qanastek/EMEA-V3 huggingface dataset:
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 FlexPen 100 V/ ml Injekcin suspensija Insulinum aspartum s. c.
72 PACKAGE LEAFLET:
70 PAKUOT S LAPELIS:
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 V/ ml injekcin suspensija užtaise Insulinas aspartas (insulinum aspartum)
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Atidžiai perskaitykite vis š lapel, prieš prad dami vartoti vaist. – Neišmeskite šio lapelio, nes v l gali prireikti j perskaityti. – Jeigu kilt daugiau klausim, kreipkit s gydytoj, diabeto slaugytoj arba vaistinink. – Šis vaistas skirtas Jums, tod l kitiems žmon ms jo duoti negalima.
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
KAS YRA NOVOMIX 30 IR KAM JIS VARTOJAMAS
NovoMix 30 is an insulin analogue to treat diabetes.
NovoMix 30 yra insulino analogas, skirtas diabetui gydyti.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Jis yra 3 ml talpos užtaisuose, vadinamose Penfill, kurie dedami švirkštimo sistem.
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
NovoMix 30 yra greitai veikian io insulino analogo (30%) ir ilgai veikian io insulino analogo (70%) mišinys.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 24 hours.
Tai reiškia, kad jis pradeda mažinti J s cukraus kiek kraujyje per 10 - 20 minu i po injekcijos, maksimal efekt pasiekia 1 - 4 valand, ir poveikis t siasi iki 24 valand.
It may be used in combination with certain oral antidiabetic drugs.
NovoMix 30 gali b ti vartojamas kartu su tam tikrais geriamaisiais vaistais nuo diabeto.
BEFORE YOU USE NOVOMIX 30
KAS ŽINOTINA PRIEŠ VARTOJANT NOVOMIX 30
Do not use NovoMix 30
NovoMix 30 vartoti negalima
If you are allergic (hypersensitive) to this insulin product or any of the other ingredients (see 7 Further information).
7 skyri Kita informacija).
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).
5 skyriuje Galimas šalutinis poveikis; jei jau iate art jan i hipo (hipo yra hipoglikemijos trumpinys ir pasireiškia sumaž jusio cukraus kiekio kraujyje simptomais).
See 4 What to do in an emergency for more about hypos.
Daugiau apie hipoglikemij skaitykite 4 skyriuje K daryti nenumatytais atvejais.
Take special care with NovoMix 30
Speciali atsargumo priemoni vartojant NovoMix 30 reikia
If you have trouble with your kidneys or liver, your doctor may decide to alter your insulin dose If you are drinking alcohol (also beer, wine): watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin.
jei yra inkst ar kepen veiklos sutrikim, J s gydytojas gali nuspr sti pakeisti insulino doz; jei geriate alkohol (taip pat al, vyn), steb kite hipoglikemijos simptomus ir niekada negerkite alkoholio nevalg; jei sportuojate daugiau nei paprastai, ar norite pakeisti prast diet; jei sergate: nenutraukite insulino vartojimo.
Your need for insulin may change If you have an infection, fever or have had an operation you may need more insulin than usual If you suffer from diarrhoea, vomiting or eat less than usual you may need less insulin than usual If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
J s insulino poreikis gali keistis; jei karš iuojate, sergate infekcine liga ar buvote operuojamas, Jums gali reik ti daugiau insulino nei paprastai; jei viduriuojate, vemiate ar valgote mažiau nei esate prat s, Jums gali reik ti mažiau insulino nei paprastai; jei vykstate užsien: laiko juost pasikeitimas gali daryti tak J s insulino poreikiui ir švirkštimo laikui.
Consult your doctor if you are planning such travelling.
Prieš keliaudami, pasikonsultuokite su gydytoju.
Many medicines affect the way your glucose works in your body and this may influence your insulin dose.
Daugelis vaist turi takos gliukoz s veikimo mechanizmui J s organizme ir jie gali takoti J s insulino doz.
Listed below are the most common medicines which may affect your insulin treatment.
Žemiau pateikti svarbiausi vaistai, galintys paveikti J s gydym insulinu.
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jeigu vartojate ar neseniai vartojote kit vaist, skaitant sigytus be recepto, apie tai pasakykite savo gydytojui arba vaistininkui.
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, 73 angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
71 J s insulino poreikis gali keistis, jei vartojate: geriamuosius vaistus nuo diabeto, monoamino oksidaz s (MAO) inhibitorius, beta adrenoblokatorius, angiotenzin konvertuojan i ferment (AKF) inhibitorius, salicilatus, anabolinius steroidus ir gliukokortikoidus (išskyrus vietin vartojim), geriamuosius kontraceptikus, tiazidus, skydliauk s hormonus, simpatomimetikus, danazol, oktreotid ir sulfonamidus.
Pregnancy and breast-feeding If you are planning a pregnancy or if you are pregnant or breast-feeding: please contact your doctor for advice.
N štumas ir žindymo laikotarpis Jei planuojate n štum, esate n š ia ar žindote: susisiekite su gydytoju patarimo.
There is limited clinical experience with insulin aspart in pregnancy.
Turima ribota klinikin patirtis, vartojant insulin aspart n štumo metu.
Driving and using machines If you drive or use tools or machines: watch out for signs of a hypo.
