qanastek/EMEA-V3 huggingface dataset:
In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. ro
Insulino infuzijos siurblio gedimas ar infuzijos sistemos ar
If repeated or severe low blood glucose levels occur, the patient should notify the health care professional and the need to reduce or stop the insulin administration should be considered.
nepraeinamumas gali sukelti greit gliukoz s kiekio padid jim.
A pump lp
Jei pacientas taria, jog sutriko ep
malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
insulino patekimas, privalo apie tai pranešti sveikatos prieži ros specialistui.
Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily available in case of emergency or pump interruption or failure, in order that insulin can be ic
Pacientai, vartojantys Velosulin NPII, privalo tur ti švirkštus ir kit insulin, kad gal t jo sušvirkšti pr
administered by subcutaneous injection. ed
po oda skubios pagalbos reikalaujan iais bei insulino infuzijos siurblio pažeidimo ar gedimo atvejais. is
M
Insulino švirkštimas: in
Intravenous administration should only be carried out by health care professionals.
Velosulin taip pat galima vartoti, švirkš iant j po oda ar ven. ven gali švirkšti tik sveikatos prieži ros specialistas. t
Velosulin is administered subcutaneously in the abdominal wall.
Po oda Velosulin švirkš iamas pilvo sien.
The thigh, the gluteal region or the deltoid region may also be used.
Taip pat galima švirkšti šlaun, s dmen ar deltinio is
Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
Poodin injekcija pilvo sien lemia greitesn rezorbcij, palyginus su kitomis injekcijos vietomis.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Injekcija pakelt odos raukšl sumažina rizik vaisto nety ia suleisti raumenis.
3 Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Siekiant išvengti lipodistrofijos, injekcijos vietos tur t b ti kei iamos neišeinant už anatomin s srities rib.
The vials may be used with insulin syringes with a corresponding unit scale.
Velosulin iš buteliuko gali b ti vartojamas švirkštais, turin iais insulino vienetus atitinkan i skal.
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Kai maišomi dviej tip insulinai, pirmiausia švirkšt pritraukiama greitai veikian io insulino ir tik po to - ilgai veikian io insulino.
Velosulin is accompanied by a package leaflet with detailed instruction for use to be followed.
3 Velosulin tiekiamas su pakuot s lapeliu, kuriame pateikta išsami vaisto vartojimo instrukcija, ja reik t vadovautis.
ed Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
6. 1 skyri).
is 4.4 Special warnings and precautions for use
4. 4 Special s sp jimai ir atsargumo priemon s
or Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to
Nepakankama doz ar gydymo nutraukimas, ypa sergant 1 tipo cukriniu diabetu, gali paskatinti
th hyperglycaemia.
as hiperglikemijos atsiradim.
au Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Tai gali
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.
ot b ti troškulys, padažn j s šlapinimasis, pykinimas, v mimas, mieguistumas, rausva sausa oda, burnos dži vimas, apetito sumaž jimas, taip pat acetono kvapas iš burnos.
er In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. ng Due to the lack of long-acting insulin, patients receiving continuous subcutaneous insulin infusion via lo
tru Esant 1 tipo diabetui, negydoma hiperglikemija gali sukelti diabetin ketoacidoz, kuri gali b ti
an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion. no
is mirtina.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9). ct
g D l ilgai veikian io insulino tr kumo, pacientams, gydomiems nepertraukiama poodine insulino
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. du
re infuzija insulino infuzij siurbliais, yra greito ketoacidoz s išsivystymo rizika, jei ilgesn laik nepertraukiama poodin insulino infuzija bus nevykdoma.
Patients whose blood glucose control is greatly improved e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised ro
Hipoglikemija gali atsirasti, jei insulino doz yra per didel, lyginant su insulino poreikiu (žr.
accordingly.
4. 8 ir ne 4. 9 skyrius).
Usual warning symptoms may disappear in patients with longstanding diabetes. lp
Pacientams, kuri gliukoz s kiekio kraujyje kontrol pager jo (pvz., taikant intensyvesn insulino as
Transferring a patient to another type or brand of insulin should be done under strict medical a
Paprastai sp jamieji simptomai gali dingti pacientams, ilgai sergantiems cukriniu diabetu. at
supervision.
Pakeitus insulino ar
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), in
stiprum, prekin ženkl (gamintoj), tip (veikiantis greitai, dvejopo poveikio, ilgai veikiantis, kt.), ep
origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
kilm (gyvuli, žmogaus ar analogišk insulino preparat), ir/ ar gamybos b d (rekombinantin s DNR ar gyvulin s kilm s), gali atsirasti poreikis keisti insulino doz.
If an adjustment is needed when ic
Prad jus vartoti Velosulin, jei reikia, doz galima sureguliuoti iš karto arba per pirmas kelet savai i ar m nesi. pr
switching the patients to Velosulin, it may occur with the first dose or during the first several weeks ed
Vartojant bet kokios r šies ar tipo insulin, gali atsirasti injekcijos vietos reakcijos, pasireiškian ios is
or months.
skausmu, niež jimu, dilg line, patinimu bei uždegimu.
M
Injekcijos viet reikia nuolat keisti tame in
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
pa iame plote, norint išvengti ar sušvelninti šias reakcijas.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Paprastai reakcijos išnyksta per kelias dienas ar savaites.
