দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Paliperidone 12mg (Drug Layer 1 = 3.6 mg, Drug Layer 2 = 8.4 mg.)
Janssen-Cilag (New Zealand) Ltd
Paliperidone 12 mg (Drug Layer 1 = 3.6 mg, Drug Layer 2 = 8.4 mg.)
12 mg
Modified release tablet
Active: Paliperidone 12mg (Drug Layer 1 = 3.6 mg, Drug Layer 2 = 8.4 mg.) Excipient: Butylated hydroxytoluene Carnauba wax Cellulose acetate Hyetellose Hypromellose Iron oxide red Iron oxide yellow Macrogol 3350 Macrogol 400 Opacode black NS-78-17821 Polyethylene oxide Povidone Sodium chloride Stearic acid Titanium dioxide
Blister pack, PVC-PCTFE/Paper-Al, 28 tablets
Prescription
Prescription
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
INVEGA prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.
Package - Contents - Shelf Life: Blister pack, PVC-PCTFE/Al or OPA-Al-PVC/Al or PVC-PCTFE/Paper-Al - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC-PCTFE/Al or OPA-Al-PVC/Al or PVC-PCTFE/Paper-Al - 56 tablets - 24 months from date of manufacture stored at or below 25°C
2006-08-17
INVEGA SUSTENNA ® 1 INVEGA SUSTENNA ® _MODIFIED RELEASE SUSPENSION FOR INJECTION _ _Paliperidone palmitate _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about INVEGA SUSTENNA. 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 INVEGA SUSTENNA, ASK YOUR DOCTOR OR PHARMACIST. Your doctor and pharmacist have more information. KEEP THIS INFORMATION HANDY. You can refer to it later if you have any questions. WHAT INVEGA SUSTENNA IS USED FOR INVEGA SUSTENNA belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. It is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings and behaviour. INVEGA SUSTENNA helps to correct a chemical imbalance in the brain associated with this condition. It can also be used to lessen the chance of your schizophrenia symptoms from coming back. Some of the most common symptoms of schizophrenia may include: • Seeing, hearing, or sensing things that are not there (hallucinations) • Believing that what other people say is not true (delusions) • Not trusting others and feeling very suspicious (paranoia) • Avoiding family and friends and wanting to be alone It may take some time before your symptoms of schizophrenia start to improve. Remember that INVEGA SUSTENNA is one part of your overall treatment plan. It is important to keep all your appointments, so you can get your treatments on time and your doctor can check your progress. Your doctor, however, may prescribe this medicine for another use. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED TO YOU. BEFORE YOU TAKE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE INVEGA SUSTENNA IF YOU KNOW YOU ARE ALLERGIC TO ANY OF ITS INGREDIENTS LISTED AT THE END OF THIS LEAFLET OR MEDICINES CONTAINING PALIPERIDONE (E.G. INVEGA) OR RISPERIDONE (E.G. সম্পূর্ণ নথি পড়ুন
CCDS180507 Page 1 of 26 INVEGA TABS(180723)ADS INVEGA ® PALIPERIDONE NEW ZEALAND DATASHEET 1. PRODUCT NAME INVEGA 3 mg modified release tablets INVEGA 6 mg modified release tablets INVEGA 9 mg modified release tablets INVEGA 12 mg modified release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paliperidone INVEGA (paliperidone) is a novel antipsychotic agent belonging to the benzisoxazole-derivatives class. Excipient(s) with known effect The 3 mg tablet contains 13.2 mg lactose For a full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Modified release tablet 3 mg White, capsule shaped tablets imprinted with “PAL 3”. 6 mg Beige, capsule shaped tablets imprinted with “PAL 6”. 9 mg Pink, capsule shaped tablets imprinted with “PAL 9”. 12 mg Dark yellow, capsule shaped tablets imprinted with “PAL 12”. INVEGA utilises osmotic drug-release technology, whereby osmotic pressure delivers paliperidone from the dosage form at a controlled rate. The system, which resembles a capsule-shaped tablet in appearance, comprises an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each strength is identified by a unique colour overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible colour overcoat erodes quickly. Water is then imbibed through the semipermeable, rate-controlling membrane. The membrane controls the rate at which water enters the tablet core, which, in turn, controls drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, সম্পূর্ণ নথি পড়ুন