ZOLETIL- tiletamine and zolazepam for injection injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
20-02-2024

Aktiv ingrediens:

TILETAMINE HYDROCHLORIDE (UNII: 99TAQ2QWJI) (TILETAMINE - UNII:2YFC543249), ZOLAZEPAM HYDROCHLORIDE (UNII: 45SJ093Q1N) (ZOLAZEPAM - UNII:G1R474U58U)

Tilgjengelig fra:

Virbac AH, Inc

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION

Indikasjoner:

Dogs Zoletil for Injection is indicated in dogs for restraint and minor procedures of short duration (30 min. avg.) requiring mild to moderate analgesia. Minor surgery is considered to be laceration repair, draining of abscesses, castrations and other procedures requiring mild to moderate analgesia. (See Dogs under Dosage and Administration.) Zoletil for Injection administered intravenously is indicated in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. Cats Zoletil for Injection is indicated in cats for restraint or for anesthesia combined with muscle relaxation. The use of Zoletil for Injection is contraindicated in dogs and cats with pancreatic disease. Zoletil for Injection should not be used in dogs and cats with severe cardiac or pulmonary dysfunction. Because the teratogenic potential of Zoletil for Injection is unknown, it should not be used in pregnant bitches or queens at any stage of pregnancy. Also, a study has shown that tiletamine and zolazepam for injection crosses the placental barrier and produces respiratory depression in the newborn; therefore, its use for Cesarean section is contraindicated.

Produkt oppsummering:

Zoletil for Injection (tiletamine and zolazepam for injection) is available in individual vials of 5 mL solution when reconstituted. The addition of 5 mL diluent produces a solution containing the equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg mannitol per milliliter. 5 mL vial – 100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) when reconstituted.

Autorisasjon status:

Abbreviated New Animal Drug Application

Preparatomtale

                                ZOLETIL- TILETAMINE AND ZOLAZEPAM FOR INJECTION INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
VIRBAC AH, INC
----------
ZOLETIL FOR INJECTION (TILETAMINE AND ZOLAZEPAM FOR INJECTION)
CIII
100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL
zolazepam)
For Intramuscular and Intravenous Injection in Dogs
For Intramuscular Injection only in Cats
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Zoletil™ for Injection (tiletamine and zolazepam for injection) is a
nonnarcotic,
nonbarbiturate, injectable anesthetic agent for dogs and cats.
Chemically, Zoletil for
Injection is a combination of equal parts by weight of base of
tiletamine hydrochloride (2-
[ethylamino]-2-[2-thienyl]-cyclohexanone hydrochloride), an
arylaminocycloalkanone
dissociative anesthetic, and zolazepam hydrochloride
(4-[o-fluorophenyl]-6, 8-dihydro-
1,3,8-trimethylpyrazolo [3,4-e] [1,4] diazepin-7
[1H]-1-hydrochloride), a
nonphenothiazine diazepinone having minor tranquilizing properties.
The product
is supplied sterile in vials. The addition of 5 mL diluent produces a
solution containing the
equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg
mannitol per
milliliter. This solution has a pH of 2 to 3.5 and is recommended for
deep intramuscular
injection.
INDICATIONS
DOGS
Zoletil for Injection is indicated in dogs for restraint and minor
procedures of short
duration (30 min. avg.) requiring mild to moderate analgesia. Minor
surgery is
considered to be laceration repair, draining of abscesses, castrations
and
other procedures requiring mild to moderate analgesia. (See Dogs under
Dosage and
Administration.)
Zoletil for Injection administered intravenously is indicated in dogs
for induction of
anesthesia followed by maintenance with an inhalant anesthetic.
CATS
Zoletil for Injection is indicated in cats for restraint or for
anesthesia combined with
muscle relaxation.
DOSAGE AND ADMINISTRATION
THE DOSE IS DETERMINED BY THE TOTAL COMBINED CONCENTRATION OF 100
MG/ML
(SEE
                                
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