ES V 0281 001 FinalSPC

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
HEMOSILATE 125 mg/ml Solution for injection (ES, IT, PT, EL, CY, MT)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Etamsylate 125 mg
Excipients:
Benzyl alcohol (E1519) 10 mg
Sodium metabisulphite (E223) 0.4 mg
Sodium sulphite 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, goat, pig, horse, dog and cat.
4.2 Indications for use, specifying the target species
Cattle, sheep, goat, pig, horse, dog and cat:
Prevention and treatment of surgical, post traumatic, obstetric and gynecological hemorrhages.
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.
Hemo/Etam 125 mg/ml Solution for injection

SPC proposal D105 10/2017
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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
People with known hypersensitivity to etamsylate should avoid any contact with the veterinary
medicinal product.
Administer this veterinary medicinal product with caution
In case of accidental self-injection, seek medical advice immediately and show the package leaflet
or the label to the physician.
4..6 Adverse reactions (frequency and seriousness)
None known.
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 all the species: Intravenous or intramuscular route.

- 5 to 12.5 mg of etamsilate/kg bw, equivalent to 0.04 to 0.1 ml/ kg/day of the veterinary
medicinal product, according to the severity of the process.
For prevention of surgical bleeding it should be administered at least 30 minutes before surgery.
For treatment of an ongoing process, it 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Etamsylate has a broad safety margin.
Hemosilate 125 mg/ml Solution for injection

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4.11 Withdrawal period(s)
Meat: After IVadministration: Zero days

After IM administration: 1 day
Milk: Zero days
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antihaemorragic. Other systemic hemostatics

ATCvet code: QB02BX01
5.1 Pharmacodynamic properties
Ethamsylate 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, (dog, cat, cow, man) after an intravenous administration, etamsylate
shows a limited tissue distribution, substantiated by a low Volume of Distribution (Vd) 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 (T1/2 ) of 0.75 to 2h, via urine, practically unaltered.
When administered intramuscularly, etamsylate is absorbed very rapidly and almost completely,
reaching the maximum blood concentrations (C max) approximately 1h after its administration
(Tmax).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol (E1519)

Sodium metabisulphite (E 223)
Sodium sulphite anhydrous (E 221)
Edetate disodium
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.
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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
Ambar glass type I vial containing 20 ml, with type I chlorobutyl stopper and flip-off 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.

Avenida Rio de Janeiro 60-66, planta 13
08016 - Barcelona (Spain)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: DD/MM/YYYY
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
For animal treatment only

To be supplied only on veterinary prescription


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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

For a full list of excipients, see section 6.1.

Solution for injection

4.1 Target species

Cattle, sheep, goat, pig, horse, dog and cat.

4.2 Indications for use, specifying the target species

Cattle, sheep, goat, pig, horse, dog and cat:

4.4 Special warnings for each target species

Hemo/Etam 125 mg/ml Solution for injection

Special precautions for use in animals

4..6 Adverse reactions (frequency and seriousness)

4.7 Use during pregnancy, lactation or lay

4.9 Amounts to be administered and administration route

For all the species: Intravenous or intramuscular route.

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

Etamsylate has a broad safety margin.

Hemosilate 125 mg/ml Solution for injection

Meat: After IVadministration: Zero days

Milk: Zero days

Pharmacotherapeutic group: Antihaemorragic. Other systemic hemostatics

5.1 Pharmacodynamic properties

Ethamsylate is a hemostatic and angioprotective drug that stimulates platelet adhesiveness

5.2 Pharmacokinetic particulars

6.1 List of excipients

Benzyl alcohol (E1519)

6.2 Major incompatibilities

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

6.4. Special precautions for storage

6.5 Nature and composition of immediate packaging

Not all pack sizes may be marketed.

7. MARKETING AUTHORISATION HOLDER

Ecuphar Veterinaria S.L.U.

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: DD/MM/YYYY

10. DATE OF REVISION OF THE TEXT

PROHIBITION OF SALE, SUPPLY AND/OR USE

For animal treatment only

Hemosilate 125 mg/ml Solution for injection

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