TYLOKEL 20 Solution for Injection Veterinary 
 
1.    Name of the Veterinary Medicinal Product, Its Shape, and Strength:
TYLOKEL 20 Solution for Injection Veterinary 
 
2.    Active Substance
Each ml of the injectable solution contains 200 mg of Tylosin
Tylosin Tartrate 200,000 IU/ml (equivalent to 200mg/ml Tylosin base)
Excipients: Each ml of this medicinal product contains 40 mg of Benzyl Alcohol.
See detailed information in Section 13, Additional Information.
 
3.  What the Medicinal Product Is Intended for 
Tylokel 20 is an antibiotic- active against Gram-positive bacteria, certain spirochhetes, vibrio's and particularly against Mycoplasma or PPLO's and is indicated for metritis, foul-in-the-foot, mastitis and several respiratory infections in cattle.
Therapeutic group: Macrolide antibiotics.
 
4.  Contraindications:
Use of this preparation is prohibited in animals with past allergic reactions to Tylosin or to the active substances.
Do not use in poultry or turkeys as intramuscular administration of this medicinal product may kill these animals.
Do not use in horses as the injection of Tylosin may kill horses.
 
5. Side Effects: 
•    Rare effects of an allergic reaction to the medicinal product have been observed.
•    The development of lesions at the injection site has been observed up to 21 days after the injection.
•    In very rare cases, the following effects have been reported:
o    Swelling and inflammation at the injection site
o    Vaginal swelling
o    Anaphylactic shock or death
•    Side effects can be reported to the Ministry of Health by clicking on the link “Reporting Side Effects and Drug-related Adverse Events” on the homepage of the Ministry of Health website (https://sideeffects.health.gov.il), which redirects to an online form for reporting side effects.
 
6. Target Species
Cattle
 
7. Administration Route and Dose
Recommended dose: 2.5 - 10 mg/kg for 1 - 3 days. Do not inject more than 15 ml at each injection site.
To ensure a correct dose, bodyweight should be determined as accurately as possible to avoid underdosing. 
 
8. Way of Using the Preparation
Deep intramuscular injection; slow intravenous infusion
 
9. Washout period - Cattle
Meat - 29 days
Milk - 6 days 
 
10. Warnings
Special Warnings Regarding the Use of the Medicinal Product for the Treatment of the Target Species
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. 
If this is not possible, therapy should be based on local epidemiological information.
The selective development of antimicrobial resistance may occur with some pathogenic microorganisms.
Incorrect use of the preparation may increase the incidence of bacterial resistance to Tylosin. Cross resistance may reduce the efficacy of treatment with other macrolide antibiotics.
Testing of the efficacy of this product has not proven it is effective in the treatment of udder infection caused by mycoplasma spp.

Special Warnings Regarding the Safety of the Person Administering the Preparation
Be careful not to self-administer the medicinal product; in such a case, seek immediate medical treatment and bring with you the package or the insert of this preparation.
Avoid direct contact between the preparation and the skin.
Wash immediately with water and soap in case of contact with the skin.
Wash immediately with water in case of contact with the eyes.
Wash your hands after use.
In case of known sensitivity to Tylosin, avoid contact with the medicinal product.
Severe allergic reactions to the product may occur. Cases of irritated skin and allergies have been reported in humans following exposure to the medicinal product.
Should signs of exposure appear, such as a skin rash, seek medical treatment immediately and bring with you the package or the insert of the medicinal product.  Swelling of the face, lips, or eyes or breathing difficulties require urgent medical care. 
 
Pregnancy and lactation in the treated specie
The safety of using this product during pregnancy or during the lactation period has not been scientifically established. Use the product only after a veterinarian completes a risk-benefit assessment. 
Drug Interactions and Other Forms of Interaction
Unknown
Overdose
No side effects have been observed following the daily injection of 30 mg/kg over a period of 5 days.
Incompatibility
Do not mix the medicinal product with other medicinal products within the same syringe to prevent incompatibility.
 
11. Storage Instructions 
Prevent poisoning! This medicinal product and any other medicinal product should be kept in a closed place out of the reach and sight of children and/or infants and by doing this you will prevent poisoning.
Do not use this medicinal product after the expiration date that appears on the package. The expiration date refers to the last day of that month.
Store at a temperature between 2°C and 8°C.
Shelf life after opening for the first time: 28 days.
 
12. Instructions Pertaining to the Disposal of the Preparation/Remaining Quantity of the Preparation Once Its Use Is Over
Any remaining quantity of a veterinary preparation or any waste material that results from the use of a veterinary preparation must be disposed of as toxic waste; do not discard in wastewater.
 
13. Additional Information
In addition to the active substances, this medicinal product also contains the following excipients: 
Benzyl Alcohol, Disodium Edetate, Propylene Glycol, Water for Injection