natgillin/translations-raw huggingface dataset:
.)!
Octreotide/ lanreotide may both decrease and increase insulin requirement.
&
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
!
However, the Protaphane 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).
18 &.
18 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
4. 4).
4.8 Undesirable effects
.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Protaphane!,!
Therefore, no specific frequency can be presented.
. $
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.
,
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
#
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.
) #
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
NovoFine. /.
Most reactions are transitory and disappear during continued treatment.
Protaphane.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
6. 1)...
These symptoms are usually of transitory nature.
4. 4
Generalised hypersensitivity reactions are potentially life- threatening.
. - &,. &
PHARMACOLOGICAL PROPERTIES
-
5.1 Pharmacodynamic properties
% $& +:!
Pharmacotherapeutic group:
% $& +:!
ATC code:
#
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.
/ lanreotide
5.2 Pharmacokinetic properties
in utero.
Insulin in the blood stream has a half-life of a few minutes.
0
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
20 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Protaphane.
Trials have indicated a t½ of about 5-10 hours.
4. 7
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.
(+
6.
$* '+% +
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
%.. $2 +) 1
6.2 Incompatibilities
&
Insulin suspensions should not be added to infusion fluids.
4. 8 0 +
6.3 Shelf life
2.
30 months when stored between 2°C - 8°C.
'
6 weeks when used or carried as a spare (below 30°C).
Protaphane
6.4 Special precautions for storage
!. (
Do not freeze.
< 1/ 100).
During use: do not refrigerate.
(< 1/ 10. 000
Do not store above 30°C.
!
Protect from excessive heat and sunlight.
!!!!!,
Pack sizes:
- 0!, '/ - #
1, 5 and 10 cartridges x 3 ml.
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.
- 2 2!.
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.
,,
8.
!,,!,
EU/ 1/ 02/ 234/ 005-007
$% $&! $'
07 October 2002
:
Date of latest renewal:
1 mg)
18 September 2007
10
10.
15
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.
5.
For a full list of excipients, see section 6.1.
#
Suspension for injection in a pre-filled pen.
5
Cloudy, white, aqueous suspension.
. 1
4.
. $.
4.1 Therapeutic indications
(+
Treatment of diabetes mellitus.
3
4.2 Posology and method of administration
: 4
Protaphane is a long-acting insulin.
,
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.
,
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
(
Close blood glucose monitoring is therefore recommended.
0!
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
ATC:
Renal or hepatic impairment may reduce insulin requirement.
A10A C01.
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).
*
Insulin suspensions are never to be administered intravenously.
!!
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
!
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
.
The dose is set by turning the selector, which returns to zero during the injection.
'
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
1½
Usual warning symptoms may disappear in patients with longstanding diabetes.
4- 12!
Continuous rotation of the injection site within a given area may help to
22
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.
. $
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.
. 0
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
(..
4.6 Pregnancy and lactation
,!
25 4.7 Effects on ability to drive and use machines
0
4.8 Undesirable effects
'
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
!
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
&
Most reactions are transitory and disappear during continued treatment.
2- 18!
These symptoms are usually of transitory nature.
0
4.9 Overdose
#
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
$&
5.1 Pharmacodynamic properties
-
Insulins and analogues for injection, intermediate-acting, insulin (human).
%, - &
ATC code:
!.
A10A C01.
6.
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.
6. 1 - $'
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
(4)
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.
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.
6. 2
6.
%.
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
30°C).
6 weeks when used or carried as a spare (below 30°C).
(2°C 8°C). * '
Before use: store in a refrigerator (2°C - 8°C).
'!
28 6.5 Nature and contents of container
x 3 ml.
5 and 10 pre-filled pens x 3 ml.
Protaphane Penfill.
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.
25°C)!
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.
24 8. #
8.
Protaphane NovoLet 100 IU/ ml
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
$
Suspension for injection in a pre-filled pen.
'
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
2
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
NovoFine., #
The needle box is marked with an S.
NovoLet.
InnoLet delivers 1-50 units in increments of 1 unit.
(!
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.
!!
After delivery, insulin requirements return rapidly to pre-pregnancy values.
!
Insulin treatment of the nursing mother presents no risk to the baby.
4. 7
32 4.7 Effects on ability to drive and use machines
-%
The advisability of driving should be considered in these circumstances.
1 mg)
4.9 Overdose
&
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.
(t½)
6.1 List of excipients
*
Protect from excessive heat and sunlight.
!.
35 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), /.
The pen injector is made of plastic.
: 5
Pack sizes:
x 3 ml.
1, 5 and 10 pre-filled pens x 3 ml.
6. 6 $, & "
Not all pack sizes may be marketed.
(
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Protaphane NovoLet!
The container must not be refilled.
*
Insulin preparations which have been frozen must not be used.
,!
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.
!
Any unused product or waste material should be disposed of in accordance with local requirements.
100 IU
DATE OF REVISION OF THE TEXT
36
36 1.
,
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
!!!
2.
.
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
in utero.
1 ml contains 100 IU of insulin human.
0 '
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.
Protaphane is a suspension of isophane (NPH) insulin.
4. 7
For a full list of excipients, see section 6.1.
(+
3.
$* '+% +
PHARMACEUTICAL FORM
)
Suspension for injection in a pre-filled pen.
%.. $2 +) 1
Cloudy, white, aqueous suspension.
4. 8 0 +
4.1 Therapeutic indications
2.
Treatment of diabetes mellitus.
'
4.2 Posology and method of administration
!. (
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.
