INNOHEP INJECTION 4500 ANTIXA IU/0.45ML (PREFILLED SYRINGE)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TINZAPARIN SODIUM

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

TINZAPARIN SODIUM

Unit dalam pakej:

10Units Units

Dikeluarkan oleh:

LEO Pharma A/S

Risalah maklumat

INNOHEP
®
Tinzaparin Sodium (10,000 anti-Xa IU/ml, 20,000 anti-Xa IU/ml)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
_innohep_
_® _
is used for
2.
How
_innohep_
_® _
works
_3._
_ _
Before you use
_innohep_
_®_
_ _
_4._
_ _
How to use
_innohep_
_®_
_ _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_innohep_
_®_
_ _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Reference Number
WHAT _INNOHEP_
_® _
IS USED FOR
_innohep_
_® _
is a blood thinning medication
that inhibit the natural ability of the blood
to clot (coagulate).
_innohep_
_® _
is used to treat blood clots and
prevent blood clots.
You must talk to a doctor if you do not
feel better or if you feel worse.
HOW _INNOHEP_
_® _
WORKS
_innohep® _
is a type of heparin – a low
molecular weight heparin – and belongs
to
a
group
of
medicines
called
anticoagulants; these medicines prevents
clotting,
allowing
normal
blood
flow
through the arteries and veins.
BEFORE YOU USE _INNOHEP_
_®_
_ _
_When you must not use it _

If you are allergic to Tinzaparin
sodium or any other ingredients
of this medicine

If you have ever had a reaction to
heparin that caused a severe drop
in the number of your clotting
cells (platelets) - this reaction is
called
heparin-
induced
thrombocytopenia (HIT).

If
you have a major bleeding
(e.g. in the brain, spine, eye or
stomach).

If you have an infection in the
heart
membranes
(septic
endocarditis)

(For treatment indication) If you
are planned to undergo spinal or
epidural anaesthesia or lumbar
puncture.
_Pregnancy and lactation _
_ _
If
you
are
pregnant
or
breast-feeding,
think you may be pregnant or are planning
to
have
a
baby,
ask
your
doctor
or
pharmacist for advice before taking this
medicine.
If epidural anaesthesia is needed you must
tell
your
doctor
that
you
are
using
_innohep_
®.
Talk to your doctor of nurse if you have
an artificial heart valve.
_Before you start use it _
_ _

Ciri produk

028625-00
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 _
_bisulphite._
SYRINGE OF 0.35 ML OR 0.45
ML FOR INJECTION
_Tinzaparin sodium _
_10,000 _
_anti-Xa _
_IU/ml._
SYRINGE OF 0.5 ML, 0.7
ML FOR INJECTION
_Tinzaparin sodium _
_20,000 _
_anti-Xa IU/ml, stabilized with sodium _
_bisulphite._
PRODUCT DESCRIPTION
innohep® injection 14,000 anti-Xa IU/0.7 ml (pre-filled syringes)
innohep® injection 3,500 anti-Xa IU/0.35 ml (pre-filled syringes)
innohep® injection 4,500 anti-Xa IU/0.45 ml (pre-filled syringes)
innohep® injection 10,000 anti-Xa IU/0,5 ml (pre-filled syringes)
Clear solution, colorless to straw colored, free of particles.
innohep® injection 10,000 anti-Xa IU/ml (vials)
innohep® injection 20,000 anti-Xa IU/ml (vials)
Colorless to slightly yellow solution.
PROPERTIES
_Tinzaparin sodium is a low molecular weight heparin produced _
_by _
_enzymatic _
_depolymerization of conventional heparin of porcine origin. _
_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._
PHARMACODYNAMICS
INNOHEP
_®_
_ _