Lovenox injection solution 4000 Anti-IU/0.4 ml of prophylactic treatment of venous thrombosis (2 tubes)

Dosage form 2 -tube box
Specifications Enoxaparin sodium

Ingredient

Thành phần cho 0.4ml

Composition information	Content
Enoxaparin sodium	40mg

Uses

Indications

This is a low molecular weight heparin (LMWH). The drug is indicated in the following cases:

Preventive treatment for venous thrombosis during surgery is at an average or high risk.

Preventive treatment for deep vein thrombosis in patients with acute medical disease:

heart failure III or IV (classification of NYHA);

acute respiratory infections;

Pharmacokological

Enoxaparin is a low molecular weight heparin in which the anti -thrombotic and anticoagulant activity of the standard heparin has been separated. The drug is characterized by an anti -away or antithrombin activity. For Enoxaparin, the ratio between these two activity is 3: 6.

At the backup dose, Enoxaparin does not cause any changes to APTT.

At the treatment dose, with the maximum active peak, APTT can last from 1.5 to 2.2 times the control time. This extension of APTT reflects the remaining thrombin activity.

pharmacokinetic pharmacokinetics

Enoxaparin pharmacokinetics parameters are evaluated based on changes in anti -far and anti -IIA activity in plasma plasma in those recommended (verified by the amidon resolution method) after subcutaneous injection of the only dose and repeated dose and after the only dose intravenous injection.

Birth

After subcutaneous injection, the drug is absorbed quickly and completely (nearly 100%); The active peak in plasma is noticed for 3 to 4 hours after the injection. This value is represented by an international unit (IU) anti - far and equal to 0.18 ± 0.04 (after the dose of 2000 anti - Xa IU), 0.43 ± 0.11 (after the dose of 4000 Anti -IU) in preventive treatment, and 1.01 ± 0.14 (after the dose of 10000 anti - far) in thorough treatment.

ENOXAPARIN pharmacokinetics seems linearly within the recommended dose range.

The variation in each patient and between patients is low. After the subcutaneous injection repeats 4,000 anti - Xa IU once a day for healthy volunteers, the stable state of concentration is achieved on the 2nd day with the average Enoxaparin activity higher than the value achieved after a single dose of about 15%.

Enoxaparin activity level is in a stable state that can predict from pharmacokinetics after the single dose injection.

After subcutaneous injection, repeat 100 anti - IU/kg/day twice a day, the stable state of concentration is reached around the 3rd and 4th day with a higher average exposure than after the single dose of about 65% and the maximum and minimum value of anti -xa activity, in order, about 1.2 and 0.52 anti -anti -IU/mL.

Based on Enoxaparin pharmacokinetics, this difference may be expected in a stable state and it is in the therapeutic dose range.

After subcutaneous injection, anti -active - far in plasma is about 10 times lower than the anti -xa activity.

Anti activity - Maximum distance is noticeable about 3 to 4 hours after subcutaneous injection and reaches 0.13 anti - Xa IU/mL after the injection repeats 100 anti -IU/kg/day twice a day.

Distribution

The distribution of anti -away activity of Enoxaparin is about 5 liters and is nearly equal to blood volume.

Metabolism

mainly occurs in the liver (reducing sulfate, stool disinfection).

Elimination

After subcutaneous injection, low molecular weight heparin has a longer apparent half -selling time than non -segmented heparin.

Enoxaparin elimination takes place in one phase with a half -life of about 4 hours after the subcutaneous injection.

With low molecular weight heparin, anti -iia activity disappears from plasma faster than anti -away activity.

Enoxaparin and its metabolites are eliminated through the kidneys (unsaturated mechanisms) and bile ducts.

The retention of the kidneys, in the form of anti-active segments, accounting for about 10% of the dose used and the total excretion in the kidneys for active and inactivated products is 40% of the injected dose.

High -risk populations

Elderly:

On the elderly, the renal function has a physiological property, and the slower elimination. Treat with LMWH.

Before taking Lovenox injection solution 4000 Anti-IU/0.4 ml of prophylactic treatment of venous thrombosis (2 tubes)

How to use

drugs used by subcutaneous injection. Do not use intramuscularly.

1ml of injection solution is equivalent to about 100,000 anti - far from the international unit (IU) of Enoxaparin.

Skin injection technique

Pumps are ready to use for use immediately.

Do not push air bubbles out of the syringe.

