natgillin/translations-raw huggingface dataset:
%
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.
!!
Most reactions are transitory and disappear during continued treatment.
)%
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
NovoFine. &
These symptoms are usually of transitory nature.
.
Generalised hypersensitivity reactions are potentially life- threatening.
19 '%.
19 4.9 Overdose
Protaphane.
A specific overdose of insulin cannot be defined.
4. 5
5.
(&, -
PHARMACOLOGICAL PROPERTIES
- & '#
5.1 Pharmacodynamic properties
(+
Pharmacotherapeutic group:
(&,)),
ATC code:
.
A10A C01.
# & &
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
/ -
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
(+ & '#,,
5.2 Pharmacokinetic properties
.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
- '#
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
,.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
'$&:
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
-
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
20 4. 6
20 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
0 (
5.3 Preclinical safety data
-
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
1 (
6.
utero. & '
6.1 List of excipients
,
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
.
6.2 Incompatibilities
,,
Insulin suspensions should not be added to infusion fluids.
.
6.3 Shelf life
Protaphane.
30 months when stored between 2°C - 8°C.
4
6 weeks when used or carried as a spare (below 30°C).
. 7.
6.4 Special precautions for storage
1 * -
Do not store them in or too near the freezer section or cooling element.
! 2.)
Do not freeze.
Protaphane.
During use: do not refrigerate.
, Protaphane.,
Do not store above 30°C.
:
Keep the cartridge in the outer carton in order to protect from light.
< 1/ 100). "
Protect from excessive heat and sunlight.
< 1/ 10 000,
6.5 Nature and contents of container
.
The cartridge contains a glass ball to facilitate the re-suspension.
# – & * “
Pack sizes:
”,
1, 5 and 10 cartridges x 3 ml.
# – / &. '.
Not all pack sizes may be marketed.
21%
21 6.6 Special precautions for disposal and other handling
.
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
,
Protaphane Penfill is for single person use only.
- $$,.
The container must not be refilled.
'! – / /
Insulin preparations which have been frozen must not be used.
)
After removing Protaphane Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
(
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
,
Any unused product or waste material should be disposed of in accordance with local requirements.
,.
7.
,
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
. &
8.
– '
EU/ 1/ 02/ 234/ 005-007
4. 9
9.
&!
Date of first authorisation:
&.,: •
07 October 2002
$
18 September 2007
•
10.
1 mg),
22 1.
.
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
")
2.
,
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
.
1 pre-filled pen contains 3 ml equivalent to 300 IU.
.,
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
.
Protaphane is a suspension of isophane (NPH) insulin.
!.
For a full list of excipients, see section 6.1.
3
Suspension for injection in a pre-filled pen.
4
Cloudy, white, aqueous suspension.
& (
4.
-
4.1 Therapeutic indications
, -
Treatment of diabetes mellitus.
+
4.2 Posology and method of administration
(
Protaphane is a long-acting insulin.
(0)
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
(10 () 01.
Protaphane may be used alone or mixed with fast-acting insulin.
%
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
,
Renal or hepatic impairment may reduce insulin requirement.
&
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
.
23 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
%
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Protaphane
Protaphane NovoLet is designed to be used with NovoFine needles.
%
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
!
4.3 Contraindications
22
4.4 Special warnings and precautions for use
%
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
%
Usual warning symptoms may disappear in patients with longstanding diabetes.
1½
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
,
Continuous rotation of the injection site within a given area may help to
24
24 reduce or prevent these reactions.
.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
4- 12
Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
5. 2
Insulin suspensions are not to be used in insulin infusion pumps.
(
Protaphane contains metacresol, which may cause allergic reactions.
-
4.5 Interaction with other medicinal products and other forms of interaction
, -
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
-
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
%
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
.)
Octreotide/ lanreotide may both decrease and increase insulin requirement.
,
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
(
4.6 Pregnancy and lactation
,
After delivery, insulin requirements return rapidly to pre-pregnancy values.
,).
However, the Protaphane dosage may need to be adjusted.
,
25 4.7 Effects on ability to drive and use machines
.
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.
.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
(
Nervous system disorders Very 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 temporary worsening of diabetic retinopathy.
2- 18
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.
/
Most reactions are transitory and disappear during continued treatment.
.
These symptoms are usually of transitory nature.
(
Generalised hypersensitivity reactions are potentially life- threatening.
per se
4.9 Overdose
(t½)
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
5. 3
5.
& # &
5.1 Pharmacodynamic properties
!)!
ATC code:
5
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
6. 1
5.2 Pharmacokinetic properties
- 1
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
(/
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
/ -
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
4 3 # +
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
(
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
)
Trials have indicated a t½ of about 5-10 hours.
, & -
5.3 Preclinical safety data
(
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
23 6. 2
6.1 List of excipients
30°)).
6 weeks when used or carried as a spare (below 30°C).
