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Xarelto 20 mg tablets

Manufactured by Bayer
Sourced in Germany, Mexico

Xarelto® 20 mg tablets is a prescription medication used to treat and prevent blood clots. It is an oral anticoagulant that works by inhibiting the activity of a specific clotting factor in the body.

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Lab products found in correlation

3 protocols using xarelto 20 mg tablets

1

Rivaroxaban Quantification and Coagulant Activity

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Rivaroxaban was extracted from Xarelto® 20 mg tablets (Bayer). A single tablet was dissolved in 1 ml Dimethyl sulfoxide, vortexed and diluted in calcium-free PBS to generate 2.6 μg/ml of the Rivaroxaban working solution. The exact active concentration was determined using a Liquid Anti-Xa assay kit (IL, Italy) based on a calibration curve generated with commercial Rivaroxaban calibrators (IL, Italy) and FXDP (IL, Italy) on an ACL-TOP 500 automated coagulometer (IL, Italy) according to manufacturer directions. Rivaroxaban was added up to a final concentration of 800 ng/ml in 200 ng/ml increments. Normal plasma pool (IL, Italy) served as a control. Coagulant activity was immediately measured using an extended PT assay.
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2

Rivaroxaban Dosage Evaluation in Dogs

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Commercially available 20 mg rivaroxaban tablets (Xarelto 20 mg tablets; Bayer HealthCare AG, Leverkussen, Germany) were split using a pill cutter and then administered to the dogs. Single PO doses of rivaroxaban at 0.5, 1, 2, and 4 mg/kg were administered to 6 dogs with a 2‐week washout period between the different dosages. To detect residual activity and cumulative effect of rivaroxaban, 0.5 and 1 mg/kg rivaroxaban were administered to 3 randomly selected dogs every 24 hours for 3 consecutive days. The dogs were not fasted and were evaluated twice daily during the study for any adverse effects. General physical examination and signs of bleeding were evaluated.
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3

Xarelto and Rivaroxaban Bioequivalence Study

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The reference and test formulations used in this study were Xarelto 20‐mg tablets (lot no. BXHZ5T1, expiration date October 2019; Bayer de México, SA de CV, Mexico) and Rivaroxaban 20‐mg tablets (lot no. 8MXA002; expiration date July 2020; Sanofi Aventis de Mexico, S.A. de CV, Mexico), respectively.
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