natgillin/translations-raw huggingface dataset:
(> 1/ 10. 000, < 1/ 1. 000). # (< 1/ 10. 000),
No studies on the effects on the ability to drive and use machines have been performed.
-,
The advisability of driving should be considered in these circumstances.
(- * '!
4.8 Undesirable effects
%
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
32 & - 3 ".
The frequencies are defined as:
& - #.
Immune system disorders Uncommon - Urticaria, rash, eruptions
,%
29 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
).)
These symptoms are usually of transitory nature.
& -).
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
%
These reactions are usually transitory and normally they disappear during continued treatment.
. #
These symptoms are usually of transitory nature.
# NovoMix 30,
30 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
34
Children and adolescents:
NovoMix 30,
5.2 Pharmacokinetic properties
35 6.
32 6.
6. 2% / 0 (+
6.1 List of excipients
"
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
-%.
Do not freeze.
# NovoMix 30 FlexPen,
NovoMix 30 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
30°C.
Do not refrigerate.
30°C). 9
Do not store above 30°C.
NovoMix 30
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
FlexPen
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to allow NovoMix 30 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
-
6.5 Nature and contents of container
,.
Each pre-filled pen contains 3 ml suspension.
,
Cartons of 5 or 10 pre-filled pens.
NovoMix 30 Flexpen
Not all pack sizes may be marketed.
NovoMix 30 Flexpen -,
6.6 Special precautions for disposal and other handling
NovoMix 30
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
NovoMix 30
NovoMix 30 FlexPen must not be refilled.
# NovoMix 30
NovoMix 30 which has been frozen must not be used.
NovoMix 50 FlexPen 100 U/ ml
NAME OF THE MEDICINAL PRODUCT
.
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
Saccharomyces
1 pre-filled pen contains 3 ml equivalent to 300 U.
3.
Suspension for injection in a pre-filled pen.
40 4. 7
4.7 Effects on ability to drive and use machines
(> 1/ 1. 000, < 1/ 100))
Uncommon (> 1/ 1,000 ,< 1/100) and rare (> 1/10 ,000, < 1/1,000).
.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
&
These reactions are usually transitory and normally they disappear during continued treatment.
-.
These symptoms are usually of transitory nature.
-
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
.
39 5.2 Pharmacokinetic properties
)
6.1 List of excipients
0 0 "
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
%
6.2 Incompatibilities
% (
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
# NovoMix 50 FlexPen
40 NovoMix 50 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
-
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
,
Each pre-filled pen contains 3 ml suspension.
!
Cartons of 1, 5 or 10 pre-filled pens.
NovoMix 50 FlexPen
Not all pack sizes may be marketed.
-,
6.6 Special precautions for disposal and other handling
NovoMix 50
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
. # NovoMix 50 FlexPen
NovoMix 50 FlexPen must not be refilled.
NovoMix 70.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
-
After delivery, insulin requirements return rapidly to pre-pregnancy levels.
48 4. 7
4.7 Effects on ability to drive and use machines
. "
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
!.,
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
)
Glucose Infusion Rate
NovoMix 70,
46 5.2 Pharmacokinetic properties
(
6.1 List of excipients
)
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
0 0 "
6.2 Incompatibilities
%
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
-
47 6.4 Special precautions for storage
# NovoMix 70 FlexPen
NovoMix 70 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 FlexPen
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
-
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to allow NovoMix 70 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
NovoMix 70 FlexPen
Not all pack sizes may be marketed.
NovoMix 70
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
. # NovoMix 70 FlexPen
NovoMix 70 FlexPen must not be refilled.
5 #
A.
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
)
B.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
CONDITIONS OF THE MARKETING AUTHORISATION
NovoMix 50 Penfill
50 A.
NovoMix 50 FlexPen:
Name and address of the manufacturer of the biological active substance
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
NovoMix 70 Penfill
Name and address of the manufacturers responsible for batch release
NovoMix 70 FlexPen:
NovoMix 30 Penfill and NovoMix 30 FlexPen:
# 1.
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
NovoMix 30 Penfill 100 U/ ml ",
NovoMix 50 Penfill and NovoMix 50 FlexPen:
100 U (3, 5 mg)
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
70%
NovoMix 70 Penfill and NovoMix 70 FlexPen:
5
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
#
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
,,
B.