Reactions usually resolve in a few days to a few weeks.
Retais atvejais reikia nutraukti Velosulin vartojim, d l injekcijos vietos reakcij. t is
On rare occasions, injection site reactions may require discontinuation of Velosulin.
Keletas pacient, kuriems pasireišk hipoglikemija, pakeitus vartot gyvulin insulin kitu, praneš, Va
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.
kad ankstyvieji sp jamieji hipoglikemijos požymiai buvo silpnesni ar kitokie, negu vartojant ankstesniojo insulino.
4 Patients using CSII may be more prone to infection at the site of infusion.
Pacientai, naudojantys NPII, turi didesn polink infekcijoms atsirasti infuzijos vietoje.
Infections can be minimised by careful attention to personal hygiene of the hands and infusion site and by frequent changes of catheter (maximum usage 2 days).
Infekcijos rizika gali b ti sumažinama atidžiai palaikant rank ir infuzijos vietos švar bei dažnai kei iant kateter (ilgiausias naudojimo laikas yra 2 dienos).
Velosulin contains metacresol, which may cause allergic reactions.
Velosulin sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
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 jo vartojamus vaistus.
ed The following substances may reduce insulin requirement:
Šios medžiagos gali mažinti insulino poreik:
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta-
Geriamieji vaistai nuo diabeto, monoaminoksidaz s inhibitoriai (MAOI), neselektyv s beta- blokatoriai, angiotenzin konvertuojan i ferment (AKF) inhibitoriai, salicilatai, alkoholis, anaboliniai steroidai ir sulfonamidai.
is blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
Geriamieji kontraceptikai, tiazidai, gliukokortikoidai, skydliauk s hormonai ir beta- simpatomimetikai,
or The following substances may increase insulin requirement:
as augimo hormonas ir danazolis.
th Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth
ot Beta- blokatoriai gali maskuoti hipoglikemijos simptomus ir prailginti išgijim po hipoglikemijos.
au hormone and danazol.
tru Oktreotidas/ lanreotidas gali ir padidinti, ir sumažinti insulino poreik.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from
is Alkoholis gali sustiprinti ir prailginti gliukoz s kiek kraujyje mažinant insulino poveik.
er hypoglycaemia.
g 4. 6 N štumo ir žindymo laikotarpis
Octreotide/ lanreotide may both decrease and increase insulin requirement. lo
re N ra joki diabeto gydymo insulinu n štumo metu apribojim, nes insulinas nepraeina pro placent. be Ir hipoglikemija, ir hiperglikemija, kurios atsiranda d l nepakankamos diabeto kontrol s, padidina ne išsigimim ir embrion mirties rizik.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin. no
Rekomenduojama intensyvi n š i j, sergan i diabetu, gydymo kontrol n štumo ir n štumo planavimo metu.
4.6 Pregnancy and lactation
Po gimdymo insulino poreikis greitai tampa toks, koks buvo iki n štumo. at
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not ct
Ta iau Velosulin doz ar
pass the placental barrier. du
gali reik ti koreguoti. ep
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes ro
4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus pr
therapy, increase the risk of malformations and death in utero.
Pacient sugeb jimas susikoncentruoti ir reaguoti gali sumaž ti d l hipoglikemijos.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when lp
Tai gali b ti rizikinga situacijose, kai šie sugeb jimai ypa svarb s (pvz., vairuojant automobil ar valdant is
contemplating pregnancy.
mechanizmus). in
third trimesters. in
Pacientui reik t patarti imtis atsargumo priemoni siekiant išvengti hipoglikemijos vairuojant.
After delivery, insulin requirements return rapidly to pre-pregnancy values. ic
Tai ypa svarbu tiems, kuriems persp jamieji hipoglikemijos simptomai susilpn j, j visai n ra arba t
Insulin treatment of the nursing mother presents no risk to the baby.
dažnai pasireiškia hipoglikemija.
However, the Velosulin dosage ed
Esant šioms aplinkyb ms reik t apsvarstyti galimyb vairuoti. is Va
M
4. 8 Nepageidaujamas poveikis
4.7 Effects on ability to drive and use machines
Taip gali atsitikti, jei insulino doz yra per didel, lyginant su insulino poreikiu.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Sunki hipoglikemija gali sukelti s mon s praradim ir / ar m šlung, taip pat laikin ar nuolatin smegen pažeidim ar net mirt.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su greito veikimo žmogaus insulino (Actrapid) vartojimu, pateikiamas žemiau.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Dažnis apib dinamas kaip: nedažni (1/ 1 000, iki < 1/ 100).
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip < 1/ 10 000, skaitant ir pavienius pranešimus.
The advisability of driving should be considered in these circumstances.
Kiekvienoje dažnio grup je nepageidaujamas poveikis pateikiamas maž jan io sunkumo tvarka.
5 4.8 Undesirable effects
5 Nerv sistemos sutrikimai Nedažni - Periferin neuropatija.
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
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.
It may occur if the insulin dose is too high in relation to the insulin requirement.
Aki sutrikimai Nedažni - Refrakcijos sutrikimai.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Refrakcijos sutrikim gali atsirasti gydymo insulinu pradžioje.
Therefore, no specific frequency can be presented.
