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NOAH Compendium | Panacur Granules 22.2 % w/w

14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 1 of 7 CompendiumNOAH CompendiumPanacur Granules % w/wPanacur Granules % w/w Species:Species:Cats, DogsTherapeutic indication:Therapeutic indication:Pharmaceuticals: Pharmaceuticals: Endoparasiticides:Endoparasiticides:Anth elmintics for dogs, Anthelmintics for catsActive ingredient:Active ingredient:FenbendazoleProduct:Product:P anacur Granules w/wProduct index:Product index: Panacur granulesQualitative and quantitative compositionQualitative and quantitative compositionActive ingredientActive ingredientFenbendazole: % w/w For full list of excipients, see section Pharmaceutical particulars . Pharmaceutical formPharmaceutical or yellowish-white granular particularsClinical particularsTarget speciesTarget speciesDomestic dogs, cats, puppies and Animal HealthMSD Animal Health 14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 2 of 7 for useIndications for useFor the treatment of domestic dogs and cats infected with immature and maturestages of nematodes of the gastro-intestinal and respiratory tracts.

Fenbendazole is metabolised mainly by enzymes of the cytochrome P -450 system in the liver. The major oxidative metabolite is fenbendazole sulfoxide which is further metabolised to fenbendazole sulfone. Fenbendazole and its metabolites are distributed throughout the body but highest concentrations are found in the liver.

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Transcription of NOAH Compendium | Panacur Granules 22.2 % w/w

1 14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 1 of 7 CompendiumNOAH CompendiumPanacur Granules % w/wPanacur Granules % w/w Species:Species:Cats, DogsTherapeutic indication:Therapeutic indication:Pharmaceuticals: Pharmaceuticals: Endoparasiticides:Endoparasiticides:Anth elmintics for dogs, Anthelmintics for catsActive ingredient:Active ingredient:FenbendazoleProduct:Product:P anacur Granules w/wProduct index:Product index: Panacur granulesQualitative and quantitative compositionQualitative and quantitative compositionActive ingredientActive ingredientFenbendazole: % w/w For full list of excipients, see section Pharmaceutical particulars . Pharmaceutical formPharmaceutical or yellowish-white granular particularsClinical particularsTarget speciesTarget speciesDomestic dogs, cats, puppies and Animal HealthMSD Animal Health 14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 2 of 7 for useIndications for useFor the treatment of domestic dogs and cats infected with immature and maturestages of nematodes of the gastro-intestinal and respiratory tracts.

2 Adult dogs and cats:Adult dogs and cats: For the treatment of adult dogs and cats infected withgastro-intestinal nematodes and cestodes:Ascarid spp. (Toxocara canis, Toxocara cati, Toxascaris leonina)Ancylostoma spp. Puppies and kittens:Puppies and kittens: For the treatment of weaned puppies and kittens infectedwith gastro-intestinal nematodes and puppies infected with protozoa (Giardia spp): Pregnant dogs:Pregnant dogs: For the treatment of pregnant dogs to reduce prenatal infectionswith Toxocara canis and the transfer of and Ancylostoma caninum to theirpups via the milk. Also for the treatment of dogs infected with lungworm Oslerus (Filaroides) osleri orprotozoa Giardia spp. and cats infected with lungworm Aelurostrongyles abstrusus Panacur also has an ovicidal effect on nematode warnings for each target speciesSpecial warnings for each target precautions for useSpecial precautions for useSpecial precautions for use in animalsAssess body weight as accurately as possible before calculating the warnings:Direct contact with the skin should be kept to a inhalation of granule dust.

3 Wash hands after 08:22 NOAH Compendium | Panacur Granules % w/wPage 3 of 7 reactionsAdverse reactionsGastrointestinal signs (such as vomiting and diarrhoea) can occur in very rare casesin dogs and during pregnancy, lactation or layUse during pregnancy, lactation or layThe product can also be safely administered to pregnant dogs and teratogenic effects in dogs and cats cannot be completely ruled out in very rarecases, the treatment in the first two trimesters of pregnancy should be based on thebenefit-risk evaluation by the responsible to be administered and administrationAmounts to be administered and administrationrouterouteRoutine treatment of adult dogs and catsAdminister 100mg fenbenbazole per 1 kg ( lb) body weight as a single dosage recommendations:1 g sachet /doseTreats 22 kg ( ) body weight as a single dose ( kg) g sachet / doseTreats 44 kg ( ) body weight as a single dose ( kg) g sachet /doseTreats 1010 kg (22lb) body weight as a single dose (5 10 kg)For dogs weighing over 10 kg (22 lbs), additional sachets are required according tothe additional body body weight as accurately as possible and then administer one or acombination of the above sachets, which most closely doses this body weight.

4 Thedose should be administered by mixing into the a 9kg dog = 22 kg dose (1g sachet) + 44 kg dose ( sachet) + 44 kg dose ( sachet). 1 gram sachet + two sachets (1010 kg dose)orone gram sachet (1010 kg dose)Treatment should be repeated when natural re-infection with parasitic wormsoccurs. Routine treatment of adult animals with minimal exposure to infection isadvisable 2 to 4 times per year. More frequent treatment, at 6 to 8 weekly intervals isadvisable for dogs in puppies and kittens under six months ofWeaned puppies and kittens under six months ofageageAdminister 50 mg fenbendazole per 1 kg ( lbs) body weight daily for 3consecutive dosage recommendations:1 g sachet /doseTreats 44kg ( lb) body weight (minimum weight kg) dosed daily for14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 4 of 7 consecutive days ( kg) g sachet / doseTreats 88 kg ( lb) body weight dosed daily for three consecutive days( 8 kg) g sachet /doseTreats 2020 kg (44 lb) body weight dosed daily for three consecutive days(10 20 kg)For dogs/puppies weighing over 20 kg (44 lbs) additional sachets are requiredaccording to the additional body body weight as accurately as possible and then administer one or acombination of the above sachets, which most closely doses this body weight.

