Paccal Vet-ca1
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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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Paccal Vet-ca1 Manufacturers
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Abbott Laboratories
![Paccal Vet-ca1 (Paclitaxel) Injection, Powder, Lyophilized, For Solution [Abbott Laboratories]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Paccal Vet-ca1 | Abbott Laboratories
Always provide the Client Information Sheet to the dog owner with each dose administration.
Administer Paccal Vet-CA1 at 150 mg/m2 body surface area (BSA) intravenously over 15-30 minutes, once every three weeks for up to four doses. Dose reductions of 10 mg/m2 or dose delays may be used to manage adverse reactions.
Reconstitution and administration of Paccal Vet-CA1Paccal Vet-CA1 is supplied as a sterile powder for reconstitution before use. After reconstitution the solution contains 1 mg of paclitaxel/mL. Paccal Vet-CA1 should be protected from light throughout the preparation process. Paccal Vet-CA1 preparation should be done with aseptic technique and the reconstituted product should be used immediately.
Obtain the desired number of vials from the refrigerator. The powder should be greenish-yellow to yellow. In case of discoloration, discard the vial. Let the vials stand protected from light at room temperature for approximately 20 to 30 minutes. The room temperature should not exceed 25°C (77°F). Using a sterile syringe, inject 60 mL of Lactated Ringer’s solution, USP, into a vial of Paccal Vet-CA1. Pressure must be equilibrated by a needle or vial spike before injection. The Lactated Ringer’s solution should be injected slowly, directed onto the inside wall of the vial and not directly onto the powder as this will result in foaming. Gently swirl the vial by hand for 20 to 30 seconds. Protect from light and allow the vial to stand for 3 to 5 minutes. Gently and slowly swirl and/or invert the vial until the powder is completely dissolved. Do not shake, this will result in foaming. If foam develops, allow the solution to stand for several minutes. Reconstitution can continue even if all of the foam has not dissipated. If undissolved product is present, the vial should be placed on a shaker and rotated for up to 15 minutes, while protecting from light. The solution should be clear and greenish-yellow without visible precipitates. If precipitates or discoloration (orange-reddish) are observed, the solution should be discarded. Inject the appropriate amount of reconstituted Paccal Vet-CA1 into an empty, sterile, EVA (ethyl vinyl acetate) infusion bag. Protect the reconstituted product in the EVA infusion bag from light. The reconstituted product should be used immediately. Administer Paccal Vet-CA1 intravenously over 15-30 minutes.Compatibility of administration sets containing DEHP (di(2-ethylhexyl) phthalate) has not been demonstrated.
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