innohep

innohep

tinzaparin sodium

Manufacturer:

LEO Pharma

Distributor:

Getz Bros
Full Prescribing Info
Contents
Tinzaparin sodium.
Description
Each 10,000 vial of Innohep also contains benzyl alcohol as preservative.
Tinzaparin sodium is a low molecular weight heparin produced by enzymatic depolymerization of conventional heparin.
The molecular mass is between 1000 and 14,000 dalton, with a peak maximum molecular mass of approximately 4500 dalton.
Action
Anticoagulant.
Tinzaparin sodium is an antithrombotic agent.
Pharmacokinetics: Innohep has a bioavailability of about 90% following SC injection. The absorption half-life is 200 min, peak plasma activity being observed after 4-6 hrs.
The elimination half-life is about 80 min. Tinzaparin sodium is eliminated, primarily with the urine, as unchanged drug.
The pharmacokinetics/pharmacodynamics of Innohep are monitored by anti-Xa activity. There is a linear dose-response relationship between plasma activity and the dose administered.
The biological activity of Innohep is expressed in anti-Xa international units.
Indications/Uses
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) (not amounting to hemodynamic instability).
Prevention of postoperative DVT in patients undergoing general and orthopaedic surgery.
Dosage/Direction for Use
Treatment of DVT: Recommended Dose: 175 anti-Xa IU/kg body weight SC once daily.
Thromboprophylaxis in Patients with Moderate Risk of Thrombosis (General Surgery): On the day of operation, 3500 anti-Xa IU SC 2 hrs before surgery and postoperatively once daily, 3500 anti-Xa IU for 7-10 days.
Thromboprophylaxis in Patients with High Risk of Thrombosis (eg, Total Hip Replacement): On the day of operation, 4500 anti-Xa IU SC 12 hrs before surgery or 50 anti-Xa IU/kg body weight SC 2 hrs before surgery and then once daily until the patient has been mobilized.
Short-Term Hemodialysis (<4 hrs): A bolus dose of 2000-2500 anti-Xa IU into the arterial side of the dialyser (or IV) at the beginning of dialysis.
Long-Term Hemodialysis (>4 hrs): A bolus dose of 2500 anti-Xa IU into the arterial side of the dialyser (or IV) at the beginning of dialysis, followed by an infusion of 750 anti-Xa IU/hr.
Dose Adjustment: Increase or decrease of the bolus dose, if required, can be made in steps of 250-500 anti-Xa IU until a satisfactory response is obtained.
Overdosage
Symptoms: An overdose of Innohep may be complicated by haemorrhage.
Treatment: At recommended doses, there should be no need for an antidote, but in the event of accidental administration of an overdose, the effect of Innohep can be reversed by IV administration of 1% protamine sulfate solution.
The dose of protamine sulfate required per neutralization should be accurately determined by titrating with the plasma of the patient. As a rule, 1 mg of protamine sulfate neutralizes the effect of 100 anti-Xa IU of tinzaparin.
Contraindications
Known hypersensitivity to any of the constituents of Innohep.
The 20,000 anti-Xa iu/mL formulation of Innohep contains sodium bisulfite which may cause allergic reactions, including anaphylaxis in predisposed patients. In the remaining formulations without sulfite, this risk does not exist.
Treatment of DVT in patients ≥90 years with renal insufficiency.
Other contraindications are generalized or focal haemorrhagic tendency. Uncontrolled severe hypertension. Acute cerebral insults. Septic endocarditis.
Special Precautions
Innohep should be given with caution to patients with renal or hepatic insufficiency. In such cases, a dose reduction should be considered. Innohep should not be administered by IM injection due to risk of local haematoma formation.
Patients receiving Innohep concurrently with spinal or epidural anaesthesia should be closely monitored for signs or symptoms of neurological injury.
Use in pregnancy & lactation: Data on a number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/newborn child. No transplacental passage was demonstrated in 2 clinical studies. Data from sequential pharmacokinetic monitoring in 55 pregnancies suggest that pharmacokinetic properties of tinzaparin do not differ from the non-pregnant state.
Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
Caution should be exercised when prescribing tinzaparin to pregnant women.
For Vials Only: Cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/kg/day). Despite the low content of benzyl alcohol in the vials (10 mg/mL), as it may cross the placenta, the use of Innohep formulations containing benzyl alcohol is not recommended during pregnancy.
There are no data available concerning lactation.
Use In Pregnancy & Lactation
Data on a number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/newborn child. No transplacental passage was demonstrated in 2 clinical studies. Data from sequential pharmacokinetic monitoring in 55 pregnancies suggest that pharmacokinetic properties of tinzaparin do not differ from the non-pregnant state.
Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
Caution should be exercised when prescribing tinzaparin to pregnant women.
For Vials Only: Cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/kg/day). Despite the low content of benzyl alcohol in the vials (10 mg/mL), as it may cross the placenta, the use of Innohep formulations containing benzyl alcohol is not recommended during pregnancy.
There are no data available concerning lactation.
Adverse Reactions
Innohep is safe with regard to bleeding risks when applied at the doses recommended, provided that patients with increased bleeding potential (bleeding disorders, severe thrombocytopenia) are excluded or treated with special care. Priapism and skin necrosis have been reported in only a few cases.
Drug Interactions
Concomitant administration of other drugs affecting haemostasis eg, salicylates, NSAIDs, vitamin K antagonists and dextran, may enhance the anticoagulant effect of Innohep.
Incompatibilities: Innohep is compatible with isotonic sodium chloride (9 mg/mL) or isotonic glucose (50 mg/mL). It should not be admixed with other infusion fluids.
Storage
Store at controlled room temperature (15-25°C).
Shelf-Life: 2 years.
ATC Classification
B01AB10 - tinzaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Inj (vial) 10,000 anti-Xa IU/mL x 2 mL x 10's. (syringe) 3500 anti-Xa IU/mL x 0.35 mL x 10's. (syringe) 4500 anti-Xa IU/mL x 0.45 mL x 10's.
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