Enoxaparin needs to be injected under the skin when the patient lies on his back. Should alternate the injection site between the anterior abdominal wall - the side or the back wall - right and left.

Poise the needle perpendicular, not under the skin, the length of the needle and the skin clamped between the thumb and index finger. This skin must be kept in the entire injection process.

Dosage

Dosage depends on the indication and condition of the patient.

Surgery is at risk of blood thrombosis

For surgery in patients with average risk of thrombosis and when the patient does not have any risk of any important thrombosis, can effectively prevent thrombosis by injecting a dose of 2000 anti - Xa IU (0.2ml) per day.

The therapeutic regimen is studied including a 2 -hour injection.

Surgery is at high risk of thrombosis

Hip and knee joint surgery:

Dosage is 4000 anti - Xa IU (0.4 ml) injected once a day.

The therapeutic regimen is studied, including a 4000 anti -fuel injection (total dose) over 12 hours before surgery, or 2000 anti -away (half -dose) injecting 2 hours before surgery.

Other cases:

When the risk of venous thrombosis is associated with surgery (especially cancer surgery and or related to the patient (especially a history of venous thrombolytic embolism), an increase may consider using a spare dose like the dose used in high -risk surgery (such as hip surgery and knee joint).

Treatment time:

Treatment with Enoxaparin, combined with common tape methods using elastic in the lower limb, must be maintained until the patient is completely proactive.

In general surgery, Enoxaparin treatment time takes less than 10 days, unless there is a risk of venous thrombosis especially related to patients.

The therapeutic benefits of preventive treatment by injection of Enoxaparin 4,000 anti - far away every day for 4 to 5 weeks after hip surgery have been proven.

If the patient still has the risk of venous thrombosis after the recommended treatment period, it is necessary to consider continuing to prevent prophylaxis, especially taking oral anticoagulants. However, the clinical benefits of long -term treatment with low molecular weight heparin or oral anticoagulant drugs have not been evaluated.

Treatment of venous thrombosis in acute medical diseases:

Dosage:

Dosage is 40mg or 4,000 anti - Xa IU/0.4ml injected under the skin once a day.

Treatment time:

Treatment for 6 to 14 days is shown to be beneficial. So far, there is no data on the effectiveness and safety of prophylaxis for more than 14 days.

If the risk of intravenous thrombosis is persistent, it is advisable to consider prolonged preventive treatment, especially with oral antibodies.

Preventing blood clotting in the body of the body of hemolysis.

Injecting into the blood vessel (into the tube of the usker system connected to the artery).

On patients, hemolysis must repeat many sessions, can prevent blood clotting in the dialysis system outside the kidney by adding an initial dose of 100 anti - far away IU/kg to the tube connecting to the artery of the fertilizer system at the beginning of the dialysis.

This dose is the only intake dose (bolus) injected into the blood vessels, only suitable for a 4 -hour or shorter dialysis. This dose can be adjusted later because of the significant variation in each individual and between individuals.

The maximum dose recommended is 100 anti - far from IU/kg. In patients with high hemorrhage, there is a high risk of hemorrhage (especially before or after surgery) or there is an active bleeding syndrome, which can perform carpeting sessions by taking a dose of 50 anti - far IU/kg (if there are two tubes connected to the blood vessel) or 75 anti - far IU/kg (if there is only one tube connected to the blood vessel).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose? In case of bleeding, it is possible to indicate treatment with protamine sulfate in some cases, but remember:

The drug will be less effective when overdose of heparin without segmentation.

Because of side effects (especially anaphylaxis), carefully evaluating the benefit/risk ratio of protamin sulfate before prescribing.

Can neutralize by slow intravenous injection (sulfate or hydrochlorid).

The dose of protamin should be used depending on:

Heparin dose was injected: 100 protamin heparin resistance units neutralize the activity of 100 anti - Xa IU of heparin low molecular weight, if used Enoxaparin sodium in the past 8 hours.

Time from heparin injection:

It is possible to infer 50 IU anti-heparin intravenously for each 100 anti-IU of Enoxaparin sodium, if you have injected Enoxaparin sodium for more than 8 hours, or if you need to use a second dose of protamine. If the Enoxaparin sodium has been injected for more than 12 hours, it is not necessary to use protamine.

Despite this, the anti -anti -active activity of Enoxaparin is never completely neutralized.

Moreover, this neutralization is only temporary due to the low molecular heparin's absorption dynamics.

In this case, the total number of protamin dose is needed into several injections (2 to 4 times in 24 hours).