, -,
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
%
Medicinal product subject to medical prescription.
(,
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
4.
Not applicable.
5 x 3 ml 10 x 3 ml
51 ANNEX III
5.
LABELLING AND PACKAGE LEAFLET
# #
52 A.
# NovoMix 30 Penfill Novo Nordisk # 0%, $1. & $+' 3
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
(+) $* '+% +
OUTER CARTON
#
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
#
2.
,
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
8
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
#
4.
55 =
5 x 3 ml 10 x 3 ml
1 &
5.
,
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
0 $&
6.
$% '! $' -
Keep out of the reach and sight of children
6 *%%. / 16 /
OTHER SPECIAL WARNINGS, IF NECESSARY
NovoMix 30 Penfill $$! $
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
, $/ $/ ($
EXPIRY DATE
3 ';' /
EXP/
(4 0 $/, 6
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cartridges in the outer carton in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
13. #
13.
*:
Batch:
< 5
15.
15. # 5
INSTRUCTIONS ON USE
BRAILLE
INFORMATION IN BRAILLE
1.
LABEL
#
1.
NovoMix 30 Penfill 100 U/ ml ", SC
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
5
METHOD OF ADMINISTRATION
6 *%
Resuspend according to instructions
%.
3.
3 ';' /
EXPIRY DATE
4. #
EXP/
8 P
4.
8 P, '5
BATCH NUMBER
60
OTHER
#
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
<
OUTER CARTON
NovoMix 50 Penfill 100 U/ ml ",
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
2. #
2.
100 U (3, 5 mg)
STATEMENT OF ACTIVE SUBSTANCE
(DNA) (50%
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 50% and insulin aspart crystallised with protamine 50%),
1 x 3 ml 5 x 3 ml 10 x 3 ml
LIST OF EXCIPIENTS
5.
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
5
1 x 3 ml 5 x 3 ml 10 x 3 ml
NovoMix 50 Penfill
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
% 4% + + $$!
Keep out of the reach and sight of children
To NovoMix 50 Penfill
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
$$
8.
, $/ $
EXPIRY DATE
9.
57 9.
Novo Nordisk A/ S Novo Alle DK- 2880 Bagsvaerd
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
12. #
12.
# #
LABEL
NovoMix 50 Penfill 100 U/ ml E, SC
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
8, '5
BATCH NUMBER
63
OTHER
#
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
NovoMix 70 Penfill 100 U/ ml ",
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
(DNA) (70%
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
NovoMix 70 Penfill
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
#
Keep out of the reach and sight of children
To NovoMix 70 Penfill
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
NovoMix 70 Penfill 100 U/ ml E, SC
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
66
OTHER
#
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
NovoMix 30 FlexPen 100 U/ ml ",
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
(DNA) (30%
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
5 x 3 ml 10 x 3 ml
LIST OF EXCIPIENTS
(0 & (# 0%
5 x 3 ml 10 x 3 ml
!
5.
8 mm.
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Read the package leaflet before use
$NovoMix 30 FlexPen $$!
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
$°
°
(2°C – 8°C) + $7.) $$4! $16
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cap on the pen in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
68
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NovoMix 30 FlexPen 100 U/ ml ", SC
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
#
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
NovoMix 50 FlexPen 100 U/ ml ",
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
(0 & (# 0%
1 x 3 ml 5 x 3 ml 10 x 3 ml
$NovoMix 50 FlexPen $$!
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
') *% +
66 8.
71
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NovoMix 50 FlexPen 100 U/ ml E, SC
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
72
OTHER
#
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
NovoMix 70 FlexPen 100 U/ ml ",
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
$NovoMix 70 FlexPen $$!
