Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Water for Injections

6.2     Incompatibilities

Incompatibility has been reported with novobiocin sodium, oxytetracycline hydrochloride, sodium bicarbonate, sodium calcium edetate, and sulphadiazine sodium.

Medicinal products containing oxalate, phosphate, or carbonate/bicarbonate may cause precipitation upon mixing with Compound Sodium Lactate.

No other medicinal product or substance should be added to the fluid unless known to be compatible.

6.3     Shelf life

- unopened
The expiry date of the product is indicated on the packaging materials.
- after first opening
Not applicable, see section 6.6
- after admixture of additives
From the 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, unless dilution has taken place in controlled and validated aseptic conditions.


6.4     Special precautions for storage
Do not store above 25°C.

For storage conditions after admixture of additives to medicinal product, see section 6.3.


6.5     Nature and contents of container
●     Bottles of low-density polyethylene (LD-PE), contents: 500 ml, 1000 ml available in packs of 10 × 500 ml, 10 × 1000 ml.

Not all pack sizes may be marketed.

6.6     Special precautions for disposal

No special requirements for disposal.

Only to be used if solution is clear, colourless and the container and its closure do not show visible signs of damage.

Containers are for single-use. Discard container and any unused content after use.
Do not reconnect partially used containers.