Vairavimas ir mechanizm valdymas Jei vairuojate ar valdote mechanizmus: steb kite hipoglikemijos simptomus.
Your ability to concentrate or to react may be reduced during a hypo.
J s sugeb jimas susikoncentruoti ar reaguoti gali sumaž ti, esant hipoglikemijai.
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e. g. driving a car or operating machinery).
Atsiminkite apie tai visose situacijose, kuriose galite sukelti pavoj sau ar aplinkiniams (pvz., vairuodami automobil ar valdydami renginius).
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.
Aptarkite su gydytoju, ar J s iš viso galite vairuoti ar valdyti mechanizmus, jei dažnai pasireiškia hipoglikemijos epizod ar Jums sunku atpažinti hipoglikemijos simptomus.
For children 6-9 years limited clinical data exists.
Turima ribota klinikin patirtis, skiriant vaisto 6- 9 met vaikams.
HOW TO USE NOVOMIX 30
KAIP VARTOTI NOVOMIX 30
When NovoMix 30 is used in combination with oral antidiabetic drugs the dosage should be adjusted.
Jei NovoMix 30 yra vartojamas kartu su geriamaisiais vaistais nuo diabeto, doz s turi b ti perži r tos.
Eat a meal or snack containing carbohydrates within 10 minutes of the injection.
Pavalgykite ar užk skite angliavandeni turin io maisto per 10 min. po injekcijos.
NovoMix 30 may also be given soon after the meal.
NovoMix 30 taip pat gali b ti vartojamas iškart po valgio.
NovoMix 30 is for use by one person only.
NovoMix 30 skirtas vartoti tik vienam asmeniui.
Before using NovoMix 30
Prieš vartojant NovoMix 30
Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper).
Visada patikrinkite užtais, taip pat ir gumin st mokl.
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Nenaudokite, jei matomas koks nors pažeidimas ar jei matosi daugiau guminio st moklio nei balto br kšninio kodo juostos plotis.
Take it back to your supplier.
Gr žinkite užtais tiek jui.
See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination.
Kiekvienai injekcijai naudokite nauj adat, kad išvengtum te užteršimo.
NovoMix 30 should not be used
NovoMix 30 vartoti negalima
In insulin infusion pumps If the cartridge or the device containing the cartridge 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 30) 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.
6 skyri Kaip laikyti NovoMix 30); jei insulinas po sumaišymo n ra tolygiai baltas ir drumstas; jei yra koki nors medžiagos gabal li, arba jei vientisos baltos dalel s prilimpa prie užtaiso dugno ar sieneli ir suspensija atrodo apšalusi.
How to use this insulin
72 Kaip naudoti š insulin
NovoMix 30 is for injection under the skin (subcutaneously).
NovoMix 30 švirkš iamas po oda.
Never inject your insulin directly into a vein or muscle.
Niekada nešvirkškite insulino ven ar raumenis.
The best places to give
Nuolat keiskite injekcijos viet, kad išvengtum te gumb (žr. 5 skyri Galimas šalutinis poveikis).
74 yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Geriausios vietos sušvirkšti insulin pa iam yra priekin juosmens dalis (pilvas); s dmenys; šlaunies ar žasto išor.
Your insulin will work more quickly if you inject around the waist.
Insulinas prad s veikti grei iau, jei švirkšite pilvo srityje.
NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 30 Penfill užtaisai skirti naudoti su Novo Nordisk insulino švirkštimo sistemomis ir NovoFine adatomis.
If you are treated with NovoMix 30 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jei J s gydot s NovoMix 30 Penfill ir kitu insulinu Penfill užtaise, tuomet turite naudoti po vien insulino švirkštimo sistem kiekvienam insulino tipui.
Do not refill NovoMix 30 Penfill cartridges.
NovoMix 30 Penfill užtais nepildykite pakartotinai.
As a precautionary measure, always carry a spare Penfill cartridge in case your Penfill cartridge is lost or damaged.
Atsargumo d lei, su savimi nešiokit s kit Penfill užtais, jei J s Penfill b t pažeistas ar j pamestum te.
Resuspension of the insulin
Insulino sumaišymas
The first time you use NovoMix 30 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
A pav.).
Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
B pav.) 10 kart, kad stiklinis rutuliukas jud t iš vieno užtaiso galo kit.
Repeat the rolling and moving procedures (see pictures A and B until the liquid does appears uniformly white and cloudy.
A ir B pav.) turi b ti atliekamos tol, kol skystis taps tolygiai baltas ir drumstas.
Resuspension is easier when the insulin has reached room temperature.
Sumaišymas yra lengvesnis, kai insulino temperat ra atitinka kambario temperat r.
Complete the other stages of injection without delay For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy.
Nedelsdami vykdykite kitus injekcijos etapus. prieš kiekvien kit injekcij pavartykite insulino švirkštimo sistem su užtaisu viduje tarp a ir b pad i (žr.
Complete the other stages of injection without delay.
B pav.) bent 10 kart, kol skystis taps tolygiai baltas ir drumstas.
Pict ure A
A pav.
Picture B a
B pav. a
Check there are at least 12 units of insulin left in the cartridge to allow even resuspension.
