Ceva Sante Animale

Ceva Sante Animale Drugs

• Tildren
  

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  Tildren

  

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  A single dose of TILDREN should be administered as an intravenous infusion at a dose of 1 mg/kg (0.45 mg/lb). The infusion should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions.

  Maximum effect may not occur until 2 months post-treatment.

  Do not reconstitute or mix TILDREN with calcium containing solutions or other solutions containing divalent cations such as Lactated Ringers as it may form complexes with these ions.

  STEP 1: Preparation of the reconstituted solution (20 mg/mL). TILDREN should be reconstituted using strict aseptic technique. Remove 25 mL of solution from a 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP and add it to one vial of TILDREN. Shake gently until the powder is completely dissolved. This reconstituted solution contains 20 mg of tiludronate disodium per mL. After reconstitution further dilution is required before administration.

  STEP 2: Preparation of the solution for infusion. Using strict aseptic technique, withdraw the appropriate volume of the reconstituted solution based on the horse’s body weight (see Table 1 below). Inject that volume back into the 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP. Horses greater than 1,210 lbs. will require a second vial of reconstituted TILDREN solution. Invert the infusion bag to mix the solution before infusion. Label the infusion bag to ensure proper use.

  After preparation, the infusion should be administered either within 2 hours of preparation, or it can be stored for up to 24 hours under refrigeration at 36-46° F (2-8° C) and protected from light.

  STEP 3: Administer for infusion through a suitable intravenous catheter inserted into a jugular vein and connected to the infusion bag using sterile disposable infusion tubing.

  Table 1: Dosing Table

  Weight Range (lbs)

  Volume of Reconstituted

  TILDREN Solution (20 mg/mL) to be added to the infusion bag

  550-770

  15 mL

  771-990

  20 mL

  991-1210

  25 mL*

  1211-1430

  30 mL (25 mL* + 5 mL from additional vial)

  1431-1650

  35 mL (25 mL* + 10 mL from additional vial)

  1651-1875

  40 mL (25 mL* + 15 mL from additional vial)

  *1 vial = 25 mL

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• Meloxidyl
  

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  Meloxidyl

  

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  Always provide client information sheet with prescription. Carefully consider the potential benefits and risk of Meloxidyl Oral Suspension and other treatment options before deciding to use Meloxidyl Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual response. Meloxidyl Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Meloxidyl Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg). The syringes are calibrated to deliver the daily maintenance dose in lbs.

  The daily dose (0.045 mg/lb) contains 0.03 mL of Meloxidyl Oral Suspension for every 1 lb (0.45 kg) of dog body weight.

  Meloxidyl Oral Suspension is packaged with 2 sizes of dosing syringes. The small syringe (blue print) is calibrated for use in dogs under 15 lbs. The large syringe (green print) is calibrated for use in dogs 15 lbs or greater. Only administer Meloxidyl with the provided syringes. The container should never be used as a dropper bottle for administration of Meloxidyl.

  Dogs under 15 lbs (6.8 kg)

  Shake well before use, then remove cap. Meloxidyl Oral Suspension can be given either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, only use the small dosing syringe. The large syringe provided cannot be used to measure doses for dogs weighing less than 15 lbs (6.8 kg). For dogs less than 15 lbs, use the small dosing syringe (blue print) provided in the package (see dosing procedure below). The small dosing syringe fits onto the bottle and has dosing marks at 0.5 lb, then in 1 lb increments (ranging from 1 to 14 lbs), designed to deliver the daily maintenance dose of 0.05 mg/lb (0.1 mg/kg).

  For dogs less than 1 lb (0.45 kg), Meloxidyl can be given using the 0.5 mark on the small dosing syringe.

  For dogs between 1 - 14 lbs, Meloxidyl can be given using the marks on the small dosing syringe, beginning at 1 lb and ending at 14 lbs. When using the small dosing syringe, the dog’s weight should be rounded down to the nearest 1 lb increment. Replace and tighten cap after use.

  Dogs 15 lbs (6.8 kg) and over

  Shake well before use, then remove cap. Meloxidyl may be either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing.

  For dogs 15 lbs or greater, use the large dosing syringe (green print) provided in the package (see dosing procedure below). The large dosing syringe fits on to the bottle and has dosing marks in 5 lb increments (ranging from 5 to 140 lbs), designed to deliver the daily maintenance dose of 0.05 mg/lb (0.1 mg/kg). When using the large syringe, the dog’s weight should be rounded down to the nearest 5 lb increment. Replace and tighten cap after use.

  Meloxidyl Oral Suspension is packaged with 2 sizes of dosing syringes. The small syringe (blue print) is calibrated for use in dogs under 15 lbs. The large syringe (green print) is calibrated for use in dogs 15 lbs or greater. Only administer Meloxidyl with the provided syringes. The container should never be used as a dropper bottle for administration of Meloxidyl.

