LOXICOM- meloxicam injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Norbrook Laboratories Limited

INN (Mezinárodní Name):

meloxicam

Složení:

meloxicam 5 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION

Terapeutické indikace:

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 Loxicom 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: Loxicom® (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 Loxicom 5 mg/mL Solution for Injection.

Přehled produktů:

Loxicom 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Loxicom 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Made in the UK. Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland ® Loxicom is a registered trademark of Norbrook Laboratories Limited Rev. 06/2021 318670103

Stav Autorizace:

Abbreviated New Animal Drug Application

Charakteristika produktu

LOXICOM- MELOXICAM INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
----------
PACKAGE INSERT FOR CATS
Approved by FDA under ANADA# 200-491
LOXICOM
(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 Loxicom and
other treatment
options before deciding to use Loxicom. Use the lowest effective dose
for the shortest
duration consistent with individual response.
CATS: Administer A SINGLE, ONE-TIME SUBCUTANEOUS DOSE of Loxicom 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
Loxicom 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 DYSFUN