The world s first and only pour-on anti-inflammatory for cattle FAST PAIN RELIEF

Transcription

1 The world s first and only pour-on anti-inflammatory for cattle FAST PAIN RELIEF NOTHING IS SIMPLER THAN POUR-ON RELIEF FOR PAIN, FEVER AND ACUTE INFLAMMATION easy to dose easy to apply easy on animals

2 NOW TREAT PAIN, FEVER & ACUTE INFLAMMATION Transdermal indications: For the reduction of fever and alleviation of clinical signs of inflammation (pain, swelling, firmness, milk drop, improved milk character) associated with mastitis. For the reduction of fever and alleviation of clinical signs of inflammation associated with bovine respiratory disease (BRD), pneumonia, endotoxaemia and acute inflammatory conditions. A PROVEN SOLUTION MEETS AN EASY APPLICATION Transdermal (TD) is now making its mark as the world s first non-steroidal, anti-inflammatory cattle product available with a pour-on route of administration. TD (flunixin meglumine) combines proven efficacy with a novel delivery method that simplifies administration. This convenient route of administration contributes to improved cattle well-being and fits the requirements of best management practices. Easy to dose The pre-calibrated packaging helps ensure the right dose is given every time. The unique bottle design allows for proper topical application along the animal s back. The red-coloured solution makes it simple to accurately and quickly measure the dose volume for each animal. Easy to apply Make quick work of treating animals with this simple pour-on. Its needle-free and efficient administration means there is no need for head gates, restraints or additional labour associated with injectable administration. Because syringes and needles are no longer needed, farmers also save time administering the product and save money on supplies. The result is a decreased cost per treatment due to less time spent treating animals. Easy on animals Transdermal application requires less handling, resulting in less stress on the animals. Managing fever and inflammation is important to a sick animal s recovery, and TD is specially formulated to rapidly absorb into the bloodstream. Reducing stress through easy application and providing quick relief leads to inherent advantages. Plus, with needle-free, transdermal administration, there is no risk of injection site lesions. Reduces fever quickly TD goes to work quickly. The anti-pyretic effect has been demonstrated as early as four hours after treatment administration. 1 The result is the control of fever regulated by the central nervous system. The active ingredient, flunixin, inhibits the body s production of prostaglandins and other chemical mediators, resulting in anti-inflammatory effects. 2

3 How it works TD uses a bottle that s uniquely designed to apply the right dose topically along the animal s back. The innovative technology of TD uses penetration enhancers, such as levomenthol, to optimize flunixin absorption through the skin and into the bloodstream. New approach improves animal well-being Using pour-on application to reduce pain, fever and acute inflammation in cattle is in alignment with industry efforts to continuously improve animal care and animal welfare. It s another example of MSD Animal Health s commitment to The Science of Healthier Animals by bringing solutions that contribute to the optimal health and well-being of animals. Dosing Instructions DOSING AND ADMINISTRATION MADE EASY Transdermal is labelled to be administered once at a dose of 3.33 mg/kg (1 ml/15 kg) on dry skin. It is available in three sizes: 100 ml, 250 ml and 1,000 ml. Animals should be protected from rain exposure for two hours after treatment. Other NSAIDs should not be administered concurrently or within 24 hours of each other. There is a nil milk withhold and 21 day meat withhold. Product can be used during pregnancy except within 48 hours of calving. Peri-parturient use of NSAIDs can delay parturition and increase the risk of retained placenta. Four Simple Steps for this New Route of Administration Step 1: Determine the animal s body weight and select the correct dose using the bottle s dosing chamber, which is calibrated in kilograms of body weight. Step 3: Hold the bottle upright and at eye level while slowly and gently squeezing the bottle to fill the dosing chamber to the selected mark. Step 2: On first use, remove the cap and peelable seal from the dosing chamber. Do not remove the cap from the storage bottle. Step 4: Pour the measured volume on the midline of the animal s back extending from the withers to tail head. Localized application to smaller areas should be avoided. 3

