CLEXANE FORTE SYRINGES

Active substance: ENOXAPARIN SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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1. What Clexane Forte is and
what it is used for

tinzaparin or dalteparin

Clexane Forte works in two ways:

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Phone 0845 372 7101 for help
Read all of this leaflet carefully before
you start using this medicine

Clexane Forte can be used to:

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

In this leaflet:

2. Before you use Clexane Forte
Do not have this medicine and
tell your doctor if:

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

1
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Technical information for the administration of Clexane Syringes

1

NAME OF THE MEDICINAL PRODUCT

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

3

PHARMACEUTICAL FORM

4.2 Posology and method of administration

1

in arthritis and other illnesses
3. How to use Clexane Forte
Taking or using other medicines

conditions

In particular, do not take this medicine
and tell your doctor if:

Having this medicine

Operations and anaesthetics

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

Pregnancy and breast-feeding
How much will be given to you in
hospital

2
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)
100mg/ml
Solution for
Injection
CLEXANE
syringes

40
45
50
55
60
65

60 od
75 od
90 od

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)

100mg/ml
Solution for
Injection
CLEXANE
syringes

40
45
50
55
60
65
70
75
80
85
90
95
100

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)
150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

70
75
80
85
90
95
100

105 od
120 od
135 od
150 od

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

105
110
115
120
125
130
135
140
145
150

2

If you are aged 75 years or 520556
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older
Adults including the elderly
1) Treating blood clots that are in your
blood
c) After you have had a heart attack

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

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

i) NSTEMI type of heart attack

ii) STEMI type of heart attack
If you are under 75 years old
b) After an operation or long periods
of bed rest due to illness

3) Stop blood clots forming in the tubes
of your dialysis machine

Children

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Elderly.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)

100mg/ml
Solution
for
Injection
CLEXANE
syringes

40
45
50
55
60
65
70
75
80
85
90
95
100

Dosage chart for 1mg/kg SC treatment of STEMI
Patient
Injection
Kg
Syringe label
Dose (mg)
weight
volume (ml)
150mg/ml
Solution
for
Injection
CLEXANE
Forte
syringes

105
110
115
120
125
130
135
140
145
150

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(1)
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(1)

(1)

Renal impairment

Haemorrhage in the elderly; Renal impairment and

Monitoring
3

How to give yourself an injection of
Clexane Forte

Do not
Before injecting yourself with Clexane
Forte

2)

5)

3)

Remember:
hold the skin fold
throughout the injection.
6)
Instructions on injecting yourself with 4)
Clexane Forte:
7)

1)

4
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only)
Patient weight

100mg/ml
Solution for Injection
CLEXANE syringes

150mg/ml
Solution for Injection
CLEXANE Forte syringes

Kg

Syringe label

0.75mg/kg Dose (mg)

Adjusted dosing (mg)

Injection volume (ml)

40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150

(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)

(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)

(1)
(1)
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(1)
(1)
(1)
(1)
(1)

(1)

Renal impairment and Monitoring;
Severe renal impairment:

Standard dosing

Severe renal impairment

4

If you forget to use Clexane Forte
8)

If you stop using Clexane Forte

Blood Tests

To avoid bruising, do not rub the injection
site after you have injected yourself.

4. Possible side effects

Tell a nurse or doctor as soon as possible
if you notice any of the following side
Tell a nurse or doctor or go to hospital effects:
straight away if you notice any of the
When the container is full, give it to your following side-effects:
doctor or home care nurse for disposal.
Do not put it in the household rubbish.
9)

If you have too much or too little Clexane
Forte

5

Standard dosing

Severe renal impairment

Moderate and mild renal impairment:

Low body weight and Monitoring

Treatment of acute
ST-segment Elevation Myocardial Infarction)

5

Reporting of side effects

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What Clexane Forte looks like and contents
of the pack

5. How to store and dispose of Clexane Forte

Marketing Authorisation
Holder and Manufacturer

Other side effects that you should discuss
with your nurse or doctor if you are
concerned about them:

6. Further information
This leaflet was last revised in 12/2013.

What Clexane Forte contains

6
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Weight

Required dose
(0.3mg/kg)

Volume to inject when diluted to
a final concentration of 3mg/ml

15

5

45
50
55
60
65
70
75
80
85
90
95

6

18
21

6
7

24

8

27

9

Weight
100
105
110
115
120
125
130

135
140
145
150

Required dose
(0.3mg/kg)

Volume to inject when diluted to a final
concentration of 3mg/ml

30

10

33

11

36

12

39

13

42

14

45

15

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
6.2 Incompatibilities
Subcutaneous Injection
Intravenous (Bolus) Injection for acute STEMI indication only
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal
9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT
6

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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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