Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Sorbitol (E420)
Glacial acetic acid
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Water for injections

6.2    Incompatibilities

Tevagrastim must not be diluted with sodium chloride solution.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as described in section 6.6.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a 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 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4    Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).
Patient can store the medicine out of refrigerator below 25oC, for up to 5 days, without exceeding the expiry date. Once removed from the refrigerator, the medicine should be used within 5 days or be disposed of. The medicine should not be returned to the refrigerator.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5    Nature and contents of container
Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard.

Tevagrastim 30 MIU/0.5 ml solution for injection or infusion.
Packs containing 1, 5 or 10 pre-filled syringes with a safety device, with 0.5 ml solution for injection or infusion; or multipacks containing 10 (2 packs of 5) pre-filled syringes with a safety device, with 0.5 ml solution for injection or infusion.

Tevagrastim 48 MIU/0.8 ml solution for injection or infusion.
Packs containing 1, 5 or 10 pre-filled syringes with a safety device, with 0.8 ml solution for injection or infusion; or multipacks containing 10 (2 packs of 5) pre-filled syringes with a safety device, with 0.8 ml solution for injection or infusion.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

If required, Tevagrastim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.

The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.

Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MIU (300 μg) should be given with 0.2 mL of 200 mg/mL (20 %) human albumin solution added.

When diluted in glucose 50 mg/mL (5 %) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

Tevagrastim does not contain any preservative. In view of the possible risk of microbial contamination, Tevagrastim syringes are for single use only.

Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.

Using the pre-filled syringe with a needle safety guard
The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.
Disposal

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

7.     LICENCE HOLDER AND MANUFACTURER

Teva Israel Ltd.
124 Dvora HaNevi'a St., Tel Aviv 6944020 Israel