Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Mannitol
Citric acid monohydrate
Sodium citrate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Sodium chloride
Polysorbate 80
Sodium hydroxide
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 
6.4    Special precautions for storage

Pre-filled syringe:
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light. .
A single Humira pre-filled syringe may be stored at temperatures below 25°C for a period of up to 14 days.
The syringe must be protected from light, and discarded if not used within the 14-day period.

Pre-filled pen:
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light. .
A single Humira pen may be stored at temperatures below 25°C for a period of up to 14 days.
The pen must be protected from light, and discarded if not used within the 14-day period.

Humira 40 mg solution for injection glass vial:
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
6.5    Nature and contents of container

Pre-filled syringe:
Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer): 
Packs of:
•     1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister.
•     2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
•     4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
•     6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.

Not all pack sizes may be marketed.
Pre-filled pen:
Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. The syringe inside the pen is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:
•     1 pre-filled pen with 2 alcohol pad in a blister.
•     2 pre-filled pen, each with 1 alcohol pad, in a blister.
•     4 pre-filled pen, each with 1 alcohol pad, in a blister.
•     6 pre-filled pen, each with 1 alcohol pad, in a blister.

Not all pack sizes may be marketed.
Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals:
1 Pack of 2 boxes each containing:
1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.

Not all presentations or pack sizes may be marketed.

6.6    Special precautions for disposal any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.     Manufacturer: AbbVie Ltd., Maidenhead, UK