natgillin/translations-raw huggingface dataset:
Tel: +31 (0) 23 5153153 msdbvnl@ merck. com Norge MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@ msd. no
Nederland Merck Sharp & Dohme BV Tel: +31 (0) 23 5153153 msdbvnl@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no
Eesti Österreich Merck Sharp & Dohme OÜ Tel.: +372 613 9750 msdeesti@ merck. com
Eesti Österreich Merck Sharp & Dohme OÜ Tel.: +372 613 9750 msdeesti@merck.com
Merck Sharp & Dohme G. m. b. H.
Merck Sharp & Dohme G.m.b.H.
Tel: +34 91 321 06 00 Velmetia@ msd. es
Tel: +34 91 321 06 00 Velmetia@msd.es
Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 informacao_ doente@ merck. com
Portugal LABORATÓRIO MEDINFAR, Produtos, Farmacêuticos, SA Tel: +351 800204661 medinfar@medinfar.pt
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 49 10 80 00 contact@ msd- france. com
France Pierre Fabre Médicament Tél: +33 (0) 1 49 10 80 00
Ιtalia Merck Sharp & Dohme (Italia) S. p. A.
Ιtalia Istituto Gentili S.p.A.
Velmetia 50 mg/ 1 000 mg филмирани таблетки ситаглиптин/ метформин хидрохлорид (sitagliptin/ metformin hydrochloride)
Velmetia 50 mg/1000 mg film-coated tablets sitagliptin/metformin hydrochloride
Трябва да спрете да приемате Velmetia по време на изследване с рентгенови лъчи и няколко дни след това ако наскоро сте получили сърдечен инфаркт или имате тежки циркулаторни проблеми, като "шок" или проблеми с дишането ако имате чернодробни проблеми ако пиете алкохол в големи количества (всеки ден или само от време на време) ако кърмите
taking Velmetia at the time of the X -ray and for a few days after
Не приемайте Velmetia, ако нещо от по- горе изброените се отнася за Вас.
- if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or
60 Ако сте пропуснали да приемете Velmetia Ако сте пропуснали доза, вземете я веднага щом се сетите.
If you forget to take Velmetia If you miss a dose, take it as soon as you remember.
Опаковки по 14, 28, 56, 112, 168, 196 филмирани таблетки, мулти опаковката съдържаща 196 (2 х 98) филмирани таблетки.
Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets.
Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
58 Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl.
63 Ísland Icepharma hf.
Ísland Icepharma hf.
EMEA/ H/ C/ 423
EMEA/ H/ C/ 423
ба VELOSULIN
VELOSULIN
ре Резюме на EPAR за обществено ползване
EPAR summary for the public
от уп Настоящият документ представлява резюме на Европейския доклад за обществена оценка (EPAR).
ed This document is a summary of the European Public Assessment Report (EPAR).
за хуманна употреба (CHMP) оценява проведените проучвания, за да направи своите препоръки как да се използва лекарството.
is the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
ен Ако се нуждаете от повече информация за Вашето медицинско състояние или лечение,
or If you need more information about your medical condition or your treatment, read the Package
еш прочетете листовката (също част от EPAR) или попитайте Вашия лекар или фармацевт.
th Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
зр Какво представлява Velosulin? ра е Velosulin е инжекционен или инфузионен (капково вливане във вена) разтвор.
Velosulin is a solution for injection or infusion (drip).
Съдържа активното вещество човешки инсулин (рДНК). не
It contains the active substance insulin human ng (rDNA). lo
За какво се използва Velosulin? че
What is Velosulin used for?
Velosulin се използва за лечение на пациенти с диабет. ве
Velosulin is used to treat patients with diabetes. no
Как да използвате Velosulin? о йт
How is Velosulin used? ct
Velosulin е предназначен за продължителна субкутанна инфузия (под кожата) чрез инсулинова инсулинова инфузионна помпа.
Velosulin is intended for continuous subcutaneous infusion (under the skin) using an insulin infusion du
субкутанно чрез инжекция.
Velosulin may also be injected into a vein or given subcutaneously by injection.
Velosulin трябва да се прилага преди ядене.
Velosulin is a fast-acting insulin and may be used with longer-acting insulin products.
За определяне на точното време – ду
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. ro
вижте листовката. о пр
See the Package Leaflet for exact timings. lp
Как действа Velosulin?
