Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical Particulars
6.1 List of Excipients
Sodium chloride
Sodium hydroxide for pH adjustment
Water for injection
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
2 years.
The product has to be used immediately after opening. See section 6.6.
6.4 Special Precautions for Storage
Store in the original package in order to protect from light.
Do not store above 25°C. Do not freeze.
6.5 Nature and Contents of Container
Methotrexat "Ebewe" 20 mg/1 ml is available in pre-filled syringes with a capacity of 1.25 ml & 2.25 ml of colourless glass (type I according Ph. Eur), an elastomeric tip cap and an elastomeric plunger stopper.
Each box contains 1 pre-filled syringe with 0.375 ml, 0.5 ml, 0.625 ml, 0.75 ml, 0.875 ml, 1 ml, 1.125 ml, 1.25 ml and 1.5 ml solution for injection, safety needles and alcohol pads.
6.6 Special Precautions for Disposal and Other Handling
Handling and disposal must be consistent with that of other cytotoxic preparations in accordance with local requirements. Pregnant health care personnel should not handle and/or administer Methotrexat “Ebewe”.
For single use only. Any unused solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.
7. Registration No.
Methotrexat "Ebewe" 20 mg/1 ml: 148-50-33635-00