Šie simptomai paprastai praeina savaime.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to
Labai reti - Diabetin retinopatija.
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Ta iau,
is Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
as insulino terapijos sustiprinimas, siekiant staigaus glikemijos kontrol s pagerinimo, gali b ti susij s su laikinu diabetin s retinopatijos blog jimu.
or Nervous system disorders Uncommon - Peripheral neuropathy
ot Odos ir poodinio audinio sutrikimai
th Fast improvement in blood glucose control may be associated with a condition termed “ acute painful
Lipodistrofija gali pasireikšti injekcijos plote kaip injekcijos vietos nekeitimo pasekm.
au neuropathy”, which is usually reversible.
is Bendrieji sutrikimai ir vartojimo vietos pažeidimai
er Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
g Nedažni - Reakcijos injekcijos vietoje.
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. no
re 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 be paprastai išnyksta t siant gydym. ne Labai reti - Edema.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. ct
Edema gali atsirasti gydymo insulinu pradžioje.
Skin and subcutaneous tissue disorders du
Šie simptomai paprastai praeina savaime. as
Uncommon – Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites ro
Imunin s sistemos sutrikimai Nedažni - Dilg lin, išb rimas. at
within an area. lp
Labai reti - Anafilaksin s reakcijos.
General disorders and administration site conditions Uncommon - Injection site reactions a
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, ar
Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may in
virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo ep
occur during treatment with insulin.
spaudimo maž jim ir s mon s praradim.
Most reactions are transitory and disappear during continued treatment. ic ed
Generalizuotos padid jusio jautrumo reakcijos yra pavojingos gyvybei. pr
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Nenustatyta joki specifini insulino perdozavimo simptom.
These symptoms are usually of transitory M
Ta iau gali b ti šios hipoglikemijos in
Generalised hypersensitivity reactions are potentially life- threatening.
stadijos: • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus t
6 4.9 Overdose
produkt.
A specific overdose of insulin cannot be defined.
Va
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
• 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
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
Pacientui atgavus s mon, rekomenduojama duoti geriam j angliavandeni siekiant išvengti priepuolio pasikartojimo.
th au 5.1 Pharmacodynamic properties
5. 1 Farmakodinamin s savyb s
ATC
Farmakoterapin grup - injekciniai insulinai ir analogai, greitai veikiantys, insulinas (žmogaus), ATC kodas - A10A B01.
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose lo
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.
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous treatment with another fast ct
Klinikinis tyrimas, atliktas viename intensyvios terapijos skyriuje, gydant hiperglikemij (gliukoz s kiekis kraujyje viršija 10 mmol/ l) 204 pacientams, sergantiems cukriniu diabetu, ir 1344 cukriniu
acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%). du
ot glikemija (gliukoz s kiekis kraujyje 4, 4 - 6, 1 mmol/ l) sumažino mirtingum 42% (8% prieš 4, 6%).
Velosulin is a fast-acting insulin. ro
tru Velosulin yra greitai veikiantis insulinas.
When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours. lp
is efekt pasiekia per 1, 5 - 3, 5 valandos ir veikimo laikas yra 7 - 8 valandos.
5.2 Pharmacokinetic properties a in
g 5. 2 Farmakokinetin s savyb s
Insulin in the blood stream has a half-life of a few minutes.
re 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. ic ed
Taigi insulino preparato be veikimo laik ir poveik lemia tik jo absorbcija. ne 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 M
Nepertraukiama poodin infuzija pašalina kai kurias variacijas/ svyravimus, b dingus injekcij at
by significant intra- and inter-individual variation.
Santykinai greita tirpaus insulino absorbcija užtikrina pastov insulino tiekim krauj iš santykinai ar
Continuous subcutaneous infusion eliminates some of the variations/ fluctuations inherent to injection therapy.
mažo poodžio ploto. ep
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Absorbcija Maksimali insulino koncentracija plazmoje pasiekiama per 1, 5 - 2, 5 valandos po poodin s injekcijos. pr
7 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Jokio aiškaus prisijungimo prie plazmos protein, išskyrus cirkuliuojan ius antik nus insulinui (jei j in
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
yra), nebuvo pasteb ta. t
The
Metabolizmas is
Trials have indicated a t½
Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t Va
is of about 2-5 hours.
proteino disulfido izomeraz.
or Chrildren and adolescents The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 6-
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).
th 12 years) and adolescents (aged 13-17 years) using another fast-acting human insulin, (Actrapid).
Vaikai ir paaugliai Farmakokinetinis kito greitai veikian io žmogaus insulino (Actrapid) pob dis buvo tirtas su nedideliu skai iumi (n=18) diabetu sergan i vaik (6 - 12 met amžiaus) ir paaugli (13 - 17 met amžiaus).
The
Duomenys yra nepakankami, bet rodo, kad farmakokinetinis pob dis vaikams ir jaunuoliams yra
au data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
7 panašus kaip ir suaugusiesiems.
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Ta iau Cmax buvo skirtinga, priklausomai nuo amžiaus grupi, ir tai rodo individualios doz s parinkimo svarb.
5.3 Preclinical safety data er ng Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo
5. 3 Ikiklinikini saugumo tyrim duomenys
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. no
prast farmakologinio saugumo, kartotini dozi toksiškumo, genotoksiškumo, galimo kancerogeniškumo ir toksinio poveikio reprodukcijai ikiklinikini tyrim duomenys specifinio pavojaus žmogui nerodo.