4 PROOF FROM THE FIELD SAFE AND EFFICACIOUS AID TO RECOVERY FROM INFLAMMATORY CONDITIONS Results from the field show that TD can be an important part of treatment programs. It safely and efficaciously reduces fever and improves respiratory and depression scores associated with BRD. Plus, it offers that same safe and effective relief for fever associated with acute mastitis. This product combines convenience with a novel delivery system that simplifies administration and brings quick relief. Trials summary for BRD relief: Successfully and safely controlled fever as indicated by the significant decrease in rectal temperature Improved respiratory and depression scores Trials summary for mastitis relief: Successfully and safely controlled fever as indicated by the significant decrease in rectal temperature Demonstrated to have positive effects on clinical signs of inflammation including: o Udder pain o Udder swelling o Udder inflammation CONTROL FEVER TD was determined to be safe and efficacious in controlling fever associated with BRD. Trial setup Field studies were conducted at four U.S. locations involving 251 animals diagnosed with BRD. 2 At enrollment, rectal temperatures ranged from 40.3 to 42.1 C. Animals received either 3.33 mg/kg of TD or a placebo. Six hours after treatment, rectal temperature was measured and treatment sites were observed for abnormalities. An animal was considered a treatment success if rectal temperature was reduced by 1.1 C. Results Treatment success was 58.3 percent for animals receiving TD compared with 6.1 percent for the placebo group. Treatment sites were considered normal in animals treated with TD. 4

5 FIELD PROVEN TO ACT FAST TD was proven in the field to act fast by safely and effectively improving the overall health of animals affected by BRD. Trial setup A field study in three European countries involving seven farms and more than 200 animals was undertaken to evaluate the effectiveness and safety of TD. 3 Animals exhibiting severe signs of BRD were randomly assigned to one of two treatments on day zero: 1) TD administered at a rate of 3.33 mg/kg or 2) (1.4 mg/kg; 1 ml/35 kg), the positive control product, by subcutaneous injection. All animals were treated with cefquinome (Cobactan LA 7.5%; 1 ml/30 kg; 2.5 mg/kg) administered by subcutaneous injection on day zero and day two. Animals were observed for clinical signs of disease for six hours following treatment initiation and daily thereafter for five days. Results Greater decrease in rectal temperature Animals receiving TD had a greater decrease in rectal temperature (-1.30 C) six hours after treatment initiation (P < 0.001) compared to the positive control group that received (-0.96 C, Figure 1.) Temperature ( C) Rectal temperature Transdermal (P<0.001) Figure 1: Change of mean rectal temperature ( C) six hours post-treatment. 5

6 PROOF FROM THE FIELD Improved respiratory and depression scores Six hours post-administration, improvement in respiratory score (Figure 2) and depression score (Figure 3) was greater in animals treated with TD compared to those treated with. TD acted quickly and efficaciously improved respiratory and depression scores associated with BRD. Depression score Respiratory score Normal Mild Moderate Severe Each of the following signs counted for one point to establish the score: Polypnoea ( 40 breaths/minute) Dyspnoea (abnormal respiration) Cough Mucopurulent nasal discharge 100% 90% Proportion of animals 100% Proportion of animals 90% 80% 70% 60% 50% 60% 50% 40% 30% 10% 0% 30% 20% TD Enrollment (Time 0 hours) TD 6 hours post-treatment (Time 6 hours) Figure 2: Effect of treatment on mean respiratory character score six hours after dosing. 6 70% 20% 40% 10% 0% 80% TD Enrollment (Time 0 hours) TD 6 hours post-treatment (Time 6 hours) Figure 3: E ffect of treatment on mean depression score six hours after dosing. Depression (general condition) was evident by clinical signs, including: lethargy, abnormal posture (head carried low and ears dropped), weakness and recumbancy, isolation, and poor response to stimulation.

