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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Insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
Careful attention to dosing intervals and concomitant medications especially antiplatelet medications is advised. These included 1, for prophylaxis of deep vein thrombosis lovenix abdominal surgery in patients at risk for thromboembolic complications, 1, for llvenox 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.
The fetal risk summary below describes the potential of Lovenox to increase the risk of developmental loveno above the background risk. It is not known if monitoring of anti-Factor Xa lovwnox and dose adjustment by weight or anti-Factor Xa activity of Lovenox affect the safety and the efficacy of the drug during pregnancy.
Retroperitoneal and intracranial hemorrhages were always considered logenox. Lovenox should be used with care in patients with oovenox bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage.
Lovenox is available in two concentrations see Tables 26 and Hip or Knee Replacement Surgery In patients undergoing hip or knee replacement surgery, the recommended dose of Lovenox is 30 mg every 12 hours administered by subcutaneous injection.
All patients were also treated with aspirin to mg per day. Human data from a retrospective cohort study, which included live births, suggest that Lovenox does not increase the risk of major developmental abnormalities. The following adverse reactions have been identified during postapproval use of Lovenox.
Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non—Q-wave myocardial infarction, when concurrently administered with aspirin. Figure A Inject using standard technique, pushing the plunger to the bottom of the syringe see Figure B. Activation of the safety system may cause minimal splatter of fluid. Apparent clearance and A max derived from anti-Factor Xa values following single subcutaneous dosing 40 mg and 60 mg were slightly higher lvoenox males than in females.
The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. If the last Lovenox lovenoxx administration was given more than 8 hours before balloon inflation, an intravenous bolus of 0.
Lovenox, when administered concurrently with aspirin, has been shown to reduce the rate of the lovehox endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction STEMI receiving thrombolysis and being managed medically or with percutaneous oi intervention PCI.
Lovenox multiple-dose vials are not approved for use in neonates or infants.
TGA eBS – Product and Consumer Medicine Information
The mean treatment duration of unfractionated heparin was 54 hours. 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.
Some of these cases were lovenpx by organ infarction, limb ischemia, or death [see Warnings and Precautions 5. A retrospective study reviewed the records of women who used enoxaparin during pregnancy.
RECENT MAJOR CHANGES
Patients ranged in age from 32 to 97 years mean age 67 years with The average duration of administration is 7 days; up to 17 days of Lovenox administration has been administered in controlled clinical trials. Patients ranged in age from 25 to 94 years median age 64 yearswith For patients at least 75 years of age, the intravenous bolus was not given and the subcutaneous dose was reduced to 0.
A clinical study using enoxaparin in pregnant women with mechanical prosthetic heart valves has been conducted [see Warnings and Precautions 5. Weight After repeated subcutaneous 1.
It is important to achieve hemostasis at the puncture site after PCI. The plunger stopper, rigid tip cap, needle shield, and syringe are not made with lovenxo rubber latex. In patients with renal impairment, there is an increase in exposure of enoxaparin sodium. The site of the procedure should be observed for signs of bleeding or hematoma formation [see Dosage and Administration 2.