!
Do not freeze.
&
During use: do not refrigerate.
30°).
Do not store above 30°C.
%
28 6.5 Nature and contents of container
3 ml
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
1, 5
Pack sizes:
3 ml.
5 and 10 pre-filled pens x 3 ml.
1 # "*
Not all pack sizes may be marketed.
)
6.6 Special precautions for disposal and other handling
&,.
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Protaphane Penfill
Protaphane NovoLet is for single person use only.
Protaphane Penfill (25°))
The container must not be refilled.
.
Insulin preparations which have been frozen must not be used.
,
After removing Protaphane NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
%
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
EU/ 1/ 02/ 234/ 005- 007
EU/ 1/ 02/ 234/ 008-009
25 1.
29 1.
Protaphane NovoLet 100 IU/ ml
NAME OF THE MEDICINAL PRODUCT
.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
300 IU.
1 pre-filled pen contains 3 ml equivalent to 300 IU.
(NPH).
Protaphane is a suspension of isophane (NPH) insulin.
!!
For a full list of excipients, see section 6.1.
".
Suspension for injection in a pre-filled pen.
#
Cloudy, white, aqueous suspension.
&
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
NovoLet
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
NovoFine.
InnoLet delivers 1-50 units in increments of 1 unit.
NovoLet
The dose is set by turning the selector, which returns to zero during the injection.
2
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
27,. '%.
Hypoglycaemia.
&
4.4 Special warnings and precautions for use
. &
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
(
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
),
Reactions usually resolve in a few days to a few weeks.
,
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
4
32 4.7 Effects on ability to drive and use machines
. 7.
The advisability of driving should be considered in these circumstances.
29 –%
Generalised hypersensitivity reactions are potentially life- threatening.
'! – / /
4.9 Overdose
(0)
PHARMACOLOGICAL PROPERTIES
(10 (
5.1 Pharmacodynamic properties
) 01.
ATC code:
!
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
-
Trials have indicated a t½ of about 5-10 hours.
%
5.3 Preclinical safety data
.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
31 6. 2
6.1 List of excipients
%
35 6.5 Nature and contents of container
(3
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
ml). & /
The pen injector is made of plastic.
(. &
Pack sizes:
3 ml.
1, 5 and 10 pre-filled pens x 3 ml.
Protaphane NovoLet.
Protaphane InnoLet is for single person use only.
Protaphane NovoLet (25°))
The container must not be refilled.
,
After removing Protaphane InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
6 7
7.
EU/ 1/ 02/ 234/ 008- 009
EU/ 1/ 02/ 234/ 010-012
33 1.
36 1.
Protaphane InnoLet 100 IU/ ml
NAME OF THE MEDICINAL PRODUCT
.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
&
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Protaphane InnoLet.
Administration For subcutaneous use.
,
The dose is set by turning the selector, which returns to zero during the injection.
4. 3
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
!!!
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
35,. '%.
Hypoglycaemia.
4
39 4.7 Effects on ability to drive and use machines
37 –%
Generalised hypersensitivity reactions are potentially life- threatening.
38 Protaphane%
Protaphane is a long-acting insulin.
39 6. 2
6.1 List of excipients
)
Keep the pen cap on in order to protect from light.
ml). & /
Protect from excessive heat and sunlight.
. &
42 6.5 Nature and contents of container
3
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
1,
Pack sizes:
Protaphane InnoLet
Protaphane FlexPen is for single person use only.
Protaphane InnoLet (25°))
The container must not be refilled.
,
After removing Protaphane FlexPen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
EU/ 1/ 02/ 234/ 010- 012
EU/ 1/ 02/ 234/ 013-015
Protaphane FlexPen 100 IU/ ml
DATE OF REVISION OF THE TEXT
43,. '%.
43 ANNEX II
. &
A.
. -
B.
Protaphane.
CONDITIONS OF THE MARKETING AUTHORISATION
44 4. 6
44 A.
0 (
Name and address of the manufacturer of the biological active substance
-
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
1 (
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
Protaphane.
Protaphane, Protaphane NovoLet, Protaphane InnoLet:
4
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Protaphane.
Protaphane Penfill and FlexPen
, Protaphane.,
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
:
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
(1 1/ 1 000
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.
< 1/ 10 000,
CONDITIONS OF THE MARKETING AUTHORISATION
.
• 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
# – / &. '.
Not applicable.
45 –%
45 ANNEX III
(10 () 01.
LABELLING AND PACKAGE LEAFLET
46 Protaphane%
46 A.
1½
LABELLING
,
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
4- 12
OUTER CARTON
, -
1.
-.)
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
%.
2.
,
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
. &
3.
per se
LIST OF EXCIPIENTS
(t½)
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
). "
4.
,
Suspension for injection 1 x 10 ml 5 x 10 ml
& #
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
5
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
6. 1
Keep out of the reach and sight of children
. "
7.
