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Indications/Uses
Vial: Treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis and pulmonary embolus.
Note: Tinzaparin sodium (innohep) is not indicated for the treatment of serious pulmonary embolism, i.e. high-risk patients with hemodynamic instability.
Pre-filled syringe: 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.
Note: Tinzaparin sodium (innohep) is not indicated for the treatment of serious pulmonary embolism, i.e. high-risk patients with hemodynamic instability.
Pre-filled syringe: 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
Vial: 175 anti-Xa IU/kg body weight given subcutaneously once daily.
Oral anticoagulation should be commenced on the second day of treatment.
175 anti-Xa IU/kg body weight once daily for at least 6 days and until adequate oral anti-coagulation is established.
Prefilled syringes: The Tinzaparin sodium (innohep) syringes have a graduation of 0.05 mL which makes it possible to choose the most suitable syringe for the individual patient depending on the patient's body weight. In order to achieve the correct dosage for the individual patient the average volume is ejected before s.c. injection holding the syringe in a vertical position.
Different low molecular weight heparins are not necessarily equivalent. Therefore, specific posology and instructions for use of each one should be followed.
Children: There is no experience of use in children.
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.
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).
Pre-filled syringe: 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).
Oral anticoagulation should be commenced on the second day of treatment.
175 anti-Xa IU/kg body weight once daily for at least 6 days and until adequate oral anti-coagulation is established.
Prefilled syringes: The Tinzaparin sodium (innohep) syringes have a graduation of 0.05 mL which makes it possible to choose the most suitable syringe for the individual patient depending on the patient's body weight. In order to achieve the correct dosage for the individual patient the average volume is ejected before s.c. injection holding the syringe in a vertical position.
Different low molecular weight heparins are not necessarily equivalent. Therefore, specific posology and instructions for use of each one should be followed.
Children: There is no experience of use in children.
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.
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).
Pre-filled syringe: 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
Vial: Bleeding is the leading sign and symptom of tinzaparin overdosage.
Should bleeding occur, Tinzaparin sodium (innohep) should be discontinued in dependence on the severity of the bleeding and the risk of thrombosis.
In case of severe bleeding tinzaparin may be neutralised by protamine. After subcutaneous administration of different dosages of tinzaparin the anti-IIa-activity was neutralised to up to 85% and the anti-Xa-activity was neutralised up to 60% (47-74%) by intravenous administration of protamine sulphate (1 mg per 100 anti-Xa-I.U. tinzaparin). Repeated doses of protamine or a continuous infusion may be necessary.
Note that protamine overdosage has an anticoagulant effect in itself and that protamine may cause anaphylactoid reactions.
Pre-filled syringe: 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.
Should bleeding occur, Tinzaparin sodium (innohep) should be discontinued in dependence on the severity of the bleeding and the risk of thrombosis.
In case of severe bleeding tinzaparin may be neutralised by protamine. After subcutaneous administration of different dosages of tinzaparin the anti-IIa-activity was neutralised to up to 85% and the anti-Xa-activity was neutralised up to 60% (47-74%) by intravenous administration of protamine sulphate (1 mg per 100 anti-Xa-I.U. tinzaparin). Repeated doses of protamine or a continuous infusion may be necessary.
Note that protamine overdosage has an anticoagulant effect in itself and that protamine may cause anaphylactoid reactions.
Pre-filled syringe: 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
Vial: Hypersensitivity to tinzaparin, heparin or constituents of Tinzaparin sodium (innohep) (e.g. sodium metabisulfite); current or history of heparin-associated thrombocytopenia (type II); uncontrolled severe hypertension; septic endocarditis; intracranial or intraocular bleeding or other current active bleeding process; haemorrhagic diathesis (inherited or acquired), deficiency of coagulation factors, severe thrombocytopenia; severe impairment of liver or pancreas; active gastric and/or duodenal ulcer disease; surgery involving the brain, spinal cord or eye; lumbar puncture, spinal or epidural anaesthesia; haemorrhagic stroke, cerebral aneurysm; retinopathy, vitreous haemorrhage; in women with abortus imminens.
