qanastek/EMEA-V3 huggingface dataset:
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Tod l gydytojas tur t atsižvelgti galimas s veikas ir visada privalo paklausti savo pacient apie bet kokius j vartojamus vaistus.
The following substances may reduce insulin requirement:
Šios medžiagos gali sumažinti insulino poreik:
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Geriamieji vaistai nuo diabeto, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta- blokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
The following substances may increase insulin requirement:
Šios medžiagos gali padidinti insulino poreik:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Geriamieji kontraceptikai, tiazidai, gliukokortikoidai, skydliauk s hormonai ir beta- simpatomimetikai, augimo hormonas ir danazolis.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Beta- blokatoriai gali maskuoti hipoglikemijos simptomus ir prailginti išgijim po hipoglikemijos.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
Oktreotidas/ lanreotidas gali ir padidinti, ir sumažinti insulino poreik.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
Alkoholis gali sustiprinti ir prailginti gliukoz s kiek kraujyje mažinant insulino poveik.
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
N ra joki diabeto gydymo insulinu n štumo metu apribojim, nes insulinas nepraeina pro placent.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Ir hipoglikemija, ir hiperglikemija, kurios atsiranda d l nepakankamos diabeto kontrol s, padidina išsigimim ir embrion mirties rizik.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
Rekomenduojama intensyvi n š i j, sergan i diabetu, gydymo kontrol n štumo ir n štumo planavimo metu.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Insulino poreikis paprastai sumaž ja pirm j n štumo trimestr ir v liau padid ja antr j ir tre i j trimestr.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
Po gimdymo insulino poreikis greitai tampa toks, koks buvo iki n štumo.
Insulin treatment of the nursing mother presents no risk to the baby.
Kr timi maitinan i motin gydymas insulinu nekelia jokios rizikos vaikui.
However, the Insulatard dosage may need to be adjusted.
Ta iau Insulatard doz gali reik ti koreguoti.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Pacient sugeb jimas susikoncentruoti ir reaguoti gali sumaž ti d l hipoglikemijos.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Tai gali b ti rizikinga situacijose, kai šie sugeb jimai ypa svarb s (pvz., vairuojant automobil ar valdant mechanizmus).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Pacientui reik t patarti imtis atsargumo priemoni siekiant išvengti hipoglikemijos vairuojant.
4 hypoglycaemia or have frequent episodes of hypoglycaemia.
Tai ypa svarbu tiems, kuriems persp jamieji hipoglikemijos simptomai susilpn j, j visai n ra arba dažnai pasireiškia hipoglikemija.
The advisability of driving should be considered in these circumstances.
Esant šioms aplinkyb ms reik t apsvarstyti galimyb vairuoti.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
4 Kaip ir vartojant kitus insulino preparatus, paprastai, hipoglikemija yra dažniausiai pasireiškiantis nepageidaujamas poveikis.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Taip gali atsitikti, jei insulino doz yra per didel, lyginant su insulino poreikiu.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Klinikini tyrim metu ir pateikus vaist rink, hipoglikemijos dažnumas kinta, priklausomai nuo sergan i j kiekio tarp gyventoj ir doz s režimo.
Therefore, no specific frequency can be presented.
Ta iau jokio specifinio dažnumo negali b ti pateikiama.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Sunki hipoglikemija gali sukelti s mon s praradim ir / ar m šlung, taip pat laikin ar nuolatin smegen pažeidim ar net mirt.
Frequencies of adverse drug reactions from clinical trials that are considered related to Insulatard are listed below.
Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su Insulatard vartojimu, pateikiamas žemiau.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Dažnis apib dinamas kaip: nedažni (1/ 1 000, iki < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip < 1/ 10 000, skaitant ir pavienius pranešimus.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kiekvienoje dažnio grup je nepageidaujamas poveikis pateikiamas maž jan io sunkumo tvarka.
Nervous system disorders Very rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Greitas gliukoz s kiekio kraujyje pagerinimas gali b ti susij s su tam tikra b kle, vadinama „ mi skausminga neuropatija “, kuri paprastai yra gr žtama.