30 2°) - 8°).
OTHER SPECIAL WARNING(S), IF NECESSARY
(
8.
30°)).
EXPIRY DATE
6. 4
EXP/ During use: use within 4 weeks
48 7.
48 9.
6 7
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
7.
10.
6 7 6
11.
EU/ 1/ 02/ 234/ 013- 015
EU/ 1/ 02/ 234/ 001 1 x 10 ml EU/ 1/ 02/ 234/ 002 5 x 10 ml
9.
13.
6 7
Batch:
:
Medicinal product subject to medical prescription
07 '
15.
18)
INSTRUCTIONS ON USE
2007
16.
6
Protaphane vial 40 IU/ ml
49 II
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
A.
VIAL LABEL
6
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
3
2.
6
3.
7
EXP/
6
4.
6
Batch:
3
10 ml
0.
OTHER
6
Novo Nordisk A/ S
50 A.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
6
OUTER CARTON
3
1.
8
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
7
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
6 6
3.
,
4.
3
Suspension for injection 1 x 10 ml 5 x 10 ml
6
5.
"
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
Keep out of the reach and sight of children
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg
OTHER SPECIAL WARNING(S), IF NECESSARY
",
8.
Protaphane, Protaphane NovoLet, Protaphane InnoLet:
EXP/ During use: use within 6 weeks
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
SPECIAL STORAGE CONDITIONS
Protaphane Penfill
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
FlexPen
11.
Novo Nordisk Production SAS 45, Avenue d’ Orléans F- 28002 Chartres +
MARKETING AUTHORISATION NUMBER(S)
&
EU/ 1/ 02/ 234/ 003 1 x 10 ml EU/ 1/ 02/ 234/ 004 5 x 10 ml
,
13.
.
Batch:
0.
14.
6
Medicinal product subject to medical prescription
7 6
15.
•
16.
3
Protaphane vial 100 IU/ ml
7
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
0 0
VIAL LABEL
,
1.
6
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
7
2.
$.
3.
•
EXP/
3
4.
7
Batch:
0 6
5.
51 III
10 ml
52 A.
Novo Nordisk A/ S
53
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Protaphane 40 IU/ ml
NAME OF THE MEDICINAL PRODUCT
40 IU
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
).
2.
3.
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
,,
3.
,
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
,.
4.
,
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
3
METHOD AND ROUTE OF ADMINISTRATION
/% &
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
5
Keep out of the reach and sight of children
,
8.
4
EXP/ During use: use within 4 weeks
54 9.
54 9.
(2°C - 8°C)
SPECIAL STORAGE CONDITIONS
) &
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
6 6 6
11.
EU/ 1/ 02/ 234/ 001 1 x 10 ml EU/ 1/ 02/ 234/ 002 5 x 10 ml
EU/ 1/ 02/ 234/ 016
&:
Batch:
$
Medicinal product subject to medical prescription
40 "2 /
Protaphane vial 40 IU/ ml
55
55 PARTICULARS TO APPEAR ON THE PACKAGING
,
OUTER WRAPPER LABELON MULTIPACKS
Protaphane 40 IU/ ml
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
s. c.
2.
(
3.
)
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
3
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
3
Keep out of the reach and sight of children
3
7.
:
8.
4.
EXP/ During use: use within 4 weeks
56
56 9.
Protaphane 100 IU/ ml
SPECIAL STORAGE CONDITIONS
(
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
)
10.
2.
11.
8
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
1 ml
12.
(3, 5 mg)
EU/ 1/ 02/ 234/ 016
4.
13.
"1 x 10 ml 5 x 10 ml
BATCH NUMBER
3
Batch:
/% &
14.
6.
Medicinal product subject to medical prescription
3 3
15.
7.
16.
5
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
(2°C - 8°C)
OUTER CARTON
) &
1.
%
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
:
2.
,
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
10.
3.
5
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
6 6 6
4.
6
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
11.
5.
6
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
7 6
6.
7 6
7.
EU/ 1/ 02/ 234/ 003 1 x 10 ml EU/ 1/ 02/ 234/ 004 5 x 10 ml
OTHER SPECIAL WARNING(S), IF NECESSARY
&:
8.
14.
EXPIRY DATE
$
EXP/ During use: use within 6 weeks
58
58 9.
s. c.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
2.
10.
3
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
3.
11.
6
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
3
12.
3
EU/ 1/ 02/ 234/ 017
,
Medicinal product subject to medical prescription
10 ml
15.
6.
16.
3
INFORMATION IN BRAILLE
Novo Nordisk A/ S
Protaphane vial 100 IU/ ml
59
59 PARTICULARS TO APPEAR ON THE PACKAGING
(
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
1 ml
STATEMENT OF ACTIVE SUBSTANCE
(1, 4 mg)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
).
3.
3.
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
,,
4.