Patikrinkite, ar užtaise yra lik bent 12 vienet insulino, kad gal tum te sumaišyti.
Inject the insulin under the skin.
Adat po oda laikykite mažiausiai 6 sekundes, kad sitikintum te, jog buvo suleista visa doz.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
73 Po kiekvienos injekcijos sitikinkite, kad nu m te ir išmet te adat, ir laikykite NovoMix be adatos.
If you get a hypo (hypoglycaemia)
Jei Jums pasireišk hipoglikemija
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Hipoglikemija reiškia per maž cukraus kiek kraujyje. sp jamieji hipoglikemijos simptomai gali pasireikšti staiga ir tai gali b ti: šaltas prakaitas; šalta, blyški oda; galvos skausmas; dažnas širdies plakimas; šleikštulio jausmas; alkio jausmas; laikini reg jimo poky iai; mieguistumas; ne prastas nuovargis ir silpnumas; nervingumas ar drebulys; neramumo, sumišimo jausmas; sunku susikaupti.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jei pasireišk bet kokie aukš iau min ti simptomai: išgerkite gliukoz s tablet ar suvalgykite daug cukraus turin io produkto (saldaini, sausaini, išgerkite vaisi sul i), po to pails kite.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case it is needed.
Atsargumo d lei, jei prireikt, su savimi visada nešiokit s gliukoz s table i, saldaini, sausaini ar vaisi sul i.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and get medical help straight away.
Papasakokite gimin ms, draugams ir artimiems kolegoms, kad jei J s apalpsite (neteksite s mon s), jie turi: paversti Jus ant šono ir nedelsiant kviesti medicinos pagalb.
They must not give you any food or drink, as it could choke you.
Jie turi neduoti Jums jokio maisto ar g rimo, nes galite uždusti.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Jei Jums kartojasi hipoglikemin s reakcijos ar pasireišk reakcija, kurios metu netekote s mon s, pasikalb kite su gydytoju.
The amount or timing of insulin, food or exercise may need to be adjusted.
Gali reik ti pakeisti J s vartojamo insulino doz ar laik, diet ar pratimus.
Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
Apsilankykite pas savo gydytoj ar ligonin s priimamajame skyriuje po gliukagono injekcijos: b tina nustatyti hipoglikemin s reakcijos priežast, kad išvengtum te kit reakcij.
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
Taip gali atsitikti: • jei vartojate per daug insulino; • jei per mažai valgote ar praleidžiate valg; • jei sportuojate daugiau nei paprastai.
If you get any of these signs, test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.
Jei pasireišk bet kokie aukš iau min ti simptomai: pasitikrinkite cukraus kiek kraujyje; jei galite, išsitirkite, ar n ra keton J s šlapime; po to nedelsdami kreipkit s gydytoj.
Causes of hyperglycaemia
74 Hiperglikemijos priežastys
• 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.
• pamiršote susišvirkšti insulino; • pakartotinai švirkš iate insulino mažiau, nei Jums reikia; • sergate infekcine liga ar karš iuojate; • valgote daugiau nei paprastai; • sportuojate mažiau nei paprastai.
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
NovoMix 30, kaip ir visi kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
The most common side effect is low blood sugar (hypoglycaemia).
Dažniausiai pasireišk s šalutinis poveikis yra sumaž j s cukraus kiekis kraujyje (hipoglikemija).
(less than 1 in 100)
(re iau nei 1 iš 100)
When you first start your insulin treatment, it may disturb your vision, but the condition usually disappears.
Pirm kart prad jus gydytis insulinu gali sutrikti J s reg jimas, bet ši b kl paprastai praeina.
Changes of the injection site (Lipodystrophy).
Poky iai injekcijos vietoje (lipodistrofija).
Changing the site with each injection may help to prevent such skin changes.
Nuo to galima apsisaugoti keisdami injekcijos viet.
Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions).
Kai kurios reakcijos (paraudimas, patinimas, niež jimas) gali pasireikšti injekcijos vietoje (vietin s alergin s reakcijos).
Seek medical advice immediately: • If signs of allergy spread to other parts of your body, or • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Nedelsdami kreipkit s gydytoj: • jei alergijos požymiai plinta kitas k no vietas, ar • staiga blogai pasijutote ir: prad jote prakaituoti; pajutote šleikštul (prasid jo v mimas); pasidar sunku kv puoti; prad jo dažnai plakti širdis; jau iat s apsvaig s.
You may have a very rare serious allergic reaction to NovoMix 30 or one of its ingredients (called a systemic allergic reaction).
Jums gali b ti reta, bet rimta alergin reakcija NovoMix 30 ar kuriai nors iš pagalbini medžiag (vadinamoji sistemin alergin reakcija).
See also the warning in 2 Before you use NovoMix 30.
Ži r kite sp jim 2 skyriuje Kas žinotina prieš vartojant NovoMix 30.
Diabetic retinopathy.
Diabetin retinopatija.
Normally, this soon disappears.
Paprastai šis poveikis netrukus praeina.
(less than 1 in 1,000)
(re iau nei 1 iš 1000)
Painful neuropathy.
Skausminga neuropatija.
If your blood glucose levels improve very fast, you may get nerve related pain – this is called acute painful neuropathy and is usually transient.
