General information

NITOX FORTE

(495) 510-86-04 (499) 168-85-86
Moscow, Open Highway, Building 5, Building 6

(495) 972-74-06 (499) 261-70-83
Moscow, st. 28, Nizhnyaya Krasnoselskaya

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for treatmentcattle

with diseases of bacterial etiology

(development organization: NITA-PHARM LLC, Saratov)

I.General information

1. Trade name of the drug Nitox Forte (Nitox Forte).

International Nonproprietary Name: Oxytetracycline, flunixin meglumine.

2. Dosage form: injection.

1 ml of the drug contains as active ingredients oxytetracycline (in the form of dihydrate) - 300 mg, flunixin meglumine 20.0 mg, as auxiliary substances of magnesium oxide (prolongator) - 20.0 mg, rongalite (sodium formaldehyde sulfoxylate) - 6, 0 mg, N-methyl pyrrolidone - up to 1 ml.

In appearance, the drug is a viscous liquid from green-brown to dark brown.

3. Nitox Forte is packaged in 20, 50, 100 ml in glass vials or 250, 500 in glass bottles sealed with rubber stoppers, reinforced with aluminum caps with first opening control clips. Bottles with a preparation of 20, 50, 100 ml are packed into individual packs of cardboard. Each unit of packaging is supplied with instructions for use.

4. Store the drug in the sealed packaging of the manufacturer, separately from food and feed, in a dry, dark place, at a temperature of 5 ° C to 25 ° C.

The shelf life of the drug under the storage conditions is 24 months from the date of production, after opening the bottle - 28 days.

Do not use Nitoks Forte after the expiration date.

5. Nitoks Forte should be kept out of the reach of children.

6. Unused drug is disposed of in accordance with the requirements of the legislation.

Ii.Pharmacological properties

7. Nitoks Forte belongs to the group of combined antibacterial drugs.

Oxytetracycline, antibiotic, antibiotic and spirochete. The mechanism of action of oxytetracycline is to suppress the synthesis of protein microorganisms. The prolonged (prolonged) effect of the drug is due to the oxytetracycline dihydrate complex with magnesium. For intramuscular administration, oxytetracycline dihydrate is rapidly absorbed from the injection site and reaches maximum concentrations in organs and tissues 30–50 minutes after administration.

Flunixin, which is a part of the drug, is a non-steroidal anti-inflammatory agent, is a non-selective inhibitor of cyclooxygenases (TSOG1 and TSOG2), inhibits the synthesis of prostaglandins E2 - mediators of inflammation, which causes its analgesic, anti-inflammatory, antipyretic and anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, inhibitory, anti-inflammatory, anti-inflammatory, inhibitory, anti-inflammatory, anti-inflammatory, inhibitor of inflammatory mediators. After parenteral administration, flunixin is rapidly absorbed from the injection site and penetrates into most organs and tissues, reaching a maximum concentration in the blood in 5-45 minutes.

Oxytetracycline dihydrate is excreted mainly with urine and bile, in lactating animals it is partially with milk. Flunixin is excreted mainly from the feces and to a lesser extent with urine.

Nitox Forte according to the degree of impact on the body belongs to moderately hazardous substances (3 hazard class according to GOST 12.1.007-76).

Iii.Application procedure

8. Nitoks Forte used cattle for the treatment of infectious diseases caused by pathogens sensitive to oxytetracycline, including respiratory diseases, pleurisy, pneumonia, pasteurellosis, keratoconjunctivitis, hoof rot, purulent arthritis, abscess, peritonitis, wound infections, and post-partum, anaplasmosis , as well as secondary infections in viral diseases.

9. It is prohibited to use Nitox Forte to lactating animals whose milk is used for nutritional purposes, as well as to animals with cardiac, hepatic and renal insufficiency, mycoses, as well as for hypersensitivity to the antibiotics of the tetracycline and / or NSAIDs.

Prohibited intravenous and intra-aortic administration of the drug.

10. The drug is used in animals once deeply intramuscularly at a dose of 1 ml of Nitox Forte per 10 kg of animal weight (30 mg of oxytetracycline dihydrate and 2 mg of flunixin per 1 kg of weight). If necessary, and in the chronic course of the disease, re-introduction of Nitox Forte is allowed after 5 days.

The maximum dose for administration to cattle in one body point is 10 ml. If the volume of the injected solution is more than the specified one, it should be administered to animals in several places.

