20 mg / ml + 0.70 ml / ml Cutaneous solution
3
1. WHAT CHLORAPREP COLORED IS AND WHAT IT IS USED FOR
Chloraprep stained 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 surgeries. Chloraprep dyed contains color to color the skin, which has no effect on the antiseptic effect.
2. BEFORE YOU USE CHLORAPREP COLORED
Do not use CHLORAPREP COLORED
- if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Chloraprep stained, especially if you have previously had allergic reactions that may be related to the use of chlorhexidine (listed in section 6).
Take special care with CHLORAPREP COLORED
ChloraPrep stained should only be used for external use.
ChloraPrep stained 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 stained 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 stained and consult a doctor as soon as possible (see section 4, “Possible side effects”).
Apply Chloraprep stained gently on the skin. If the solution has been applied too abundantly to very sensitive or sensitive skin or with repeated use, rash, 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 staining 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.
Children
Use with caution in newborns, especially those born prematurely. Chloraprep stained can cause chemical burns to the skin.
Use of other medicines
Tell your doctor or nurse if you have recently been vaccinated or had an allergy test on your skin ( patch test ).
Pregnancy and breastfeeding
There are no studies of Chloraprep stained in pregnant or lactating women.
Pregnancy
No effects are expected during pregnancy, as systemic exposure to
chlorhexidine gluconate is negligible. Chloraprep stained can be used during pregnancy.
Breast-feeding
No effects are expected on breast-fed infants / infants, as the systemic exposure of the lactating woman to chlorhexidine gluconate is negligible. Chloraprep stained can be used during breastfeeding.
Fertility
The effects of chlorhexidine gluconate on human reproduction have not been studied.
Driving and using machines
Chloraprep stained does not affect the ability to drive or use machines.
3. HOW TO USE CHLORAPREP COLORED
The antiseptic solution in the Chloraprep stained 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.
Chloraprep dyed 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 stained can cause side effects, although not everybody gets them.
If you experience any of the following reactions, stop using Chloraprep stained 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, or your skin starts to itch, hurt, become red, get blisters, become dry or inflamed where you have used the product as a skin cleanser, stop using Chloraprep stained and talk to a doctor or pharmacist.
In very rare cases (affects less than 1 in 10,000 people), allergic reactions or irritated skin have been reported on the ingredients in Chloraprep dyed ( chlorhexidine gluconate , isopropyl alcohol and the dye Sunset Yellow E110).
Other possible side effects with unknown frequency are: eye irritation, pain, impaired vision, chemical burns, eye injuries, skin burns in newborns / infants.
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 COLORED
Flammable. No special temperature instructions.
Store in the original package. 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 out of 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
Content declaration
- The active substances are chlorhexidine gluconate 20 mg / ml and isopropyl alcohol 0.70 ml / ml.
- Other ingredients are purified water and Sunset Yellow (E110).
What the medicine looks like and the contents of the pack
All 3 ml and 10.5 ml applicators consist of a latex-free round foam foam sponge attached to a plastic container containing a glass ampoule containing 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 a clear film.
Pack size:
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
France
Phone: 0200-895-463