Chlorhexidine Acetate BP 0.05% w/v Irrigation solution

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Chlorhexidine acetate

זמין מ:

Baxter Holding B.V.

קוד ATC:

B05CA; B05CA02

INN (שם בינלאומי):

Chlorhexidine acetate

כמות:

0.05 percent weight/volume

טופס פרצבטיות:

Irrigation solution

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Antiinfectives; chlorhexidine

מצב אישור:

Marketed

תאריך אישור:

1983-04-01

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORHEXIDINE ACETATE BP 0.05% W/V IRRIGATION SOLUTION
ACTIVE SUBSTANCE: CHLORHEXIDINE ACETATE
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Throughout this leaflet, Chlorhexidine Acetate BP 0.05% w/v Irrigation
Solution will be called
Chlorhexidine Irrigation Solution.
WHAT IS IN THIS LEAFLET:
1. What Chlorhexidine Irrigation Solution is and what it is used for
2. What you need to know before you use Chlorhexidine Irrigation
Solution
3. How to use Chlorhexidine Irrigation Solution
4. Possible side effects
5. How to store Chlorhexidine Irrigation Solution
6. Contents of the pack and other information
1. WHAT CHLORHEXIDINE IRRIGATION SOLUTION IS AND WHAT IT IS USED FOR
Chlorhexidine Irrigation Solution contains a medicine called
chlorhexidine acetate. This belongs to a
group of medicines called ‘antiseptics’, which are used to kill
bacteria.
Chlorhexidine Irrigation Solution is used:
• for cleaning (irrigating) the skin
• for wound and burn cleaning (irrigation)
• as a disinfectant for respirators.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORHEXIDINE IRRIGATION
SOLUTION
Your doctor will not use Chlorhexidine Irrigation Solution:
• if you are allergic to Chlorhexidine acetate or any of the other
ingredients of this medicine (listed in
section 6)
• for irrigation of your eyes, mouth or ears
• for irrigation of the brain or spinal cord or surrounding
membranes (meninges).
WARNINGS AND PRECAUTIONS
• anaphylactic reactions have been reported following use of
products containing chlorhexidine in
patients with an allergy to this ingredient. Sometimes these reactions
have been fatal
• some patients ma

מאפייני מוצר

Health Products Regulatory Authority
17 December 2018
CRN008KF4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Acetate BP 0.05% w/v Irrigation solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One litre contains:
Chlorhexidine Acetate 0.5g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Irrigation solution.
Clear colourless, sterile, aqueous irrigation solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a disinfectant for topical irrigation of wounds and burns.
For disinfection of respirators.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and duration of administration are to be individualized and
depend upon the
indication for use, the patient’s age, weight, clinical condition,
and concomitant
treatment, and on patient’s clinical response to treatment (See
Section 4.4 Chemical
Burns in Neonates and Preoperative Skin Preparation).
Not for intravenous or oral route of administration.
Product should be inspected visually for particulate matter and
discolouration prior
to administration whenever solution and container permit. Do not use
unless the
solution is clear and the seal is intact.
_Method of administration:_
Topical Irrigation
Health Products Regulatory Authority
17 December 2018
CRN008KF4
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in the eye, auditory canal (especially in perforated
eardrums), or near
meninges, brain or spinal cord. (See Section 4.4 Special Warnings and
Precautions for
Use).
Do not use in patients with known hypersensitivity to chlorhexidine.
Not for us in abdominal cavities, unless under supervision of a
specialist.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Anaphylactic/anaphylactoid reactions to chlorhexidine have been
reported.
Manifestations of such reactions have included hypotension,
bronchospasm, rash,
erythema, tachycardia and shock. Fatal anaphylactic reaction has been
reported.
Hypersensitivity reactions have been reported on contact with
chlorhexidine.
If any signs or symptoms of a sus