7 FIELD PROVEN TO QUICKLY ALLEVIATE SYMPTOMS Field study results show that TD is a safe and effective therapy to reduce pyrexia and clinical signs of inflammation associated with bovine mastitis. Trial setup A field study in three European countries involving 133 cows from 48 dairy farms was conducted to evaluate the efficacy of TD as adjunct therapy in the treatment of clinical mastitis. 4 Cows showing severe clinical signs of mastitis disease were randomly assigned to receive either: TD according to label, or red dye saline, the negative control product. After six hours, all animals received the intramammary and systemic antibiotics Cobactan LC and Cobactan 2.5%. Rectal temperature, udder inflammation (clinical signs of pain, swelling and firmness) and general attitude (signs of loss of appetite, decreased rumination, lethargy and abnormal posture) were observed, measured or scored (normal = 0, mild = 1, moderate = 2 and severe = 3) on day 0 (enrollment), 6 ± 1 hour post-treatment, day 1, day 2, day 3 and day 6 post-treatment by the investigator, who was blinded to treatment. Results Faster alleviation of udder inflammation Animals receiving TD showed a quicker reduction in udder inflammation in the first 24 hours than those receiving only Cobactan. Faster udder pain alleviation Udder pain was reduced faster within six hours of being treated with TD than with Cobactan only. Udder pain was significantly lower for up to 48 hours in animals treated with Transdermal than in animals treated with only Cobactan. Reduced udder swelling Udder swelling was reduced and alleviated faster in animals treated with TD than in those treated with Cobactan only. Udder inflammation score Udder pain score Udder swelling score Cobactan only Cobactan + Transdermal Cobactan only Cobactan + Transdermal Cobactan only Cobactan + Transdermal Mean inflammation score * * * * Day 0 6 hours Day 1 Day 2 Day 3 Day 0 6 hours Day 1 Day 2 Day 3 Day 0 6 hours Day 1 Day 2 Day 3 Mean pain score Mean swelling score (P < 0.01) * (P 0.06) (P < 0.01) * (P 0.06) (P < 0.01) * (P 0.17) Figure 4: Progress of udder inflammation score from day 0 (enrollment) until day 3 post-treatment Figure 5: Progress of udder pain score from day 0 (enrollment) until day 3 post-treatment Cobactan = Cobactan LC and Cobactan 2.5% Figure 6: Progress of udder swelling score from day 0 (enrollment) until day 3 post-treatment 7

8 CONVENIENT TRANSDERMAL DOSING OFFERS QUICK RELIEF FINADYNE Transdermal the world s first pour-on, non-steroidal, anti-inflammatory cattle product uniquely and effectively delivers easy and quick relief of pain, fever and acute inflammation to cattle. EASY TO DOSE: Pre-calibrated packaging ensures the right dose is given every time Unique bottle makes it easy to apply along the animal s back Red-coloured solution makes it simple to measure and identify EASY TO APPLY: Needle-free and efficient administration means no need for head gates, restraints or additional labour No need for syringes or needles: save administration time and save money on supplies Convenient pour-on makes quick work of treating animals Decreased cost per treatment due to less time spent treating animals EASY ON ANIMALS: Less handling results in less stress on animals Specially formulated to rapidly absorb into bloodstream, providing quick relief No risk of injection site lesions Available in 100ml, 250ml, 1000ml pack sizes Dosage: 1ml/15kg Nil milk withhold. 21 day meat withhold. References: 1. MSD Animal Health. Data on File 2. Meadows C, Brianceau P, Peterson MA and Torres S (2014) Clinical efficacy of a novel flunixin transdermal formulation for the control of pyrexia associated with naturally occurring bovine respiratory disease: a multicenter field trial. Proceedings of the XXVIII World Buiatrics Congress, Cairns, Australia. Oral Communications and Poster Abstracts, pp Thiry J, González-Martín JV, Chenneveau P, Van Huffel B, Daugschies A, Brianceau P and de Haas V (2015) Effectiveness and safety of a novel flunixin meglumine transdermal pour-on solution in the treatment of bovine respiratory disease. J J Vet Sci Res. 1(3): Thiry J, Milon-Harnois G, Chiquet M, Daluzeau L, Borchert-Stuhlträger M, Sander B, Thomas E, Boeckh A, de Haas V, Brianceau P (2016) Effectiveness and safety of a novel flunixin meglumine transdermal pour-on solution in the treatment of bovine mastitis. Proceedings of the World Buiatrics Congress, Dublin, Ireland. Oral Communications and Poster Abstracts AVAILABLE ONLY UNDER VETERINARY AUTHORISATION. ACVM No: A11281, A8163 and A8116. Registered trademark. Schering-Plough Animal Health Ltd. Phone: NZ/FDTD/1216/0008