OVAMED- altrenogest solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALTRENOGEST (UNII: 2U0X0JA2NB) (ALTRENOGEST - UNII:2U0X0JA2NB)

Available from:

Bimeda, Inc.

INN (International Name):

ALTRENOGEST

Composition:

ALTRENOGEST 2.2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: OvaMed™ (altrenogest ) Solution 0.22% is indicated to suppress estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season. CONTRAINDICATIONS: OvaMed™ (altrenogest ) Solution 0.22% is contraindicated for use in mares having a previous or current history of uterine inflammation (i.e., acute, subacute, or chronic endometritis). Natural or synthetic gestagen therapy may exacerbate existing low-grade or “smoldering” uterine inflammation into a fulminating uterine infection in some instances.

Product summary:

OvaMed™ (altrenogest ) Solution 0.22% (2.2 mg/mL). Each mL contains 2.2 mg altrenogest in an oil solution. Available in 1000 mL plastic bottles. Manufactured for : Bimeda, Inc., Le Sueur, MN 56058 MADE IN USA ANADA # 200-481, Approved by FDA

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

OVAMED- ALTRENOGEST SOLUTION
BIMEDA, INC.
----------
OVAMED™ (ALTRENOGEST)
SOLUTION 0.22%
(2.2 mg/mL)
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION: OvaMed™ (_altrenogest_) Solution 0.22% contains the
active synthetic progestin,
altrenogest. The chemical name is
17α-allyl-17β-hydroxyestra-4,9,11-trien-3-one. The CAS Registry
Number is 850-52-2. The chemical structure is:
Each mL of OvaMed™ (_altrenogest_) Solution 0.22% contains 2.2 mg of
altrenogest in an oil solution.
ACTIONS: OvaMed™ (_altrenogest_) Solution 0.22% produces a
progestational effect in mares.
INDICATIONS: OvaMed™ (_altrenogest_) Solution 0.22% is indicated to
suppress estrus in mares.
Suppression of estrus allows for a predictable occurrence of estrus
following drug withdrawal. This
facilitates the attainment of regular cyclicity during the transition
from winter anestrus to the
physiological breeding season. Suppression of estrus will also
facilitate management of prolonged
estrus conditions. Suppression of estrus may be used to facilitate
scheduled breeding during the
physiological breeding season.
CONTRAINDICATIONS: OvaMed™ (_altrenogest_) Solution 0.22% is
contraindicated for use in mares
having a previous or current history of uterine inflammation (i.e.,
acute, subacute, or chronic
endometritis). Natural or synthetic gestagen therapy may exacerbate
existing low-grade or “smoldering”
uterine inflammation into a fulminating uterine infection in some
instances.
PRECAUTIONS: Various synthetic progestins, including altrenogest, when
administered to rats during
the embryogenic stage of pregnancy at doses manyfold greater than the
recommended equine dose
caused fetal anomalies, specifically masculinization of the female
genitalia.
DOSAGE AND ADMINISTRATION: While wearing protective gloves, remove
shipping cap and
seal; replace with enclosed plastic dispensing cap. Remove cover from
bottle dispensing tip and
connect luer lock syringe (without needle). Draw out appropriate