qanastek/EMEA-V3 huggingface dataset:
6 weeks when used or stored at room temperature (below 25°C).
6 ned as lietojot vai uzglab jot temperat r l dz 25°C.
14 Insulin preparations which have been frozen must not be used.
Insul na prepar tus, kas bijuši sasaluši, nedr kst lietot.
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.
P c Insulatard flakona iz emšanas no ledusskapja, ir ieteicams aut flakonam sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
14 Insul na suspensijas nedr kst lietot, ja p c saskalošanas t s nav vienm r gi baltas un du ainas.
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge.
Insulatard Penfill 100 SV/ ml suspensija injekcij m k rtridž
1 ml contains 100 IU of insulin human.
1 ml satur 100 SV cilv ka insul na.
1 cartridge contains 3 ml equivalent to 300 IU.
1 k rtridž ir 3 ml, kas atbilst 300 SV.
Suspension for injection in a cartridge.
Suspensija injekcij m k rtridž.
Renal or hepatic impairment may reduce insulin requirement.
16 Nieru vai aknu darb bas trauc jumi var mazin t vajadz bu p c insul na.
16 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Var b t j maina deva, kad pacients s k lietot citu insul na prepar tu (skat t apakšpunktu 4. 4).
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Lai izvair tos no lipodistrofijas, injekcijas vietas j maina anatomisk apvidus robež s.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
K rtridži paredz ti lietošanai kop ar Novo Nordisk ievad šanas ier c m (iztur gas ier ces atk rtotai lietošanai) un NovoFine adat m.
Detailed instruction accompanying the delivery system must be followed.
J iev ro detaliz t instrukcija, kas pievienota ievad šanas ier cei.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
T pat k pie jebkuras insul na terapijas, injekcijas viet var b t reakcijas, ieskaitot s pes, niezi, n treni, piet kumu un iekaisumu.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Past v ga injekcijas vietas rot cija nor d taj apvid var pal dz t
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.
Daži pacienti, kuriem p c dz vnieku cilmes insul na nomai as bijusi hipoglik mija, zi o, ka hipoglik mijas agr nie br din juma simptomi bijuši v j k izteikti vai atš ir gi no tiem, k di rad s, lietojot iepriekš jo insul na prepar tu.
18 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
18 br din juma simptomus vai kuriem bieži rodas hipoglik mija.
19 4.9 Overdose
4. 9 P rdoz šana
A specific overdose of insulin cannot be defined.
Insul nam nav specifiskas p rdoz šanas defin cijas.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
19 • Vieglu hipoglik miju var rst t, peror li lietojot glikozi vai produktus, kuru sast v ir cukurs.
5.2 Pharmacokinetic properties
Farmakokin tisk s paš bas
20 The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Elimin cija Termin lo elimin cijas pusperiodu nosaka uzs kšan s trums no zem das audiem.
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 Ne- kl niskajos standartp t jumos ieg tie dati par farmakolo isko droš bu, atk rtotu devu toksicit ti, genotoksicit ti, iesp jamu kancerogenit ti un toksisku ietekmi uz reproduktivit ti neliecina par pašu risku cilv kam.
6 weeks when used or carried as a spare (below 30°C).
6 ned as lietojot vai n s jot l dzi rezervei (temperat r l dz 30°C).
Do not store above 30°C.
Uzglab t temperat r l dz 30°C.
Keep the cartridge in the outer carton in order to protect from light.
K rtridžus uzglab t r j iepakojum, lai pasarg tu no gaismas.
3 ml glass cartridge (type 1) with a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
3 ml stikla k rtridžs (1. klase), kur ir brombutilgumijas virzulis un brombutil/ poliizopr na gumijas aizb znis.
The cartridge contains a glass ball to facilitate the re-suspension.
K rtridž ir stikla lod te suspensijas saskalošanai.
1, 5 and 10 cartridges x 3 ml.
1, 5 vai 10 k rtridži x 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.
K rtridžus dr kst lietot tikai kop ar sader giem izstr d jumiem, kas auj tiem funkcion t droši un efekt vi.
Insulatard Penfill is for single person use only.
Insulatard Penfill paredz ts tikai individu lai lietošanai.
