natgillin/translations-raw huggingface dataset:
10.
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
:
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
12. #
7.
/:
8.
BRAILLE
EXPIRY DATE
Protaphane
EXP/ During use: use within 6 weeks
Protaphane 100 IU/ ml SC
MARKETING AUTHORISATION NUMBER(S)
(- DNA)
EU/ 1/ 02/ 234/ 017
3.:
BATCH NUMBER
2 & 8 & /:
Batch:
4. #
14.
/:
Medicinal product subject to medical prescription
10 ml
INSTRUCTIONS ON USE
Protaphane 40 IU/ ml (- DNA)
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
1 ml
3.
40 IU (1, 4 mg)
LIST OF EXCIPIENTS
(- DNA).
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
$1 x 10 ml
PHARMACEUTICAL FORM AND CONTENTS
'!
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
#
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
:
EXP/ During use: use within 6 weeks
61 #
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
3:
OUTER CARTON
Protaphane 40 IU/ ml (- DNA)
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
3
PHARMACEUTICAL FORM AND CONTENTS
$5 x (1 x 10 ml) '!
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
#
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Protaphane Penfill is for use by one person only
'!
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
#
PENFILL LABEL
Protaphane 100 IU/ ml (- DNA)
Protaphane Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
100 IU (3, 5 mg)
EXPIRY DATE
,!
4.
$1 x10 ml
Batch:
#
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
33;
OUTER CARTON
#
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
#
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
8
3.
7
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
(
Suspension for injection 5 x 3 ml 10 x 3 ml
)
5.
# () # (
Subcutaneous use Protaphane NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Protaphane NovoLet is for use by one person only
), (
6.
)
Keep out of the reach and sight of children
8.:
7.
2 & 8 & /:
8.
) +%. $+0! $
EXPIRY DATE
4 -
EXP/ During use: use within 6 weeks
'!
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
EU/ 1/ 02/ 234/ 017
EU/ 1/ 02/ 234/ 008 5 x 3 ml EU/ 1/ 02/ 234/ 009 10 X 3 ml
Protaphane
Protaphane NovoLet
100 IU/ ml
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 #
NOVOLET LABEL
Protaphane 100 IU/ ml (- DNA)
Protaphane NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
,, ',!
EXP/
$5 x (1 x 10 ml) '!
BATCH NUMBER
(6 5 $.
5.
(2˚C - 8˚C)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
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6.
11.
OTHER
#
OUTER CARTON
Protaphane Penfill 100 IU/ ml (- DNA)
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
1 ml
2.
100 IU (3, 5 mg)
STATEMENT OF ACTIVE SUBSTANCE
(- DNA).
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
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LIST OF EXCIPIENTS
$1 x 3ml 5 x 3 ml 10 x 3 ml
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Novo Nordisk
METHOD AND ROUTE OF ADMINISTRATION
$
Subcutaneous use Protaphane InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Protaphane InnoLet is for use by one person only
- +) *% +:
EXP/ During use: use within 6 weeks
68
68 9.
Protaphane Penfill
Protaphane InnoLet
Protaphane Penfill 100 IU/ ml (- DNA) SC
Protaphane InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
2 & 8 & /:
EXP/
Protaphane NovoLet 100 IU/ ml (- DNA)
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
$5 x 3 ml 10 x 3 ml
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Protaphane NovoLet!! # Protaphane NovoLet
METHOD AND ROUTE OF ADMINISTRATION
#
Subcutaneous use
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OTHER SPECIAL WARNING(S), IF NECESSARY
#
EXP/ During use: use within 6 weeks
*
9.
7
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
EU/ 1/ 02/ 234/ 008 5 x 3 ml EU/ 1/ 02/ 234/ 009 10 X 3 ml
EU/ 1/ 02/ 234/ 013 1 x 3 ml EU/ 1/ 02/ 234/ 014 5 x 3 ml EU/ 1/ 02/ 234/ 015 10 x 3 ml
Protaphane NovoLet
Protaphane FlexPen
Protaphane NovoLet 100 IU/ ml (- DNA) SC
Protaphane FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
100 IU (3, 5 mg)
PACKAGE LEAFLET
74
74 PACKAGE LEAFLET:
(2˚C - 8˚C)
INFORMATION FOR THE USER
7
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
!
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
30˚C
Do not pass it on to others.
EU/ 1/ 02/ 234/ 010 1 x 3 ml EU/ 1/ 02/ 234/ 011 5 x 3 ml EU/ 1/ 02/ 234/ 012 10 X 3 ml
Protaphane is often given in combination with fast-acting insulin products.
/:
2.
#
See 4 What to do in an emergency for more about hypos.