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.
Pre-filled syringe: 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.
Pre-filled syringe: 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.
Special Precautions
Vial: Tinzaparin sodium (innohep) should be given with caution to patients with: hepatic and renal insufficiency; uncontrolled arterial hypertension; gastrointestinal ulceration; suspicion of malignoma with bleeding tendency; history of peptic ulcer disease; nephrolith and/or ureterolith; concomitant use of drugs which increases the serum potassium levels, oral anticoagulants, platelet inhibitors (e.g. ASA).
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.
Platelet counts are recommended before administration of tinzaparin, on the first day of therapy and then regularly every 3 or 4 days and at the end of therapy.
As with other LMWHs, the administration of Tinzaparin sodium (innohep) in some patients undergoing surgical procedures (especially orthopaedic) or presenting a concomitant inflammatory process, has coincided with an asymptomatic increase of platelet count, which in many cases subsided without stopping administration of Tinzaparin sodium (innohep). If an increase in platelet count occurs, evaluation of the benefit/risk of continuing therapy for that patient should be made.
Due to the content of sodium metabisulfite, Tinzaparin sodium (innohep) should not be used in patients with asthma and hypersensitivity to sulphites.
Caution in the treatment of elderly patients.
Must not be administered by intramuscular or intravenous injection.
Due to the risk of haematoma during Tinzaparin sodium (innohep) therapy the intramuscular injection of other agents should be avoided.
Pre-filled syringe: 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.
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.
Platelet counts are recommended before administration of tinzaparin, on the first day of therapy and then regularly every 3 or 4 days and at the end of therapy.
As with other LMWHs, the administration of Tinzaparin sodium (innohep) in some patients undergoing surgical procedures (especially orthopaedic) or presenting a concomitant inflammatory process, has coincided with an asymptomatic increase of platelet count, which in many cases subsided without stopping administration of Tinzaparin sodium (innohep). If an increase in platelet count occurs, evaluation of the benefit/risk of continuing therapy for that patient should be made.
Due to the content of sodium metabisulfite, Tinzaparin sodium (innohep) should not be used in patients with asthma and hypersensitivity to sulphites.
Caution in the treatment of elderly patients.
Must not be administered by intramuscular or intravenous injection.
Due to the risk of haematoma during Tinzaparin sodium (innohep) therapy the intramuscular injection of other agents should be avoided.
Pre-filled syringe: 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
Anticoagulant treatment of pregnant women requires specialist involvement.
Data on a limited number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available. No transplacental passage was demonstrated in two clinical studies. Animal data do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing tinzaparin to pregnant women.
There are no data available concerning lactation.
Pregnant patients with prosthetic heart valves: Therapeutic failures have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of tinzaparin and other LMWHs. Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
In the absence of clear dosing, efficacy and safety information in this circumstance, any at-tempt to anti-coagulate such patients must only be undertaken by medical practitioners with expertise and experience in this clinical area, and only if no safer alternative is available.
The use of Tinzaparin sodium (innohep) in women with abortus imminens is contraindicated.
An epidural anaesthesia during birth in pregnant women treated with LMW-heparin is contraindicated.
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). Therefore the use of this formulation in newborns especially in preterm babies is contraindicated.
The 2mL vial of Tinzaparin sodium (innohep) 20,000 IU/mL contains 20mg of benzyl alcohol (10mg of benzyl alcohol per mL). As benzyl alcohol may cross the placenta, the use of Tinzaparin sodium (innohep) formulations containing benzyl alcohol is not recommended during pregnancy.
Data on a limited number (637) of exposed pregnancies indicate no additional risk of tinzaparin on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available. No transplacental passage was demonstrated in two clinical studies. Animal data do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing tinzaparin to pregnant women.
There are no data available concerning lactation.
Pregnant patients with prosthetic heart valves: Therapeutic failures have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of tinzaparin and other LMWHs. Tinzaparin is not recommended for use in pregnant women with prosthetic heart valves.
In the absence of clear dosing, efficacy and safety information in this circumstance, any at-tempt to anti-coagulate such patients must only be undertaken by medical practitioners with expertise and experience in this clinical area, and only if no safer alternative is available.
