Enixum injection for injection 6000 anti-XA ME / 0.6 ml ampoules 10 pcs. (enoksaparyn sodium)

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Pharmacological action

Antitumor agent from the group of antimetabolites - folic acid antagonists. Acts in the S-phase of mitosis. The mechanism of action is associated with the inhibition of the synthesis of purine nucleotides and thymidylate as a result of irreversible binding to dihydrofolate reductase, which prevents the restoration of dihydrofolate to active tetrahydrofolate. More active against rapidly growing cells. It has some immunosuppressive effect. Buy Enixum injection for injection 6000 anti-XA ME / 0.6 ml ampoules 10 pcs. (enoksaparyn sodium) in florida free shipping. Fast international shipping USA, AU, EU, UK and others.
Pharmacological action

Antitumor agent from the group of antimetabolites - folic acid antagonists. Acts in the S-phase of mitosis. The mechanism of action is associated with the inhibition of the synthesis of purine nucleotides and thymidylate as a result of irreversible binding to dihydrofolate reductase, which prevents the restoration of dihydrofolate to active tetrahydrofolate. More active against rapidly growing cells. It has some immunosuppressive effect.

Indications

Acute lymphocytic leukemia, trophoblastic disease, skin cancer, cancer of the cervix and vulva, esophageal cancer, squamous cell carcinoma of the head and neck, renal pelvis and ureter cancer, osteogenic and soft-cell sarcoma, Ewing's lung cancer, lung cancer, lung cancer tumors of the testis and ovaries, liver cancer, kidney cancer, retinoblastoma, medulloblastoma, penile cancer, lymphogranulomatosis.

Severe forms of psoriasis (in case of failure of standard therapy).

Severe form of rheumatoid arthritis (in case of failure of standard therapy).

Contraindications

Severe impaired liver and / or kidney function, leukopenia, thrombocytopenia, pregnancy. Methotrexate should not be used in immunodeficiency conditions.

Special instructions

Methotrexate should not be used for ascites, pleural effusion, peptic ulcer of the stomach and duodenum, ulcerative colitis, gout or nephropathy (including history).

It is not recommended for use in patients with chickenpox (including recently transferred or after contact with patients), herpes zoster and other acute infectious diseases.

Before starting therapy and during treatment, the picture of peripheral blood, liver and kidney function, and chest x-ray should be monitored.

In the treatment of rheumatoid arthritis or psoriasis, a comprehensive blood count should be done at least 1 time per month, and laboratory tests of liver or kidney function at least 1 time in 1-2 months.

When applied for psoriasis, the local treatment of the disease should not be interrupted. In case of an overdose, the use of calcium folinate is recommended (but not later than 4 hours later).

When conducting combination antitumor therapy, special care should be taken while using methotrexate in high doses with drugs that have a nephrotoxic effect (for example, with cisplatin).

Do not recommend vaccinating patients and their families.

Methotrexate (even at low doses) with acetylsalicylic acid should be combined with caution.

In experimental studies, the carcinogenic and mutagenic effects of methotrexate have been established.

Dosage and administration of

Except in special cases (see below Treatment of myocardial infarction with ST segment elevation, medication or by means of percutaneous coronary intervention, and Prevention of thrombosis in the extracorporeal circulatory system during hemodialysis), enoxaparin sodium is administered. Injections are preferably carried out in a patient lying position. Injections should be carried out alternately in the left or right anterolateral or posterolateral surface of the abdomen.

The needle must be inserted vertically (not from the side) into the skin fold for the entire length, assembled and held until the injection is completed between the thumb and forefinger. Skin fold, released only after completion of the injection. Do not massage the injection site after drug administration.

A pre-filled disposable syringe is ready to use.

The drug can not be administered intramuscularly!

Prevention of venous thrombosis and embolism during surgical interventions, especially during orthopedic and general surgical operations

For patients with a moderate risk of developing thrombosis and embolism (general surgery), the recommended dose of the drug is 20 mg once a day subcutaneously. The first injection is made 2 hours before surgery.

For patients with a high risk of thrombosis and embolism (general and orthopedic surgery), the drug is recommended at a dose of 40 mg once a day subcutaneously, the first dose is administered 12 hours before surgery, or 30 mg 2 times a day with the start of administration after 12-24 h after surgery.

The duration of treatment with the drug on average is 7-10 days. If necessary, therapy can be continued until while there remains a risk of thrombosis and embolism (for example, in orthopedics, enoxaparin sodium is used 40 mg once a day for 5 weeks).

Peculiarities of prescribing the drug in spinal / epidural anesthesia, as well as in percutaneous coronary angioplasty, are described in the Special Instructions section.

Prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases

Recommended dose of enoxaparin sodium is 40 mg once daily subcutaneously for 6-14 days.

Treatment of deep vein thrombosis, which is accompanied or not accompanied by pulmonary thromboembolism

Enixum® is administered subcutaneously at a rate of 1.5 mg / kg once a day or at a dose of 1 mg / kg twice a day. In patients with complicated thromboembolic disorders, the drug is recommended to be used at a dose of 1 mg / kg twice a day.

