INSTRUCTIONS FOR USE
Yodosept-A
Trade name of the medicinal product
Chapter 1 “GENERAL PROVISIONS”
1. Name: Iodosept-A.
2. Composition: 1 ml of the drug contains active ingredients: potassium iodide – 11 mg, prednisolone – 1 mg, excipients: propylene glycol up to 1 ml, propellant-difluorochloromethane (hladon-22).
3. Dosage form: Foaming solution for topical use in aerosol packaging.
In appearance, Iodosept-A is a solution from orange to dark orange in color. Opalescence is allowed.
4. International nonproprietary name: Potassium iodide, prednisone.
5. Pharmacotherapeutic group: Combined antibacterial and anti-inflammatory drugs.
6. Properties of active substances: Pharmacotherapeutic group: antibacterial drug of the tetracycline group.
Iodide ions cause a pronounced bactericidal and bacteriostatic effect against a wide range of microorganisms – pathogens of gynecological diseases. It is active against E. coli, Pseudomonas aeruginosa, common proteus, Candida albicans, Aspergillus, Penicillin, Trichophyton, microsporum, Staphylococcus aureus, fecal Streptococcus, Streptococcus pyogenes, Mycoplasma, Enterobacter spp, Bacillus subtilis. Does not create resistance in pathogenic microflora. It has a general stimulating effect on the immune system.
Prednisone has an anti-inflammatory and mild analgesic effect. The hydrophilic base of the drug is physiologically indifferent, eliminates the irritating effect of active components on the mucous membranes of the glandular epithelium of the endometrium of the gland; adsorbs and neutralizes microbial and tissue toxins.
Forming a foam when sprayed, the drug is applied to the mucous membrane with a thin layer and spreads easily between the folds of the endometrium, which improves the contact of drugs with the uterine mucosa and increases the effectiveness of the drug.
Propellant evaporating, have some cooling effect, which reduces the pain syndrome.
7. Label and labeling:
A label made of writing paper or label paper is pasted on each cylinder with the drug, indicating:
– the name of the manufacturing organization, its address and trademark;
– trade and international nonproprietary names of the drug;
– the dosage form of the drug;
– name and content of active substances in 1 ml;
– the volume of the drug in ml;
– inscriptions: “For veterinary use”;
– method of application;
– series numbers;
– production dates;
– vacation conditions;
– bar identification code;
– expiration date;
– storage conditions;
– warning labels;
– registration certificate numbers;
– designations of a HUNDRED.
⃰ Part of the information from the instructions for use of the drug may be placed on the label.
Cylinders with the drug are packed in shrink wrap or boxes made of cardboard or corrugated cardboard boxes. Each box contains instructions for the use of the drug at the rate of 1 copy. for 1 consumer package of the drug.
On each box, the box is marked with the indication of the manipulation sign “Top”, “Protect from direct sunlight”.
Additionally indicate:
– the name of the manufacturing organization, its address and trademark;
– the dosage form of the drug;
– nominal volume of the package, in ml;
– quantity per box;
– serial number;
– date of manufacture;
– bar code;
– expiration date;
– storage conditions;
– warning labels.
The marking should be applied in the state and Russian languages, be strong, clear and easy to read. Methods and means of labeling should not affect the quality and safety of the packaged drug.
The combination of the transport marking and the marking characterizing the packaged products on one side of the transport container is not allowed.
8. Packaging: Iodosept-A is produced packaged in 46 and 93 ml in aerosol cans or aluminum cylinders with a capacity of 100 and 170 ml, respectively, with spray heads and protective caps, complete with pipettes for intrauterine administration.
9. Storage and transportation: The shelf life of the drug “Iodosept-A”, subject to storage conditions in the manufacturer’s closed packaging, is 2 years from the date of production. It is forbidden to use Iodosept-A after the expiration date.
Store the drug in the manufacturer’s closed packaging, away from heating devices, separately from food and feed, in a dry place protected from direct sunlight, at a temperature of 5 to 25 ° C. Iodosept-A should be stored in places inaccessible to children.