The use of Tinzaparin sodium (innohep) in women with abortus imminens is contraindicated.
An epidural anaesthesia during birth in pregnant women treated with LMW-heparin is contraindicated.
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). Therefore the use of this formulation in newborns especially in preterm babies is contraindicated.
The 2mL vial of Tinzaparin sodium (innohep) 20,000 IU/mL contains 20mg of benzyl alcohol (10mg of benzyl alcohol per mL). As benzyl alcohol may cross the placenta, the use of Tinzaparin sodium (innohep) formulations containing benzyl alcohol is not recommended during pregnancy.
Adverse Reactions
Vial: Frequent: Bleeding complications (skin, mucous membrane, wounds, gastrointestinal, urogenital).
Increase in aminotransferases, gamma-GT, LDH, lipase.
Injection site haematoma and pain, rarely skin necrosis.
Increase of serum potassium concentration.
Occasional: A mild transient thrombocytopenia (type I) at the beginning of heparin therapy with platelet counts between 100,000/μl and 150,000/μl due to temporary platelet activation. As a rule no complications occur, therefore, treatment can be continued.
Rare: Cases of antibody-mediated severe thrombocytopenia (type II) with platelet counts clearly below 100,000/μl or a rapid decrease to less than 50% of baseline have been observed. In patients not sensitized the decrease in platelet count generally sets in 6-14 days after the beginning of treatment. In sensitized patients this may happen within few hours. This severe type of thrombocytopenia can be related to arterial and venous thromboses/thromboembolisms, consumption coagulopathy, possibly skin necroses at injection site, petechiae, purpura and melaena. The anticoagulant effect of heparin may be reduced (heparin tolerance). In such cases use of Tinzaparin sodium (innohep) is to be discontinued immediately. The patient must be informed of the fact that he/she must also avoid taking heparin-containing medicinal products in the future.
Anaphylactic reactions, in rare cases anaphylactic shock. Allergic reactions with symptoms such as e.g. nausea, vomiting, fever, headache, urticaria, pruritus, dyspnoea, bronchospasm, hypotension.
Transient hair loss.
Rare cases of serious adverse drug reactions for Tinzaparin sodium (innohep) such as subdural or epidural haematoma, intracranial haemorrhage, retroperitoneal haemorrhage, metrorrhagia, angioedema, epidermal necrolysis, Stevens-Johnson-Syndrome, priapism have been reported.
In very rare cases: hypoaldosteronism, associated with hyperkaliaemia and metabolic acidosis (especially in patients with renal impairment and diabetes mellitus).
Note: Due to the sodium metabisulfite content hypersensitivity reactions can occur in individual cases, especially in patients suffering from bronchial asthma, which can be expressed as vomiting, diarrhoea, dyspnoea, acute asthmatic attack, disturbance of consciousness or shock.
Pre-filled syringe: 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.
Increase in aminotransferases, gamma-GT, LDH, lipase.
Injection site haematoma and pain, rarely skin necrosis.
Increase of serum potassium concentration.
Occasional: A mild transient thrombocytopenia (type I) at the beginning of heparin therapy with platelet counts between 100,000/μl and 150,000/μl due to temporary platelet activation. As a rule no complications occur, therefore, treatment can be continued.
Rare: Cases of antibody-mediated severe thrombocytopenia (type II) with platelet counts clearly below 100,000/μl or a rapid decrease to less than 50% of baseline have been observed. In patients not sensitized the decrease in platelet count generally sets in 6-14 days after the beginning of treatment. In sensitized patients this may happen within few hours. This severe type of thrombocytopenia can be related to arterial and venous thromboses/thromboembolisms, consumption coagulopathy, possibly skin necroses at injection site, petechiae, purpura and melaena. The anticoagulant effect of heparin may be reduced (heparin tolerance). In such cases use of Tinzaparin sodium (innohep) is to be discontinued immediately. The patient must be informed of the fact that he/she must also avoid taking heparin-containing medicinal products in the future.
