Composition:

Each 100 gm contains:
Sulphaquinoxaline Sodium          20 g
Amprolium HCl                               20 g
Diaveridine HCl                               2.1 g
Vitamin K3.                                        2 g

Properties:

Noxapromartin is a powder for oral solution containing Sulfaquinoxaline sodium, Amprolium Hydrochloride, Diaveridine Hydrochloride & Vitamin K3. Sulfaquinoxaline is a sulfonamide antibacterial. It has a broad spectrum of activity against numerous gram-positive (Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Corynebacterium pyogenes) and gram-negative (Escherichia coli, Salmonella spp., Klebsiella spp., Bordetella bronchiseptica, Pasteurella spp.) bacteria as well as coccidiostats against various Eimeria species of the poultry. Sulfonamides compete with para-aminobenzoic acid (PABA) for enzyme that synthesizes dihydrofolic acid in bacteria. Sulfonamides are folic acid antagonists. Amprolium a structural analogue of thiamine (Vitamin B1). It is an anticoccidial agent that acts as competitive inhibitor of thiamine in the parasite metabolism, and interferes with the metabolism of glucides necessaries for coccidian multiplication and survival. It acts primarily upon the first generation schizont in the celle of intestinal wall, preventing differentiation of metrozoites. Efficacy of amprolium against E. acervulina and E. tenella was good and, in order to increase the spectrum of activity, it was usually mixed with sulphaquinoxaline. Diaveridine Hydrochloride active against the protozoan enzyme dihydrofolate reductase. It has synergistic activity with sulfonamides and often is used in mixtures with these compounds.Vitamin K3 is a synthetic analog of vitamin K. Vitamin K is essential in the formation of several coagulation factors in the liver. Normally its synthesis is made by intestinal bacteria. Its supplementation is recommended in bleeding conditions.

Indications:

• Chicken (broilers, pullets, layers, breeder hens): Coccidiosis caused by Eimeria tenella, necatrix, E. acervulina, E. maxima, and E. brunette.
• Turkeys: Coccidiosis caused by Eimeria meleagrimitis and adenoeides.

Target Species:

Chickens (broilers, pullets, layers, breeder hens), Turkeys.

Dosage & route of administration:

Route of administration: Orally in drinking water.

For active ingredient:

– ( 20 mg amprolium) + (21.06 mg sulfaquinoxaline) + (2.37 mg diaveridine HCl) +

(2.26 mg Vitamin K 3) /kg. b.wt., daily for 5-7 days.

For whole product:

– 1.13 gm of product /1 liter drinking water / daily for 5-7 days.

Warnings:

• As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
• In case of detection a lack of efficacy during treatment, communicate it to the national competent authorities.
• Do not use sulfaquinoxaline in birds producing eggs, or animals producing milk for human consumption.
• It must be stopped in animals producing meat for human consumption 10 days before slaughter.

Precautions:

Special precautions for use in animals: 

• This product should be reserved in case of coccidiosis outbreaks due to non-availability of vaccine, in case of lack of efficacy of vaccine and in vaccinated flocks if a severe coccidial challenge is diagnosed before immunity has fully developed.
• Ensure adequate drinking water intake during treatment.
• Due to its low tolerability, Noxapromartin should only be used if strictly indicated.
• The use of Noxapromartin should be based on an antibiogram.
• Make fresh drinking water daily.

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

• This is an irritant and corrosive product. It could cause airway, eye and skin irritation. Wear impervious gloves and protective glasses when handling the product.
• Avoid inhalation of vapours.
• Avoid contact with the skin and eyes. In the case of contact with skin or eyes, wash the affected area with clean running water immediately and remove any contaminated clothes. If irritation persists, seek medical advice and show the package leaflet to the doctor.
• This product is harmful when ingested. In case of accidental ingestion, rinse the mouth with fresh water, seek medical advice immediately and show the label to the doctor.
• Person with known hypersensitivity to the active substance or to any of excipients should avoid contact with the product.
• Wash hands and exposed skin after use.

Use during pregnancy, lactation or lay:

• Studies in laboratory animals have not produced any evidence of teratogenic effects.
• The safety of Amprolium & Sulphonamides has not been investigated during pregnancy & laying.
• Use only according to the risk/benefit assessment by the responsible veterinarian.
• Do not use on chickens, turkeys whose eggs are intended for human consumption

Contra-indication:

• Severe liver and kidney dysfunction
• Diseases with greatly reduced fluid intake or strong Fluid losses go along damage to the hematopoietic system
• Hypersensitivity to sulfonamides
• Resistance to sulfonamides
• Do not use on chickens, turkeys whose eggs are intended for human consumption.

Interaction with other medicinal products and other forms of interaction:

• Amprolium is a thiamine analogue. Therefore, the efficacy of amprolium may be reduced during a simultaneous administration of products containing vitamin B-complex.
• Sulfonamide solutions are incompatible with calcium- or other polyionic-containing fluids as well as many other preparations.
• Sulfonamides may be displaced from their plasma-protein-binding sites by other acidic drugs with higher binding affinities.
• Antacids tend to inhibit the GI absorption of sulfonamides. Alkalinization of the urine promotes sulfonamide excretion, and urinary acidification increases the risk of crystalluria.

Side Effects:

• The active ingredient of Noxapromartin, sulfaquinoxaline sodium, has a relatively low tolerance in chickens. Even with appropriate intermittent treatment can lead to the formation of a hemorrhagic syndrome with bleeding in the subcutaneous tissue and musculature.
• When administered via the drinking water, the change in taste causes a decrease in water absorption. The associated weight reduction can be avoided by discontinuous administration of Noxapromartin.
• Adverse effects associated with sulfonamides include allergic reactions, type II and type III hypersensitivity, arthropathy, anemia, thrombocytopenia.

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

• In addition to vitamin K or folic acid administration, an increase in renal sulfonamide excretion by alkalinizing agents (e.g., sodium bicarbonate) is indicated.
• Toxicity is observed only at high doses of amprolium. CNS signs are caused by thiamine deficiency, which may be reversed by adding thiamine to the diet.
• If there is evidence of kidney damage: fluid intake and urinary alkalization.

Withdrawal Period:

• Chickens (broilers, pullets, layers, breeder hens) & Turkeys (edible tissue): 10 days
• Do not use on chickens, turkeys whose eggs are intended for human consumption.

Storage conditions:

• Keep in a dry, cool place away from the light.
• Keep out of reach of children.
• Store at temperature not exceeding 30ﹾ

Packagings:

HDPE White opaque plastic jar contains LDPE colorless plastic bag contains 100, 250, 500 and 1000 gm 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