Redefining Hygiene
How to Use:
➢ Pour Glutradex 2% in an instrument tray.
➢ Activate with activator provided.
➢ To activate 5 litres, add total content of activator bottle.
➢ To activate less than 5 litres add proportionately.
➢ Rinse under running water, the adherent material (blood, mucous etc.) from used instruments & drain thoroughly.
➢ Dry & immerse the instruments & scopes in the prepared Glutradex 2% solution.
➢ Immersion Time: Total disinfection: 10-15 minutes
Total sterilization: 10 hours
➢ Remove instruments from Glutradex 2% solution.
➢ Rinse thoroughly with sterile water & store in dry condition.
➢ Activated solution should be discarded after 14 days.
4.3 Contraindications
Not to be used in cases of sensitivity to any of the ingredients used.
4.4 Special warnings and precautions for use
➢ Use in well ventilated areas.
➢ Keep soaking trays covered at all times except when instruments are removed or added to the solution
➢ Avoid direct skin contact.
➢ Wear rubber gloves while cleaning and disinfecting medical devices.
➢ Replace cap tightly after use.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No special precautions.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Undesirable effects occur very occasionally and mostly involve mild local skin rashes and irritation. Very rarely, a severe reaction may occur particularly on the hands or when the product is used excessively and allowed to spread onto surrounding normal skin. If the irritation is severe, patients should stop treatment immediately and seek medical advice.
5. Pharmacological properties
6. Pharmaceutical particulars
Like formaldehyde, the biocidal activity of glutaraldehyde results from its alkylation
of sulfhydryl, hydroxyl, carboxyl, and amino groups of microorganisms, which alters RNA, DNA, and protein synthesis.
5.1 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6.1 List of ingredients
Glutaraldehyde, Purified water.
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Store in cool and dry place. Keep out of reach of children.
6.5 Nature and contents of container
Glutradex 2% solution is packed in 5000 ml white HDPE can with cap and inner plug.
6.6 Special precautions for disposal and other handling
Not applicable.
1. Name of the medicinal product
Glutradex 2% (Glutaraldehyde Solution)
2. Qualitative and quantitative composition
Glutaraldehyde USP 2% w/v
Purified water q.s.
3. Pharmaceutical form
Solution
4. Clinical particulars
4.1 Therapeutic indications
Glutradex 2% is a liquid chemical sterilant & high-level disinfectant intended to sterilize or disinfect reusable medical devices.
4.2 Posology and method of administration
FOR EXTERNAL USE ONLY.
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