The container must not be refilled.
K rtridžu nedr kst atk rtoti uzpild t.
Insulin preparations which have been frozen must not be used.
21 Insul na prepar tus, kas bijuši sasaluši, nedr kst lietot.
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.
P c Insulatard Penfill iz emšanas no ledusskapja, ir ieteicams aut tam sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Insul na suspensijas nedr kst lietot, ja p c saskalošanas t s nav vienm r gi baltas un du ainas.
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard NovoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc
1 pre-filled pen contains 3 ml equivalent to 300 IU.
1 pildspalvveida pilnš irce satur 3 ml, kas atbilst 300 SV.
Suspension for injection in a pre-filled pen.
Suspensija injekcij m pildspalvveida pilnš irc.
Renal or hepatic impairment may reduce insulin requirement.
23 Nieru vai aknu darb bas trauc jumi var mazin t vajadz bu p c insul na.
23 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Var b t j maina deva, kad pacients s k lietot citu insul na prepar tu (skat t apakšpunktu 4. 4).
Insulatard NovoLet is designed to be used with NovoFine needles.
Insulatard NovoLet paredz ta lietošanai kop ar NovoFine adat m.
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.
Pirms injekcijas j p rbauda pildspalvveida pilnš irces darb ba – devas selektoram j atgriežas iepretim nullei un adatas gal j par d s insul na pilienam.
The dose is set by turning the selector, which returns to zero during the injection.
Devu nom ra, griežot selektoru, kas injekcijas laik atgriežas iepretim nullei.
24 reduce or prevent these reactions.
24 T pat k pie jebkuras insul na terapijas, injekcijas viet var b t reakcijas, ieskaitot s pes, niezi, n treni, piet kumu un iekaisumu.
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.
Daži pacienti, kuriem p c dz vnieku cilmes insul na nomai as bijusi hipoglik mija, zi o, ka hipoglik mijas agr nie br din juma simptomi bijuši v j k izteikti vai atš ir gi no tiem, k di rad s, lietojot iepriekš jo insul na prepar tu.
25 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
25 Hipoglik mijas d var pav jin ties pacienta koncentr šan s un reakcijas sp ja.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Pacientiem j iesaka iev rot piesardz bu, lai izvair tos no hipoglik mijas transportl dzek a vad šanas laik. paši svar gi tas ir pacientiem, kuriem ir samazin ta vai zudusi sp ja sajust hipoglik mijas br din juma simptomus vai kuriem bieži rodas hipoglik mija.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Uzs kot insul nterapiju, var att st ties t ska.
These symptoms are usually of transitory nature.
Šie simptomi parasti ir p rejoši.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions
Im n s sist mas trauc jumi Ret k - n trene, izsitumi.
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.
Visp r jas paaugstin tas jut bas simptomi var b t eneraliz ti das izsitumi, nieze, sv šana, gastrointestin li trauc jumi, angioneirotiska t ska, apgr tin ta elpošana, pa trin ta sirdsdarb ba, asinsspiediena pazemin šan s un bonis/ sama as zudums.
4.9 Overdose
26 4. 9 P rdoz šana
27 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolisms Zi ots, ka cilv ka insul nu š e insul na prote ze vai insul nu š e ošie enz mi un, iesp jams, prote nu disulf du izomer ze.
5.3 Preclinical safety data
27 5. 3 Prekl niskie dati par droš bu
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.
Ne- kl niskajos standartp t jumos ieg tie dati par farmakolo isko droš bu, atk rtotu devu toksicit ti, genotoksicit ti, iesp jamu kancerogenit ti un toksisku ietekmi uz reproduktivit ti neliecina par pašu risku cilv kam.
Keep the pen cap on in order to protect from light.
Lai pasarg tu no gaismas, turiet pildspalvveida pilnš irci ar uzliktu uzgali.
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Pildspalvveida pilnš irce (vienreiz jas lietošanas pildspalvveida pilnš irce, kur ir daudzas devas) sast v no pildspalvveida injektora un k rtridža (3 ml).
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a
K rtridžs ir gatavots no stikla (1. klase), kur ir brombutilgumijas virzulis un brombutil/ poliizopr na gumijas aizb znis.
