CHLORAPREP WITH TINT

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Доступна з:

BECTON DICKINSON (BD) ISRAEL LTD., ISRAEL

Код атс:

D08AC52

Фармацевтична форма:

CUTANEOUS SOLUTION

Склад:

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

Адміністрація маршрут:

EXTERNAL

Тип рецепту:

Not required

Виробник:

CAREFUSION 213 LLC., USA

Терапевтична области:

CHLORHEXIDINE, COMBINATIONS

Терапевтичні свідчення:

Chloraprep with tint is indicated for disinfection of the skin prior to invasive medical procedures.

Дата Авторизація:

2023-03-21

інформаційний буклет

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
The medicine is dispensed without a doctor’s prescription
CHLORAPREP WITH TINT
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
with Tint, especially if you have a history of possible
chlorhexidine-related allergic reactions (see Section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
ChloraPrep with Tint is for external use only.
ChloraPrep with Tint 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 with Tint 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 with Tint and contact your doctor as

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
ChloraPrep with Tint
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.
Orange 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 with Tint may be used on all age groups and patient
populations.
_Paediatric population _
However, ChloraPrep with Tint 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 3 ml, 10.5 ml or 26 ml of the
ChloraPrep withTint 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:
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 lever is pressed).
Pinch wings ONCE ONLY to activate the applicator and release the
antiseptic. Do not repeatedly
pinch or pump the wings in an attempt to accelerate the saturation of
the foam. The broken
ampoule remains safely contained within the applicator. The sponge