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Panoquell-CA1 (Fuzapladib Sodium) Injection 14mg (4mg/mL)

$375.00

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Ceva SKU: G44310B

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Targeted Pancreatitis Support for Dogs

Product Description

PANOQUELL®-CA1 is an FDA conditionally approved injectable treatment designed to manage clinical signs associated with acute-onset pancreatitis in dogs. Formulated with fuzapladib sodium, it works by inhibiting LFA-1 activation to help reduce inflammatory cell migration and limit pancreatic tissue damage. Administered intravenously for three consecutive days, it complements standard supportive care under veterinary supervision.

Benefits

  • Targets Inflammation: Inhibits LFA-1 activation to reduce inflammatory cell adhesion and migration into pancreatic tissue.
  • Clinically Evaluated: Demonstrated statistically significant improvement in clinical scores compared to vehicle control in pilot study.
  • Designed for Dogs: Specifically indicated for managing clinical signs of acute-onset pancreatitis in dogs.
  • IV Administration: Delivered by controlled intravenous bolus for precise dosing under veterinary supervision.
  • Minimal Accumulation: Shows minimal drug accumulation with repeated once daily dosing in pharmacokinetic studies.

Ingredients

Active Ingredients

Fuzapladib sodium.

Inactive Ingredients

D-mannitol, tromethamine, benzyl alcohol, bacteriostatic water for injection.

How to Use

Recommended-Dosage Chart

Body Weight (kg)

Dose (mg/kg)

Volume (mL/kg)

Frequency

Duration

Per kg body weight

0.4 mg/kg

0.1 mL/kg

Once daily

3 consecutive days

Dosage & Administration Instructions

  • Prescription Only: Federal law restricts use to licensed veterinarians or on their order.
  • Reconstitution Required: Reconstitute lyophilized powder with 3.5 mL supplied sterile diluent before use.
  • Gentle Swirling: Gently swirl the vial until fully dissolved before each subsequent dose withdrawal.
  • IV Bolus Use: Administer intravenously over 15 seconds to one minute for proper delivery.
  • Prompt Administration: Draw the calculated dose using a sterile syringe and administer immediately after preparation.

Disclaimer: This dosage information is provided by the manufacturer. Always consult your veterinarian before administering or adjusting any supplement for your pet.

Additional Information

Precautions

  • Protein-Bound Drug: Use with caution if the dog is taking other medications that bind strongly to proteins, as this may increase the risk of drug interactions.
  • Limited Safety Data: This product has not been studied in dogs with heart disease, liver failure, or kidney problems.
  • Breeding Status: Its safety has not been evaluated in pregnant, nursing, or breeding dogs.
  • Young Dogs: It has not been studied in dogs younger than six months of age.
  • Human Safety: Not for human use and avoid exposure if pregnant or hypersensitive.

Possible Side Effects

  • Digestive Signs: Dogs may throw up, have diarrhea, spit up food, feel nauseous, or develop gut inflammation during treatment.
  • Appetite Changes: Some dogs in the study ate less than usual or lost their appetite.
  • Heart-Related Effects: Irregular heartbeat, high blood pressure, and in very rare cases, heart failure were reported.
  • Injection Reactions: Swelling, bruising, and subcutaneous hemorrhage were noted at injection sites.
  • Hypersensitivity Reactions: Pruritus, urticaria, facial swelling, and anaphylaxis have been reported in some cases.

Storage Information

  • Unopened Storage: Store unopened vials at 59°F to 77°F room temperature conditions.
  • Refrigerated Storage: Keep the reconstituted product refrigerated at 36°F to 46°F.
  • Use Period: Once the vial has been punctured and mixed, use the solution within 28 days.

Shipping & Return

We offer ground, express, priority, and international delivery; see our shipping policy for details.

For return instructions or product concerns, please refer to our detailed refund policy.

Prescription items are NON-RETURNABLE and NON-REFUNDABLE.

Frequently Asked Questions

Q1: What is PANOQUELL®-CA1 used for in dogs?

Ans: PANOQUELL®-CA1 is used to help manage the clinical signs of sudden, acute pancreatitis in dogs. It’s meant to be part of a complete treatment plan, alongside supportive care like IV fluids, proper nutrition, and pain control, all under the guidance of a veterinarian.

Q2: How does PANOQUELL®-CA1 work?

Ans: PANOQUELL®-CA1 contains fuzapladib sodium, a selective inhibitor of leukocyte function-associated antigen-1 activation. Inhibiting LFA-1 reduces inflammatory cell adhesion and migration into pancreatic tissue, helping limit lesion expansion and inflammatory complications.

Q3: How is PANOQUELL®-CA1 administered?

Ans: After mixing the powder with the sterile diluent provided, PANOQUELL®-CA1 is given through an IV at a dose of 0.4 mg per kg of body weight. It is administered once a day for three days in a row. Each dose is delivered as a slow IV bolus over about 15 seconds to one minute.

Q4: Is PANOQUELL®-CA1 FDA-approved?

Ans: PANOQUELL®-CA1 has received conditional approval from the FDA under application number 141-567 while full effectiveness data is still being completed. This status allows the product to be legally marketed as additional studies continue to confirm its effectiveness.

Q5: What side effects have been reported with PANOQUELL®-CA1?

Ans: Reported side effects include loss of appetite, digestive or breathing issues, diarrhea, irregular heartbeat, high blood pressure, swelling at the injection site, and allergic reactions such as itching or facial swelling.

Some of these reactions were seen during clinical studies, while others were reported after the product was approved and used in other countries.

Clinical Research

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13134

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm