LUTALYSE HIGHCON STERILE- dinoprost tromethamine injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DINOPROST TROMETHAMINE (UNII: CT6BBQ5A68) (DINOPROST - UNII:B7IN85G1HY)

Tilgjengelig fra:

Zoetis Inc.

INN (International Name):

DINOPROST TROMETHAMINE

Sammensetning:

DINOPROST 12.5 mg in 1 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION

Indikasjoner:

LUTALYSE HighCon Injection is indicated as a luteolytic agent. LUTALYSE HighCon Injection is effective only in those cattle having a corpus luteum, i.e., those which ovulated at least five days prior to treatment.     • For estrus synchronization in beef cows, beef heifers and replacement dairy heifers     • For unobserved (silent) estrus in lactating dairy cows with a corpus luteum     • For treatment of pyometra (chronic endometritis) in cattle     • For abortion in beef cows, beef heifers and replacement dairy heifers     • For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows     • For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows     • For  use  with  EAZI-BREED™  CIDR®  (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heif

Produkt oppsummering:

LUTALYSE HighCon Injection is available in 20, 100 and 250 mL vials.

Autorisasjon status:

New Animal Drug Application

Preparatomtale

LUTALYSE HIGHCON STERILE- DINOPROST TROMETHAMINE INJECTION, SOLUTION
ZOETIS INC.
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LUTALYSE® _HIGHCON_
LUTALYSE® HIGHCON INJECTION
(DINOPROST TROMETHAMINE INJECTION)
12.5 MG DINOPROST/ML AS DINOPROST TROMETHAMINE
FOR USE IN CATTLE ONLY.
NOT FOR USE IN HORSES AND SWINE.
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed
veterinarian.
DESCRIPTION
LUTALYSE® HighCon Injection (12.5 mg dinoprost/mL) is a sterile
solution containing the
naturally occurring prostaglandin F2 alpha (dinoprost) as the
tromethamine salt. Each
mL contains dinoprost tromethamine equivalent to 12.5 mg dinoprost:
also, benzyl
alcohol, 16.5 mg added as preservative and water for injection. When
necessary, pH
was adjusted with sodium hydroxide and/or hydrochloric acid. Dinoprost
tromethamine
is a white or slightly off-white crystalline powder that is readily
soluble in water at room
temperature in concentrations to at least 200 mg/mL.
INDICATIONS FOR USE
LUTALYSE HighCon Injection is indicated as a luteolytic agent.
LUTALYSE HighCon
Injection is effective only in those cattle having a corpus luteum,
i.e., those which
ovulated at least five days prior to treatment.
• For estrus synchronization in beef cows, beef heifers and
replacement dairy heifers
• For unobserved (silent) estrus in lactating dairy cows with a
corpus luteum
• For treatment of pyometra (chronic endometritis) in cattle
• For abortion in beef cows, beef heifers and replacement dairy
heifers
• For use with FACTREL (gonadorelin injection) Injection to
synchronize estrous cycles
to allow fixed-time artificial insemination (FTAI) in lactating dairy
cows
• For use with EAZI-BREED™ CIDR® (progesterone intravaginal
insert) Cattle Insert
for synchronization of estrus in lactating dairy cows
• For use with EAZI-BREED™ CIDR® (progesterone intravaginal
insert) Cattle
Insert for synchronization of estrus in suckled beef cows and
replacement beef and
dairy heifers, advancement of first postpartum estrus in suckled beef
cows, an