The drug is transported by all modes of transport in accordance with the rules of cargo transportation applicable to the corresponding mode of transport.
10. Methods of destruction of a defective or unused/ underused veterinary drug: An unused drug with an expired shelf life is disposed of in accordance with the requirements of the legislation.
Special precautions are not required when destroying an unused medicinal product with an expired expiration date.
Chapter 2. PROCEDURE FOR THE USE OF VETERINARY MEDICINE
11. Preparatory procedures before using a veterinary drug: The drug is allowed to be used only by qualified specialists with higher or secondary specialized education.
Vacation conditions: without a veterinary doctor’s prescription.
A contraindication to the use of Iodosept-A is an individual hypersensitivity to its components.
Together with the drug, intrauterine medications that have an alkaline reaction cannot be administered.
The peculiarities of the action at the beginning of the use of Iodosept-A or at its cancellation were not revealed.
12. Procedures for the use of veterinary medicine: Iodosept-A is used intrauterine to cows, mares, sows, sheep and goats.
Before administration, the drug is heated to 37 ° C – 39 ° C.
In the treatment of endometritis and in the case of pyometra, the drug is used after the release of the uterine cavity from exudate and pus by rectal massage. The drug is administered intrauterine after sanitary treatment of the external genitalia, the root of the tail and preliminary examination and massage of the uterus through the rectum. To use the drug, a spray head with a pipette is put on an aerosol balloon, the cervix is grasped by hand through the rectum and holding the aerosol balloon vertically, the contents are injected into the uterine cavity: cows, mares – 93 ml each (the contents of one balloon with a capacity of 170 ml, spraying is performed within 12-15 seconds); sows, sheep and goats – 46 ml each (the contents of one cylinder with a capacity of 100 ml or half a cylinder with a capacity of 170 ml, spraying is performed within 8-10 seconds).
In most cases, a single application is sufficient. In severe cases, the drug is recommended to be used 2-3 times with an interval of 7 days.
Failure to comply with the recommended interval during repeated administration of the drug may lead to a decrease in its effectiveness. If the next dose of the drug is missed, its use is resumed as soon as possible in the same dosage and according to the same scheme.
13. Indications for the forced use of a veterinary drug: Iodosept-A is used intrauterine as an antiseptic and anti-inflammatory agent for the prevention and treatment of vulvitis, cervicitis, postpartum acute, chronic endometritis in cows, mares, sows, sheep and goats.
14. Keeping and use of animals after the application of a veterinary drug, including the period until the next treatment of animals with other veterinary drugs: No special measures are required.
15. The timing of the onset of immunity and its duration in different ways of using a veterinary drug: Not applicable.
16. The reaction of animals to the veterinary drug, including the reaction at the site of administration of the veterinary drug and the general temperature and clinical reactions of the animal, as well as their intensity and duration: The drug by the degree of exposure to the body refers to low-hazard substances (hazard class 4 in accordance with GOST 12.1.007-76).
Symptoms of overdose when using the drug in accordance with this instruction, it is not established.
17. Measures to prevent possible complications as a result of the use of a veterinary drug:
Animals: A contraindication to the use of Iodosept-A is an individual hypersensitivity to its components.
Personnel: When working with Iodosept-A, the general rules of personal hygiene and safety provided for when working with medicines should be observed.
When working with the drug, it is forbidden to drink, smoke and eat. After working with the drug, you should wash your hands with soap.
If the drug accidentally gets on the skin or mucous membranes, it must be washed off with running water and soap. In case of allergic reactions and accidental ingestion, immediately contact a medical institution (have the instructions for the use of the drug or label with you).
18. Methods for determining the immune background of animals after the use of a veterinary drug: Not applicable.
19. Use of raw materials and products from animals on which the veterinary drug was used: Milk with intrauterine use of the drug is used for food without restrictions. Meat of slaughtered animals is used without restrictions when using the drug.
20. Forms of veterinary accounting and the procedure for reporting on the use of a veterinary drug: Not applicable.
