LOVENOX PI PDF

LOVENOX® is indicated to help reduce the risk of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE). Read full important safety. /83/EC for Lovenox and associated names, in order to resolve divergences The PI was split as follows according to the indications the. Save money on your Lovenox® Injection prescription by switching to Teva’s FDA- approved generic version, Enoxaparin Sodium Injection, USP.

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Activation of the safety system may cause minimal splatter of fluid. Some of these cases have been fatal. The plunger stopper, rigid tip cap, needle shield, and syringe are not made with natural rubber latex. Cases of hyperkalemia have been reported. Increases of up to 1. In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of patients were enrolled in the study, and patients were treated.

These results were observed in an analysis of both all-randomized and all-treated patients. Treatment with Lovenox should be prescribed for a minimum of 2 days and continued until clinical stabilization. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. Lovenox has been shown to reduce the risk of postoperative deep vein thrombosis DVT following hip or knee replacement surgery.

The mean treatment duration for enoxaparin was 6. If at least 12 hours have elapsed since the last enoxaparin sodium injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin.

Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. The multiple-dose vial of Lovenox contains 15 mg benzyl alcohol per 1 mL as a preservative [see Warnings and Precautions 5. Weight After repeated subcutaneous 1. These highlights do not include all the information needed to use Lovenox safely and effectively.

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In a double-blind study, Lovenox 30 mg every 12 hours subcutaneously was compared to placebo in patients undergoing knee replacement surgery.

Teva’s generic of Lovenox® Injection: Enoxaparin Sodium Injection, USP

Safety and effectiveness of Lovenox in pediatric patients have not been established. Retroperitoneal and intracranial hemorrhages were always considered major.

For additional information consult the labeling of protamine sulfate injection products. The following adverse reactions have been identified during postapproval use of Lovenox.

Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation.

Lovenox 30 and 40 mg prefilled syringes, and 60, 80, and mg graduated prefilled syringes each livenox 10 mg enoxaparin sodium per 0. Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism [see Warnings and Precautions 5.

For intravenous use i. The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when Lovenox was administered at doses of 1.

Enoxaparin Sodium Injection, USP

Treatment was initiated within two days after surgery and was continued for 7 to 11 days lovwnox surgery. In the pivotal clinical study, the Lovenox treatment duration was 8 days or until hospital discharge, whichever came first. Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges [see Dosage and Administration 2 ].

Abdominal surgery patients at risk include those who are over 40 years of lvoenox, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes or who have additional risk factors such as malignancy or a history of deep vein thrombosis DVT or pulmonary embolism PE.

The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation see Figure D. Additionally, in an open-label, parallel group, randomized clinical study, Lovenox 30 mg every 12 hours subcutaneously in patients undergoing elective knee replacement surgery was compared to heparin U every 8 hours subcutaneously. Mean peak anti-Factor Xa activity was 0. Lovenox once a day versus heparin The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known Lovenox multiple-dose vials contain 15 mg of benzyl alcohol per mL [see Use in Specific Populations 8.

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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Lovenox or standard heparin therapy was administered for a minimum of 5 days. The product catalog provides you with a full listing of Teva’s brand and generic product lines. The catalog displays all strengths and sizes along with the description, imprint code, NDC and photo for each product.

In humans, enoxaparin given at a dose of 1.

Similar significant increases in aminotransferase levels have also been observed in patients and healthy volunteers treated with heparin and other low lovenix weight heparins.

In this population of patients, the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo. Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with Lovenox.

Not adequately studied 8. The rate of the primary efficacy endpoint death or myocardial re-infarction was 9. Patients ranged in age from 18 to 92 years mean age