PDF4PRO ⚡AMP

Modern search engine that looking for books and documents around the web

Example: biology

PI: XEVUDY (Sotrovimab) Concentrated injection solution ...

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 AUSTRALIAN PRODUCT INFORMATION XEVUDY (Sotrovimab) Concentrated i njection solution for infusion 1 NAME OF THE MEDICINE Sotrovimab 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of sotrovimab in 8 mL ( mg/mL). For the full list of excipients, see Section LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Sotrovimab is a clear, colourless or yellow to brown Concentrated injection solution for intravenous infusion.

4. Discard any unused portion left in the vial as the product contains no preservative. The vial is single-use only and should only be used for one patient. 5. Prior to the infusion, gently rock the infusion bag back and forth 3 to 5 times. Do not invert the infusion bag. Avoid forming air bubbles.

Fullscreen Download

Tags:

  Preservative

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Spam in document Broken preview Other abuse

Transcription of PI: XEVUDY (Sotrovimab) Concentrated injection solution ...

Documents from same domain

Guideline for the labelling of medicines

www.tga.gov.au

Guideline for the labelling medicines of istorical consultation document Draft - Version 1.0, August 2014

  Guidelines, Labelling, Guideline for the labelling

Australian public assessment report for Linagliptin

www.tga.gov.au

• An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.

  Assessment, Report, Public, Australian, Public assessment, Australian public assessment report for linagliptin, Linagliptin

Australian Public Assessment Report for Silodosin

www.tga.gov.au

Australian Public Assessment Report for Silodosin Proprietary Product Name: Urorec ... • To report a problem with a medicine or medical device, please see the information on ... //www.tga.gov.au>. About AusPARs • An Australian Public Assessment Re port (AusPAR) provides information about the evaluation of a prescription medicine and the ...

  Assessment, Report, Public, Australian, Ports, Australian public assessment report for silodosin, Silodosin, Public assessment re port

Guidance 18: Impurities in drug substances and …

www.tga.gov.au

Therapeutic Goods Administration Guidance 18: Impurities in drug substances and drug products V1.0 August 2013 Page 3 of 13 Version history Version Description of change Author Effective date

  Drug, Impurities, Substance, Impurities in drug substances and, Impurities in drug substances and drug

Explanatory notes for pharmaceutical manufacturers on the ...

www.tga.gov.au

PE 008-4 3 of 8 1 January 2011 4. SCOPE These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / …

  Notes, Pharmaceutical, Life, Manufacturers, Explanatory notes, Explanatory, Explanatory notes for pharmaceutical manufacturers

The use of GMDN codes for IVD medical devices in Australia

www.tga.gov.au

Global Medical Device Nomenclature (GMDN) The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices: 1 • consistent assessment of devices before they are approved for supply . GMDN codes are used to

  Devices, Medical, Global, Nomenclature, Global medical device nomenclature

COMIRNATY™ COVID-19 VACCINE

www.tga.gov.au

Do not receive this vaccine if you are allergic to any of these ingredients. What COMIRNATY looks like COMIRNATY is a white to off-white suspension provided in a multidose clear glass vial. After dilution, each vial contains 6 doses of vaccine. AUST R 346290. Who distributes COMIRNATY Pfizer Australia Pty Ltd Sydney NSW www.pfizer.com.au

  Ingredients, Vaccine

COVID-19 rapid antigen self-tests

www.tga.gov.au

COVID-19 rapid antigen self-tests. This guidance refe rs to COVID -19 (caused by SARS-CoV-2) only and does not include self-tests to detect other types of coronavirus , or COVID_19 rapid antibody tests . COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct a test and interpret the results by themselves.

  Rapid

AUSTRALIAN PRODUCT INFORMATION (ChAdOx1-S) …

www.tga.gov.au

AUSTRALIAN PRODUCT INFORMATION COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection . 1 NAME OF THE MEDICINE . ChAdOx1-S (provisional ABN) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION . Each multi-dose vial contains 5x10. 11. viral particles (vp) of (ChAdOx1-S . a, b) in 5 mL. One dose (0.5 mL) contains 5x10. 10. vp of …

  Information, Product, Name, Product information, Qualitative, Astrazeneca

Australian public assessment report for BNT162b2 (mRNA)

www.tga.gov.au

The RNA is encapsulated in lipid nanoparticles (LNPs), which enables entry into host cells, expression of the S protein, and elicitation of both antibody and cellular immune responses. The vaccine is supplied as a white to off white sterile frozen liquid, packaged in a multi dose clear glass 2 mL vial with a rubber stopper,

  Lipids, Nanoparticles, Lipid nanoparticles