natgillin/translations-raw huggingface dataset:
NovoMix 70.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
18
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
NovoMix 70
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
70
The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
NovoMix 70
NovoMix 70 should never be administered intravenously.
NovoMix 70 "
4.3 Contraindications
NovoMix 70,
NovoMix 70 should be administered in immediate relation to a meal.
21
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
NovoMix 70
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
"
On rare occasions, injection site reactions may require discontinuation of NovoMix 70.
.
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70
There is limited clinical experience with NovoMix 70 in pregnancy.
NovoMix 70
There are no restrictions on treatment with NovoMix 70 during lactation.
NovoMix 70.
However, the NovoMix 70 dosage may need to be adjusted.
,
4.7 Effects on ability to drive and use machines
* #
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
,
The advisability of driving should be considered in these circumstances.
,
Generalised hypersensitivity reactions are potentially life threatening.
,
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.
. 1.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
,
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 symptoms are usually of transitory nature.
. 1 *
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
10
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
5.
21 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
NovoMix 70 NPH
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
"
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.
70%
NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
(30%)
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
NovoMix 70 * 1
Hours NovoMix 70
/ NovoMix 70
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
1:
22 5.2 Pharmacokinetic properties
NovoMix 70
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 70, as compared with soluble human insulin.
NovoMix 70, # NovoMix 70,
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
0, 30 U/ kg
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
721 ±
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
NovoMix 70
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
IGF- 1
Non-clinical data with insulin aspart reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
#
Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
NovoMix 70 Penfill,
6.3 Shelf life
4
23 6.4 Special precautions for storage
(
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
$, NovoMix 70 Penfill ".
6.5 Nature and contents of container
NovoMix 70 Penfill
NovoMix 70 Penfill is for use by one person only.
NovoMix 70
The necessity of resuspending the NovoMix 70 suspension immediately before use is to be stressed to the patient.
NovoMix 70, "
NovoMix 70 which has been frozen must not be used.
EU/ 1/ 00/ 142/ 017 EU/ 1/ 00/ 142/ 018 EU/ 1/ 00/ 142/ 019
EU/ 1/ 00/ 142/ 017 EU/ 1/ 00/ 142/ 018 EU/ 1/ 00/ 142/ 019
8 9 /
24 9.
: 1%
1 August 2005
NovoMix 30 FlexPen 100 U/ ml,
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
* ……... 100 U/ ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
*
Soluble insulin aspart*/ protamine-crystallised insulin aspart*………… 100 U/ ml in the ratio of 30/ 70
Saccharomyces cerevisiae.
* produced by recombinant DNA technology in Saccharomyces cerevisiae.
4. 1
Suspension for injection in a pre-filled pen.
(
26 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
30 U1 NovoMix 30
Pre-meal blood glucose level
NovoMix 30
NovoMix 30 dose adjustment
- 2U
-2U
4, 4 6, 2 7, 9 >
80 – 110 mg/ dL
– 6, 1 mmol/ l – 7, 8 mmol/ l – 10 mmol/ l 10 mmol/ l
6.2 – 7.8 mmol/ l 7.9 – 10 mmol/ l > 10 mmol/ l
29
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
'
27 Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
30
Combination of NovoMix 30 with pioglitazone:
0
28 4.6 Pregnancy and lactation
,
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.
NovoMix 30)).
NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
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.
,
The maximum effect is exerted between 1 and 4 hours after injection.
33 (# *
Hours
30.
Compared to biphasic human insulin 30, administration of NovoMix 30 before breakfast and dinner resulted in lower postprandial blood glucose after both meals (breakfast and dinner).
2
A meta-analysis including nine trials in patients with type 1 and type 2 diabetes showed that fasting blood glucose was higher in patients treated with NovoMix 30, than in patients treated with biphasic human insulin 30.
..
In one study, 341 patients with type 2 diabetes were randomised to treatment with NovoMix 30 either alone or in combination with metformin, or to metformin together with sulfonylurea.
6
32 6.
6. 1
6.1 List of excipients
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
- 7
6.2 Incompatibilities
7 0
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
0 & - 0
6.3 Shelf life
.
2 years.
30° ().
The in-use shelf life is 4 weeks (not above 30°C).
(2° (- 8° ()
6.4 Special precautions for storage
.
Store in a refrigerator (2°C – 8°C) away from the freezing compartment.
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.
(
Do not store above 30°C.
NovoMix 30 FlexPen
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
,
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.
, NovoMix 30 FlexPen
Cartons of 5 or 10 pre-filled pens.
"
Not all pack sizes may be marketed.
"
6.6 Special precautions for disposal and other handling
NovoFine
NovoFine S needles are designed to be used with the pre-filled pen.
NovoMix 30 FlexPen
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
NovoMix 30 FlexPen.
NovoMix 30 FlexPen is for use by one person only.
30 FlexPen
NovoMix 30 FlexPen must not be refilled.
)
The resuspended liquid must appear uniformly white and cloudy.
