natgillin/translations-raw huggingface dataset:
.
• Do not share your FlexPen with anyone else.
NovoMix 50 FlexPen 100 U/ ml
100 PACKAGE LEAFLET:
(Insulin aspart)
NovoMix 50 FlexPen 100 U/ ml suspension for injection in a pre-filled pen Insulin aspart
-
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
0
What NovoMix 50 is and what it is used for 2.
NovoMix 50
Before you use NovoMix 50 3.
NovoMix 50
How to use NovoMix 50 4.
NovoMix 50 - + #
How to store NovoMix 50 7 Further information
$! & -
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
.
See overleaf for detailed instructions.
"$/ NovoMix 50"
NovoMix 50 should not be used
4
In insulin infusion pumps If FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 50) If the insulin is not uniformly white and cloudy when it’ s mixed 102 If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
NovoMix 50) 4
NovoMix 50 is for injection under the skin (subcutaneously).
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4.
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WHAT TO DO IN AN EMERGENCY
•
5.
8
When you first start your insulin treatment, it may disturb your vision, but the condition usually disappears.
6
If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
.
Signs of allergy.
, NovoMix 50
You may have a very rare serious allergic reaction to NovoMix 50 or one of its ingredients (called a systemic allergic reaction).
4.
Diabetic retinopathy.
). '
Swollen joints.
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Normally, this soon disappears.
(
Side effects reported rarely
(
(less than 1 in 1,000)
).)
Painful neuropathy.
. '
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
- '+ 0!
104 6.
50.
HOW TO STORE NOVOMIX 50
%!
Keep out of the reach and sight of children.
NovoMix 50
Do not use NovoMix 50 after the expiry date which is stated on the label and carton.
NOVOMIX 50
NovoMix 50 FlexPen that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
NovoMix 50,
NovoMix 50 FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 50
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use.
FlexPen,! / 0
See overleaf.
NovoMix 50 FlexPen
NovoMix 50 FlexPen must be protected from excessive heat and sunlight.
NovoMix 50 FlexPen
NovoMix 50 should not be disposed of via wastewater or household waste.
Saccharomyces cerevisiae (50%)
FURTHER INFORMATION
–
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (50% insulin aspart in a soluble fraction and 50% insulin aspart crystallised with protamine) – The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
,
What NovoMix 50 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
100 U (3, 5 mg) 300 U.
1 pre-filled pen contains 3 ml equivalent to 300 U.
3 # FlexPen.
Now turn over for information on how to use your FlexPen.
3 # NovoMix
105 Introduction
50 FlexPen.
Please read the following instructions carefully before using your NovoMix 50 FlexPen.
NovoMix 50 FlexPen
NovoMix 50 FlexPen Pen cap
3 # NovoMix 50 FlexPen
Preparing your NovoMix 50 FlexPen
3 # FlexPen 0 & '&%
This makes it easier to resuspend.
FlexPen, #.
106 Pull off the pen cap.
-
If the moving procedure alone is not enough to give a uniformly white and cloudy liquid, repeat the rolling and moving procedures (see B and C) until the liquid does appear uniformly white and cloudy
FlexPen.
Screw the needle straight and tightly onto your FlexPen.
"1! +
107 D
/ (
E Pull off the big outer needle cap and keep it for later.
$
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108 Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
2
H
.
The dose selector returns to 0.
'"0
109 J
•
• Do not use the residual scale to measure your dose of insulin.
.
This will ensure that the full dose has been injected.
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When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
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Dispose of it carefully and put the pen cap back on.
120 '
110 M
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Otherwise, the liquid may leak out which can cause inaccurate dosing.
,
• Caregivers should be most careful when handling used needles to avoid needle sticks.
•
• Do not share your FlexPen with anyone else.
FlexPen
111 PACKAGE LEAFLET:
FlexPen
INFORMATION FOR THE USER
NovoMix 70 FlexPen 100 U/ ml
NovoMix 70 FlexPen 100 U/ ml suspension for injection in a pre-filled pen Insulin aspart
%! +
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
(Insulin aspart)
Do not pass it on to others.
0
What NovoMix 70 is and what it is used for 2.
NovoMix 70
Before you use NovoMix 70 3.
NovoMix 70
How to use NovoMix 70 4.
NovoMix 70 - + #
How to store NovoMix 70 7 Further information
NovoMix 70 e
NovoMix 70 is an insulin analogue to treat diabetes.
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2.
NovoMix 70
BEFORE YOU USE NOVOMIX 70
(70%)
Do not use NovoMix 70
"
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
(30%).) 14- 24
See 4 What to do in an emergency for more about hypos.
