Heparinised Saline (Pfizer)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Heparin sodium 10 IU/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Heparin sodium 10 IU/mL

Dosage:

50 IU/5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Heparin sodium 10 IU/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Units in package:

Ampoule, plastic, 5 mL LDPE, 50 ampoules, 50 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Product summary:

Package - Contents - Shelf Life: Ampoule, plastic, 5 mL LDPE - 50 dose units - 20 months from date of manufacture stored at or below 25°C

Authorization date:

2009-04-21

Patient Information leaflet

HEPARINISED SALINE INJECTION 
1 
HEPARINISED SALINE 
INJECTION 
_ _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Heparinised Saline 
Injection.  It does not contain all the 
available information.  It does not 
take the place of talking to your 
doctor or pharmacist. 
All medicines have benefits and 
risks.  Your doctor has weighed the 
risks of you being given Heparinised 
Saline Injection against the benefits 
this medicine is expected to have for 
you. 
This medicine is likely to be used 
while you are at the clinic or in 
hospital.  If possible, please read this 
leaflet carefully before this medicine 
is given to you.  In some cases this 
leaflet may be given to you after the 
medicine has been used. 
IF YOU HAVE ANY CONCERNS ABOUT 
BEING GIVEN THIS MEDICINE, ASK YOUR 
DOCTOR, NURSE OR PHARMACIST. 
KEEP THIS LEAFLET. 
You may need to read it again. 
This medicine is available only with 
a doctor's prescription. 
WHAT HEPARINISED 
SALINE INJECTION IS 
USED FOR 
Heparinised Saline Injection belongs 
to a group of medicines known as 
anticoagulants.  Anticoagulants work 
by decreasing the clotting ability of 
your blood and help stop clots 
forming in the blood vessels.  
Anticoagulants are sometimes called 
"blood thinners", although they do 
not actually thin the blood.  Heparin 
will not dissolve blood clots that 
have already formed, but it may 
prevent any clots that have already 
formed from becoming larger and 
causing serious problems. 
Heparinised Saline Injection is used 
to prevent the blocking of injection 
equipment often caused by blood 
clots. 
Heparinised Saline Injection may be 
used for the treatment of other 
conditions that are not mentioned 
above.  Your doctor will be

Summary of Product characteristics

Version: pfdhepsi11221
Supersedes: pfdhepsi10219
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
Heparinised Saline (Pfizer) Injection 50 IU/5mL Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule contains heparin sodium 10 IU/mL, in 5mL ampoules
Heparin sodium is a white or almost white powder, moderately
hygroscopic, freely soluble in
water.
Heparin sodium is a preparation containing the sodium salt of a
sulphated glucosaminoglycan
present in mammalian tissues. It is prepared from the intestinal
mucosae of pigs.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Heparinised Saline Injection is a clear, colourless, sterile,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
maintenance of the patency of intravenous injection devices
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Heparinised Saline Injection contains no antimicrobial agent and is
therefore intended for
single use only.
To maintain the patency of intravenous injection devices and prevent
clot formation, flush the
catheter/cannula with 10 – 50 IU every four hours. The solution may
be used following initial
placement of the device in the vein, after each injection of a
medication, or after withdrawal of
blood for laboratory tests. If the drug to be administered is
incompatible with Heparin (see
section 4.5), the device must be flushed through with normal 0.9%
Sodium chloride solution
before and after the drug is administered. When heparin would
interfere with or alter the results
of blood tests, the heparin solution should be cleared from the device
by aspirating and
discarding it before withdrawing the blood sample. Consult the device
manufacturer’s
instructions for specific details.
Version: pfdhepsi11221
Supersedes: pfdhepsi10219
Page 2 of 10
Note: Since repeated injections of small doses of heparin can alter
tests for activated partial
thromboplastin time (APTT), a baseline value for APTT should be
obtained prior to insertion
of an in