How does Velosulin work? a
Velosulin е заместващ инсулин, който е идентичен с инсулина, н ве
The active in
произвеждан от панкреаса.
substance in Velosulin, insulin human (rDNA), is produced by a method known as ‘ recombinant DNA ic
дрожди, получили ген (ДНК), който им позволява да произвеждат инсулин.
technology ’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Заместващият инсулин действа по същия начин, както естествено произведеният инсулин, и помага на р ка
The replacement insulin acts in same way as naturally produced insulin and helps ed
глюкозата (захарта) да навлезе от кръвта в клетките.
glucose to enter cells from the blood.
Разтворът на инсулин във Velosulin е Ле
The solution of insulin in Velosulin is specially prepared to M
специално приготвен, така че да е стабилен по време на въвеждането с инжекционната помпа.
make it stable for the duration of administration in an infusion pump.
Проучванията, използвани в подкрепа на Velosulin, са тези, използвани в подкрепа на Actrapid, друг инсулин, одобрен в Европейския съюз (ЕС).
Velosulin has also been studied used in an insulin pump.
Проучванията измерват нивото на кръвната захар на гладно или веществото в кръвта, наречено гликиран хемоглобин (HbA1c), който 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 показва колко добре се контролира кръвната захар.
(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 What benefit has Velosulin shown during the studies?
Velosulin е проучван също така при употреба в инсулинова помпа.
Velosulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with the other human insulin.
ба Какви са рисковете, свързани с Velosulin?
What is the risk associated with Velosulin?
За пълния списък на всички наблюдавани при Velosulin нежелании реакции –
As with all insulins, Velosulin may cause hypoglycaemia (low blood glucose).
Velosulin е противопоказен за пациенти, които биха могли да проявят свръхчувствителност
For the full list of all side effects reported with Velosulin, see the Package Leaflet.
уп (алергични реакции) към човешки инсулин (рДНК) или някоя от другите съставки.
Velosulin should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
за лекарства, които могат да повлияят на кръвната захар.
Velosulin doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
ен Основания за одобряване на Velosulin?
ed Why has Velosulin been approved?
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от
The Committee for Medicinal products for Human Use (CHMP) decided that Velosulin’ s benefits are
еш Velosulin са по- големи от рисковете за лечението на диабет.
The Committee recommended that Velosulin be
Комитетът препоръчва на Velosulin да бъде издадено разрешение за употреба.
or given marketing authorisation.
зр Допълнителна информация за Velosulin:
th Other information about Velosulin:
ра Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за Velosulin на Novo Nordisk A/ S на 7 октомври 2002 г.
au The European Commission granted a marketing authorisation valid throughout the EU for Velosulin to Novo Nordisk A/ S on 7 October 2002.
Разрешението за употреба е е подновено на 7 октомври 2007 г. не
The marketing authorisation was renewed on 7 October 2007.
Пълният текст на EPAR относно Velosulin може да се намери тук. че ве
er The full EPAR for Velosulin is available here.
Дата на последно актуализиране на текста 10- 2007. о йт, ко кт
This summary was last updated in 10-2007. no ct du ro a lp in ic ed M
о
lo
ба ре от
EU number
Количество на
Invented name Strength
Количество в
Pharmaceutical form
уп Номер в ЕС
Route of administration
опаковка
ed (concentration)
EU/ 1/ 02/ 232/ 001
is EU/ 1/ 02/ 232/ 001 Velosulin
инфузионен разтвор
Solution for injection or infusion
флакон (стъкло)
Subcutaneous and intravenous Vial (glass) use
10 ml (3. 5 mg/ ml)
10ml (3.5 mg/ ml)
EU/ 1/ 02/ 232/ 002
or EU/ 1/ 02/ 232/ 002 Velosulin
10 ml (3. 5 mg/ ml)
10 ml (3.5 mg/ ml)
EU/ 1/ 02/ 232/ 03
th EU/ 1/ 02/ 232/ 003 Velosulin
интравенозна употреба
Solution for injection or infusion Subcutaneous and intravenous vial (glass)
флакон (стъкло)
10 ml (3.5 mg/ ml)
10 ml (3. 5 mg/ ml)
5 x (1 x 10 ml) vials
флакона
au use
зр ра е не че ве о йт ко, кт ду о пр н ве р ст ка
er ng lo o tn uc od pr al in ic ed M
1/ 1 Ле
1/ 1
Ле ка
ed is or th au ANNEX I er ng SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lp a in ic ed M
1 че
1 1.
