국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
patisiran, Quantity: 10 mg
Alnylam Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: PEG2000-C-DMG; sodium chloride; DLin-MC3-DMA; water for injections; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; cholesterol; distearoylphosphatidylcholine
Intravenous Infusion
Single vial
(S4) Prescription Only Medicine
Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Visual Identification: A sterile, preservative-free, white to off-white, opalescent, homogeneous liquid for intravenous infusion in a Type I clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-11-21
Onpattro CMI Ver 1.0 1 ONPATTRO® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING ONPATTRO? Onpattro contains the active ingredient patisiran. Onpattro is used to treat an illness which runs in families called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). For more information, see Section 1. Why am I using Onpattro? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ONPATTRO? Do not use if you have ever had an allergic reaction to patisiran or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Onpattro? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Onpattro and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ONPATTRO? • The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every 3 weeks. • Onpattro will be given to you by a doctor or nurse. It is given as a drip into a vein (‘intravenous infusion’) usually over about 80 minutes. More instructions can be found in Section 4. How do I use Onpattro? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ONPATTRO? THINGS YOU SHOULD DO • Tell your doctor if you are pregnant or breastfeeding, or are planning to become pregnant • Remind any doctor, dentist, or pharmacist you visit that you are using Onpattro. THINGS YOU SHOULD NOT DO • Your doctor will tell you how long you need to receive Onpattro. Do not stop treatment with Onpattro unless your doctor tells you to. DRIVING OR USING MACHINES • Onpattr 전체 문서 읽기
1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – ONPATTRO ® (PATISIRAN) 1. NAME OF THE MEDICINE Patisiran 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran. Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles. Excipients with known effect Each mL of concentrate contains 3.99 mg sodium. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Concentrated injection for infusion (sterile concentrate). White to off-white, opalescent, homogeneous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. DOSAGE The recommended dose of Onpattro is 300 micrograms per kg body weight administered via intravenous (IV) infusion once every 3 weeks. Dosing is based on actual body weight. For patients weighing ≥ 100 kg, the maximum recommended dose is 30 mg. ▼ 2 Vitamin A supplementation at approximately 2500 IU vitamin A per day is advised for patients treated with Onpattro (see section 4.4 Special Warnings and Precautions for Use). _Required premedication _ All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4 Special Warnings and Precautions for Use). Each of the following medicinal products should be given on the day of Onpattro infusion at least 60 minutes prior to the start of infusion: • Intravenous corticosteroid (dexameth 전체 문서 읽기