Phosprenyl

used for stimulation of innate immunity and treatment of viral infections in animals and birds (Product developer: ZAO Micro-Plus, Moscow)

I GENERAL INFORMATION

1. Trade name: Phosprenyl. International nonproprietary name: disodium salt of polyprenyl phosphate.

2. Pharmaceutical form: sterile solution for injection.

Each 1 ml of Phosprenyl contains 4 mg of disodium salt of polyprenyl phosphate as an active ingredient and 0.03 ml of glycerol, 0.029 ml of ethanol, 0.0025 ml of Tween 80 and up to 1 ml of water for injection as excipients.

The product is a clear or slightly opalescent and colorless or yellowish solution.

3. Phosprenyl is packaged in 10 ml and 50 ml glass vials, closed with a rubber stopper and sealed with an aluminum cap. Glass vials with product are placed in cardboard boxes. Each packing unit is provided with the package insert.

4. Store in sealed original container, away from food and feed, in a dry place protected from direct sunlight at 4°C to 25 °C.

Shelf-life when stored according to storage conditions is 2 years from date of manufacture.

Do not use after the expiration date.

5. Keep out of the reach of children.

6. Dispose unused product in accordance with applicable legal requirements.

II. PHARMACOLOGICAL PROPERTIES

7. Phosprenyl is an antiviral drug product with immunomodulatory properties.

It activates body's systems of innate immunity (bactericidal activity of blood serum and phagocytosis) and enhances the humoral immune response to vaccines, thus, increasing the body's immunity to infections and reducing disease incidence. Phosprenyl activates metabolic cell processes and, therefore, increases weight gain while reducing the cost of feed. It has antiviral activity against paramyxoviruses, ortomicoviruses, togaviruses, herpesviruses, coronaviruses and some others.

After parenteral administration, Phosprenyl enters the bloodstream of an animal and accumulates mainly in the liver, spleen and reproductive organs, reaching maximum concentrations after 0.5-3 hours and staying at a therapeutic level for 10-16 hours. It is excreted from the body mainly with faeces and urine.

Phosprenyl belongs to low-hazardous materials by its degree of impact on the body (hazard class 4, according to GOST 12.1.007-76), and has no local irritating, allergenic, embryotoxic, teratogenic or carcinogenic effects in recommended doses.

III. APPLICATION

8. Phosprenyl is used in agricultural and domestic animals, fur animals and poultry for stimulation of innate immunity and treatment of viral infections, enhancement of immune response to vaccines, reduction of disease incidence and increase in weight gain in animals and poultry.

9. Contraindications include increased individual sensitivity of animals and birds to the components of Phosprenyl.

10. Phosprenyl is administered intramuscularly, subcutaneously, intravenously or orally. Treatment should be started as early as possible from the onset of disease clinical signs. Treatment is most effective in the prodromal period. For viral infections, Phosprenyl should be combined with symptomatic and pathogenetic therapy, especially in cases of severe and complicated infections. In severe cases, it is recommended that therapeutic dose of Phosprenyl be doubled. Treatment should be stopped 2-3 days after the disappearance of the main symptoms of the disease. If necessary, courses of treatment may be repeated.

When treating viral infections of small animals, Phosprenyl is administered for 5-7 days in the doses (ml/kg) listed in Table 1.

Table I

If a large dose of Phosprenyl is needed, it should be administered in two or three points on the body, or in three or four injections during the day, or intravenously at a half of the dose. In order to prevent recurrence of canine distemper, the product should be administered for at least 14 days, even if clinical signs of disease disappear. Course duration can be increased up to 1 month, if needed.

For prevention of nonspecific diseases and reduction of mortality, Phosprenyl is administered in a dose of 0,05 ml/kg of body weight according to the regimen shown in Table 2.

Table 2 

* To prepare working solution, dilute 20 ml of Phosprenyl in 1 L of water with 10% glycerol and spray via SAG or APA type aerosol generators calculated on the basis of 0.4 mL of working solution per 1 m3 of poultry premises with an exposure of 15 minutes.

In order to reduce disease incidence, mortality, increase weight gain, and reduce feed costs, young animals (pigs, horses, cattle) and poultry (chickens) are given Phosprenyl in a preventive dose of 0.05 ml/kg intramuscularly or orally in the first month of life or, in case of bird, with water on Days 2, 5, 10, 14 and 20 of life. Fur animals are given Phosprenyl with feed once every 7 days for 1 month after caging, then once in 14 days prior to slaughter.

In order to increase the immune response to vaccines and prevent post-vaccination complications, Phosprenyl is administered at a dose of 0.05 ml/kg concurrently with the vaccine in different syringes intramuscularly, orally or, to poultry, with water. The product is not used as a booster.

11. No cases of overdose were established.

12. No specifics of the action at the first use or its discontinuation were found.

13. Avoid gaps when administering regular doses of Phosprenyl, as this may lead to reduction of therapeutic efficacy. When a dose is missed, it should be administered as soon as possible. Further, the interval before the next injection is not changed.

14. When using Phosprenyl in accordance with this insert, no side effects or complications are generally observed.

In the case of allergic reactions, discontinue the drug product and prescribe antihistamines or other symptomatic treatment.

15. Combination with steroids reduces the therapeutic effect of Phosprenyl. It is not recommended to dilute Phosprenyl with saline solutions.

16. Products from animals and birds, which were given Phosprenyl, is used for food purposes without any restrictions.

IV. INDIVIDUAL PREVENTIVE MEASURES

17. When handling Phosprenyl, general rules of personal hygiene and safety should be followed required for handling veterinary drug products. It is prohibited to drink, smoke or eat when handling the product. Wash hands with soap and water after handling the product.

18. People with known hypersensitivity to the product components should avoid direct contact with Phosprenyl. In case of accidental contact with the skin or mucous membranes, immediately rinse with running water and soap. In case of allergic reactions and/or ingestion, immediately contact a medical facility (bring product insert or label).

19. Empty containers from the drug product should not be used for domestic purposes; they should be disposed with household waste.

20. Product developer: ZAO Micro-Plus 18 Gamalei St, Moscow 123098. Package insert for Phosprenyl was developed by ZAO Micro-Plus: 18 Gamalei St, Moscow 123098. With the approval of this insert, package insert for Phosprenyl approved by Rosselkhoznadzor on May 15, 2009, is voided.

The drug product is recommended for authorization in the Russian Federation by Federal State Budget Institution "All-Russia State Centre for Quality and Standardization of Veterinary Drugs and Feed" (VGNKI)

Marketing authorization No. 77-3-5.14-2060№ПВР-3-1.9/00010