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Phesgo product monograph canada

WebSep 10, 2024 · A product monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications, and … Web• PHESGO has different dosage and administration instructions than intravenous pertuzumab and trastuzumab products. • Do not administer intravenously. (2.2) • Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (1, 2.1) • The initial dose of PHESGO is 1,200 mg pertuzumab, 600 mg

OZEMPIC - pdf.hres.ca

WebAdverse Reaction Reporting and Re-Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada’s Canada Vigilance Program at 1-866-234-2345. The Product Monograph will be re-issued in the event of serious safety concerns WebFeb 7, 2024 · The Product Monograph includes three sections: Part I: Health Professional Information; Part II: Scientific Information; and; Patient Medication Information; Search Regulatory Decision Summaries: The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. elephant walk bar employees obituaries https://mission-complete.org

Targeted therapy for breast cancer Canadian Cancer …

WebMar 2, 2024 · Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Assessment history Changes since initial authorisation of medicine WebDocuments provided here are for informational use and for residents of Canada only. If you are a customer and have questions about Lilly medicines, please call our Customer Response Centre at 1-888-545-5972 or submit your questions using this online form. If you are seeking medical advice, contact your health care provider. WebThis product contains 3 ingredients: pertuzumab, trastuzumab, and hyaluronidase. It is used to treat a certain type of breast cancer. The cancer cells make more than the usual amount of a certain... elephant videos download

Phesgo: Package Insert / Prescribing Information

Category:Details for: PHESGO - Drug and Health Products Portal

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Phesgo product monograph canada

PHESGO (Pertuzumab and Trastuzumab)

WebPhesgo combines pertuzumab and trastuzumab into a single dose. It is given by a needle just under the skin (subcutaneously) instead of through a needle in a vein (intravenously). This means that treatment can be given more quickly and easily than giving the 2 drugs separately. Phesgo may be combined with chemotherapy for inflammatory breast cancer. WebNov 16, 2024 · When administered with PHESGO, the recommended initial dose of docetaxel is 75 mg/m 2 administered as an intravenous infusion. The dose may be escalated to 100 mg/m 2 administered every 3 weeks if the initial dose is well tolerated. Administer PHESGO until disease progression or unmanageable toxicity, whichever occurs first.

Phesgo product monograph canada

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WebThe NDC Packaged Code 50242-245-01 is assigned to a package of 1 vial, single-dose in 1 carton / 15 ml in 1 vial, single-dose of Phesgo, a human prescription drug labeled by Genentech, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form. WebMar 16, 2024 · Phesgo 600 mg/600 mg, 1200 mg/600 mg solution for injection Package leaflet: Information for the user 1. What Phesgo is and what it is used for 2. What you need to know before you are given Phesgo 3. How you are given Phesgo 4. Possible side effects 5. How to store Phesgo 6. Contents of the pack and other information

Webpdf.hres.ca WebJul 20, 2024 · 1 Phesgo Canadian Product Monograph 2024. 2 Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in …

WebJun 29, 2024 · Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a prescription medicine approved for use in combination with chemotherapy for: use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than 2 cm in diameter or node-positive). WebApr 12, 2024 · The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Monograph Order Requests (OMORs): Format and Content.'' This draft guidance provides recommendations on the format and content of the information that a...

WebPHESGO is a prescription medicine approved for use in combination with docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body …

WebJun 29, 2024 · Phesgo can be administered at home by a health care professional once chemotherapy is finished. FDA approves Phesgo to treat adult patients with HER2-positive … foot dr on 59th stWebThis document outlines and describes what a monograph is and how it can be used in a product application for natural health products sold in Canada. For more information Self-care products How self-care products, including natural heath products, cosmetics and over-the-counter drugs, are regulated in Canada. Report a problem or mistake on this page elephant vs vici gaming predictionWebJun 18, 2015 · Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: availability of the drug in Canada … elephant vs battle wiki