3
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.
BRAILLE
Using other medicines
Protaphane InnoLet
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
#
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
#
Driving and using machines
:
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.
INNOLET
HOW TO USE PROTAPHANE
1.
It is recommended that you measure your blood glucose regularly.
Protaphane InnoLet 100 IU/ ml (- DNA) SC
Before using Protaphane
2 & 8 & /:
Do not use Protaphane
4. #
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier 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.
/:
How to use this insulin
5.
Your insulin will work more quickly if you inject it around the waist.
8
Protaphane vials are for use with insulin syringes with the corresponding unit scale.
Protaphane FlexPen 100 IU/ ml (- DNA)
To mix Protaphane with fast-acting insulin
100 IU (3, 5 mg)
Check the dose 5.
(- DNA).
Pull the needle out of the vial.
3
Always mix fast-acting and long-acting insulin in this order.
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Inject the insulin
$1 x 3 ml 5 x 3 ml 10 x 3 ml
Inject the insulin under the skin.
To Protaphane FlexPen
A hypo means your blood sugar level is too low.
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Using glucagon
), (
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
77 8.:
77 Causes of a hypo
2 & 8 & /:
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
- +) *% +:
If your blood sugar gets too high
) +%. $+0! $
The warning signs appear gradually.
4 -
See the advice in 4 What to do in an emergency.
9.
Side effects reported uncommonly (in less than 1 patient in 100)
(2˚C - 8˚C)
Changes at the injection site (Lipodystrophy).
10.
Signs of allergy.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
See also warning in 2 Before you use Protaphane.
EU/ 1/ 02/ 234/ 013 1 x 3 ml EU/ 1/ 02/ 234/ 014 5 x 3 ml EU/ 1/ 02/ 234/ 015 10 x 3 ml
Diabetic retinopathy (eye background changes).
13. #
Ask your doctor about this.
14.
Swollen joints.
15. # 3
This soon disappears.
16.
Vision problems.
BRAILLE
When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.
Protaphane FlexPen
If it does not disappear, see your doctor.
78
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.
FLEXPEN
HOW TO STORE PROTAPHANE
1.
Keep out of the reach and sight of children.
Protaphane FlexPen 100 IU/ ml E SC
Do not use Protaphane after the expiry date which is stated on the label and the carton.
(- DNA)
The vials that are not being used are to be stored in a refrigerator (2°C - 8°C).
2.
Do not freeze.
4. #
You can carry them with you and keep them at room temperature (not above 25°C) for up to 4 weeks.
/:
These measures will help to protect the environment.
8
What Protaphane contains
,
1 vial contains 10 ml equivalent to 400 IU
'
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
3
What Protaphane looks like and contents of the pack
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Not all packs may be marketed.
#
79 Marketing Authorisation Holder and Manufacturer
79 B. # 3
This leaflet was last approved in
& $Protaphane 40 IU/ ml
INFORMATION FOR THE USER
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:
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-!% - 4% $:
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*
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
4
Pregnancy and breast-feeding
& 4
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
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If you drive or use tools or machines: watch out for signs of a hypo.
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Before using Protaphane
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Each vial has a protective, tamper-proof plastic cap.
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How to use this insulin
Protaphane):
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1.
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Do this until the liquid is uniformly white and cloudy.
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Draw as much air into the syringe as the dose of Protaphane you need.
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Protaphane
Pull the needle out of the vial.
5.
Check the dose 5.
.; #
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2
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WHAT TO DO IN AN EMERGENCY
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3
Using glucagon
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Then seek medical advice straight away.
• • •
Causes of hyperglycaemia
2 6
• 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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Swollen joints.
84
84 Painful neuropathy (nerve related pain).
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6.
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HOW TO STORE PROTAPHANE
Protaphane).;.
Keep out of the reach and sight of children.
Protaphane.
Do not use Protaphane after the expiry date which is stated on the label and the carton.
5 +% $
The expiry date refers to the last day of that month.
#
Do not store them in or too near the freezer section or cooling element.
+ (% +.
Do not freeze.
PROTAPHANE
Keep the vials in the original package.
'
7.
'
– The active substance is insulin human made by recombinant biotechnology.
(2°C - 8°C)
Protaphane is an isophane insulin suspension (NPH).
*
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
.
What Protaphane looks like and contents of the pack
.
It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
. $$2 $
Not all packs may be marketed.
*
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
. #
This leaflet was last approved in
85
85 PACKAGE LEAFLET:
.;
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
3
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
25ºC)
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
. 1
2.
