Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate; Isopropyl alcohol
3M Deutschland GmbH
D08AC; D08AC52
Chlorhexidine gluconate; Isopropyl alcohol
20 milligram(s)/millilitre
Cutaneous solution
Biguanides and amidines; chlorhexidine, combinations
Not marketed
2019-08-13
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOLUPREP WITH TINT 2% W/V / 70% V/V CUTANEOUS SOLUTION Chlorhexidine Gluconate / Isopropyl Alcohol Green tinted solution: 10.5 mL/26 mL in applicator 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Soluprep with tint is and what it is used for 2. What you need to know before Soluprep with tint is used 3. How Soluprep with tint is used 4. Possible side effects 5. How to store Soluprep with tint 6. Contents of the pack and other information 1. WHAT SOLUPREP WITH TINT IS AND WHAT IT IS USED FOR Soluprep with tint is a sterile antiseptic solution of chlorhexidine gluconate 20mg/mL and isopropyl alcohol 0.70mL/mL in an applicator with a sponge tip on one end. The applicator contains a fast acting antiseptic solution, which is used in subjects aged 1 year and above to disinfect the skin before invasive medical procedures (such as insertion of catheters, minor and major surgery) to help reduce bacteria that potentially can cause skin infection. Soluprep with tint tinted solution contains a tint to colour the skin, _ _ it plays no role in the antiseptic properties of the solution. 2. WHAT YOU NEED TO KNOW BEFORE SOLUPREP WITH TINT IS USED SOLUPREP WITH TINT MUST NOT BE USED: - if you are allergic to chlorhexidine gluconate, isopropyl alcohol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Soluprep with tint is for external use only on intact skin. The solution is flammable. Do not use electrocautery procedures (i.e. surgical procedures where a surgeon or doctor used electricity to heat tissue to prevent or stop bleeding or remove abnormal tissue growth) or other ignit read_full_document
Health Products Regulatory Authority 05 December 2023 CRN00DJ3R Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SoluPrep with tint 2%w/v/70%v/v cutaneous solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 20 mg chlorhexidine digluconate and 0.70 mL isopropyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. Green tinted solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The medicinal product is to be used in subjects aged 1 year and above for disinfection of the skin prior to invasive medical procedures to help reduce bacteria that can potentially cause skin infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For cutaneous use. SoluPrep may be used in all age groups and patient populations. However, SoluPrep is not recommended in the paediatric population less than 1 year old (see Section 4.4 Special warnings and precautions for use). Two sized single use applicators are available: - 10.5 mL green tinted or colourless solution - 26 mL green tinted solution The choice of applicator size will depend on the type of invasive medical procedure being performed and the preference of the clinician. As this product does not have presentations of smaller volumes, prescribers should use alternate products for disinfection of skin prior to simple invasive procedures that require small volume. SOLUTION VOLUME (ML) MAXIMUM COVERAGE AREA (CM X CM) TO BE USED FOR: 10.5 (COLOURLESS) 34 cm x 34 cm (1156 cm 2 ) Head, neck and small prep areas - Minor and Major surgical procedures - Implantable device placement - Prosthetic device placement or removal - Midline, peripheral intravascular central catheter (PICC), central venous catheter (CVC) Health Products Regulatory Authority 05 December 2023 CRN00DJ3R Page 2 of 8 insertion and maintenance - Cardiac catheterization and Cardiac Cath Lab procedure - Interventional Radiology procedures 10.5 (GREEN TINTED) 34 cm x 34 cm (1156 cm 2 ) Head, neck and small prep read_full_document