!:
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
(11/ 1. 000
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
(< 1/ 10. 000
Close blood glucose monitoring is therefore recommended.
#
Renal or hepatic impairment may reduce insulin requirement.
!!!!!,
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
37
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
-
Insulin suspensions are never to be administered intravenously.
#
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
#
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
(
The dose is set by turning the selector, which returns to zero during the injection.
#
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
#
4.3 Contraindications
- 2 2!.
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.
((
Usual warning symptoms may disappear in patients with longstanding diabetes.
,,,
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.
!
On rare occasions, injection site reactions may require discontinuation of Protaphane.
)
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.
!
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.
- (
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 contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
- 0!, '-
4.6 Pregnancy and lactation
–
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
#
After delivery, insulin requirements return rapidly to pre-pregnancy values.
,,
However, the Protaphane dosage may need to be adjusted.
,
39 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.
,
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.
!,
These symptoms are usually of transitory nature.
•
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary 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.
.),
Generalised hypersensitivity reactions are potentially life- threatening.
30 '2°C – 8°C..
30 months when stored between 2°C - 8°C.
(2°C - 8°C)
Before use: store in a refrigerator (2°C - 8°C).
!.
42 6.5 Nature and contents of container
Protaphane InnoLet.
Not all pack sizes may be marketed.
(!.
Any unused product or waste material should be disposed of in accordance with local requirements.
40 7. #
7.
43
43 ANNEX II
),
A.
- '
B.
/ lanreotide
CONDITIONS OF THE MARKETING AUTHORISATION
44
44 A.
#
Name and address of the manufacturer of the biological active substance
0
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
,
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
!!
Name and address of the manufacturers responsible for batch release
4. 7
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Protaphane
Protaphane Penfill and FlexPen
(< 1/ 10. 000
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
!
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
#
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.
#
Medicinal product subject to medical prescription
. (
Not applicable.
45
45 ANNEX III
1 mg)
LABELLING AND PACKAGE LEAFLET
46
46 A.
Protaphane
LABELLING
.
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
5- 10!
OUTER CARTON
6. 1 - $'
1.
& $
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
(4)
2.
+! "
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
..% $
LIST OF EXCIPIENTS
'
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
(+ 5
5.
,
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
6. 3
6.
# -
Keep out of the reach and sight of children
64 *
7.
30 '2°C – 8°C.
OTHER SPECIAL WARNING(S), IF NECESSARY
6 #
8.
30ºC).
EXPIRY DATE
48 7. #
48 9.
8. #
12.
/
Batch:
07 (
14.
2002
15.
10.
Protaphane vial 40 IU/ ml
3
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
#
EXP/
3 3
Batch:
#
10 ml
B.
6.
#
Novo Nordisk A/ S
8
OUTER CARTON
3 3
1.
,
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
STATEMENT OF ACTIVE SUBSTANCE
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
Protaphane, Protaphane NovoLet, Protaphane InnoLet:
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
PHARMACEUTICAL FORM AND CONTENTS
Protaphane Penfill
Suspension for injection 1 x 10 ml 5 x 10 ml
FlexPen
5.
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd
METHOD AND ROUTE OF ADMINISTRATION
Novo Nordisk Production SAS 45, Avenue d’ Orléans F- 28002 Chartres "
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
B. #
7.
8
8.
• 9
EXPIRY DATE
.
EXP/ During use: use within 6 weeks
51
51 9.
# 3
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
52 A.
10.
53
11.
#
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
:
12.
#
EU/ 1/ 02/ 234/ 003 1 x 10 ml EU/ 1/ 02/ 234/ 004 5 x 10 ml
3
13.
1.
14.
Protaphane 40 IU/ ml (- DNA)
Medicinal product subject to medical prescription
2. #
15.
1 ml
16.
40 IU (1, 4 mg)
Protaphane vial 100 IU/ ml
(- DNA).
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
3
VIAL LABEL
!
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
'
2.
,, ',!
EXPIRY DATE
!!.
EXP/
$1 x 10 ml 5 x 10 ml
Batch:
.
OTHER
$
Novo Nordisk A/ S
#
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
!
OUTER CARTON
6.
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
#
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
33;
3.
#
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
8
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
7
6.
), (
OTHER SPECIAL WARNING(S), IF NECESSARY
8.:
8.
0
EXPIRY DATE
4 #
EXP/ During use: use within 4 weeks
(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
/:
Batch:
3
Medicinal product subject to medical prescription
Protaphane
Protaphane vial 40 IU/ ml
#
OUTER WRAPPER LABELON MULTIPACKS
:
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 IU/ ml SC
METHOD AND ROUTE OF ADMINISTRATION
(- DNA)
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
3.:
7.
2 & 8 & /:
EXPIRY DATE
4. #
EXP/ During use: use within 4 weeks
#
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.
Protaphane 100 IU/ ml (- DNA)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
2. #
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
100 IU (3, 5 mg)
MARKETING AUTHORISATION NUMBER(S)
(- DNA).
EU/ 1/ 02/ 234/ 016
,!
13.
,, ',!
BATCH NUMBER
!!.
Batch:
$1 x 10 ml 5 x 10 ml
GENERAL CLASSIFICATION FOR SUPPLY
5.
Medicinal product subject to medical prescription
33;
15.
# () # (
INSTRUCTIONS ON USE
8.:
16.
) +%. $+0! $
INFORMATION IN BRAILLE
57 9.
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).
*
3.
25˚C
LIST OF EXCIPIENTS