Duration of treatment is an average of 10 days. It is advisable to immediately start anticoagulant therapy for oral administration, while enoxaparin sodium therapy should be continued until a sufficient anticoagulant effect is achieved, i.e. INR should be 2.0-3.0. If necessary, control of the anticoagulant effect should be evaluated by anti-Xa activity.

Treatment of unstable angina pectoris and myocardial infarction without Q wave in combination with acetylsalicylic acid Enixum® is administered at a rate of 1 mg / kg body weight every 12 hours subcutaneously, with the appointment of acetylsalicylic acid inside at a dose of 100-325 mg once a day.

The average duration of treatment is 2-8 days (until stabilization of the clinical condition of the patient).

Treatment of myocardial infarction with ST-segment elevation, medication or with percutaneous coronary intervention

Treatment begins with an intravenous bolus of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) is administered subcutaneously at a dose of 1 mg / kg (and during the first two subcutaneous injections, 100 mg of enoxaparin sodium can be administered as much as possible). Then, all subsequent subcutaneous doses are administered every 12 hours at a rate of 1 mg / kg (i.e., with a body weight of more than 100 kg, the dose may exceed 100 mg).

In persons 75 years of age and older, the initial intravenous bolus is not used. Enoxaparin sodium is administered subcutaneously at a dose of 0.75 mg / kg every 12 hours (moreover, during the first two subcutaneous injections, 75 mg of enoxaparin sodium can be administered as much as possible). Then, all subsequent subcutaneous doses are administered every 12 hours at a rate of 0.75 mg / kg (i.e., with a body weight of more than 100 kg, the dose may exceed 75 mg).

When combined with thrombolytics (fibrin-specific and fibrin-specific), enoxaparin sodium should be administered in the range from 15 minutes before starting thrombolytic therapy to 30 minutes after it. After the detection of acute myocardial infarction with an ST segment elevation, acetylsalicylic acid should be started at the same time as soon as possible, which, in the absence of contraindications, should continue for at least 30 days in doses of 75 to 325 mg daily.

The recommended duration of treatment with the drug is 8 days or until the patient is discharged from the hospital, if the hospitalization period is less than 8 days. The bolus administration of enoxaparin sodium should be given through a venous catheter, and enoxaparin sodium should not be mixed or administered with other drugs. In order to avoid the presence of traces of other drugs in the system and their interaction with enoxaparin sodium, the venous catheter should be flushed with a sufficient amount of 0.9% sodium chloride or dextrose solution before and after the intravenous bolus administration of enoxaparin sodium. Enoxaparin sodium is compatible with 0.9% sodium chloride solution and 5% dextrose solution.

For bolus administration of 30 mg of enoxaparin sodium in the treatment of acute myocardial infarction with ST segment elevation, 60 mg, 80 mg and 100 mg of excess syringe are removed from glass syringes so that so that only 30 mg (0.3 ml) is left in them. A dose of 30 mg can be directly administered intravenously.

For intravenous bolus administration of enoxaparin sodium through a venous catheter, pre-filled syringes for subcutaneous administration of 60 mg, 80 mg and 100 mg can be used. 60 mg syringes are recommended, as this reduces the amount of drug removed from the syringe. 20 mg syringes are not used, because they do not have enough drug for the bolus administration of 30 mg of enoxaparin sodium. 40 mg syringes are not used, since there are no divisions on them and therefore it is impossible to accurately measure the amount of 30 mg.

In patients undergoing transdermal coronary intervention, in case if the last subcutaneous injection of enoxaparin sodium was carried out less than 8 hours before the balloon catheter introduced into the site of narrowing of the coronary artery was inflated, additional administration of enoxaparin sodium was not required. If the last subcutaneous injection of enoxaparin sodium was administered more than 8 hours before the balloon catheter was inflated, an additional intravenous bolus injection of enoxaparin sodium at a dose of 0.3 mg / kg should be performed.

To increase the accuracy of additional bolus injection of small volumes into the venous catheter during percutaneous coronary interventions, it is recommended to dilute the drug to a concentration of 3 mg / ml. Dilution of the solution is recommended immediately before administration.

To obtain a solution of enoxaparin sodium with a concentration of 3 mg / ml using a pre-filled syringe, it is recommended to use a container with an infusion solution, from which part of the solution is removed using a regular syringe to the required volume. Enoxaparin sodium (the contents of the hypodermic syringe) is injected into the remaining infusion solution.

Volume of pre-filled syringe

Amount of

infusion solution left in the container 0.3 ml

10 ml

0.6 ml

20 ml

The contents of the diluted enoxaparin sodium solution are mixed gently. For injection, the required volume of the diluted solution of enoxaparin sodium is extracted with a syringe, which is calculated by the formula:

Volume of the diluted solution = Patient's body weight (kg) x 0, 1 or using the table below.

