Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Chlorhexidine acetate
Baxter Healthcare Limited
B05CA; B05CA02
Chlorhexidine acetate
0.05 percent weight/volume
Solution for Irrigation
Medicinal product not subject to medical prescription
Antiinfectives; chlorhexidine
Marketed
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 ma Aqra d-dokument sħiħ
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Aqra d-dokument sħiħ