INNOHEP INJECTION 10000 Anti-Xa iu0.5ml (pre-filled syringes)

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

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资料单张 资料单张 (PIL)
28-01-2013
产品特点 产品特点 (SPC)
27-08-2019

有效成分:

TINZAPARIN SODIUM

可用日期:

LEO PHARMA ASIA PTE LTD

ATC代码:

B01AB10

剂量:

20000 axa iu/ml

药物剂型:

INJECTION

组成:

TINZAPARIN SODIUM 20000 axa iu/ml

给药途径:

SUBCUTANEOUS

处方类型:

Prescription Only

厂商:

LABORATOIRES LEO

授权状态:

ACTIVE

授权日期:

1999-02-18

资料单张

                                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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产品特点

                                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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