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Refrakcijos sutrikim gali atsirasti gydymo insulinu pradžioje.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Ilg laik gerinant glikemijos kontrol, sumaž ja diabetin s retinopatijos progresavimo rizika.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Ta iau, insulino terapijos sustiprinimas, siekiant staigaus glikemijos kontrol s pagerinimo, gali b ti susij s su laikinu diabetin s retinopatijos blog jimu.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Lipodistrofija gali pasireikšti injekcijos plote kaip injekcijos vietos nekeitimo pasekm.
Most reactions are transitory and disappear during continued treatment.
Reakcijos injekcijos vietoje (paraudimas, patinimas, niež jimas, skausmas ir hematoma injekcijos vietoje) gali pasireikšti gydymo insulinu metu, Dauguma ši reakcij yra praeinan ios savaime ir paprastai išnyksta t siant gydym.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
Generalised hypersensitivity reactions are potentially life- threatening.
Generalizuotos padid jusio jautrumo reakcijos yra pavojingos gyvybei.
5 A specific overdose of insulin cannot be defined.
Nenustatyta joki specifini insulino perdozavimo simptom.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Ta iau gali b ti šios hipoglikemijos stadijos: • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
5 kelet cukraus gabal li, saldaini, sausaini ar saldži vaisi sul i. • Stipr s hipoglikemijos epizodai, kai pacientas netenka s mon s, gali b ti gydomi gliukagono (0, 5 - 1 mg) injekcija raumenis ar po oda (jo sušvirkšti gali apmokytas asmuo), arba gliukoze, kurios ven turi sušvirkšti gydytojas.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Taip pat ven gliukoz s turi b ti švirkš iama tada, kai gliukagonas per 10 - 15 minu i nepadeda.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Pacientui atgavus s mon, rekomenduojama duoti geriam j angliavandeni siekiant išvengti priepuolio pasikartojimo.
A10A C01.
Farmakoterapin grup – injekciniai insulinai ir analogai, vidutinio veikimo, insulinas (žmogaus), ATC kodas - A10A C01.
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Gliukoz s kiek kraujyje mažinantis insulino poveikis pasireiškia tod l, kad insulinas, prisijungdamas prie receptori raumenyse ir riebal l stel se, gerina gliukoz s sisavinim ir tuo pa iu metu slopina gliukoz s išsiskyrim iš kepen.
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
Poveikis pasireiškia per 1½ valandos po injekcijos, maksimal efekt pasiekia 4 - 12 valand ir veikimo trukm yra apie 24 valandas.
Insulin in the blood stream has a half-life of a few minutes.
Insulino pusin s eliminacijos periodas kraujyje yra tik kelios minut s.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Taigi insulino preparato veikimo laik ir poveik lemia tik jo absorbcija.
This process is influenced by several factors (e. g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Šis procesas priklauso nuo daugelio veiksni (pvz., insulino doz s, injekcijos b do ir vietos, poodinio audinio riebal kiekio, diabeto tipo).
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Tod l insulino preparat farmakokinetika gali reikšmingai skirtis tam pa iam žmogui bei tarp individ.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Absorbcija Maksimali insulino koncentracija plazmoje pasiekiama per 2 - 18 valand po injekcijos po oda.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Pasiskirstymas Jokio aiškaus prisijungimo prie plazmos protein, išskyrus cirkuliuojan ius antik nus insulinui (jei j yra), nebuvo pasteb ta.
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Nustatyta keletas žmogaus insulino molekul s skilimo (hidroliz s) viet; po skilimo nei viena iš metabolitini form n ra aktyvi.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of
Tod l pusin s eliminacijos periodas (t½) grei iau yra absorbcijos, o ne insulino eliminacijos per se iš plazmos, matas (insulino pusin s eliminacijos periodas t½ kraujyje yra tik kelios minut s).
Trials have indicated a t½ of about 5-10 hours.
Tyrimai parod, kad t½ yra apie 5 - 10 valand.
5.3 Preclinical safety data
5. 3 Ikiklinikini saugumo tyrim duomenys
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
6.1 List of excipients
6. 1 Pagalbini medžiag s rašas
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
Cinko chloridas Glicerolis Metakrezolis Fenolis Dinatrio vandenilio fosfato dihidratas Natrio hidroksidas (pH sureguliavimui) Vandenilio chlorido r gštis (pH sureguliavimui) Protamino sulfatas Injekcinis vanduo
Insulin products should only be added to compounds with which it is known to be compatible.