The cartridge contains a glass ball to facilitate the re- suspension.
K rtridž ir stikla lod te suspensijas saskalošanai.
5 and 10 pre-filled pens x 3 ml.
5 vai 10 pildspalvveida pilnš irces x 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.
28 Pildspalvveida pilnš irces dr kst lietot tikai kop ar sader giem izstr d jumiem, kas auj t m funkcion t droši un efekt vi.
Insulatard NovoLet is for single person use only.
Insulatard NovoLet paredz ta tikai individu lai lietošanai.
The container must not be refilled.
To nedr kst atk rtoti uzpild t.
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.
P c Insulatard NovoLet iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard InnoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc
Renal or hepatic impairment may reduce insulin requirement.
30 Nieru vai aknu darb bas trauc jumi var mazin t vajadz bu p c insul na.
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
Devas piel gošana var b t nepieciešama ar pacientiem, kuriem main s fizisk aktivit te vai kuri maina šanas paradumus.
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Var b t j maina deva, kad pacients s k lietot citu insul na prepar tu (skat t apakšpunktu 4. 4).
Insulatard InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard InnoLet paredz ta lietošanai kop ar 8 mm vai s k m NovoFine adat m.
The needle box is marked with an S.
Uz adatu kast tes j b t apz m jumam S.
InnoLet delivers 1-50 units in increments of 1 unit.
Ar InnoLet var ievad t no 1 l dz 50 vien b m, mainot devu pa 1 vien bai.
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.
Pirms injekcijas j p rbauda pildspalvveida pilnš irces darb ba – devas selektoram j atgriežas iepretim nullei un adatas gal j par d s insul na pilienam.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), 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.
Ja, s kot
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
31 lietot Insulatard, nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai p ris pirmo ned u vai m nešu laik.
31 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
T pat k pie jebkuras insul na terapijas, injekcijas viet var b t reakcijas, ieskaitot s pes, niezi, n treni, piet kumu un iekaisumu.
32 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
32 Hipoglik mijas d var pav jin ties pacienta koncentr šan s un reakcijas sp ja.
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.
Visp r jas paaugstin tas jut bas simptomi var b t eneraliz ti das izsitumi, nieze, sv šana, gastrointestin li trauc jumi, angioneirotiska t ska, apgr tin ta elpošana, pa trin ta sirdsdarb ba, asinsspiediena pazemin šan s un bonis/ sama as zudums.
4.9 Overdose
33 4. 9 P rdoz šana
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Uzs kšan s Maksim l insul na koncentr cija plazm tiek sasniegta 2 - 18 stundu laik p c subkut nas ievad šanas.
34 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolisms Zi ots, ka cilv ka insul nu š e insul na prote ze vai insul nu š e ošie enz mi un, iesp jams, prote nu disulf du izomer ze.
5.3 Preclinical safety data
34 5. 3 Prekl niskie dati par droš bu
The cartridge contains a glass ball to facilitate the re- suspension.
K rtridž ir stikla lod te suspensijas sakalošanai.
1, 5 and 10 pre-filled pens x 3 ml.
1, 5 vai 10 pildspalvveida pilnš irces x 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.
35 Pildspalvveida pilnš irces dr kst lietot tikai kop ar sader giem izstr d jumiem, kas auj t m funkcion t droši un efekt vi.
Insulatard InnoLet is for single person use only.
Insulatard InnoLet paredz ta tikai individu lai lietošanai.
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.
P c Insulatard InnoLet iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard FlexPen 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc
Renal or hepatic impairment may reduce insulin requirement.
37 Nieru vai aknu darb bas trauc jumi var mazin t vajadz bu p c insul na.
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Var b t j maina deva, kad pacients s k lietot citu insul na prepar tu (skat t apakšpunktu 4. 4).
Insulatard FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard FlexPen paredz ta lietošanai kop ar 8 mm vai s k m NovoFine adat m.
FlexPen delivers 1-60 units in increments of 1 unit.
Ar FlexPen var ievad t no 1 l dz 60 vien b m, mainot devu pa 1 vien bai.
