Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Glucose monohydrate, (S)-lactic acid,1.2 N hydrochloric acid, water for injection 
6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Unless compatibility with other solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.9 – 4.5).

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 once opened (see section 6.4).

6.4. Special precautions for storage

Do not store above 25°C, keep in the original package in order to protect from light, do not freeze. Discard if you see alterations on the packaging or in the liquid contained therein.
Any unused solution should be disposed of.
Since ciprofloxacin is light sensitive, the bag overwrap should only be removed immediately before its administration.

6.5. Nature and contents of container

Flexible bag of laminated PVC. Bags containing 100 ml or 200 ml of solution for infusion. The packaging is of 50 bags of 100 ml or 20 bags of 200 ml. It's possible that not all the presentations are commercialized.

The solution is clear and colourless.

6.6. Special precautions for disposal and other handling
Intravenous infusion
Ciprofloxacin infusion has been shown to be compatible with glucose 5%, glucose 10% solution, fructose 10%, 0.9% saline solution, Ringer’s lactate solution and glucosaline solution.
After dilution: Chemical and physical stability has been demonstrated for 18 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Any unused solution should be disposed of in accordance with local requirements.