Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium hydroxide, water for injections
6.2   Incompatibilities

Known incompatibilities:
Strong oxidants and strong acids
Chlorpromazine HCl (turbidity, yellow precipitate)
Droperidol
Idarubicin
Metoclopramide HCl
Prednisolone sodium phosphate
Promethazine HCl
Incompatibilities of methotrexate with cytarabine and fluorouracil have been reported; however, the incompatibility with fluorouracil is in doubt.

As a rule, the prepared solution for infusion should be used within 24 hours of preparation.
Furthermore, incompatibilities with other substances may occur (e.g. bleomycin) during longer storage.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials The medicinal product must be used immediately after opening.
For single use only. Discard any remaining product.

Infusion solution after dilution

Methotrexat “Ebewe” diluted in 5% glucose solution and 0.9% sodium chloride solution is stable at 25oC (exposed to light) for 24 hours.
Chemical and physical stability of the ready-to-use preparation were demonstrated after first opening over 28 days at 2‒8°C and under 25oC with light protection.

From a microbiological point of view, the ready-for-use preparation should be used immediately.
If not used immediately, the user is responsible for the duration and conditions of storage. If the ready-for-use preparation is not prepared under controlled and validated aseptic conditions, it must not be stored longer than 24 hours at 2 to 8 °C.

6.4   Special precautions for storage

Do not store above 25°C.
Keep container in the outer carton, in order to protect from light.
For storage conditions after dilution, see section 6.3.
6.5   Nature and contents of container

Vials.
Vials with or without a transparent plastic container (Onco-Safe).

Pack sizes:
Vial: 1 x 5 ml, 1 x 10 ml, 1 x 50 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The solution must be visually inspected prior to use.
Only clear solutions practically free from particles should be used.

All contact of methotrexate with skin and mucosa is to be avoided
In the event of contamination, the affected areas must be rinsed immediately with plenty of water 
Instructions for healthcare professionals:
As is usual when dealing with cytostatics, handling methotrexate requires extreme care: gloves, masks, protective clothes and if possible ventilation should be used. Skin and mucous membrane contact must be prevented. Pregnant women should not come into contact with methotrexate.

Observe the disposal and handling regulations for cytostatic agents.

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