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Vision problems.
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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
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HOW TO STORE PROTAPHANE
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Keep out of the reach and sight of children.
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The expiry date refers to the last day of that month.
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Do not store them in or too near the freezer section or cooling element.
95
95 temperature before resuspending the insulin as instructed for the first time use.
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1 ml contains 100 IU of insulin human.
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– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
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What Protaphane looks like and contents of the pack
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It is supplied in packs of 5 or 10 pre-filled pens of 3 ml.
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Not all packs may be marketed.
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Marketing Authorisation Holder and Manufacturer
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Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
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Now turn over for information on how to use your NovoLet.
)
This leaflet was last approved in
96
96 Information on how to use Protaphane NovoLet
#
Please read the following instructions carefully before using your Protaphane NovoLet.
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Introduction
Protaphane).;.
Protaphane NovoLet is a simple, compact pre-filled pen.
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Protaphane NovoLet is designed to be used with NovoFine needles.
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Dosage indicator
Protaphane.
Colour coding
30ºC)
Push button scale
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Push button
97
97 Getting started
(NPH).
Take off the pen cap.
1 ml
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
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Repeat this movement at least 10 times before each injection.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsvaerd,
Do not discard the big outer needle cap.
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a
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B
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b
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Priming to expel air
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Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture C) • Still with the needle upwards, press the push-button fully down (picture D) • A drop of insulin must appear at the needle tip.
Novo Nordisk A/ S, Novo Allé, DK- 2880 Bagsværd,
If not, change the needle and repeat the procedure no more than 6 times.
Production SAS, 45 Avenue d’ Orléans F- 28002 Chartres, "
If a drop of insulin still does not appear, the device is defective and must not be used.
:
C
3
D
Protaphane NovoLet 100 IU/ ml
Setting the dose
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If the push-button cannot rise freely, some of your insulin will be pushed out of the needle • The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units.
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For every click you feel when you turn the cap, you set 2 units more.
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Every time you fully turn the cap, you set 20 units.
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You’ ve now set 20 units.
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Keep turning the cap until 6 is opposite the dosage indicator.
$Protaphane!
On the push-button scale you’ ll see a 20- line.
4. $Protaphane
There, you’ ve set 26 units (picture G).
99
99 G
:
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
-
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
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Turn the cap back as far as you can.
4
Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator.
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Now set the dose again.
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Injecting the insulin
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• Insert the needle into your skin.
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This will ensure that the full dose has been delivered.
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Don’ t use this to set or check your dose; it may not be accurate • You can’ t set a dose higher than the number of units left in the cartridge • You can use the insulin level indicator to estimate how much is left, but you can’ t use it to set or select your dose.
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Removing the needle
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• Replace the big outer needle cap and unscrew the needle.
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Dispose of it carefully.
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Use a new needle for each injection.
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100 Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
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Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
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Maintenance
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Your Protaphane NovoLet is designed to work accurately and safely.
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It must be handled with care.
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Do not refill Protaphane NovoLet.
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Do not soak it, wash or lubricate it.
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This may damage the mechanism.
101
101 PACKAGE LEAFLET:
• • •
INFORMATION FOR THE USER
2 6
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
#
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
3
This side of the leaflet:
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1.
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What to do in an emergency 5.
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Possible side effects 6.
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Further information
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How to use your InnoLet
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Protaphane is a long-acting insulin.
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Do not use Protaphane
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Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
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Take special care with Protaphane
4. -!
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
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Using other medicines
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Listed below are the most common medicines which may affect your insulin treatment.
102
Talk to your 102 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
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Pregnancy and breast-feeding
,
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
(2°C - 8°C).
Talk about your insulin needs with your doctor and diabetes nurse.
$NovoLet $) +%. $! $
Follow their advice carefully.
Protaphane.
This leaflet is a general guide.
30ºC)
Injecting insulin
6 #
See overleaf for detailed instructions.
