Enoksaparin-Pharmex solution for infection. 2000 Anti-ha ME/0.2ml syringe of 0.2 ml No. 1

Solution is applied to injections of Enoksaparin-Pharmex at the following indications:

• prevention of a venous thrombembolia at surgical interventions which are followed by moderate and high thrombogenic risk;
• prevention of a deep vein thrombosis at the patients who are on a bed rest in connection with acute therapeutic diseases: heart failure ІІІ or class ІV on classification NYHA, acute respiratory insufficiency, an acute infectious or rheumatic disease, with at least one more risk factor of a venous thrombembolia;
• prevention of a thrombogenesis in an extracorporal contour of blood circulation during a hemodialysis (the procedure on average lasts approximately till 4 o'clock);
• treatment of the diagnosed deep vein thrombosis which is followed or is not followed by a pulmonary embolism and has no heavy clinical symptoms, except for a pulmonary embolism which demands treatment by thrombolytic means or surgical intervention;
• treatment of unstable stenocardia and acute myocardial infarction without Q tooth in a combination with acetylsalicylic acid;
• treatment of an acute myocardial infarction with rise / elevatsiyey ST segment in a combination with thrombolytic means at patients, which perhaps further use of coronary angioplasty and also at patients to whom this procedure is not carried out.

Structure

Active ingredient: enoksaparin sodium;

1 ml of solution 10000 Anti-ha that is equivalent to 100 mg to a sodium enoksaparin;

2000 Anti-ha ME / 0.2 ml that is equivalent to an enoksaparin of sodium of 20 mg;

4000 Anti-ha ME / 0.4 ml that is equivalent to an enoksaparin of sodium of 40 mg;

6000 Anti-ha ME / 0.6 ml that is equivalent to an enoksaparin of sodium of 60 mg;

8000 Anti-ha ME / 0.8 ml that is equivalent to an enoksaparin of sodium of 80 mg;

Excipients: water for injections.

Contraindication

• Hypersensitivity to an enoksaparin, heparin or its derivatives, including to other low-molecular heparins.
• Existence in the anamnesis heavy the II heparin-the induced thrombocytopenia (HIT) which was caused by not fractional heparin or low-molecular heparin.
• Bleeding or the tendency to bleeding connected with disturbance of a hemostasis (DVS can be a possible exception of this contraindication if it is not connected with a geparinoterapiya.
• Organic lesions which can cause bleeding.
• Active clinically significant bleeding.

Route of administration

1 mg (0.01 ml) of an enoksaparin of sodium corresponds to about 100 activity units Anti-ha of ME. Фленокс® it is necessary to enter subcutaneously at preventive and medical use, except for the following cases:

• use of medicament for anti-coagulation in practice of a hemodialysis;
• treatment of patients with a myocardial infarction with an elevation of a segment of ST which need intravenous bolyusny administration.

Feature of use

pregnant only in case of establishment by the doctor of the accurate need for such treatment.

to

Children

It is contraindicated.

Drivers

Influence of an enoksaparin of sodium on ability to run vehicles and to work with other mechanisms is absent or is insignificant.

Accidental overdose at hypodermic introduction of considerable doses of NMG can lead

to emergence of hemorrhagic complications.

in case of bleeding of some patients can treat protamin sulfate, at the same time it is necessary to consider that:

efficiency of protamin of sulfate is much lower than

• , than efficiency which is observed at overdose of not fractional heparin;
• before sulfate protamin use because of possibility of the undesirable phenomena (in particular an acute anaphylaxis) should weigh carefully a ratio advantage/risk.

Neutralization of an enoksaparin to carry out

by slow intravenous administration of protamin (sulfate or a hydrochloride).

Necessary dose of protamin depends from:

• entered heparin dose (100 anti-heparin units of protamin neutralize activity 100 Anti-ha of ME NMG) if from the moment of introduction of an enoksaparin of sodium there passed no more than 8 hours;
• time, passed after a heparin injection:
• if enoksaparin sodium was entered more than 8 hours ago or it is necessary to enter the second dose of protamin, it is possible to carry out infusion of 50 anti-heparin units of protamin on 100 Anti-ha of ME of an enoksaparin;
• if enoksaparin was entered more than 12 hours ago, then there is no need for administration of protamin.

These recommendations are intended to

for patients with normal function of kidneys which receive repeated doses of drug.

However completely cannot neutralize Anti-ha activity of an enoksaparin.

Besides, neutralization can be temporary owing to features of pharmacokinetics of absorption of NMG therefore there can be a need to distribute the general calculated protamin dose on several injections (2-4) which to enter within 24 hours.

At hit of low-molecular heparin in a stomach, even in large numbers, heavy complications are improbable (such cases were not registered) owing to insignificant absorption of medicine in a stomach and intestines.

Side effects

In clinical trials by undesirable reactions about which it was reported most often were the hemorrhagic phenomena, thrombocytopenia and a thrombocytosis.

Subcutaneous injection - not to mix

with other medicines.

Storage conditions

to Store

in original packing at a temperature not above 25 °C. Not to freeze.

to Store

out of children's reach.

Expiration date - 2 years.