Drontal Plus: Product Information (Page 2 of 3)

DIAGNOSIS:

Diagnosis of E. multilocularis in canids is difficult. The adult tapeworm produces no clinical signs of infection. Tapeworm segments (proglottids) are usually not observed in the feces. E. multilocularis eggs, observed using microscopic fecal examination procedures, are similar in appearance to those of common species such as Taenia pisiformis.

Assistance in the diagnosis of E. multilocularis may be available from a state veterinary diagnostic laboratory. Additional information regarding areas where E. multilocularis is suspected or has been confirmed may be obtained from area veterinary schools or the Centers for Disease Control in Atlanta, GA.

TREATMENT:

Dogs infected with E. multilocularis should be treated to prevent exposure of humans to infective eggs and to break the parasite’s life cycle.

The dosage of Drontal® Plus Tablets for removal of E. multilocularis is the same as that indicated for the removal of the other tapeworm species listed on the label. Laboratory efficacy studies have demonstrated the recommended dosage is 100% effective.

Under condition of continual exposure to wild rodents, retreatment of the dog at 21-26 day intervals is recommended to prevent the shedding of infectious eggs.

PRECAUTIONS:

Strict hygienic precautions should be taken when handling dogs or feces suspected of harboring E. multilocularis. Infected dogs treated for the first time with Drontal® Plus Tablets and dogs treated at intervals greater than 28 days may shed eggs in the feces after treatment. The animal should be held in the clinic during this interval and all feces should be incinerated or autoclaved. If these procedures are not possible, the eggs can be destroyed by soaking the feces in a sodium hypochlorite (bleach) solution of 3.75% or greater.7 All areas where the animal was maintained or in contact with should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

EFFICACY:

A total of 176 dogs and puppies with naturally acquired or experimental parasite infections were included in 4 well-controlled laboratory studies to establish the efficacy of Drontal® Plus Tablets. In addition, 103 dogs and puppies were included in clinical field studies conducted in 5 veterinary clinics at different geographic locations throughout the United States to further evaluate safety and efficacy. These studies included dogs of various sizes, ages and breeds. Data from these studies demonstrated Drontal® Plus Tablets are safe and efficacious for the removal of the parasite species indicated on the label when used as directed.

Results obtained in the laboratory and clinical studies indicate small numbers of hookworm or roundworm eggs may be passed in the feces for up to 7 days after treatment although the worms themselves were eliminated. A follow-up fecal examination should be conducted 2 to 4 weeks after treatment to determine the need for retreatment.

ADVERSE REACTIONS:

None of the 103 dogs treated with Drontal® Plus Anthelmintic Tablets in the clinical field studies exhibited drug-related side effects.

For customer service or to obtain product information, including Material Safety Data Sheet, call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.

ANIMAL SAFETY:

Controlled safety evaluations have been conducted in dogs with Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets. Dogs receiving up to 5 times the label dosage (35 mg praziquantel, 35 mg pyrantel pamoate and 179 mg febantel per kg of body weight) for 3 consecutive days (3 times the label duration) showed clinical signs of vomition and non-formed stools. One dog receiving a 3 times labeled dose had elevated SGPT, SGOT, CPK and GGT readings (outside of normal range) at 6 days post-treatment. No additional findings were noted in hematology/clinical chemistry parameters nor were there any treatment-related histological lesions. Vomition was the only side effect observed when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate and 305 mg febantel/kg with one dog having an elevated SGPT reading (outside of normal range) at 24 hours post-treatment which had returned to normal by 7 days.

WARNING:

KEEP OUT OF REACH OF CHILDREN.

STORAGE CONDITIONS:

Drontal® Plus Tablets should be stored at controlled room temperatures between 59-86°F (15- 30°C).

HOW SUPPLIED:

Each tablet size is available in bottles of 50 (puppies and small dogs, medium sized dogs) or 30 (large dogs).

Code 08713130-176099 50 Tablets/Bottle (Puppies and Small Dogs)
Code 08713149-177099 50 Tablets/Bottle (Medium Sized Dogs)
Code 08724639 30 Tablets/Bottle (Large Dogs)

REFERENCES:

1 Andrews P. 1976. Pharmacokinetlc Studies with DRONCIT® in Animals Using a Biological Assay. Veterinary Medical Review. 2:154-165.

2 Campbell WC. 1986. The Chemotherapy of Parasitic Infections. J. Parasit. 72(1):45-61.

3 Hildreth MB Johnson MD and Kazacos KR. 1991. A Zoonosis of Increasing Concern in the United States. Compendium for Cont. Ed. 13(5): 727-740.

4 Lieby PD Carney WP and Woods CE. 1970. Studies on Sylvatic Echinococcosis, III. Host Occurrence and Geographic Distribution of Echinococcus multilocularis in the North Central United States. J. Parasit. 56(6): 1141-1150.

5 Georgi JR and Georgi ME. 1990. Parasitology for Veterinarians. W.B. Saunders Co. 118-138.

6 Soulsby EJL. 1982. Helminths, Arthropods and Protozoa of Domesticated Animals. 7th Edition. Lea & Febiger. 118-138.

7 Craig PS and McPharson CNL. 1988. Sodium Hypochlorite as an Ovicide for Echinococcus. Ann Trop Med. and Parasit. 82(2): 211-213.

8 Freedom of Information Summary (FOI) NADA 133-953 Vercom Paste (febantel and praziquantel).

Bayer, the Bayer Cross, and Drontal are registered trademarks of Bayer.

Bayer Logo

Bayer HealthCare LLC
Animal Health Division
Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

©2013 Bayer HealthCare LLC January, 201308954340, R.2 17919

PRINCIPAL DISPLAY PANEL

Drontal Plus (praziquantel/pyrantel pamoate/febantel) tablets; Broad spectrum anthelmintic for puppies and small dogs (2 to 25 lbs.) label
(click image for full-size original)

Drontal® Plus
(praziquantel/pyrantel pamoate/febantel) tablets

Broad spectrum anthelmintic for
puppies and small dogs (2 to 25 lbs.)

EACH TABLET CONTAINS: 22.7 mg praziquantel, 22.7 mg
pyrantel base as pyrantel pamoate, and 113.4 mg febantel.

CAUTION: Federal (U.S.A.) law restricts this drug to use by
or on the order of a licensed veterinarian.

WARNING: KEEP OUT OF REACH OF CHILDREN.

Bayer

50 Tablets

Bayer HealthCare LLC, Animal Health Division Shawnee Mission,Kansas 66201, USA NADA 141-007, Approved by FDA

PRINCIPAL DISPLAY PANEL

Drontal Plus (praziquantel/pyrantel pamoate/febantel) tablets; Broad spectrum anthelmintic for medium dogs (26 to 60 lbs.) label
(click image for full-size original)

Drontal® Plus
(praziquantel/pyrantel pamoate/febantel) tablets

Broad spectrum anthelmintic for
medium sized dogs (26 to 60 lbs.)

EACH TABLET CONTAINS: 68.0 mg praziquantel,
68.0 mg pyrantel base as pyrantel pamoate, and
340.2 mg febantel.

CAUTION: Federal (U.S.A.) law restricts this drug to
use by or on the order of a licensed veterinarian.

WARNING: KEEP OUT OF REACH OF CHILDREN.

Bayer

50 Tablets

Bayer HealthCare LLC, Animal Health Division
Shawnee Mission, Kansas 66201, USA NADA 141-007, Approved by FDA

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