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ChloraPrep Cutaneous Solution (Chlorhexidine Gluconate / Isopropyl Alcohol)

What is ChloraPrep and why is it used?

ChloraPrep is a plastic applicator with a sponge tip on one end. The applicator contains a fast acting antiseptic solution, which is used to disinfect the skin and help prevent infections before medical procedures, such as injections, insertion of catheters and surgery.

Before ChloraPrep is used

Do not use ChloraPrep

  • if you are allergic (hypersensitive) to chlorhexidine gluconate or isopropyl alcohol. (See Section 6 “Further information’ for a full list of ingredients.)
  • on babies less than 2 months old. ChloraPrep* can sometimes irritate and pass through a baby’s skin,
  • near eyes or delicate linings, as it may cause irritation. If it does get into the eye or the delicate linings to the body passages (mucous membranes), it should be washed quickly with plenty of water,
  • on open skin wounds.
  • on the part of the ear that is inside the body (middle ear),
  • on a lumbar puncture (where a needle is inserted to the small of your back).

Using other medicines

Tell your doctor or nurse if you have recently had a vaccine or skin test injection (patch test used to test for allergies).

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast feeding, ChloraPrep*can still be used. You can talk about this more with your doctor or nurse.

Driving and using machines

ChloraPrep does not affect your driving or ability to use machines.

How ChloraPrep will be used

The antiseptic solution within the ChloraPrep system is kept inside the plastic applicator. Your doctor or nurse will rub the sponge over your skin, covering the skin area that needs to be prepared. Depending on your medical procedure, more than one applicator may be used,

ChloraPrep is only used on the skin and each applicator is only used once.

If you have any further questions on the use of this product, ask your doctor or nurse,

Possible side effects

Like all medicines, ChloraPrep can cause side effects, although not everybody gets them. Rarely (fewer than 1 in 1,000 people), allergic or irritated skin reactions have been reported with the active ingredients, chlorhexidine or isopropyl alcohol. If the side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse immediately.

The following information is intended for medical or healthcare professionals only

ChloraPrep

2%w/v/70%v/v Cutaneous Solution

Chlorhexidine Gluconate / Isopropyl Alcohol

Sepp 0.67-mL / Frepp 1.5-mL / 1.5-mL / 3-mL / 10.5-mL / 26-mL

Instructions for using the applicators:

For cutaneous use. For external use only,

  • Remove the applicator from the wrapper and hold it with the sponge facing downward,
  • Squeeze the applicator:
    • 0.67-mL (Sepp) squeeze barrel
    • 26-mL squeeze lever on handle
    • other products, squeeze wings
  • Gently press the sponge against the patient’s skin in order to apply the antiseptic solution, A back and forth action of the sponge should be used for 30 seconds.
  • The 26-mL applicator includes two swabs. Clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)
  • Allow the covered area to dry naturally.

ChloraPrep can be left on the skin post procedure.

Maximum coverage areas:

  • Sepp (0.67-mL)       5 cm x 8 cm
  • Frepp (1.5-mL)        10 cm x 13 cm
  • 1.5-mL                     10cmx13cm
  • 3-mL                       15 cm x 15 cm
  • 10.5-mL                   25 cm x 30 cm
  • 26-mL                     50 cm x 50 cm

Precautions for Use:

  • Do not use on babies less than 2 months old. ChloraPrep can sometimes irritate and pass through a baby’s skin,
  • Do not use near eyes or mucous membranes, as it may cause irritation.

If it does get into the eye or the mucous membranes, it should be washed quickly with plenty of water.

  • Do not use on open skin wounds.
  • Do not use on a lumbar puncture.
  • ChloraPrep should not come into contact with the brain, the meninges, or the middle ear.
  • Allow ChloraPrep to dry completely before starting any medical procedure.
  • Do not use with electrocautery procedures until dry. Remove any soaked materials, towels, drapes or gowns before proceeding.
  • Chlorhexidine is incompatible with soap and other anionic agents.

Special precautions for disposal

the solution is flammable. Do not use while smoking or near any naked flames or strong heat source. Avoid exposure of the container and contents to naked flames during use, storage and disposal. Discard the applicator after use as per clinical waste procedures.

Please refer to the Summary of Product Characteristics for ChloraPrep for further detailed information.

Storage Procedures

ChloraPrep is for single use only and is sterile until the packaging is opened.

Do not use ChloraPrep after the expiry date stated on the label or carton. The expiry date refers to the last day of that month. Do not store above 25°C. Avoid freezing. Store in the original packaging.

Active Substances

The active substances in ChloraPrep are chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v). The inactive ingredient in ChloraPrep is purified water.

How to store Chloraprep

Do not store ChloraPrep above 25°C. Do not freeze.

Store in the original packaging. Do not use past the expiry date.

Keep out of the reach and sight of children.

Further information

ChloraPrep is a plastic applicator with a sponge tip on one end and contains an antiseptic solution. The cutaneous solution (a solution for use on the skin) is contained in a glass ampoule which is inside the plastic applicator.

The active substances in ChloraPrep are chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v). The inactive ingredient in ChloraPrep* is purified water.

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