Paccal Vet-ca1 Recall
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Questions & Answers
Side Effects & Adverse Reactions
Paclitaxel can cause severe, transient bone marrow suppression within four to seven days of administration (see ADVERSE REACTIONS).
Paclitaxel can cause gastrointestinal adverse reactions due to transient gastrointestinal mucosal cell toxicity. Monitor patients carefully for vomiting, diarrhea and dehydration. Provide supportive care as clinically indicated.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Paccal Vet-CA1 is indicated for the treatment of:
• Nonresectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy or radiotherapy.
• Resectable and nonresectable squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy.
There is currently no drug history available for this drug.
Paccal Vet®-CA1 is an antimicrotubule agent. The empirical formula of paclitaxel is C47H51NO14 and the molecular weight is 854. It is highly lipophilic and practically insoluble in water. The chemical name for paclitaxel is 5β,20-epoxy-1,7β-dihydroxy-9-oxotax-11-ene-2α,4,10β,13α-tetrayl 4,10-diacetate 2 benzoate 13-[(2R,3S)-3-(benzoylamino)-2-hydroxy-3-phenylpropanoate]. Paclitaxel has the following structural formula:
Paccal Vet-CA1 is supplied as a greenish-yellow to yellow sterile lyophilized powder in the form of a cake. Reconstitute the powder prior to intravenous infusion. Each single use vial contains 60 mg of paclitaxel, 40 mg of N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt and 40 mg of N-(13- cis-retinoyl)-L-cysteic acid methyl ester sodium salt. The reconstituted concentration is 1 mg/mL. In the aqueous solution for infusion these constituents are soluble and form micellar nanoparticles with a size of approximately 20-40 nm.