NovoMix 30
NovoMix 30 which has been frozen must not be used.
.
Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 00/ 142/ 009 EU/ 1/ 00/ 142/ 010
EU/ 1/ 00/ 142/ 009 EU/ 1/ 00/ 142/ 010
NovoMix 50 FlexPen 100 U/ ml,
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
,
Suspension for injection in a pre-filled pen.
50
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
*
Physical activity may reduce the patients’ insulin requirements.
,
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
39
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
-% #
Immune system disorders Uncommon - Urticaria, rash, eruptions
*
Generalised hypersensitivity reactions are potentially life threatening.
,
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
-,
These reactions are usually transitory and normally they disappear during continued treatment.
. 1.
These symptoms are usually of transitory nature.
5.
38 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
1:
39 5.2 Pharmacokinetic properties
+ $
6.2 Incompatibilities
, 0$
In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
(2° (- 8° ()
6.3 Shelf life
..
Do not freeze.
NovoMix 50 FlexPen
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
,
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.
, NovoMix 50 FlexPen
6.5 Nature and contents of container
(
Each pre-filled pen contains 3 ml suspension.
1, 5
Cartons of 1, 5 or 10 pre-filled pens.
44 6. 6
Not all pack sizes may be marketed.
+ $
6.6 Special precautions for disposal and other handling
NovoFine S
NovoFine S needles are designed to be used with the pre-filled pen.
NovoMix 50 FlexPen,
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
NovoMix 50 FlexPen.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen
NovoMix 50 FlexPen must not be refilled.
EU/ 1/ 00/ 142/ 014 EU/ 1/ 00/ 142/ 015 EU/ 1/ 00/ 142/ 016
EU/ 1/ 00/ 142/ 014 EU/ 1/ 00/ 142/ 015 EU/ 1/ 00/ 142/ 016
8 9
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
45 1.
41 1.
NovoMix 70 FlexPen 100 U/ ml,
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
70
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
47
Concomitant illness, especially infections, usually increases the patient’ s insulin requirements.
.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
.
Immune system disorders Uncommon - Urticaria, rash, eruptions
49!
Generalised hypersensitivity reactions are potentially life threatening.
–! #
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.
.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with worsening of diabetic retinopathy.
– &
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.
5.
45 glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person or glucose given intravenously by a medical professional.
1:
Insulin aspart is equipotent to human insulin on a molar basis.
75
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
in vitro,
5.3 Preclinical safety data
4
47 6.4 Special precautions for storage
NovoMix 70
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
FlexPen
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
6.5 Nature and contents of container
6. 5
Each pre-filled pen contains 3 ml suspension.
52 6. 6
Not all pack sizes may be marketed.
! "
6.6 Special precautions for disposal and other handling
NovoMix 70 FlexPen
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
NovoMix 70 FlexPen.
NovoMix 70 FlexPen is for use by one person only.
70 FlexPen
NovoMix 70 FlexPen must not be refilled.
EU/ 1/ 00/ 142/ 020 EU/ 1/ 00/ 142/ 021 EU/ 1/ 00/ 142/ 022
EU/ 1/ 00/ 142/ 020 EU/ 1/ 00/ 142/ 021 EU/ 1/ 00/ 142/ 022
8 9 /
48 9.
53 II
49 ANNEX II
2.
B.
54 A.
50 A.
8
Name and address of the manufacturer of the biological active substance
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
,
Name and address of the manufacturers responsible for batch release
NovoMix 30 Penfill
NovoMix 30 Penfill and NovoMix 30 FlexPen:
Novo Nordisk Production SAS 45, Avenue d’ Orléans F- 28002 Chartres
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
NovoMix 50 Penfill
NovoMix 50 Penfill and NovoMix 50 FlexPen:
NovoMix 70 Penfill
NovoMix 70 Penfill and NovoMix 70 FlexPen:
$
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.
8
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
9 8
Medicinal product subject to medical prescription.
2
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
!.
Not applicable.
55 III
51 ANNEX III
8
LABELLING AND PACKAGE LEAFLET
56 A.
52 A.
57
LABELLING
,
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
2
OUTER CARTON
NovoMix 30 Penfill 100 U/ ml
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
(3, 5 mg)
STATEMENT OF ACTIVE SUBSTANCE
(),
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
:
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
5 x 3 ml 10 x 3 ml
PHARMACEUTICAL FORM AND CONTENTS
4
5 x 3 ml 10 x 3 ml
',
5.
NovoMix 30 Penfill. $0
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
6
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
,
Keep out of the reach and sight of children
4
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
0, 0
8.
/ 0 & ($0
EXPIRY DATE
0,! +
EXP/
(2°C - 8°C) $
SPECIAL STORAGE CONDITIONS
0 $
°
!!
°
!, "'0'
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
8 8 8
11.
