Other names: Clexane

 

Enoxaparin sodium

Each prefilled syringe contains 40 mg enoxaparin sodium as the active ingredient equivalent to 4000 I.U.

Clexane also contains water for injections as an inactive ingredient.

 

Clexane (Heparin), is available as a solution for injection in ready to use prefilled syringes. Packs of 2 and 10 prefilled syringes of 0.4 ml each containing 40 mg (4000 IU) of the product are available. Clexane 40 mg (4000 IU) syringes contain a low molecular weight heparin (LMWH) denomintated enoxaparin which acts by preventing blood clot formation and has a high anti Xa activity and a low anti IIa activity. This medication belongs to the group called anticoagulant agents.

 

This medication is indicated for the prevention of venous thrombosis in particular those which may be associated with orthopedic or general surgery and in non surgical, immobilized patients whose situation could be considered moderate or high risk for clotting. It is also indicated for the prevention of thrombus formation in the extracorporeal circulation during hemodialysis, in the treatment of established deep vein thrombosis (with or without pulmonary embolism) and in the treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.

 

- If you are allergic to enoxaparin sodium, heparin or its derivatives including other low molecular weight heparins (LMWH's)

- If you suffer active major bleeding (accumulation of blood in blood vessels that cause them to burst) or conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke (bleeding caused by a blood vessel in the brain that breaks).

- If you have ever suffered a decrease in the number of platelets in the blood (thrombocytopenia) or formation of thrombus due to the administration of enoxaparin.

- In cases of inflammation with ulcers of the membrane lining of the heart (acute bacterial endocarditis).

- If you have organic lesions liable to bleed such as stomach or duodenal ulcers.

- If you suffer a major hemorrhage related to the process of stopping or slowing the circulation of the blood (hemostasis) except in cases where the problem with coagulation that is not heparin induced.

If you intend to undergo surgery where local anesthesia cannot be used.

 

 

- As with any other anticoagulant it may cause bleeding in other parts of the body.

- Never interchange Clexane (Heparin) with any other heparin without consulting your doctor beforehand.

- In conditions with increased potential for bleeding such as: changes in the coagulation process, impaired hepatic function (hepatic insufficiency), history of ulcer due to excess stomach acid (peptic ulcer), uncontrolled severe arterial hypertension, a disorder of the retina caused by hypertension or by diabetes (metabolic disorder characterized by a lack of insulin secretion or insulin action), spinal or epidural anesthesia, use of tubes or probes of intrathecal type or recently undergone brain or eye surgery.

- If undergoing a type of anesthesia called spinal anesthesia (into the spine) or epidural (in one of the membranes that cover the spinal cord) your doctor should decide whether it is convenient to administer this medication at prophylactic dosage ranges. If administered, inform your doctor if you notice any signs or symptoms of neurological impairment such as back pain, numbness, weakness in your legs or bowel or bladder dysfunction. In addition your doctor should take into account when the anticoagulant effect of Clexane is lower to place or remove the catheter.

- No increased bleeding tendency is observed in the elderly (especially patients eighty years of age and older) with the prophylactic dosage ranges. Elderly patients may be at an increased risk for bleeding complications with higher doses. In this case your doctor may request you have blood analysis done during treatment.

- Patients whose kidney function is impaired (renal insufficiency) should inform their doctor because there is an increased the risk of bleeding when using Clexane. If you suffer severe renal impairment, your doctor should indicate what dosage you should take. Although no dose adjustment is recommended in patients with mild or moderate renal impairment, your doctor may recommend you have blood analysis' done. (See 3 How to use Clexane 40 mg (4000 IU) syringes).

- Low-weight women (less than 45 kg) or low-weight men (less than 57 kg) should take into account that treatment with Clexane may lead to a higher risk of bleeding. Therefore, careful clinical observation is advised in these patients during treatment.

- If you are being treated for unstable angina in hospital with subcutaneous injections (percutaneous coronary revascularisation procedures), the administration of Clexane should be strictly controlled by your doctor since there is an increased risk of bleeding.

- The use of Clexane by persons with prosthetic heart valves usually causes problems, therefore if this is your case inform your doctor before initiating treatment.

- At doses used to prevent blood clots (prophylaxis of venous thromboembolism), Clexane does not usually influence blood test results.

- This risk of reducing blood platelet count (thrombocytopenia) between the 5th and 21st day following the beginning of treatment exists with Clexane. Your doctor should determine whether it is necessary to do blood tests or to take appropriate measures.