Jei gliukoz s kiekis kraujyje yra pagerinamas labai greitai, Jums gali pasireikšti nerv skausmas – tai vadinama mia, skausminga neuropatija, kuri paprastai yra trumpalaik.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
Jeigu pasireišk sunkus šalutinis poveikis arba pasteb jote šiame lapelyje nenurodyt šalutin poveik,
HOW TO STORE NOVOMIX 30
KAIP LAIKYTI NOVOMIX 30
Do not use NovoMix 30 after the expiry date which is stated on the label and carton.
Ant etiket s ir d žut s po „ Exp “ ir „ Tinka iki “ nurodytam tinkamumo laikui pasibaigus, NovoMix 30 vartoti negalima.
The expiry date refers to the last day of that month.
Vaistas tinka vartoti iki paskutin s nurodyto m nesio dienos.
NovoMix 30 Penfill that is not being used is to be stored in the refrigerator (2°C – 8°C), not in or too near the freezer section or cooling element.
Nenaudojamas NovoMix 30 Penfill turi b ti laikomas šaldytuve (2 °C – 8 °C temperat roje), toliau nuo šaldymo kameros ar šaldymo elemento.
NovoMix 30 Penfill that is being used or about to be used is not to be kept in the refrigerator.
Prad tas naudoti NovoMix 30 Penfill (arba jei j ketinama netrukus prad ti naudoti) neturi b ti laikomas šaldytuve.
After removing NovoMix 30 Penfill from the refrigerator it is recommended to mix the insulin as instructed 77 for the first time use.
Žr.
See 3 How to use NovoMix 30.
3 skyri Kaip vartoti NovoMix 30.
You can carry it with you and keep it at room temperature (not above 30°C) for up to 4 weeks, but any remainder must then be discarded.
J s galite nešiotis su savimi ir laikyti j kambario temperat roje (ne aukštesn je kaip 30 °C) iki 4 savai i, ta iau po to bet koks likutis turi b ti išmetamas.
Always keep the cartridge in the outer carton when you’ re not using it in order to protect it from light.
Visada, kai užtaiso nenaudojate, laikykite j išorin je d žut je, kad vaistinis preparatas b t apsaugotas nuo šviesos.
NovoMix 30 Penfill must be protected from excessive heat and sunlight.
NovoMix 30 Penfill turi b ti apsaugotas nuo didelio karš io ir saul s spinduli.
NovoMix 30 should not be disposed of via wastewater or household waste.
NovoMix 30 negalima išpilti kanalizacij arba išmesti su buitin mis atliekomis.
What NovoMix 30 contains
NovoMix 30 sud tis
– The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (30% insulin aspart in a soluble fraction and 70% 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.
Kitos pagalbin s medžiagos yra glicerolis, fenolis, metakrezolis, cinkas (chlorido pavidalu), – natrio chloridas, dinatrio fosfato dihidratas, protamino sulfatas, natrio hidroksidas, vandenilio chlorido r gštis ir injekcinis vanduo.
What NovoMix 30 looks like and contents of the pack The suspension for injection comes as a white suspension in packs of 5 or 10 cartridges of 3 ml (not all packs may be marketed).
NovoMix išvaizda ir kiekis pakuot je Injekcin suspensija yra balta suspensija, pakuojama po 5 ar 10 užtais, kuriuose yra po 3 ml insulino (gali b ti tiekiamos ne vis dydži pakuot s).
1 ml contains 100 U (3.5 mg) of insulin aspart.
1 ml yra 100 V (3, 5 mg) insulino asparto.
Marketing Authorisation Holder Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S, Novo Allé, DK- 2880 Bagsværd, Danija
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Gamintojas Gamintojas identifikuojamas pagal serijos numer, kuris atspausdintas ant d žut s ir etiket s:
– If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue d’ Orléans F-28002 Chartres, France is the manufacturer.
- Jei antras ir tre ias simboliai yra H7 ar T6, tuomet gamintojas yra Novo Nordisk Production
This leaflet was last approved in
SAS, 45 Avenue d’ Orléans F- 28002 Chartres, Pranc zija.
78 PACKAGE LEAFLET:
76 PAKUOT S LAPELIS:
NovoMix 50 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 V/ ml, injekcin suspensija užtaise Insulinas aspartas (insulinum aspartum)
WHAT NOVOMIX 50 IS AND WHAT IT IS USED FOR
KAS YRA NOVOMIX 50 IR KAM JIS VARTOJAMAS
NovoMix 50 is an insulin analogue to treat diabetes.
NovoMix 50 yra insulino analogas, skirtas diabetui gydyti.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Jis tiekiamas 3 ml talpos užtaisuose, vadinamuose Penfill, kurie dedami švirkštimo sistem.
NovoMix 50 is a mixture of rapid-acting insulin analogue (50%) and long-acting insulin analogue (50%).
NovoMix 50 yra greitai veikian io insulino analogo (50%) ir ilgai veikian io insulino analogo (50%) mišinys.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 14-24 hours.
Tai reiškia, kad jis pradeda mažinti j s cukraus kiek kraujyje per 10 - 20 minu i po injekcijos, maksimal efekt pasiekia tarp 1 ir 4 valandos ir poveikis t siasi iki 14 - 24 valand.
