natgillin/translations-raw huggingface dataset:
Protaphane е инсулин с дълготрайно действие, той може да се прилага като инжекция веднъж или два пъти дневно със или без бързодействащ инсулин (по време на хранене), съгласно лекарското предписание.
Protaphane is a long-acting insulin, it can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Protaphane е заместващ инсулин, който е еднакъв с инсулина, произвеждан от панкреаса.
Protaphane is a replacement insulin which identical to the insulin made by the pancreas.
Активното вещество в Protaphane, човешкия инсулин (rDNA), се произвежда по метод, познат като „ рекомбинантна технология ”:
The active substance in Protaphane, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’:
Инсулинът се получава от фермент, получил ген (ДНК), който прави възможно производството на инсулин.
The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Protaphane съдържа инсулин, смесен с друго вещество - протамин, във форма на „ изофан ”, която се усвоява много по- бавно през деня.
Protaphane contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Това дава на Protaphane по- дълго време на действие.
This gives Protaphane a longer duration of action.
Заместващият инсулин действа по същия начин, както естествено произведения инсулин и помага на глюкозата да навлезе в кръвните клетки.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Как е проучен Protaphane?
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protaphane been studied?
Protaphane е проучен в четири основни клинични изпитвания, включващи общо 557 пациенти с диабет тип 1, кога81 пациенти) или диабет тип 2, когато тялото не може ефективно да усвоява инсулина (две проучвания, включващи 476 пациенти).
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
При повечето пациенти, Protaphane е сравняван с други типове човешки инсулин или инсулинови аналози.
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Проучванията измерват нивото на кръвна захар на гладно или вещество в кръвта, наречено „ глюколизиран хемоглобин ” (HbA1c), което показва колко добре се контролира кръвната захар.
The studies measured the level of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Също така са проведени и допълнителни проучвания при 225 пациенти, сравняващи инжектиране на Protaphane чрез спринцовка или чрез предварително напълнена писалка (InnoLet, NovoPen или FlexPen).
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Protaphane води до намаляване на нивото на HbA1c, което показва, че нивата на кръвната захар се контролират до ниво, подобно на наблюдаваното при друг човешки инсулин.
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Protaphane е ефективен и за двата типа диабет - 1 и 2, при използване както на стандартна инжекция, така и на която и да е от писалките.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Както при всички инсулини, Protaphane може да причини хипогликемия (ниско ниво на кръвната захар).
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
За пълния списък на всички наблюдавани при Protaphane нежелани реакции - вижте листовката.
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Protaphane не трябва да се използва при пациенти, които биха могли да проявяват свръхчувствителност (алергични реакции) към човешки инсулин (rDNA) или някоя от другите съставки.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Може да се наложи и коригиране на дозите Protaphane, когато се прилага в комбинация с някои други лекарствени продукти, които могат да повлияят на кръвната захар.
Protaphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Основания за одобряване на Protaphane?
Why has Protaphane been approved?
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от Protaphane са по- големи от рисковете за лечението на диабет.
The Committee for Medicinal products for Human Use (CHMP) decided that Protaphane’ s benefits are greater than its risks for the treatment of diabetes.
Комитетът препоръчва на Protaphane да бъде издадено разрешение за употреба.
The Committee recommended that Protaphane be given marketing authorisation.
Допълнителна информация за Protaphane:
Other information about Protaphane:
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз за Protaphane на Novo Nordisk A/ S на 7 октомври 2002 г.
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Пълният текст на EPAR относно Protaphane може да се намери тук.
The full EPAR for Protaphane is available here.
Дата на последно актуализиране на текста 10- 2007 г.
This summary was last updated in 10-2007.
Protaphane 40 IU/ ml
Protaphane 40 IU/ ml suspension for injection in a vial.
(insulin human, rDNA) (
QUALITATIVE AND QUANTITATIVE COMPOSITION
Saccharomyces cerevisiae).
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
40 IU 10 ml,
1 ml contains 40 IU of insulin human.
400 IU.
1 vial contains 10 ml equivalent to 400 IU.
IU (
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Protaphane
Protaphane is a suspension of isophane (NPH) insulin.
(NPH).
For a full list of excipients, see section 6.1.
!!
3.
6. 1.
Suspension for injection in a vial.
,,
Cloudy, white, aqueous suspension.
Protaphane
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.
-
The physician determines whether one or several daily injections are necessary.
Protaphane
Protaphane may be used alone or mixed with fast-acting insulin.
.
Close blood glucose monitoring is therefore recommended.
,
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.
2
2 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
Administration For subcutaneous use.
Protaphane
Protaphane is administered subcutaneously in the thigh.
,
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
. (
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Protaphane
4.3 Contraindications
('
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
4. 9).
Hypoglycaemia.
,
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.
Protaphane,
On rare occasions, injection site reactions may require discontinuation of Protaphane.
,
3 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.
.
Insulin suspensions are not to be used in insulin infusion pumps.
Protaphane.
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.
.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
,
Octreotide/ lanreotide may both decrease and increase insulin requirement.
!
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
,
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.