Insulino preparatai turi b ti maišomi tik su tais komponenais, kurie ne takoja vaisto veikimo.
30 months when stored between 2°C - 8°C.
30 m nesi, kai laikoma 2 °C – 8 °C temperat roje.
4 weeks when used or stored at room temperature (below 25°C).
4 savaites, atidarius arba laikant kambario temperat roje (žemesn je kaip 25 °C).
6.4 Special precautions for storage
6. 4 Specialios laikymo s lygos
Before use: store in a refrigerator (2°C - 8°C).
Prieš atidarym laikyti šaldytuve (2 °C - 8 °C temperat roje).
Do not store above 25°C.
Negalima laikyti aukštesn je kaip 25 °C temperat roje.
Keep the vial in the outer carton in order to protect from light.
Laikyti buteliuk išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
Protect from excessive heat and sunlight.
Saugoti nuo didelio karš io ir saul s spinduli.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
10 ml stiklinis buteliukas (1 tipo), uždarytas bromobutilo/ poliizopreno gumos kamš iu ir apsauginiu plastiko dangteliu.
Pack sizes:
Pakuot s dydis:
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 ir 5 buteliukai po 10 ml ir didel pakuot, kurioje yra 5 x (1 x 10 ml) buteliukai.
Not all pack sizes may be marketed.
Gali b ti tiekiamos ne vis dydži pakuot s.
6.6 Special precautions for disposal and other handling
6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
Insulin preparations which have been frozen must not be used.
Insulino preparat, kurie buvo užšaldyti, vartoti negalima.
7 After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Iš mus Insulatard buteliuk iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti buteliuk kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Any unused product or waste material should be disposed of in accordance with local requirements.
Nesuvartot preparat ar atliekas reikia tvarkyti laikantis vietini reikalavim.
Date of first authorisation:
Rinkodaros teis s suteikimo data:
07 October 2002
2002 m. spalio m n.
Date of latest renewal:
Rinkodaros teis s atnaujinimo data:
18 September 2007
2007 m. rugs jo m n.
DATE OF REVISION OF THE TEXT
TEKSTO PERŽI ROS DATA
Insulatard 100 IU/ ml suspension for injection in a vial.
Insulatard 100 TV/ ml injekcin suspensija buteliuke.
1 ml contains 100 IU of insulin human.
1 ml yra 100 TVžmogaus insulino.
9 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4 skyriuje).
The vials are for use with insulin syringes with a corresponding unit scale.
Buteliukai skirti naudoti kartu su švirkštais, turin iais vienetus atitinkan i skal.
10 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
10 Keletas pacient, kuriems pasireišk hipoglikemija, pakeitus gyvulin insulin, praneš, kad ankstyvieji sp jamieji hipoglikemijos požymiai buvo silpnesni ar kitokie, negu vartojant ankstesnio insulino.
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.
Prieš keliaudami pacientai tur t pasitarti su savo gydytoju, nes laiko tarp šali skirtumai gali reikšti, kad pacientai turi vartoti insulino ir valgyti kitu laiku nei paprastai.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Geriamieji vaistai nuo diabeto, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta - blokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
11 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Pacientui reik t patarti imtis atsargumo priemoni siekiant išvengti hipoglikemijos vairuojant.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Tai ypa svarbu tiems, kuriems persp jamieji hipoglikemijos simptomai susilpn j, j visai n ra arba dažnai pasireiškia hipoglikemija.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
11 Kaip ir vartojant kitus insulino preparatus, paprastai, hipoglikemija yra dažniausiai pasireiškiantis nepageidaujamas poveikis.
A specific overdose of insulin cannot be defined.
Nenustatyta joki specifini insulino perdozavimo simptom.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
12 • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Tod l rekomenduojama, kad cukriniu diabetu sergantys pacientai nešiot si kelet cukraus gabal li, saldaini, sausaini ar saldži vaisi sul i. • Stipr s hipoglikemijos epizodai, kai pacientas netenka s mon s, gali b ti gydomi gliukagono (0, 5 - 1 mg) injekcija raumenis ar po oda (jo sušvirkšti gali apmokytas asmuo), arba gliukoze, kurios ven turi sušvirkšti gydytojas.