NOVOMIX 70
Take special care with NovoMix 70
"
Your need for insulin may change If you have an infection, fever or have had an operation you may need more insulin than usual
$/ NovoMix 70 "
Consult your doctor if you are planning such travelling.
0 $((0 & *, 0 (
Using other medicines
$) 5
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
0 NovoMix 70
Your need for insulin may change if you also take:
4
There is limited clinical experience with insulin aspart in pregnancy.
!
Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
"$/ NovoMix 70"
NovoMix 70 should not be used
4
In insulin infusion pumps If FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin 113 If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoMix 70) If the insulin is not uniformly white and cloudy when it’ s mixed If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
NovoMix 70) 4
NovoMix 70 is for injection under the skin (subcutaneously).
#
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a
-
If you don’ t treat it, this could lead to diabetic coma and death.
•
Causes of hyperglycaemia
+
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
! + #). '
Signs of allergy.
2.
Diabetic retinopathy.
NovoMix 70.
Ask your doctor about this.
# '!
Side effects reported rarely
70,
Do not use NovoMix 70 after the expiry date which is stated on the label and carton.
NovoMix 70 (2° (- 8° ()
NovoMix 70 FlexPen that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or to near the freezer section or cooling element.
FlexPen,! /,,.
Do not freeze.
NovoMix 70
NovoMix 70 FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoMix 70 FlexPen
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use.
. &
See overleaf.
"'FlexPen,
Getting Started.
NovoMix 70 FlexPen
NovoMix 70 FlexPen must be protected from excessive heat and sunlight.
NovoMix 70 $"'#
NovoMix 70 should not be disposed of via wastewater or household waste.
Saccharomyces cerevisiae (70%)
FURTHER INFORMATION
! "% 'NovoMix 70
What NovoMix 70 contains
!!
What NovoMix 70 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 1, 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
3 # NovoMix
116 Introduction
70 FlexPen.
Please read the following instructions carefully before using your NovoMix 70 FlexPen.
NovoMix 70 FlexPen
NovoMix 70 FlexPen Pen cap
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Pointer
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Dose
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Maintenance
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Your FlexPen is designed to work accurately and safely.
3 # NovoMix 70 FlexPen
Preparing your NovoMix 70 FlexPen
FlexPen, #.
117 Pull off the pen cap.
"1! +
118 D
,
119 Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
'"0
120 J
•
121 M
FlexPen
Otherwise, the liquid may leak out which can cause inaccurate dosing.
133
122
EMEA/ H/ C/ 187
EMEA/ H/ C/ 187
NOVONORM
NOVONORM
Предлага се под формата на кръгли таблетки (бели:
It is available as round tablets (white:
0, 5 mg; жълти:
0.5 mg; yellow:
1 mg; прасковен цвят:
1 mg; peach:
2 mg).
2 mg).
NovoNorm може да се използва в комбинация с метформин (друго лекарство) при пациенти с диабет тип 2, при пациенти с диабет тип 2, при
It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
които самостоятелното приложение на метформин не осигурява задоволителен контрол.
NovoNorm may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Кръвната глюкоза на пациента трябва да се изследва редовно от лекар, за да се установи най- ниската ефективна доза.
A doctor should regularly test the patient ’ s blood glucose to find the lowest effective dose.
Препоръчваната начална доза е 0, 5 mg.
The recommended starting dose is 0.5 mg.
NovoNorm не се препоръчва при деца под 18- годишна възраст поради липса на данни за неговата безопасност и ефективност в тази възрастова група.
NovoNorm is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Захарният диабет тип 2 е заболяване, при което панкреасът не произвежда достатъчно инсулин, за да се контролира нивото на кръвната глюкоза, или когато организмът е неспособен да
NovoNorm helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Reproduction is authorised provided the source is acknowledged. усвоява инсулина ефективно.
Reproduction is authorised provided the source is acknowledged.
NovoNorm помага на панкреаса да произвежда повече инсулин по време на хранене и се използва за контролиране на диабет тип 2.
The main studies compared NovoNorm with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
Общо 2156 пациенти приемат NovoNorm във всички изпитвания.
Another study looked at the effect of adding NovoNorm to metformin.
Друго проучване разглежда ефекта при добавяне на NovoNorm към метформин.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
В проучването, при което NovoNorm е добавен към метформин, ефектите на двете лекарства са най- малкото допълващи се (равни на ефектите на двете добавени лекарства, взети заедно).
