Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Mannitol
Cysteine
Water for injections

6.2   Incompatibilities
Paracetamol Fresenius 10 mg/ml must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Unopened:
The expiry date of the product is indicated on the packaging materials.
After first opening:
The infusion should commence immediately after connecting the container to the giving set.
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

After dilution:
If diluted in sodium chloride 9 mg/ml (0.9 %) solution or 50 mg/ml glucose (5 %) solution, the solution should also be used immediately.
However, if the diluted solution is not used immediately, do not store for more than 1 hour (infusion time included).

6.4   Special precautions for storage

Store below 25°C. Do not refrigerate or freeze.
For storage conditions after first opening and after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

50ml and 100ml glass vials.
Pack size: 1, 10, 12 or 20 vials
Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

No special requirements for disposal.

Paracetamol Fresenius 10 mg/ml can be diluted in 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion or a combination of both solutions up to one tenth. For shelf life after dilution see section 6.3.

7.    MANUFACURER

Fresenius Kabi Austria GmbH
Hafnerstrasse 36, A-8055 Graz, Austria