A10A C01.
Farmakoterapin grup - injekciniai insulinai ir analogai, vidutinio veikimo, insulinas (žmogaus), ATC kodas - A10A C01.
13 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
The 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).
Tod l pusin s eliminacijos periodas (t½) grei iau yra absorbcijos, o ne insulino eliminacijos per se iš plazmos, matas (insulino pusin s eliminacijos periodas t½ kraujyje yra tik kelios minut s).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
13 prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
Insulin products should only be added to compounds with which it is known to be compatible.
Insulino preparatai turi b ti maišomi tik su tais komponentais, kurie ne takoja vaisto veikimo.
6 weeks when used or stored at room temperature (below 25°C).
6 savaites, atidarius arba laikant kambario temperat roje (žemesn je kaip 25 °C).
Before use: store in a refrigerator (2°C - 8°C).
Prieš atidarym laikyti šaldytuve (2 °C – 8 °C temperat roje).
Do not store above 25°C.
Laikyti ne aukštesn je kaip 25 °C temperat roje.
14 Insulin preparations which have been frozen must not be used.
Insulino preparat, kurie buvo užšaldyti, vartoti negalima.
After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Iš mus Insulatard buteliuk iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti buteliuk kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
14 Negalima vartoti insulino suspensijos, jei po sumaišymo ji neatrodo tolygiai balta ir drumsta.
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge.
Insulatard Penfill 100 TV/ ml injekcin suspensija užtaise.
Suspension for injection in a cartridge.
Injekcin suspensija užtaise.
16 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4 skyriuje).
Insulatard is administered subcutaneously in the thigh.
Insulatard paprastai švirkš iamas po oda, šlaun.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
Užtaisai yra skirti vartoti su Novo Nordisk insulino švirkštimo sistemomis (ilgalaik mis švirkštimo priemon mis pakartotiniam naudojimui) ir NovoFine adatomis.
Detailed instruction accompanying the delivery system must be followed.
Vadovaukit s išsamia instrukcija, kuri pateikiama kartu su švirkštimo sistema.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
17 pa iame plote, norint išvengti ar sušvelninti šias reakcijas.
17 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Keletas pacient, kuriems pasireišk hipoglikemija, pakeitus gyvulin insulin kitu, praneš, kad ankstyvieji sp jamieji hipoglikemijos požymiai buvo silpnesni ar kitokie, negu vartojant ankstesnio insulino.
18 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Pacientui reik t patarti imtis atsargumo priemoni siekiant išvengti hipoglikemijos vairuojant.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Dažnis apib dinamas kaip: nedažni (1/ 1 000 iki < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip < 1/ 10 000, skaitant pavienius pranešimus.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
19 • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
20 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
20 prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
Insulin products should only be added to compounds with which it is known to be compatible.
Insulino preparatai turi b ti maišomi tik su komponentais, kurie ne takoja vaisto veikimo.
6 weeks when used or carried as a spare (below 30°C).
6 savaites, atidarius arba jei nešiojamasi, kaip atsarg (žemesn je kaip 30 °C temperat roje).
Do not store above 30°C.
Laikyti ne aukštesn je kaip 30 °C temperat roje.
Keep the cartridge in the outer carton in order to protect from light.
Laikyti užtais išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
3 ml stikliniame (1 tipo) užtaise yra guminis bromobutilo st moklis ir guminis bromobutilo/ poliizopreno kamštis.
The cartridge contains a glass ball to facilitate the re-suspension.
Užtaise taip pat yra stiklinis rutuliukas, kad b t lengviau sumaišyti.
1, 5 and 10 cartridges x 3 ml.
1, 5 ir 10 užtais po 3 ml.
21 Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
Užtaisai turi b ti naudojami tik su jais deran iais produktais, leidžian iais veikti saugiai ir efektyviai.
Insulatard Penfill is for single person use only.
Insulatard Penfill skirtas vartoti tik vienam asmeniui.
The container must not be refilled.
Talpykl s iš naujo užpildyti negalima.
