Pharmaceutical particulars : מידע רוקחי

6   PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Hydrochloride acid 37%
Water for injection.
6.2 Incompatibilities
In the absence of compatibility studies, Levoflox 5mg/ml solution for infusion must not be mixed with other medicinal products.
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after removal of the outer packaging: 3 days (under indoor light conditions) For the possibility of microbial contamination, the product should be used immediately. If the medication is not used immediately, the time and storage conditions during use of the product are the responsibility of the user.
6.4 Special precautions for storage
Keep the vial in the original packaging in order to protect from light (see section 6.3 "Shelf life”). Inspect visually prior to use. Only clear solutions without particles should be used.
Store below 25 ºC.
6.5 Nature and contents of container
100 ml, type II glass vial with chlorobutyl rubber stopper and tear-off alluminium lid. Each vial contains 100 ml solution for infusion.
Packs of 1, 5 and 25 vials.
Not all packs sizes may be marketed.
6.6 Special precautions for disposal and other handling
Levoflox 5mg/ml solution for infusion should be used immediately 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.
As for all medicines, any unused medicinal product should be disposed of accordingly and in compliance with local environmental regulations.
7 MARKETING AUTHORISATION HOLDER
Tec-O-Pharm-Libra LTD POB 45054, Jerusalem 91450