Composition:

Each 1 gm contains:

Spiramycin (as adipate)                  1.5 MIU.

Properties:

Spiramycin is an antibiotic belonging to the macrolide family. Spiramycin acts on bacterial protein synthesis by reversibly binding to the 50S subunit of the ribosome. It binds to the donor site and prevents the translocation necessary for the growth of the peptide chain. This results in an inhibition of protein synthesis and therefore an arrest of the growth of the bacterial culture. It mainly acts on rapidly dividing organisms. Spiramycin has mainly bacteriostatic activity. The spectrum of activity of spiramycin extends to Gram-positive bacteria (Streptococcus, Staphylococcus.),To mycoplasmas (Mycoplasma spp.) and to some Gram-negative bacteria (Mannheimia haemolytica, Pasteurella multocida).

Indications:

It is used for treatment of:
In pigs:
Enzootic Pneumonia cused by Mycoplasma hyopneumoniae.

Target Species:

Pigs.

Dosage & route of administration:

Route of administration: Orally in drinking water.

For active ingredient:

• Pigs: 100,000 IU of spiramycin /kg. b.wt.per day for 3 to 5 days.

For whole product:

• Pigs: 0.66 g of powder /10 kg.b.wt.per day for 3 to 5 consecutive days.

Warnings:

• The amount of medicated drinking water consumed by animals depends on their physiological and clinical condition.

Precuations:

Special precautions for use in animals: 

• This powder for oral solution is intended to be dissolved in drinking water and cannot be used as it is.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: 

• Handle this product taking the recommended precautions to avoid any risk of exposure: wearing a mask, goggles and protective gloves is recommended.
• Avoid breathing dust and avoid contact with skin and eyes. If symptoms such as a rash appear after exposure to the product, seek medical advice and show this warning.
• Swelling of the face, lips or eyelids, or difficulty breathing, are more serious symptoms and require urgent medical attention.
• Avoid handling this product or supplemented food in the event of a history of allergy to spiramycin.

Use during pregnancy, lactation or lay:

• No teratogenic effects have been reported in studies in mice.
• Embryotoxic effects were observed in rabbits but at maternotoxic oral doses.
• The safety of the specialty has not been studied in sows during gestation and lactation. However, its use during lactation and gestation does not appear to pose any particular problem.

Contra-indication:

• Do not use in case of known hypersensitivity to spiramycin or to any other substance of the macrolide group.

Side Effects:

• Toxicity and adverse effects are uncommon for most macrolides (except tilmicosin).

Overdose (symptoms, emergency procedures, antidotes), if necessary:

• Gastrointestinal disturbances and allergic-type reactions may occur in animals with hypersensitivity to macrolides very rarely.

Withdrawal Period:

• Pigs: Meat and offal: 21 days

Storage conditions:

Store at temperature not exceeding 30ﹾc

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