Abilify Maintena pre-filled syringe 400mg (300mg not marketed) *

The amendment is a change to the MA holder address in Section 7.  

New address as follows:  

Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

The address of the Marketing Authorisation holder has been amended to:  

Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

The following changes have been made due to the 5 year licence renewal.  In the main these are formatting changes,

Section 4.2: Revision of text on missed doses

Section 4.4: Addition of Sodium Statement as follows:  "Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose."

Section 6.3: Addition of existing reconstitution text from section 2

Section 6.5: More detailed description of contents of container

Section 6.6: Moving of existing text from Carton to Section 6.6

Amendments and updates to Section 4,4 and 4.8 with regards to impulse control disorders.

Addition of 'hiccup' in Section 4.8 as 'uncommon'

In section 4.8, hyperprolactinaemia, diplopia and aggression have been added.
Text regarding prolactin blood levels have been moved from seciton 4.8 to 5.1
Date of revision of the text has been updated.

Section 4.2 Method of administration Abilify Maintena is only intended for intramuscular use and should not be administered intravenously or subcutaneously. It should only be administered by a healthcare professional. The suspension should be injected immediately after reconstitution but can be stored below 25 °C for up to 4 hours in the vial. The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel. Sites of injections should be rotated between the two gluteal or deltoid muscles. 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 50 mm (2 inch), 21 gauge hypodermic safety needle should be used. 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 (see section 6.6). Section 4.8 Injection site reactions During the double blind, .../..... In an open label study comparing bioavailability of Abilify Maintena administered in the deltoid or gluteal muscle, injection site related reactions were slightly more frequent in the deltoid muscle. The majority were mild and improved on subsequent injections. When compared to studies where Abilify Maintena was injected in the gluteal muscle, repeated occurrence of injection site pain is more frequent in the deltoid muscle. Section 5.2 Absorption Aripiprazole absorption …/…. The average absorption half-life …/…. Following a single dose administration of Abilify Maintena in the deltoid and gluteal muscle, the extent of absorption (AUC) was similar for both injection sites, but the rate of absorption (Cmax) was higher following administration to the deltoid muscle. Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median Tmax of 7 days for the gluteal muscle and 3 days for the deltoid muscle. Steady state concentrations for the typical subject were attained by the fourth dose for both sites of administration. 6.5 Nature and contents of container 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 50 mm (2 inch) 21 gauge. 6.6 Special precautions for disposal and other handling. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Step 1: Preparation prior to reconstitution of the powder. (a) Lay out and confirm that components listed below are provided: - Abilify Maintena package leaflet and instructions for healthcare professionals - Vial of powder - 2 ml vial of solvent Important: the solvent vial contains an overfill. - 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 - One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device - One 38 mm (1.5 inch) 22 gauge hypodermic safety needle with needle protection device - One 50 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device - Syringe and needle instructions Step 2: Reconstitution of the powder (a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab. (b) Using the syringe with pre-attached needle, withdraw the pre-determined solvent volume from the vial of the solvent into the syringe. 400 mg vial: Add 1.9 ml solvent to reconstitute the powder A small amount of residual solvent will remain in the vial following withdrawal. Any excess should be discarded. (c) Slowly inject the solvent into the vial containing the powder. (d) Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger. (e) Subsequently, remove the needle from the vial. Engage the needle safety device by using the one-handed technique . Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath. Visually confirm that the needle is fully engaged into the needle protection sheath, and discard. Cover Discard (f) Shake the vial vigorously for 30 seconds until the suspension appears uniform. (g) Visually inspect the reconstituted suspension for particulate matter and discolouration prior to administration. The reconstituted medicine is a white to off-white, fluid suspension. Do not use if reconstituted suspension contains particulate matter or any discolouration. (h) If the injection is not performed immediately after reconstitution, keep the vial below 25 °C for up to 4 hours and shake it vigorously for at least 60 seconds to re-suspend prior to injection. (i) Do not store the reconstituted suspension in the syringe. Step 3: Preparation prior to injection (a) Remove the cover, but not the adapter from the package. (b) Using the vial adapter package to handle the vial adapter, attach the pre-packaged luer lock syringe to the vial adapter . (c) Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package . Do not touch the spike tip of the adapter at any time. (d) Determine the recommended volume for injection. Abilify Maintena 400 mg Vial Dose Volume to Inject 400 mg 2.0 ml 300 mg 1.5 ml 200 mg 1.0 ml 160 mg 0.8 ml (e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab. (f) Place and hold the vial of the reconstituted suspension on a hard surface. Attach the adapter-syringe assembly to the vial by holding the outside of the adapter and pushing the adapter’s spike firmly through the rubber stopper, until the adapter snaps in place. (g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection. A small amount of excess product will remain in the vial. Step 4: Injection procedure (a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial. (b) Select one of the following hypodermic safety needles depending on the injection site and patient’s weight and attach the needle to the luer lock syringe containing the suspension for injection. Ensure the needle is firmly seated on the needle protection device with a push and clockwise twist and then pull the needle cap straight away from the needle. Body type Injection site Needle size Non-obese Deltoid Gluteal 25 mm (1 inch) 23 gauge 38 mm (1.5 inch) 22 gauge Obese Deltoid Gluteal 38 mm (1.5 inch) 22 gauge 50 mm (2 inch) 21 gauge (c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle. Do not massage the injection site. Care must be taken to avoid inadvertent injection into the blood vessel. Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises. For deep intramuscular gluteal or deltoid injection only. deltoid gluteal Remember to rotate sites of injections between the two gluteal or deltoid muscles. Look for signs or symptoms of inadvertent intravenous administration. Step 5: Procedures after injection (a) Engage the needle safety device as described in Step 2 e). Dispose of the vials, adapter, needles, and syringe appropriately after injection. The powder and solvent vials are for single-use only. Cover Discard 10. DATE OF REVISION OF THE TEXT 22/01/2015

Correct of typos
Deletion of multipack from section 6.5

None provided