국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
imdevimab, Quantity: 120 mg/mL
Roche Products Pty Ltd
Injection, solution
Excipient Ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections
Intravenous Infusion, Subcutaneous
20 mL multidose vials
(S4) Prescription Only Medicine
Ronapreve has provisional approval for the indications below:,Treatment:,Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.,Post-exposure prophylaxis:,Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, OR,? are not vaccinated against COVID-19. (,refer to section 4.2 Dose and method of administration and section 5.1, Clinical Trials),Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.,The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,The use of Ronapreve should take into account information on the activity of Ronapreve against viral variants of concern. See sections 4.4 and 5.1.
Visual Identification: 20 ml glass vial containing clear to slightly opalescent and colourless to pale yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered (Provisional)
2021-10-18
RONAPREVE ® R o n a p r e v e 2 0 2 2 1 1 2 5 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 BEING GIVEN RONAPREVE? RONAPREVE contains the active ingredients casirivimab and imdevimab. RONAPREVE is used in patients 12 years and older and weighing at least 40 kg to: • treat COVID-19 in those who are at an increased risk of progressing to severe disease, or • prevent COVID-19 post-exposure, in those who are unlikely to be protected by a COVID-19 vaccine. For more information, see Section 1. Why am I being given RONAPREVE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN RONAPREVE? You must not be given RONAPREVE if you have ever had an allergic reaction to casirivimab and imdevimab or any of the ingredients listed at the end of this CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant, plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given RONAPREVE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS RONAPREVE GIVEN? TREATMENT: RONAPREVE is given either as a single infusion into the vein (intravenous infusion) or an injection under the skin (subcutaneous injection) after a positive test for the SARS-COV-2 virus. PREVENTION: RONAPREVE is given by either intravenous infusion or a subcutaneous injection. It can be given as a single dose following exposure to SARS-COV-2 or it can be repeated once every 4 weeks if required. Mor 전체 문서 읽기
Ronapreve 20221125 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 RONAPREVE ® (CASIRIVIMAB AND IMDEVIMAB) 1. NAME OF THE MEDICINE Casirivimab and imdevimab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ronapreve is available as: a. Co-packaged 6 mL single-use vials Each casirivimab 6 mL vial contains 300 mg of casirivimab per 2.5 mL (120 mg/mL). Each imdevimab 6 mL vial contains 300 mg imdevimab per 2.5 mL (120 mg/mL). b. Co-packaged 20 mL multidose vials Each casirivimab 20 mL multidose vial contains 1 332 mg of casirivimab per 11.1 mL (120 mg/mL). Each imdevimab 20 mL multidose vial contains 1 332 mg imdevimab per 11.1 mL (120 mg/mL). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection or infusion. Clear to slightly opalescent and colourless to pale yellow solution with a pH of 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ronapreve has PROVISIONAL APPROVAL for the indications below: TREATMENT Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19. POST-EXPOSURE PROPHYLAXIS Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either: • have a medical condition making them unlikely to respond to or be protected by vaccination, OR • are not vaccinated against COVID-19. (refer to section 4.2 Dose and method of administration and section 5.1, Clinical Trials) ▼ Ronapreve 20221125 2 Ronapreve is not intended to be used as a substitute for vaccination against COVID-19. The decision ha 전체 문서 읽기