If an adjustment is needed when switching the patients to Insulatard, it may occur with the first dose or during the first several weeks or months.
38 lietot Insulatard, nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai p ris pirmo ned u vai m nešu laik.
38 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
T pat k pie jebkuras insul na terapijas, injekcijas viet var b t reakcijas, ieskaitot s pes, niezi, n treni, piet kumu un iekaisumu.
39 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
39 Hipoglik mijas d var pav jin ties pacienta koncentr šan s un reakcijas sp ja.
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.
Visp r jas paaugstin tas jut bas simptomi var b t eneraliz ti das izsitumi, nieze, sv šana, gastrointestin li trauc jumi, angioneirotiska t ska, apgr tin ta elpošana, pa trin ta sirdsdarb ba, asinsspiediena pazemin šan s un bonis/ sama as zudums.
4.9 Overdose
40 4. 9 P rdoz šana
41 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolisms Zi ots, ka cilv ka insul nu š e insul na prote ze vai insul nu š e ošie enz mi un, iesp jams, prote nu disulf du izomer ze.
5.3 Preclinical safety data
41 5. 3 Prekl niskie dati par droš bu
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
42 Pildspalvveida pilnš irces dr kst lietot tikai kop ar sader giem izstr d jumiem, kas auj t m funkcion t droši un efekt vi.
Insulatard FlexPen is for single person use only.
Insulatard FlexPen paredz ta tikai individu lai lietošanai.
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.
P c Insulatard FlexPen iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
BIOLO ISKI AKT V S VIELAS RAŽOT JS UN RAŽOŠANAS LICENCES PAŠNIEKS, KURŠ ATBILD PAR S RIJAS IZLAIDI
CONDITIONS OF THE MARKETING AUTHORISATION
RE ISTR CIJAS APLIEC BAS NOSAC JUMI
Name and address of the manufacturer of the biological active substance
Biolo iski akt v s vielas ražot ja nosaukums un adrese
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd D nija
Novo Nordisk A/ S Hallas Allé DK-4400 Kalundborg Denmark
Novo Nordisk A/ S Hallas Allé DK- 4400 Kalundborg D nija
Name and address of the manufacturers responsible for batch release
Ražot ju, kas atbild par s rijas izlaidi, nosaukums un adrese
Insulatard Penfill and FlexPen
Insulatard Penfill un FlexPen
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
Z u lietošanas instrukcij j uzr da ražot ja, kas atbild par attiec g s s rijas izlaidi, nosaukums un adrese.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• NOSAC JUMI UN IEROBEŽOJUMI ATTIEC B UZ PIEG DI UN LIETOŠANU, KAS UZLIKTI RE ISTR CIJAS APLIEC BAS PAŠNIEKAM
Medicinal product subject to medical prescription
Recepšu z les
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
NOSAC JUMI VAI IEROBEŽOJUMI ATTIEC B ŠO Z U LIETOŠANU
Not applicable.
Nav piem rojama.
LABELLING AND PACKAGE LEAFLET
MAR JUMA TEKSTS UN LIETOŠANAS INSTRUKCIJA
LABELLING
JUMA TEKSTS
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
OUTER CARTON
KAST TE
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 SV/ ml suspensija injekcij m flakon Insulinum humanum (rDNA)
STATEMENT OF ACTIVE SUBSTANCE
AKT V S( O) VIELAS( U) NOSAUKUMS( I) UN DAUDZUMS( I)
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
1 ml suspensijas satur 40 SV (1, 4 mg) cilv ka insul na (rDNS),
LIST OF EXCIPIENTS
PAL GVIELU SARAKSTS
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
cinka hlor du, glicer nu, metakrezolu, fenolu, n trija hidrog nfosf ta dihidr tu, n trija hidroks du, s lssk bi, protam na sulf tu un deni injekcij m.
PHARMACEUTICAL FORM AND CONTENTS
U FORMA UN SATURS
Suspension for injection 1 x 10 ml 5 x 10 ml
Suspensija injekcij m 1 x 10 ml 5 x 10 ml
METHOD AND ROUTE OF ADMINISTRATION
LIETOŠANAS METODE UN IEVAD ŠANAS VEIDS
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
U UZGLAB ŠANU B RNIEM NEPIEEJAM UN
Keep out of the reach and sight of children
Uzglab t b rniem nepieejam un neredzam viet.