At temperatures below 5 ° C, the viscosity of the drug increases slightly and its introduction can be difficult. In this case, it is recommended to warm the solution and syringes to room temperature, which will make it easy to draw the drug into the syringe and inject it into animals.

11. In case of overdose of the drug, the animal may experience refusal of the feed, an inflammatory reaction at the injection site, symptoms of nephropathy, gastrointestinal bleeding. In this case, intravenous administration of calcium preparations (calcium chloride, calcium borgluconate), symptomatic therapy is recommended.

12. The specific features of the effect on the first use of the drug and on its cancellation were not revealed.

13 . The drug is intended for single use.

14. When using the drug in accordance with this instruction, side effects and complications, as a rule, are not observed. In some animals, a local inflammatory reaction may appear in the form of erythema and itching, which quickly disappear and do not require treatment.

In case of increased individual sensitivity of the animal to the antibiotics of the tetracycline group and the development of a stable allergic reaction, desensitization therapy is carried out. In case of anaphylactic shock, animals are given adrenaline, corticosteroids, and antihistamines in accordance with the instructions for their use.

15. The drug can not be used simultaneously with estrogen. In connection with a marked decrease in the antibacterial effect of oxytetracycline, the drug is not recommended to be used simultaneously with penicillin and cephalosporin antibiotics. Do not use the drug at the same time or less than 24 hours before or after using another NSAID or corticosteroid due to the increased risk of ulceration in the gastrointestinal tract.

16. Slaughter of animals for meat is allowed not earlier than 35 days after the last injection of the drug. The meat of animals that were involuntarily killed before the expiration of these periods is used to feed carnivores.

Iv.Personal preventive measures

17. When working with Nitoks Forte, you should follow the general rules of personal hygiene and safety precautions provided when working with medicines for animals. During work, it is forbidden to drink, smoke and eat. At the end of the work hands should be washed with warm water and soap.

18. In case of accidental contact of the drug with the skin or mucous membranes of the eyes, they should be washed with plenty of water. People with hypersensitivity to the components of the drug should avoid direct contact with Nitoksom Forte. In the event of an allergic reaction or in case of accidental ingestion of the drug in the human body, you should immediately contact a medical institution (you should have the instructions for use of the drug or a label with you).

19. It is prohibited to use empty packaging from under the medicinal product for domestic purposes, they must be disposed of with household waste.

20. Production organization: NITA-PHARM LLC, 410010, Saratov, ul. them. Osipova V.I., Address of the place of production: 410010, Saratov, ul. them. Osipova V.I., d. 1.

Recommended for registration in the Russian Federation FSBI "VGNKI."

