Instruction for use of Sepranol

I. General

1. Tradename of the veterinary medicinal product: Sepranol

International nonproprietary name: chlorhexidine, propranolol

2. Two tablets of Sepranol are packaged in foil blisters; 5 blisters are packed in a cardboard box.

3. Shelf-life of the medicinal product under specified conditions is 18 months from the date of manufacture, after first opening – 28 days. The use of the Sepranol after the expiration date is prohibited.

The veterinary medicinal product is stored in sealed original package, separately from food and feed, in a dry place, protected from direct sunlight.

4. Sepranol should be kept out of reach of children.

5. The veterinary medicinal product Sepranol is available without veterinary prescription.

II. Сomposition

6. Pharmaceutical form: tablets for intrauterine administration

1 tablet of Sepranol contains 60 mg of chlorhexidine hydrochloride, 343 mg of propranolol hydrochloride as an active substance and excipients.

Sepranol is flat tablet of a light yellow color.

III. Pharmacological properties

7. Pharmacotherapeutic group: antimicrobial agents.

Chlorhexidine hydrochloride, an ingredient of Sepranol, has a broad spectrum antibacterial effect against gram-positive and gram-negative bacteria (E.coli, Klebsiella, Salmonella, Shigella and Proteus, Staphylococcus, Streptococcus, Micrococcus, Bacillus, Corynebacterium pyogenes, Campylobacter fetus, Enterobacter), protozoa (Trichomonas vaginalis) and fungi (Candida albicans). Chlorhexidine acts by disrupting the plasma membrane of bacterial cells.

Propranolol hydrochloride stimulates uterine activity and is a beta blocker of myometrium adrenergic receptors.

By the degree of its impact on the body, Sepranol is considered a low-risk substance.

IV. Administration procedure

8. Sepranol is administered to cows for the stimulation of placenta separation and the prevention and treatment of acute postpartum endometritis caused by microorganisms (including fungi and protozoa) sensitive to chlorhexidine hydrochloride.

9. Contraindications include individual sensitivity of animals to the product’s ingredients.

10. The animals’ external genitalia and tailhead are sanitized before applying the product.

Sepranol is for intrauterine application in the following doses:

- Stimulation of placenta separation and prevention of acute postpartum endometritis: 2 tablets, single dose;

- Prevention of acute postpartum endometritis: 2 tablets, single dose 2-4 hours after placenta separation;

- Treatment of acute postpartum endometritis: 2 tablets, two doses 24 hours apart;

- Treatment of other inflammatory diseases of the uterus: 2 tablets every 24 hours for 2-5 days (in special cases treatment is continued until recovery as a part of combination therapy).

If the product cannot be administered as a suppository, the dissolved form should be used. It is recommended to dissolve two tablets of Sepranol in 150-200 ml of sterile water or saline, pre-warmed to 40 °C.

The foam that may form is removed by mechanical means or by using defoaming agents (ethyl alcohol). Draw the produced solution into a Janet's syringe or a fountain syringe; then, using a catheter for artificial insemination or a silicone tube 20-25 cm in length and 0.5 cm in diameter with a polystyrene pipette at the tip, slowly inject the solution into the uterus. The procedure is performed once a day, daily until recovery.

11. Overdose of the medicinal product results in bradycardia, hypotension, dyspnea, dyspepsia, or pruritus may occur. In this case, the product is discontinued and detoxifying and symptomatic treatment is prescribed.

12. No specific actions were reported at the first use and discontinuance of the drug.

13. Avoid missing prescribed dose administration as this may reduce the treatment effectiveness. When a dose is missed, continue to administer the product in the same dose and according to the same schedule.

14. No adverse reactions were observed at the administration of Sepranol if administered subject to the instructions for use.

15. The administration of Sepranol does not exclude the concurrent use of other systemic medications. The drug should not be used in combination with other medications for intrauterine administration.

16. The products for human consumption obtained from animals during or after the treatment with Sepranol may be consumed by humans no earlier than 48 hours after the last dose of the medication. If the animals must be slaughtered earlier than that, their meat can be used to feed fur-bearing animals.

V. Special precautions for use

17. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Sepranol. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product. Polyethylene gloves should be worn all the time while handling the product.

18. People with hypersensitivity to the drug components should avoid direct contact with Sepranol. If product accidentally comes in contact with mucous membranes, flush them with water. In the case of allergic reactions or accidental ingestion of the product, you should contact your medical facility (you should take the instructions for use of the product or the product label with you).

19. Use of the empty package of Sepranol for domestic purposes is prohibited; they must be disposed of along with household waste.