Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injection
Sodium hydroxide (for pH adjustment)

6.2 Incompatibility
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There is the potential for precipitation and/or interaction if mixed with other solutions or medicinal products. The compatibility with containers other than glass, polyethylene and PVC is not known.


6.3 Shelf life
Shelf-life of the product as packed for sale:
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, the product should be used immediately.

Shelf-life after dilution with sterile 0.9% m/V sodium chloride (NaCl) solution: From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.


6.4 Special precautions for storage
Prescribed storage conditions: 4 –25 °C.
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.


6.5 Nature and content of container
5 ml solution in one ampoule (type I glass) in pack sizes of 5.

6.6 Special precautions for disposal and other handling
Ampoules should be visually inspected for sediment and damage before use. Use only those containing a sediment free and homogenous solution.
FERROVIN must not be mixed with other medicinal products except sterile 0.9% m/V sodium chloride solution for dilution. For instructions on dilution of the product before administration, see section 4.2.
The diluted solution must appear as brown and clear.
Each ampoule of FERROVIN is intended for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. MANUFACTURER:
Rafarm S. A., Greece
12 Korinthou St., 154 51 N Psihiko Athenes, Greece