Pharmaceutical particulars : מידע רוקחי

6         PHARMACEUTICAL PARTICULARS

6.1       List of excipients
L-Lactic acid Sol. 90%
Sodium chloride
Hydrochloric acid
Water for injections
6.2       Incompatibilities
▪   This medicinal product is incompatible with injection solutions (e.g. penicillins, heparin solutions) which are chemically or physically unstable at pH of 3.9 - 4.5.
▪   The solution should be clear. Do not use if particles are present.
▪   Unless compatibility is proven, the infusion should always be administered separately.
▪   Solutions containing ciprofloxacin should not be mixed with or added to solutions containing other agents unless compatibility has been proven.

6.3       Shelf life
The expiry date of the product is indicated on the packaging materials From a microbiological point of view, the product should be used immediately on opening.

6.4       Special precautions for storage
▪   Store below 300C . Do not refrigerate or freeze
▪   Keep the vial in the original container until time of use in order to protect from light.
▪   The infusion solution must be used immediately after opening.

For ease of use the infusion vial stopper should be penetrated in the central ring.
Penetration of the outer ring may result in damage to the vial stopper.
Any unused solution should be disposed off.
6.5       Nature and contents of container
Giroflox 2 mg/ml solution for infusion is packaged in a colorless, transparent plastic bottle with inner cap, rubber stoper and flip cap.
Pack sizes:
1 or 10 x 100 ml
1 or 10 x 200 ml
It's possible that not all the presentations are commercialized.

6.6     Special precautions for disposal and other handling
Intravenous infusion:
The use of freshly prepared solutions is recommended (see section 6.3).
▪ The solution should be visually inspected for particulate matter and discoloration prior to administration. Only clear and colourless or slightly yellow solution should be used.
▪ For single use only.
▪ Unless compatibility is proven, the infusion solution should always be administered separately.
▪ Any unused solution and the vials should be adequately disposed of, in accordance with local requirements.