Pregnancy category c studies in mice, rats, and rabbits in which diclofenac was administered orally throughout gestation revealed no evidence of teratogenicity despite the induction of maternal toxicity and fetal toxicity corresponding to a human equivalent dose approximately 4.
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Health professionals are reminded of the cardiovascular risks associated with treatment with Diclofenac sodium drug delivery system and the additional risk of hepatotoxicity with diclofenac.
The TGA reviews have found that use of OTC NSAIDs is safe when they are used according to the recommended doses for short durationsas instructed on the labelHoweverinappropriate use or overuse of these medicines can pose a significant health risk.
If you have any questions or concerns about this issuetalk to your health professional.
Only two comments were received and both were favourableBased on the results of this consultationthe Minister of Health intends to revise the diclofenac sodium drug delivery system for diclofenac by increasing the concentration from 1to 2for human non-prescription useThis revision will be diclofenac sodium drug delivery system effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.
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If you or someone you care for has pre-existing cardiovascular disease or risk factorsyou should consult a health professional before using these products and consider using an alternative medicine.
The reviews involved evaluation of relevant medical literatureassessing input from sponsors and industry stakeholdersand diclofenac sodium drug delivery system expert advice from the Advisory Committee on the Safety of Medicines.
Viclofen TabletsConsumer Medicines Information leaflets of prescription and over-the-counter medicines.
The reviews involved evaluation of relevant medical literatureassessing input diclofenac sodium drug delivery system sponsors and industry stakeholdersand obtaining expert advice from the Advisory Committee on the Safety of Medicines.
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