OTHER SPECIAL WARNING(S), IF NECESSARY
CITI PAŠI BR DIN JUMI, JA NEPIECIEŠAMS
EXPIRY DATE
DER GUMA TERMI Š
EXP/ During use: use within 4 weeks
Lietošanas laik: izlietot 4 ned
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PAŠI PIESARDZ BAS PAS KUMI, IZN CINOT NEIZLIETOTO PREPAR TU VAI IZMANTOTOS MATERI LUS, KAS BIJUŠI SASKAR AR ŠO PREPAR TU (JA PIEM ROJAMS)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
RE ISTR CIJAS APLIEC BAS PAŠNIEKA NOSAUKUMS UN ADRESE
BATCH NUMBER
S RIJAS NUMURS
Batch:
S rija:
GENERAL CLASSIFICATION FOR SUPPLY
IZSNIEGŠANAS K RT BA
Medicinal product subject to medical prescription
Recepšu z les.
INSTRUCTIONS ON USE
NOR D JUMI PAR LIETOŠANU
INFORMATION IN BRAILLE
INFORM CIJA BRAILA RAKST
Insulatard vial 40 IU/ ml
Insulatard flakons 40 IU/ ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
VIAL LABEL
FLAKONA ETI ETE
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
U NOSAUKUMS UN IEVAD ŠANAS VEIDS
Insulatard 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 40 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
SATURA SVARS, TILPUMS VAI VIEN BU DAUDZUMS
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Insulatard 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 100 SV/ ml suspensija injekcij m flakon Insulinum humanum (rDNA)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
1 ml suspensijas satur 100 SV (3, 5 mg) cilv ka insul na (rDNS),
EXP/ During use: use within 6 weeks
Lietošanas laik: izlietot 6 ned
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
Insulatard vial 100 IU/ ml
Insulatard flakons 100 IU/ ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
Insulatard 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Suspensija injekcij m 1 x 10 ml Š ir da a no daudzdevu iepakojuma un nav paredz ta p rdošanai pa atseviš iem flakoniem.
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
55 PARTICULARS TO APPEAR ON THE PACKAGING
55 INFORM CIJA, KAS J NOR DA UZ IEPAKOJUMA
OUTER WRAPPER LABELON MULTIPACKS
R J APVILKT ETI ETE DAUDZDEVU IEPAKOJUMAM
STATEMENT OF ACTIVE SUBSTANCE
AKT V S( O) VIELAS( U) NOSAUKUMS( I) UN DAUDZUMS
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Suspensija injekcij m 5 x (1 x 10 ml) Šis ir daudzdevu iepakojums un nav paredz ta p rdošanai pa atseviš iem flakoniem.
SPECIAL STORAGE CONDITIONS
PAŠI UZGLAB ŠANAS NOSAC JUMI
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
59 PARTICULARS TO APPEAR ON THE PACKAGING
59 INFORM CIJA, KAS J NOR DA UZ IEPAKOJUMA
60 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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Insulatard Penfill 100 SV/ ml suspensija injekcij m k rtridž Insulinum humanum (rDNA)
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Suspensija injekcij m 1 x 3 ml 5 x 3 ml 10 x 3 ml
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Insulatard Penfill is for use by one person only
Insulatard Penfill ir paredz ts tikai individu lai lietošanai.
62 9.
62
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 30°C.
EU/ 1/ 02/ 233/ 005… 1 x 3 ml EU/ 1/ 02/ 233/ 006 5 x 3 ml EU/ 1/ 02/ 233/ 007 10 x 3 ml
EU/ 1/ 02/ 233/ 005… 1 x 3 ml EU/ 1/ 02/ 233/ 006 5 x 3 ml EU/ 1/ 02/ 233/ 007 10 x 3 m
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
PENFILL LABEL
PENFILL ETI ETE
Insulatard Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard Penfill 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard NovoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Suspension for injection 5 x 3 ml 10 x 3 ml
Suspensija injekcij m 5 x 3 ml 10 x 3 ml
Subcutaneous use Insulatard NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Insulatard NovoLet is for use by one person only
Insulatard NovoLet ir paredz ta tikai individu lai lietošanai.