PHARMACEUTICAL PARTICULARS ct
FARMACIN INFORMACIJA
6.1 List of excipients du
6. 1 Pagalbini medžiag s rašas
Zinc chloride ro
as Cinko chloridas
Glycerol Metacresol lp
ot Glicerolis Metakrezolis
Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) a
tru Dinatrio vandenilio fosfato dihidratas Natrio hidroksidas (pH sureguliavimui)
Hydrochloric acid (for pH adjustment) in
is Vandenilio chlorido r gštis (pH sureguliavimui) Injekcinis vanduo
M
g re 6. 2 Nesuderinamumas be Insulino preparatai turi b ti maišomi tik su tais komponenais, kurie ne takoja vaisto veikimo.
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Medicinos produktai, prid ti insulino tirpal, gali b ti insulino degradacijos priežastis, pvz., jei t ne produkt sud tyje yra tioli ar sulfit.
Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section 6.6.
Apie insulino infuzij siurblio, rezervuar, kateteri ir adat suderinamum, žr.
6 weeks when used or stored at room temperature (below 25°C).
6. 6 skyri. as
8 After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
6. 3 Tinkamumo laikas at
6.4 Special precautions for storage
30 m nesi, kai laikoma 2 °C – 8 °C temperat roje. ar ep
Before use: store in a refrigerator (2°C - 8°C).
6 savaites, atidarius arba laikant kambario temperat roje (žemesn je kaip 25 °C).
Do not freeze.
Po pirmo panaudojimo infuzijai, insulino tirpalas infuzij siurblio rezervuare gali b ti laikomas šešias dienas iki 37 °C temperat ros (prie k no). pr
During use: do not refrigerate.
6. 4 Specialios laikymo s lygos is in
Do not store above 25°C.
Prieš atidarym laikyti šaldytuve (2 °C - 8 °C temperat roje).
After first use as infusion: the insulin solution may be stored in the pump reservoir at up to 37°C (close to the body).
Negalima laikyti šaldymo kameroje arba per arti šaldymo kameros ar šaldymo elemento. t
ed Keep the vial in the outer carton in order to protect from light.
Negalima užšaldyti. is Va
is Protect from excessive heat and sunlight.
Laikyti buteliuk išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
or 6.5 Nature and contents of container
6. 5 Pakuot ir jos turinys
th 10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective
10 ml stiklinis buteliukas (1 tipo), uždarytas bromobutilo/ poliizopreno gumos kamš iu ir apsauginiu pirmo atidarymo kontrol s dangteliu.
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 po 5 x (1 x10 ml) buteliukai.
6.6 Special precautions for disposal and other handling er ng Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to lo
8 6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
the infusion material.
Sumaišius Velosulin su infuziniais skys iais, nenustatomas insulino kiekis absorbuosis ant infuzijos priemoni.
Monitoring of the patient's blood glucose during infusion is therefore recommended. no
Tod l rekomenduojama infuzijos metu steb ti paciento gliukoz s kiek kraujyje.
When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin. ct du
Kai atliekama NPII, infuzin s pompos rezervuare Velosulin negalima maišyti su kitais vaistiniais preparatais, arba insulino preparatais.
When combination with long-acting insulin is necessary it is only possible to mix Velosulin with isophane or premixed insulin products.
Kuomet reikalinga skirti kartu su ilgai veikian iu insulinu, Velosulin galima maišyti tik su izofanu arba insulino mišiniais.
since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way. lp
Velosulin negalima maišyti su insulino cinko suspensijomis, kadangi, fosfatinis buferis gali reaguoti su cinku, esan iu suspensijoje, ir nenusp jamai takoti insulino veikimo laik.
Insulin preparations which have been frozen must not be used. a
as Insulino preparat, kurie buvo užšaldyti, vartoti negalima.
Insulin solutions should not be used if they do not appear water clear and colourless. in
ot Negalima vartoti insulino tirpalo, jei jis n ra vandens skaidrumo ir bespalvis.
Insulin infusion (CSII): ic
tru Insulino infuzija (NPII):
Use only syringes made of polyethylene, polypropylene or glass. ed
Naudoti tik tuos švirkštus, kurie pagaminti iš polietileno, polipropileno ar stiklo.
M
is Naudoti tik tuos kateterius, kuri su insulinu besilie iantis paviršius pagamintas iš polietileno ar polipropileno.
Use only teflon-coated or stainless steel needles.
g Naudoti tik teflonu padengtas ar ner dijan io plieno adatas.
7.
re Nesuvartot preparat ar atliekas reikia tvarkyti laikantis vietini reikalavim. be ne 7.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S, as
EU/ 1/ 02/ 232/ 001-003
EU/ 1/ 02/ 232/ 001- 003 pr is
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
RINKODAROS TEIS S SUTEIKIMO / ATNAUJINIMO DATA in
Date of first suthorisation:
Rinkodaros teis s suteikimo data:
is or th au er ng lo no ct du ro ed M
18 d. is Va
10 ed is or th au ANNEX II er ng
TEKSTO PERŽI ROS DATA
MANUFACTURER OF THE BIOLOGICAL ACTIVE lo
9 as ot tru is g re II PRIEDAS be A.
SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE no
BIOLOGIN S VEIKLIOSIOS MEDŽIAGOS GAMINTOJAS IR ne GAMYBOS LICENCIJOS TUR TOJAI, ATSAKINGI UŽ SERIJ IŠLEIDIM as
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
RINKODAROS TEIS S S LYGOS at ar ep pr is int is Va
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
BIOLOGIN S VEIKLIOSIOS MEDŽIAGOS GAMINTOJAS IR GAMYBOS LICENCIJOS TUR TOJI, ATSAKINGI UŽ SERIJ IŠLEIDIM
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK-2880 Bagsværd Denmark Denmark
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK- 2880 Bagsværd Danija Danija
Name and address of the manufacturers responsible for batch release
Gamintojo, atsakingo už serijos išleidim, pavadinimas ir adresas
is Novo Allé DK-2880 Bagsværd
as Novo Allé DK- 2880 Bagsværd
or Denmark
ot Danija
th au B.
tru B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
is • TIEKIMO IR VARTOJIMO S LYGOS AR APRIBOJIMAI, TAIKOMI RINKODAROS
er
g TEIS STUR TOJUI
THE MARKETING AUTHORISATION HOLDER
re Receptinis vaistinis preparatas.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT no
• S LYGOS IR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO ne PREPARATO VARTOJIMUI UŽTIKRINTI
Not applicable. ct du ro ed M
Neb tini as at ar ep pr is in t is Va
ic
11 as ot tru is g re III PRIEDAS be ŽENKLINIMAS IR PAKUOT S LAPELIS ne as at ar ep pr is int is Va
12 ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
12 Va is tin is pr ep ar at
13 M ed ic in alp ro du ct
13 as A.
14 no
is tru ot
A.
as
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 TV/ ml injekcinis ar infuzinis tirpalas buteliuke Insulinum humanum (rDNA)
is 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
as 1 ml tirpalo yra 100 TV (3, 5 mg) žmogaus insulino (rDNR),
or th 3.
ot tru 3.
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
is cinko chlorido, glicerolio, metakrezolio, dinatrio vandenilio fosfato dihidrato, natrio hidroksido, vandenilio chlorido r gšties ir injekcinio vandens.
er ng 4.
g re 4.
PHARMACEUTICAL FORM AND CONTENTS lo
FARMACIN FORMA IR KIEKIS PAKUOT JE
Solution for injection or infusion no
Injekcinis arba infuzinis tirpalas ne
1 x 10 ml 5 x 10 ml ct du
1 x 10 ml 5 x 10 ml as
METHOD AND ROUTE(S) OF ADMINISTRATION ro
VARTOJIMO METODAS IR B DAS at ar
Subcutaneous or intravenous use Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel. ep pr
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT in
SPECIALUS SP JIMAS, KAD VAISTIN PREPARAT B TINA LAIKYTI VAIKAMS NEPASIEKIAMOJE IR NEPASTEBIMOJE VIETOJE is
Keep out of the reach and sight of children ed M
Laikyti vaikams nepasiekiamoje ir nepastebimoje vietoje. in t is
OTHER SPECIAL WARNING(S), IF NECESSARY
KITAS SPECIALUS SP JIMAS (JEI REIKIA) Va
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 May be kept in an infusion pump at up to 37°C for 6 days
Infuzij siurbliuose galima laikyti ne aukštesn je kaip 37 °C temperat roje 6 dienas.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
SPECIALIOS ATSARGUMO PRIEMON S D L NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEK (JEI REIKIA)
ed APPROPRIATE
as 11.
th Novo Nordisk A/ S
ot tru Novo Nordisk A/ S, Novo Allé, DK- 2880 Bagsværd,
au Novo Allé DK-2880 Bagsværd Denmark
is Danija
er ng 12.
g re 12.
MARKETING AUTHORISATION NUMBERS lo
RINKODAROS PAŽYM JIMO NUMERIS
EU/ 1/ 02/ 232/ 001 1 x 10 ml EU/ 1/ 02/ 232/ 002 5 x 10 ml no
EU/ 1/ 02/ 232/ 001 1 x 10 ml ne EU/ 1/ 02/ 232/ 002 5 x 10 ml as
BATCH NUMBER ct du
SERIJOS NUMERIS at
Batch: ro
Serija: ar ep
GENERAL CLASSIFICATION FOR SUPPLY lp
PARDAVIMO (IŠDAVIMO) TVARKA pr
Medicinal product subject to medical prescription a in ic
Receptinis vaistinis preparatas. is
INSTRUCTIONS ON USE ed
VARTOJIMO INSTRUKCIJA in t is
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
INFORMACIJA BRAILIO RAŠTU Va
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO B DAS
Velosulin 100 IU/ ml solution for injection or infusion Insulin human (rDNA) SC, IV use
Velosulin 100 TV/ ml injekcinis ar infuzinis tirpalas Insulinum humanum (rDNA) s. c., i. v.
is or 3.
as 3.
th au EXP/
ot tru EXP /
er 4.
is 4.
5.
g re Lot: be 5.