400 IU.
BEFORE YOU USE PROTAPHANE
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Do not use Protaphane
). $+%% (
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
'(4'
See 4 What to do in an emergency for more about hypos.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsvaerd,
Take special care with Protaphane
$(, 2 & $$+' 1) *% +
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.
'! 0+' &
Using other medicines
!, $-%
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
86
86 Driving and using machines
& $Protaphane 100 IU/ ml
If you drive or use tools or machines: watch out for signs of a hypo.
- $& & $$, 2 & $$+' 1) *% +
Your ability to concentrate or to react will be less during a hypo.
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Follow their advice carefully.
Protaphane
This leaflet is a general guide.
2
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
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Take it back to your supplier.
:
In insulin infusion pumps If Penfill or the device containing Penfill 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.
4. $Protaphane
Do not refill Protaphane Penfill.
4
Resuspending the insulin
& 4
Complete the other stages of injection without delay.
#
Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
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If there are less than 12 units left, use a new one.
PROTAPHANE
How to use this insulin
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How to inject this insulin
) +%. $*%
Inject the insulin under the skin.
5
If you get a hypo
Protaphane!.
A hypo means your blood sugar level is too low.
>% + $Protaphane. $(
Using glucagon
1.
If you are given glucagon you will need glucose or a sugary snack
!
Causes of a hypo
.
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
2.
If your blood sugar gets too high
# '
If you don’ t treat it, this could lead to diabetic coma and death.
,
Causes of hyperglycaemia
3.
• 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.
$Protaphane.
POSSIBLE SIDE EFFECTS
Protaphane
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
#
Side effects reported uncommonly (in less than 1 patient in 100)
'
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
.; #!
Signs of allergy.
Protaphane.
If they do not disappear, see your doctor.
Protaphane
See also warning in 2 Before you use Protaphane.
.; #
Ask your doctor about this.
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Painful neuropathy (nerve related pain).
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If it does not disappear, see your doctor.
• • •
The expiry date refers to the last day of that month.
2 6
Do not store them in or too near the freezer section or cooling element.
-!
These measures will help to protect the environment.
,
7.
,
1 cartridge contains 3 ml equivalent to 300 IU
#
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
Protaphane
What Protaphane looks like and contents of the pack
(
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
).;
Not all packs may be marketed.
% * 0%
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
, (.
– 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
0 + 2.
– 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.
5 * •
This leaflet was last approved in
3
INFORMATION FOR THE USER
*!
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
25ºC)
This side of the leaflet:
$Protaphane
How to use Protaphane 4.
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Possible side effects 6.
1 ml
Further information
100 IU
Overleaf:
. 1
1.
10 ml
This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours.
., -% + $Protaphane
Protaphane is often given in combination with fast-acting insulin products.
10 ml
BEFORE YOU USE PROTAPHANE
5 x (1
Do not use Protaphane
- $) $
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).
92
92 Using other medicines
# 3
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Protaphane PenFill 100 IU/ ml
Pregnancy and breast-feeding
%. $
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
1 +.%,%! '$'
Driving and using machines
# 5%
If you drive or use tools or machines: watch out for signs of a hypo.
+% $& +%.! –
Never drive or use machinery if you feel a hypo coming on.
01 +.
This leaflet is a general guide.
% $& + '!
Injecting insulin
+
See overleaf for detailed instructions.
1½
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
Protaphane
Do not use Protaphane
2.
In insulin infusion pumps If NovoLet 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.
$Protaphane
Protaphane is for injection under the skin (subcutaneously).
4. $Protaphane
Never inject your insulin directly into a vein or muscle.
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WHAT TO DO IN AN EMERGENCY
(+) 1
If you get a hypo
'&! *. +) *.
A hypo means your blood sugar level is too low.
PROTAPHANE
Don’ t take any insulin if you feel a hypo coming on.
$Protaphane
Using glucagon
:
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
$&. - +%. $! $
Causes of a hypo
&% *.. - + 5 -. $2 '5 & (
You get a hypo if your blood sugar gets too low.
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If your blood sugar gets too high
Protaphane):
Your blood sugar may get too high (this is called hyperglycaemia).
($, & ($.
The warning signs appear gradually.
Protaphane Penfill.
Then seek medical advice straight away.
NovoFine.
If you don’ t treat it, this could lead to diabetic coma and death.
Protaphane Penfill
Causes of hyperglycaemia
Penfill,
• 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.
$&)% $12. - - $
POSSIBLE SIDE EFFECTS
.
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
- 4
See the advice in 4 What to do in an emergency.
($
Side effects reported uncommonly (in less than 1 patient in 100)
.%
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
. -
Signs of allergy.
Protaphane!
See also warning in 2 Before you use Protaphane.
#
Ask your doctor about this.