#
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
'
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
1 ml
If you get a hypo
300 IU.
A hypo means your blood sugar level is too low.
.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
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The amount or timing of insulin, food or exercise may need to be adjusted.
3 ml.
Using glucagon
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If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsvaerd,
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
(+ - & & & +
Causes of a hypo
$NovoLet.
You get a hypo if your blood sugar gets too low.
$Protaphane NovoLet
If your blood sugar gets too high
$Protaphane NovoLet.
Your blood sugar may get too high (this is called hyperglycaemia).
Protaphane NovoLet
The warning signs appear gradually.
Protaphane NovoLet
Causes of hyperglycaemia
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• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
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POSSIBLE SIDE EFFECTS
Protaphane NovoLet
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
Protaphane NovoLet
Protaphane may cause hypoglycaemia (low blood sugar).
Protaphane NovoLet (
104 Side effects reported uncommonly (in less than 1 patient in 100)
$Protaphane NovoLet. + 5 & ($& $,%! '$. $- &%.
Changes at the injection site (Lipodystrophy).
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Signs of allergy.
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If they do not disappear, see your doctor.
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See also warning in 2 Before you use Protaphane.
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Diabetic retinopathy (eye background changes).
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Ask your doctor about this.
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Swollen joints.
0, 2, 4,!)
This soon disappears.
6, 8,
Side effects reported very rarely (in less than 1 patient in 10,000)
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Vision problems.
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Painful neuropathy (nerve related pain).
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If it does not disappear, see your doctor.
60
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
'6 #
6.
&
The expiry date refers to the last day of that month.
20
Do not store them in or too near the freezer section or cooling element.
20 G).
Do not freeze.
& '"
These measures will help to protect the environment.
•
7.
1%
FURTHER INFORMATION
1%
What Protaphane contains
$7+ &
1 pre-filled pen contains 3 ml equivalent to 300 IU
$
What Protaphane looks like and contents of the pack
0 (.
Not all packs may be marketed.
#
Marketing Authorisation Holder and Manufacturer
•
Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
$% 0%
Now turn over for information on how to use your InnoLet.
$2$
This leaflet was last approved in
106
106 Information on how to use Protaphane InnoLet
•
Please read the following instructions carefully before using your Protaphane InnoLet.
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Introduction
!
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
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Look for an S on the needle box.
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The S stands for short cap.
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Push- button
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Preparing for injection
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Check the label to make sure that your Protaphane InnoLet contains the correct type of insulin.
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Take off the pen cap (as shown by the arrow).
Protaphane
Suspending the insulin
NovoLet Protaphane NovoLet
Repeat this movement at least 10 times before each injection.
107
107 1A
#
A
'!
B
Protaphane NovoLet
Attaching the needle
.
You may want to store the big outer needle cap in the compartment.
.
1B
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Priming to expel air
,
If not, change the needle and repeat the procedure no more than 6 times.
108
108 If a drop of insulin still does not appear, the device is defective and must not be used.
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Setting the dose
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Do not use the residual scale to measure your dose of insulin • You will hear a click for every single unit dialled.
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The dose can be corrected by turning the dial either way.
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You cannot set a dose larger than the number of units left in the cartridge.
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• Insert the needle into your skin.
3.
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button fully down (picture 3).
109
109 3
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Removing the needle
4
• Replace the big outer needle cap and unscrew the needle (picture 4).
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Dispose of it carefully.
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Use a new needle for each injection.
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Otherwise, the liquid may leak out which can cause inaccurate dosing.
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Maintenance
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Your Protaphane InnoLet is designed to work accurately and safely.
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It must be handled with care.
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Do not refill Protaphane InnoLet.
110
110 PACKAGE LEAFLET:
#
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
. 7
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist.
#
This side of the leaflet:
. &
1.
:
Overleaf:
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How to use your FlexPen
!
Protaphane is often given in combination with fast-acting insulin products.
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Do not use Protaphane
3
See 4 What to do in an emergency for more about hypos.