Nitox forte

Name NITOX FORTE Name (lat.) Nitox Forte Composition and release form 1 ml of the medicinal product contains 300 mg of oxytetracycline (in the form of dihydrate) as active substances, 300 mg, flunixin meglumine 20.0 mg, as auxiliary substances of magnesium oxide (prolongator) - 20.0 mg, rongalite (sodium formaldehyde sulfoxylate) - 6.0 mg, N-methyl pyrrolidone - up to 1 ml. In appearance, the drug is a viscous liquid from green-brown to dark brown.
Nitox Forte is packaged in 20, 50, 100 ml in glass bottles or 250, 500 in glass bottles, sealed with rubber stoppers, reinforced with aluminum caps with clip of the first opening. Bottles with a preparation of 20, 50, 100 ml are packed into individual packs of cardboard. Each unit of packaging is supplied with instructions for use. Pharmacological properties Nitoks Forte belongs to the group of combined antibacterial drugs.
Oxytetracycline, antibiotic, antibiotic and spirochete. The mechanism of action of oxytetracycline is to suppress the synthesis of protein microorganisms. The prolonged (prolonged) effect of the drug is due to the oxytetracycline dihydrate complex with magnesium. For intramuscular administration, oxytetracycline dihydrate is rapidly absorbed from the injection site and reaches maximum concentrations in organs and tissues 30–50 minutes after administration.
Flunixin, which is a part of the drug, is a non-steroidal anti-inflammatory agent, is a non-selective inhibitor of cyclooxygenases (TSOG1 and TSOG2), inhibits the synthesis of prostaglandins E2 - mediators of inflammation, which causes its analgesic, anti-inflammatory, antipyretic and anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, anti-inflammatory, inhibitory, anti-inflammatory, anti-inflammatory, inhibitory, anti-inflammatory, anti-inflammatory, inhibitor of inflammatory mediators. After parenteral administration, flunixin is rapidly absorbed from the injection site and penetrates into most organs and tissues, reaching a maximum concentration in the blood in 5-45 minutes.
Oxytetracycline dihydrate is excreted mainly with urine and bile, in lactating animals it is partially with milk. Flunixin is excreted mainly from the feces and to a lesser extent with urine.
Nitox Forte according to the degree of impact on the body belongs to moderately hazardous substances (3 hazard class according to GOST 12.1.007-76). Indications of Nitox Forte are used in cattle for the treatment of infectious diseases caused by otsitelin-sensitive agents, which are caused by pathoids, including: respiratory diseases, pleurisy, pneumonia, pasteurellosis, keratoconjunctivitis, hoof rot, purulent arthritis, abscess, peritonitis, rheumatitis, hoofed rot, purulent arthritis, abscess, peritonitis, rheumatoid junctivitis, hoof rot, purulent arthritis, abscess, peritonitis, rheumatitis, hoofed rot, purulent arthritis, abscess, peritonitis, rash as well as secondary infections in viral diseases. Doses and method of use The drug is used once deeply intramuscularly in animals in a dose of 1 ml of Nitox Forte per 10 kg of animal weight (30 mg of oxytetracycline dihydrate and 2 mg of flunixin per 1 kg of weight). If necessary, and in the chronic course of the disease, it is allowed to reintroduce Nitox Forte after 5 days.
The maximum dose for administration to cattle in one body point is 10 ml. If the volume of the injected solution is more than the specified one, it should be administered to animals in several places. At temperatures below 5 ° C, the viscosity of the drug increases slightly and its introduction can be difficult. In this case, it is recommended to warm the solution and syringes to room temperature, which will make it easy to draw the drug into the syringe and inject it into animals.
In case of overdose of the drug, the animal may experience refusal of the feed, an inflammatory reaction at the injection site, symptoms of nephropathy, gastrointestinal bleeding. In this case, intravenous administration of calcium preparations (calcium chloride, calcium borgluconate), symptomatic therapy is recommended.
Features of the action at the first use of the drug and its cancellation was not detected.
The drug is intended for single use. Side effects When using the drug in accordance with this instruction, side effects and complications, as a rule, are not observed. In some animals, a local inflammatory reaction may appear in the form of erythema and itching, which quickly disappear and do not require treatment.
In case of increased individual sensitivity of the animal to the antibiotics of the tetracycline group and the development of a stable allergic reaction, desensitization therapy is carried out. In case of anaphylactic shock, animals are given adrenaline, corticosteroids, and antihistamines in accordance with the instructions for their use. Contraindications The use of Nitox Forte for lactating animals whose milk is used for food purposes, as well as animals with cardiac, hepatic and renal insufficiency, mycoses, in case of hypersensitivity to tetracycline antibiotics and / or NSAIDs is prohibited.
Prohibited intravenous and intra-aortic administration of the drug. Specific guidance The drug can not be used simultaneously with estrogen. In connection with a marked decrease in the antibacterial effect of oxytetracycline, the drug is not recommended to be used simultaneously with penicillin and cephalosporin antibiotics. Do not use the drug at the same time or less than 24 hours before or after using another NSAID or corticosteroid due to the increased risk of ulceration in the gastrointestinal tract.
Slaughter of animals for meat is allowed not earlier than 35 days after the last injection of the drug. The meat of animals that were involuntarily killed before the expiration of these periods is used to feed carnivores.

Personal preventive measures
During the work with Nitoks Forte it is necessary to follow the general rules of personal hygiene and safety measures provided during the work with medicines for animals. During work, it is forbidden to drink, smoke and eat. At the end of the work hands should be washed with warm water and soap.
In case of accidental contact of the drug with the skin or mucous membranes of the eyes, they must be washed with plenty of water. People with hypersensitivity to the components of the drug should avoid direct contact with Nitoksom Forte. In the event of an allergic reaction or in case of accidental ingestion of the drug in the human body, you should immediately contact a medical institution (you should have the instructions for use of the drug or a label with you).
Empty packaging of the medicinal product is prohibited to use for domestic purposes, they must be disposed of with household waste. Storage conditions Store the drug in the sealed packaging of the manufacturer, separately from food and feed, in a dry, dark place at a temperature of 5 ° C to 25 ° C. The shelf life of the drug under the storage conditions is 24 months from the date of production, after opening the bottle - 28 days.
Do not use Nitoks Forte after the expiration date.
Nitox Forte should be kept out of the reach of children.
Unused drug is disposed of in accordance with the requirements of the legislation. Manufacturer Nita-Farm CJSC, Russia

Address: 410010, Saratov, ul. Osipova, 1.
Address for correspondence: 410010, Saratov, PO Box 1796.
Tel./Fax: (8452) 33-86-00 (multichannel)

Address: 107497, Moscow, st. Biryusinka d. 7 p. 1

"Nitoks Forte": description

"Nitoks Forte" is a professional medicinal product in the form of a sterile solution for injection, intended for the treatment of small and cattle, as well as pigs from infectious diseases of bacterial origin and secondary infections in viral diseases.