In the study where NovoNorm was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Най- честите нежелани реакции при NovoNorm (наблюдавани при между 1 до 10 от 100 пациенти) са хипогликемия (ниски нива на кръвната захар), абдоминална (коремна) болка и диария).
The most common side effects with NovoNorm (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
Лекарството е противопоказно и при пациенти с диабет тип 1 (инсулинозависим), които нямат ‘ C- пептид ’ в кръвта си (маркер на диабет тип 1).
It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘ C-peptide ’ in their blood (a marker of type 1 diabetes).
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от NovoNorm са по- големи от рисковете при лечението на диабет тип 2.
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за NovoNorm на Novo Nordisk A/ S на 17 август 1998 г.
The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/ S on 17 August 1998.
NovoNorm 0, 5 mg таблетки
NovoNorm 0.5 mg tablets
Всяка таблетка съдържа 0, 5 mg репаглинид (repaglinide)
Each tablet contains 0.5 mg of repaglinide.
Репаглинид е показан при пациенти с диабет тип 2 (Неинсулинозависим Захарен Диабет (НИЗЗД), при които с диета, намаляване на теглото и физическа активност, хипергликемията вече не може да се контролира добре.
Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Репаглинид също е показан в комбинация с метформин при пациенти с диабет тип 2, при които самостоятелното приложение на метформин не осигурява задоволителен контрол.
Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Допълнително към обичайния самоконтрол на кръвната захар и/ или захарта в урината, извършвани от пациента, кръвната захар на пациента трябва да бъде мониторирана периодично от лекар, за да се определи минималната ефективна доза на пациента.
In addition to the usual self-monitoring by the patient of blood and/ or urinary glucose, the patient ’ s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Определянето на нивата на гликозилирания хемоглобин има значение при мониториране на отговора на пациента към лечението.
Glycosylated haemoglobin levels are also of value in monitoring the patient’ s response to therapy.
Периодично мониториране е необходимо за установяване на неадекватно понижаване на кръвната захар при максималната препоръчвана доза (т. н. първично изчерпване) и за установяване на отслабването на адекватен понижаващ кръвната захар отговор след начален период на ефективност (т. н. вторично изчерпване).
Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i. e. primary failure) and to detect loss of adequate blood glucose- lowering response after an initial period of effectiveness (i. e. secondary failure).
Репаглинид трябва да се приема преди основните хранения (т. е. препрандиално).
Repaglinide should be taken before main meals (i. e. preprandially).
Дозите обикновено се приемат 15 минути преди хранене, но времето може да варира от непосредствено преди до 30 минути преди хранене (т. е. препрандиално 2, 3 или 4 хранения дневно).
Doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal (i. e. preprandially 2, 3, or 4 meals a day).
В случай на едновременна употреба с други активни вещества, вижте точки 4. 4 и 4. 5, за да прецените дозирането.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess the dosage.
2 Начална доза Дозировката трябва да бъде определена от лекар, според нуждите на пациента.
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
Ако пациентите преминават от други перорални хипогликемизиращи средства, началната препоръчвана доза е 1 mg.
If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is
Поддържаща доза Максималната препоръчвана единична доза е 4 mg, приета с основните хранения.
Maintenance The recommended maximum single dose is 4 mg taken with main meals.
Специфични групи пациенти Репаглинид основно се екскретира чрез жлъчката и следователно екскрецията не се повлиява от бъбречни нарушения.
Specific patient groups Repaglinide is primarily excreted via the bile and excretion is therefore not affected by renal disorders.
(вж. точка 4. 4).
No clinical studies have been conducted in patients > 75 years of age or in patients with hepatic insufficiency (see section 4.4).
Репаглинид не се препоръчва за употреба при деца под 18- годишна възраст поради липса на данни за безопасност и/ или ефикасност.
Repaglinide is not recommended for use in children below age 18 due to a lack of data on safety and/ or efficacy.
Пациенти, получаващи други перорални хипогликемизиращи средства (ПХС) Пациентите могат да преминат директно на репаглинид от други перорални хипогликемизиращи средства.
Patients receiving other oral hypoglycaemic agents (OHAs) Patients can be transferred directly from other oral hypoglycaemic agents to repaglinide.
Въпреки това, не съществува точна връзка между дозите на репаглинид и другите перорални хипогликемизиращи средства.
However, no exact dosage relationship exists between repaglinide and the other oral hypoglycaemic agents.
Началната доза репаглинид е 0, 5 mg, приет преди основните хранения; определянето на дозата е в зависимост от отговора на кръвната захар както при монотерапия.
The starting dose of repaglinide is 0.5 mg, taken before main meals; titration is according to blood glucose response as for monotherapy.
