Mycelvan may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Mycelvan in the following countries:
International Drug Name Search
Chewables
NADA 140-971, Approved by the FDA
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).
HEARTGARD® Plus should be administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) of body weight. The recommended dosing schedule for prevention of canine heartworm disease and for the treatment and control of ascarids and hookworms is as follows:
| Dog Weight | Chewables Per Month | Ivermectin Content | Pyrantel Content | Color Coding on Foil Backing and Carton |
|---|---|---|---|---|
| Heartgard Plus is recommended for dogs 6 weeks of age and older. For dogs over 100 lb use the appropriate combination of these chewables. | ||||
| Up to 25 lb | 1 | 68 mcg | 57 mg | Blue |
| 26 to 50 lb | 1 | 136 mcg | 114 mg | Green |
| 51 to 100 lb | 1 | 272 mcg | 227 mg | Brown |
Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light. Because most dogs find Heartgard Plus palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a small amount of dog food. The chewable should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewables may be broken into pieces and fed to dogs that normally swallow treats whole.
Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.
Heartgard Plus should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the dog's first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dog's last exposure to mosquitoes.
When replacing another heartworm preventive product in a heartworm disease preventive program, the first dose of Heartgard Plus must be given within a month (30 days) of the last dose of the former medication.
If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. Therefore, for optimal performance, the chewable must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with Heartgard Plus and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.
Monthly treatment with Heartgard Plus also provides effective treatment and control of ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense). Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites.
HEARTGARD® Plus (ivermectin/pyrantel) Chewables, given orally using the recommended dose and regimen, are effective against the tissue larval stage of D. immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage. Heartgard Plus Chewables are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense).
In acceptability and field trials, Heartgard Plus was shown to be an acceptable oral dosage form that was consumed at first offering by the majority of dogs.
All dogs should be tested for existing heartworm infection before starting treatment with Heartgard Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with Heartgard Plus.
While some microfilariae may be killed by the ivermectin in Heartgard Plus at the recommended dose level, Heartgard Plus is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating microfilariae.
Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans.
Store between 68°F° - 77°F (20° - 25°C). Excursions between 59°F - 86°F (15° - 30°C) are permitted. Protect product from light.
In clinical field trials with Heartgard Plus, vomiting or diarrhea within 24 hours of dosing was rarely observed (1.1% of administered doses). The following adverse reactions have been reported following the use of HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.
Heartgard Plus has been shown to be bioequivalent to HEARTGARD, with respect to the bioavailability of ivermectin. The dose regimens of Heartgard Plus and HEARTGARD are the same with regard to ivermectin (6 mcg/kg). Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. HEARTGARD demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials and bioequivalency studies, support the safety of HEARTGARD products in dogs, including Collies, when used as recommended.
Heartgard Plus has shown a wide margin of safety at the recommended dose level in dogs, including pregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. In clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines and steroid preparations have been administered with Heartgard Plus in a heartworm disease preventive program.
In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy against intestinal nematodes, possibly due to a change in intestinal transit time.
Heartgard Plus is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 and 12 chewables.
For customer assistance, please contact Merial at 1-888-637-4251.
Marketed by
Merial Limited
Duluth, GA 30096-4640
Merial Limited, a company limited by shares registered in England and Wales [registered number 3332751] with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow Essex CM19 5QA, England, and domesticated in Delaware, USA as Merial LLC, with a place of business at 3239 Satellite Blvd., Duluth, GA 30096-4640 USA.
Made in U.S.A.
©2010 Merial. All Rights Reserved.
Rev. April 2010
1050-1999-02
®HEARTGARD and the Dog & Hand logo are registered trademarks of Merial.
Heartgard®Plus
(ivermectin/pyrantel)
Administer once a month to prevent
heartworm disease and to treat and control
ascarid and hookworm infections in dogs.
For
DOGS
UP TO 25 lbs
12 Chewables
Each chewable contains 68 mcg ivermectin
and 57 mg pyrantel as pamoate salt.
Keep this and all drugs out
of the reach of children.
Caution: Federal (U.S.A.) law restricts
this drug to use by or on the order of
a licensed veterinarian.
MERIAL
Heartgard®Plus
(ivermectin/pyrantel)
Administer once a month to prevent
heartworm disease and to treat and control
ascarid and hookworm infections in dogs.
For
DOGS
26-50 lbs
12 Chewables
Each chewable contains 136 mcg ivermectin
and 114 mg pyrantel as pamoate salt.
Keep this and all drugs out
of the reach of children.
Caution: Federal (U.S.A.) law restricts
this drug to use by or on the order of
a licensed veterinarian.
MERIAL
Heartgard®Plus
(ivermectin/pyrantel)
Administer once a month to prevent
heartworm disease and to treat and control
ascarid and hookworm infections in dogs.
For
DOGS
51-100 lbs
12 Chewables
Each chewable contains 272 mcg ivermectin
and 227 mg pyrantel as pamoate salt.
Keep this and all drugs out
of the reach of children.
Caution: Federal (U.S.A.) law restricts
this drug to use by or on the order of
a licensed veterinarian.
MERIAL
| HEARTGARD PLUS ivermectin and pyrantel pamoate tablet, chewable | ||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA140971 | 01/15/1993 | |
| HEARTGARD PLUS ivermectin and pyrantel pamoate tablet, chewable | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA140971 | 01/15/1993 | |
| HEARTGARD PLUS ivermectin and pyrantel pamoate tablet, chewable | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA140971 | 01/15/1993 | |
| Labeler - Merial Limited (034393582) |
Pressfall may be available in the countries listed below.
Hydralazine hydrochloride (a derivative of Hydralazine) is reported as an ingredient of Pressfall in the following countries:
International Drug Name Search
Rec.INN
N06AA05
0000315-72-0
C23-H29-N3-O
363
Antidepressant, tricyclic
1-Piperazineethanol, 4-[3-(5H-dibenz[b,f]azepin-5-yl)propyl]-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Fosalan may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Fosalan in the following countries:
International Drug Name Search
Propranolol Ecar may be available in the countries listed below.
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Propranolol Ecar in the following countries:
International Drug Name Search
Prevention and long-term treatment of asthma. It is also used in certain patients to relieve runny nose caused by allergies and to prevent asthma attacks caused by exercise. It may also be used for other conditions as determined by your doctor.
Montelukast Granules are a leukotriene receptor antagonist. It works by blocking a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Montelukast Granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Montelukast Granules. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Montelukast Granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Montelukast Granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Montelukast Granules.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; chest pain; dark urine; disorientation; fever; flu-like symptoms; hallucinations; irregular heartbeat; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of the hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Montelukast side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.
Store Montelukast Granules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Montelukast Granules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Montelukast Granules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