"Nitoks Forte" is packaged in 20, 50, and 100 ml in glass vials, which are sealed with rubber stoppers and rolled with aluminum caps. It is a clear, viscous brown liquid with a characteristic odor.

Store in a dark place at a temperature of 5 to 25 ° C. Shelf life "Nitoks Forte" - 24 months, subject to proper storage. "Nitoks Forte" is protected by a patent, its manufacturer - the company "Nita-Farm" in Russia.

Mechanism of action and active substance

"Nitoks Forte" - a representative of the group of combined antibacterial drugs. The active ingredient "Nitox Forte" is oxytetracycline dihydrate (1 ml of the drug contains 200 mg) and additional substances (magnesium oxide, rongalite (formaldehyde sodium sulfoxylate), N-methylpyrrolidone).

Препарат оказывает бактериостатическое действие на большинство грамотрицательных и грамположительных бактерий, в том числе и стафилококков, фузобактерий, стрептококков, клостридий, коринебактерий, пастерелл, эризипелотриксов, псевдомонад, хламидий, сальмонелл, актинобактерий, эшерихий, риккетсий.

Продолжительное действие определено комплексом окситетрациклина с магнием. With intramuscular injection from the injection site, the active substance is absorbed extremely rapidly, and 30-50 minutes after the injection, the maximum concentration in the tissues and organs is reached.

Therapeutic level of antibiotic in the serum can be maintained for 72 hours. Oxytetracycline is excreted from the body, as a rule, with bile and urine, and in lactating animals, and with milk.

Indications for use

"Nitoks Forte" has found its use in the control and prevention of infectious diseases caused by pathogens that are sensitive to oxytetracycline. Also used for the treatment and prevention of secondary infections caused by viral diseases.

Nitox Forte is recommended for calves and cattle for the treatment of pneumonia, mastitis, pleurisy, pasteurellosis, wound infections, foot rot, diphtheria calves, keratoconjunctivitis, anaplasmosis.

In pigs, the drug is used to treat pleurisy, pneumonia, mastitis, pasteurellosis, atrophic rhinitis, purulent arthritis, erysipelas, MMA syndrome, abscess, umbilical sepsis, wound and postpartum infections.

In goats and sheep, the drug is used to treat ungulate rot, enzootic abortion, mastitis, peritonitis, metritis, wound infections, and goat pneumonia.

In addition, some are known. restrictions on the use of the drug:

  • The drug is prohibited for animals during lactation and animals whose milk is eaten (milk is not used for food and is not processed for at least a week after injection, but after heat treatment it can be used for feeding animals).
  • Animals with liver, heart and kidney failure.
  • An animal with mycosis.
  • Animals that are extremely sensitive to tetracycline antibiotics.
  • The drug is prohibited to use together with estrogen, with antibiotics cephalosporin and penicillin. And also at the same time or less than a day before or after the use of a corticosteroid or another NSAID, since the risk of ulceration in the gastrointestinal tract is increased.
  • Do not use the drug cats, dogs, horses.

Instructions for use

Applying "Nitoks Forte", you must adhere to certain instructions. The drug is used by animals once and is administered deeply intramuscularly (it can not be administered intravenously and intraaortally). If absolutely necessary, the injection is repeated again after three days.

"Nitoks Forte" is administered in a dose of 1 ml per 10 kg of animal. But there is a maximum dose for the introduction of the drug in one point of the body of the animal. The maximum dose of Nitoks Forte for cows (cattle) is 20 ml, for pigs - 10 ml, for sheep - 5 ml.

From overdose "Nitoks Forte" in animals can be a failure of the feed, you may receive an inflammatory reaction at the injection site, gastrointestinal bleeding and symptoms of nephropathy.

After vaccination, allergic reactions (erythema and itching) are possible in animals, but they quickly disappear without any treatment. If there is such a need (persistent allergic reactions or overdose), then you can enter intravenous potassium chloride or calcium borgluconate.

