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Clexane syringes

Generic name: Enoxaparin sodium

Clexane is available as a solution for injection, in ready-to-use pre-filled syringes. Clexane is a low molecular weight heparin (LMWH) denomintated enoxaparin which acts by preventing blood clot formation, it has a high anti-Xa activity and a low anti-IIa activity. Clexane belongs to the group called anticoagulant agents. Clexane is indicated for the prevention of venous thrombosis, in particular those which may be associated with orthopaedic or general surgery and in non-surgical, immobilized patients whose situation could be considered moderate or high risk. Clexane is also indicated for the prevention of thrombus formation in the extracorporeal circulation during haemodialysis, 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

Before you use Clexane

Do not use Clexane syringes
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 haemorrhage including recent haemorrhagic 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 major haemorrhage related to the process of stopping or slowing the circulation of the blood (haemostasis) except in cases where the problem with coagulation that is not heparin-induced.
If you intend to undergo surgery and are taking Clexane, regional anaesthesia can't be used.

Take special care with Clexane syringes
As with any other anticoagulant it may cause bleeding in other parts of the body.
Never interchange Clexane 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 anaesthesia, use of tubes or probes of intrathecal type or recently undergone brain or eye surgery.

If undergoing a type of anaesthesia called spinal anaesthesia (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 and 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 treament.

Patients whose kidney function is impaired (renal insufficiency) should inform their doctor because there is an increased the risk of bleeding when usign 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.

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.

Pregnancy and Clexane
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.

Lactation
Ask your doctor or pharmacist for advice before taking any medication.
Clexane syringes should not be used during breast-feeding.

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

Use in children
Clexane is not recommended for use in children, as the safety and effectiveness of enoxaparin in this group have not been established.

Using other medications

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.

Agents that affect the mechanisms of blood coagulation (haemostasis) include:
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 necesaary, Clexane should be used with careful clinical and laboratory monitoring since the risk of bleeding is considerably increased.

How to use Clexane
Follow these instructions unless otherwise specified by your doctor.

Before you use Clexane syringes carefully read the following instructions.

Do not administer by the intramuscular route.
The prefilled Clexane 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 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 adminsitration of Clexane the patient should be semi-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.

Prophylaxis of venous thrombosis
If you have undergone surgery, for example abdominal surgery and therefore 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 haemodialysis, 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 haemorrhage, who have to undergo haemodialysis, for example, before or after an operation, or if they suffer a hemorrage at the moment, their doctor should reduce the dose to one or two punctures.

Treatment of established deep vein thrombosis
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.

Treatment of unstable angina and non-Q-wave myocardial infarction
If you suffer a heart disiease, 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 treament with Clexane should be indicated by your doctor, the usual duration of treatment is 2 to 8 days maximum.

Clexane is not recommended for use in children, as the safety and effectiveness of enoxaparin in this group have 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 is too strong or too weak, inform your doctor or pharmacist.

If you use more Clexane) syringes than you should
If you use more Clexane 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 haemorrhagic complications. This effect can be largely neutralised 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.

If you forget to use Clexane syringes
If you forget to use Clexane syringes do not use a double dose to make up for forgotten individual doses.

Side effects of Clexane
As with all medications, Clexane 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 haemorrhages have been reported; 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 haematomas or of the membrane that covers it (epidural) with the concurrent use of Clexane at prophylactic dosage ranges and epidural anaesthesia. These events have resulted in varying degrees of neurologic injuries including transient or permanent paralysis.

General disorders & administration site conditions:
Rarely irritation at the injection site, pain and haematoma 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.

Immune system disorders
Although rare, cutaneous (reddening of the skin with blisters or bullous eruptions) or systemic allergic reactions may occur. Should this occur discontinuation of treatment is 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.

Storing Clexane syringes
Keep Clexane syringes out of the reach and sight of children.
Clexane syringes should not be stored above 25°C.

Expiry
Do not use Clexane syringes after the expiry date indicated on the pack.