SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

HEMOSILATE 125 mg/ml Solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Etamsylate Excipients:	125 mg
Benzyl alcohol (E1519)	10 mg
Sodium metabisulfite (E223)	0.4 mg

Sodium sulfite anhydrous (E221) 0.3 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

Clear and colourless solution, free from visible particles.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, sheep, goats, pigs, horses, dogs and cats.

4.2 Indications for use, specifying the target species

Prevention and treatment of surgical, post traumatic, obstetric and gynecological haemorrhages.

4.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance and/or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use Special precautions for use in animals

In case of surgical or traumatic rupture of large blood vessels, it is necessary to ligate the affected vessels to block blood flow prior to etamsylate administration.

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

• Etamsylate,sulfites and benzyl alcohol may cause hypersensitivity (allergic) reactions. Symptoms may include nausea, diarrhoea and skin rashes. People with known hypersensitivity to etamsylate or any of the excipients, or those with asthma, should avoid contact with the product.

• Administer this product with caution to avoid accidental self-injection.

• In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

• This product may cause skin and eye irritation. In case of accidental skin or eye contact, wash the affected area thoroughly.

4.6 Adverse reactions (frequency and seriousness)

Anaphylactic reactions to similar products have been reported in humans due to the presence of sulfites. It is possible that similar reactions may occur in the target animal species.

4.7 Use during pregnancy, lactation or lay

Laboratory studies performed with rats and mice have not demonstrated any teratogenic or toxic effect to the fetus or the mother. The safety of the product has not been established in the target species during pregnancy and lactation. Use only according to a benefit/risk evaluation performed by the veterinary responsible.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

For intravenous or intramuscular use.

5 to 12.5 mg of etamsylate/kg bw, equivalent to 0.04 to 0.1 ml/kg bw of the product, according to the severity of the procedure/haemorrhage.

Treatment is normally made until the desired effect is reached; it may be for one day but could be repeated for a further 2 to 3 days in order to obtain control of the bleeding

For prevention of surgical bleeding the product should be administered at least 30 minutes before surgery.

For treatment of an ongoing haemorrhage, the product can be administered up to every 6 hours until bleeding has stopped completely.

In case of rupture of large blood vessels, it is necessary to ligate the affected vessels before administering this veterinary medicine.

Do not administer more than 20 ml of this product in a single injection site. Each injection should be given at a different site.

The stopper should not be punctured more than 25 times.

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

None known

4.11 Withdrawal period(s)

Cattle, Sheep, Goats and Horses:

Meat and offal: After IV administration: Zero days After IM administration: 1 day

Milk: Zero hours

Pigs

Meat and offal: After IV administration: Zero days

After IM administration: 1 day

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antihaemorragics. Other systemic hemostatics ATCvet code: QB02BX01

5.1 Pharmacodynamic properties

Etamsylate is a hemostatic and angioprotective drug that stimulates platelet adhesiveness shortening bleeding time and normalizing rapidly and lastly the altered vascular fragility and permeability.

Its mechanism of action is attributed to the inhibition of prostacyclin (PGI₂) synthesis that causes the platelet disaggregation, vasodilation and increase of capillary permeability and to the activation of P-selectine, which facilitates the interaction between platelets, leucocytes and endothelium. It acts on primary hemostasis without affecting prothrombin time, fibrinolysis or platelet count.

In animal models of capillary bleeding, the administration of etamsylate shortens bleeding time and the severity of the hemorrhage up to 50% reaching its maximum effect between 30 minutes and 4 hours after its administration.

5.2 Pharmacokinetic particulars

In all the species studied, after an intravenous administration, etamsylate shows a limited tissue distribution, substantiated by a low Volume of Distribution (Vd: 0,4; 0,36 and 0.44 L/kg in dogs, cats and cattle respectively) due to its low liposolubility. Therefore, its action is practically limited to the circulatory system and blood vessels of highly irrigated organs. It is eliminated rapidly from the body with an elimination Half Life (T_1/2) of 1,14; 0.75 and 1.24 h in dogs, cats and cattle, respectively, via urine, practically unaltered.

When administered intramuscularly, etamsylate is absorbed very rapidly and almost completely (F: 97.5; 99.8 and 98.4 % in dogs, cats and cattle respectively). Etamsylate reaches the maximum blood concentrations (C_max: 27; 25.8 and 10,7 µg/ml in dogs, cats and cattle respectively) approximately 1h after its administration (T_max: 0.42; 0.54 and 1.3 h in dogs, cats and cattle respectively).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E1519)

Sodium metabisulfite (E 223)

Sodium sulfite anhydrous (E 221)

Disodium edetate

Water for injection

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 14 days

6.4 Special precautions for storage

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging

Amber glass type I vial containing 20 ml, with type I chlorobutyl stopper and flipoff aluminum cap in a carton box.

Pack sizes:

Box with 1 vial of 20 ml

Box with 5 vials of 20 ml

Box with 10 vials of 20 ml

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Ecuphar Veterinaria S.L.U.

C/Cerdanya, 10-12 Planta 6º

08173 Sant Cugat del Vallés Barcelona (Spain)

8. MARKETING AUTHORISATION NUMBER

Vm 46037/4005

9. DATE OF FIRST AUTHORISATION

23 April 2020

10. DATE OF REVISION OF THE TEXT

July 2022

PROHIBITION OF SALE, SUPPLY AND/OR USE

For animal treatment only

To be supplied only on veterinary prescription

Approved 29 July 2022