BEFORE YOU USE NOVOMIX 50
KAS ŽINOTINA PRIEŠ VARTOJANT NOVOMIX 50
Do not use NovoMix 50
NovoMix 50 vartoti negalima
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).
Daugiau apie hipoglikemij žr.
Take special care with NovoMix 50
Speciali atsargumo priemoni vartojant NovoMix 50 reikia
If you have trouble with your kidneys or liver, your doctor may decide to alter your insulin dose If you are drinking alcohol (also beer, wine): watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin.
jei yra inkst ar kepen veiklos sutrikim, J s gydytojas gali nuspr sti pakeisti insulino doz; jei geriate alkohol (taip pat al, vyn), steb kite, ar neatsiranda hipoglikemijos simptom ir niekada negerkite alkoholio nevalg; jei sportuojate daugiau nei paprastai ar norite pakeisti prast diet; jei sergate: nenutraukite insulino vartojimo.
Consult your doctor if you are planning such travelling.
Prieš keliaudami pasikonsultuokite su gydytoju.
Many medicines affect the way your glucose works in your body and this may influence your insulin dose.
Daugelis vaist turi takos gliukoz s veikimo mechanizmui J s organizme ir tai gali takoti J s insulino doz.
Listed below are the most common medicines which may affect your insulin treatment.
Žemiau pateikti dažniausiai vartojami vaistai, galintys paveikti J s gydym insulinu.
Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jeigu vartojate ar neseniai vartojote kit vaist, skaitant sigytus be recepto, pasakykite savo gydytojui arba vaistininkui.
Your need for insulin may change if you also take:
J s insulino poreikis gali keistis, jei vartojate:
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids 79 (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
77 geriamuosius vaistus nuo diabeto, monoamino oksidaz s (MAO) inhibitorius, beta adrenoblokatorius, angiotenzin konvertuojan i ferment (AKF) inhibitorius, salicilatus, anabolinius steroidus ir gliukokortikoidus (išskyrus vietin vartojim), geriamuosius kontraceptikus, tiazidus, skydliauk s hormonus, simpatomimetikus, danazol, oktreotid ir sulfonamidus.
Pregnancy and breast-feeding If you are planning a pregnancy or if you are pregnant or breast-feeding: please contact your doctor for advice.
N štumas ir žindymo laikotarpis Jei planuojate n štum, esate n š ia ar žindote: kreipkit s gydytoj patarimo.
Your ability to concentrate or to react may be reduced during a hypo.
Esant hipoglikemijai, J s sugeb jimas susikoncentruoti ar reaguoti gali sumaž ti.
There is no clinical experience in children and adolescents under the age of 18 years.
N ra klinikin s patirties, skiriant vaisto vaikams ir paaugliams iki 18 met amžiaus.
HOW TO USE NOVOMIX 50
KAIP VARTOTI NOVOMIX 50
Talk about your insulin needs with your doctor and diabetes nurse.
Aptarkite savo insulino poreik su gydytoju ar diabeto slaugytoju.
When NovoMix 50 is used in combination with metformin the dosage should be adjusted.
Jei NovoMix 50 yra vartojamas kartu su metforminu, doz s turi b ti perži r tos.
NovoMix 50 may also be given soon after the meal.
NovoMix 50 taip pat gali b ti vartojamas iškart po valgio.
It is recommended that you measure your blood glucose regularly.
Rekomenduojama reguliariai tikrinti gliukoz s kiek kraujyje.
NovoMix 50 is for use by one person only.
NovoMix 50 yra skirtas vartoti tik vienam asmeniui.
Before using NovoMix 50
Prieš vartojant NovoMix 50
Take it back to your supplier.
Gr žinkite užtais savo tiek jui.
NovoMix 50 should not be used
NovoMix 50 vartoti negalima
In insulin infusion pumps If the cartridge or the device containing the cartridge 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 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.
6 skyri Kaip laikyti NovoMix 50); jei insulin sumaišius jis n ra tolygiai baltas ir drumstas; jei yra koki nors medžiagos gabal li arba jei prie užtaiso dugno ar sieneli yra prilipusi vientis balt daleli ir suspensija atrodo apšalusi.
How to use this insulin
Kaip naudoti š insulin
NovoMix 50 is for injection under the skin (subcutaneously).
NovoMix 50 švirkš iamas po oda.
The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
78 Geriausios vietos sušvirkšti insulin pa iam yra priekin juosmens dalis (pilvas); s dmenys; šlaunies ar žasto išor.
80 NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 50 Penfill užtaisai skirti naudoti su Novo Nordisk insulino švirkštimo sistemomis ir NovoFine adatomis.
If you are treated with NovoMix 50 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jei J s gydot s NovoMix 50 Penfill ir kitu insulinu Penfill užtaise, tuomet turite naudoti po vien insulino švirkštimo sistem kiekvienam insulino tipui.
Do not refill NovoMix 50 Penfill cartridges.
NovoMix 50 Penfill užtais nepildykite pakartotinai.
The first time you use NovoMix 50 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
A pav.).
Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white and cloudy.
A ir B pav.), kol skystis taps tolygiai baltas ir drumstas.
Resuspension is easier when the insulin has reached room temperature.
Sumaišyti yra lengviau, kai insulinas yra kambario temperat ros.
