CLEXANE MULTIDOSE VIAL

Active substance: ENOXAPARIN SODIUM

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THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY
®

100mg/ml multidose vial
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight

Clexane 100mg/ml multidose vial
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or
both

Technical information for the administration of Clexane
Syringes
1

NAME OF THE MEDICINAL PRODUCT

2

Patient weight

QUALITATIVE AND QUANTITATIVE COMPOSITION

3

Kg

Dose (mg)

40
45
50
55
60
65
70
75
80
85

300mg/3ml
Solution for Injection
Clexane Multidose Vial

Injection
volume
(ml) (1)

60 od

300mg/3ml
Solution for Injection
Clexane Multidose Vial

PHARMACEUTICAL FORM

75 od

100

Dose (mg)

Injection
volume
(ml)

40
45
50
55
60
65
70
75
80
85
100
105
110
115
120
125
130
135
140
145
150

105 od
120 od
135 od

4.2 Posology and method of administration

Kg

150 od

(1)

Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight
Kg
Dose (mg) Injection volume (ml)
40
300mg/3ml
45
Solution for
Injection Clexane 50
55
Multidose Vial
60
65
70
75
80
85
100
105 (1)
110 (1)
115 (1)
120 (1)
125 (1)
130 (1)
135 (1)
140 (1)
145 (1)
150 (1)

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Elderly

PACKAGE LEAFLET: INFORMATION FOR THE USER

®

2. Before you have Clexane

100mg/ml multidose vial

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

Taking or using other medicines

Do not have this medicine and tell your doctor,
pharmacist or nurse if:
±
3. How Clexane is given
Do not take and tell your doctor if you are taking
the following medicine:

Read all of this leaflet carefully before you start using
this medicine

±

±

Having this medicine

Tell your doctor if you are taking any of the
following medicines:

±
±
±
±
In this leaflet:

Important information about some of the ingredients
of Clexane

operation

illnesses

How much will be given to you

1) Treating blood clots that are in your blood

1. What Clexane is and what it is used for

Clexane works in two ways.

Take special care with Clexane
Check with your doctor or pharmacist or nurse before
having this medicine if:
c
c
c
c
c
c
c

Clexane can be used to:

c
c
c
c

illness

Operations and anaesthetics

2) Stopping blood clots forming in your blood in the
following situations:
a) Unstable angina

b) After an operation or long periods of bedrest
due to illness
Pregnancy and breast-feeding

Patient weight

Kg
115
120
125
130
135
140
145
150

0.75mg/kg
Dose (mg)
(2)
(2)
(2)
(2)
(2)
(2)
(2)
(2)

Injection
volume (ml) (1)
(2)
(2)
(2)
(2)
(2)
(2)
(2)
(2)

Standard dosing

Severe renal impairment

Moderate and mild renal impairment:

(1)
6
PHARMACEUTICAL PARTICULARS
6.1 List of excipients

(2)

6.2 Incompatibilities
Subcutaneous Injection

Renal impairment;
Renal impairment and Monitoring;

Haemorrhage in the elderly; Renal impairment and Monitoring;

Low body weight and Monitoring;
Intravenous (Bolus) Injection for acute STEMI
indication only:

Severe renal impairment:
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only)
Patient weight
300mg/3ml
Solution for Injection
Clexane Multidose Vial

Kg

0.75mg/kg
Dose (mg)

Injection
volume
(ml) (1)

40
45
50
55
60
65
70
75
80
85
100
105
110

6.3 Shelf life
Standard dosing

6.4 Special precautions for storage

Severe renal impairment

6.5 Nature and contents of container
6.6 Special precautions for disposal
9

10
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
DATE OF REVISION OF THE TEXT

(2)
(2)

c) After you have had a heart attack

People with kidney problems

Tell a nurse or doctor as soon as possible if you notice
any of the following side effects:

5. How to store Clexane

If you have more Clexane than you should
i) NSTEMI type of heart attack

If you stop using Clexane
ii) STEMI type of heart attack
If you are under 75 years old
6. Further Information

Blood Tests

What Clexane contains

4. Possible side-effects
Other side effects that you should discuss with your
doctor if you are concerned about them:
If you are aged 75 years or older

What Clexane looks like and contents of the pack

Tell a nurse or doctor straight away if you
notice any of the following side-effects:
Marketing Authorisation Holder and Manufacturer

For patients having an operation called
Percutaneous Coronary Intervention (PCI)

This leaflet was last revised in 12/2013
3) Stop blood clots forming in the tubes of your
dialysis machine

Reporting of side effects

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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