Triamcol®

Solution for injection.

Analgesic.

Horses.

Tramadol Hydrochloride is a synthetic opioid agonist that acts primarily through binding to μ receptors, as well as inhibiting the reuptake of serotonin and norepinephrine monoamines. It is from the two mechanisms mentioned above, that the sensation of pain is inhibited at a central level, causing a powerful analgesia (antinociception) and a moderate anxiolytic effect.

Each 1 mL of solution for injection contains:
Tramadol Hydrochloride……………….. 50 mg
(Equivalent to 43.9 mg tramadol base)
Excipients c.s.p………………………….. 1mL

Triamcol®, Tramadol Hydrochloride 5%, Solution for Injection, is indicated as an analgesic in the management of acute pain of low to severe intensity that accompanies colic in horses.

Endovenous.

Administration of the product should be slow (5 to 10 minutes) to minimize possible adverse effects.

• Dosage of the active substance:
  2 mg of Tramadol Hydrochloride per kg of body weight.
• Product dosage:
  4 mL per 100 kilos of body weight.

Single dose. Up to a second dose of the product can be administered with at least 4 hours between treatments.

• Do not administer to horses that have a known hypersensitivity to Tramadol.
• Do not administer to pregnant or lactating females.

In horses, nausea, salivation, and tremors may be observed during intravenous administration of tramadol hydrochloride. These effects disappear if administration this route is done slowly (within 5 to 10 minutes). Increased systolic blood pressure and tachycardia may occur after intravenous administration in more sensitive individuals, which should subside within 30 to 60 minutes of administration.

• Keep out of reach of children and pets.
• It is recommended not to administer in animals with a history of seizures.

• To increase the analgesic efficacy of Tramadol, it may be administered concomitantly with other analgesics such as opioids (Morphine, Pethidine, Fentanyl, Methadone, Codeine, Butorphanol, Buprenorphine) and N-methyl-D-Aspartate (NMDA) receptor antagonists (Ketamine, Memantine, Amantadine, Dextromethorphan). It can also be administered with NSAID-type anti-inflammatories.
• Do not administer Tramadol in conjunction with Monoamine Oxidase (MAO) inhibitor drugs such as Selegiline and Isoniazid; tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) such as Fluoxetine, Sertraline and Paroxetine; SSRIs and norepinephrine reuptake inhibitors such as Clomipramine, serotonin antagonists such as Cyproheptadine; noradrenaline antagonists such as Prazosin; noradrenaline agonists such as Clonidine. The drugs mentioned when given together with Tramadol can lead to serotonin syndrome.
• Naloxone reverses the eventual respiratory depression that could be caused by Tramadol, but is not useful in treating other symptoms caused by inhibition of monoamine reuptake. Naloxone may even increase the risk of seizures.

During the handling and application of the product, the use of gloves is recommended. In the case of accidental ingestion, contact or injection, it is recommended:

• First aid: People who develop serious hypersensitivity (anaphylactic) reactions should get medical attention right away. If the person is not breathing, give artificial respiration. If breathing is labored, provide oxygen. Get medical attention.
• Risk of skin contact: In the event of contact with the skin, it is recommended to wash immediately with plenty of soap and water. In the event of any type of irritation, it is recommended to see a doctor.
• Risk of eye contact: In the event that there is contact with the eyes, it is recommended to wash immediately with plenty of water for approximately 15 minutes. In the event of any type of irritation, it is recommended to go to the doctor.
• Risk of ingestion: In the case of accidental ingestion, it is recommended to rinse the mouth with plenty of water. Do not induce vomiting unless directed by a doctor. It is recommended to go to a care center promptly.

Do not administer to horses whose meat is intended for human consumption.

Empty containers can be discarded as household waste, without any special precautions. Do not dispose of containers with product residues on the ground or in waterways. For expired or unused products, contact the manufacturing laboratory.

Store between 2 and 30 °C, away from light. Once opened, use within 28 days. Discard the unused product after that period of time.

Sale under prescription Withheld Veterinary Doctor.

VETERINARY USE

Ampoule bottle with 50 mL

Chile: Reg. SAG N° 2169
Bolivia: Reg. SENASAG PUV- N° 10000/21
Peru: Reg. SENASA F.G4.01.I.0001

Laboratorio Drag Pharma Chile Invetec S.A.
Lautaro N° 300. Quilicura. Santiago. Chile.