INNOHEP INJECTION 10000 Anti-Xa iu0.5ml (pre-filled syringes)
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
28-01-2013
Summary of Product characteristics
(SPC)
27-08-2019
Active ingredient:
TINZAPARIN SODIUM
Available from:
LEO PHARMA ASIA PTE LTD
ATC code:
B01AB10
Dosage:
20000 axa iu/ml
Pharmaceutical form:
INJECTION
Composition:
TINZAPARIN SODIUM 20000 axa iu/ml
Administration route:
SUBCUTANEOUS
Prescription type:
Prescription Only
Manufactured by:
LABORATOIRES LEO
Authorization status:
ACTIVE
Authorization date:
1999-02-18
Patient Information leaflet
INNOHEP®
ANTICOAGULANT
Tinzaparin sodium
VIALS OF 2 ML
Tinzaparin sodium 10,000 anti-Xa IU/ml, preserved with
benzyl alcohol.
Tinzaparin sodium 20,000 anti-Xa IU/ml,
preserved with benzyl alcohol, stabilized with sodium
metabisulphite.
SYRINGE OF 0.35 ML AND 0.45ML
Tinzaparin sodium 10,000 anti-Xa IU/ml.
SYRINGE OF 0.5 ML AND 0.7ML
Tinzaparin sodium 20,000 anti-Xa IU/ml, stabilized with sodium
metabisulphite.
Not all presentations listed above are available locally.
PROPERTIES
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 anti-Xa
international units.
INDICATIONS
Treatment of deep-vein thrombosis.
Treatment of 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
Treatment of DVT:
The recommended dose is 175 anti-Xa IU/kg body-weight s.c. once
daily.
Treatment of pulmonary embolism:
The recommended dose is 175 anti-Xa IU/kg body-weight s.c.once
daily.
Thromboprophylaxis in patients with moderate risk of t
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Summary of Product characteristics
INNOHEP®
ANTICOAGULANT
Tinzaparin sodium
VIALS OF 2 ML
Tinzaparin sodium 10,000 anti-Xa IU/ml, preserved with benzyl alcohol.
Tinzaparin sodium 20,000 anti-Xa IU/ml, preserved with benzyl alcohol,
stabilized with sodium metabisulfite.
SYRINGE OF 0.35 ML AND 0.45ML
Tinzaparin sodium 10,000 anti-Xa IU/ml.
SYRINGE OF 0.5 ML AND 0.7ML
Tinzaparin sodium 20,000 anti-Xa IU/ml, stabilized with sodium
metabisulfite.
Not all presentations listed above are available locally.
PROPERTIES
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 anti-Xa
international units.
INDICATIONS
Treatment of deep-vein thrombosis.
Treatment of 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
Treatment of DVT:
The recommended dose is 175 anti-Xa IU/kg body-weight s.c. once daily.
Treatment of pulmonary embolism:
The recommended dose is 175 anti-Xa IU/kg body-weight s.c.once daily.
Thromboprophylaxis in patients with moderate risk of thrombosis
(general surgery):
On the day of operation 3,500 anti-Xa IU s.c. 2 hours before surgery
and postoperatively
once daily 3,500 anti-Xa IU for 7–10 days.
Thromboprophyla
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