I не е ра зр еш ен за уп от ре ба 1.
NAME OF THE MEDICINAL PRODUCT
Velosulin 100 IU/ ml
Velosulin 100 IU/ ml solution for injection or infusion in a vial.
(Insulin human, rDNA) (
QUALITATIVE AND QUANTITATIVE COMPOSITION
ба Saccharomyces cerevisiae).
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1
1 ml contains 100 IU of insulin human.
уп
ed One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
IU (
is For a full list of excipients, see section 6.1.
)
or 3.
0, 035 mg
PHARMACEUTICAL FORM
.
th au Solution for injection or infusion in a vial.
ен еш 3.
Clear, colourless, aqueous solution.
ра
er ng 4.
(& & "")
CLINICAL PARTICULARS lo
Velosulin
4.1 Therapeutic indications no
ду
Treatment of diabetes mellitus.
'
4.2 Posology and method of administration ct du
!
This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps. ro
'
Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin lp
6. 2.
products.
40- 60%
Dosage in
р
Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% ic
ка
as boluses divided between the three main meals. ed
90%
In general, when patients are transferred from injection to infusion therapy, it may be advisable to M
, 40%
reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals.
Ле
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.
50%
Close blood glucose monitoring is therefore recommended.
2 (..
2 An injection or infusion should be followed within 30 minutes by a meal or snack containing carbohydrates.
*
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
!
Renal or hepatic impairment may reduce insulin requirement.
,
Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
ре от
ed Administration
ен еш &.
is For subcutaneous or intravenous use.
(& & ""):
or Insulin infusion (CSII):
(& & "") е
th administered in the abdominal wall.
Velosulin
Velosulin should never be mixed with any other insulin products
6. 6).
au when used in a pump.
"
Patients started on CSII must receive comprehensive instruction in the use of the pump, and the
йт
The patient should read and follow the instructions that accompany the infusion pump and use the ng correct reservoir and catheter for the pump (see section 6.6).
48
The infusion set should be changed every 48 hours using aseptic technique when inserting the lo
. ду
infusion set.
, о
The patient should follow the instructions from the physician about the basal infusion rate and the mealtime insulin boluses to be taken. ct
. пр
To get the benefit of insulin infusion, and to detect possible malfunction of the pump, the patient du
& &
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. ro
н
If repeated or severe low blood glucose levels occur, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered.
! ве
A pump lp
..) ст
If the patient suspects an interruption to insulin flow the patient should notify the health care professional. a in
+ ка
Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily available in case of emergency or pump interruption or failure, in order that insulin can be ic
Ле
administered by subcutaneous injection. ed
Velosulin
Insulin injection:
!
M
Velosulin
Administration of Velosulin is also possible by subcutaneous or intravenous injection.
Velosulin
Velosulin is administered subcutaneously in the abdominal wall.
"
Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
6
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
.
3 Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
!
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Velosulin
Velosulin is accompanied by a package leaflet with detailed instruction for use to be followed.
еш 4. 3
4.3 Contraindications
зр
ed Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
6. 1).
Hypoglycaemia.
!
is 4.4 Special warnings and precautions for use
1,
or Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to
(". о
th hyperglycaemia.
(
They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
,
er In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. ng Due to the lack of long-acting insulin, patients receiving continuous subcutaneous insulin infusion via lo
йт
an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion. no
,
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9). ct
,
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. du
.
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised ro
4. 9).
accordingly.
,
Transferring a patient to another type or brand of insulin should be done under strict medical a
&. р
supervision.
ка
If an adjustment is needed when ic
&
switching the patients to Velosulin, it may occur with the first dose or during the first several weeks ed
,.
or months.
(
M
'.
On rare occasions, injection site reactions may require discontinuation of Velosulin.
&
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
4 Patients using CSII may be more prone to infection at the site of infusion.
Velosulin,
Velosulin contains metacresol, which may cause allergic reactions.
,
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-
,
is blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
+
or The following substances may increase insulin requirement:
,,
th Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth
от Velosulin.
au hormone and danazol.
уп
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from
зр ра
er hypoglycaemia.
