Chlorhexidine Acetate BP 0.05% w/v Irrigation solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Chlorhexidine acetate
Available from:
Baxter Healthcare Limited
ATC code:
B05CA; B05CA02
INN (International Name):
Chlorhexidine acetate
Dosage:
0.05 percent weight/volume
Pharmaceutical form:
Solution for Irrigation
Prescription type:
Medicinal product not subject to medical prescription
Therapeutic area:
Antiinfectives; chlorhexidine
Authorization status:
Marketed
Authorization number:
PA0167/010/012
Authorization date:
1983-04-01

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 may be hypersensitive to chlorhexidine which is an ingredient in this

medicine.

Use with care when this medicine is used to clean the skin, before an operation for

your face or head

Children

Use with care in newborn babies, especially those born prematurely. Chlorhexidine

Irrigation Solution may cause chemical skin burns.

Your doctor will not use Chlorhexidine Irrigation Solution if any of the above apply. If you

are not sure talk to your doctor, nurse or pharmacist before using Chlorhexidine Irrigation

Solution.

This solution is not for intravenous administration and must not be taken orally.

Other medicines and Chlorhexidine Irrigation Solution

Tell your doctor or pharmacist if you are using, have recently used or might use any other

medicines.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a

baby, ask your doctor or pharmacist for advice before using this medicine. They will advise if

you can have this treatment.

Driving and using machines

Chlorhexidine Irrigation Solution has no affect on your ability to drive or use machines.

Please tell your doctor or pharmacist and they will advise you if you can drive or use

machines.

3. How to use Chlorhexidine Irrigation Solution

Chlorhexidine Irrigation Solution may be used by a doctor or nurse, or you may use the

solution yourself. Only use if the solution is clear and the seal is intact.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

The recommended dose

Your doctor will decide how much you will need and for how long it will be used.

Your age, weight and clinical condition will be taken in to account.

The solution must be used undiluted and is for topical application. This means that it

is for cleaning (irrigation) of your skin on the outside of your body.

If you have more Chlorhexidine Irrigation Solution than you should

It is unlikely that you will have or use more Chlorhexidine Irrigation Solution than you

should.

If you accidentally swallow Chlorhexidine Irrigation Solution

If Chlorhexidine Irrigation Solution is accidentally swallowed, seek medical assistance.

This can be treated with a stomach wash of milk, egg white, gelatine or mild soap.

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

nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine.

Tell your doctor, nurse or pharmacist straight away if you notice any of the following side

effects:

allergic reaction. The signs of this may include eczema, rash, and itching. If you have

a reaction to the medicine, it will be stopped.

Fatal anaphylactic reaction has been reported.

Other possible side effects

low blood pressure (hypotension). This may cause you to feel lightheaded, dizzy or to

faint.

tingling sensations in your skin (paraesthesia)

difficulty breathing

increased heart rate

cold sweats

reddening or itching of your skin

loss of consciousness.

Rash

Coughing or wheezing (Bronchospasm)

Heart stops pumping (cardiac arrest)

Blood vessels stop working properly (circulatory collapse)

Shock

Additional side effects in children

Chemical burns

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via

HPRA Pharmacovigilance,

Earlsfort Terrace, IRL – Dublin 2;

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie; E-

mail:medsafety@hpra.ie. By reporting side effects you can help provide more information on

the safety of this medicine.

5. How to store Chlorhexidine Irrigation Solution

Keep this medicine out of the sight and reach of children.

Make sure that the product is stored and disposed of correctly and not used after the expiry

date stated on the product. The storage conditions, should you need them, are given below.

Do not store above 25ºC. Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label after

EXPIRY. The expiry date refers to the last day of that month.

Do not use this medicine if the container is damaged or the solution is not clear.

The solution should only be used once. Any leftover solution should be discarded.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6. Contents of the pack and other information

This leaflet does not contain all the information about this medicine. If you have any

questions or are not sure about anything, ask your doctor, nurse or pharmacist.

