LONGRANGE- eprinomectin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

eprinomectin (UNII: 75KP30FD8O) (eprinomectin - UNII:75KP30FD8O)

Available from:

Merial, Inc.

INN (International Name):

eprinomectin

Composition:

eprinomectin 50 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Extended-Release Injectable Parasiticide 5% Sterile Solution For the Treatment and Control of Internal and External Parasites of Cattle on Pasture with Persistent Effectiveness Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Not for use in calves to be processed for veal. Not for use in breeding bulls, or in calves less than 3 months of age. Not for use in cattle managed in feedlots or under intensive rotational grazing. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. LONGRANGE, when administered at the recommended dose volume of 1 mL per 110 lb (50 kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Persistent Activity LONGRANGE has been proven to effectively protect cattle from reinfection with the following parasites for the indicated amounts of time following treatment:

Product summary:

LONGRANGE is available in three ready-to-use glass bottle sizes. The 100, 250 and 500 mL bottles contain sufficient solution to treat 20, 50 and 100 head of 550 lb (250 kg) cattle, respectively. The 250 and 500 mL bottles are supplied in a removable plastic protector. Store at 77° F (25° C) with excursions between 59° and 86° F (15° and 30° C). Protect from light.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

LONGRANGE- EPRINOMECTIN INJECTION, SOLUTION
MERIAL, INC.
----------
LONGRANGE
(EPRINOMECTIN)
Extended-Release Injectable Parasiticide
5% Sterile Solution
For the Treatment and Control of Internal and External Parasites of
Cattle on Pasture with Persistent
Effectiveness
NOT FOR USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER,
INCLUDING DRY DAIRY COWS. NOT FOR USE
IN CALVES TO BE PROCESSED FOR VEAL.
NOT FOR USE IN BREEDING BULLS, OR IN CALVES LESS THAN 3 MONTHS OF AGE.
NOT FOR USE IN CATTLE MANAGED IN FEEDLOTS OR UNDER INTENSIVE
ROTATIONAL GRAZING.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION
LONGRANGE (eprinomectin) is a ready-to-use, sterile injectable
preparation containing
eprinomectin, a member of the macrocyclic lactone class of
antiparasitics. Each mL of LONGRANGE
contains 50 mg of eprinomectin in a co-solvent system of
N-methyl-2-pyrrolidone (30% v/v) and
triacetin (qs), along with 50 mg of poly-lactide-co-glycolic-acid
75:25 (PLGA), a polymer that allows a
slow release of eprinomectin from the formulation, thereby maintaining
a prolonged duration of product
effectiveness. Butylated hydroxytoluene (0.2 mg/mL) acts as an
antioxidant in the formulation.
The chemical name of eprinomectin is
4"-deoxy-4"-epiacetylamino-avermectin B . It is a semi-
synthetic member of the avermectin family of compounds consisting of a
mixture of two homologous
components, B and B
, which differ by a single methylene group at C
.
INDICATIONS FOR USE
LONGRANGE, when administered at the recommended dose volume of 1 mL
per 110 lb (50 kg) body
weight, is effective in the treatment and control of the following
internal and external parasites of cattle:
®
®
1
1a
1b
26
GASTROINTESTINAL ROUNDWORMS
LUNGWORMS
_Bunostomum phlebotomum_ – Adults and L
_Dictyocaulus viviparus_ – Adults
_Cooperia oncophora_ – Adults and L
_Cooperia punctata_ – Adults and L
_Cooperia surnabada_ – Adults and L
GRUBS
_Haemonchus placei_ – Adults
_Hypoderma bovis_
_Oesophagostomum radia