Heparin sodium Solution for Injection 5000IU/ml

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

HEPARIN SODIUM

Inapatikana kutoka:

Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France

ATC kanuni:

B01AB01

INN (Jina la Kimataifa):

HEPARIN SODIUM 5000 IU/ml

Dawa fomu:

SOLUTION FOR INJECTION

Tungo:

HEPARIN SODIUM 5000 IU/ml

Dawa ya aina:

POM

Eneo la matibabu:

ANTITHROMBOTIC AGENTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2018-05-08

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEPARIN SODIUM 5,000 I.U./ML, SOLUTION FOR INJECTION
Heparin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Heparin sodium 5,000 I.U./ml is and what it is used for
2.
What you need to know before you are given Heparin sodium 5,000
I.U./ml
3.
How Heparin sodium 5,000 I.U./ml is given
4.
Possible side effects
5.
How to store Heparin sodium 5,000 I.U./ml
6.
Contents of the pack and other information
1.
WHAT HEPARIN SODIUM 5,000 I.U./ML IS AND WHAT IT IS USED FOR
The name of this medicine is Heparin sodium 5,000 I.U./ml, solution
for injection (referred to as
‘Heparin sodium 5,000 I.U./ml’ in this leaflet).
Heparin sodium 5,000 I.U./ml belongs to a group of medicines called
anticoagulants. Heparin
prevents blood clotting.
Heparin sodium 5,000 I.U./ml is used to treat and prevent:
•
blood clots in leg veins (deep vein thrombosis)
•
blood clots in the lung (pulmonary embolism) as well as for:
•
the treatment of chest pains resulting from disease of the heart
arteries (unstable angina
pectoris)
•
the treatment of severe blockages affecting arteries in the legs
(acute peripheral arterial
occlusion)
•
the prevention of blood clots in the heart following a heart attack
(mural thrombosis).
It is also used during heart and lung operations and during kidney
dialysis.
2 .
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN SODIUM 5,000
I.U./ML
YOU SHOULD NOT BE GIVEN HEPARIN SODIUM 5,000 I.U./ML IF YOU:
-
are allergic to heparin or any of the other ingred

Tabia za bidhaa

ANNEXE I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Heparin sodium 5,000 I.U./ml, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule with 1 ml solution for injection contains 5,000 I.U. of
sodium heparin (from
porcine intestinal mucosa).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL IPARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prophylaxis of deep vein thrombosis and pulmonary embolism.
-
Treatment of deep vein thrombosis and pulmonary embolism, unstable
angina pectoris
and acute peripheral arterial occlusion.
-
Prophylaxis of mural thrombosis following myocardial infarction.
-
In extracorporeal circulation and haemodialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
By continuous intravenous infusion in 5% glucose or 0.9% sodium
chloride or by intermittent
intravenous injection, or by subcutaneous injection.
The intravenous injection volume of heparin injection should not
exceed 15ml. As the effects of
heparin
are short-lived,
administration
by
intravenous
infusion
or subcutaneous injection is
preferable to intermittent intravenous injections.
Posology
Prophylaxis of deep vein thrombosis and pulmonary embolism
_Adults:_
2 hours pre-operatively: 5,000 units subcutaneously
followed by:
5,000 units subcutaneously every 8-12 hours, for 7-10 days or until
the patient is fully ambulant.
No
laboratory
monitoring
should
be
necessary
during
low
dose
heparin
prophylaxis.
If
monitoring is considered desirable, anti-Xa assays should be used as
the activated partial
thromboplastin time (APTT) is not significantly prolonged.
During pregnancy:
5,000
-
10,000
units
every
12
hours,
subcutaneously,
adjusted
according to APTT or anti-Xa assay
_Elderly:_
Dosage reduction and monitoring of APTT may be advisable.
_Paediatric population:_
No dosage recommendations.
Treatment of deep vein thrombosis and pulmonary embolism:
_Adults:_
Loading dose:
5,000 units intravenously (10,000 units may be requir