&. #: • # • * •.
Take special care with Protaphane
!
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
'(+% $!. & 6
Using other medicines
%
Listed below are the most common medicines which may affect your insulin treatment.
111
Talk to your 111 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
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Pregnancy and breast-feeding
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If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
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Driving and using machines
• • •
HOW TO USE PROTAPHANE
2 6
It is recommended that you measure your blood glucose regularly.
3
Injecting insulin
-!
See overleaf for detailed instructions.
,
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
(
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
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Your insulin will work more quickly if you inject it around the waist.
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WHAT TO DO IN AN EMERGENCY
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If you get a hypo
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A hypo means your blood sugar level is too low.
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The amount or timing of insulin, food or exercise may need to be adjusted.
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Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
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Causes of a hypo
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If your blood sugar gets too high
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If you don’ t treat it, this could lead to diabetic coma and death.
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Causes of hyperglycaemia
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• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
5 * •
5.
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POSSIBLE SIDE EFFECTS
Protaphane.
Protaphane may cause hypoglycaemia (low blood sugar).
0 1%
113 Side effects reported uncommonly (in less than 1 patient in 100)
10. 000)
Changes at the injection site (Lipodystrophy).
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Signs of allergy.
PROTAPHANE
If they do not disappear, see your doctor.
'
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
$InnoLet $
Ask your doctor about this.
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Swollen joints.
*
Side effects reported very rarely (in less than 1 patient in 10,000)
(2°C - 8°C). * '.
Vision problems.
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Painful neuropathy (nerve related pain).
* Protaphane.
If it does not disappear, see your doctor.
!
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
6 # *
6.
Protaphane
HOW TO STORE PROTAPHANE
$Protaphane
Keep out of the reach and sight of children.
1 ml 3 ml
The expiry date refers to the last day of that month.
., -% + $Protaphane
The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
3 ml.
Do not freeze.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsvaerd,
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
$Protaphane InnoLet.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
50 Protaphane InnoLet
Always keep the pen cap on your FlexPen when you’ re not using it in order to protect it from light.
Protaphane InnoLet. •
Protaphane must be protected from excessive heat and sunlight.
114
114 Protaphane should not be disposed of via wastewater or household waste.
1A
7.
$&. - +%. $!
FURTHER INFORMATION
+ &% *.. - +5
What Protaphane contains
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– The active substance is insulin human made by recombinant biotechnology.
Protaphane InnoLet (
Protaphane is an isophane insulin suspension (NPH).
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1 ml contains 100 IU of insulin human.
-
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
$Protaphane InnoLet
What Protaphane looks like and contents of the pack
. + 5 & (
Not all packs may be marketed.
!
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
) $
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
- 4)
– If the second and third characters are W5, S6, P5, K7, or ZF Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark is the manufacturer
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– If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue d’ Orléans F-28002 Chartres, France is the manufacturer.
& $,%! '$
Now turn over for information on how to use your FlexPen.
($5 &
This leaflet was last approved in
115
115 Introduction
& -
Please read the following instructions carefully before using your Protaphane FlexPen.
.,%!.%
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
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The colour of the pen in the illustrations differs from your FlexPen.
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Protaphane FlexPen Pen cap
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tab
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Your FlexPen is designed to work accurately and safely.
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It must be handled with care.
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Do not soak it, wash or lubricate it as it may damage the pen.
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Do not refill your FlexPen.
(
Preparing your Protaphane FlexPen
.!
Before your first injection with a new FlexPen you must resuspend the insulin:
- 4 (
This makes it easier to resuspend.
116
116 Pull off the pen cap.
6
A
(&
Repeat until the liquid appears uniformly white and cloudy.
•
For every following injection move the pen up and down between position 1 and 2 at least ten times until the liquid appears uniformly white and cloudy.
8 5 40
After you have resuspended the insulin, complete all the following steps of injection without delay.
.
• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension.
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If there are less than 12 units left, use a new FlexPen.
