20 mg / ml + 0.70 ml / ml cutaneous solution
Chlorhexidine gluconate + Isopropyl alcohol
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
– Save this information. You may need to read it again.
– If you have any further questions, ask your doctor or nurse.
– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.
This leaflet contains information on:
1. What Chloraprep is and what it is used for
2. Before you use Chloraprep
3. How to use Chloraprep
4. Possible side effects
5. How to store Chloraprep
6. Other information
1. WHAT CHLORAPEPREP IS AND WHAT IT IS USED FOR
Chloraprep is a skin solution with chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml in a plastic applicator with a sponge tip at one end. The applicator contains a fast-acting antiseptic solution, which is used by healthcare professionals to disinfect the skin and avoid infection before medical procedures, such as injections, catheter insertion, and major or minor surgical procedures.
2. BEFORE YOU USE CHLORAPREP
Do not use Chloraprep
– if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Chloraprep (listed in section 6).
Take special care with Chloraprep
Chlorine prep should only be used for topical use.
Chlorine prep should not be used:
- close eyes or delicate mucous membranes, as it may cause irritation. If it gets in the eyes or mucous membranes in body openings, it must be quickly rinsed with plenty of water.
- in open wounds in the skin.
- in the parts of the ear that are inside the body (middle ear).
- in direct contact with nerve tissue (eg brain or spinal cord tissue).
Chloraprep can in rare cases cause severe allergic reactions that can lead to a drop in blood pressure and even unconsciousness. Early symptoms of a severe allergic reaction can be a skin rash or asthma. If you notice any such symptoms, stop using Chloraprep and talk to a doctor as soon as possible (see section 4, “Possible side effects”).
Apply Chloraprep gently on the skin. If the solution has been applied too abundantly to very sensitive or sensitive skin, or with repeated use, rashes, inflammation, itching, dry and/or flaky skin and pain may form. As soon as signs of any of these reactions appear, the application of Chloraprep must be stopped.
Avoid prolonged skin contact.
Wet materials, such as surgical drapes or protective coats, should be removed before use. The solution must not be collected in a puddle.
The solution is flammable. Do not use ignition sources until it has dried.
Use with caution in newborns, especially those born prematurely. Chloraprep can cause chemical burns to the skin.
Use of other medicines
Pregnancy and breastfeeding
There are no studies of Chloraprep in pregnant or lactating women.
No effects are expected during pregnancy, as systemic exposure to chlorhexidine gluconate is negligible. Chloraprep can be used during pregnancy.
No effects are expected on breast-fed infants/infants, as the systemic exposure of the lactating woman to chlorhexidine gluconate is negligible. Chlorine prep can be used during breastfeeding.
The effects of chlorhexidine gluconate on human reproduction have not been studied.
Driving and using machines
Chloraprep does not affect your ability to drive or use machines.
3. HOW TO USE CHLORAPREP
The antiseptic solution in the Chloraprep system is stored inside the plastic applicator. The doctor or nurse will choose the size of the applicator depending on the treatment area and the area to be covered. The doctor or nurse will gently apply the sponge over the skin, to cover the area to be prepared. Depending on the treatment, more than one applicator may need to be used.
Chlorine prep is used only on the skin and each applicator is used only once.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chloraprep can cause side effects, although not everybody gets them.
In very rare cases (affects less than 1 in 10,000 people), allergic reactions or irritated skin have been reported by the ingredients in Chloraprep ( chlorhexidine gluconate and isopropyl alcohol).
If you experience any of the following reactions, stop using Chloraprep and seek medical attention immediately: swelling of the face, lips, tongue, or throat; red rash and itching; wheezing or difficulty breathing; dullness or dizziness; a strange metallic taste in the mouth or collapse. You may have an allergic reaction.
If you get a rash, itching, or red, dry, or inflamed skin where you have used the product as a skin cleanser, stop using it and talk to a doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Reporting of side effects ar
If you get any side effects, talk to your doctor or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via:
The Medical Products Agency
751 03 Uppsala
By reporting side effects, you can help increase drug safety information.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE CHLORAPREP
Flammable. No special temperature instructions.
Store in original packaging; the applicator is sterile as long as the seal is intact.
Do not expose the container or its contents to open flames during use, storage, or disposal. Do not use this medicine after the expiry date which is stated on the label or carton. The expiration date is the last day of the specified month.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
- The active substances are chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.
- Other ingredients are purified water.
What the medicine looks like and the contents of the pack
The Sepp 0.67 ml applicator consists of a latex-free foam tip attached to a plastic container containing a glass ampoule with the antiseptic solution.
The Fripp 1.5 ml applicator consists of a latex-free rectangular foam sponge attached to a plastic container containing a glass ampoule with the antiseptic solution.
The 1 ml, 1.5 ml, 3 ml, and 10.5 ml applicators consist of a latex-free round sponge made of foam plastic attached to a plastic container containing a glass ampoule with the antiseptic solution. The 26 ml applicator consists of a latex-free square foam sponge attached to a plastic container containing two glass ampoules with the antiseptic solution. The sterile applicators are individually packaged in clear film.
- 0.67 ml Sepp: 200 applicator is
- 1 ml: 60 applicator is
- 1.5 ml Frepp: 20 applicators are
- 1.5 ml: 1 applicator or 25 applicator is
- 3 ml: 1 applicator or 25 applicator is
- 10.5 ml: 1 applicator or 25 applicator is
- 26 ml: 1 applicator
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Becton Dickinson France
11 Rue Aristide Bergès
38800 Le Pont de Claix