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Date: Monday, June 24, 2024 17:01

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.74
Denagard 200 mg/ml Solution for Injection
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Tiamulin Hydrogen Fumarate
Product:Denagard 200 mg/ml Solution for Injection
Product index: Denagard 200 mg/ml Solution for Injection
Pig - meat: 22 Days
Incorporating:
Qualitative and quantitative composition
Each ml provides tiamulin base equivalent to 200 mg tiamulin hydrogen fumarate.
Tiamulin hydrogen fumarate 200 mg/ml
For full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Solution for injection.
Clear yellow oily solution.
Clinical particulars
Target species
Pigs.
Indications for use, specifying the target species
Swine dysentery: For the treatment of swine dysentery caused by Brachyspira hyodysenteriae and complicated by Bacteroides spp and Fusobacterium spp.
Enzootic pneumonia complex of pigs: For the treatment of enzootic pneumonia complex, caused by M. hyopneumoniae and where the secondary bacteria are sensitive to tiamulin.
Mycoplasmal arthritis: For the treatment of arthritis caused by Mycoplasma hyosynoviae, to reduce lameness and restore growth performance.
Contraindications
Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before and after treatment with Denagard 200 Solution for Injection. Severe growth depression or death may result.
Special warnings for each target species
For intramuscular use only in pigs.
Special precautions for use
i. Special precautions for use in animals
As Denagard 200 Solution for Injection 200 mg/ml is formulated with sesame oil, it is important to ensure that the syringe used is dry. The admixture of oil and water may cause the plunger to stick.
ii. Special precautions for the person administering the veterinary medicinal product to animals
Avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
In case of skin contact with the product, wash immediately with running water in order to minimise absorption through the skin.
In case of eye contact with the product, wash immediately with running water and seek medical advice.
Adverse reactions (frequency and seriousness)
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of this product.
Use during pregnancy, lactation or lay
Can be use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Animals should not receive products containing monensin, narasin or salinomycin during or for at least seven days before and after treatment with Denagard 200 Solution for Injection. Severe growth depression or death may result.
Amounts to be administered and administration route
To be administered by intramuscular injection. Swab the rubber septum before removing each dose. Use a dry, sterile, needle and syringe. The maximum volume to be administered at any one intramuscular injection site should not exceed 10 ml. Swine dysentery Treatment: The dose is 1 ml/20 kg bodyweight (equivalent to 10 mg tiamulin hydrogen fumarate/kg body weight) intramuscularly administered as a single treatment to pigs showing clinical signs of the disease.
Follow-up treatment should be provided when necessary with either Denagard 12.5% w/v Concentrate for Oral Solution or Denagard 2% Premix for Medicated Feedingstuff administered according to directions in the drinking water or in the feed, respectively.
Enzootic pneumonia complex of pigs Treatment: The dose is 1.5 ml/20 kg bodyweight (equivalent to 15 mg tiamulin hydrogen fumarate/kg body weight) administered intramuscularly for a period of 3 consecutive days to pigs showing clinical signs of the disease.
Mycoplasmal arthritis Treatment: The dose is 1.5 ml/20 kg bodyweight (equivalent to 15 mg tiamulin hydrogen fumarate/kg body weight) administered intramuscularly for a period of 3 consecutive days to pigs
showing clinical signs of the disease.
Overdose (symptoms, emergency procedures, antidotes) if necessary
Pleuromutilins have a wide margin of safety. Do not exceed the specified dosage.
Withdrawal period(s)
Meat and offal: 22 days
Pharmacological particulars
Pharmacotherapeutic group: Antibacterial for systemic use.
ATCVet Code: QJ01XQ01
Pharmacodynamic properties
The following organisms show sensitivity to tiamulin in vitro:
Brachyspira: Brachyspira hyodysenteriae, Brachyspira pilosicoli
Mycoplasmas: Mycoplasma hyopneumoniae, M. hyorhinis, M. hyosynoviae, M. dispar,Ureaplasma spp,Gram-positive: Staphylococcus spp., Streptococcus spp., Corynebacterium pyogenes.
Gram-negative: Pasteurella spp., Klebsiella pneumoniae, Actinobacillus (Haemophilus)spp., Fusobacterium necrophorum, Bacteroides spp., Campylobacter coli,Lawsonia intracellularis.
Pharmacokinetic particulars
Following oral administration the active ingredient, tiamulin, is rapidly absorbed, peak serum levels being achieved within two hours. Tiamulin distributes widely in tissues, including the colon. High tiamulin concentrations are found in the lung of up to approximately 20 times the value found in the serum. Two hours post-injection, tiamulin lung levels of 14.5 – 16.7 mg/g have been found.
Pharmaceutical particulars
List of excipients
Ethanol
Sesame oil
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Shelf life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25°C. Do not refrigerate.
This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Nature and composition of immediate packaging
100 ml Type III glass vial, closed with a rubber stopper with aluminium seal.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4053
Significant changes
Date of the first authorisation or date of renewal
31 July 1985
Date of revision of the text
11 March 2022
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Denagard 200 mg/ml Solution for Injection 100ml
GTIN:05037694009601