Patient Medication Information: uses, side effects, how to take - Recothrom
What is RECOTHROM used for?
The active substance of RECOTHROM is recombinant human thrombin. It belongs to a group of medicines called topical hemostats.
RECOTHROM is used during surgery to stop local bleeding (this is called hemostasis) on the surface of the bleeding tissue of your body. It may be used by itself or with an absorbable sponge.
How does RECOTHROM work?
RECOTHROM is thrombin that has been developed in the laboratory. It is very similar to thrombin that occurs naturally in human blood. When RECOTHROM solution comes into contact with blood it helps clotting, and bleeding will stop.
What are the ingredients in RECOTHROM?
Medicinal ingredients: Thrombin alfa (Recobinant)
Non-medicinal ingredients: Calcium chloride dehydrate, histidine, mannitol, polyethylene glycol 3350, sucrose, sodium chloride, water for injection
RECOTHROM comes in the following dosage forms:
- 1 vial of 6,000 IU RECOTHROM, 1 bottle with 5 mL sodium chloride solution, 1 sterile, needle-free transfer device, and 1 sterile empty syringe (5 mL).
- 1 vial of 24,000 IU RECOTHROM, 1 bottle with 20 mL sodium chloride solution, 1 sterile, needle-free transfer device, and 1 sterile empty syringe (20 mL).
Serious Warnings and Precautions
Do not inject RECOTHROM directly into the bloodstream. Intravascular injection of thrombin-containing hemostats may result in life-threatening intravascular coagulation or death.
Do not use RECOTHROM if:
- you are allergic (hypersensitive) to RECOTHROM or any of the other ingredients of RECOTHROM
- you have severe bleeding
There is a risk of blood clots forming if RECOTHROM enters into the blood stream. In severe cases, formation of blood clots could interrupt blood flow.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RECOTHROM. Talk about any health conditions or problems you may have, including if you:
- There is a potential risk of thrombosis if RECOTHROM (Thrombin alfa [Recombinant]) is absorbed systemically
- In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with other drugs, food, herbal preparations, or laboratory tests have not been established.
How to take RECOTHROM:
- RECOTHROM will be given to you by a healthcare professional in a healthcare setting.
Usual dose:
The healthcare professional will determine the amount of RECOTHROM to use based on your needs.
Overdose:
A maximum dose of topically applied RECOTHROM (Thrombin alfa [Recombinant]) has not been established. In clinical studies, the maximum volume administered was 48 mL.
| If you think you, or a person you are caring for, have taken too much RECOTHROM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
What are possible side effects from using RECOTHROM?
These are not all the possible side effects you may have when taking RECOHTROM. If you experience any side effects not listed here, tell your healthcare professional.
- thrombosis if it enters the circulatory system
- hypersensitivity reactions, including anaphylaxis, may occur.
In rare cases you may develop antibodies against RECOTHROM. These are not expected to be associated with any side effects.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| No serious side effects with topical use of RECOTHROM were observed. | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
The hospital stores RECOTHROM at room temperature. It should not be stored above 25°C or frozen.
Reconstituted solution of RECOTHROM prepared with sterile 0.9% sodium chloride may be stored for up to 24 hours at 2°C to 25°C. Reconstituted solution should be discarded after 24 hours.
Keep out of reach and sight of children.
If you want more information about RECOTHROM:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.baxter.ca, or by calling 1-888-719-