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.

Author: Fenrishicage Samukree
Country: Niger
Language: English (Spanish)
Genre: Environment
Published (Last): 14 November 2005
Pages: 106
PDF File Size: 16.81 Mb
ePub File Size: 2.79 Mb
ISBN: 557-7-80756-962-1
Downloads: 67345
Price: Free* [*Free Regsitration Required]
Uploader: Mazugul

Therapy continued for up to 8 days median duration of 2. Increased risk of hemorrhage: Each of these medicines has its own instructions for use. Lovenox may be safely administered with normal saline solution 0.

An infusion of 0. In a second study, patients undergoing hip replacement surgery were treated, while hospitalized, with Lovenox 40 mg subcutaneously, initiated up to 12 hours prior to surgery.

Where can I find Teva medications?

Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring 5. Patients ranged in age from 41 to 84 years mean age Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia e.

The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration 2 and How Supplied 16 ].

RECENT MAJOR CHANGES

There also have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis. Kaplan-Meier Plot — Death or Myocardial Re-infarction at 30 Days — ITT Population There is a trend in favor of enoxaparin during the first 48 hours, but most of the treatment difference is attributed to a step increase in the event rate in the UFH group at 48 hours seen in Figure 2an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation.

  AKTA BEKALAN ELEKTRIK 1994 PDF

When administered in conjunction with a thrombolytic fibrin specific or non—fibrin specificLovenox should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.

All pregnancies have a background risk of birth defect, loss, or other adverse outcome regardless of drug exposure.

TGA eBS – Product and Consumer Medicine Information

Urgent revascularization denotes episodes of recurrent myocardial ischemia without infarction leading to the clinical decision to perform coronary revascularization during the same hospitalization. Activation of the safety system may cause minimal splatter of fluid.

There are no adequate and well-controlled studies in pregnant women. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.

Treatment was initiated after surgery and continued up to 14 days. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.

The mean treatment duration for enoxaparin was 6. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis.

  DIRVISH THE DAMNED PDF

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

Retroperitoneal and intracranial hemorrhages were always considered major. Lovenox or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: The safety system should not be sterilized.

If neurological compromise is noted, urgent treatment is necessary. If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness especially in the lower limbs and muscular weakness.

Patients who could not receive outpatient therapy were excluded from entering the study. There were 14 cases of neonatal hemorrhage.

Enoxaparin Sodium Injection, USP

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins LMWH or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture.

Race was distributed as follows: In humans, enoxaparin given at a dose of 1. In this population of patients, the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo.