Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Hydrochloric acid concentrated (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injection
6.2 Incompatibilities
This medicinal product must not be mixed with heparin or alkaline solutions (e.g., sodium bicarbonate). This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after perforation of the rubber stopper: immediate use (within 3 hours) (see section 6.6).
Shelf life after removal of the outer packaging: 3 days (under indoor light conditions).
From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.


6.4 Special precautions for storage
Keep the bottle in the outer carton in order to protect from light.
Inspect visually prior to use. Only clear solutions without particles should be used.

6.5 Nature and contents of container
100 ml, type 1 glass bottle with flanged aluminium cap, chlorobutyl rubber stopper and tear-off polypropylene lid. Each bottle contains 100 ml solution for infusion.
Pack size of 1 bottle.

6.6 Special precautions for disposal
Tavanic solution for infusion should be used immediately (within 3 hours) after perforation of the rubber stopper in order to prevent any bacterial contamination. No protection from light is necessary during infusion.
This medicinal product is for single use only.
The solution should be visually inspected prior to use. It must only be used if the solution is clear, greenish-yellow solution, practically free from particles.
As for all medicines, any unused medicinal product should be disposed of accordingly and in compliance with local environmental regulations.

Mixture with other solutions for infusion:
Tavanic solution for infusion is compatible with the following solutions for infusion:
•   0.9% sodium chloride solution.
•   5% glucose injection.
•   2.5% glucose in Ringer solution.
•   Combination solutions for parenteral nutrition (amino acids, glucose, electrolytes).
See section 6.2 for incompatibilities.