Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1     List of excipients
Maltose                                 100 mg/ml
Octoxynol                                < 5 µg/ml
TNBP [Tri n-butyl phosphate]            <1 µg/ml

Water for injections                    ad 1ml

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
6.4 Special precautions for storage

The product should be stored and transported at +2°C to +25°C.
Do not freeze.
Keep container in the outer carton in order to protect from light.
Do not use after expiry date.

6.5 Nature and contents of container

Package size           Contents          Container
OCTAGAM 1 g            20 ml             30 ml infusion bottle
OCTAGAM 2.5 g          50 ml             70 ml infusion bottle
OCTAGAM 5 g            100 ml            100 ml infusion bottle
OCTAGAM 10 g           200 ml            250 ml infusion bottle

Not all pack sizes may be marketed.
The primary container is made of Ph. Eur. type II glass closed with bromobutyl rubber stopper.
Components used in the packaging of OCTAGAM are latex-free.


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6.6 Special precautions for disposal and other handling
The product should be brought to room or body temperature before use.
Do not use solutions that are cloudy or have deposits.
Due to the possibility of bacterial contamination, any remaining contents must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.


7    REGISTRATION HOLDER

Dover medical & Scientific Equipment Ltd.,
11 Hamaalot St.,
Herzliya 46583, Israel


8    REGISTRATION NUMBER

143 22 31778 00