EU/ 1/ 00/ 142/ 004 5
MARKETING AUTHORISATION NUMBERS
EU/ 1/ 00/ 142/ 005 10 x 3 ml
EU/ 1/ 00/ 142/ 004 5 x 3 ml EU/ 1/ 00/ 142/ 005 10 x 3 ml
$:
Batch:
!
Medicinal product subject to medical prescription
8 8
16.
30 $#
NovoMix 30 Penfill
59
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
2
LABEL
NovoMix 30 Penfill 100 U/ ml
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
4
METHOD OF ADMINISTRATION
0, 0
Resuspend according to instructions
'
3.
/ 0 & ($0 0
EXPIRY DATE
,! +
EXP/
4.
Batch:
$:
5.
5.
3 ml
6
6.
4
OTHER
60
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
(),
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
PHARMACEUTICAL FORM AND CONTENTS
4
1 x 3 ml 5 x 3 ml 10 x 3 ml
NovoMix 50 Penfill. $0
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
4
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
61 9.
57 9.
EU/ 1/ 00/ 142/ 011 1 EU/ 1/ 00/ 142/ 012 5
EU/ 1/ 00/ 142/ 011 1 x 3 ml EU/ 1/ 00/ 142/ 012 5 x 3 ml EU/ 1/ 00/ 142/ 013 10 x 3 ml
50 $#
NovoMix 50 Penfill
62
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NovoMix 50 Penfill 100 U/ ml
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
63
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
(),
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. $0
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
4
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
64 9.
60 9.
EU/ 1/ 00/ 142/ 017 1 EU/ 1/ 00/ 142/ 018 5
EU/ 1/ 00/ 142/ 017 1 x 3 ml EU/ 1/ 00/ 142/ 018 5 x 3 ml EU/ 1/ 00/ 142/ 019 10 x 3 ml
70 $#
NovoMix 70 Penfill
65
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NovoMix 70 Penfill 100 U/ ml
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
66
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
NovoMix 30 FlexPen 100 U/ ml
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoTwist
5 x 3 ml 10 x 3 ml
($
5.
! $)
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
0, 0 '/ 0 & ($0 0
OTHER SPECIAL WARNINGS, IF NECESSARY
NovoMix 30 FlexPen "
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
.
8.
8
EXPIRY DATE
67 1 /
EXP/
6
63 9.
'"
°
-
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
.: '
10.
10.
11.
EU/ 1/ 00/ 142/ 009 5 x 3 ml EU/ 1/ 00/ 142/ 010 10 x 3 ml
EU/ 1/ 00/ 142/ 009 5 x 3 ml EU/ 1/ 00/ 142/ 010 10 x 3 ml
30 -
NovoMix 30 FlexPen
$
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68
LABEL
NovoMix 30 FlexPen 100 U/ ml
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
69
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
8 mm
5.
NovoTwist
METHOD AND ROUTE OF ADMINISTRATION
($
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 50 FlexPen "
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
', $,
66 8.
70 1 /
EXP/
EU/ 1/ 00/ 142/ 014 1 x 3 ml EU/ 1/ 00/ 142/ 015 5 x 3 ml EU/ 1/ 00/ 142/ 016 10 x 3 ml
EU/ 1/ 00/ 142/ 014 1 x 3 ml EU/ 1/ 00/ 142/ 015 5 x 3 ml EU/ 1/ 00/ 142/ 016 10 x 3 ml
50 -
NovoMix 50 FlexPen
$
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
71
LABEL
NovoMix 50 FlexPen 100 U/ ml
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
72
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
$0
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
2
Keep out of the reach and sight of children
NovoMix 70 FlexPen "
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
', $,
69 8.
1 /
EXP/
.: '
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
EU/ 1/ 00/ 142/ 020 1 x 3 ml EU/ 1/ 00/ 142/ 021 5 x 3 ml EU/ 1/ 00/ 142/ 022 10 x 3 ml
EU/ 1/ 00/ 142/ 020 1 x 3 ml EU/ 1/ 00/ 142/ 021 5 x 3 ml EU/ 1/ 00/ 142/ 022 10 x 3 ml
70 -
NovoMix 70 FlexPen
NovoMix 70 FlexPen 100 U/ ml
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
4
LABEL
/
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
2
2.
6
Resuspend according to instructions
4
EXPIRY DATE
%! +
EXP/
"#
4.
(Insulin spart)
BATCH NUMBER
–
Batch:
#
5.
. &
3 ml
!
6.
'' "
OTHER
$(.
71 B.
0
PACKAGE LEAFLET
–
72 PACKAGE LEAFLET:
– –
INFORMATION FOR THE USER
)%
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
,
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
.).
Do not pass it on to others.
NOVOMIX 30
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
NovoMix 30
NovoMix 30 is an insulin analogue to treat diabetes.
(30%)
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
8 8
2.
NOVOMIX 30
BEFORE YOU USE NOVOMIX 30
"$/ NovoMix 30"
Do not use NovoMix 30
4
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).
0 NovoMix 30
See 4 What to do in an emergency for more about hypos.
NovoMix 30
Take special care with NovoMix 30