
Protoclear

Spiradipate
(water soluble granules)
Composition :
Each 1gm contains:
Tiamulin Hydrogen Fumarate 450 mg
(Equivalent to Tiamulin base 364.2 mg)
Properties:
Tiamulin is usually a bacteriostatic antibiotic, but can be bactericidal in very high concentrations against susceptible organisms. The drug acts by binding to the 50S ribosomal subunit, thereby inhibiting bacterial protein synthesis.
Tiamulin has good activity against many Gram-positive Cocci, including most Staphylococci and Streptococci (not group D streps).
It also has good activity against Mycoplasma and Spirochetes. With the exception of Haemophilus spp. and some E. coli and Klebsiella strains, the drug’s activity is quite poor against gram-negative organisms.
Indications:
For the treatment of:
A-Pigs:
-Swine dysentery caused by tiamulin hydrogen fumarate-susceptible Brachyspira hyodysenteriae.
– Enzootic pneumonia caused by tiamulin hydrogen fumarate-susceptible Mycoplasma hyopneumoniae.
B-Non-laying chickens:
-Chronic respiratory disease caused by Mycoplasma gallisptecum.
Target Species:
Pigs& Non-laying chickens.
Route of Administration:
Taken orally via drinking water.
Dose for whole product:
A-Pigs:
-Swine dysentery :0.88 gm (1gm) of product/45 kgm.b.wt in drinking water daily for 5 days.
-Enzootic pneumonia : 1.5-2 gm of product/ 45 kgm.b.wt in drinking water daily for 5 days.
B-Non-laying chicken:
– Chronic respiratory disease: 27.78– 55.56 gm of product/ 1oook.g b.wt in drinking water daily for 3:5 days. (0.28 gm -0,56 gm of product/liter in drinking water)
Warnings and precautions:
- The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water, animals should be treated parent rally.
- Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
- Strategic treatment should be limited to animals where tiamulin hydrogen fumarate susceptible agents have been isolated in the herd.
- Tiamulin hydrogen fumarate may lessen the antibacterial activity of β-lactam antibiotics whose action is dependent on bacterial growth.
- Do not mix with other medicated veterinary products.
Contra-indications
- Do not use in animals with known hypersensitivity to the active ingredient or to any excipient.
- Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least 7 days before or after treatment with Respmutin.
- Tiamulin hydrogen fumarate is known to produce clinically important – often lethal – interactions with antibiotics belonging to the ionophores. Therefore, pigs should not receive products containing monensin, narasin, salinomycin during or at least 7 days before and after treatment with the product.”
- Do not use in chickens producing eggs for human consumption.
Adverse effects:
On rare occasions, hypersensitivity to tiamulin hydrogen fumarate following oral administration is reported in terms of increased salivation, mild oedema, acute dermatitis with cutaneous erythema and intense pruritus. The adverse reactions are often mild and transient but on very rare occasions may be serious and can lead to apathy or death.
Withdrawal periods:
A-Pigs:
Meat and offal: 5 days
B-Non-laying chicken:
Meat: 5 days
Storage condition:
Store at temperature not exceeding 30◦ C in dry place and used immediately after opening and used within 24 hours after reconstitution when stored at temperature not exceeding 30◦ C
Packaging:
White ( HDPE) plastic jars Containing ( LDPE ) sachet of 20,25,30,50,75,100,150,200,250,300,500 and 1000 gm W.S.G. with white ( HDPE) plastic cap with an outer label without insert