Propofol product monograph page 1 of 48 product monograph prpropofol propofol injectable emulsion, bp 1% wv 10 mgml intravenous emulsion anaesthetic sedative. The benefit of vigiv treatment of other vaccinia complications that include vaccinia keratitis. Product monograph midazolam injection usp preservativefree page 6 of 39 following intravenous administration, midazolam is rapidly metabolized to 1hydroxymethyl. The product monograph is developed by a drug sponsor according to guidelines published by health canada that provide direction on the content and format. Strawinskylaan 3051 1077zx amsterdam netherlands imported distributed by. A product monograph is a factual, scientific document on a drug product that. General there is no experience with the use of enstilar in guttate psoriasis. Overthecounter monograph reform in the cares act march 27, 2020 pharma and biotech on march 27, 2020, congress passed h. Norfloxacin inhibits bacterial deoxyribonucleic acid synthesis and is bactericidal.
Angioedema has been reported in patients treated with trintellix. Page 2 of 42 product monograph prnorfloxacin norfloxacin tablets, usp 400 mg therapeutic classification antibacterial agent actions and clinical pharmacology norfloxacin is a quinolone carboxylic acid antibacterial agent for oral administration. Redact them to permanently delete sensitive information. The properties and bookmarks can be set in two ways. Subtitle f of the cares act would significantly change fdas regulations of overthecounter otc monograph.
Kofax power pdf products are powerful and intuitive tools designed to let you create, convert, edit, share and esign pdf files. Summary product information route of administration dosage form strength nonmedicinal ingredients transdermal sandoz rivastigmine patch 5, each patch of 5 cm2. Xeomin product monograph page 7 of 38 ophthalmologic blepharospasm because of the anticholinergic effect of botulinum toxin type a, xeomin should be used with caution in patients at risk of developing angle closure glaucoma. The veterinary labelling is developed by the drug sponsor according to the food and drug regulations. Product monograph prrocuronium bromide injection rocuronium bromide 10 mgml solution for injection prrocuronium bromide injection sdz rocuronium bromide 10 mgml solution for injection sterile nondepolarizing. Product monograph prsandoz sertraline sertraline hydrochloride 25 mg, 50 mg and 100 mg capsules as sertraline antidepressant antipanic antiobsessional agent sandoz. Atrovent hfa is a bronchodilator for the maintenance treatment of. When inserting pages, you can choose whether to insert an entire document or just. Product monograph prdeferoxamine mesylate for injection page 6 of 27 neurologic in patients with aluminumrelated encephalopathy, high doses of deferoxamine mesylate for injection may exacerbate neurological dysfunction seizures, probably due to an increase in circulating aluminum. Canada authorized product monograph to be submitted in pdf format. User guide on how to generate pdf versions of the product.
Preparation of monographs thmp european medicines agency. For a complete listing of excipients, see the dosage forms, composition and packaging section of the product monograph. Create and compile pdfs from almost any document or file type. Sandoz rivastigmine patch 5, each patch of 10 cm 2 contains 18 mg rivastigmine base, in vivo release rate of 9. Uspfda otc drug substances and drug products workshop. The product monograph will be reissued in the event of serious safety concerns previously unidentified or at such time as the sponsor provides the additional data in support of the product. Product monograph prsandoz sertraline sertraline hydrochloride 25 mg, 50 mg and 100 mg capsules as sertraline antidepressant antipanic antiobsessional agent sandoz canada inc. A large number of substance and product monographs need to be updated or added in order to fully achieve modernization. Product monograph prdeferoxamine mesylate for injection page 6 of 27 neurologic in patients with aluminumrelated encephalopathy, high doses of deferoxamine mesylate for injection may exacerbate neurological dysfunction. Fetzima levomilnacipran extendedrelease capsules should not be used.
Atrovent hfa product monograph november 4, 2019 page 4 of 30 warnings and precautions. Nitro pro enables you to combine pages from multiple pdfs into a single file. Ttr is a carrier protein for retinolbinding protein 4 rbp4 which is the principle carrier of vitamin a retinol. Product monograph prprocytox cyclophosphamide tablets usp. Product monograph pr sandoz ofloxacin ofloxacin ophthalmic solution usp, 0. Vigiv is not indicated for the treatment of isolated keratitis. Product monograph including patient medication information pronpattro patisiran lipid complex for injection lipid complex solution. Combine or merge files into a single pdf, adobe acrobat dc. Ivacaftor granules 50 mg per packet, 75 mg per packet. Summary product information route of administration dosage form strength nonmedicinal ingredients transdermal sandoz rivastigmine patch 5, each patch of 5 cm2 contains 9 mg rivastigmine base, in vivo release rate of 4.
Product monograph prnorfloxacin norfloxacin tablets, usp 400 mg therapeutic classification antibacterial agent actions and clinical pharmacology norfloxacin. Repatha evolocumab is a fully human immunoglobulin g2 igg2 monoclonal antibody that has high affinity binding to proprotein convertase subtilisinkexin type 9 pcsk9. They can be signed electronically, and you can easily view pdf files on windows or mac os using. Open the pdf that serves as the basis of the combined file. Summary product information route of administration dosage form strength nonmedicinal ingredients intramuscular injection inject into anterolateral aspect of the thigh.
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