CONTENTS BY WEIGHT, BY VOLUME OR
KIEKIS (MAS, T RIS ARBA VIENETAI) ne
10 ml ct du
10 ml. as
OTHER ro
KITA at ar
Novo Nordisk A/ S
Novo Nordisk A/ S ep pr is in t is Va
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human( rDNA)
Velosulin 100 TV/ ml injekcinis ar infuzinis tirpalas buteliuke Insulinum humanum (rDNA)
Solusion for injection or infusion 1 x 10 ml no
1 x 10 ml Tai yra didel s pakuot s dalis, neparduodama atskirais buteliukais. as
METHOD AND ROUTE(S) OF ADMINISTRATION du
VARTOJIMO METODAS IR B DAS at ar
Subcutaneous or intravenous use ro
Vartoti po oda arba ven.
Read the package leaflet before use lp
Prieš vartojim perskaitykite pakuot s lapel. ep pr
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
SPECIALUS SP JIMAS, KAD VAISTIN PREPARAT B TINA LAIKYTI VAIKAMS NEPASIEKIAMOJE IR NEPASTEBIMOJE VIETOJE is
Keep out of the reach and sight of children ed
Laikyti vaikams nepasiekiamoje ir nepastebimoje vietoje. in t is
OTHER SPECIAL WARNING(S), IF NECESSARY M
KITAS SPECIALUS SP JIMAS (JEI REIKIA) Va
EU/ 1/ 02/ 232/ 003 no
EU/ 1/ 02/ 232/ 003 ne
BATCH NUMBER ct
SERIJOS NUMERIS as
Batch: du ro
Serija: at ar
GENERAL CLASSIFICATION FOR SUPPLY lp
PARDAVIMO (IŠDAVIMO) TVARKA ep
Medicinal product subject to medical prescription a in
Receptinis vaistinis preparatas. pr is
INSTRUCTIONS ON USE ic ed
VARTOJIMO INSTRUKCIJA in t is
INFORMATION IN BRAILLE M
INFORMACIJA BRAILIO RAŠTU Va
19 PARTICULARS TO APPEAR ON THE PACKAGING
18 INFORMACIJA ANT PAKUOT S
OUTER WRAPPER LABLE ON MULTIPACKS
DIDEL S PAKUOT S IŠORINIO APLANKO ETIKET
Velosulin 100 IU/ ml Solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 TV/ ml injekcinis ar infuzinis tirpalas buteliuke Insulinum humanum (rDNA)
ed 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
as 1 ml tirpalo yra 100 TV (3, 5 mg) žmogaus insulino (rDNR),
is or 3.
ot tru 3.
au acid and water for injections.
is cinko chlorido, glicerolio, metakrezolio, dinatrio vandenilio fosfato dihidrato, natrio hidroksido, vandenilio chlorido r gšties ir injekcinio vandens.
er 4.
g re 4.
Solusion for injection or infusion 5 x (1 x 10 ml) lo
5 x (1 x 10 ml) Tai yra didel pakuot, neparduodama atskirais buteliukais. as
METHOD AND ROUTE(S) OF ADMINISTRATION ct
VARTOJIMO METODAS IR B DAS (- AI) at ar
Subcutaneous or intravenous use du
Vartoti po oda arba ven.
Read the package leaflet before use ro
Prieš vartojim perskaitykite pakuot s lapel. ep pr
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
SPECIALUS SP JIMAS, KAD VAISTIN PREPARAT B TINA LAIKYTI VAIKAMS NEPASIEKIAMOJE IR NEPASTEBIMOJE VIETOJE is
Keep out of the reach and sight of children in ic
Laikyti vaikams nepasiekiamoje ir nepastebimoje vietoje. in t is
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
KITAS SPECIALUS SP JIMAS (JEI REIKIA) Va
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
SPECIALIOS ATSARGUMO PRIEMON S D L NESUVARTOTO VAISTINIO PREPARATO AR JO ATLIEK TVARKYMO (JEI REIKIA)
MARKETING AUTHORISATION NUMBER(S) lo
RINKODAROS PAŽYM JIMO NUMERIS
INSTRUCTIONS ON USE ic ed
VARTOJIMO INSTRUKCIJA in t
INFORMATION IN BRAILLE M
INFORMACIJA BRAILIO RAŠTU is Va
21 M ed ic in alp ro du ct
PAKUOT S LAPELIS be re
22 no lo B.
is tru ot
PACKAGE LEAFLET ng er au th or is ed PACKAGE LEAFLET:
PAKUOT S LAPELIS:
Velosulin 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Velosulin 100 TV/ ml injekcinis tirpalas buteliuke Žmogaus insulinas (insulinum humanum), (rDNR)
ed is 1.
as ot 1.
WHAT VELOSULIN IS AND WHAT IT IS USED FOR
KAS YRA VELOSULIN IR KAM JIS VARTOJAMAS
or Velosulin is human insulin to treat diabetes.
tru Velosulin yra žmogaus insulinas, skirtas diabetui gydyti.
Velosulin is a fast-acting insulin.
Velosulin yra greitai veikiantis insulinas.
This means that it will start to lower your blood sugar about half an hour after you take it.
Tai reiškia, kad jis pradeda mažinti cukraus kiek J s kraujyje per pus valandos po injekcijos.
th au 2.
is g 2.
