PROFENDER- emodepside/praziquantel solution PROFENDER- emodepside/praziquantel kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457), EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9)

Available from:

Bayer HealthCare LLC Animal Health Division

INN (International Name):

PRAZIQUANTEL

Composition:

PRAZIQUANTEL 30 mg in 0.35 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.

Product summary:

Code Number       Applications per Package 82232699               8 – 0.35 mL tubes (2 blisters of 4 tubes)                               20 - 0.7 mL tubes (5 blisters of 4 tubes)                                8 – 1.12 mL tubes (2 blisters of 4 tubes) 82482521             20 - 0.35 mL tubes (5 blisters of 4 tubes) 03615026             40 - 0.35 mL tubes (10 blisters of 4 tubes) 82482572             20 - 0.7 mL tubes (5 blisters of 4 tubes) 03615034             40 - 0.7 mL tubes (10 blisters of 4 tubes) 82482580             20 - 1.12 mL tubes (5 blisters of 4 tubes) 82482602             40 - 1.12 mL tubes (10 blisters of 4 tubes) Profender is protected by the following U.S. Patents: 5514773 and other patents pending. Made in Germany NADA 141-275, Approved by FDA © 2014 Bayer HealthCare LLC Bayer, the Bayer Cross and Profender are registered trademarks of Bayer. February, 2014 Bayer HealthCare LLC Animal Health Division P.O. Box 390 Shawnee Mission, Kansas 66201 U.S.A.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROFENDER- EMODEPSIDE/PRAZIQUANTEL SOLUTION
PROFENDER- EMODEPSIDE/PRAZIQUANTEL
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
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TOPICAL SOLUTION
PROFENDER
(EMODEPS IDE/PRAZIQUANTEL)
CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the
order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm
and tapeworm infections in
cats and kittens that are at least 8 weeks of age and weigh at least
2.2 lbs (1 kg).
DESCRIPTION:
PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a
clear yellow ready-to-
use solution packaged in single unit dosing applicator tubes for
topical (dermal) treatment of cats 8
weeks of age and older and weighing at least 2.2 lbs (1 kg). The
formulation and dosage schedule is
designed to provide a minimum of 1.36 mg/lb (3 mg/kg) emodepside and
5.45 mg/lb (12 mg/kg)
praziquantel based on body weight. Emodepside, a semi-synthetic
molecule, is a cyclic depsipeptide.
The chemical name is Cyclo
[D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-
D-2-hydroxypropanoyl-N-methyl-L-leucyl-D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-
morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl].
Praziquantel is an isoquinoline
cestocide. The chemical name is
2-Cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazine-2,1-a-
isoquinoline-4-one.
INDICATIONS:
PROFENDER Topical Solution is indicated for the treatment and control
of hookworm infections
caused by _Ancylostoma tubaeforme_ (adults, immature adults, and
fourth stage larvae), roundworm
infections caused by _Toxocara cati_ (adults and fourth stage larvae),
and tapeworm infections caused by
_Dipylidium caninum _(adults) and _Taenia taeniaeformis _(adults) in
cats.
DOSAGE AND ADMINISTRATION:
The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45
mg/lb (12 mg/kg)
praziquantel as a single topical dose. A single treatment is effective
and a second treatment should not
be necessary. If re-infection occurs, the product can be re-applied
after 30 day