5 Thedose should be administered by mixing into the Smaller or unweaned puppies and kittens should be treated with Panacur 10% Liquid or Panacur a 9 kg dog = 44 kg dose (1g sachet) + 88 kg dose ( sachet) daily for 3 consecutive 1 gram sachet + one sachets. (1212 kg) dose daily for 3 daysorthree 1 gram sachet (1212 kg dose) daily for 3 daysPuppies should be treated at 2 weeks of age, 5 weeks of age and again beforeleaving the breeder's premises. Treatment may also be required at 8 and 12 weeks ofage. Thereafter, frequency of treatment can be reduced unless the pups remain inkennels where re-infestation occurs more dogsPregnant dogsAdminister 25mg fenbendazole per 1 kg ( lb) body weight daily from day 40 ofpregnancy continuously to 2 days post-whelping (approximately 25 days).Practical dosage recommendations:1 g sachet /doseTreats 88 kg ( lb) body weight dosed daily for approx. 25 g sachet / doseTreats 1616 kg ( lb) bod yweight dosed daily for approx.

6 25 g sachet /doseTreats 4040 kg (88 lb) body weight dosed daily for approx. 25 daysFor bitches weighing over 40 kg, additional sachets are required according to theadditional body catsPregnant cats can be safely treated with this dosing for specific infectionsIncreased dosing for specific infectionsFor the treatment of clinical worm infestations in adult dogs and cats or Giardia in dogs, administer 50mg fenbendazole per 1kg ( lb) body weight dailyfor 3 consecutive control of lungworm Oslerus (Filaroides) osleri in dogs administer 50mgfenbendazole per 1kg ( lb) body weight, daily for 7 consecutive days. A repeatedcourse of treatment may be required in some the control of lungworm Aelurostrongylus abstrusus in cats administer 50mgfenbendazole per 1kg ( lb) body weight daily for 3 consecutive 08:22 NOAH Compendium | Panacur Granules % w/wPage 5 of 7 have a high margin of safety. No specific overdose symptoms areknown.

7 No specific actions periodsWithdrawal periodsNot particularsPharmacological particularsPharmacodynamic propertiesPharmacodynamic propertiesATC Vet Code: QP52 AC 13 fenbendazole is an anthelmintic belonging to the benzimidazole carbamates acts by interfering in the energy metabolism of the nematode. The anthelminticefficacy is based on inhibition of the polymerisation of tubulin to microtubuli. Theanthelmintic affects both adult and immature stages of gastro-intestinal andrespiratory propertiesPharmacokinetic propertiesFenbendazole is only partly absorbed from the intestine and reaches maximumplasma concentration in dogs 6 - 24 hours after oral administration. In cats the meanmaximum serum concentration of fenbendazole was reached about 4 hours aftertreatment. Administration of fenbendazole in food did significantly increase itsbioavailability compared to the administration on an empty is metabolised mainly by enzymes of the cytochrome P -450 systemin the liver.

8 The major oxidative metabolite is fenbendazole sulfoxide which is furthermetabolised to fenbendazole and its metabolites are distributed throughout the body but highestconcentrations are found in the elimination half-life from plasma is about 15 hours after oral administration. fenbendazole and its metabolites are predominantly excreted via the particularsPharmaceutical particularsExcipientsExcipientsLactose monohydrate, Povidone 2500 and Maize incompatibilitiesMajor incompatibilities14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 6 of 7 lifeShelf lifeShelf life of the veterinary medicinal product as packaged for sale: 36 precautions for storageSpecial precautions for storageNo special precautions for packagingImmediate packagingPack sizes: 1g, and : Low density polyethylene/aluminium foil/paper laminated all pack sizes may be unused veterinary medicinal product or waste materials derived from suchveterinary medicinal products should be disposed of in accordance with Authorisation NumberMarketing Authorisation NumberVm 01708/4427 Significant changesSignificant changesDate of the first authorisation or date of renewalDate of the first authorisation or date of renewal23 January of revision of the textDate of revision of the textMay other informationAny other informationFor animal treatment only.

9 Keep out of the sight and reach of categoryLegal categoryLegal category:Legal category:NFA-VPS14/06/2017 08:22 NOAH Compendium | Panacur Granules % w/wPage 7 of 7 from NOAH Compendium ( ). (c) CopyrightPrinted from NOAH Compendium ( ). (c) CopyrightNOAH Compendium 2017. All Rights Compendium 2017. All Rights : Wednesday, June 14, 2017 7:22 Date: Wednesday, June 14, 2017 7:22 GTINGTINGTIN description:GTIN description: Panacur Granules :GTIN:GTIN:05032984101140,GTIN description:GTIN description: Panacur Granules :GTIN:GTIN:05032984101164,GTIN description:GTIN description: Panacur Granules :GTIN:GTIN:05032984101195,GTIN description:GTIN description: Panacur Granules :GTIN:GTIN:05032984101188


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