Complete the other stages of injection without delay For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy.
Nedelsdami vykdykite kitus injekcijos etapus. prieš kiekvien kit injekcij pavartykite insulino švirkštimo sistem su užtaisu viduje aukštyn - žemyn tarp a ir b pad i (ži r kite B pav.) mažiausiai 10 kart, kol skystis taps tolygiai baltas ir drumstas.
If the moving procedure alone is not enough to give a uniformly white and cloudy liquid, repeat the rolling and moving procedures described above until the liquid does appear uniformly white and cloudy.
Jei vartymo nepakanka, kad susidaryt tolygiai baltas ir drumstas skystis, pakartokite prieš tai aprašyt ritinimo ir vartymo proced r, kol skystis taps tolygiai baltas ir drumstas.
Complete the other stages of injection without delay.
Nedelsdami atlikite kitus injekcijos etapus.
Inject the insulin under the skin.
Švirkškite insulin po oda.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
Po kiekvienos injekcijos sitikinkite, kad nu m te ir išmet te adat, ir laikykite NovoMix be adatos.
81 4.
79 4.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Hipoglikemija reiškia, kad cukraus kiekis kraujyje yra per mažas. sp jamieji hipoglikemijos simptomai gali pasireikšti staiga ir tai gali b ti: šaltas prakaitas; šalta, blyški oda; galvos skausmas; dažnas širdies plakimas; šleikštulio jausmas; alkio jausmas; laikini reg jimo poky iai; mieguistumas; ne prastas nuovargis ir silpnumas; nervingumas ar drebulys; neramumo, sumišimo jausmas; sunku susikaupti.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jei pasireišk bet kurie iš min t simptom, suvalgykite gliukoz s table i ar daug cukraus turin io produkto (saldaini, sausaini, išgerkite vaisi sul i), po to pails kite.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case it is needed.
D l atsargumo, jei prireikt, visada nešiokit s gliukoz s table i, saldaini, sausaini ar vaisi sul i.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and get medical help straight away.
Pasakykite gimin ms, draugams ir artimiems kolegoms, kad jei J s apalpsite (neteksite s mon s), jie turi paversti Jus ant šono ir nedelsdami kviesti medicinos pagalb.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Jei Jums pasireišk hipoglikemija, kurios metu netekote s mon s, arba Jums kartojasi hipoglikemin s reakcijos, pasitarkite su gydytoju.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
S mon gal tum te atgauti grei iau, jei mokantis injekuoti asmuo Jums sušvirkšt hormono gliukagono.
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Kai tik atgausite s mon po gliukagono injekcijos, iš karto turite suvalgyti daug cukraus turin io produkto ar išgerti gliukoz s.
Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
Po gliukagono injekcijos apsilankykite pas savo gydytoj ar ligonin s priimamajame skyriuje: b tina nustatyti hipoglikemin s reakcijos priežast, kad išvengtum te kit reakcij.
You get a hypo if your blood sugar gets too low.
Jums pasireiškia hipoglikemija, jei cukraus kiekis kraujyje pasidaro per mažas.
The warning signs appear gradually.
J s cukraus kiekis kraujyje gali pasidaryti per didelis (tokia b kl vadinama hiperglikemija). sp jamieji simptomai pasireiškia palaipsniui.
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 fruity (acetone) smell of the breath.
Tai gali b ti: padažn j s šlapinimasis; troškulys; apetito praradimas; šleikštulio poj tis (pykinimas ar v mimas); mieguistumas ir nuovargis; rausva, sausa oda; sausa burna ir vaisi (acetono) kvapas iš burnos.
If you get any of these signs, test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.
Jei pasireišk bet kurie iš min t simptom: pasitikrinkite cukraus kiek kraujyje; jei galite, išsitirkite, ar n ra keton J s šlapime; po to nedelsdami kreipkit s gydytoj.
• 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.
• pamiršote susišvirkšti insulino; • pakartotinai švirkš iate insulino mažiau, nei jums reikia; • sergate infekcine liga ar karš iuojate;
Like all medicines, NovoMix 50 can cause side effects, although not everybody gets them.
NovoMix 50, kaip ir visi kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
The most common side effect is low blood sugar (hypoglycaemia).
Dažniausias pasireišk s šalutinis poveikis yra sumaž j s cukraus kiekis kraujyje (hipoglikemija).
When you first start your insulin treatment, it may disturb your vision, but the condition usually disappears.
Pirm kart prad jus gydytis insulinu, gali sutrikti J s reg jimas, bet ši b kl paprastai praeina.
Changing the site with each injection may help to prevent such skin changes.
Nuo to galite apsisaugoti keisdami injekcijos viet.
If they do not disappear, see your doctor.
Jei jie neišnyksta, kreipkit s gydytoj.
Seek medical advice immediately: • If signs of allergy spread to other parts of your body, or • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Nedelsdami kreipkit s gydytoj: • jei alergijos požymiai plinta kitas k no vietas, ar • jei staiga blogai pasijutote ir: prad jote prakaituoti; pajutote šleikštul (prasid jo v mimas); pasidar sunku kv puoti; prad jo dažnai plakti širdis; jau iat s apsvaig s.
