Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 37.5 mg
Janssen-Cilag Pty Ltd
Injection, modified release
Excipient Ingredients: citric acid; sodium chloride; carmellose sodium; polysorbate 20; dibasic sodium phosphate dihydrate; sodium hydroxide; water for injections
Intramuscular
1 5mL vial with 1 3mL prefilled syringe of diluent
(S4) Prescription Only Medicine
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.
Visual Identification: Clear colourless liquid.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2003-04-04
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 Read the complete document
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 Read the complete document