Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Lactic acid
Water for injections
Hydrochloric acid for pH adjustment
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 discoloration.

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.
Single-dose container.

From a microbiological point of view, the product should be used immediately once opened (see section 6.4).

6.4 Special precautions for storage
Unopened:
Store below 25ºC.
Keep the bottles in the outer carton in order to protect from light.
Do not refrigerate or freeze.

Bottles after removing from carton:
To be used immediately after removing from carton.
Since Cipro-Teva 2 mg/ml Solution for infusion is light-sensitive, the bottles should always be stored in the outer container.
No special precautions are required during the normal 60 minute infusion period.

6.5 Nature and contents of container

100 mL polypropylene bottles:
Plastic bottles of polypropylene of 100 mL, with a twin port cap, which includes the rubber gasket in the inside and two pull rings in the outside.

The bottles are placed in carton boxes of 10, 20 or 24 bottles.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

Intravenous infusion:
Cipro-Teva 2 mg/mL should not be mixed with other drug products which are chemically or physically unstable at pH of 3.9 - 4 .5 (see section 6.2).

The solution should be clear. Do not use if particles are present.

Cipro-Teva 2 mg/mL is compatible with the following commonly used infusion fluids: Ringer's solution, Ringer lactate solution, 0.9% sodium chloride solution, dextrose 5% and dextrose 10% solutions, fructose 10% solution, sodium chloride 0.45% + dextrose 5% solution and sodium chloride 0.225% + dextrose 5% solution. All solutions are stable for 48 hours below 25°C, with the only exception of the mixture of Cipro-Teva 2 mg/mL with Ringer’s solution, which is stable for 12 hours below 25°C. Unless compatibility is proven, the infusion solution should always be administered separately.
Since the infusion solution is photosensitive, the infusion bottles should be removed from the box only immediately before use.

Any unused solution should be disposed of in accordance with local requirements.

7. REGISTRATION NUMBER
157.11.35047