents of the pack and other information

1. What is CETRIFARM and what is it used for

CETRIFARM contains two active ingredients, chlorhexidine gluconate and cetrimide, which belong
to a group of medicines called antiseptics and disinfectants that reduce or block the growth
of bacteria.
CETRIFARM is indicated for cleaning and disinfecting:

• the skin, both intact and in the presence of lesions (wounds, burns);
• the external genitalia in obstetrics, gynecology and urology.

Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using CETRIFARM

Do not use CETRIFARM

• if you are allergic to chlorhexidine, cetrimide or any of the other ingredients of this medicine (listed in section 6);
• for disinfecting mucous membranes of the body, for example to perform washes and irrigations.

Warnings and precautions
Consult your doctor or pharmacist before using CETRIFARM.
This medicine should only be applied to the skin (external use).
Do not apply this medicine to the ear.
Furthermore, it is recommended to avoid contact with the brain or with the membranes that line the
brain (meninges).
CETRIFARM must not come into contact with the eyes due to the risk of vision impairment. If
it comes into contact with the eyes, wash immediately and thoroughly with water. In case of
irritation, redness or eye pain or visual disturbance, consult a
doctor immediately.
Following accidental contact of similar products with the eye during surgical procedures on
patients under general anesthesia (induced deep sleep) there have been reports of serious
permanent corneal trauma (injury to the surface of the eye). Such injuries may
require a corneal transplant.
CETRIFARM must not be ingested, as serious consequences, including
fatal ones, may occur.
Avoid applying CETRIFARM under a non-breathable (occlusive) bandage.
After applying this medicine to the skin, do not expose yourself to the sun.
Do not use this medicine for prolonged treatments, as if you use CETRIFARM for a long
time, allergic reactions (hypersensitivity reactions) may occur. In this case,
stop treatment and consult your doctor who will establish a suitable therapy.

Children
CETRIFARM can cause chemical burns in newborns, especially in those born
prematurely.

Other medicines and CETRIFARM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
During treatment with CETRIFARM, it is recommended to avoid using other similar medicines
(disinfectants or detergents).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
You can use this medicine if you are pregnant and if you are breastfeeding.

Driving and operating machinery
This medicine does not alter the ability to drive or operate machinery.

Cetrifarm contains ethanol
This medicine contains 57 mg of alcohol (ethanol) in 100 ml of solution, which is equivalent to
0.057% w/v. It may cause a burning sensation on damaged skin.

3. How to use CETRIFARM

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The product can be used on broken skin and intact skin.
Dab the skin with cotton wool soaked in the medicine.
If necessary, repeat the application up to a maximum of 4-5 times a day.
Do not exceed the recommended doses.

If you use more CETRIFARM than you should
No cases of overdose have been reported under normal conditions of use.
Accidental ingestion of this medicine may cause symptoms such as: nausea, vomiting, difficulty
breathing (dyspnea), bluish discoloration of the skin due to oxygen deficiency (cyanosis),
suffocation (asphyxia) due to blockage of the respiratory muscles, lowering of blood
pressure (hypotension), deep state of unconsciousness (coma).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• burning or irritation of the skin (intolerance). These effects generally do not require changes to the treatment;
• idiosyncratic reactions (abnormal reactions to the medicine);
• burns (chemical burns) in newborns (frequency not known);
• corneal trauma (injury to the surface of the eye) and permanent eye damage, including permanent impairment of vision (following accidental exposure of the eyes during surgeries to the head, face and neck) in patients under general anesthesia (induced deep sleep) (frequency not known).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store CETRIFARM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after
“Expiry”.
Store in the original package.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CETRIFARM contains

• The active ingredients are chlorhexidine gluconate and cetrimide. 100 g of solution contains 0.015 g of chlorhexidine gluconate and 0.150 g of cetrimide. The other ingredients are: ethyl alcohol 95°, purified water.

Description of the appearance of CETRIFARM and contents of the pack
Pack of 1 sachet containing 25 ml of clear sterile solution.

Marketing Authorisation Holder and Manufacturer
Nuova Farmec S.r.l. – Via W. Flemming, 7 – Settimo di Pescantina (VR) - Italy