65 9.
65
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 30°C.
EU/ 1/ 02/ 233/ 008 5 x 3 ml EU/ 1/ 02/ 233/ 009 10 X 3 ml
EU/ 1/ 02/ 233/ 008 5 x 3 ml EU/ 1/ 02/ 233/ 009 10 X 3 m
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NOVOLET LABEL
NOVOLET ETI ETE
Insulatard NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard NovoLet 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard InnoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Subcutaneous use Insulatard InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Insulatard InnoLet is for use by one person only
Insulatard InnoLet ir paredz ta tikai individu lai lietošanai.
68 9.
68
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
INNOLET LABEL
INNOLET ETI ETE
Insulatard InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard InnoLet 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard FlexPen 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Subcutaneous use
Subkut nai lietošanai.
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Insulatard FlexPen is for use by one person only
Insulatard FlexPen ir paredz ta tikai individu lai lietošanai.
71 EXP/ During use: use within 6 weeks
Lietošanas laik: izlietot 6 ned
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
FLEXPEN LABEL
FLEXPEN ETI ETE
Insulatard FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard FlexPen 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
74 PACKAGE LEAFLET:
74
INFORMATION FOR THE USER
INFORM CIJA Z
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 SV/ ml suspensija injekcij m flakon Cilv ka insul ns (insulinum humanum), rDNS
Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Pirms z u lietošanas uzman gi izlasiet visu instrukciju. – Saglab jiet šo instrukciju!
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Iesp jams, ka v l k to vajadz s p rlas t. – Ja jums rodas v l k di jaut jumi, vaic jiet savam rstam, diab ta apr pes m sai vai farmaceitam. – Š s z les ir parakst tas tieši jums.
Do not pass it on to others.
Nedodiet t s citiem.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
T s var nodar t aunumu pat tad, ja šiem cilv kiem ir l dz gi simptomi. – Ja j s nov rojat jebk das blakuspar d bas, kas šaj instrukcij nav min tas vai k da no min taj m blakuspar d b m jums izpaužas smagi, l dzu izst stiet to savam rstam, diab ta apr pes m sai vai farmaceitam.
WHAT INSULATARD IS AND WHAT IT IS USED FOR
KAS IR INSULATARD UN K DAM NOL KAM TO LIETO
Insulatard is human insulin to treat diabetes.
Insulatard ir cilv ka insul ns diab ta rst šanai.
Insulatard is a long-acting insulin.
Insulatard ir ilgstošas darb bas insul ns.
This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours.
Tas noz m, ka Insulatard s ks pazemin t j su glikozes l meni asin s apm ram p c 1 ½ stundas p c t ievad šanas un darb ba ilgs, apm ram, 24 stundas.
Insulatard is often given in combination with fast-acting insulin products.
Insulatard bieži noz m kop ar tras darb bas insul na prepar tiem.
BEFORE YOU USE INSULATARD
PIRMS INSULATARD LIETOŠANAS
Do not use Insulatard
Nelietojiet Insulatard š dos gad jumos
► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Ja jums ir aler ija (paaugstin ta jut ba) pret šo insul nu, metakrezolu vai k du citu sast vda u (skat t 7.
Look out for the signs of allergy in 5 Possible side effects ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Ja j s saj tat hipoglik mijas tuvošanos (zema glikozes l me a asin s simptomus).
See 4 What to do in an emergency for more about hypos.
K r koties neatliekam situ cij.
Take special care with Insulatard
paša piesardz ba, lietojot Insulatard, nepieciešama š dos gad jumos
► 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 stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Ja j s dodaties uz rvalst m: laika zonu starp ba daž d s valst s ietekm s nepieciešam bu p c insul na un ievad šanas laiku.
Using other medicines
Citu z u lietošana
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
Daudzi medikamenti ietekm glikozes darb bu organism un tie var ietekm t j su insul na devu.
Listed below are the most common medicines which may affect your insulin treatment.
