Universal reference book for medicines
Product name: FORTELYSIN (FORTESILIN)

Active substance: nonappropriate

Type: Thrombolitic

Manufacturer: SupraGen (Russia)

Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration
in the form of a formless or in the form of a tablet of a lyophilized mass of white or almost white color.

1 f.

(recombinant protein containing the amino acid sequence of staphylokinase) 5 mg (745,000 IU)

Excipients: L-arginine 15 mg, L-histidine 2 mg, glycine 30 mg, povidone K17 20 mg, polysorbate 20 0.4 mg.

The composition of the solvent: sodium chloride injection for 0.9% 5 ml.

5 mg - vials of glass (1) complete with a solvent of 5 ml amp.
1 PC. - Packing contour (1) polymeric - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

The active principle of Fortilitis is the substance of Forteplase, which is a single-chain molecule consisting of 138 amino acids, with a molecular weight of 15.5 kDa.

Forteplase activates plasminogen with the formation of a stoichiometric complex in the ratio 1: 1.
Forteplaze reacts only with plasminogen associated with partially degraded fibrin located in the thrombus region (the so-called? -plasminogen), and does not interact with plasminogen in the systemic circulation, which determines its fibrin selectivity. The resulting complex of Plateplase-plasminogen transforms plasminogen into plasmin, which lyses (dissolves) fibrin clots into the thrombus.
The fibrin selectivity of the substance of Forteplase is also due to the high rate of neutralization of its complex with plasma in the blood plasma in comparison with the thrombus.
Therefore, the fibrinolytic effect is not accompanied by a decrease in fibrinogen of the blood. With the use of the drug Fortelizin, no anti-staphylokinase neutralizing antibodies are formed in the blood in connection with the amino acid substitutions in the immunodominant epitope of native staphylokinase. In rare cases, transient formation of antibodies to the drug Fortyuzin (in low titres) can be observed.
After intravenous administration of Fortilitis, a slight decrease in blood fibrinogen is observed, less than 10%, within 1 day after its administration.
Angiographic data show that with the use of Fortilitin, the restoration of coronary blood flow is observed in no less than 80% of patients with acute myocardial infarction with ST-segment elevation.
PHARMACOKINETICS

No pharmacokinetics studies have been performed.

INDICATIONS

- Acute myocardial infarction (in the first 6 hours).

DOSING MODE

Only for intravenous administration!

Fortylysine is administered at a dose of 15 mg.

Before the administration of the preparation, the contents of the 5 mg bottle (745,000 IU) are diluted in 5 ml of 0.9% sodium chloride solution.

The drug Fortilitis is recommended to enter one of the two schemes presented.

The first scheme: Fortylysine is administered by two boluses (this scheme is recommended for use in prehospital and early hospital stages).
10 mg (2 bottles) and after 30 minutes - 5 mg (1 bottle).
Second scheme: Fortylysine is administered bolus-infusion (this scheme is recommended for use in hospital settings).

10 mg (2 bottles) is administered bolus, 5 mg (1 bottle) is further diluted in 50 ml of 0.9% sodium chloride solution and injected infusion for 30 minutes.
Solution of the drug Fortylezin is prepared immediately before use, not subject to storage!
Do not dilute the contents of the bottle with water for injection!
Do not dilute with dextrose (glucose) solution!
SIDE EFFECT

There may be bleeding of varying severity.
The types of hemorrhage associated with thrombolytic therapy can be divided into two large groups:
- external bleeding (usually from the sites of blood vessel puncture);

- internal bleeding in any part or body cavity.

There may be reperfusion arrhythmias (ventricular arrhythmia, extrasystole, atrial fibrillation, atrioventricular block from I degree to complete blockade, ventricular fibrillation, ventricular tachycardia), which can lead to cardiac arrest, death and require cardiac re- cardation.
The possibility of developing allergic reactions is not ruled out.
The administration of Fortilitis in therapeutic doses, as a rule, does not lead to arterial hypotension, but it can not be ruled out that it can occur.

