Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium chloride
Sodium hydroxide for pH adjustment
Water for injections
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.
Special precautions for storage

Store below 25 °C. Keep the pre-filled syringes in the outer carton in order to protect from light.

6.5     Nature and contents of container
Nature of container
Pre-filled syringes of colourless glass (type I) of 1 ml capacity with embedded injection needle. Plunger stoppers of chlorobutyl rubber (type I) and polystyrene rods inserted on the stopper to form the syringe plunger
 or

Pre-filled syringes of colourless glass (type I) of 1 ml capacity with embedded injection needle. Plunger stoppers of chlorobutyl rubber (type I), polystyrene rods inserted on the stopper to form the syringe plunger and a patient safety built-in system to prevent needle stick injury and reuse of the needle.

Pack sizes
Pre-filled syringes containing 7.5 mg/0.15 ml, 10 mg/0.20 ml, 12.5 mg/0.25 ml, 15 mg/0.30 ml, 17.5 mg/0.35 ml, 20 mg/0.40 ml, 22.5 mg/0.45 ml, 25 mg/0.50 ml, 27.5 mg/0.55 ml or 30 mg/0.60 ml solution are available in packs of 1, 4, 6, 12 and 24 syringes with embedded s.c. injection needle.
 or

Pre-filled syringes containing 7.5 mg/0.15 ml, 10 mg/0.20 ml, 12.5 mg/0.25 ml, 15 mg/0.30 ml, 17.5 mg/0.35 ml, 20 mg/0.40 ml, 22.5 mg/0.45 ml, 25 mg/0.50 ml, 27.5 mg/0.55 ml or 30 mg/0.60 ml solution are available in packs of 1, 4, 6, 12 and 24 syringes with embedded s.c. injection needle with a patient safety built-in system.

All pack sizes are available with graduation marks.

Not all pack sizes may be marketed.
6.6     Special precautions for disposal and other handling
The manner of handling and disposal must be consistent with that of other cytotoxic preparations in accordance with local requirements. Pregnant healthcare personnel should not handle and/or administer Metoject.

Methotrexate should not come into contact with the skin or mucosa. In the event of contamination, the affected area must be rinsed immediately with ample amount of water.

For single use only.

Any unused medicinal product or waste should be disposed of in accordance with local requirements.
Metoject may be marketed with a safety system to prevent needle stick injury and reuse of the needle.

Instructions for subcutaneous use of Metoject without patient safety built-in system The best places for the injection are:
- upper thighs,
- abdomen except around the navel.

1.    Clean the area of and around the chosen injection site with soap and water or disinfectant.
2.    Pull the protective plastic cap straight off.
3.    Build a skin fold by gently squeezing the area at the injection site.
4.    The fold must be held pinched until the syringe is removed from the skin after the injection.
5.    Push the needle fully into the skin at a 90-degree angle.
6.    Push the plunger down slowly and inject the liquid underneath the skin. Remove the syringe from the skin at the same 90-degree angle.

Instructions for subcutaneous use of Metoject with patient safety built-in system The best places for the injection are:
- upper thighs,
- abdomen except around the navel.

1.    Clean the area of and around the chosen injection site with soap and water or disinfectant.
2.    Pull the protective plastic cap straight off.
3.    Build a skin fold by gently squeezing the area at the injection site.
4.    The fold must be held pinched until the syringe is removed from the skin after the injection.
5.    Push the needle fully into the skin at a 90-degree angle.
6.    Push the plunger down slowly and inject the liquid underneath the skin. Remove the syringe from the skin at the same 90-degree angle.
7.    A protective cover will automatically enclose the needle.

Note: The protection system that is triggered by the release of the protective cover can only be activated when the syringe has been emptied completely by pushing down the plunger as far as it goes.