Medicinal Products

ACTOSOLV 100,000 IU

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Urokinase
laboratory: Eumedica SA

Powder for solution for injection
Box of 1 Bottle
All forms

Indication

- Treatment of arterial and venous occlusions caused by formation or newly formed thrombi, pulmonary embolism, especially when recent streptokinase thrombolytic therapy is contraindicated. - Restoration of the permeability of venous catheters (central venous catheters and dialysis catheters), in case of obstruction related to a thrombus formation or newly formed.

Dosage ACTOSOLV 100, 000 IU Powder for solution for injection Box of 1 vial

- This product should only be used in hospital and under strict medical supervision. Its use prohibits any intramuscular injection.
- The dosage varies according to the nature of the condition and the route of administration.
INTRAVENOUS PATH :
- Moderate dosage:
. 2000 IU / kg / h for 24 hours and beyond, in venous thromboses and arterial ischemia of the limbs.
. At the time of introduction of the infusion, an initial dose of 2000 IU / kg of urokinase can be injected in 20 minutes.
. At this dose, heparin can be immediately associated with urokinase at its usual dosage, but this requires more stringent biological monitoring.
- Strong dosage:
. 4000 to 5000 IU / kg / h for 12 hours. This dosage was used in pulmonary embolism without the addition of heparin, the heparin therapy being started after the urokinase infusion.
. At the time of the introduction of the infusion, some authors recommend the injection of an initial dose of 4400 IU / kg of urokinase passed in 20 minutes.
OTHER WAYS :
In some cases, urokinase injection may be performed near the site of thrombosis or embolism:
- injection into the pulmonary artery in pulmonary embolism;
- intracoronary injection in myocardial infarction;
- intra-arterial injection in the vicinity of the thrombus in the acute limb ischemia;
pulmonary embolism: about 2000 IU / kg / h for 24 hours; severe pulmonary embolism: 15000 IU / kg delivered in 10 minutes by single injection into the pulmonary artery;
- acute limb ischemia: about 1000 IU / kg / h.
RESTORATION OF THE PERMEABILITY OF VENOUS CATHETERS (CENTRAL VENOUS CATHETERS AND DIALYSIS CATHETERS) :
Before administering urokinase, it is important to make sure that the catheter dysfunction is not related to mechanical malposition or obstruction.
AT THE ADULT :
- In first intention:
. Check the catheter occlusion by attempting to aspirate the blood with a syringe.
. In case of failure, aspirate and then inject urokinase according to the recommended dosage.
. Injection of a solution of concentration 5000 to 10000 IU / ml, in quantity depending on the volume of the catheter and to be injected into each obstructed branch.
. Wait at least 15 to 30 minutes and attempt to aspirate the catheter.
. Verification of the repealing after at least 15 to 30 minutes.
. The operation is renewable if necessary 1 to 4 times.
- In case of failure:
. If reversal is not achieved, and after verification of catheter placement and absence of contraindication to administration of urokinase generally, an infusion may be initiated as described below.
. Adult infusion of 20000 IU / h for hemodialysis catheters and 40000 IU / h for other catheters for a minimum of 1 h or until repealing without exceeding a maximum dose of 250000 IU.
IN THE CHILD :
- In first intention:
. Check the catheter occlusion by attempting to aspirate the blood with a syringe.
. In case of failure, aspirate and then inject urokinase according to the recommended dosage.
. Injection of a solution of concentration 5000 IU / ml to 10000 IU / ml in quantity depending on the volume of the catheter or 4400 IU / kg, and to be injected into each obstructed branch.
. Wait at least 15 to 30 minutes and attempt to aspirate the catheter.
. Verification of the repealing after at least 15 to 30 minutes.
. The operation is renewable if necessary 1 to 4 times.
- In case of failure:
. If reversal is not achieved, and after verification of catheter placement and absence of contraindication to administration of urokinase generally, an infusion may be initiated as described below.
. Infusion in the child of 4400 IU / kg / h according to the echographic evolution or during 4 h at most.

Against indications

CONTRAINDICATED:
- Clinics :
Like all thrombolytic agents, ACTOSOLV should not be used in all cases associated with a high bleeding risk:
. Hemorrhagic diathesis known.
. Concomitant treatment with oral anticoagulants (eg warfarin).
. Severe or potentially dangerous haemorrhage, manifest or recent.
. Uncured gastroduodenal ulcers.
. History or suspicion of intracranial hemorrhage.
. Suspected subarachnoid hemorrhage or history of subarachnoid hemorrhage associated with aneurysm.
. History of severe central nervous system injury (eg neoplasia, aneurysm, intracerebral or intraspinal surgery).
. Recent traumatic external cardiac massage (less than 10 days), delivery, recent puncture of a vessel not accessible to compression (eg puncture of the subclavian or jugular vein).
. Uncontrolled severe hypertension.
. Bacterial endocarditis, pericarditis.
. Acute pancreatitis.
. Gastrointestinal ulcers documented during the past 3 months, esophageal varices, arterial aneurysm, arterial or venous malformations.
. Neoplasia increasing the risk of haemorrhage.
. Severe hepatopathy, including hepatic failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis.
. Surgical intervention or major trauma during the last 3 months. In special cases where the operative wound can be perfectly compressed, this time can be shortened: contraindicated for 15 days.
- Biological :
Treatment is contraindicated in the event of TP reduction, prolongation of Howell's time, or activated partial thromboplastin unless these abnormalities are due to previously prescribed anti-vitamin K or heparin. It is then necessary to wait a few hours or possibly to introduce the treatment while compensating or neutralizing the deficit.
- Its use prohibits any intramuscular injection.
NOT RECOMMENDED :
Pregnancy: Given the existence of a high level of urokinase inhibitors that progressively increases to the end, there is a risk of inefficacy of treatment.

Adverse effects Actosolv

- Possibility of febrile episodes.
- Haemorrhages (most often at the injection site or general).
In the indication of restoration of the permeability of venous catheters (central venous catheters and dialysis catheters) in direct injection, the product is supposed to remain in the catheter; in the case of an infusion, the dose administered being very low compared to the doses possibly delivered by infusion in the other indications, the risk of haemorrhages is much lower.
- The risk of transmission of infectious agents can not be definitively excluded when drugs prepared from human urine are administered.
- This also applies to previously unknown pathogens.
This risk is, however, limited by the extraction / purification process which includes viral elimination and / or inactivation steps, the capacity of which has been validated on model viruses and in particular for HIV, herpesviruses and viruses. papillomavirus.
- No case of viral contamination associated with administration of urokinase extracted from human urine has been reported.

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