ALLOXATE- meloxicam injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

meloxicam (UNII: VG2QF83CGL) (meloxicam - UNII:VG2QF83CGL)

Available from:

Aspen Veterinary Resources

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery. Cats with known hypersensitivity to meloxicam should not receive Alloxate 5 mg/mL Solution for Injection. Additional doses of meloxicam or other NSAIDs in cats are contraindicated, as no safe dosage for repeated NSAID administration has been established (See Animal Safety). Do not use meloxicam in cats with pre-existing renal dysfunction. Dogs: Alloxate™ (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis. Dogs with known hypersensitivity to meloxicam should not receive Alloxate 5 mg/mL Solution for Injection.

Product summary:

Alloxate 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Alloxate 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Made in the UK. Manufactured For: Aspen Veterinary Resources® , LTD. Liberty, MO 64068 www.pivetalvet.com P235NB     Rev. 08/21 Alloxate™ is a trademark of Aspen Veterinary Resources® , LTD. Pivetal™ is a trademark, or registered trademark, of Aspen Veterinary Resources® , LTD. All rights reserved. 653974I03

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

                                ALLOXATE- MELOXICAM INJECTION, SOLUTION
ASPEN VETERINARY RESOURCES
----------
PACKAGE INSERT FOR CATS
Approved by FDA under ANADA # 200-491
ALLOXATE™
(MELOXICAM)
5 MG/ML SOLUTION FOR INJECTION
Non-steroidal anti-inflammatory drug for use in dogs and cats only.
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
WARNING: REPEATED USE OF MELOXICAM IN CATS HAS BEEN ASSOCIATED WITH
ACUTE RENAL FAILURE AND DEATH. DO NOT ADMINISTER ADDITIONAL INJECTABLE
OR
ORAL MELOXICAM TO CATS. SEE CONTRAINDICATIONS, WARNINGS, AND
PRECAUTIONS FOR DETAILED INFORMATION.
DESCRIPTION:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
oxicam class. Each
mL of this sterile product for injection contains meloxicam 5.0 mg,
alcohol 15%,
glycofurol 10%, poloxamer 188 5%, sodium chloride 0.6%, glycine 0.5%
and meglumine
0.3%, in water for injection, pH adjusted with sodium hydroxide and
hydrochloric acid.
INDICATIONS:
CATS: For the control of postoperative pain and inflammation
associated with orthopedic
surgery, ovariohysterectomy and castration when administered prior to
surgery.
DOSAGE AND ADMINISTRATION:
Carefully consider the potential benefits and risk of Alloxate and
other treatment options
before deciding to use Alloxate. Use the lowest effective dose for the
shortest duration
consistent with individual response.
CATS: Administer A SINGLE, ONE-TIME SUBCUTANEOUS DOSE of Alloxate™ 5
mg/mL
Solution for Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg)
body weight. USE OF
ADDITIONAL MELOXICAM OR OTHER NSAIDS IS CONTRAINDICATED. (SEE
CONTRAINDICATIONS). To ensure accuracy of dosing, the use of a 1 mL
graduated
syringe is recommended.
CONTRAINDICATIONS:
Cats with known hypersensitivity to meloxicam should not receive
Alloxate 5 mg/mL
Solution for Injection. Additional doses of meloxicam or other NSAIDs
in cats are
contraindicated, as no safe dosage for repeated NSAID administration
has been
established (SEE ANIMAL SAFETY). DO NOT USE MELOXICAM IN CATS WITH
PRE-
EXISTING RENAL
                                
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