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: Dule Arashit
Country: Ethiopia
Language: English (Spanish)
Genre: Music
Published (Last): 21 May 2006
Pages: 486
PDF File Size: 6.18 Mb
ePub File Size: 17.34 Mb
ISBN: 350-1-12067-663-4
Downloads: 15559
Price: Free* [*Free Regsitration Required]
Uploader: Shaktisida

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.

For patients managed with percutaneous coronary intervention PCIif the last Lovenox subcutaneous administration was given less than 8 hours before balloon inflation, no additional dosing is needed. Lovenox may be safely administered with normal saline solution 0.

Bleeding can occur at any site during therapy with Lovenox. Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation see Figure D.

Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

A total of pregnancies resulted in live births. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. Women with mechanical prosthetic heart valves may be at higher risk for thromboembolism during pregnancy and, when pregnant, have a higher rate of fetal loss from stillbirth, spontaneous abortion, and premature delivery. The incidence of deep vein thrombosis loveno lower for Lovenox compared to heparin.

Lovenox cannot be used interchangeably unit for unit with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.

  DX5150 MT PDF

The dose of protamine sulfate should be equal to the dose of Lovenox injected: In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages.

Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used.

loovenox

Local Reactions Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of Lovenox. Lovenox must not be administered by intramuscular injection. Hemorrhage The following rates of major bleeding events have been reported during clinical trials with Lovenox see Tables 2 to 7.

Lovenox is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration. Patients ranged in age from 41 to 84 years mean age Treatment was initiated within two days after surgery and was continued for 7 to 11 days after surgery. These hematomas may result in long-term or permanent paralysis.

For patients at least 75 years of age, the intravenous bolus was not given and the subcutaneous dose was reduced to 0. Maximum anti-Factor Xa and anti-thrombin anti-Factor IIa activities occur 3 to 5 hours after subcutaneous injection of enoxaparin.

There also have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis.

If the treatment with enoxaparin sodium lovenos to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. Lovenox lkvenox a low molecular weight heparin LMWH indicated for: Obese patients are at higher risk for thromboembolism.

Enoxaparin Sodium Injection, USP

Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg subcutaneous once a day dose. Very rare pk of hyperlipidemia have also been reported, with one lovnox of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined. In a double-blind study, Lovenox 30 mg every 12 hours subcutaneously lovenxo compared to placebo in patients undergoing knee replacement surgery.

In a single study, elimination rate appeared similar but AUC was two-fold higher than control population, after a single 0. Figure C Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

  CAMBIOS CADAVERICOS TEMPRANOS Y TARDIOS PDF

TGA eBS – Product and Consumer Medicine Information

All patients were treated with aspirin for a minimum of 30 days. Retroperitoneal and intracranial hemorrhages were always considered major although none were reported during the trial. These included 1, for prophylaxis lovennox deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1, for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1, for prophylaxis of ischemic complications in unstable angina and non—Q-wave myocardial infarction, 10, for treatment of acute ST-elevation myocardial infarction, and for treatment of deep vein thrombosis with or without pulmonary embolism.

Prophylaxis of deep vein thrombosis DVT in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness 1.

For intravenous use i. The risk of Lovenox-associated bleeding increased with age. Indication Dose DVT prophylaxis in abdominal surgery. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

At the end of the peri-operative period, all patients underwent bilateral venography. There was no significant difference between the 30 mg every 12 hours and 40 mg once a day regimens. At approximately 3 months following enrollment, the incidence of venous thromboembolism remained lower in the Lovenox 40 mg treatment group versus the placebo treatment group. The product catalog provides you with a full listing of Teva’s brand and generic product lines. Urgent revascularization denotes episodes of recurrent myocardial ischemia without infarction leading to the clinical decision to perform coronary revascularization during the same hospitalization.

Author: admin