ÜRÜNLER
BALANCED STERIL SALINE SOLUTION
Adjuvant in eye surgery for intraocular irrigation and cornea hydration.
| Sterilisation In autoclave by overheated water. Classification Sterile, apyrogenic solution for irrigation. Class IIa as for Directive 93/42/EEC. |
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Composition
100ml contain:
• Sodium chloride 0.640g
• Potassium chloride 0.075g
• Calcium chloride dihydrate 0.048g
• Magnesium chloride hexahydrate 0.030g
• Sodium acetate trihydrate 0.390g
• Sodium citrate dihydrate 0.170g
• Water for injection: filler
• Hydrochloric acid: filler at pH 7.2.
Nature and capacity of container
• Polypropylene bottle with a luer-lokTM attachment.
• Type-1 glass bottle with chlorobutyl rubber cap and painted aluminium sealing “tear off” ring, various sizes.
• Soft plastic bag for medical use, bearing product-specific printed wordings and colors, with one or two tubes with pierceable vial-type cap and/or luer fitting. Special fittings available upon request.
Outer packaging: two-bag container, vacuum-sterilized (inner bag sterile only) if required, in various sizes.
I nstructions for glass bottles and plastic bags:
To be used for intraocular irrigation. Do not inject. Remove the protective cap.Pierce the cap with the outflow tip. Open the air valve of the dripper and fill it for about two thirds. If necessary, connect the line to the tube of the phacoemulsifier or directly to the irrigation needle. During the procedure, ensure that the level in the dripper is steady in order to avoid irrigation interruptions.
The precautions to be taken are those normally recommended in surgery. As in any ophthalmic surgery procedure on diabetic patients, the solutions for intraocular irrigation, iso-osmotic with the aqueous humor, must be used with caution. Rare cases of cornea opacization and edema have been reported following intraocular procedures with irrigation solutions similar to the Balanced Sterile Saline solution; however the relationship between the use of these solutions and the onset of such phenomena have not been proved. Do not use the solution if the packaging is damaged. The solution must be limpid and colorless: use at room temperature. Do not use for parenteral injections (IV or IA). Irrigate in fully sterile conditions. The solution does not contain preservatives and must not be used on more than one patient. Do not store the product once opened. Do not re-sterilise. Use in one single irrigation only. Do not use after the expiry date. Incompatibilities
The use of any active drug in association with the Balanced Sterile Saline solution may cause damage to intraocular tissues. Shelf Life
24 months from date of manufacture.