T l k uzskait ti izplat t kie medikamenti, kuri var ietekm t j su rst šanu ar insul nu.
Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Past stiet savam rstam vai farmaceitam par vis m z l m, kuras lietojat vai p d j laik esat lietojis, ieskaitot z les, ko var ieg d ties bez receptes.
Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Nepieciešam ba p c insul na var main ties, ja lietojat: peror los pretdiab ta l dzek us, monoam noksid zes inhibitorus (MAOI), beta blokatorus, AKE inhibitorus, acetilsalicilsk bi, anabolos stero dus, sulfonam dus, peror los pretapaug ošan s l dzek us, tiaz dus, glikokortiko dus, vairogdziedzera hormonus, beta simpatomim tiskos l dzek us, augšanas hormonu, danazolu, oktreot du un lanreot du.
Pregnancy and breast-feeding
75 Gr tniec ba un z d šanas periods
75 If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Ja esat gr tniece, pl nojat gr tniec bu vai barojat ar kr ti: l dzu, konsult jieties ar savu rstu.
Driving and using machines
Transportl dzek u vad šana un meh nismu apkalpošana
If you drive or use tools or machines: watch out for signs of a hypo.
Ja j s vad t transportl dzek us vai apkalpojat iek rtas vai meh nismus: paturiet pr t hipoglik mijas simptomu iesp jam bu.
Your ability to concentrate or to react will be less during a hypo.
J su sp jas koncentr ties vai rea t hipoglik mijas laik var pav jin ties.
Never drive or use machinery if you feel a hypo coming on.
Nekad nevadiet transportl dzekli un neapkalpojiet meh nismus, ja saj tat hipoglik mijas simptomu tuvošanos.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Konsult jieties ar savu rstu, vai j s varat vad t transportl dzekli vai apkalpot meh nismus, ja jums bieži rodas hipoglik mija vai hipoglik mijas br din juma paz mes ir v ji izteiktas.
HOW TO USE INSULATARD
K LIETOT INSULATARD
Talk about your insulin needs with your doctor and diabetes nurse.
Jums j konsult jas ar savu rstu vai diab ta apr pes m su par j su insul na nepieciešam bu.
Follow their advice carefully.
R p gi iev rojiet vi u nor d jumus.
This leaflet is a general guide.
Šaj lietošanas instrukcij ir visp r ja inform cija.
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.
Ja rsts jums nomaina iepriekš lietoto insul na tipu vai t z molu uz citu, rstam deva var b t j piel go.
It is recommended that you measure your blood glucose regularly.
Jums ir ieteicams regul ri m r t glikozes l meni asin s.
Before using Insulatard
Pirms lietojat Insulatard
► Check the label to make sure it is the right type of insulin ► Disinfect the rubber membrane with a medicinal swab.
Dezinfic jiet gumijas membr nu ar medic nisko salveti.
Do not use Insulatard
Nelietojiet Insulatard
► In insulin infusion pumps ► If the protective cap is loose or missing.
Ja plastmasas aizsargv ci š ir va gs vai t nav.
Each vial has a protective, tamper-proof plastic cap.
Ja, sa emot flakonu, tas nav lab st vokl, atdodiet to pieg d t jam.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Insulatard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
How to use this insulin
K lietot šo insul nu
Insulatard is for injection under the skin (subcutaneously).
Insulatard ir paredz ts injic šanai zem das (subkut ni).
Never inject your insulin directly into a vein or muscle.
Insul nu nedr kst injic t v n vai muskul.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Injekcijas vieta ir j maina, lai izvair tos no sabiez jumu rašan s d (skat t 5.
The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms may be used.
Ja injekciju izdar t pats, piem rot k vieta insul na ievad šanai ir v dera priekš j sien, s žas apvid un augšstilbu vai augšdelmu priekšpus.
Your insulin will work more quickly if you inject it around the waist.
Insul ns iedarbosies tr k, ja injic siet viduk a apvid.
Insulatard vials are for use with insulin syringes with the corresponding unit scale.
Insulatard flakoni j lieto kop ar insul na š irc m, kam ir atbilstoša vien bu skala.
To inject Insulatard on its own
Ja lietojat tikai Insulatard
Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly white and cloudy.