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
($(
69 8.
NovoMix 70 FlexPen 100 U/ ml E, SC
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
5
LABEL
6 *%
1.
%.
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
/ 16 /
2.
$+ '!
Resuspend according to instructions
3. <
3.
75 8. # 5
OTHER
NovoMix
71 B.
30 Penfill
PACKAGE LEAFLET
+ /% 1%! '$'
72 PACKAGE LEAFLET:
, $& & $$1. & $+' 3) *% + (+ & $
INFORMATION FOR THE USER
$$.
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
($1, / $. – – –
Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet.
–
Do not pass it on to others.
# NovoMix 30
NovoMix 30 is an insulin analogue to treat diabetes.
$NovoMix 30
Do not use NovoMix 30
=
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
$NovoMix 30
Take special care with NovoMix 30
=
Consult your doctor if you are planning such travelling.
, $& / 6 "$! +,
Using other medicines
(*
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
*% +, & 1 /, 6 & 6
Your need for insulin may change if you also take:
*. *
There is limited clinical experience with insulin aspart in pregnancy.
,
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e. g. driving a car or operating machinery).
'/ $%. + * 4,: + & -
Never drive or use machinery if you feel a hypo coming on.
!
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred.
$+ '! *) +% / $$!.'
For children 6-9 years limited clinical data exists.
(!
This leaflet is a general guide.
NovoMix 30
When NovoMix 30 is used in combination with oral antidiabetic drugs the dosage should be adjusted.
# NovoMix 30
NovoMix 30 is for use by one person only.
$NovoMix 30
Before using NovoMix 30
=
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
(stopper).!
Take it back to your supplier.
$NovoMix 30
NovoMix 30 should not be used
4
In insulin infusion pumps If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 30) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
= $1%! '$* +%%
How to use this insulin
NovoMix 30) =
NovoMix 30 is for injection under the skin (subcutaneously).
=,)%%% 3% + & $.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
) +% / $$*%
The best places to give
* +
Your insulin will work more quickly if you inject around the waist.
$NovoMix 30
NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
# NovoMix 30 Penfill
If you are treated with NovoMix 30 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
%
Resuspension of the insulin
NovoMix 30 Penfill.
Complete the other stages of injection without delay.
2 Penfill
Pict ure A
Penfill,
Picture B a
*: =
b
+ 3 + 1$, $10).
If there are less than 12 units left, use a new one.
$NovoMix
How to inject this insulin
30 Penfill%
Inject the insulin under the skin.
$& 4 $
75 4.
(
WHAT TO DO IN AN EMERGENCY
$&)% $12 / $,,
If you get a hypo (hypoglycaemia)
.,
The amount or timing of insulin, food or exercise may need to be adjusted.
NovoMix
Using glucagon
!
Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
& $4 / *%!
Causes of a hypo
(
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
+% $0
If your blood sugar gets too high
•
Your blood sugar may get too high (this is called hyperglycaemia).
0$ &, 7+ &!,
The warning signs appear gradually.
% / 3 /%,,%
Causes of hyperglycaemia
(
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
, $$
76 5.
• • • •
POSSIBLE SIDE EFFECTS
NovoMix 30
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
!
Side effects reported uncommonly
% +. &
Vision problems.
%,
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.
% $1!).,
If they do not disappear, see your doctor.
# 0+ * / 1 0 +% $
Ask your doctor about this.
. +
Swollen joints.
$, 4!
Normally, this soon disappears.
. "
Side effects reported rarely
. "
Painful neuropathy.
.
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.
9 9
Keep out of the reach and sight of children.
NovoMix 30%
Do not use NovoMix 30 after the expiry date which is stated on the label and carton.
$NovoMix 30 Penfill $$NovoMix 30 Penfill $$
The expiry date refers to the last day of that month.
(2°C – 8°C),
NovoMix 30 Penfill that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or too near the freezer section or cooling element.
-.,!
Do not freeze.
