TORBUGESIC SA- butorphanol tartrate solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

מאפייני מוצר מאפייני מוצר (SPC)
20-03-2020

מרכיב פעיל:

BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)

זמין מ:

Zoetis Inc.

INN (שם בינלאומי):

BUTORPHANOL TARTRATE

הרכב:

BUTORPHANOL TARTRATE 2 mg in 1 mL

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION

סממני תרפויטית:

TORBUGESIC-SA (butorphanol tartrate injection) is indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

leaflet_short:

10 mL vials TORBUGESIC-SA (butorphanol tartrate injection) Veterinary Injection, 2 mg base activity per mL. 10 mL —vials Store at controlled room temperature 20°- 25°C (68°-77°F) with excursions between 15°- 30°C (59°-86°F).

מצב אישור:

New Animal Drug Application

מאפייני מוצר

                                TORBUGESIC SA- BUTORPHANOL TARTRATE SOLUTION
ZOETIS INC.
----------
TORBUGES IC-SA®
(BUTORPHANOL TARTRATE INJECTION)
Torbugesic-SA®
(butorphanol tartrate injection)
CIV
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Butorphanol tartrate, is a synthetic, centrally acting, narcotic
agonist-antagonist analgesic with potent
antitussive activity. The results from laboratory and clinical studies
suggest the existence of several
distinct types of receptors that are responsible for the activity of
opioid and opioid-like drugs. When
activated, the _μ_(mu)-receptors are involved in analgesia,
respiratory depression, miosis, physical
dependence and feelings of well-being (euphoria). When activated, the
_κ_(kappa)-receptors are involved
in analgesia, as well as less intense (as compared to _μ_-receptors)
miosis and respiratory depression.
Butorphanol is considered to be a weak antagonist at the
_μ_-receptor, but a strong agonist at the _κ_-
receptor. Thus, butorphanol provides analgesia with a lower incidence
and/or intensity of adverse
reactions (e.g., miosis and respiratory depression) than traditional
opioids.
Butorphanol tartrate is a member of the phenanthrene series. The
chemical name is Morphinan-3, 14-
diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))- 2,3-
dihydroxybutanedioate (1:1) (salt). It is a white,
crystalline, water soluble substance having a molecular weight of
477.55; its molecular formula is
C21H29NO2• C4H6O6.
CHEMICAL STRUCTURE
Each mL of TORBUGESIC-SA contains 2 mg butorphanol base (as
butorphanol tartrate, USP); 3.3 mg
citric acid, USP; 6.4 mg sodium citrate, USP; 4.7 mg sodium chloride;
and 0.1 mg benzethonium
chloride; q.s. with water for injection.
CLINICAL PHARMACOLOGY
FELINE PHARMACOLOGY
The magnitude and duration of analgesic activity of butorphanol were
studied in cats under controlled
laboratory conditions using both a visceral pain model and a somatic
pain model.1,2 Subcutaneous
butorphanol dosages of 0.4 mg/kg produced
                                
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