Intravas SC Injection

• Each 0.2 ml pre-filled syringe contains Enoxaparin Sodium BP 20 mg equivalent to 2000 anti-Xa III.
• Each 0.4 ml pre-filled syringe contains Enoxaparin Sodium BP 40 mg equivalent to 4000 anti-Xa III.
• Each 0.6 ml pre-filled syringe contains Enoxaparin Sodium BP 60 mg equivalent to 6000 anti-Xa IU.
• Each 0.8 ml pre-filled syringe contains Enoxaparin Sodium BP 80 mg equivalent to 8000 anti-Xa IU.

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Instructions on injecting yourself with Enoxaparin Sodium Syringes: Preparing the injection site:

• Choose an area on the right or left side of your stomach. This should be at least 5 centimeters away from your belly button and out towards your sides.
• Do not inject yourself within 5cm of your belly button or around existing scars or bruises.
• Change the place where you inject between the left and right sides of your stomach, depending on the area you last injected.
• Wash your hands. Cleanse (do not rub) the area that you will inject with an alcohol swab or soap and water.
• Sit or lie in a comfortable position so that you are relaxed. Make sure you can see the place you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.

Selecting your dose:

• Carefully pull off the needle cap from the syringe. Throw away the cap.
• Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead to a loss of the medicine.
• Once you have removed the cap, do not allow the needle to touch anything. This is to make sure the needle stays clean (sterile).
• When the amount of medication in the syringe matches your prescribed dose, there is no need to adjust the dose. You are now ready to inject.
• When the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In that case, you can get rid of any extra medicine by holding the syringe pointing down (to keep the air bubble in the syringe) and ejecting the extra amount into a container.
• A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by tapping on the syringe with the needle pointing down. You are now ready to inject.

Injecting:

• Hold the syringe in the hand you write with (like a pencil). With your other hand, gently pinch the cleaned area of your stomach between your forefinger and thumb to make a fold in the skin.
• Make sure you hold the skin fold throughout the injection.
• Hold the syringe so that the needle is point in straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.
• Press down on the plunger with your thumb. This will send the medication into the fatty tissue of the stomach. Complete the injection using all of the medicine in the syringe.

When you have finished:

• To avoid bruising, do not rub the injection site after you have injected yourself.
• Drop the used syringe into a sharps container. Close the container lid tightly and place the container out of reach of the children. When the container is full, dispose of it as your doctor or pharmacist has instructed. Any unused medicine or waste material should be disposed of in accordance with local requirements.

It is recommended that agents which affect hemostasis should be discontinued prior to Intravas therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Intravas and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Intravas should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Intravas should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Intravas may lead to hemorrhagic complications. Injected Intravas may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Intravas injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Intravas.

Parenteral anti-coagulants

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children