In case of oral overdose, even high doses, with low molecular weight heparin (no cases have been reported), not afraid of serious consequences because the drug is poorly absorbed in the stomach and intestines.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

As all other drugs, this drug may have annoying effects at different levels on some patients.

Bleeding inside or outside at different levels of severity.

must immediately notify the doctor or nurse. Hemorrhage may start due to lesions that are likely to bleed, due to renal failure or by simultaneously used with some other drugs.

Reducing the number of platelets in the blood, may be serious in some cases and must be reported immediately to the treating doctor (see special note). Therefore, you must regularly monitor the number of platelets.

Restoration of platelets has also been reported.

The rare heavy reactions on the skin in the injection site.

More common may appear bruising or hematoma (small tumors) under the skin in the injection site and may cause pain to different degrees. These signs will disappear naturally and do not need to stop treatment.

Local or body allergic reactions.

Risk of osteoporosis (bone loss of minerals leads to brittle bone) when prolonged treatment.

Other effects: increased the concentration of some liver enzymes in the blood, hyperboly in the blood, eosinophilia occurs sporadically or along with skin reactions.

In some very rare cases, nerve damage has been reported after this injection in some anesthetic procedures.

A very rare number of allergic cases in small blood vessels have been reported.

Please inform the doctor or pharmacist to know all unwanted or uncomfortable effects that have not been stated in this guide.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

should not be used if there is any of the following situations:

Never use this drug in the following cases:

allergies to enoxaparin, heparin or its conductors, including other low molecular weight heparin.

History of serious platelet reduction II caused by heparin when using heparin without segmentation or heparin low molecular weight.

There are symptoms or hemorrhage trends associated with hemostasis (an exception that may be available to this rule is scattered intravascular coagulation, when this syndrome is not associated with heparin treatment - see the "Precautions at the time of use").

Insorbal damage can cause bleeding.

Big hemorrhage and cases of high risk of uncontrolled bleeding, including recent stroke.

often not recommended in the following cases:

Severe kidney failure (defined as clearinine clearing about 30ml/min according to the cockcroft formula, see the section "Caution at use").

In the first 24 hours after intracranial hemorrhage.

If a patient over 65 years old is in combination with aspirin (at the dose for pain and fever reduction), nonsteroidal anti -inflammatory drugs (NSAIDs) systemic, Dextran 40 (infusion).

Be cautious when using

like all other anticoagulants, hemorrhage may occur.

If bleeding occurs, you must find the cause and initiate the appropriate treatment.

In some cases, especially in thorough treatment, there may be hemorrhage:

on elderly patients;

Weight under 40kg;

kidney failure;

If the treatment continues to exceed the common treatment time of 10 days;

Used in combination with some drugs (see interactions with other drugs and other interactions);

Used in combination with some drugs that increases the risk of bleeding (see interaction with other drugs and other interactions).

These situations need special monitoring: general examination and may have to take blood tests.

Do not combat endicinal anesthesia or spinal anesthesia when this drug is used in prophylactic dose. However, there must be some measures to prevent the gap between injections and specific anesthetic monitoring.

If you are or have liver or kidney disease, ulcers or another lesions may bleed, let your doctor know.

Need to adjust the dose in patients with liver failure, kidney failure (non -dialysis).

Lovenox cannot be used swap (from unit to unit) with conventional heparin (not segmented) or heparin with other low molecular weight.

Pregnancy and lactation

Pregnancy

It is best not to take this medication for the first three months of pregnancy. In the middle and the last three months, the drug is only used if the doctor is noticeable.

If the patient finds out that he is pregnant during treatment, consult a doctor because only the doctor can assess whether or not to continue treatment.

Breastfeeding

This drug is not contraindicated in women who are breastfeeding. Normally, when pregnant or breastfeeding, patients should consult a doctor or pharmacist before taking any medicine.

Drug interaction

because of the possibility of hemorrhage, always have to tell the doctor if the patient is using one of the following drugs:

aspirin;

Non -steroid anti -inflammatory drugs (NSAIDs);

Platelet inhibitors ( abciximab , ertifibatid, isoprost, ticlopidin, tirofiban);

dextran (drug used in emergency resuscitation);

Oral anticoagulants (inhibitors of vitamin K).

To avoid possible interactions between drugs, always inform the doctor or pharmacist about the drugs that the patient is taking.

The doctor will adjust the appropriate treatment.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

Other drugs

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