CONTRAINDICATIONS

- diseases that show increased bleeding (hemorrhagic diathesis, hemophilia, thrombocytopenia), or a condition with a high risk of bleeding;

- extensive surgical interventions or extensive injuries up to 4 weeks;

- carrying out resuscitation measures that required intensive indirect cardiac massage, including cardiopulmonary resuscitation (more than 10 minutes);

- cardiogenic shock (class IV according to Kiplip);

- severe liver disease with severe hemostatic system disorders (hepatic insufficiency, liver cirrhosis, portal hypertension, active hepatitis);

- Puncture of uncompressed vessels (jugular vein, subclavian vein);

- hemorrhagic retinopathy (including diabetic);

- hemorrhagic stroke (prescription less than 6 months);

- refractory arterial hypertension (systolic blood pressure (BP) more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg);

- Suspicion of exfoliating aortic aneurysm;

- septic endocarditis;

- simultaneous reception of indirect anticoagulants;

- continuing severe or threatening bleeding (including recently transferred);

- Intracranial hemorrhage in anamnesis or suspicion of intracranial hemorrhage;

aneurysm of blood vessels;

- intracranial or spinal surgery (in the past 2 months);

- pericarditis;

- Acute pancreatitis, peptic ulcer of the stomach and duodenum (within 3 months after the exacerbation), varicose veins of the esophagus;

- Central nervous system diseases in the anamnesis (neoplasms, aneurysm, surgical intervention on the brain and spinal cord);

- neoplasms with an increased risk of bleeding;

- age under 18 years (effectiveness and safety not established);

- Hypersensitivity to the drug.

With caution: age over 75 years, arterial hypertension.

PREGNANCY AND LACTATION

In preclinical studies it was shown that the drug does not have embryotoxic, teratogenic and rsprotoxic properties.

The drug Fortylezin is not recommended for use during pregnancy, except when the benefit to the mother exceeds the potential risk to the fetus.

There is no data on excretion of the drug Fortylezin with breast milk.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe liver disease with severe disorders of the hemostasis system (hepatic insufficiency, cirrhosis, portal hypertension, active hepatitis).

APPLICATION FOR CHILDREN

Contraindicated for children under 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution: age over 75 years.

SPECIAL INSTRUCTIONS

Fortilitis should be administered as early as possible from the onset of clinical symptoms of acute myocardial infarction.

It is necessary to control the use of the drug Fortelizin behind the places of possible bleeding, including the place of insertion of the catheter and puncture.
In the event of serious bleeding, the administration of heparin should be discontinued.
Impact on the ability to drive vehicles and manage mechanisms

Effect of the drug Fortelizin on the ability to drive vehicles, machinery, etc.
not studied.
OVERDOSE

Symptoms: hemorrhagic complications, bleeding of varying severity, up to life-threatening.

Treatment: small bleedings can be stopped by temporarily stopping infusion of heparin with additional control of activated partial thromboplastin time (APTT).

If life-threatening bleeding occurs, transfusion of freshly frozen plasma, whole blood or its components may be required.
If necessary, the administration of antifibrinolytic agents (aminocaproic and / or tranexamic acid) is possible.
DRUG INTERACTION

No clinically significant side effects of the drug Fortylysine administered together with other drugs used in patients with acute myocardial infarction: heparin, acetylsalicylic acid as antiplatelet agent, clopidogrel, narcotic analgesics, nitrates for intravenous administration, beta-adrenoblockers, ACE inhibitors.

With the simultaneous use of the drug Fortylysine with antiplatelet agents and drugs that affect the blood coagulation system, the risk of bleeding increases.

The drug Fortylezin can not be mixed with other medicinal products in one vial for infusions or in a common system for intravenous administration.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a vertical position, in a dry, protected from light place at a temperature of 2 to 25 ° C.
Keep out of the reach of children. Shelf life - 3 years. Solvent - 5 years.
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