CHLORAPREP

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

متاح من:

BECTON DICKINSON (BD) ISRAEL LTD., ISRAEL

ATC رمز:

D08AC52

الشكل الصيدلاني:

CUTANEOUS SOLUTION

تركيب:

ISOPROPYL ALCOHOL 0.7 ML / 1 ML; CHLORHEXIDINE GLUCONATE 20 MG / 1 ML

طريقة التعاطي:

EXTERNAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

CAREFUSION 213 LLC., USA

المجال العلاجي:

CHLORHEXIDINE, COMBINATIONS

الخصائص العلاجية:

Chloraprap is indicated for disinfection of the skin prior to invasive medical procedures.

تاريخ الترخيص:

2023-03-21

نشرة المعلومات

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
The medicine is dispensed without a doctor’s prescription
CHLORAPREP
COMPOSITION:
ACTIVE INGREDIENTS
Chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.
INACTIVE INGREDIENTS AND ALLERGENS - see section 6 "Further
information".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, consult the doctor or pharmacist.
Use this medicine in accordance with the instructions in the dosage
section in this
leaflet. Consult the pharmacist if you need further information. Refer
to the doctor if
signs of the illness worsen or do not improve.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicinal product is to be used for disinfection of the skin prior
to invasive
medical procedures.
Therapeutic group: Chlorhexidine, combinations.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are allergic (hypersensitive) to chlorhexidine gluconate or any of
the other
ingredients of ChloraPrep, especially if you have a history of
possible
chlorhexidine-related allergic reactions (see Section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
ChloraPrep is for external use only.
ChloraPrep should not be used:
-
near eyes or delicate linings (mucous membranes), as it may cause
irritation.
If it does get into the eye or the delicate linings to the body
passages, 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).
-
in direct contact with neural tissue (for example brain and spinal
cord tissue).
ChloraPrep may in rare cases cause severe allergic reactions, leading
to a drop in
blood pressure and even to unconsciousness. Early symptoms of a severe
allergic
reaction may be skin rash or asthma. If you notice these symptoms,
stop using
ChloraPrep and contact your doctor as soon as possible
(see under section 4: “S
ide
effects”)

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
ChloraPrep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 20 mg/ml
Isopropyl alcohol 0.70 ml/ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous Solution.
Clear Solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The medicinal product is to be used for disinfection of the skin prior
to invasive medical
procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ChloraPrep may be used on all age groups and patient populations.
_Paediatric population _
However, ChloraPrep should be used with care in newborn babies,
especially those born
prematurely (see also section 4.4, Special warnings and precautions
for use).
One applicator is used containing 1 ml, 1.5 ml, 3 ml, 10.5 ml or 26 ml
of the ChloraPrep
alcoholic solution.
Method of administration
For cutaneous use
The choice of applicator will depend on the invasive procedure being
undertaken and the
clinician’s preference.
APPLICATOR
COVERAGE AREA (CM X CM)
FOR PROCEDURES SUCH AS:
1 ML
8 X 10
- Routine venipuncture
- Blood culture collection
- Peripheral (arterial line) cannulation
- Simple biopsy
1.5 ML
10 X 13
-Routine venipuncture
- Blood culture collection
- Peripheral (arterial line) cannulation
- Simple biopsy
- Dialysis Fistula/Graft site cleansing
1.5 ML (FREPP)
3 ML
15 X 15
- Midline & Central Venous Catheter
(CVC) insertion and maintenance
- Peritoneal dialysis site cleansing
10.5 ML
25 X 30
- Minor and major surgical procedures
- Implantable device placement
- Prosthetic device placement or removal
- Midline, Peripheral Intravascular
Central Catheter (PICC) & CVC
insertion and maintenance
- Cardiac catheterisation and Cardiac
Cath Lab procedures
- Interventional Radiology procedure
26 ML
50 X 50
The applicator is removed from the wrapper and held with the sponge
facing downward. The
applicator is squeezed gently to break the ampoule containing the
antiseptic solution, which is
released onto the sponge in a controlled flow (for the 26 ml
applicator the lev