国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
elasomeran, Quantity: 0.05 mg/mL; imelasomeran, Quantity: 0.05 mg/mL
Moderna Australia Pty Ltd
Injection, suspension
Excipient Ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; water for injections; trometamol; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; cholesterol; glacial acetic acid; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride
Intramuscular
10 x 2.5mL, 10 x 5mL
(S4) Prescription Only Medicine
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran/imelasomeran) COVID-19 Vaccine has provisional approval for the indication below:,As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.,The use of this vaccine should be in accordance with official recommendations.,The decision has been made on the basis of immunogenicity and short-term safety data. Continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.
Visual Identification: white to off-white frozen suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 9 Months; Container Temperature: Store between minus 50 - minus 15 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered (Provisional)
2022-08-30
SPIKEVAX BIVALENT ORIGINAL/OMICRON_CMI_v3.1_23Nov22 1 SPIKEVAX BIVALENT ORIGINAL/OMICRON COVID-19 VACCINE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about being given this vaccine, speak to your healthcare provider. This vaccine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I BEING GIVEN SPIKEVAX BIVALENT ORIGINAL/OMICRON? SPIKEVAX BIVALENT ORIGINAL/OMICRON contains the active ingredients elasomeran and imelasomeran. It is a vaccine used as a booster dose to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged 18 years and older. For more information, see Section 1. Why am I being given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN SPIKEVAX BIVALENT ORIGINAL/OMICRON? You should not be given SPIKEVAX BIVALENT ORIGINAL/OMICRON if you have ever had an allergic reaction to SPIKEVAX (original) or SPIKEVAX BIVALENT ORIGINAL/OMICRON or any of the ingredients listed at the end of the CMI. Check with your doctor, pharmacist, or nurse before vaccination if you: have previously had a severe allergic reaction after any other vaccine injection or after you were given SPIKEVAX (original) in the past; have a very weak or poorly functioning immune system; have ever fainted following any needle injection; have a bleeding disorder; have a high fever or severe infection; have any serious illness; have anxiety related to injections. TALK TO YOUR DOCTOR IF YOU HAVE A WEAKENED IMMUNE SYSTEM, HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. SPIKEVAX BIVALENT ORIGINAL/OMICRON should not be given to children and adolescents under the age of 18 years. For more information, see Section 2. What should I know before I am given SPIKEVAX BIVALENT ORIGINAL/OMICRON? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Tell your doctor or pharmacist if you are taking any other m 完全なドキュメントを読む
SPIKEVAX BIVALENT ORIGINAL/OMICRON_PI_3.0_22Nov22 1 This vaccine 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 www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – SPIKEVAX BIVALENT ORIGINAL/OMICRON (ELASOMERAN/IMELASOMERAN) COVID‐19 VACCINE 1 NAME OF THE MEDICINE Elasomeran/imelasomeran 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CONCENTRATION PRESENTATION DOSE(S) COMPOSITION 0.1 mg/mL Multidose vial 2.5 mL: 5 doses of 0.5 mL each 5 mL: 10 doses of 0.5 mL each One dose (0.5 mL) contains 25 micrograms of elasomeran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles), and 25 micrograms of imelasomeran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). Pre-filled syringe 1 dose of 0.5 mL For single use only. One dose (0.5 mL) contains 25 micrograms of elasomeran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles) and 25 micrograms of imelasomeran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). Elasomeran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2. Imelasomeran contains mRNA, 5’-capped, encoding a full-length, codon-optimised pre-fusion stabilised conformation variant (K983P and V984P) of the SARSCoV-2 spike (S) glycoprotein (Omicron variant, B.1.1.529). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Suspension for injection. White to off white suspension. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ▼ SPIKEVAX BIVALENT ORIGINAL/OMICRON_PI_3.0_22Nov22 2 SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran/imelasomeran) COVID-19 Vaccine has PROVISIONAL APPROVAL for the indication below: As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age a 完全なドキュメントを読む