RISPERDAL CONSTA risperidone 25mg powder for injection vial with diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 25 mg

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Injection, modified release

Composition:

Excipient Ingredients: sodium hydroxide; citric acid; sodium chloride; carmellose sodium; dibasic sodium phosphate dihydrate; polysorbate 20; water for injections

Administration route:

Intramuscular

Units in package:

1 5mL vial with 1 3mL prefilled syringe of diluent

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RISPERDAL CONSTA is indicated for the treatment of schizophrenia and related psychoses. RISPERDAL CONSTA is indicated for Monotherapy for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in patients with a manic or mixed episode, following stabilisation with oral risperidone. Adjunctive maintenance treatment with lithium or sodium valproate in treatment refractory patients with bipolar I disorder who have at least 4 relapses in a 12 month period.

Product summary:

Visual Identification: Clear colourless liquid.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-04-04

Patient Information leaflet

RISPERDAL CONSTA
®
1
RISPERDAL CONSTA
®
_INTRAMUSCULAR INJECTION _
_Risperidone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains important
information about RISPERDAL
CONSTA. It does not contain all of
the available information. It does not
take the place of talking to your
doctor or pharmacist.
If you have any concerns about using
RISPERDAL CONSTA, ask your
doctor, pharmacist or nurse. Your
doctor and pharmacist have more
information.
Keep this leaflet with your
RISPERDAL CONSTA. You may
need to read it again.
WHAT RISPERDAL
CONSTA IS USED FOR?
RISPERDAL CONSTA is used to
treat symptoms of schizophrenia and
other types of related psychoses.
These are disorders related to
thought, feeling and/or action.
RISPERDAL CONSTA is also used
to treat bipolar disorder to prevent or
delay mood swings which consist of
alternating periods of high (manic) or
elevated mood with periods of
depression. During the manic
episodes you may feel very excited,
elated, agitated, enthusiastic, or
hyperactive, or have poor judgment
including disruptive or aggressive
behaviours. During the episodes of
depression you may experience
sadness, low energy, lack of
motivation, feelings of guilt and
worthlessness, and changes in sleep
or appetite.
RISPERDAL CONSTA helps to
correct a chemical imbalance in the
brain associated with these
conditions.
RISPERDAL CONSTA has been
approved for the uses mentioned
above. However, your doctor may
prescribe this medicine for another
use.
IF YOU WANT MORE INFORMATION, ASK
YOUR DOCTOR.
RISPERDAL CONSTA is not
addictive.
BEFORE YOU ARE GIVEN
RISPERDAL CONSTA
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN
RISPERDAL CONSTA:
•
if you know you are allergic to
any of its ingredients (see the last
section of this leaflet for a list of
ingredients)
Signs of allergy include skin rash,
itching, shortness of breath,
and/or swollen face
•
if the packaging is torn or shows
signs of having been tampered
with.
_BEFORE YOU START TO USE IT _
RISPERDAL CONSTA should be
used

Summary of Product characteristics

CCDS200407ver27
Page 1 of 34
Risperdal Consta(200724)API
AUSTRALIAN PRODUCT INFORMATION
RISPERDAL CONSTA

RISPERIDONE
POWDER FOR INJECTION WITH DILUENT SYRINGE
1
NAME OF THE MEDICINE
Risperidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RISPERDAL CONSTA is an extended release microspheres formulation of
risperidone micro-
encapsulated in polyglactin for intramuscular injection, in strengths
of 25 mg, 37.5 mg and 50 mg
when suspended in 2 mL diluent.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RISPERDAL CONSTA contains either 25 mg, 37.5 mg or 50 mg risperidone
and is presented as a
white to off-white free-flowing powder in a 5 mL vial and a prefilled
syringe containing 2 mL diluent,
together with:
•
One Vial Adapter
for reconstitution and
•
Two Terumo SurGuard
®-
3 Needles for intramuscular injection (a 21G UTW 1-inch safety
needle with needle protection device for deltoid administration and a
20G TW 2-inch safety
needle with needle protection device for gluteal administration)
(“Rx-only” = device to be sold with prescription medicines only).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
RISPERDAL CONSTA is indicated for:
-
Treatment of schizophrenia and related psychoses.
-
Adjunctive maintenance treatment with lithium or sodium valproate in
treatment refractory
patients with bipolar I disorder who have at least 4 relapses in a 12
month period.
-
Monotherapy for maintenance treatment to prevent the recurrence of
manic or mixed
episodes of bipolar I disorder in patients with a manic or mixed
episode, following stabilisation
with oral risperidone.
CCDS200407ver27
Page 2 of 34
Risperdal Consta(200724)API
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
TREATMENT INITIATION: FOR RISPERIDONE NAÏVE PATIENTS, IT IS
RECOMMENDED TO ESTABLISH
TOLERABILITY WITH IMMEDIATE RELEASE ORAL FORMULATIONS OF RISPERIDONE
PRIOR TO INITIATING
TREATMENT WITH RISPERDAL CONSTA.
RISPERDAL CONSTA should be administered every two weeks by deep
intramuscular deltoid or
gluteal injection