BEFORE YOU USE VELOSULIN
KAS ŽINOTINA PRIEŠ VARTOJANT VELOSULIN
er Do not use Velosulin
re Velosulin vartoti negalima
Look out for the signs of allergy in 5 Possible side lo
Apie alergijos simptomus ži r kite 5 skyriuje Galimas šalutinis poveikis; jei jau iate art jan i hipo (hipo yra hipoglikemijos trumpinys ir rodo sumaž jusio gliukoz s as
of low blood sugar).
kiekio kraujyje simptomus).
See 4 What to do in an emergency for more about hypos.
Daugiau apie hipoglikemij skaitykite 4 skyriuje K daryti nenumatytais atvejais. at
Take special care with Velosulin ct du
Speciali atsargumo priemoni reikia ar ep
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty ro
jei yra inkst, kepen ar antinks i, hipofiz s ar skydliauk s liauk veiklos sutrikim; jei geriate alkohol: steb kite hipoglikemijos simptomus ir niekada negerkite alkoholio nevalg; pr
stomach If you are exercising more than usual or if you want to change your usual diet lp
jei sportuojate daugiau nei paprastai, ar norite pakeisti prast diet; jei sergate: nenutraukite insulino vartojimo; is
If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the a
jei vykstate užsien: laiko juost pasikeitimas gali daryti tak J s insulino poreikiui ir in
timing of your injections. in
švirkštimo laikui. t
Using other medicines ic ed
Kit vaist vartojimas is Va
Talk to your M
Žemiau pateikti dažniausi medikamentai, galintys paveikti J s gydym insulinu.
doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Pasakykite savo gydytojui ar vaistininkui, jeigu vartojate ar vartojote kit vaist, skaitant sigytus be recepto, ar jeigu pakeit te j dozes.
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
22 N štumas ir žindymo laikotarpis Jei esate n š ia, planuojate n štum ar žindote: susisiekite su gydytoju patarimo.
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.
HOW TO USE VELOSULIN
KAIP VARTOTI VELOSULIN
Talk about your insulin needs with your doctor and diabetes nurse.
as Aptarkite J s insulino poreik su gydytoju ar diabeto slaugytoju.
This leaflet is a general guide.
Šis
ed If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Jei gydytojas pakeit vieno tipo ar r šies insulin kitu, doz turi sureguliuoti J s gydytojas.
is Eat a meal or snack containing carbohydrates within 30 minutes of administration.
tru Pavalgykite ar užk skite angliavandeni turin io maisto per 30 min. po vartojimo.
or Before using Velosulin
g re Patikrinkite etiket je ir sitikinkite, kad turite reikiamo tipo insulin.
th au Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Dezinfekuokite gumin membran medicinine šluoste.
er Do not use Velosulin ng If the protective cap is loose or missing.
jei apsauginis dangtelis pažeistas, arba jei jo išvis n ra.
Each vial has a protective, tamper-proof plastic cap.
Kiekvienas buteliukas yra su apsauginiu plastiko dangteliu.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier lo
Jei jis buvo pažeistas tuo metu kai gavote buteliuk, gr žinkite j as
If it hasn’ t been stored correctly or been frozen (see 6 How to store Velosulin) If it does not appear water clear and colourless. no
6 skyriuje Kaip laikyti Velosulin); at
Use in infusion pump ct
Vartojimas infuzij siurbliu ep
Follow the instructions and recommendations from your doctor regarding the use of Velosulin in a du
Naudokit s instrukcija ir j s gydytojo rekomendacijomis vartodami Velosulin infuzij siurbliu.
Velosulin should never be mixed with any other insulin when used in a pump. ro
Velosulin niekada negalima maišyti su jokiu kitu insulinu, kai jis naudojamas infuzij siurbliu. pr
Read and follow carefully the instructions that accompany your insulin pump.
Perskaitykite ir laikykit s vartojimo instrukcijos, prid tos prie insulino infuzij siurblio.
Always have ordinary syringes available in case of pump interruption or failure. lp
Visada su savimi tur kite paprast švirkšt tam atvejui, jei infuzij siurblys b t pažeistas ar sugest. is in
Use in syringes a in
Vartojimas švirkštais t
Velosulin is for injection under the skin (subcutaneously).
Velosulin skirtas injekcijoms po oda.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
5 is
waist (abdomen); your buttocks; the front of your thighs or upper arms.
skyri Galimas šalutis poveikis).
Your insulin will work more ed
Geriausia vieta sušvirkšti insulin pa iam yra: priekin juosmens Va
quickly if you inject it around the waist.
dalis (pilvas); s dmenys; šlaunies ar ž sto išor.
Velosulin vials are for use with insulin syringes with the corresponding unit scale.
Insulinas prad s veikti grei iau, jei švirkšite pilvo srityje.
M
Velosulin buteliukai skirti naudoti su insulino švirkštais, turin iais atitinkam vienet skal.
Velosulin may also be administered intravenously in special situations by medical professionals.
Velosulin ven gali sušvirkšti gydytojas, esant specifin ms situacijoms.
To inject Velosulin on its own
Vartojant vien tik Velosulin
1.
1. švirkšt pritraukite tiek oro, kiek užima Jums reikalinga insulino doz.
Pull the needle out of the vial 6.
23 6. sitikinkite, kad švirkšte neliko oro: adat nukreipkite aukštyn ir išstumkite or.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 7.
7. sitikinkite, kad švirkšte reikiama doz.
