DEXMEDETOMIDINE HYDROCHLORIDE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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Vara einkenni Vara einkenni (SPC)
12-03-2021

Virkt innihaldsefni:

Dexmedetomidine Hydrochloride (UNII: 1018WH7F9I) (Dexmedetomidine - UNII:67VB76HONO)

Fáanlegur frá:

Akorn.

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION

Ábendingar:

Dexmedetomidine Hydrochloride Injection is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine Hydrochloride Injection is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. Do not use Dexmedetomidine Hydrochloride Injection in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. As with all alpha2 -adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.

Vörulýsing:

Dexmedetomidine Hydrochloride Injection is supplied in 10 mL, multi-dose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL.

Leyfisstaða:

Abbreviated New Animal Drug Application

Vara einkenni

                                DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION
AKORN ANIMAL HEALTH, INC.
----------
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
0.5 MG/ML
Intramuscular and Intravenous use in Dogs
Intramuscular use in Cats
Sedative, Analgesic, Preanesthetic
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
Dexmedetomidine Hydrochloride Injection is a synthetic alpha
-adrenoceptor agonist
with sedative and analgesic properties. The chemical name is
(+)-4-[1-(2,3-
dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. It is a white,
or almost white,
crystalline, water soluble substance having a molecular weight of
236.7. The molecular
formula is C
H
N •HCl and the structural formula is:
Each mL of Dexmedetomidine Hydrochloride Injection contains 0.5 mg
dexmedetomidine
hydrochloride, 1.6 mg methylparaben, 0.2 mg propylparaben, 9.0 mg
sodium chloride,
water for injection, q.s.
INDICATIONS:
Dexmedetomidine Hydrochloride Injection is indicated for use as a
sedative and
analgesic in dogs and cats to facilitate clinical examinations,
clinical procedures, minor
surgical procedures, and minor dental procedures. Dexmedetomidine
Hydrochloride
Injection is also indicated for use as a preanesthetic to general
anesthesia in dogs and
cats.
DOSAGE AND ADMINISTRATION:
_DOGS: SEDATION AND ANALGESIA: 500 MCG/M_ INTRAMUSCULARLY (IM) OR 375
MCG/M INTRAVENOUSLY (IV).
PREANESTHESIA: 125 OR 375 MCG/M IM.
The choice of preanesthetic dose depends on the duration and severity
of the
procedure, as well as the anesthetic regime. The following two tables
may be used to
2
13
16
2
2
2
2
determine the correct dexmedetomidine dosage. NOTE THAT THE MCG/KG
DOSAGE
DECREASES AS BODY WEIGHT INCREASES. For example, dogs weighing 2 kg
are dosed
at 28.1 mcg/kg dexmedetomidine IV, compared to dogs weighing 80 kg
that are dosed
at 8.7 mcg/kg. Due to the small volume of administration, accurate
dosing is not
possible in dogs weighing less than 2 kg (4.4 lb).
TABLE 1: CANINE SEDATION/ANAL
                                
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