Volumes to be administered intravenously after dilution

Patient body weight (kg)

Required dose (0.3 mg / kg) [mg]

Required volume of solution diluted to 3 mg / ml [ml]

45

13.5

4.5

50

15

5

55

16.5

5.5

60

18

6

65

19.5

6.5

70



21

5

7.5

80

24

8

85

25.5

8.5

90

27

9

95

28.5

contact system 30

during hemodialysis (usually with a session duration of no more than 4 hours)

The dose of enoxaparin sodium is on average 1 mg / kg. For patients with a high risk of bleeding, the dose should be reduced to 0.5 mg / kg with dual vascular access or to 0.75 mg with single vascular access.

For hemodialysis, Enixum® should be injected into the arterial area of ​​the shunt at the beginning of the hemodialysis session. One dose, as a rule, is enough for a four-hour session, however, if fibrin rings are detected with longer hemodialysis, you can additionally introduce the drug at a rate of 0.5-1 mg / kg.

Elderly patients

With the exception of treatment for myocardial infarction with ST-segment elevation (see above), for all other indications of reduced doses of enoxaparin sodium in elderly patients, if they do not have impaired renal function, it is not required.

Patients with renal failure

Severe renal impairment (endogenous creatinine clearance less than 30 ml / min). The dose of enoxaparin sodium is reduced in accordance with the tables below, since the accumulation of the drug occurs in these patients.

When using the drug for therapeutic purposes, the following dosage regimen correction is recommended:

Normal dosing regimen

Dosing regimen for severe renal failure

1 mg / kg subcutaneously 2 times a day

1 mg / kg subcutaneously 1 time per day

1.5 mg subcutaneously once a day

1 mg / kg subcutaneously once a day

Treatment of acute myocardial infarction with ST segment elevation in patients <75 years old

Once: 75 mg / kg subcutaneously 1 mg / kg subcutaneously twice a day without initial bolus injection (maximum 75 mg for each of the first two subcutaneous injections)

1 mg / kg subcutaneously once a day without initial bolus injection (maximum 100 mg for the first subcutaneous injection)

When using the drug for prophylactic purposes, the following correction of the

dosing regimen is recommended. Normal dosing regimen

Dosing regimen for severe renal failure

40 mg subcutaneously once a day

20 mg subcutaneously once a day

20 mg subcutaneously once daily

20 mg subcutaneously once daily

recommended correction mode can not be applied during hemodialysis.

In case of mild (creatinine clearance of 50-80 ml / min) and moderate (creatinine clearance of 30- 50 ml / min) renal failure, dose adjustment is not required, however, laboratory monitoring of therapy should be carried out more carefully.

Patients with liver failure

Due to the lack of clinical studies, caution should be exercised when using enoxaparin sodium in patients with impaired liver function.

Side effects

From the digestive system: possible ulcerative stomatitis, anorexia, gingivitis, pharyngitis, nausea rarely - diarrhea, melena, enteritis, pancreatitis in some cases (with prolonged daily use) - liver necrosis, cirrhosis, fatty atrophy, periportal liver fibrosis.

From the hemopoietic system: leukopenia, anemia, thrombocytopenia.

From the side of the central nervous system: feeling tired, dizziness rarely - headache, aphasia, drowsiness, cramps.

From the reproductive system: disorders of oogenesis and spermatogenesis, oligospermia, menstrual irregularities, decreased libido, impotence.

From the urinary system: hematuria, cystitis, severe renal impairment.

Allergic reactions: chills, decreased resistance to infection rarely - urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Dermatological reactions: skin rash, photosensitivity, pigmentation disorders, telangiectasia, acne, furunculosis.

Overdose

Symptoms: hemorrhagic complications in case of accidental overdose with subcutaneous administration of enoxaparin sodium. In case of accidental ingestion of even large doses, absorption of the drug is unlikely.

Treatment: neutralize the effect of enoxaparin sodium by slow intravenous (iv) administration of protamine sulfate. 1 mg of protamine sulfate neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if the drug was administered no more than 8 hours before the administration of protamine sulfate.

0.5 mg protamine sulfate neutralizes the anticoagulant effect of 1 mg enoxaparin sodium if it was administered more than 8 hours ago or if a second dose of protamine sulfate is needed.

If, however, 12 hours or more have passed after the administration of enoxaparin sodium, administration of protamine sulfate is not required. However, even with the introduction of large doses of protamine sulfate, anti-Xa, the activity of enoxaparin sodium is not completely neutralized (by a maximum of 60%).

Storage conditions

At a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Expiration

2 years. Do not use after the expiration date indicated on the package.

Terms and conditions

prescription

dosage form

injection



Enixum injection for injection 6000 anti-XA ME / 0.6 ml ampoules 10 pcs. (enoksaparyn sodium) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Enixum injection for injection 6000 anti-XA ME / 0.6 ml ampoules 10 pcs. - Sale. PayPal accept. Free shipping florida. Fast international shipping.

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