NovoMix 30 Penfill -
NovoMix 30 Penfill that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 30.
NovoMix 30 Penfill must be protected from excessive heat and sunlight.
$NovoMix 30
NovoMix 30 should not be disposed of via wastewater or household waste.
).
7.
/ 1,% + $NovoMix 30
What NovoMix 30 contains
) (/ $+%%
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (30% insulin aspart in a soluble fraction and 70% insulin aspart crystallised with protamine) – The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
%!
What NovoMix 30 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 5 or 10 cartridges of 3 ml (not all packs may be marketed).
ml 100 U (3, 5 mg)
1 ml contains 100 U (3.5 mg) of insulin aspart.
, $) $, Novo Nordisk A/ S,
1 cartridge contains 3 ml equivalent to 300 U.
Novo Allé, DK- 2880
Marketing Authorisation Holder Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Bagsværd,
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Novo Nordisk A/ S, Novo Allé, DK- 2880 Bagsværd,
– 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
Production SAS, 45 Avenue d’ Orléans F- 28002 Chartres,
– 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.
50 Penfill
This leaflet was last approved in
100 U/ ml,
78 PACKAGE LEAFLET:
$$.
NovoMix 50 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
TO NOVOMIX 50
WHAT NOVOMIX 50 IS AND WHAT IT IS USED FOR
# NovoMix 50
NovoMix 50 is an insulin analogue to treat diabetes.
TO NOVOMIX 50
BEFORE YOU USE NOVOMIX 50
$NovoMix 50
Do not use NovoMix 50
$NovoMix 50
Take special care with NovoMix 50
84 *% +, & 1 /, 6 & 6
Your need for insulin may change if you also take:
. *
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e. g. driving a car or operating machinery).
$'//! -' / $%. + *
Never drive or use machinery if you feel a hypo coming on.
TO NOVOMIX 50
HOW TO USE NOVOMIX 50
(.,
This leaflet is a general guide.
NovoMix 50 (# NovoMix 50
Eat a meal or snack containing carbohydrates within 10 minutes of the injection.
NovoMix 50) =
NovoMix 50 is for use by one person only.
$NovoMix 50
Before using NovoMix 50
$$
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
%,%). #
Take it back to your supplier.
# NovoMix 50 Penfill
NovoMix 50 should not be used
Novo
In insulin infusion pumps If the cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 50) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Penfill.
How to use this insulin
% 2,
80 NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 50 Penfill.
If you are treated with NovoMix 50 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
$NovoMix 50 Penfill,
Do not refill NovoMix 50 Penfill cartridges.
8) 10
Resuspension of the insulin
. '.)
Pict ure A
a
Picture B a
b (!.
b
8)
If there are less than 12 units left, use a new one.
$&)% $12 / $,,
How to inject this insulin
+ 0 & (
81 4.
NovoMix
WHAT TO DO IN AN EMERGENCY
!
If you get a hypo (hypoglycaemia)
. (
The amount or timing of insulin, food or exercise may need to be adjusted.
,,,,,,,
Using glucagon
,
Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
, +% $0 * $'!!
If your blood sugar gets too high
&
Your blood sugar may get too high (this is called hyperglycaemia).
:.,!: • •
The warning signs appear gradually.
0$ &, 7+ &!,
If you don’ t treat it, this could lead to diabetic coma and death.
• • • • •
• 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.
3 3 #,
82 5.
5
POSSIBLE SIDE EFFECTS
NovoMix 50
Like all medicines, NovoMix 50 can cause side effects, although not everybody gets them.
% $1!).,
Changes of the injection site (Lipodystrophy).
).,
Signs of allergy.
$&%,% $0 * & '*. &
If they do not disappear, see your doctor.
* / 1 0 +% $
Ask your doctor about this.
. &%!
Swollen joints.
4 / +.
Normally, this soon disappears.
'
Side effects reported rarely
.,
Painful neuropathy.
NovoMix 50%
Do not use NovoMix 50 after the expiry date which is stated on the label and carton.