Check you have the right dose 24 8.
8.
Inject the insulin straight away under the skin.
Suleiskite insulin po oda.
Use the injection technique advised by your doctor or diabetes nurse 9.
Naudokite J s gydytojo ar diabeto slaugytojo pateikt injekcijos technik.
Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Adat po oda palaikykite bent 6 sekundes, kad sitikintum te, jog buvo suleista visa doz.
To mix Velosulin with long acting insulin
Velosulin maišant su ilgai veikian iu insulinu
Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
Vadovaukit s savo gydytojo ar diabeto slaugytojo pateikta instrukcija kaip teisingai atlikti insulin sumaišymo proced r.
ed If you get a hypo
as Jei Jums pasireišk hipoglikemija
is A hypo means your blood sugar level is too low.
ot Hipoglikemija reiškia per maž cukraus kiek kraujyje.
or headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling
tru 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
th confused; difficulty in concentrating.
is reg jimo poky iai; mieguistumas; ne prastas nuovargis ir silpnumas; nervingumas ar drebulys; neramumo, orientacijos sutrikimo jausmas; sunku susikaupti.
au If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
g Jei pasireišk bet kokie aukš iau min ti simptomai, išgerkite gliukoz s tablet ar suvalgykite daug
er Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
re cukraus turin io produkto (saldaini, sausaini, išgerkite vaisi sul i), po to pails kite.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they ng must: turn you on your side and seek medical advice straight away.
Papasakokite giminai iams, draugams ar artimiems kolegoms, kad jei J s apalpsite (neteksite ne s mon s), jie privalo: paversti Jus ant šono ir nedelsiant kviesti medicinos pagalb.
They must not give you any food or drink as it could choke you. lo
Jie turi neduoti jums jokio maisto ar g rimo, nes J s galite uždusti.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death no
Jei Jums kartojasi hipoglikemin s reakcijos ar pasireišk reakcija, kurios metu netekote at
If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
s mon s, pasikalb kite su gydytoju.
The amount or timing of insulin, food or exercise may need to be adjusted. ct
Gali reik ti pakeisti J s vartojamo insulino doz ar laik, diet ar fizin kr v. ar ep
Using glucagon du
Gliukagono vartojimas
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by ro
S mon gal tum te atgauti grei iau, jei Jums b t sušvirkšta hormono gliukagono injekcija, kuri pr
someone who knows how to use it.
atlikt mokantis injekuoti asmuo.
If you do not respond to glucagon treatment, you will have to be treated lp
Jei gliukagonas nepadeda, J s is
in a hospital.
turite b ti gydomas ligonin je.
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more. a in
Kreipkit s gydytoj po gliukagono injekcijos: b tina nustatyti in
Causes of a hypo ic
hipoglikemin s reakcijos priežast, kad išvengtum te kit reakcij. t
You get a hypo if your blood sugar gets too low.
Hipoglikemijos priežastys is Va
• If you take too much insulin • If you eat too little or miss a meal M
Jums pasireiškia hipoglikemin reakcija, jei cukraus kiekis kraujyje pasidaro per mažas.
• If you exercise more than usual.
Taip gali atsitikti: • jei vartojate per daug insulino; • jei per mažai valgote ar praleidžiate valg; • jei J s fizinis kr vis didesnis nei paprastai.
If you get any of these signs, test your blood sugar level and test your urine for ketones if you can.
24 Jei pasireišk bet kokie aukš iau min ti simptomai, pasitikrinkite cukraus kiek kraujyje ir, jei galite, išsitirkite, ar n ra keton J s šlapime.
25 Causes of hyperglycaemia
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; • J s fizinis kr vis mažesnis nei paprastai.
5.
as 5.
ed Like all medicines, Velosulin can cause side effects, although not everybody gets them.
ot Velosulin, kaip ir kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
Velosulin may cause hypoglycaemia (low blood sugar).
tru Velosulin gali sukelti hipoglikemij (sumaž j s cukraus kiekis kraujyje).
is Side effects reported uncommonly (in less than 1 patient in 100)
is Nedažnas šalutinis poveikis (re iau nei 1 pacientui iš 100)
or Vision problems.
g re Reg jimo sutrikimai.
When you first start your treatment, it may disturb your vision, but the reaction
Pirm kart prad jus gydytis insulinu, gali sutrikti J s reg jimas, bet ši be reakcija paprastai praeina.
th usually disappears.
Poky iai injekcijos vietoje (Lipodistrofija).
au Changes at the injection site (Lipodystrophy).
poodinis riebalinis audinys gali suplon ti (lipoatrofija) arba pastor ti (lipohipertrofija).
Changing the
Jei injekcijos vietoje pasteb jote dubim arba gumb, pasakykite apie tai savo gydytojui arba diabeto slaugytojui, nes šios reakcijos as
er site with each injection may help to prevent such skin changes.
gali pasunk ti arba tose vietose gali pasikeisti insulino absorbcija. at
If they do not disappear, no
Reakcijos (paraudimas, patinimas, niež jimas) gali pasireikšti injekcijos vietoje ar
see your doctor.
(vietin s alergin s reakcijos).
Seek medical advice immediately: • if signs of allergy spread to other parts of the body, or ct
Jei neišnyko, kreipkit s gydytoj. ep