{"product_id":"equest_pramox","title":"Equest Pramox *Prescription Required*","description":"\u003ch3\u003e1. NAME OF THE VETERINARY MEDICINAL PRODUCT\u003c\/h3\u003e\n\u003cp\u003eEquest Pramox 19.5 mg\/g + 121.7 mg\/g oral gel for horses\u003c\/p\u003e\n\u003ch3\u003e2. QUALITATIVE AND QUANTITATIVE COMPOSITION\u003c\/h3\u003e\n\u003cp\u003eEach g contains:\u003c\/p\u003e\n\u003cp\u003eActive substances\u003cbr\u003eMoxidectin 19.5 mg\u003cbr\u003ePraziquantel 121.7 mg\u003c\/p\u003e\n\u003cp\u003eExcipients\u003cbr\u003eBenzyl alcohol (E1519) 220.0 mg\u003cbr\u003eButylhydroxytoluene (E321) 0.8 mg\u003c\/p\u003e\n\u003cp\u003eFor a full list of excipients, see section 6.1\u003c\/p\u003e\n\u003ch3\u003e3. PHARMACEUTICAL FORM\u003c\/h3\u003e\n\u003cp\u003eOral Gel.\u003cbr\u003ePale yellow to orange\/pink oral gel.\u003c\/p\u003e\n\u003ch3\u003e4. CLINICAL PARTICULARS\u003c\/h3\u003e\n\u003ch4\u003e4.1 Target species\u003c\/h4\u003e\n\u003cp\u003eHorses.\u003c\/p\u003e\n\u003ch4\u003e4.2 Indications for use, specifying the target species\u003c\/h4\u003e\n\u003cp\u003eFor the treatment of mixed cestodes and nematodes or arthropods infections, caused by\u003cbr\u003emoxidectin and praziquantel sensitive strains of:\u003c\/p\u003e\n\u003cp\u003eLarge strongyles:\u003c\/p\u003e\n\u003cp\u003eStrongylus vulgaris (adult stages)\u003c\/p\u003e\n\u003cp\u003eStrongylus edentatus (adult stages)\u003c\/p\u003e\n\u003cp\u003eTriodontophorus brevicauda (adults)\u003c\/p\u003e\n\u003cp\u003eTriodontophorus serratus (adults)\u003c\/p\u003e\n\u003cp\u003eTriodontophorus tenuicollis (adults)\u003c\/p\u003e\n\u003cp\u003eSmall strongyles (adults and intraluminal larval stages):\u003c\/p\u003e\n\u003cp\u003eCyathostomum spp\u003c\/p\u003e\n\u003cp\u003eCylicocyclus spp\u003c\/p\u003e\n\u003cp\u003eCylicostephanus spp\u003c\/p\u003e\n\u003cp\u003eCylicodontophorus spp\u003c\/p\u003e\n\u003cp\u003eGyalocephalus spp\u003c\/p\u003e\n\u003cp\u003eAscarids:\u003c\/p\u003e\n\u003cp\u003eParascaris equorum (adults)\u003c\/p\u003e\n\u003cp\u003eOther species:\u003c\/p\u003e\n\u003cp\u003eOxyuris equi (adult stages)\u003c\/p\u003e\n\u003cp\u003eHabronema muscae (adults)\u003c\/p\u003e\n\u003cp\u003eGasterophilus intestinalis (L2, L3)\u003c\/p\u003e\n\u003cp\u003eGasterophilus nasalis (L2, L3)\u003c\/p\u003e\n\u003cp\u003eStrongyloides westeri (adults)\u003c\/p\u003e\n\u003cp\u003eTrichostrongylus axei (adult stages)\u003c\/p\u003e\n\u003cp\u003eTapeworm (adults):\u003c\/p\u003e\n\u003cp\u003eAnoplocephala perfoliata\u003c\/p\u003e\n\u003cp\u003eAnoplocephala magna\u003c\/p\u003e\n\u003cp\u003eParanoplocephala mammillana\u003c\/p\u003e\n\u003cp\u003eThe egg reappearance period of small strongyles is 90 days.\u003cbr\u003eThe veterinary medicinal product is effective against (developing) intramucosal L4 stages\u003cbr\u003eof small strongyles. At 8 weeks after treatment, early (hypobiotic) EL3 stages of small\u003cbr\u003estrongyles are eliminated.\u003c\/p\u003e\n\u003ch4\u003e4.3 Contraindications\u003c\/h4\u003e\n\u003cp\u003eDo not administer to young foals less than 6.5 months old.\u003cbr\u003eDo not use in cases of hypersensitivity to the active substance or to any of the excipients.\u003c\/p\u003e\n\u003cp\u003eThe veterinary medicinal product has been formulated specifically for use in horses only.\u003cbr\u003eDogs and cats may be adversely affected by the concentration of moxidectin in this\u003cbr\u003eveterinary medicinal product if they are allowed to ingest spilled gel or have access to\u003cbr\u003eused syringes.\u003c\/p\u003e\n\u003ch4\u003e4.4 Special warnings for each target species\u003c\/h4\u003e\n\u003cp\u003eCare should be taken to avoid the following practices, because they increase the risk of\u003cbr\u003edevelopment of resistance and could ultimately result in ineffective therapy:\u003cbr\u003e- Too frequent and repeated use of anthelmintics from the same class, over an\u003cbr\u003eextended period of time;\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eUnder-dosing which may due to underestimation of body weight, misadministration of\u003cbr\u003ethe product, or lack of calibration of the dosing device (If any).