• Свръхчувствителност към репаглинид или някое от помощните вещества в NovoNorm • Диабет тип 1 (Инсулинозависим Захарен Диабет:
• Hypersensitivity to repaglinide or to any of the excipients in NovoNorm • Type 1 diabetes (Insulin-Dependent Diabetes Mellitus:
ИЗЗД), С- пептид отрицателен • Диабетна кетоацидоза, с или без кома • Тежко чернодробно нарушение • Едновременна употреба с гемфиброзил (вж. точка 4. 5).
IDDM), C-peptide negative • Diabetic ketoacidosis, with or without coma • Severe hepatic function disorder • Concomitant use of gemfibrozil (see section 4.5).
Общи Репаглинид трябва да се предписва, само когато кръвната захар е лошо контролирана и симптомите на диабета персистират, независимо от адекватните опити с диета, физическа активност и понижаване на теглото.
General Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction.
3 Репаглинид, подобно на всички други инсулинови секретагози може да доведе до хипогликемия.
Repaglinide like other insulin secretagogues, is capable of producing hypoglycaemia.
Понижаващият кръвната захар ефект на пероралните хипогликемизиращи средства намалява при пациентите след продължителен прием.
The blood glucose-lowering effect of oral hypoglycaemic agents decreases in many patients over time.
Това може да се дължи на прогресиране на тежестта на заболяването или на понижения отговор към продукта.
This may be due to progression of the severity of the diabetes or to diminished responsiveness to the product.
Този феномен е известен като вторично изчерпване, за да се разграничи от първично изчерпване, където лекарството е неефективно при отделния пациент след първия прием.
This phenomenon is known as secondary failure, to distinguish it from primary failure, where the drug is ineffective in an individual patient when first given.
Репаглинид действа чрез специално свързващо място с краткотраен ефект върху β- клетките.
Repaglinide acts through a distinct binding site with a short action on the β -cells.
Няма проведени проучвания за комбиниране с инсулинови секретагози и акарбоза.
Trials investigating the combination with other insulin secretagogues and acarbose have not been
Проведени са проучвания за комбинирана терапия с Neutral Protamine Hagedorn (NPH) инсулин или тиазолидиндиони.
Trials of combination therapy with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones have been performed.
Когато пациент, стабилизиран с перорален хипогликемиращ продукт е изложен на стрес като повишена температура, травма, инфекция или хирургическа операция, може да се наруши контролът на кръвната захар.
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Употребата на репаглинид може да се свърже с повишена заболеваемост от остър коронарен синдром (напр. инфаркт на миокарда) (вж. точки 4. 8 и 5. 1).
The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e. g. myocardial infarction) (see sections 4.8 and 5.1).
Едновременна употреба Репаглинид трябва да се прилага с повишено внимание или да се избягва при пациенти, приемащи лекарства, които влияят върху метаболизма на репаглинид (вж. точка 4. 5).
Concomitant use Repaglinide should be used with caution or be avoided in patients receiving drugs which influence repaglinide metabolism (see section 4.5).
Специфични групи пациенти Няма проведени клинични проучвания при пациенти с увредена чернодробна функция.
Specific patient groups No clinical studies have been conducted in patients with impaired hepatic function.
Клинични проучвания не са провеждани при деца и юноши под 18- годишна възраст или при пациенти над 75- годишна възраст.
No clinical studies have been performed in children and adolescents < 18 years of age or in patients > 75 years of age.
Следователно не се препоръчва лечение при тези групи паценти.
Therefore, treatment is not recommended in these patient groups.
Препоръчително е внимателно титриране на дозата при изтощени или недохранени пациенти.
Careful dose titration is recommended in debilitated or malnourished patients.
Първоначалната и поддържащите дози трябва да бъдат умерени (вж. точка 4. 2).
The initial and maintenance dosages should be conservative (see section 4.2).
Известно е, че някои лекарствени продукти могат да повлияят върху метаболизма на репаглинид.
A number of drugs are known to influence repaglinide metabolism.
Специално
Consequently metabolism, and by that clearance of repaglinide, may be altered by drugs which influence these cytochrome P-450 enzymes via inhibition or induction.
4 внимание трябва да се обърне, когато едновременно се прилагат инхибитори на CYP2C8 и 3A4 с репаглинид.
Special care should be taken when both inhibitors of CYP2C8 and 3A4 are co- administered simultaneously with repaglinide.
Въз основа на in vitro данни репаглинид се проявява като субстрат на активно чернодробно захващане (органичен анион- пренасящ протеин OATP1B1).
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).