Risperdal Consta

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Patient Information leaflet (PIL)

30-11-2020

Summary of Product characteristics (SPC)

18-11-2020

Active ingredient:

Risperidone 25mg

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Risperidone 25 mg

Dosage:

25 mg/2mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Risperidone 25mg Excipient: Polyglactin Carmellose sodium Citric acid Dibasic sodium phosphate dihydrate Polysorbate 20 Sodium chloride Sodium hydroxide Water for injection

Units in package:

Combination pack, Vial + 2mL diluent, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

Therapeutic indications:

Risperdal Consta is indicated for the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent. Risperdal Consta also alleviates affective symptoms (such as depression, guilt-feelings, anxiety) associated with schizophrenia. In addition, Risperdal Consta also appears effective in maintaining the clinical improvement during continuation therapy in patients who have should an initial response to treatment with this agent.

Product summary:

Package - Contents - Shelf Life: Combination pack, Vial + 2mL diluent - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours reconstituted stored at or below 25°C - Syringe, diluent - 2 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, powder - 25 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2001-10-08

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

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Summary of Product characteristics

CCDS200407ver27
Page 1 of 33
RISPERDALCONSTA(200629)ADS
RISPERDAL CONSTA
®
RISPERIDONE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
RISPERDAL CONSTA 25 mg/2 ml Suspension for injection
RISPERDAL CONSTA 37.5 mg/2 ml Suspension for injection
RISPERDAL CONSTA 50 mg/2 ml Suspension for injection
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 25mg, 37.5mg and 50mg when
suspended in 2mL diluent.
For a full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
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 5mL vial and a prefilled
syringe containing 2mL diluent,
together with:
-
One Vial Adapter for reconstitution (referred as Vial Adapter), and
-
Two Terumo SurGuard 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).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL CONSTA
is indicated for the treatment of schizophrenia and other psychotic
disorders.
These include first episode psychoses, acute schizophrenic
exacerbations, chronic schizophrenia
and other psychotic conditions, in which positive symptoms (such as
hallucinations, delusions,
thought disturbances, hostility, suspiciousness), and/or negative
symptoms (such as blunted effect,
emotional and social withdrawal, poverty of speech) are prominent.
RISPERDAL CONSTA also alleviates affective symptoms (such as
depression, guilt-feelings,
anxiety) associated with schizophrenia. In addition, RISPERDAL CONSTA
also appears effective
in maintaining the clinical improvement during continuation therapy in
patients who have shown an
initial response to treatment with this agent.
RISPERDAL CONST

Read the complete document