Chlorhexidine acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine acetate; Cetrimide

Available from:

Baxter Healthcare Limited

ATC code:

D08AC; D08AC52

INN (International Name):

Chlorhexidine acetate; Cetrimide

Dosage:

.015/.15 percent weight/volume

Pharmaceutical form:

Infus/Pdr/Oral Soln

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Biguanides and amidines; chlorhexidine, combinations

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v,
Irrigation Solution
Active substances: Chlorhexidine Acetate, Cetrimide
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.
Throughout this leaflet, Chlorhexidine Acetate 0.015% w/v and
Cetrimide 0.15% w/v,
Irrigation Solution will be called Chlorhexidine and Cetrimide
Irrigation Solution.
WHAT IS IN THIS LEAFLET:
1. What Chlorhexidine and Cetrimide Irrigation Solution is and what it
is used for
2. What you need to know before you use Chlorhexidine and Cetrimide
Irrigation Solution
3. How to use Chlorhexidine and Cetrimide Irrigation Solution
4. Possible side effects
5. How to store Chlorhexidine and Cetrimide Irrigation Solution
6. Contents of the pack and other information
1. WHAT CHLORHEXIDINE AND CETRIMIDE IRRIGATION SOLUTION IS AND WHAT IT
IS USED FOR
Chlorhexidine and Cetrimide Irrigation Solution contains medicines
called chlorhexidine
acetate and cetrimide. These belong to a group of medicines called
‘antiseptics’, which are
used to kill bacteria.
Chlorhexidine and Cetrimide Irrigation Solution is used:
-
for cleaning (irrigating) the skin
-
for wound and burn cleaning (irrigation)
-
for irrigation of body cavities such as the bladder
-
as a disinfectant for respirators.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORHEXIDINE AND CETRIMIDE
IRRIGATION
SOLUTION
Your doctor will not use Chlorhexidine and Cetrimide Irrigation
Solution:
-
if you are allergic to Chlorhexidine acetate or cetrimide 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation
solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One litre contains:
Chlorhexidine Acetate 0.150 g
Cetrimide 1.5 g
Excipients with known effect: Sunset Yellow (E110) 8mg/L
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Irrigation solution
A clear, yellow, sterile, nonpyrogenic, aqueous irrigation solution.
pH 5.0-6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a disinfectant for topical antibacterial irrigation of wounds and
burns, and some body cavities such as the bladder.
For disinfection of respirators.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage is dependant upon the age, weight and clinical condition of
the patient.
METHOD OF ADMINISTRATION
Topical irrigation.
4.3 CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to the active
substances or to any of the excipients listed in section
6.1.
This product should not be used in the eye, intravenously, orally, in
the auditory canal, or near meninges, brain or
spinal cord.
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 acetate or Cetrimide.
If any signs or symptoms of a suspected hypersensitivity reaction
develop, immediately stop use. Appropriate
therapeutic countermeasures must be instituted as clinically
indicated.
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