 

Ask your doctor or pharmacist for advice before taking any medication.

Clexane 40 mg (4000 IU) syringes should not be used during the first trimester of pregnancy and it is not recommended for use in pregnant women with prosthetic heart valves.

 

 

Ask your doctor or pharmacist for advice before taking any medication.

Clexane 40 mg (4000 IU) syringes should not be used during breastfeeding.

 

Clexane has no effect on the ability to drive and operate machines.

 

Clexane (Heparin) is not recommended for use in children as the safety and effectiveness of enoxaparin in this group has not been established.

 

It is important that you tell your doctor or pharmacist if you are taking or have recently taken any other medications including any you have bought without a prescription.

 

It is recommended that agents which affect the organism's mechanisms of blood coagulation and the function of the blood cells called platelets, be discontinued prior to Clexane therapy unless strictly indicated.

 

 

- Some medications used to treat inflammation and pain, for example acetylsalicylic acid, salicylates and other non-steroidal anti-inflammatory drugs (NSAID's) administered via injection such as ketorolac.

- Oral medicines used to prevent blood clots (oral anticoagulants) and medicines used to break up blood clots (thrombolytics).

- Medications called glucocorticoids administered via injection.

Agents that prevent blood clot formation include medications such as:

- Medications that contain active substances such as ticlopidine, dipiridamol, sulfinpyrazone and clopidogrel.

- Medications with dextran as the active substance and that are administered via injection.

- Other anti platelet agents including glycoprotein IIb/IIIa anticoagulants

If the combination treatment is necessary Clexane should be used with careful clinical and laboratory monitoring since the risk of bleeding is considerably increased.

 

Follow these instructions unless otherwise specified by your doctor. Before you use Clexane 40 mg (4000 IU) syringes carefully read the following instructions.

 

Do not administer by the intramuscular route.

The prefilled Clexane 40 mg (4000 IU) syringes should be used only once and are ready for use. The air bubble in the syringe should not be expelled before the injection.

 

Take into account that the different low molecular weight heparins (LMWH's) are not equivalent, therefore you should follow the specific dosage schedule and method of administration recommended for Clexane 40 mg. (4000 IU) syringes.

 

Your doctor will decide what daily dose you should receive and the duration of your treatment. Do not suspend treatment before. The dosage is prescribed for you personally and should only be changed by your doctor depending on your response to the treatment.

 

For the correct administration of Clexane the patient should be seated and skin of the stomach area should be held between the thumb and index finger. Then the whole length of the needle should be introduced vertically into the skin fold and the syringe should be pushed softly to the end. The skin fold should not be released until the injection is complete.

 

If you have undergone surgery and have a moderate risk of thrombosis the recommended Clexane dosage to prevent it is 20 mg (2000 IU) or 40 mg (4000 IU) subcutaneously once daily. In moderate risk patients undergoing surgery the initial dose should be given approximately 2 hours preoperatively.

In patients with a higher risk of thrombosis, such as in orthopaedic surgery, the dosage should be 40 mg (4000 IU) Clexane subcutaneously once daily with the initial dose administered 12 hours before surgery. Your doctor may prolong treatment up to a maximum of 4 weeks.

 

 

If you have not undergone surgery but are immobilized or are going to be immobilized your doctor will inform you that that you have a risk of thrombosis. If your doctor considers the risk to be moderate the recommended Clexane dosage is 40 mg (4000 IU) subcutaneously once daily. If your doctor considers the risk to be high the recommended Clexane dosage is 40 mg (4000 IU) subcutaneously once daily.

 

The duration of the treatment depends on the risk of thrombosis and should be decided by your doctor. In any case your doctor will determine the duration of your treatment with Clexane.

 

Prevention of extracorporeal thrombus formation during haemodialysis

If you have to undergo repeated sessions of hemodialysis, Clexane should be used to prevent thrombus formation when passing through the dialysis machine. Your doctor will determine the dose that should be introduced into the arterial line of the circuit but as a general guideline a dose of 40 mg (4000 IU) for a patient weighing 60 kg is usually effective and well tolerated.

 

For patients with a high risk of hemorrhage, who have to undergo hemodialysis before or after an operation or if they suffer a hemorrhage at the moment their doctor should reduce the dose to one or two punctures.

