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ARGATROBAN 1 MG/ML SOLUTION FOR INFUSION

Active substance(s): ARGATROBAN MONOHYDRATE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Argatroban

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

4 (Page 1 of 2)

Date

02:06:17 (Argatroban 1x50ml(ACC-UK)-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package Leaflet: Information for the user

Argatroban 1 mg/ml
Solution for Infusion
argatroban

Approved By
Quality Assurance

● vomiting or coughing up blood
● black stools
● difficulty in breathing
● cold sweaty skin
● dry mouth
● dilated pupils and/or weak, rapid pulse.

These symptoms could indicate that you are
experiencing bleeding problems.

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

Common side effects (affects more than 1 user
in 100):
● Anaemia
● blood clotting
● bleeding, including numerous small bleedings in
skin and mucus membranes (purpura)
● nausea.

In this leaflet:
1. What Argatroban Infusion is and what it is
used for
2. What you need to know before you use
Argatroban Infusion
3. How to use Argatroban Infusion
4. Possible side effects
5. How to store Argatroban Infusion
6. Contents of the pack and other information

Uncommon side effects (affects more than 1
user in 1,000):
● Infections such as urinary tract infection
● changes in blood values
● blood clotting
● lack of appetite
● low blood sugar levels
● low sodium levels in the blood
● confusion
● dizziness
● fainting
● headache
● stroke
● muscle disorders
● speech disorder
● vision problems
● deafness
● heart attack
●fluid in the heart sac
● abnormal heart rhythm
● fast heartbeat
● low blood pressure
● high blood pressure
● inflammation of veins
● shock
● reduced oxygen supply to the tissues
● breathing difficulties
● fluid around the lungs
● hiccup
●blood in cough, vomit or stools
● constipation
● diarrhoea
● stomach inflammation
● difficulty in swallowing
● tongue disorder
● abnormal liver function
● jaundice (yellowing of the skin and eyes)
● changes in blood tests for liver function
● rash including nettle rash
● itching,
● increased sweating
● hair loss
● muscle weakness
● muscle pain
● kidney failure
● fever
● pain
● tiredness
● injection site reactions
● swelling of the legs
● increased wound drainage
● abnormal laboratory results.

1. What Argatroban Infusion is
and what it is used for
Argatroban Infusion is an anticoagulant (a drug
that helps to prevent blood clots from forming in
your blood circulation). It works by blocking the
action of thrombin, a substance in your blood that
is important in blood clotting.
Argatroban Infusion is used if you are suffering
from a disorder known as heparin-induced
thrombocytopenia type II (HIT type II). If you have
HIT type II, you are at risk of developing blood
clots in your blood circulation that can cause
heart attacks, stroke, breathing problems and
problems with the blood supply to your limbs.
Argatroban Infusion can prevent these problems
or prevent them from becoming worse.

2. What you need to know before
you use Argatroban Infusion
Do not use Argatroban Infusion
Argatroban Infusion will not be given to you:
• If you have uncontrolled bleeding.
• If you are allergic (hypersensitive) to argatroban
or to any of the other ingredients in Argatroban
Infusion.
• If you have severely impaired liver function.
Take special care with Argatroban Infusion
Argatroban Infusion will be given to you with
special care:
• If there is an increased risk of bleeding
• If you have recently had injections or infusions
of other anticoagulants such as heparin
• If you have liver disease
Other medicines and Argatroban Infusion
Please tell your doctor if you are taking, or have
recently taken, any other medicines, including
medicines obtained without prescription.
Combined use with other blood thinning or blood
clot dissolving medicines can increase the risk of
bleeding.
Pregnancy and breast-feeding
If you are pregnant, your doctor will only give you
Argatroban Infusion if it is absolutely necessary.
Avoid breast-feeding while you are being given
Argatroban Infusion.
Driving and using machines
The effect of treatment with Argatroban Infusion
on patient’s ability to drive or operate machinery
has not been evaluated.
Argatroban Infusion contains sorbitol
This medicine contains sorbitol. If you have been
told by your doctor that you have an intolerance
to some sugars. Contact your doctor before
taking this medicinal product.
Argatroban Infusion contains sodium
This medicinal product contains 3.54 mg of
sodium per ml solution. To be taken into
consideration by patients on controlled sodium
diet.

3. How to use Argatroban
Infusion
Argatroban Infusion will always be given to you
by medical personnel. Argatroban Infusion will be
given to you intravenously (into a vein) by
continuous infusion. The doctor will decide the
dose and how long you will be treated.

4. Possible side effects
Like all medicines, Argatroban Infusion can
cause side effects, although not everybody gets
them.
The most common side-effects are bleeding.
Major bleeding can occur in approximately 5% of
patients and minor bleeding in about 39% of
patients. You must tell your doctor
immediately if you experience any of the
following symptoms:
● Bleeding or bruising
● blood in urine or stools

The following information is intended for
healthcare professionals only:
Instructions for use, handling and disposal
Argatroban Infusion is supplied as a ready to use
solution for infusion with concentration of 1 mg/ml
(50 mg/50 ml).
The vial is for single use only. The pH of the

If any of these side effects get serious or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via the national reporting Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard
.By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Argatroban
Infusion
Keep this medicine out of the sight and reach of
children.
Do not freeze. Keep vial in the outer carton in
order to protect from light.
The product should be used immediately after
opening
Solutions should not be used if they are cloudy
or contain any particles.
Do not use after the expiry date which is stated
on the carton/vial label. The expiry date refers to
the last day of that month.

6. Contents of the pack and
other information
What Argatroban Infusion contains
The active substance is argatroban. The other
ingredients are sorbitol, sodium chloride and
water for injections.
1 ml solution for infusion contains 0.966 mg of
argatroban equivalent to 1 mg argatroban
monohydrate.
1 vial with 50 ml solution for infusion contains
48.30 mg of argatroban equivalent to 50 mg
argatroban monohydrate.
What Argatroban Infusion looks like and
contents of the pack
This medicinal product is a clear colourless to
pale yellow solution for infusion and supplied in a
clear glass vial sealed with a rubber stopper and
an aluminium seal with a flip-off cap.
Each vial contains 50 ml of the solution and the
vials are packed in cardboard boxes of 1, 5 or 6
vials pack.

intravenous infusion solution is 3.2- 7.5
Light resistant measures such as foil protection
for intravenous lines are not necessary. No
significant potency losses have been noted
following simulated delivery of the solution
through intravenous tubing.
Any unused product or waste material should be
disposed of in accordance with local requirements.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Argatroban

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

4 (Page 1 of 2)

Date

02:06:17 (Argatroban 1x50ml(ACC-UK)-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Manufacturer:
Accord Healthcare Limited
Sage House,319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Or
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047, Hungary
This leaflet was last revised in 06/2017

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Further information

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