InnoLet!
Attaching a needle
Protaphane InnoLet
Disinfect the rubber membrane with a medicinal swab.
,
C Remove the protective tab from a new disposable needle.
#
Screw the needle straight and tightly onto your FlexPen.
4
C
Protaphane InnoLet
D Pull off the big outer needle cap and keep it for later.
117
117 D
'Protaphane InnoLet.
E Pull off the inner needle cap and dispose of it.
Protaphane InnoLet
Checking the insulin flow
.
To avoid injection of air and ensure proper dosing:
#
F Turn the dose selector to select 2 units.
,
2 units- selected
118
118 G
Protaphane FlexPen 100 IU/ ml
H Keeping the needle upwards, press the push-button all the way in.
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The dose selector returns to 0.
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A drop of insulin should appear at the needle tip.
- $, 2 & $$+' 1) *% +: &
If not, change the needle and repeat the procedure no more than six times.
1.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
!
H
$Protaphane $!
Selecting your dose
PROTAPHANE
Check that the dose selector is set at 0.
4. $Protaphane
I Turn the dose selector to select the number of units you need to inject.
:
When turning the dose selector be careful not to push the push- button as insulin will come out.
-)
You cannot select a dose larger than the number of units left in the cartridge.
119
119 I
4
5 units selected
$'.! 6...
24 units selected
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• Do not use the residual scale to measure your dose of insulin.
(+) 1
Making the injection
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Insert the needle into your skin.
PROTAPHANE
Use the injection technique shown by your doctor or nurse.
).
J Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
? $FlexPen%,, 0! *% -%?
Be careful only to push the push-button when injecting.
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Turning the dose selector will not inject insulin.
-
J
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The needle must remain under the skin for at least six seconds.
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This will ensure that the full dose has been injected.
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120
120 Dispose of it carefully and put the pen cap back on.
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Otherwise, the liquid may leak out which can cause inaccurate dosing.
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• Caregivers should be most careful when handling used needles to avoid needle sticks.
,!
• Dispose of the used FlexPen carefully without the needle attached.
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• Do not share your FlexPen with anyone else.
Τι είναι το PROTELOS; To PROTELOS είναι ένα φάρμακο που περιέχει τη δραστική ουσία ρανελικό στρόντιο.
PROTELOS is a medicine containing the active substance strontium ranelate.
Σε ποιες περιπτώσεις χρησιμοποιείται το PROTELOS; Το PROTELOS χρησιμοποιείται για τη θεραπεία της οστεοπόρωσης (νόσος που καθιστά τα οστά εύθραυστα) σε εμμηνοπαυσιακές γυναίκες για τον περιορισμό του κινδύνου σπονδυλικών και ισχιακών καταγμάτων.
PROTELOS is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
Πώς χρησιμοποιείται το PROTELOS; Λαμβάνεται ένας φακελίσκος PROTELOS μία φορά την ημέρα.
PROTELOS is taken as one sachet once a day.
Το PROTELOS πρέπει να λαμβάνεται τουλάχιστον δύο ώρες μετά από τη λήψη τροφής, γάλακτος, γαλακτοκομικών προϊόντων ή συμπληρωμάτων ασβεστίου, κατά προτίμηση κατά την κατάκλιση.
PROTELOS should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Το PROTELOS προορίζεται για μακροχρόνια χρήση.
PROTELOS is intended for long-term use.
Οι ασθενείς πρέπει να λαμβάνουν συμπληρώματα ασβεστίου ή βιταμίνης D και ασβεστίου, εφόσον δεν λαμβάνουν επαρκείς ποσότητες από τη διατροφή τους.
Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.
Πώς δρα το PROTELOS; Η οστεοπόρωση παρουσιάζεται όταν δεν αναπτύσσονται επαρκώς νέα οστά για να αντικαταστήσουν όσα έχουν εξασθενήσει.
Gradually, the bones become thin and fragile, and more likely to break (fracture).