. "
ng
е
Octreotide/ lanreotide may both decrease and increase insulin requirement. lo
,
Alcohol may intensify and prolong the hypoglycaemic effect of insulin. no
Velosulin
4.6 Pregnancy and lactation
,
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not ct
(&,
pass the placental barrier. du
-
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes ro
- & '+ #
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when lp
& '+.
contemplating pregnancy.
(
Insulin requirements usually fall in the first trimester and subsequently increase during the second and a
(&, -
third trimesters. in
"
After delivery, insulin requirements return rapidly to pre-pregnancy values. ic
ка Ле
However, the Velosulin dosage ed
utero. & (
may need to be adjusted.
,,
The advisability of driving should be considered in these circumstances.
.
5 4.8 Undesirable effects
,
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Velosulin.
Therefore, no specific frequency can be presented.
ре от
The frequencies are defined as: uncommon (≥ 1/ 1,000 to
).
ed < 1/ 100).
ен
is Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
.%
or Nervous system disorders Uncommon - Peripheral neuropathy
,
th Fast improvement in blood glucose control may be associated with a condition termed “ acute painful
зр ра
au neuropathy”, which is usually reversible.
не
Eye disorders
е
These symptoms are usually of ng transitory nature. lo
'-
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. no
!
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. ct
.%
Skin and subcutaneous tissue disorders du
.,
Uncommon – Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites ro
.% ве
within an area. lp
/ о
General disorders and administration site conditions Uncommon - Injection site reactions a
.
Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may in
(Actrapid).
occur during treatment with insulin.
< 1/ 100). "< 1/ 10 000
These symptoms are usually of transitory M
.
nature.
+ кт
Generalised hypersensitivity reactions are potentially life- threatening.
6 – $
6 4.9 Overdose
ре.
A specific overdose of insulin cannot be defined.
10- 15
ed 15 minutes.
+ кт
is patient in order to prevent relapse.
5.
or 5.
5. 1 ве
PHARMACOLOGICAL PROPERTIES
(
th au 5.1 Pharmacodynamic properties
& (
Pharmacotherapeutic group: insulins and analogues for injection, fast-acting, insulin (human).
ка
ATC
:
er code:
&
ng
!
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 lo
10 mmol/ l),
output from the liver. no
204,,
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous treatment with another fast ct
42% (8%
acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%). du
Velosulin
Velosulin is a fast-acting insulin. ro
'
When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours. lp
Velosulin
5.2 Pharmacokinetic properties a in
(.
Insulin in the blood stream has a half-life of a few minutes.
зр ра)
The pharmacokinetics of insulin products are therefore affected M
., кт ду
by significant intra- and inter-individual variation.
'
The relatively fast absorption of soluble insulin ensures a constant supply of insulin to the blood from a relatively small pool under the skin.
.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
&
7 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
о
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
,
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
пр
The
per se
ed terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
(t½
Trials have indicated a t½
). "н
is of about 2-5 hours.
,
or Chrildren and adolescents The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 6-
6- 12 ст
th 12 years) and adolescents (aged 13-17 years) using another fast-acting human insulin, (Actrapid).
) +
The
(
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
13- 17
5.3 Preclinical safety data er ng Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo
, (Actrapid).,
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. no
- 1
6.1 List of excipients du
ба
Zinc chloride ro
(
Glycerol Metacresol lp
)
Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) a
ре
Hydrochloric acid (for pH adjustment) in
от,
Water for injections ic
уп
6.2 Incompatibilities ed
6. 2
Insulin products should only be added to compounds with which it is known to be compatible.
"
M
. &
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
,
Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section 6.6.
зр ра
6.3 Shelf life
6. 3 30
30 months when stored between 2°C - 8°C.
,
8 After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
че
6.4 Special precautions for storage
25° *).
Before use: store in a refrigerator (2°C - 8°C).
(2° * - 8° *).
Do not freeze.
.., кт
During use: do not refrigerate.
25° *.
Do not store above 25°C.
*
ed Keep the vial in the outer carton in order to protect from light.
пр
is Protect from excessive heat and sunlight.
о
or 6.5 Nature and contents of container
37°C (
th 10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective
:
Pack sizes:
1)
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
10 ml
6.6 Special precautions for disposal and other handling er ng Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to lo
/
Monitoring of the patient's blood glucose during infusion is therefore recommended. no
ка
When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin. ct du
,
Velosulin should not be mixed with insulin zinc suspensions ro