Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
paliperidone palmitate, Quantity: 312 mg/mL (Equivalent: paliperidone, Qty 200 mg/mL)
Janssen-Cilag Pty Ltd
Paliperidone palmitate
Injection, suspension
Excipient Ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections
Intramuscular
1 assembled prefilled syringe
(S4) Prescription Only Medicine
Indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.
Visual Identification: White to off-white suspension; Container Type: Syringe; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-09-23
INVEGA TRINZA™ 1 INVEGA TRINZA™ _MODIFIED RELEASE AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION _ _Paliperidone palmitate _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Invega Trinza. 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 TRINZA, 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 TRINZA IS USED FOR Invega Trinza belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain type of mental illness. It is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings and behaviour. Invega Trinza 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) • a false belief or wrong judgment, sometimes associated with hallucinations, held with conviction despite evidence to the contrary (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 Trinza 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 TRINZA IF YOU KNOW YOU ARE ALLERGIC TO ANY OF ITS INGREDIENTS LISTED AT THE END OF T Прочитајте комплетан документ
CCDS200612ver06 Page 1 of 35 INVEGATRINZA(200729)API INVEGA TRINZA ® PALIPERIDONE PALMITATE AUSTRALIAN PRODUCT INFORMATION 1. NAME OF THE MEDICINE Paliperidone palmitate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA TRINZA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM INVEGA TRINZA is available as a white to off-white sterile modified release aqueous suspension for intramuscular injection in dose strengths of 175 mg, 263 mg, 350 mg and 525 mg paliperidone (as 273 mg, 410 mg, 546 mg and 819 mg paliperidone palmitate, respectively). INVEGA TRINZA paliperidone (as palmitate) 175 mg suspension for injection pre-filled syringe. Each 0.875 mL prefilled syringe contains 175 mg of paliperidone as 273 mg paliperidone palmitate INVEGA TRINZA paliperidone (as palmitate) 263 mg suspension for injection pre-filled syringe. Each 1.315mL prefilled syringe contains 263 mg of paliperidone as 410 mg paliperidone palmitate INVEGA TRINZA paliperidone (as palmitate) 350 mg suspension for injection pre-filled syringe. Each 1.75 mL prefilled syringe contains 350 mg of paliperidone as 546 mg paliperidone palmitate INVEGA TRINZA paliperidone (as palmitate) 525 mg suspension for injection pre-filled syringe. Each 2.625 mL prefilled syringe contains 525 mg of paliperidone as 819 mg paliperidone palmitate 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INVEGA TRINZA, a 3-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. 4.2 DOSE AND METHOD OF Прочитајте комплетан документ