Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of excipients

Mannitol
Lactic acid
Sodium hydrogen carbonate
Water for injection

6.2.   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Octreotide is not stable in Total Parenteral Nutrition (TPN) solutions.

6.3.   Shelf life

The expiry date of the product is indicated on the packaging materials. Ampoules should be opened just prior administration, and any unused portion should be discarded.

6.4.   Special precautions for storage

Store in the original package in order to protect from light.
For prolonged storage, Octreostat ampoules must be stored at 2 to 8°C.
For day-to-day use, Octreostat ampoules may be stored not above 25°C for up to 2 weeks.
Octreostat must be kept out of the reach and sight of children.
For further instructions on handling and instructions for dilution of the medicinal product, refer to section 6.6.

6.5.   Nature and contents of container

An ampoule made of amber glass, type I containing clear, colourless solution.

Packs of ten ampoules of 1 ml.

6.6.   Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions for use and handling
Ampoules are intended for single use only and should be opened just prior to administration and any unused portion discarded.

Subcutaneous administration
Patients who are to self-administer the drug by s.c. injection must receive precise directions from the physician or the nurse.
Ampoules should be opened just prior to administration and any unused portion discarded.
To reduce local discomfort, it is recommended that the solution should be at room temperature before injection. Multiple injections at short intervals at the same site should be avoided.

Intravenous infusion
Parenteral drug products should be inspected visually for discoloration and particulate matter prior to administration.
In case of intravenous infusion, the product must be diluted before administration.
Octreostat (octreotide) is physically and chemically stable for 24 hours in sterile physiological saline solutions. The diluted solutions are physically and chemically stable for at least 24 hours below 25°C.
From a microbiological point of view, the diluted solution should be used immediately. If the solution is not used immediately, the timing and conditions of use are the responsibility of the user.
Before administration the solution has to be brought to room temperature again.
The cumulated time between reconstitution, dilution with infusion media, storage in a refrigerator, and end of administration must not be longer than 24 hours.
In cases where Octreostat is to be administered by i.v. infusion, the contents of one 0.5 mg ampoule should normally be dissolved in 60 mL physiological saline (0.9% sodium chloride), relatively 0.1 mg Octreotide acetate in 12 ml physiological saline solution.and the resulting solution should be infused by means of an infusion pump. This should be repeated as often as necessary until the prescribed duration of treatment is reached. Octreostat has also been infused in lower concentrations.
Dilute immediately prior to administration.


7. REGISTRATION HOLDER AND IMPORTER:
Easy Care Ltd., POB
48577, Tel-Aviv
6148403 Israel.