After removing Insulatard Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
21 Iš mus Insulatard Penfill iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti Penfill kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard NovoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Žmogaus insulinas, rDNR (pagamintas pagaminta Saccharomyces cerevisiae rekombinantin s DNR technologijos b du).
1 pre-filled pen contains 3 ml equivalent to 300 IU.
1 užpildytoje švirkštimo priemon je esantys 3 ml atitinka 300 TV.
Suspension for injection in a pre-filled pen.
Injekcin suspensija užpildytoje švirkštimo priemon je.
23 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4 skyriuje).
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Adat po oda reik t palaikti mažiausiai 6 sekundes, kad sitikintum te, jog sušvirkšt te vis doz.
Insulatard NovoLet is designed to be used with NovoFine needles.
Insulatard NovoLet skirtas naudoti su NovoFine adatomis.
NovoLet delivers 2-78 units in increments of 2 unitsThe pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Prieš injekcij užpildytos švirkštimo priemon s turi b ti paruošiamos taip, kad, doz s parink jui gr žtant nulin pad t, ant adatos galo pasirodyt insulino lašas.
The dose is set by turning the selector, which returns to zero during the injection.
Doz yra nustatoma sukant doz s parink j, kuris gr žta nulin pad t injekcijos metu.
Continuous rotation of the injection site within a given area may help to
Injekcijos viet reikia nuolat keisti tame
24 reduce or prevent these reactions.
24 pa iame plote, norint išvengti ar sušvelninti šias reakcijas.
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.
Keletas pacient, kuriems pasireišk hipoglikemija, pakeitus gyvulin insulin kitu, praneš, kad ankstyvieji sp jamieji hipoglikemijos požymiai buvo silpnesni ar kitokie, negu vartojant ankstesnio insulino.
Insulin suspensions are not to be used in insulin infusion pumps.
Insulino suspensij negalima vartoti insulino infuzij pompose.
25 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Pacient sugeb jimas susikoncentruoti ir reaguoti gali sumaž ti d l hipoglikemijos.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions
Labai reti - Anafilaksin s reakcijos.
26 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
26 • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
27 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
27 prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
Do not store above 30°C.
Negalima laikyti aukštesn je kaip 30 °C temperat roje.
Keep the pen cap on in order to protect from light.
Laikyti užpildytos švirkštimo priemon s dangtel užd t, kad insulinas b t apsaugotas nuo šviesos.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Užpildyta švirkštimo priemon (turinti daug dozi) susideda iš injektoriaus ir užtaiso (3 ml).
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a
Stikliniame užtaise (1 tipo) yra guminis bromobutilo st moklis ir guminis bromobutilo/ poliizopreno kamštis.
The cartridge contains a glass ball to facilitate the re- suspension.
Užtaise taip pat yra stiklinis rutuliukas, kad b t lengviau suspensij sumaišyti.
5 and 10 pre-filled pens x 3 ml.
5 ir 10 užpildyt švirkštimo priemoni po 3 ml.
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Užpildytos švirkštimo priemon s turi b ti naudojamos tik su deramais produktais, leidžian iais veikti saugiai ir efektyviai.
Insulatard NovoLet is for single person use only.
Insulatard NovoLet skirtas vartoti tik vienam asmeniui.
Insulin preparations which have been frozen must not be used.
28 Insulino preparat, kurie buvo užšaldyti, vartoti negalima.
After removing Insulatard NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Iš mus Insulatard NovoLet iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti NovoLet kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Date of latest renewal:
7 d Rinkodaros teis s atnaujinimo data:
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard InnoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Suspension for injection in a pre-filled pen.
Injekcin suspensija užpildytoje švirkštimo priemon je
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4 skyriuje).
Insulatard InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard InnoLet skirtas naudoti su 8 mm ilgio ar trumpesn mis NovoFine adatomis su dangteliu.
The needle box is marked with an S.
Adat d žut pažym ta ž nklu S.
InnoLet delivers 1-50 units in increments of 1 unit.
InnoLet galima sušvirkšti 1 - 50 vienet dozes, doz didinant po 1 vienet.
The pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Prieš injekcij užpildytos švirkštimo priemon s turi b ti paruošiamos taip, kad, doz s parink jui gr žtant nulin pad t, ant adatos galo pasirodyt insulino lašas.
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.
Tai gali b ti troškulys, padažn j s šlapinimasis, pykinimas, v mimas, mieguistumas, rausva sausa oda, sausa burna, apetito sumaž jimas, taip pat acetono kvapas iš burnos (žr.
31 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
31 pa iame plote, norint išvengti ar sušvelninti šias reakcijas.
32 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Pacient sugeb jimas susikoncentruoti ir reaguoti gali sumaž ti d l hipoglikemijos.
33 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
A specific overdose of insulin cannot be defined.
Ta iau galimos šios hipoglikemijos stadijos:
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
33 • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
A10A C01.
Farmakoterapin grup - injekciniai inulinai ir analogai, vidutinio veikimo, insulinas (žmogaus), ATC kodas - A10A C01.
34 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
34 prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Užpildyta švirkštimo priemon (turinti daug dozi), susideda iš injektoriaus ir užtaiso (3 ml).
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a
Stikliniame (1 tipo) užtaise yra guminis bromobutilo st moklis ir guminis bromobutilo/ poliizopreno kamštis.
The cartridge contains a glass ball to facilitate the re- suspension.
Užtaise taip pat yra stiklinis rutuliukas, kad b t lengviau sumaišyti.
1, 5 and 10 pre-filled pens x 3 ml.
1, 5 ir 10 užpildyt švirkštimo priemoni po 3 ml.
Insulatard InnoLet is for single person use only.
Insulatard InnoLet skirtas vartoti tik vienam asmeniui.
Insulin preparations which have been frozen must not be used.
35 Insulino preparat, kurie buvo užšaldyti, vartoti negalima.
After removing Insulatard InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Iš mus Insulatard InnoLet iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti InnoLet kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard FlexPen 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
Doz taip pat gali tekti koreguoti pacientams, kurie kei ia fizin kr v ar prast mityb.
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4 skyriuje).
Insulatard FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard FlexPen skirtas naudoti su 8 mm ilgio ar trumpesn mis NovoFine adatomis su dangteliu.
FlexPen delivers 1-60 units in increments of 1 unit.
FlexPen galima sušvirkšti 1 - 60 vienet dozes, doz didinant po 1 vienet.
Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulatard parduodami su pakuot s lapeliu vartotojui, kuriame yra išsami vartojimo instrukcija, ja reikia vadovautis.
38 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
38 pa iame plote, norint išvengti ar sušvelninti šias reakcijas.
39 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Pacient sugeb jimas susikoncentruoti ir reaguoti gali sumaž ti d l hipoglikemijos.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Dažnis apib dinamas kaip: nedažni (1/ 1000 iki < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip < 1/ 10000, skaitant ir pavienius pranešimus.
40 Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
40 • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
41 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
41 prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Užpildytos švirkštimo priemon s turi b ti naudojamos tik su deran iais produktais, leidžian iais veikti saugiai ir efektyviai.
Insulatard FlexPen is for single person use only.
Insulatard FlexPen skirtas vartoti tik vienam asmeniui.
After removing Insulatard FlexPen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
42 Iš mus Insulatard FlexPen iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti FlexPen kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
43 ANNEX II
43 II PRIEDAS
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
BIOLOGIN S VEIKLIOSIOS MEDŽIAGOS GAMINTOJAS IR GAMYBOS LICENCIJOS TUR TOJAI, ATSAKINGI UŽ SERIJ IŠLEIDIM
CONDITIONS OF THE MARKETING AUTHORISATION
RINKODAROS TEIS S S LYGOS
Name and address of the manufacturer of the biological active substance
Biologin s veikliosios medžiagos gamintojo pavadinimas ir adresas
Name and address of the manufacturers responsible for batch release
Gamintoj, atsaking už serijos išleidim, pavadinimai ir adresai
Insulatard Penfill and FlexPen
Insulatard Penfill ir FlexPen:
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
Novo Nordisk Production SAS 45, Avenue d’ Orleans F- 28002 Chartres Pranc zija
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Vaistinio preparato pakuot s lapelyje turi b ti nurodyta gamintojo, atsakingo už konkre ios serijos išleidim, pavadinimas ir adresas.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• TIEKIMO IR VARTOJIMO S LYGOS AR APRIBOJIMAI, TAIKOMI RINKODAROS TEIS S TUR TOJUI
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• S LYGOS IR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO PREPARATO VARTOJIMUI UŽTIKRINTI
Not applicable.
