LEVAFEN- carprofen injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

carprofen (UNII: FFL0D546HO) (carprofen - UNII:FFL0D546HO)

Saatavilla:

Patterson Veterinary

INN (Kansainvälinen yleisnimi):

carprofen

Koostumus:

carprofen 50 mg in 1 mL

Antoreitti:

SUBCUTANEOUS

Prescription tyyppi:

PRESCRIPTION

Käyttöaiheet:

Levafen Injection is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. Carprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Tuoteyhteenveto:

Levafen Injection is supplied in 20 mL and 50 mL, amber, glass, sterile, multi-dose vials.

Valtuutuksen tilan:

Abbreviated New Animal Drug Application

Valmisteyhteenveto

LEVAFEN- CARPROFEN INJECTION, SOLUTION
PATTERSON VETERINARY
----------
ANADA 200-520, APPROVED BY FDA
LEVAFEN™ INJECTION
(CARPROFEN)
STERILE INJECTABLE SOLUTION
50 MG/ML
Non-steroidal anti-inflammatory drug
For subcutaneous use in dogs only
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
Levafen
Injection is a sterile solution containing carprofen, a non-steroidal
anti-inflammatory drug
(NSAID) of the propionic acid class that includes ibuprofen, naproxen,
and ketoprofen. Carprofen is the
non-proprietary designation for a substituted carbazole,
6-chloro-α-methyl-9H-carbazole-2-acetic acid.
The empirical formula is C
H ClNO and the molecular weight 273.72. The chemical structure of
carprofen is:
Each mL of Levafen Injection contains 50.0 mg carprofen, 30.0 mg
arginine, 88.5 mg glycocholic acid,
169.0 mg lecithin, 10.0 mg benzyl alcohol, 6.17 mg sodium hydroxide,
with additional sodium
hydroxide and hydrochloric acid as needed to adjust pH, and water for
injection.
CLINICAL PHARMACOLOGY:
Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent
with characteristic analgesic and
antipyretic activity approximately equipotent to indomethacin in
animal models.
The mechanism of action of carprofen, like that of other NSAlDs, is
believed to be associated with the
inhibition of cyclooxygenase activity. Two unique cyclooxygenases have
been described in mammals.
The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins
necessary for normal
gastrointestinal and renal function. The inducible cyclooxygenase,
COX-2, generates prostaglandins
involved in inflammation. Inhibition of COX-l is thought to be
associated with gastrointestinal and renal
toxicity while inhibition of COX-2 provides anti-inflammatory
activity. The specificity of a particular
NSAID for COX-2 versus COX-1 may vary from species to species.
In an _in vitro_ study using canine
cell cultures, carprofen demonstrated selective inhibition of COX-2
versus COX-1.
Clinical relevance
of th