DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Beli sekarang

Ciri produk Ciri produk (SPC)
05-12-2018

Bahan aktif:

DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (dexmedetomidine - UNII:67VB76HONO)

Boleh didapati daripada:

Putney, Inc.

INN (Nama Antarabangsa):

DEXMEDETOMIDINE HYDROCHLORIDE

Komposisi:

dexmedetomidine 0.5 mg in 1 mL

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION

Tanda-tanda terapeutik:

INDICATIONS: Dexmedetomidine HCl 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 HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. CONTRAINDICATIONS: Do not use Dexmedetomidine HCl 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.

Ringkasan produk:

HOW SUPPLIED: Dexmedetomidine HCl is supplied in 10-mL, multidose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL. NDC # 26637-341-05.

Status kebenaran:

Abbreviated New Animal Drug Application

Ciri produk

                                DEXMEDETOMIDINE HYDROCHLORIDE- DEXMEDETOMIDINE HYDROCHLORIDE
INJECTION,
SOLUTION
PUTNEY, INC.
----------
DEXMEDETOMIDINE HCL
(dexmedetomidine hydrochloride)
Sterile Injectable Solution-0.5 mg/mL
For Intramuscular and Intravenous Use in Dogs and For 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 HCl (dexmedetomidine hydrochloride) is a
synthetic alpha -
adrenoreceptor 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 HCl contains 0.5 mg dexmedetomidine
hydrochloride, 1.6 mg
methylparaben (NF), 0.2 mg propylparaben (NF), 9.0 mg sodium chloride
(USP), and water for injection
(USP), q.s.
INDICATIONS: Dexmedetomidine HCl 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 HCl 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 determine
the correct dexmedetomidine
hydrochloride 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
hydrochloride 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
                                
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