PHARMASIN 250 ML INJECTABLE FOR CATTLE, SHEEP, GOATS AND PIGS

PHARMASIN

INJECTABLE SOLUTION FOR CATTLE, SHEEP, GOATS AND PIGS

PHARMASIN 200 MG/ML

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tylosin 200.000 IU/ml
Excipients:
Benzyl alcohol (E1519) 40 mg/ml For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Injectable solution. Pale yellow to amber liquid.

4. CLINICAL DATA
4.1 Target species
Cattle, sheep, goats and pigs.
4.2 Indications for use, specifying the target species
Infections caused by microorganisms susceptible to tylosin.
Cattle (adult):
– Treatment of respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Streptococcus spp., Staphylococcus spp. either Mycoplasma and interdigital necrobacillosis, ie, whitlow or septic pododermatitis.
Calves:
– Treatment of respiratory infections and necrobacillosis.
Porcine:
– Treatment of enzootic pneumonia, hemorrhagic enteritis, erysipelas and uterine inflammation.
– Treatment of arthritis caused by Mycoplasma y Staphylococcus spp..
Sheep and goats:
– Treatment of respiratory infections, metritis caused by Gram positive microorganisms, mastitis caused by Gram+ microorganisms or Mycoplasma spp..
4.3 Contraindications
Do not use on horses. Intramuscular injection can be fatal in chickens and turkeys.
Do not use in animals with known hypersensitivity to tylosin or other macrolides.
4.4 Special warnings (for each target species)
None.
4.5 Special precautions for use
4.5i) Special precautions for use in animals
Due to the possible variability (temporal, geographical) of the susceptibility of the bacteria to tylosin, the collection of bacteriological samples and the performance of susceptibility tests are recommended. The use of the veterinary medicinal product in a way other than that indicated in the data sheet may increase the prevalence of bacteria resistant to tylosin and decrease the efficacy of treatment with other macrolide antibiotics due to possible cross-resistance. It is advisable to use different sites for each injection when they have to be administered repeatedly.

4.5ii) Specific precautions to be taken by the person administering the drug to animals

Precautions should be taken to avoid possible self-injection. In case of accidental self-injection, consult a doctor immediately. In case of accidental contact with the skin, wash the affected area thoroughly with soap.
and water. In case of accidental contact with the eyes, rinse them with plenty of clean water. Wash hands after use.
Tylosin may cause irritation. Macrolides such as tylosin may also cause hypersensitivity (allergy) after injection, inhalation, ingestion, or contact with the skin or eyes. Hypersensitivity to tylosin may lead to a cross reaction with other macrolides and vice versa. Allergic reactions to these substances can be severe and therefore direct contact should be avoided. Do not use the veterinary medicinal product if you are allergic to any of its components.
If you develop symptoms after exposure to the veterinary medicinal product, such as a rash, see your doctor and show him or her this warning. Symptoms such as swelling of the face, lips and eyes or difficulty breathing are considered serious and require urgent medical attention.

4.6 Adverse reactions (frequency and seriousness)
Spotting may appear at the injection site and persist for up to 21 days after administration.
Possible adverse reactions attributed to the veterinary medicinal product after use as recommended and the frequency of these are: swelling/inflammation at the injection site has been observed in very rare cases, vaginal swelling in cattle, edema of the rectal mucosa, protuberance partial anal (“rosebud-shaped”), erythema and pruritus in swine. Anaphylactic shock and death.

4.7 Use during pregnancy, lactation or lay
Laboratory studies in animals have not shown teratogenic, foetotoxic or maternotoxic effects. No studies have been carried out in the target species. Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Intramuscular or slow intravenous injection (only in cattle)
Meat:
5-10 mg tylosin/kg body weight per day for 3 days (2,5-5 ml of solution for injection per 100 kg body weight). The maximum volume per injection site should not exceed 15 ml.
Sheep and goats:
10 mg tylosin/kg body weight per day for 3 days (5 ml of solution for injection per 100 kg body weight)
Porcine:
5-10 mg tylosin/kg body weight per day for 3 days (2,5-5 ml of solution for injection per 100 kg body weight)
Plugs should not be pierced more than 15 times. To avoid excessive puncturing of the plug, a suitable multi-dose device should be used. In order to ensure administration of the correct dose, body weight should be determined as accurately as possible to avoid underdosing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In pigs and calves, an intramuscular injection of 30 mg/kg per day for 5 consecutive days produced no adverse effects.
4.11 Waiting time(s)
Bovine:
Meat: 28 days.
Milk: 108 hours
Sheep and goats:
Meat: 42 days.
Milk: 108 hours
Porcine:
Meat: 14 days.
5. PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES
ATCvet code:
Pharmacotherapeutic group: Antibacterial for systemic use, macrolides, tylosin, ATCvet code: QJ01FA90.
5.1 Pharmacodynamic properties
Tylosin is a macrolide antibiotic with a pKa of 7,1. Tylosin is structurally similar to erythromycin. It is produced by the Streptomyces fradiae. Tylosin has a low solubility in water. Tylosin exerts its antibiotic activity through a mechanism similar to that of other macrolides, i.e., binding to the 50 S fraction of ribosomes, resulting in a
inhibition of protein synthesis. Tylosin has mainly bacteriostatic activity. Tylosin has an antibiotic effect against Gram-positive cocci (staphylococci, streptococci), Gram-positive bacilli (Arcanobacterium spp., Clostridium spp., erysipelothrix, Bacillus anthracis, Actinomyces), some Gram negative bacilli (haemophilus spp., pasteurella spp., mannheimia spp.) and Mycoplasma. Tylosin's antibiotic spectrum covers most of the microorganisms responsible for primary infections in young cattle.
5.2 Pharmacokinetic data
Absorption:
Following intramuscular injection, the tylosin concentration reaches its maximum level 3 to 4 hours after administration.
Distribution:
The maximum concentration in milk of cows and sows is 3 to 6 times higher than the concentration in blood approximately 6 hours after injection. In the lungs of cattle and pigs, peak tylosin concentrations 7 to 8 times higher than peak serum concentrations were found 6 to 24 hours after intramuscular injection. In cattle (in heat or not) the mean residence time in uterine secretions of tylosin injected intravenously at a dose of 10 mg/kg was about 6 to 7 times longer than that measured in serum. This demonstrates that in uterine secretions, a single injection of tylosin at a dose of 10 mg/kg over 24 hours can generate concentrations exceeding the MIC90 of tylosin for Arcanobacterium pyogenes, one of the frequently isolated pathogens when metritis is diagnosed in cows.

Elimination: Tylosin is eliminated in its unchanged form in the bile and urine.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Benzyl alcohol (E1519)
Propylene glycol
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Protect from light. Store in its original container. Do not store at temperatures above 25°C. Do not freeze.
6.5 Nature and composition of immediate packaging
The veterinary medicinal product is supplied in 50 ml, 100 ml or 250 ml type II colorless glass vials with a bromobutyl stopper and aluminum cap in a cardboard box. One vial per box. Not all formats may be marketed.
6.6 Special precautions for disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance with local regulations.
7.1 MARKETING AUTHORIZATION HOLDER AND MANUFACTURER
Huvepharma NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
8. MARKETING AUTHORIZATION NUMBER(S)
2783 ESP

9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 17th 2013
10. DATE OF REVISION OF THE TEXT
24th October 2013
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use-Medication subject to veterinary prescription. Exclusive administration by the veterinarian.

PHARMASIN

DATA SHEET