,
Insulin treatment of the nursing mother presents no risk to the baby.
Protaphane
However, the Protaphane dosage may need to be adjusted.
%
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Protaphane.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
4
4 hypoglycaemia or have frequent episodes of hypoglycaemia.
Protaphane.
4.8 Undesirable effects
,, Protaphane.,
Therefore, no specific frequency can be presented.
:
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
< 1/ 100). "
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
&
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.
< 1/ 10 000,
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
# – & * “
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.
.
Most reactions are transitory and disappear during continued treatment.
,
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
# – / &. '.
These symptoms are usually of transitory nature.
5 –%
Generalised hypersensitivity reactions are potentially life- threatening.
'! – / /
5 4.9 Overdose
&.,: •
A specific overdose of insulin cannot be defined.
3
5.1 Pharmacodynamic properties
4
Insulins and analogues for injection, intermediate-acting, insulin (human).
(0)
ATC code:
(10 () 01.
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.
6 Protaphane%
Protaphane is a long-acting insulin.
24
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- 12
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
5. 2
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.
-.)
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.
5
PHARMACEUTICAL PARTICULARS
4 3 # +
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 + & -
6.3 Shelf life
30 2°) - 8°).
30 months when stored between 2°C - 8°C.
4
4 weeks when used or stored at room temperature (below 25°C).
25°)).
6.4 Special precautions for storage
(2°) - 8°)).
Before use: store in a refrigerator (2°C - 8°C).
25°).
During use: do not refrigerate.
6. 5!
Do not store above 25°C.
)
Protect from excessive heat and sunlight.
(
6.5 Nature and contents of container
1)
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
1 # "*
Pack sizes:
Protaphane (25°))
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
.
7 6.6 Special precautions for disposal and other handling
,
Insulin preparations which have been frozen must not be used.
%
After removing Protaphane vial from the refrigerator it is recommended to allow the vial 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.
EU/ 1/ 02/ 234/ 001- 002, 016
EU/ 1/ 02/ 234/ 001-002, 016
6
Date of first authorisation:
07 '
07 October 2002
2002
Date of latest renewal:
18)
18 September 2007
2007
10.
Protaphane 100 IU/ ml
NAME OF THE MEDICINAL PRODUCT
.
Protaphane 100 IU/ ml suspension for injection in a vial.
100 IU 10 ml,
1 ml contains 100 IU of insulin human.
1 000 IU.
1 vial contains 10 ml equivalent to 1000 IU.
Protaphane
CLINICAL PARTICULARS
1, 0 IU/ kg /
4.1 Therapeutic indications
(
Treatment of diabetes mellitus.
%
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.
!
The physician determines whether one or several daily injections are necessary.
,
Close blood glucose monitoring is therefore recommended.
. (
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
!
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
&
9 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.
.
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
,
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
4. 3
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
!
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
6. 1).
4.3 Contraindications
!
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
&
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.
!
Reactions usually resolve in a few days to a few weeks.
,
10 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.
Protaphane.
Insulin suspensions are not to be used in insulin infusion pumps.
Protaphane
Protaphane contains metacresol, which may cause allergic reactions.
.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
4. 5
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
(&, -
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
- & '#
Octreotide/ lanreotide may both decrease and increase insulin requirement.
+
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
utero. & '
4.6 Pregnancy and lactation
.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
,,
Insulin treatment of the nursing mother presents no risk to the baby.
Protaphane.
However, the Protaphane dosage may need to be adjusted.
4
4.7 Effects on ability to drive and use machines
. 7.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
1 * -
The advisability of driving should be considered in these circumstances.
, Protaphane.,
Therefore, no specific frequency can be presented.
13 –%
Generalised hypersensitivity reactions are potentially life- threatening.
'! – / /
12 4.9 Overdose
14 Protaphane%
Protaphane is a long-acting insulin.
15 6. 2
6.1 List of excipients
- 1 (
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
6 weeks when used or stored at room temperature (below 25°C).
.
14 6.6 Special precautions for disposal and other handling
EU/ 1/ 02/ 234/ 003- 004, 017
EU/ 1/ 02/ 234/ 003-004, 017
Protaphane Penfill 100 IU/ ml
NAME OF THE MEDICINAL PRODUCT
.
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
1 ml 1
1 ml contains 100 IU of insulin human.
300 IU.
1 cartridge contains 3 ml equivalent to 300 IU.
6. 1.
Cloudy, white, aqueous suspension.
".
4.1 Therapeutic indications
,,
4.2 Posology and method of administration
.
Protaphane is a long-acting insulin.
4.
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.
4. 1
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.
"
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.
4. 2
16 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.
%
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
!
Detailed instruction accompanying the delivery system must be followed.
. "
4.3 Contraindications
.
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.
0, 3
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.
1, 0 IU/ kg /
Reactions usually resolve in a few days to a few weeks.
(
17 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 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.
/
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
)
Octreotide/ lanreotide may both decrease and increase insulin requirement.
%
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
!
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.
()
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.
Protaphane
4.8 Undesirable effects
. (
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.
Novo Nordisk
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.