Safety

Must adhere to common safety regulations and personal hygiene when working with "Nitoks Forte":

  • Drinking, eating and smoking when working with the drug is strictly prohibited.
  • Work with the drug only in gloves.
  • Wash your hands with soap and warm water after handling.
  • In case of contact with the mucous membranes of the eyes or skin, immediately rinse them well with running water.
  • If the drug gets into the human body or if an allergic reaction occurs, you should immediately contact a medical institution.
  • It is necessary to keep the drug out of the reach of children.

In veterinary medicine, "Nitoks Forte" is used extremely widely, since it is endowed with a huge spectrum of action and is very effective in combating most infections of farm animals.

His patented production technology certifies the high quality of the drug, and the dosage form and special composition provide antibiotic therapy for several days. Another indisputable advantage of "Nitoks Forte" is the advantageous cost of treatment (the course of treatment often consists of a single injection).

Pharmacological properties

Nitoks Forte belongs to the group of combined antibacterial drugs. Oxytetracycline, an antibiotic from the group of tetracyclists. spirochete.

The long-term effect of the drug is due to the oxytetracycline dihydrate complex with magnesium.
With intramuscular administration, oxytetracycline is rapidly absorbed from the injection site and reaches maximum concentrations in organs and tissues 30–50 minutes after administration.

Flunixin belongs to the group of nonsteroidal anti-inflammatory drugs, is a non-selective inhibitor of TSOG1 and TSOG2, which causes anti-inflammatory, analgesic, antitoxic and antipyretic effect of the drug.

As part of Nitoks Forte, flunixin has an auxiliary effect that increases the effectiveness of oxytetracycline therapy.


The special form of the drug provides its long-lasting effect for 5 days and antibacterial activity against a wide range of pathogens.



The concentration of flunixin increases sharply and reaches its maximum during the first hour after injection, after which it remains at the therapeutic level for 12 hours, which makes it possible to alleviate the condition of the animal during the first hours of the disease.

Flunixin in the composition of Nitox Forte provides a more pronounced decrease in rectal temperature compared with oxytetracycline monotherapy.

Restrictions

Slaughter of cattle and pigs for meat is allowed no earlier than 35 days after the last injection of Nitox Forte. The meat of animals that were involuntarily killed before the expiration of these periods is used to feed carnivores.

RECOMMENDATIONS

Nitox Forte is recommended to be used with injectors equipped with silicone tubes and seals.

Release form, composition and packaging

Injection viscous, from green-brown to dark brown.

Excipients: magnesium oxide (prolongator) - 20 mg, rongalite (formaldehyde sodium sulfoxylate) - 6 mg, N-methylpyrrolidone - up to 1 ml.

Packaged in 100 ml in glass vials, sealed with rubber stoppers, reinforced aluminum caps with clips for the control of the first opening. Each unit of packaging is supplied with instructions for use of the drug.

Registration certificate 44-3-2.15-2556 No. PVR-3-2.15 / 03121 of 03/23/15

Pharmacological (biological) properties and effects

Combined antibacterial drug.

Oxytetracycline dihydrate, has a bacteriostatic effect, active against most gram-positive and gram-negative bacteriaincluding Streptococcus spp., Staphylococcus spp., Corynebacterium spp., Clostridium spp., Erysipelothrix spp., Pasteurella spp., Fusobacterium spp., Salmonella spp., Pseudomonas spp., Actinobacteria spp., Escherichia sfpp, 3. ., and Spirochaetes spp. The mechanism of action of oxytetracycline is to suppress the synthesis of protein microorganisms. The prolonged (prolonged) effect of the drug is due to the oxytetracycline dihydrate complex with magnesium. When i / m administration of oxytetracycline dihydrate is rapidly absorbed from the injection site and reaches maximum concentrations in organs and tissues 30-50 minutes after administration. Oxytetracycline dihydrate is excreted mainly with urine and bile, in lactating animals it is partially with milk.

Flunixin - NSAIDs, a non-selective inhibitor of COX-1 and COX-2, inhibits the synthesis of prostaglandins E2 - inflammatory mediators, which makes it analgesic, anti-inflammatory, antipyretic and anti-toxic against endotoxins of bacteria. After parenteral administration, flunixin is rapidly absorbed from the injection site and penetrates into most organs and tissues, reaching a maximum concentration in the blood in 5-45 minutes. Flunixin is excreted mainly from the feces and to a lesser extent with urine.

Nitox ® Forte is classified as moderately hazardous according to its degree of exposure to the body (hazard class 3 according to GOST 12.1.007-76).