Innohep

Innohep

tinzaparin sodium

Manufacturer:

LEO Pharma

Distributor:

DKSH
Full Prescribing Info
Contents
Tinzaparin sodium.
Description
Vials 2 ml: Tinzaparin sodium 10,000 IU anti-Xa/ml, preserved with benzyl alcohol (10 mg/ml).
Tinzaparin sodium 20,000 IU anti-Xa/ml, preserved with benzyl alcohol (10 mg/ml), stabilized with sodium metabisulphite.
Pre-filled syringes with needle safety device of 0.35 ml or 0.45 ml: Tinzaparin sodium 10,000 IU anti-Xa/ml.
Pre-filled syringes with needle safety device of 0.5 ml or 0.7 ml: Tinzaparin sodium 20,000 IU anti-Xa/ml, stabilized with sodium metabisulphite.
Action
Tinzaparin sodium is a low molecular weight heparin produced by enzymatic depolymerization of conventional heparin.
The molecular mass is between 1,000 and 14,000 dalton, with a peak maximum molecular mass of approx. 4,500 dalton. Tinzaparin sodium is an anti-thrombotic agent.
Innohep has a bioavailability of about 90% following subcutaneous injection. The absorption half-life is 200 minutes, peak plasma activity being observed after 4-6 hours.
The elimination half-life is about 80 minutes. 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 international units anti-Xa.
Indications/Uses
Treatment of deep-vein thrombosis and pulmonary embolism.
Prevention of postoperative deep-vein thrombosis in patients undergoing general and orthopaedic surgery.
Prevention of clotting in in-dwelling intravenous lines for extracorporeal circulation and haemodialysis.
Dosage/Direction for Use
Treatment of DVT and PE: The recommended dose is 175 IU anti-Xa/kg body-weight s.c. once daily.
Thromboprophylaxis in patients with moderate risk of thrombosis (general surgery): On the day of operation 3,500 IU anti-Xa s.c. 2 hours before surgery and postoperatively once daily 3,500 IU anti-Xa for 7-10 days.
Thromboprophylaxis in patients with high risk of thrombosis (e.g. total hip replacement): On the day of operation 4,500 IU anti-Xa s.c. 12 hours before surgery or 50 IU anti-Xa/kg body-weight s.c. 2 hours before surgery and then once daily until the patient has been mobilized.
For short-term haemodialysis (less than 4 hours): A bolus dose of 2,000-2,500 IU anti-Xa into the arterial side of the dialyser (or intravenously) at the beginning of dialysis.
Long-term haemodialysis (more than 4 hours): A bolus dose of 2,500 IU anti-Xa into the arterial side of the dialyser (or intravenously) at the beginning of dialysis, followed by an infusion of 750 IU anti-Xa/hour.
Dose adjustment: Increase or decrease of the bolus dose, if required, can be made in steps of 250-500 IU anti-Xa until a satisfactory response is obtained.
Elderly: Renal function should be assessed with e.g. the Cockcroft-Gault formula to estimate creatinine clearance levels.
No dose reduction is needed in elderly patients with normal renal function. (See Precautions.)
Renal impairment: No dose reduction is needed in patients having creatinine clearance levels down to 20 ml/min. However, precaution is recommended when treating patients with severe renal impairment (creatinine clearance <30 ml/min). (See Precautions.)
Overdosage
An overdose of innohep may be complicated by haemorrhage. 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 intravenous administration of 1% protamine sulphate solution.
The dose of protamine sulphate required per neutralization should be accurately determined by titrating with the plasma of the patient. As a rule, 1 mg of protamine sulphate neutralizes the effect of 100 IU anti-Xa of tinzaparin.
Contraindications
Known hypersensitivity to any of the constituents.
The 20,000 IU anti-Xa/ml formulation of innohep contains sodium metabisulphite, which may cause allergic reactions, including anaphylaxis in predisposed patients. In the remaining formulations without sulphite, this risk does not exist.
Other contraindications are generalized or local haemorrhagic tendency. Uncontrolled severe hypertension. Acute cerebral insults. Septic endocarditis.
For vials only: Innohep vials contain 10 mg/ml of the preservative benzyl alcohol. These formulations must not be given to premature babies and neonates due to the risk of gasping syndrome.
Special Precautions
Innohep should be given with caution to patients with hepatic insufficiency. Precaution is recommended in the treatment of patients with severe renal impairment (creatinine clearance <30 ml/min).
Precaution is recommended in the treatment of elderly patients with renal impairment. Renal function should be assessed and in patients with severe renal impairment (creatinine clearance <30 ml/min), monitoring of anti-factor Xa activity should be considered.
Innohep should not be administered by intramuscular 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/new-born child. No transplacental passage was demonstrated in two (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. There are no data available concerning lactation.
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 per ml), as it may cross the placenta the use of innohep formulations containing benzyl alcohol is not recommended during pregnancy.
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, e.g. vitamin K antagonists and dextran, may enhance the anticoagulant effect of innohep.
Caution For Usage
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
Do not store above 30°C.
Shelf life: Vials: 2 years.
Syringes: 3 years.
Patient Counseling Information
Instructions for use of the innohep syringes: Wash your hands before you inject the medicine. Wipe clean the skin around the injection site with spirit and let it dry - do not rub.
Subcutaneous injection of innohep should be carried out according to the following steps: 1. Open the tube bending the coloured lid all the way back and remove the syringe. Inspect the content of the syringe before you use it. If you observe cloudiness or precipitate in the medicine, do not use it but take another syringe. The medicine may turn yellow during storage but can still be used if the solution is clear.
2. Bend the safety device down away from the cap on the needle.
3. Remove the protective needle cap without bending the needle. Adjust the syringe to the dose prescribed by your doctor. Remove the remaining solution by pressing the plunger in vertical position. Do not pull back the plunger and do not press out the air bubble. If the air bubble is not placed right by the plunger, then tap lightly on the syringe until the air bubble is in place.
4. Hold a skin fold loosely between thumb and index finger of one hand and with the other hand insert the needle vertically at the skin fold, at a right angle to the skin.
5. Slowly inject the required dose into the fatty tissue of e.g. the abdominal skin, the extensor sides of the thigh, lower back or upper arm. Wait a few seconds to give the solution time to distribute before you remove the needle and release the skin fold.
6. Wipe off any blood with a tissue. Choose a different injection site next time (for instance, move from the left to the right of the abdomen).
7. Bend the safety device back to its original position so it is now underneath the needle. Then with the safety device flat against a hard surface, push downwards until the needle locks into the device.
8. You can either place the used syringe in the tube with the needle downwards or you can put the used syringe into a sharps container. The syringe is now secured, and the tube or sharps container can be handed over for destruction at the hospital or by the pharmacist.
ATC Classification
B01AB10 - tinzaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Vial 10,000 anti-Xa IU/mL x 2 mL x 10's. 20,000 anti-Xa IU/mL x 2 mL x 10's. Syringe 10,000 anti-Xa IU/mL x 0.35 mL x 10's, 0.45 mL x 10's. 20,000 anti-Xa IU/mL x 0.5 mL x 2's, 0.7 mL x 2's.
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