SAFE-GUARD- fenbendazole suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

Fenbendazole

Composition:

Fenbendazole 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

OTC

Therapeutic indications:

INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Lungworms: Adult Dictyocaulus viviparus ; Stomach worms: Adult brown stomach worms (Ostertagia ostertagi ), Adult and fourth stage larvae barberpole worms (Haemonchus contortus & H. placei) , and Adult and fourth stage larvae small stomach worms (Trichostrongylus axei ); Intestinal worms (Adult and fourth stage larvae): hookworms (Bunostomum phlebotomum ), thread-necked intestinal worms (Nematodirus helvetianus ), small intestinal worms (Cooperia punctata & C. oncophora ), bankrupt worms (Trichostrongylus colubriformis ), and nodular worms (Oesophagostomum radiatum ). Goats - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Stomach worms (adults): Haemonchus contortus and Teladorsagia circumcincta.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SAFE-GUARD- FENBENDAZOLE SUSPENSION
MERCK SHARP & DOHME CORP.
REFERENCE LABEL SET ID: 93C3ABE2-5D4B-4D90-AC25-B2078026629E
----------
SAFE-GUARD
(FENBENDAZOLE)
DEWORMER
INDICATIONS: BEEF AND DAIRY CATTLE - 2.3 mg/lb (5 mg/kg) body weight
for the
treatment and control of: LUNGWORMS: Adult _Dictyocaulus viviparus_;
STOMACH WORMS:
Adult brown stomach worms (_Ostertagia ostertagi_), Adult and fourth
stage larvae
barberpole worms (_Haemonchus contortus_ &_ H. placei)_, and Adult and
fourth stage
larvae small stomach worms (_Trichostrongylus axei_); INTESTINAL WORMS
(Adult and
fourth stage larvae): hookworms (_Bunostomum phlebotomum_),
thread-necked intestinal
worms (_Nematodirus helvetianus_), small intestinal worms (_Cooperia
punctata & C._
_oncophora_), bankrupt worms (_Trichostrongylus colubriformis_), and
nodular worms
(_Oesophagostomum radiatum_).
GOATS - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control
of: STOMACH
WORMS (adults): _Haemonchus contortus_ and _Teladorsagia
circumcincta._
DIRECTIONS: Administer orally. The recommended dose of 2.3 mg/lb (5
mg/kg) of
body weight is achieved when 2.3 mL of the drug are given for each 100
lb body weight.
EXAMPLES:
CATTLE:
GOATS:
BODY
WEIGHT
AMOUNT
BODY
WEIGHT
AMOUNT
100 lb
2.3 mL
25 lb
0.6 mL
200 lb
4.6 mL
50 lb
1.2 mL
300 lb
6.9 mL
75 lb
1.7 mL
400 lb
9.2 mL
100 lb
2.3 mL
500 lb
11.5 mL
125 lb
2.9 mL
1000 lb
23.0 mL
1500 lb
34.5 mL
Do not underdose. Ensure each animal receives a complete dose based on
a current
body weight.
Underdosing may result in ineffective treatment, and encourage the
development of
parasite resistance.
WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The
Safety Data Sheet (SDS) contains more detailed occupational safety
information. For
customer service, adverse effects reporting, and/or a copy of the SDS,
call 1-800-211-
3573. For additional information about adverse drug experience
reporting for animal
drugs, contact FDA at 1-888-FDAVETS, or
http://www.fda.gov/reportanimalae.
OTHER WARNINGS: Parasite resistance may d