  Dogs under 15 lbs (6.8 kg)

  Shake well before use, then remove cap. Meloxidyl Oral Suspension can be given either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, only use the small dosing syringe. The large syringe provided cannot be used to measure doses for dogs weighing less than 15 lbs (6.8 kg). For dogs less than 15 lbs, use the small dosing syringe (blue print) provided in the package (see dosing procedure below). The small dosing syringe fits onto the bottle and has dosing marks at 0.5 lb, then in 1 lb increments (ranging from 1 to 14 lbs), designed to deliver the daily maintenance dose of 0.05 mg/lb (0.1 mg/kg).

  For dogs less than 1 lb (0.45 kg), Meloxidyl can be given using the 0.5 mark on the small dosing syringe.

  For dogs between 1 - 14 lbs, Meloxidyl can be given using the marks on the small dosing syringe, beginning at 1 lb and ending at 14 lbs. When using the small dosing syringe, the dog’s weight should be rounded down to the nearest 1 lb increment. Replace and tighten cap after use.

  Dogs 15 lbs (6.8 kg) and over

  Shake well before use, then remove cap. Meloxidyl may be either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing.

  For dogs 15 lbs or greater, use the large dosing syringe (green print) provided in the package (see dosing procedure below). The large dosing syringe fits on to the bottle and has dosing marks in 5 lb increments (ranging from 5 to 140 lbs), designed to deliver the daily maintenance dose of 0.05 mg/lb (0.1 mg/kg). When using the large syringe, the dog’s weight should be rounded down to the nearest 5 lb increment. Replace and tighten cap after use.

  What To Tell/Ask Your Veterinarian Before Giving Meloxidyl

  Talk to your veterinarian about:

  • The signs of OA you have observed (for example limping, stiffness). • The importance of weight control and exercise in the management of OA. • What tests might be done before Meloxidyl is prescribed. • How often your dog may need to be examined by your veterinarian. • The risks and benefits of using Meloxidyl.

  Tell your veterinarian if your dog has ever had the following medical problems:

  • Experienced side effects from Meloxidyl or other NSAIDs, such as aspirin; • Digestive upset (vomiting and/or diarrhea); • Liver disease; • Kidney disease.

  Tell your veterinarian about:

  • Any other medical problems or allergies that your dog has now or has had. • All medicines that you are giving your dog or plan to give your dog, including those you can get without a prescription.

  Tell your veterinarian if your dog is:

  • Pregnant, nursing or if you plan to breed your dog.

  What Are The Possible Side Effects That May Occur In My Dog During Meloxidyl Therapy?

  Meloxidyl, like other drugs, may cause some side effects. Serious but rare side effects have been reported in dogs taking NSAIDs. Serious side effects can occur with or without warning and in rare situations result in death.

  The most common NSAID-related side effects generally involve stomach and liver or kidney problems. Look for the following side effects that can indicate your dog may be having a problem with Meloxidyl or may have another medical problem:

  • Decrease or increase in appetite; • Vomiting; • Change in bowel movement (such as diarrhea, or black, tarry or bloody stools); • Change in behavior (such as decreased or increased activity level, incoordination, seizure or aggression); • Yellowing of gums, skin, or whites of the eyes (jaundice); • Change in drinking habits (frequency, amount consumed); • Change in urination habits (frequency, color, or smell); • Change in skin (redness, scabs, or scratching).

  It is important to stop therapy and contact your veterinarian immediately if you think your dog has a medical problem or side effect from Meloxidyl. If you have additional questions about possible side effects, talk to your veterinarian.

  Can Meloxidyl Be Given With Other Medicines?

  Meloxidyl should not be given with other NSAIDs (for example aspirin, carprofen, etodolac, deracoxib) or steroids (for example, cortisone, prednisone, dexamethasone, triamcinolone). Tell your veterinarian about all medicines you have given your dog in the past, and any medicines that you are planning to give with Meloxidyl. This should include other medicines that you can get without a prescription. Your veterinarian may want to check that all of your dog’s medicines can be given together.

  What Can I Do In Case My Dog Eats More Than The Prescribed Amount?

  Contact your veterinarian immediately if your dog eats more than the prescribed amount of Meloxidyl.

  What Else Should I Know About Meloxidyl?

  This sheet provides a summary of information about Meloxidyl. If you have any questions or concerns about Meloxidyl or osteoarthritis pain, talk to your veterinarian.

  As with all prescribed medicines, Meloxidyl should only be given to the dog for which it was prescribed. Meloxidyl oral Suspension is for use in dogs only. Do not give Meloxidyl to cats. It should be given to your dog only for the condition for which it was prescribed. It is important to periodically discuss your dog’s response to Meloxidyl at regular checkups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving Meloxidyl.

  For technical assistance or to report suspected adverse reactions, call 1-800-999-0297.

  Meloxidyl is a registered trademark of Ceva Santé Animale, France

  Prod: C531US

  08-B1-v1

  Mfg: 140078

  Revised 08/2013

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