Target species
Cattle, sheep, goats, pigs, horses, dogs and cats.
Indications for use, specifying the target species
Prevention and treatment of surgical, post traumatic, obstetric and gynecological haemorrhages.
Contraindications
Do not use in cases of known hypersensitivity to the active substance and/or to any of the excipients.
Special warnings for each target species
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.
Adverse reactions (frequency and seriousness)
Cattle, sheep, goats, pigs, horses, dogs and cats:
Undetermined frequency (it cannot be estimated with the available data): | Anaphylactic reactions |
*due to the presence of sulfites
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Use only according to a benefit/risk evaluation performed by the veterinary responsible. Laboratory studies performed with rats and mice have not demonstrated any teratogenic or toxic effect to the fetus or the mother.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
None known
Withdrawal period(s)
Cattle, Sheep, Goats, pigs and Horses: Meat and offal: After IV administration: Zero days, After IM administration: 1 day
Cattle, sheep, goat and horse milk: Zero hours.