Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder

Carmellose sodium
Mannitol
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide
Solvent

Water for injections

6.2   Incompatibilities
Not applicable

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Abilify Maintena powder and solvent for prolonged-release suspension for injection The suspension should be injected immediately after reconstitution but can be stored below 25 °C for up to 4 hours in the vial.

Abilify Maintena powder and solvent for prolonged-release suspension for injection in pre-filled syringe
The suspension should be injected immediately after reconstitution but can be stored below 25 °C for up to 2 hours in the syringe.


After reconstitution

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of user. Do not store the reconstituted suspension in the syringe.

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.

6.4   Special precautions for storage

Do not freeze.
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Keep the syringe in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 

Vial
Type-I glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium cap.

Solvent
2 ml Type-1 glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium cap.

Single pack
Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Multipack
Bundle pack of 3 single packs.

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Clear glass pre-filled syringe (type-I glass) with grey chlorobutyl stoppers (front-, middle- and end stopper), polypropylene front assembly, polypropylene finger grip, plunger rod, and silicone over-cap.
The front chamber between front stopper and middle stopper contains the powder and the rear chamber between middle stopper and end stopper the solvent.

Single pack
Each single pack containing one pre-filled syringe, and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Multipack
Bundle pack of 3 single packs.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling.


Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.
If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and use immediately. If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

Gluteal muscle administration
The recommended needle for gluteal administration is a 38 mm (1.5 inch), 22 gauge hypodermic safety needle; for obese patients (Body mass index > 28 kg/m2), a 51 mm (2 inch), 21 gauge hypodermic safety needle should be used. Gluteal injections should be alternated between the two gluteal muscles.

Deltoid muscle administration
The recommended needle for deltoid administration is a 25 mm (1 inch), 23 gauge hypodermic safety needle; for obese patients, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle should be used.
Deltoid injections should be alternated between the two deltoid muscles.

The powder and solvent vials and the pre-filled syringe are for single-use only.

Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Full instructions for use and handling of Abilify Maintena are provided in the package leaflet (information intended for healthcare professionals).


7.
Manufacturer: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Licence Holder: LUNDBECK ISRAEL LTD ., 4 DERECH HASHALOM , POB 7382, TEL AVIV