Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium hydroxide
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.
The compatibility with containers other than polypropylene, polyethylene and glass is not known.

6.3     Shelf-life

The expiry date of the product is indicated on the packaging materials.
Shelf-life after first opening of the container:
From a microbiological point of view, preparations for parenteral administration should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Administration of the product must be carried out under controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 7 days at 30°C.

Shelf-life in polyethylene and polypropylene containers after dilution with sterile 0.9% m/V sodium chloride solution:

From a microbiological point of view, preparations for parenteral administration should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.
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 to 8°C.

Chemical and physical in-use stability has been demonstrated for 72 hours at 30°C at concentrations of 2 mg/ml and 5 mg/ml.

Shelf life in polypropylene syringe (undiluted):

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 to 8°C.
Chemical and physical in-use stability has been demonstrated for 72 hours at 30°C.

6.4   Special precautions for storage

Store in the original package in order to protect from light. Do not store above 30 °C. Do not freeze.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Ferinject is supplied in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium cap as:
10 mL dispersioncontaining 500 mg iron. Avilable in pack sizes of 1 vial and 5 vials.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal

Inspect vials visually for sediment and damage before use. Use only those containing sediment- free, homogeneous dispersion.

For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

Each vial of Ferinject is intended for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Ferinject must only be mixed with sterile 0.9% m/V sodium chloride solution. No other intravenous dilution solutions and therapeutic agents should be used, as there is the potential for precipitation and/or interaction. For dilution instructions, see section 4.2.