Anaphylactic reactions, in rare cases anaphylactic shock. Allergic reactions with symptoms such as e.g. nausea, vomiting, fever, headache, urticaria, pruritus, dyspnoea, bronchospasm, hypotension.
Transient hair loss.
Rare cases of serious adverse drug reactions for Tinzaparin sodium (innohep) such as subdural or epidural haematoma, intracranial haemorrhage, retroperitoneal haemorrhage, metrorrhagia, angioedema, epidermal necrolysis, Stevens-Johnson-Syndrome, priapism have been reported.
In very rare cases: hypoaldosteronism, associated with hyperkaliaemia and metabolic acidosis (especially in patients with renal impairment and diabetes mellitus).
Note: Due to the sodium metabisulfite content hypersensitivity reactions can occur in individual cases, especially in patients suffering from bronchial asthma, which can be expressed as vomiting, diarrhoea, dyspnoea, acute asthmatic attack, disturbance of consciousness or shock.
Pre-filled syringe: 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
Vial: Concomitant administration of drugs affecting the haemostasis, e.g. NSAID, acetylsalicylic acid, salicylates, vitamin K antagonists, dipyridamole and dextran should be used with caution in patients receiving Tinzaparin sodium (innohep).
Interaction of heparin with intravenous nitroglycerine (which can result in a decrease in efficacy) cannot be ruled out for tinzaparin.
Drugs that increase the serum potassium concentration should only be taken concomitantly under especially careful medical supervision.
Pre-filled syringe: Concomitant administration of other drugs affecting haemostasis, e.g. vitamin K antagonists and dextran, may enhance the anticoagulant effect of innohep.
Interaction of heparin with intravenous nitroglycerine (which can result in a decrease in efficacy) cannot be ruled out for tinzaparin.
Drugs that increase the serum potassium concentration should only be taken concomitantly under especially careful medical supervision.
Pre-filled syringe: Concomitant administration of other drugs affecting haemostasis, e.g. vitamin K antagonists and dextran, may enhance the anticoagulant effect of innohep.
Caution For Usage
Vial: Incompatibilities: Tinzaparin sodium (innohep) should be given by subcutaneous injection only. It should not be mixed with any other injections.
Pre-filled syringe: 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.
Instructions for use of the innohep syringes: Patient should wash hands before injecting 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 using it. If patient observes 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 the 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 removing the needle and releasing 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. Patient can either place the used syringe in the tube with the needle downwards or 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.
Pre-filled syringe: 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.
Instructions for use of the innohep syringes: Patient should wash hands before injecting 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 using it. If patient observes 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 the 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 removing the needle and releasing 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. Patient can either place the used syringe in the tube with the needle downwards or 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.
Storage
Do not store above 30°C.
Shelf-Life: Vials: 2 years.
Syringes: 3 years.
Shelf-Life: Vials: 2 years.
Syringes: 3 years.
Action
Properties: Vial: Tinzaparin sodium is a low molecular weight heparin of porcine origin with an anti-Xa/anti-IIa ratio between 1.5 and 2.5. Tinzaparin sodium is produced by enzymatic depolymerization of conventional unfractionated heparin. Like conventional heparin, Tinzaparin sodium acts as an anticoagulant by potentiating Antithrombin III's inhibition of activated coagulation factors, primarily factor Xa.
The biological activity of tinzaparin sodium is standardized against the 1st "International standards for low molecular weight heparins", and expressed in anti-Xa international units (IU).
The anti-Xa activity of tinzaparin sodium is not less than 70 and not more than 120 IU/mg.
The characteristic value of the mass-average molecular mass of tinzaparin sodium is about 6,500.
The mass percentage of chains lower than 2,000 is not more than 10.0 percent. The mass percentage of chains between 2,000 and 8,000 ranges between 60.0 and 72.0 percent (typical 66%). The mass percentage of chains above 8,000 ranges between 22.0 and 36.0 percent.
The maximum anti-Xa activity is seen after 4-6 hours following subcutaneous injection. The elimination half-life of anti-Xa activity after i.v. injection is approx. 90 minutes. Bioavailability of anti-Xa activity is 90%. Due to the very long biological half-life of Tinzaparin sodium (innohep), administration once daily is sufficient.
