TM Brief Summary of full Prescribing Information.
WITHDRAW worms (adults and fourth stage larvae): Dictyocaulus viviparus. Eyeworms (adults): Thelazia spp. Grubs (parasitic stages): Hypoderma bovis, H. lineatum. Sucking Lice: Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus. Mange Mites : Psoroptes bovis, Sarcoptes scabiei. *Adults only WARNINGS AND PRECAUTIONS: AWAL PERIODS AND RESIDUE WARNINGS: Oesophagostomum radiatum, T axei, T colubriformis, T VALCOR™ is indicated for the treatment and control of the following species of parasites in beef cattle two months of age and older and in replacement dairy heifers less than 20 months of age. Not for use in beef bulls intended for breeding over 1 year of age, dairy calves, and veal calves. Gastrointestinal Roundworms (adults and fourth stage larvae): Ostertagia oster- tagi (including inhibited larvae), Trichostrongylus T. T. longispicularis*, Cooperia oncophora, C. pectinata*, C. punctata, C. surnabada, Bunostomum phlebotomum*, Strongyloides papillosus*, Trichuris spp.*, Nematodirus helvetianus*. Lung- O. lyrata, Haemonchus placei, T INDICA (doramectin and levamisole injection) (5 mg/mL doramectin, 150 mg/mL levamisole hydrochloride) CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. ATIONS: Cattle must not be slaughtered for human consumption within 15 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. User Safety Warnings: Not for human use. Keep out of reach of children. If accidental eye contact occurs, flush eyes immediately with water for 15 minutes and seek medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses then continue rinsing for at least 15 minutes. Do not eat, drink or smoke while handling the product. Wash hands after use. Take care to avoid accidental self-injection. If accidental injection occurs, seek medical attention and provide product package insert to medical professional. To obtain a Safety Data Sheet(s), contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com. Animal Safety Warnings and Precautions: Use of levamisole in cattle treated in the last few days with cholinesterase inhibitors such as organophosphates or with morantel may enhance the toxic effects of levamisole. Use together with caution. H. bovis H. lineatum Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possi- bility of fatalities. Killing m when it is in the tissue surrounding the gullet may cause bloat; killing s when it is in the vertebral canal may cause stag- gering or paralysis. These reactions are not specific to treatment with VALCOR™ and can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development Consult your veterinarian either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment. Follow recommended dosage carefully. Reproductive safety has not been evaluated in bulls intended for breeding. ADVERSE REACTIONS: This product is likely to cause swelling at the injection site. Tissue damage at r, including possible granulomas and necrosis. These reactions have resolved without treatment. Local tissue reaction may result in trim loss of edible tissue at slaughter. A single death attributed to clos- tridial infection associated with the injection of VALCOR™ was reported in a non- pivotal effectiveness study. Observe cattle for injection site reactions. If injection site reactions are suspected, consult your veterinarian. This product is not for intravenous or intramuscular use. Hypersalivation may be observed; however, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Contact Information: Contact Zoetis Inc. at 1-888-963-8471 or www To report suspected TARGET ANIMAL SAFETY adverse drug experiences, contact Zoetis Inc. at 1-888-963-8471.Foradditional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. TA Y: Margin of Safety: Subcutaneous administration of VALCOR™ was well tolerated in calves as young as 3 months of age at 1, 2, or 3 times the recommended dose. Dose-dependent post-dose hypersalivation was seen in all treated groups compared to the controls. All cases of hypersalivation were mild, transient, and resolved without further medical intervention. Dose-related injection site reac- tions were observed, and those in the 1X group resolved between 21 and 28 days post injection. Injection site reactions were primarily swelling which resolved between 21 and 28 days post injection. Findings from the injection sites included swelling, edema, inflammation, muscle necrosis and fibrosis. Female Reproductive Safety: The reproductive safety of VALCOR™ was estab- lished in two studies with female cattle. First, a single dose of VALCOR™ was administered subcutaneously at 3 times the recommended dose at times coin- ciding with folliculogenesis, implantation, or organogenesis, and had no effects on conception, calving, abortion, and stillbirth rates, and post-natal viability up to 30±2 days post-calving. There were no congenital abnormalities. The only test article-related change was an increase in incidence and duration of swelling at injection sites compared with control, but all swellings eventually resolved. In a second study, a single dose of VALCOR™ administered subcutaneously at 3 times the recommended dose at either early or late gestation had no effects on calving, abortion, and stillbirth rates, and post-natal viability up to 30±2 days post-calving. One control calf and two treated calves were born with congen- ital abnormalities and did not survive. These were not determined to be test article-related. The only test article-related change was an increase in incidence and duration of swelling at injection sites, but all swellings eventually resolved. Not for use in bulls intended for breeding over 1 year of age, as reproductive safety has not been evaluated. HOW SUPPLIED: VALCOR™ is available in 100 mL, 250 mL and 500 mL multi-dose, rubber-capped glass vials. STORAGE, HANDLING, AND DISPOSAL: Store below 25°C (77°F). Do not expose to light for extended periods of time. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration. Approved by FDA under NADA # 141-553 .zoetis.com. T the injection site may also occur
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TOWN CREEK FARM – PAGE 44
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