You may have a very rare serious allergic reaction to NovoMix 50 or one of its ingredients (called a systemic allergic reaction).
Jums gali b ti reta, bet rimta alergin reakcija NovoMix 50 ar kuriai nors iš pagalbini medžiag (vadinamoji sistemin alergin reakcija).
See also the warning in 2 Before you use NovoMix 50.
Ži r kite sp jim 2 skyriuje Kas žinotina prieš vartojant NovoMix 50.
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Jei jums yra diabetin retinopatija, ir gliukoz s kiekis kraujyje yra pagerinamas labai greitai, retinopatija gali pablog ti.
Ask your doctor about this.
Apie tai klauskite savo gydytojo.
HOW TO STORE NOVOMIX 50
KAIP LAIKYTI NOVOMIX 50
Do not use NovoMix 50 after the expiry date which is stated on the label and carton.
Ant etiket s ir d žut s po „ Exp “ ir „ Tinka iki “ nurodytam tinkamumo laikui pasibaigus, NovoMix 50 vartoti negalima.
NovoMix 50 Penfill 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.
Nenaudojamas NovoMix 50 Penfill turi b ti laikomas šaldytuve (2 °C – 8 °C temperat roje), toliau nuo šaldymo kameros arba šaldymo elemento.
NovoMix 50 Penfill that is being used or about to be used is not to be kept in the refrigerator.
Prad tas naudoti NovoMix 50 Penfill (arba jei j ketinama netrukus prad ti naudoti) neturi b ti laikomas šaldytuve.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to mix the insulin as instructed 83 for the first time use.
Žr.
See 3 How to use NovoMix 50.
3 skyri Kaip vartoti NovoMix 50.
You can carry it with you and keep it at room temperature (not above 30ºC) for up to 4 weeks, but any remainder must then be discarded.
J s galite nešiotis ir laikyti j kambario temperat roje (ne aukštesn je kaip 30 °C) iki 4 savai i, ta iau bet koks likutis po to turi b ti išmetamas.
NovoMix 50 Penfill must be protected from excessive heat and sunlight.
NovoMix 50 Penfill turi b ti apsaugoti nuo karš io ir saul s spinduli.
NovoMix 50 should not be disposed of via wastewater or household waste.
NovoMix 50 negalima išpilti kanalizacij arba išmesti su buitin mis atliekomis.
What NovoMix 50 contains
NovoMix 50 sud tis
– 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.
Kitos pagalbin s medžiagos yra glicerolis, fenolis, metakrezolis, cinkas (chlorido pavidalu), – natrio chloridas, dinatrio fosfato dihidratas, protamino sulfatas, natrio hidroksidas, vandenilio chlorido r gštis ir injekcinis vanduo.
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 cartridges of 3 ml (not all packs may be marketed).
NovoMix 50 išvaizda ir kiekis pakuot je Injekcin suspensija yra balta suspensija, pakuojama po 1, 5 ar 10 užtais, kuriuose yra po 3 ml insulino (gali b ti tiekiamos ne vis dydži pakuot s).
Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S, Novo Allé, DK- 2880 Bagsværd, Danija
This leaflet was last approved in
Informacinis lapelis paskutin kart patvirtintas
84 PACKAGE LEAFLET:
82 PAKUOT S LAPELIS:
NovoMix 70 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 V/ ml injekcin suspensija užtaise Insulinas aspartas (insulinum aspartum)
WHAT NOVOMIX 70 IS AND WHAT IT IS USED FOR
KAS YRA NOVOMIX 70 IR KAM JIS VARTOJAMAS
NovoMix 70 is an insulin analogue to treat diabetes.
NovoMix 70 yra insulino analogas, skirtas diabetui gydyti.
NovoMix 70 is a mixture of rapid-acting insulin analogue (70%) and long-acting insulin analogue (30%).
NovoMix 70 yra greitai veikian io insulino analogo (70%) ir ilgai veikian io insulino analogo (30%) mišinys.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 14-24 hours.
Tai reiškia, kad jis pradeda mažinti J s cukraus kiek kraujyje per 10 - 20 minu i po injekcijos, maksimal efekt pasiekia tarp 1 ir 4 valandos ir poveikis t siasi iki 14 - 24 valand.
BEFORE YOU USE NOVOMIX 70
KAS ŽINOTINA PRIEŠ VARTOJANT NOVOMIX 70
Do not use NovoMix 70
NovoMix 70 vartoti negalima
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).
Apie alergijos simptomus skaitykite 5 skyriuje Galimas šalutinis poveikis; jei jau iate art jan i hipo (hipo yra hipoglikemijos trumpinys ir pasireiškia sumaž jusio cukraus kiekio kraujyje simptomais).
Take special care with NovoMix 70
Speciali atsargumo priemoni vartojant NovoMix 70 reikia
Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids 85 (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, danazol, octreotide and sulphonamides.
83 geriamuosius hipoglikeminius vaistus, monoamino oksidaz s (MAO) inhibitorius, beta adrenoblokatorius, angiotenzin konvertuojan i ferment (AKF) inhibitorius, salicilatus, anabolinius steroidus ir gliukokortikoidus (išskyrus vietin vartojim), geriamuosius kontraceptikus, tiazidus, skydliauk s hormonus, simpatomimetikus, danazol, oktreotid ir sulfonamidus.
