Composition:

Each 1.1 gm powder contains:
Tylosin 1 gm (equivalent to 1.1 g Tylosin tartrate)

Properties:

Tylosin is a macrolide antibiotic produced by a strain of Streptomyces fradiae. It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms .The tylosin spectrum of activity includes Gram-positive bacteria including Clostridium perfringens and some Gram-negative strains such as Pasteurella as well as Mycoplasma spp.

Indications:

It is used for treatment of:
• Turkeys for meat production : Infectious sinusitis caused by Mycoplasma gallisepticum.
• Pre-ruminating calves: Pneumonia caused by Mycoplasmata spp. and Pasteurella multocida.
• Laying hens : – Chronic respiratory diseases (CRD) caused by Mycoplasma gallisepticum and
Mycoplasma synoviae .
– Necrotic enteritis caused by Clostridium perfringens.
•Pigs : – Enzootic pneumonia caused by Mycoplasma hyopneumoniae and Mycoplasma hyorhinis .
– Porcine Intestinal Adenomatosis (Ileitis) caused by Lawsonia intracellularis.

Target Species:

Pre-ruminating calves, Pigs , Turkeys for meat production and Laying hens.

Dosage & route of administration:

Route of administration:
Pigs, Turkeys for meat production and laying hens: Via drinking water.
Pre ruminating Calves: the veterinary medical product can also be administrated via milk or milk replacer.
For whole product:
• Turkeys for meat production: In case of Infectious sinusitis disease 0.83 – 1.1 gm product /1L in drinking water daily 3 – 5 days.
• Pre-ruminating calves: In case of Pneumonia 0.55 –1.1 gm product /50kg. twice daily for 7 – 14 days.
• Laying hens : In case of (CRD): 0.83 — 1.1 gm product /1L in drinking water daily for 3 – 5 days.
In case of Necrotic enteritis: 0.22 gm product /1L in drinking water daily for 3 days.
• Pigs: In case of Enzootic pneumonia : 1.1gm product /50 kg in drinking water daily for 10 days
In case of ileitis: 0.28 — 0.55 gm product /50 kg in drinking water daily for 7 dayss.

Warnings:

• Due to likely variability (time, geographical) in susceptibility of bacteria to tylosin, bacteriological sampling and susceptibility testing are recommended.
• Under-dosing and/or treating for an insufficient length of time are considered to promote the development of resistance in bacteria and should be avoided.

Precuations:

Special precautions for use in animals:
• Use of this 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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.
• Whenever possible the product should only be used on the basis of susceptibility testing.
• Use of the product deviating from the instructions given in the leaflet may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolides, lincosamides and streptogramin B due to potential of cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
• Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye.
• Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
• To avoid exposure during preparation of the medicated drinking water, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator
• Wash hands after use.
• In the event of accidental skin contact, wash thoroughly with soap and water.
• In case of accidental eye contact, flush the eyes with plenty of clean, running water.
• Do not handle the product if you are allergic to ingredients in the product.
• If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning.
• Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Use during pregnancy, lactation or lay:
• No adverse effects to tylosin have been seen in fertility, multigeneration or teratology studies.

Contra-indication:

• Do not leave or dispose of water containing tylosin tartrate where it may be accessible to either animal not under treatment or wildlife.
• Do not use in animals with known hypersensitivity to tylosin or other macrolides.
Drug – drug Interaction:
• Lincosamides and aminoglycoside antibiotics antagonise the activity of tylosin.

Side Effects:

In very rare cases, the following adverse reactions have been observed in pigs administered tylosin atthe recommended dose:
– Oedema of the rectal mucosa, partial anal protrusion (rosebudding), erythema and pruritis in pigs
-Red and irritated vagina.
-Aggression.
No specific adverse reactions relating to cattle, Laying hens or turkeys for meat production have been identified.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
• There is no evidence of tylosin toxicity in rats, at dose rates of up to 1000 mg/kg.
• There is no evidence of tylosin toxicity in Laying hens , Turkeys for meat production, Pigs or Calves administered product at up to three times the recommended dose.

Withdrawal Period:

• Pre-ruminating calves (meat and offal): 12 days
• Pigs (meat and offal): 1 day
• Turkeys for meat production (meat and offal): 2 days.
• Laying hens (meat and offal): 1 day
• Laying hens (eggs): Zero days

Storage conditions:

• Store at temperature not exceeding 30°c, Used immediately after opening and reconstitution .

Packagings:

HDPE White opaque plastic jar contains LDPE colorless plastic bag contains 10, 25, 50, 100, 250, 500, 1000, 2000, 5000, 10000 or 25000 g powder tightened with LDPE white opaque plastic seal strip and the jar covered by HDPE white opaque plastic cap with HDPE safety seal with outer label