Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Heparin sodium; Sodium chloride; Sodium phosphate; Citric acid monohydrate

Διαθέσιμο από:

Baxter Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

B01AB; B01AB01

INN (Διεθνής Όνομα):

Heparin sodium; Sodium chloride; Sodium phosphate; Citric acid monohydrate

Δοσολογία:

1 international unit(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for infusion

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Heparin group; heparin

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1984-06-06

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEPARIN SODIUM BP 1000 IU/L IN 0.9% W/V SODIUM CHLORIDE IV INFUSION
Active substance: 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, nurse or
pharmacist.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See Section 4.
Throughout this leaflet, Heparin Sodium BP 1000 IU/L in 0.9% w/v
Sodium Chloride IV
Infusion will be called Heparin Sodium Solution.
WHAT IS IN THIS LEAFLET:
1. What Heparin Sodium Solution is and what it is used for
2. What you need to know before you are given Heparin Sodium Solution
3. How you will be given Heparin Sodium Solution
4. Possible side effects
5. How Heparin Sodium Solution is stored
6. Contents of the pack and other information
1. WHAT HEPARIN SODIUM SOLUTION IS AND WHAT IT IS USED FOR
Heparin Sodium Solution contains a medicine called heparin. It belongs
to a group of
medicines called antithrombotics or anticoagulants, they stop your
blood from clotting.
Heparin Sodium Solution is used to:
• stop blood clotting when it is removed from your body, for example
during dialysis.
Dialysis is used to help your kidneys remove toxins from your blood.
• stop tubes that are put into your blood vessels (catheters) from
getting blocked by blood
clots.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN SODIUM SOLUTION
YOUR DOCTOR WILL NOT GIVE YOU HEPARIN SODIUM SOLUTION IF:
• you are allergic (hypersensitive) to the active ingredient or any
of the other ingredients of
Heparin Sodium Solution (listed in section 6)
• you tend to have difficulty in stopping bleeding.
You will not be given Heparin Sodium Solution if any of the above
applies to you. If you are
not sure if you have any of these conditions, talk to your doctor,
nurse or pharmacist before
havin

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin Sodium
1000 IU/I
Sodium Chloride
9.0g/l
Disodium Phosphate dodecahydrate
5.8g/l
Citric Acid Monohydrate
405mg/l
This provides: 186 mmol/l Sodium, 154 mmol/l Chloride, 16 mmol/l
Phosphate
and 2 mmol/l Citrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion (Infusion)
Clear, colourless or straw coloured, sterile non-pyrogenic solution
for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Heparin sodium in 0.9% Sodium Chloride infusion is indicated as an
anticoagulant in extracorporeal circulation and
dialysis procedures for the maintenance of catheter patency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Dosage of heparin should be titrated against patient response.
_Heparinisation for dialysis procedures:_
Dosage is dependent upon the age, weight and clinical condition of the
patient.
It is suggested that a proper
heparinisation schedule is used before, and maintained throughout the
procedure to prevent clotting and subsequent
blood path obstruction.
_Maintenance of Catheter Patency_
The dosage should be adapted to catheter characteristics and the
clinical condition of the patient.
_Administration_
Administration is by intravenous infusion.
_Elderly patients_
A higher incidence of bleeding has been reported in patients over 60
years of age, especially women.
Clinical studies
indicate that lower doses of heparin may be indicated in these
patients.
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