HOW TO USE NOVOMIX 70
KAIP VARTOTI NOVOMIX 70
When NovoMix 70 is used in combination with metformin the dosage should be adjusted.
Jei NovoMix 70 yra vartojamas kartu su metforminu, doz s turi b ti perži r tos.
NovoMix 70 may also be given soon after the meal.
NovoMix 70 taip pat gali b ti vartojamas iškart po valgio.
NovoMix 70 is for use by one person only.
NovoMix 70 yra skirtas vartoti tik vienam asmeniui.
Before using NovoMix 70
Prieš vartojant NovoMix 70
NovoMix 70 should not be used
NovoMix 70 vartoti negalima
In insulin infusion pumps If the cartridge or the device containing the cartridge 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 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.
6 skyri Kaip lailyti NovoMix 70); jei insulinas po sumaišymo n ra tolygiai baltas ir drumstas; jei yra koki nors medžiagos gabal li arba jei prie užtaiso dugno ar sieneli yra prilipusi vientis balt daleli ir suspensija atrodo apšalusi.
NovoMix 70 is for injection under the skin (subcutaneously).
NovoMix 70 švirkš iamas po oda.
The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
84 Geriausios vietos sušvirkšti insulin pa iam yra priekin juosmens dalis (pilvas); s dmenys; šlaunies ar žasto išor.
86 NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
NovoMix 70 Penfill užtaisai skirti naudoti su Novo Nordisk insulino švirkštimo sistemomis ir NovoFine adatomis.
If you are treated with NovoMix 70 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin.
Jei J s gydot s NovoMix 70 Penfill ir kitu insulinu Penfill užtaise, tuomet turite naudoti po vien insulino švirkštimo sistem kiekvienam insulino tipui.
Do not refill NovoMix 70 Penfill cartridges.
NovoMix 70 Penfill užtais nepildykite pakartotinai.
The first time you use NovoMix 70 Penfill roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (see picture A).
A pav.).
Complete the other stages of injection without delay For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy.
Nedelsdami atlikite kitus injekcijos etapus. prieš kiekvien kit injekcij pavartykite insulino švirkštimo sistem su užtaisu viduje aukštyn - žemyn tarp a ir b pad i (ži r kite B pav.) mažiausiai 10 kart, kol skystis taps tolygiai baltas ir drumstas.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store NovoMix without the needle attached.
Po kiekvienos injekcijos sitikinkite, kad nu m te ir išmet te adat, ir laikykite NovoMix be
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case it is needed.
D l atsargumo, jei prireikt, su savimi visada nešiokit s gliukoz s table i, saldaini, sausaini ar vaisi sul i.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Jei jums pasireišk hipoglikemija, kurios metu netekote s mon s, arba Jums kartojasi hipoglikemin s reakcijos, pasitarkite su gydytoju.
• 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.
86 • pakartotinai švirkš iate insulino mažiau, nei Jums reikia; • sergate infekcine liga ar karš iuojate; • valgote daugiau nei paprastai; • sportuojate mažiau nei paprastai.
Like all medicines, NovoMix 70 can cause side effects, although not everybody gets them.
NovoMix 70, kaip ir visi kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
The most common side effect is low blood sugar (hypoglycaemia).
Dažniausias šalutinis poveikis yra sumaž j s cukraus kiekis kraujyje (hipoglikemija).
Changing the site with each injection may help to prevent such skin changes.
Nuo to apsisaugosite keisdami injekcijos viet.
You may have a very rare serious allergic reaction to NovoMix 70 or one of its ingredients (called a systemic allergic reaction).
Jums gali b ti reta, bet rimta alergin reakcija NovoMix 70 ar kuriai nors iš pagalbini medžiag (vadinamoji sistemin alergin reakcija).
See also the warning in 2 Before you use NovoMix 70.
Ži r kite sp jim 2 skyriuje Kas žinotina prieš vartojant NovoMix 70.
HOW TO STORE NOVOMIX 70
KAIP LAIKYTI NOVOMIX 70
Do not use NovoMix 70 after the expiry date which is stated on the label and carton.
Ant etiket s ir d žut s po „ Exp “ ir „ Tinka iki “ nurodytam tinkamumo laikui pasibaigus, NovoMix 70 vartoti negalima.
NovoMix 70 Penfill 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.
Nenaudojamas NovoMix 70 Penfill turi b ti laikomas šaldytuve (2 °C – 8 °C temperat roje), toliau nuo šaldymo kameros ar šaldymo elemento.
NovoMix 70 Penfill that is being used or about to be used is not to be kept in the refrigerator.
Prad tas naudoti NovoMix 70 Penfill (arba jei j ketinama netrukus prad ti naudoti) neturi b ti laikomas šaldytuve.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to mix the insulin as instructed 89 for the first time use.
Žr.
See 3 How to use NovoMix 70.
3 skyri Kaip vartoti NovoMix 70.
You can carry it with you and keep it at room temperature (not above 30ºC) for up to 4 weeks, but any remainder must then be discarded.
J s galite nešiotis su savimi ir laikyti j kambario temperat roje (ne aukštesn je kaip 30 °C) iki 4 savai i, ta iau po to bet koks likutis turi b ti išmetamas.