 

If you suffer a condition that consists of the formation of blood clots within a vein (established deep vein thrombosis) your treatment with Clexane will depend on your weight. As a general rule your doctor should prescribe a dose of 1.5 mg/kg body weight (150 IU/kg) once a day or 1 mg/kg body weight (100 IU/kg) twice a day. If you suffer this condition to a greater extent in such a way that the blood clots totally block the passage of the blood (thromboembolic disorders) the recommended dosage is 1 mg/kg body weight (100 IU/kg) twice a day. Although the duration of the treatment should be determined by your doctor, Clexane treatment is usually prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate and Clexane treatment should be continued until a therapeutic anticoagulant effect has been achieved.

 

 

If you suffer a heart disease such as unstable angina or myocardial infarction of the kind called non-Q-wave the recommended dose of Clexane is 1 mg/kg (100 IU/kg) every 12 hours, administered concurrently with oral aspirin (100 to 325 mg once daily). Although the duration of the treatment with Clexane should be indicated by your doctor, the usual duration of treatment is 2 to 8 days maximum.

 

Clexane (Lovenox, Enoxaparin Sodium) is not recommended for use in children as the safety and effectiveness of enoxaparin in this group has not been established.

 

If you suffer renal impairment and use Clexane as preventive treatment no dose adjustment is necessary. A dosage adjustment is required for patients with severe renal impairment. Although no dose adjustment is recommended in patients with mild renal impairment careful clinical monitoring is advised.

If you think that the effect of Clexane 40 mg (4000 IU) syringes are too strong or too weak inform your doctor or pharmacist.

 

If you use more Clexane 40 mg (4000 IU) syringes than you should, consult your doctor or go to the Emergency Department at your nearest hospital immediately. Take this product information leaflet with you. Accidental overdose may lead to hemorrhagic complications. This effect can be largely neutralized by the slow intravenous injection of a substance called protamine (sulphate or hydrochloride). The dose of protamine should be equal to the dose of Clexane injected, if the enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of enoxaparin may be administered if Clexane was administered greater than 8 hours previously or if it has been determined that a second dose of protamine is required. Protamine administration may not be required 12 hours after the Clexane injection. In the case of an overdose or accidental ingestion contact your local poison control centre.

 

If you forget to use Clexane 40 mg (4000 IU) syringes do not use a double dose to make up for forgotten individual doses.

 

 

As with all medications, Clexane 40 mg (4000 IU) syringes may have side effects. 

Blood and lymphatic system disorders:

As with other anticoagulants bleeding may occur often in any part of the body during enoxaparin therapy in the presence of associated risk factors such as: organic lesions liable to bleed, any condition that can cause an internal or external wound (invasive procedures) or the use of medications affecting mechanisms of blood coagulation (haemostasis) (see section "Using other medications"). Major hemorrhages have been reported and in rare instances these have been fatal.

 

Frequently there has been a decrease in the number of platelets in the blood (thrombocytopenia), which may be moderate, transient and sometimes if it occurs at the same time as a blood clot (venous or arterial thrombosis) it may be fatal. This may be complicated if there is poor blood supply to an organ or limb. In rare cases this decrease in blood platelet count is related to immuno-allergic thrombocytopenia. There have been very rare reports of intra spinal hematomas or of the membrane that covers it (epidural) with the concurrent use of Clexane at prophylactic dosage ranges and epidural anesthesia. These events have resulted in varying degrees of neurological injuries including transient or permanent paralysis.

 

Rarely irritation at the injection site, pain and hematoma may follow the subcutaneous injection of Clexane. Sometimes hard inflammatory nodules which are not cystic enclosures of Clexane have been observed at the injection site. They resolve after a few days. Very rarely hair loss and headache (cephalagia) may occur. Long term therapy may cause bones to become thin and porous (osteoporosis). Exceptional cases of skin necrosis at the injection site have been reported with this type of medication. These phenomena are usually preceded by purpura and erythematous plaques. In this case treatment with Clexane must be discontinued.

 

Although rare cutaneous (reddening of the skin with blisters or bullous eruptions) or systemic allergic reactions may occur. Should this occur discontinuation of treatment will be necessary. Asymptomatic and reversible increases in liver enzyme levels have also been reported.

Very rare cases of hypersensitivity cutaneous vasculitis have been reported.

If you notice any of these side effects or any other reaction not mentioned in this leaflet please inform your doctor or pharmacist.

 

Keep Clexane 40 mg (4000 IU) syringes out of the reach and sight of children.

Clexane 40 mg (4000 IU) syringes should not be stored above 25°C.

 

Do not use Clexane 40 mg (4000 IU) syringes after the expiry date indicated on the pack.