Neb tini.
45 ANNEX III
45 III PRIEDAS
LABELLING AND PACKAGE LEAFLET
ŽENKLINIMAS IR PAKUOT S LAPELIS
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
OUTER CARTON
IŠORIN D ŽUT
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 TV/ ml injekcin suspensija buteliuke Insulinum humanum (rDNA)
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
1 ml suspensijos yra 40 TV (1, 4 mg) žmogaus insulino (rDNR),
LIST OF EXCIPIENTS
PAGALBINI MEDŽIAG S RAŠAS
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
cinko chlorido, glicerolio, metakrezolio, fenolio, dinatrio vandenilio fosfato dihidrato, natrio hidroksido, vandenilio chlorido r gšties, protamino sulfato ir injekcinio vandens.
Suspension for injection 1 x 10 ml 5 x 10 ml
Injekcin suspensija 1 x 10 ml 5 x 10 ml
METHOD AND ROUTE OF ADMINISTRATION
VARTOJIMO METODAS IR B DAS
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
SPECIALUS SP JIMAS, KAD VAISTIN PREPARAT LAIKYTI VAIKAMS NEPASIEKIAMOJE IR NEPASTEBIMOJE VIETOJE
OTHER SPECIAL WARNING(S), IF NECESSARY
KITAS SPECIALUS SP JIMAS (JEI REIKIA)
EXP/ During use: use within 4 weeks
Tinka iki / Prad jus vartoti: sunaudoti per 4 savaites.
SPECIAL STORAGE CONDITIONS 48 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 25 °C temperat roje.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
SPECIALIOS ATSARGUMO PRIEMON S D L NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEK TVARKYMO (JEI REIKIA)
Insulatard vial 40 IU/ ml
Insulatard buteliukas, 40 TV/ ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
VIAL LABEL
BUTELIUKO ETIKET
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO B DAS
Insulatard 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 40 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
KIEKIS (MAS, T RIS ARBA VIENETAI)
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
Insulatard 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 100 TV/ ml injekcin suspensija buteliuke Insulinum humanum (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
1 ml suspensijos yra 100 TV (3, 5 mg) žmogaus insulino (rDNR),
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
SPECIALUS SP JIMAS, KAD VAISTIN PREPARAT B TINA LAIKYTI VAIKAMS NEPASIEKIAMOJE IR NEPASTEBIMOJE VIETOJE
EXP/ During use: use within 6 weeks
Tinka iki / Prad jus vartoti: sunaudoti per 6 savaites.
SPECIAL STORAGE CONDITIONS 51 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 25 °C temperat roje.
Insulatard vial 100 IU/ ml
Insulatard buteliukas, 100 TV/ ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 MINIMALI INFORMACIJA ANT MAŽ VIDINI PAKUO I
Insulatard 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Injekcin suspensija 1 x 10 ml Tai yra didel s pakuot s dalis, neparduodama atskirais buteliukais.
SPECIAL STORAGE CONDITIONS 54 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 25 °C temperat roje.
55 PARTICULARS TO APPEAR ON THE PACKAGING
55 INFORMACIJA ANT PAKUOT S
OUTER WRAPPER LABELON MULTIPACKS
DIDEL S PAKUOT S IŠORINIO APLANKO ETIKET
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 TV/ ml injekcin suspensija buteliuke Žmogaus insulinas (rDNA)
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Injekcin suspensija 5 x (1 x 10 ml) Tai yra didel pakuot, neparduodama atskirais buteliukais.
SPECIAL STORAGE CONDITIONS
SPECIALIOS LAIKYMO S LYGOS
56 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 25 °C temperat roje.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
SPECIAL STORAGE CONDITIONS 58 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 25 °C temperat roje.
59 PARTICULARS TO APPEAR ON THE PACKAGING
59 INFORMACIJA ANT PAKUOT S