What Chlorhexidine Irrigation Solution contains

The active substance is chlorhexidine acetate 0.5 g in each 1000 ml.

The other ingredients are acetic acid and sterile water (called ‘water for injections’).

What Chlorhexidine Irrigation Solution looks like and contents of the pack

It is supplied as a clear, colourless solution for irrigation in a 1000 ml plastic bottle.

Marketing Authorisation Holder and Manufacturer Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom

Send all enquiries to this address.

Chlorhexidine Irrigation Solution is made at the above address.

This leaflet was last revised in November 2015

For information about Chlorhexidine Irrigation Solution or to request this

leaflet in formats such as audio or large print please contact the Marketing

Authorisation Holder: Tel: +44 (0)1635 206345.

Baxter is a registered trademark of

Baxter International Inc.

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

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.

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Hypersensitivity reactions have been reported on contact with chlorhexidine.

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate

therapeutic countermeasures must be instituted as clinically indicated.

This product should only be used in specialist units familiar with the appropriate selection of patients.

Do not use unless solution is clear, free of particles and container intact

Use in Paediatric Patients: Chemical Burns in Neonates

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has

been associated with skin reactions such as chemical burns in neonates. This risk appears to be higher in preterm

infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive

quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in

direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to

chlorhexidine, care must be taken to ensure no excess product is present prior to application of the dressing.

Preoperative Skin Preparation

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head (See Section

4.3 Contraindications).

4.5 Interaction with other medicinal products and other forms of interaction

The activity of chlorhexidine is not significantly affected by blood or other organic materials. However, its activity is

pH-dependent (5.5-7.0) and is reduced or neutralized in the presence of non-ionic surfactants, inorganic anions (e.g.,

phosphate, nitrate, chloride, and other substances that are present in hard tap water and in many pharmaceutical

preparations), and organic anions such as natural soaps.

The activity of chlorhexidine is reduced or neutralized by an alkaline pH, the presence of organic matter, anionic

detergents, and tannins.

4.6 Fertility, pregnancy and lactation

Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing

Chlorhexidine Acetate 0.05% w/v. There are no adequate data to support the use of Chlorhexidine Acetate 0.05% w/v

in pregnant or lactating women.

4.7 Effects on ability to drive and use machines

There is no information of the effects of chlorhexidine on the ability to operate an automobile or other heavy

machinery.

4.8 Undesirable effects

The following adverse reactions have been reported in post marketing experience, listed by MedDRA System Organ

Class (SOC), then by Preferred Term in order of severity, where feasible.

Immune System Disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions (which might be fatal) manifested by cardiac

arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria.

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Skin And Subcutaneous Tissue Disorders:

Rash

The adverse events reported and/or observed with other chlorhexidine products include:

Chemical burns in neonates (See Section 4.4 Special Warnings and Precautions for Use

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Websitw; www.hpra.ie e-mail: medsafety@hpra.ie

4.9 Overdose

Overdose of chlorhexidine may constitute a medical emergency. In case of accidental overdose seek immediate medical

attention.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: D08AC02

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for Injections

Acetic Acid (for pH adjustment)

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Additives may be incompatible with chlorhexidine.

Chlorhexidine must not be mixed with soaps or other anionic materials.

6.3 Shelf life

Unopened: 2 years.

Opened: For single-use only.

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6.4 Special precautions for storage

Do not store above 25

Store in the original container in order to protect from light.

6.5 Nature and contents of container

The product will be supplied in High Density Polyethylene Single-Use containers of 1000ml.

6.6 Special precautions for disposal and other handling

Do not use unless solution is clear and the container is undamaged.

Discard unused portion.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom.

8 MARKETING AUTHORISATION NUMBER

PA0167/010/012

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

April 1983

Date of last renewal: 1

April 2008

10 DATE OF REVISION OF THE TEXT

March 2016

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