\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003eSuspected clinical cases of resistance to anthelmintics should be further investigated\u003cbr\u003eusing appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of\u003cbr\u003ethe test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic\u003cbr\u003ebelonging to another pharmacological class and having a different mode of action\u003cbr\u003eshould be used.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eFor optimum control of bots, the veterinary medicinal product should be administered in\u003cbr\u003ethe autumn, after the end of the fly season and before spring as the larvae may start to\u003cbr\u003epupate and therefore are less sensitive to treatment.\u003cbr\u003eParasite resistance to a particular class of anthelmintic may develop following frequent,\u003cbr\u003erepeated use of an anthelmintic of that class. The veterinarian should give advice regarding\u003cbr\u003eappropriate dosing programmes and stock management to achieve adequate parasite control\u003cbr\u003efor both tapeworm and roundworm infestations.\u003c\/p\u003e\n\u003ch4\u003e4.5 Special precautions for use\u003c\/h4\u003e\n\u003cp\u003eSpecial precautions for use in animals\u003c\/p\u003e\n\u003cp\u003eTo avoid overdosing, care should be taken to accurately dose foals, especially low body\u003cbr\u003eweight foals or pony foals.\u003cbr\u003eDo not use the same syringe to treat more than one animal unless horses are running\u003cbr\u003etogether or in direct contact with each other in the same premises.\u003c\/p\u003e\n\u003cp\u003eSpecial precautions to be taken by the person administering the veterinary medicinal\u003cbr\u003eproduct to animals\u003c\/p\u003e\n\u003cp\u003eThis veterinary medicinal product may cause eye irritation, skin irritation and skin\u003cbr\u003esensitisation.\u003cbr\u003eAvoid contact with skin and eyes.\u003cbr\u003ePersonal protective equipment consisting of protective gloves should be worn when\u003cbr\u003ehandling the veterinary medicinal product.\u003cbr\u003eWash hands or any exposed area after use.\u003cbr\u003eDo not smoke, drink or eat while handling the veterinary medicinal product.\u003c\/p\u003e\n\u003cp\u003eIn case of eye contact, flush the eye with copious amounts of clean water and seek\u003cbr\u003emedical advice immediately and show the package leaflet or the label to the physician.\u003cbr\u003eIn case of accidental ingestion, seek medical advice immediately and show the package\u003cbr\u003eleaflet or the label to the physician.\u003c\/p\u003e\n\u003cp\u003eSpecial precautions for the protection of the environment\u003c\/p\u003e\n\u003cp\u003eMoxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)\u003cbr\u003esubstance; therefore, exposure of the environment to moxidectin must be limited to the\u003cbr\u003eextent possible. Treatments should be administered only when necessary and should be\u003cbr\u003ebased on faecal egg counts or evaluation of the risk of infestation at the animal and\/or\u003cbr\u003eherd level. In order to reduce the emission of moxidectin to surface water and based on\u003cbr\u003ethe excretion profile of moxidectin when administered as the oral formulation to horses,\u003cbr\u003etreated animals should not have access to watercourses during the first week after\u003cbr\u003etreatment.\u003c\/p\u003e\n\u003cp\u003eLike other macrocyclic lactones, moxidectin has the potential to adversely affect non-target\u003cbr\u003eorganisms:\u003c\/p\u003e\n\u003cp\u003eFaeces containing moxidectin excreted onto pasture by treated animals may temporarily\u003cbr\u003ereduce the abundance of dung feeding organisms. Following treatment of horses with\u003cbr\u003ethe veterinary medicinal product, levels of moxidectin that are potentially toxic to dung\u003cbr\u003ebeetles and flies may be excreted over a period of more than 1 week and may decrease\u003cbr\u003edung fauna abundance.