Tinzaparin undergoes minor metabolization in the liver through a depolymerization and is excreted via the kidneys as an unchanged or almost unchanged form. The pharmacokinetic activities of Tinzaparin sodium (innohep) have been studied in pregnancy.
Data from sequential pharmacokinetic monitoring in 55 pregnancies suggests that pharmacokinetic properties do not differ from the non-pregnant state. There was a small, but non-statistically significant, decrease in anti-Xa levels with advancing gestation. Some monitoring of peak anti-Xa levels four hours following administration of tinzaparin is recommended in the first weeks of administration and in late pregnancy.
Pre-filled syringe: 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.
Toxicology: Preclinical Safety Data: Vial: Heparins and LMW-heparins are generally only slightly toxic, and this applies for tinzaparin sodium as well. The most important effect observed in studies of acute, sub-acute and chronic toxicity, reproduction toxicity and mutagenicity is haemorrhaging caused by the very high doses administered.
After intramuscular administration of LMW-heparin in animals necrotising haematoma were observed. Osteoporotic effects were revealed in a 12-months study in rats. Animal studies in rats and rabbits failed to find a teratogenic potential of LMW-heparin in doses up to 25 mg/kg bodyweight. Foetuses which were prenatally exposed to 10 mg/kg body weight were found to have lower bodyweights than controls.
The biological activity of tinzaparin sodium is standardized against the 1st "International standards for low molecular weight heparins", and expressed in anti-Xa international units (IU).
The anti-Xa activity of tinzaparin sodium is not less than 70 and not more than 120 IU/mg.
The characteristic value of the mass-average molecular mass of tinzaparin sodium is about 6,500.
The mass percentage of chains lower than 2,000 is not more than 10.0 percent. The mass percentage of chains between 2,000 and 8,000 ranges between 60.0 and 72.0 percent (typical 66%). The mass percentage of chains above 8,000 ranges between 22.0 and 36.0 percent.
The maximum anti-Xa activity is seen after 4-6 hours following subcutaneous injection. The elimination half-life of anti-Xa activity after i.v. injection is approx. 90 minutes. Bioavailability of anti-Xa activity is 90%. Due to the very long biological half-life of Tinzaparin sodium (innohep), administration once daily is sufficient.
Tinzaparin undergoes minor metabolization in the liver through a depolymerization and is excreted via the kidneys as an unchanged or almost unchanged form. The pharmacokinetic activities of Tinzaparin sodium (innohep) have been studied in pregnancy.
Data from sequential pharmacokinetic monitoring in 55 pregnancies suggests that pharmacokinetic properties do not differ from the non-pregnant state. There was a small, but non-statistically significant, decrease in anti-Xa levels with advancing gestation. Some monitoring of peak anti-Xa levels four hours following administration of tinzaparin is recommended in the first weeks of administration and in late pregnancy.
Pre-filled syringe: 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.
Toxicology: Preclinical Safety Data: Vial: Heparins and LMW-heparins are generally only slightly toxic, and this applies for tinzaparin sodium as well. The most important effect observed in studies of acute, sub-acute and chronic toxicity, reproduction toxicity and mutagenicity is haemorrhaging caused by the very high doses administered.
After intramuscular administration of LMW-heparin in animals necrotising haematoma were observed. Osteoporotic effects were revealed in a 12-months study in rats. Animal studies in rats and rabbits failed to find a teratogenic potential of LMW-heparin in doses up to 25 mg/kg bodyweight. Foetuses which were prenatally exposed to 10 mg/kg body weight were found to have lower bodyweights than controls.
MedsGo Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
Features
Brand
Innohep
Full Details
Dosage Strength
10000 anti-Xa IU / ml
Drug Ingredients
- Tinzaparin
Drug Packaging
Solution for Injection (S.C.) 0.5ml x 10's
Generic Name
Tinzaparin Sodium
Dosage Form
Solution For Injection (S.C.)
Registration Number
BR-1080
Drug Classification
Prescription Drug (RX)