ABILIFY MAINTENA aripiprazole (as monohydrate) 400 mg powder and solvent for prolonged release suspension for injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

aripiprazole, Quantity: 400 mg (Equivalent: aripiprazole monohydrate, Qty 416.07 mg)

Prieinama:

Lundbeck Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

aripiprazole

Vaisto forma:

Injection, diluent for

Sudėtis:

Excipient Ingredients: water for injections

Vartojimo būdas:

Intramuscular

Vienetai pakuotėje:

One 10 mL vial of powder with one 2 mL vial of diluent

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

For the acute and maintenance treatment of schizophrenia in adults. For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

Produkto santrauka:

Visual Identification: 2 mL clear glass vial containing a clear colourless liquid, stoppered with a FluroTec Plus laminated gray bromobutyl rubber stopper and sealed with an aluminium flip-off cap with plastic flip-off disc; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2014-07-25

Pakuotės lapelis

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ABILIFY MAINTENA?
Abilify Maintena contains the active ingredient aripiprazole. Abilify
Maintena is a long-acting medicine that is used to treat
schizophrenia and Bipolar I Disorder. For more information, see
Section 1. Why am I using Abilify Maintena? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ABILIFY MAINTENA?
ABILIFY MAINTENA SHOULD ONLY BE GIVEN BY A HEALTHCARE PROFESSIONAL.
Do not receive if you have ever had an allergic reaction to
aripiprazole or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Abilify Maintena? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Abilify Maintena and affect how it
works. These include: medicines and herbal remedies used to
treat depression and anxiety, certain medicines used to treat nicotine
dependence, anticonvulsants used to treat epilepsy, medicines
used to treat high blood pressure, medicines used to treat heart
rhythm disturbances, medicines used to treat bacterial, fungal or
viral infections.A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE ABILIFY MAINTENA?
Abilify Maintena is a long-acting medicine that a healthcare
professional will give to you by injection. More instructions can be
found
in Section 4. How do I use Abilify Maintena? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ABILIFY MAINTENA?
THINGS YOU SHOULD DO
•
Tell your doctor immediately if you become pregnant while taking
Abilify Maintena.
•
Tell your doctor if you are about to be started on any new medicine
•
Tell y

Prekės savybės

ABILIFY MAINTENA
®
(aripiprazole (as monohydrate))
1 of 46
AUSTRALIAN PRODUCT INFORMATION – ABILIFY
MAINTENA (ARIPIPRAZOLE (AS MONOHYDRATE))
PROLONGED-RELEASE SUSPENSION FOR INJECTION
(THERAPEUTIC KIT)
1
NAME OF THE MEDICINE
Aripiprazole (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole is present in Abilify Maintena as aripiprazole (as
monohydrate). Abilify
Maintena is presented as a therapeutic kit. The presentation contains
a sterile, single-dose,
lyophilised powder for reconstitution with water for injections to
give a prolonged-release
suspension for injection to deliver 400 mg or 300 mg of aripiprazole
per vial strength. The
therapeutic kit presentation contains the following excipients:
carmellose sodium, mannitol,
monobasic sodium phosphate monohydrate and sodium hydroxide.
3
PHARMACEUTICAL FORM
Abilify Maintena (aripiprazole) 300 mg powder and solvent for
prolonged-release suspension
for injection (Therapeutic Kit)
Abilify Maintena (aripiprazole) 400 mg powder and solvent for
prolonged-release suspension
for injection (Therapeutic Kit)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the acute and maintenance treatment of schizophrenia in adults.
For maintenance treatment to prevent the recurrence of manic or mixed
episodes of bipolar I
disorder in adult patients as monotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE AND DOSAGE ADJUSTMENT
Abilify Maintena is intended for intramuscular injection only. For
patients who have never
taken aripiprazole, establish tolerability with oral aripiprazole
prior to initiating treatment
with Abilify Maintena. Due to the half-life of oral aripiprazole, it
may take up to 2 weeks to
fully
assess
tolerability.
The
recommended
starting
and
maintenance
dose
of
Abilify
Maintena is 400 mg. Titration of the dose of Abilify Maintena is not
required. Abilify
Maintena is to be administered by a healthcare professional only,
once-monthly, as a single
injection into the deltoid or gluteal muscle (no sooner than 26 days
after the prev