\u003c\/p\u003e\n\u003cp\u003eMoxidectin is inherently toxic to aquatic organisms including fish. The veterinary\u003cbr\u003emedicinal product should be used only according to the label instructions.\u003c\/p\u003e\n\u003cp\u003eIn order to limit the impact of moxidectin on dung fauna, and due to insufficient data\u003cbr\u003eregarding environmental risk of praziquantel, horses should not be turned out onto pasture\u003cbr\u003ewithin 3 days of treatment.\u003c\/p\u003e\n\u003cp\u003eOther precautions\u003c\/p\u003e\n\u003cp\u003eNot applicable.\u003c\/p\u003e\n\u003ch4\u003e4.6 Adverse reactions (frequency and seriousness)\u003c\/h4\u003e\n\u003cp\u003eHorses:\u003c\/p\u003e\n\u003cp\u003e(1 to 10 animals \/ 10,000 animals Swollen muzzle1\u003cbr\u003etreated): Ataxia1, Droopy lower lip1\u003cbr\u003eAnorexia1\u003c\/p\u003e\n\u003cp\u003eVery rare Digestive tract disorder (e.g. colic, loose stool)\u003cbr\u003e(\u0026lt;1 animal \/ 10,000 animals treated, Tremor1\u003cbr\u003eincluding isolated reports): Lethargy1\u003c\/p\u003e\n\u003cp\u003e1 These adverse effects are transient and disappear spontaneously.\u003c\/p\u003e\n\u003cp\u003eReporting adverse events is important. It allows continuous safety monitoring of a\u003cbr\u003eveterinary medicinal product. Reports should be sent, preferably via a veterinarian, to\u003cbr\u003eeither the marketing authorisation holder or the national competent authority via the\u003cbr\u003enational reporting system. See the package leaflet for respective contact details.\u003c\/p\u003e\n\u003ch4\u003e4.7 Use during pregnancy, lactation or lay\u003c\/h4\u003e\n\u003cp\u003eThe veterinary medicinal product has been shown to be safe for use in breeding, pregnant and\u003cbr\u003elactating mares.\u003cbr\u003eThe administration of the veterinary medicinal product does not adversely affect the fertility of the\u003cbr\u003emares.\u003c\/p\u003e\n\u003ch4\u003e4.8 Interaction with other medicinal products and other forms of interaction\u003c\/h4\u003e\n\u003cp\u003eThe effects of GABA agonists are increased by moxidectin.\u003c\/p\u003e\n\u003ch4\u003e4.9 Amount(s) to be administered and administration route\u003c\/h4\u003e\n\u003cp\u003eOral use.\u003cbr\u003eA single oral dose of 400 g moxidectin\/kg body weight and 2.5 mg praziquantel\/kg body\u003cbr\u003eweight using the calibrated syringe of one gradation per 25 kg live weight.\u003cbr\u003eA single syringe treats a 700 kg horse.\u003c\/p\u003e\n\u003cp\u003eTo ensure administration of a correct dosage, body weight should be determined as\u003cbr\u003eaccurately as possible; accuracy of the dosing should be checked.\u003cbr\u003eUse of a scale or weight tape is recommended to ensure accurate dosing.\u003c\/p\u003e\n\u003cp\u003eDosing instructions:\u003cbr\u003eBefore the first dose, hold the syringe with the capped end pointing to the left and so that\u003cbr\u003eyou can see the weight measurements and tick marks (small black lines). Set the syringe\u003cbr\u003eto zero by moving the dial ring so the left side is set at the first full black mark and depress\u003cbr\u003ethe plunger, safely discarding any paste that is expelled.\u003c\/p\u003e\n\u003cp\u003eTo dose the veterinary medicinal product, hold the syringe as previously described. Each\u003cbr\u003etick mark relates to 25 kg of body weight and to 10 mg moxidectin\/62.5 mg praziquantel.\u003cbr\u003eTurn the dial ring until the left side of the ring lines up with the weight of the animal.\u003c\/p\u003e\n\u003cp\u003eIn the case of cestode treatment the dose of praziquantel in the veterinary medicinal\u003cbr\u003eproduct has been selected to the top end of the dosing range.\u003c\/p\u003e\n\u003cp\u003eVeterinary advice should be given on appropriate dosing programmes and stock\u003cbr\u003emanagement to achieve optimum parasite control.\u003c\/p\u003e\n\u003ch4\u003e4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary\u003c\/h4\u003e\n\u003cp\u003eTransient adverse reactions may occur at the recommended treatment dose in foals. In\u003cbr\u003eadults transient adverse reactions may occur at 3 times the recommended dose. The\u003cbr\u003esymptoms are depression, inappetence, ataxia, flaccid lower lip in the 8 to 24 hours\u003cbr\u003efollowing treatment. Symptomatic treatment is not generally necessary and recovery is\u003cbr\u003egenerally complete within 24 to 72 hours. There is no specific antidote.\u003c\/p\u003e\n\u003ch4\u003e4.11 Withdrawal period(s)\u003c\/h4\u003e\n\u003cp\u003eMeat and offal: 64 days.\u003cbr\u003eMilk: Not authorised for use in animals producing milk for human consumption.\u003c\/p\u003e\n\u003ch3\u003e5. PHARMACOLOGICAL PROPERTIES\u003c\/h3\u003e\n\u003cp\u003ePharmacotherapeutic group: antiparasitic product, endectocide\u003c\/p\u003e\n\u003cp\u003eATCvet code: QP54AB52\u003c\/p\u003e\n\u003ch4\u003e5.1 Pharmacodynamic properties\u003c\/h4\u003e\n\u003cp\u003eMoxidectin is a parasiticide active against a wide range of internal and external parasites\u003cbr\u003eand is a second generation macrocyclic lactone of the milbemycin family. Moxidectin\u003cbr\u003einteracts with GABA receptors and chloride channels. The net effect is to open the chloride\u003cbr\u003echannels on the postsynaptic junction to allow the inflow of chloride ions and induce an\u003cbr\u003eirreversible resting state. This results in flaccid paralysis and eventual death of parasites\u003cbr\u003eexposed to the drug.\u003cbr\u003ePraziquantel is a parasiticide widely used in many species as an anthelmintic.\u003cbr\u003ePraziquantel is quickly absorbed via the tegument of the parasite and distributed. In vitro\u003cbr\u003eand in vivo important lesions of the tegument of the parasite are seen that provoke\u003cbr\u003econtraction and paralysis of the parasite. Praziquantel modifies the permeability of the\u003cbr\u003eparasitic membrane to calcium ions, which disrupts the metabolism of the parasite.\u003cbr\u003eThe veterinary medicinal product is effective against benzimidazole resistant strains of\u003cbr\u003ecyathostomes.\u003c\/p\u003e\n\u003ch4\u003e5.2 Pharmacokinetic particulars\u003c\/h4\u003e\n\u003cp\u003eMoxidectin is absorbed orally and maximum blood concentration is achieved\u003cbr\u003eapproximately 6 to 8 hours after administration.\u003cbr\u003eThe drug is distributed throughout the body tissues but due to its lipophilicity it is\u003cbr\u003eselectively concentrated in the fat.\u003cbr\u003eThe elimination half-life is 11days.\u003cbr\u003eMoxidectin undergoes partial biotransformation by hydroxylation in the body and the only\u003cbr\u003esignificant route of excretion is the faeces.\u003cbr\u003ePraziquantel is quickly and almost totally absorbed in the body, rapidly distributed to all\u003cbr\u003eorgans, half life elimination is less than 1 hour in horses. Praziquantel is rapidly\u003c\/p\u003e\n\u003cp\u003emetabolised in the liver. Its principal metabolite is a related 4-hydroxycyclohexyl\u003cbr\u003ecomponent.\u003c\/p\u003e\n\u003ch4\u003e5.3 Environmental properties\u003c\/h4\u003e\n\u003cp\u003eMoxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)\u003cbr\u003esubstance. In particular, in acute and chronic toxicity studies with algae, crustaceans and\u003cbr\u003efish, moxidectin showed toxicity to these organisms, yielding the following endpoints:\u003c\/p\u003e\n\u003cp\u003eOrganism EC50 NOEC\u003cbr\u003eAlgae S. capricornutum \u0026gt;86.9 g\/l 86.9 g\/l\u003cbr\u003eCrustaceans Daphnia magna (acute) 0.0302 g\/l 0.011 g\/l\u003cbr\u003e(Water Daphnia magna 0.0031 g\/l 0.010 g\/l\u003cbr\u003efleas) (reproduction)\u003cbr\u003eFish O. mykiss 0.160 g\/l Not determined\u003cbr\u003eL. macrochirus 0.620 g\/l 0.52 g\/l\u003cbr\u003eP. promelas (early life Not 0.0032 g\/l\u003cbr\u003estages) applicable\u003cbr\u003eCyprinus carpio 0.11 g\/l Not determined\u003c\/p\u003e\n\u003cp\u003eEC50: the concentration which results in 50% of the test species individuals being\u003cbr\u003eadversely affected, i.e. both mortality and sub-lethal effects.\u003cbr\u003eNOEC: the concentration in the study at which no effects are observed.\u003c\/p\u003e\n\u003cp\u003eThis implies that when allowing moxidectin to enter water bodies, this may have a severe\u003cbr\u003eand lasting impact on aquatic life. To mitigate this risk, all precautions for use and disposal\u003cbr\u003emust be adhered to.\u003c\/p\u003e\n\u003ch3\u003e6. PHARMACEUTICAL PARTICULARS\u003c\/h3\u003e\n\u003ch4\u003e6.1 List of excipients\u003c\/h4\u003e\n\u003cp\u003eBenzyl alcohol (E1519)\u003cbr\u003eButyl hydroxytoluene (E321)\u003cbr\u003eAnhydrous colloidal silica\u003cbr\u003eEthanol, anhydrous\u003cbr\u003ePolysorbate 80\u003cbr\u003eEthyl cellulose\u003cbr\u003ePropylene glycol dicaprylate\/dicaprate\u003c\/p\u003e\n\u003ch4\u003e6.2 Major incompatibilities\u003c\/h4\u003e\n\u003cp\u003eNone known.\u003c\/p\u003e\n\u003ch4\u003e6.3 Shelf life\u003c\/h4\u003e\n\u003cp\u003eShelf life of the veterinary medicinal product as packaged for sale: 2 years.\u003cbr\u003eShelf life after first opening the immediate packaging: 6 months.\u003c\/p\u003e\n\u003ch4\u003e6.4 Special precautions for storage\u003c\/h4\u003e\n\u003cp\u003eDo not store above 25C.\u003c\/p\u003e\n\u003ch4\u003e6.5 Nature and composition of immediate packaging\u003c\/h4\u003e\n\u003cp\u003eHigh density polyethylene syringe containing 14.4 g of gel with a graduated polypropylene\u003cbr\u003eplunger with a low density polyethylene piston and cap packed as follows:\u003c\/p\u003e\n\u003cp\u003eBox containing one syringe.\u003c\/p\u003e\n\u003cp\u003eBox containing 10 individually boxed syringes.\u003c\/p\u003e\n\u003cp\u003eBox containing 20 individually boxed syringes.\u003c\/p\u003e\n\u003cp\u003eBox containing 20 syringes.\u003c\/p\u003e\n\u003cp\u003eNot all pack sizes may be marketed.\u003c\/p\u003e\n\u003ch4\u003e6.6 Special precautions for the disposal of unused veterinary medicinal product or\u003c\/h4\u003e\n\u003cp\u003ewaste materials derived from the use of such products\u003c\/p\u003e\n\u003cp\u003eMedicines should not be disposed of via wastewater.\u003cbr\u003eAny unused veterinary medicinal product or waste material derived from such veterinary\u003cbr\u003emedicinal products should be disposed of in accordance with local requirements. The\u003cbr\u003eveterinary medicinal product should not enter water courses as moxidectin may be\u003cbr\u003edangerous for fish and other aquatic organisms.\u003c\/p\u003e\n\u003ch3\u003e7. MARKETING AUTHORISATION HOLDER\u003c\/h3\u003e\n\u003cp\u003eZoetis UK Limited\u003cbr\u003e1st Floor, Birchwood Building\u003cbr\u003eSpringfield Drive\u003cbr\u003eLeatherhead\u003cbr\u003eSurrey\u003cbr\u003eKT22 7LP\u003c\/p\u003e\n\u003ch3\u003e8. MARKETING AUTHORISATION NUMBER\u003c\/h3\u003e\n\u003cp\u003eVm 42058\/5148\u003c\/p\u003e\n\u003ch3\u003e9. DATE OF FIRST AUTHORISATION\u003c\/h3\u003e\n\u003cp\u003e29 June 2006\u003c\/p\u003e\n\u003ch3\u003e10. DATE OF REVISION OF THE TEXT\u003c\/h3\u003e\n\u003cp\u003eJuly 2024\u003c\/p\u003e\n\u003cp\u003ePROHIBITION OF SALE, SUPPLY AND\/OR USE\u003c\/p\u003e\n\u003ch3\u003e11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT\u003c\/h3\u003e\n\u003cp\u003eVeterinary medicinal product subject to prescription.\u003c\/p\u003e","brand":"Zoetis","offers":[{"title":"Default Title","offer_id":46797754827094,"sku":"14271","price":26.5,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0726\/7077\/3590\/files\/EquestPramox.jpg?v=1713530118","url":"https:\/\/www.triequestrian.com\/products\/equest_pramox","provider":"TRI Equestrian","version":"1.0","type":"link"}