Tieši pirms š insul na injic šanas pavirpiniet flakonu plaukst s, l dz š idrums ir k uvis vienm r gi balts un du ains.
Inject straight away.
Injic jiet nekav joties.
Roll the vial of Insulatard between your hands.
Pavirpiniet Insulatard flakonu plaukst s.
Do this until the liquid is uniformly white and cloudy.
Dariet to, l dz š idrums ir k uvis vienm r gi balts un du ains.
Draw as much air into the syringe as the dose of Insulatard you need.
Ievelciet š irc Insulatard devai atbilstošu gaisa daudzumu.
Draw as much air into the syringe as the dose of fast-acting insulin you need.
Ievelciet š irc jums nepieciešamajai tras darb bas insul na devai atbilstošu gaisa daudzumu.
Inject the air into the fast-acting insulin vial.
Ievadiet gaisu flakon ar tras darb bas insul nu.
Draw the right dose of fast-acting insulin into the syringe.
Ievelciet š irc nepieciešamo tras darb bas insul na devu.
Make sure there is no air left in the syringe: point the needle upwards and push the air out.
P rliecinieties, vai š irc nav palicis gaiss: pagrieziet ar adatu uz augšu un izspiediet gaisu.
Now push the needle into the vial of Insulatard.
Ieduriet adatu Insulatard flakon.
Draw the right dose of Insulatard into the syringe.
Ievelciet š irc nepieciešamo Insulatard devu.
Pull the needle out of the vial.
P rliecinieties, vai š irc nav palicis gaiss, un p rbaudiet devu.
Inject the mixture straight away.
Nekav joties injic jiet mais jumu.
Always mix fast-acting and long-acting insulin in this order.
tras darb bas un ilgstošas darb bas insul nu vienm r sajauciet š d sec b.
Inject the insulin
Insul na injic šana
► Inject the insulin under the skin.
Insul ns j injic zem das.
Use the injection technique advised by your doctor or diabetes nurse ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Paturiet adatu zem das vismaz 6 sekundes, lai b tu droši, ka ievad ta visa deva.
WHAT TO DO IN AN EMERGENCY
K R KOTIES NEATLIEKAM SITU CIJ
If you get a hypo
Ja jums ir hipoglik mija
A hypo means your blood sugar level is too low.
Hipoglik mija noz m p r k zemu glikozes l meni asin s.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
T s var b t š das: auksti sviedri, v sa, b la da, galvass pes, pa trin ta sirdsdarb ba, slikta pašsaj ta, liels izsalkums, slaic gas redzes izmai as, miegain ba, neparasts nogurums un v jums, nervozit te vai tr ce, trauksmes saj ta, apjukums, apgr tin ta sp ja koncentr ties.
If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Ja jums rodas k da no š m paz m m, ap diet glikozes tabletes vai produktu, kura sast v ir cukurs (saldumus, cepumus, aug u sulu), tad atp tieties.
Don’ t take any insulin if you feel a hypo coming on.
Neinjic jiet insul nu, ja j tat hipoglik mijas tuvošanos.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Katram gad jumam n s jiet l dzi glikozes tabletes, saldumus, cepumus vai aug u sulu.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
Izst stiet saviem radiniekiem, draugiem un tuv kajiem kol iem, ka gad jum, ja jums iest jas bezsama a, vi iem j pagriež j s uz s niem un nekav joties j mekl medic niska pal dz ba.
They must not give you any food or drink as it could choke you. ► If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death ► If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Ja jums bijusi hipoglik mija ar bezsama u vai hipoglik mijas jums ir bieži, aprun jieties ar savu rstu.
The amount or timing of insulin, food or exercise may need to be adjusted.
Var b t nepieciešams piel got insul na devu, ievad šanas laiku, uzturu vai fizisko slodzi.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
J s atg sieties no bezsama as tr k, ja k ds, kurš zina, k ar to r koties, jums injic s hormonu glikagonu.
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Ja jums injic ts glikagons, uzreiz p c sama as atg šanas j ap d glikoze vai produkts, kura
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Ja nerea jat uz glikagona terapiju, j s j rst stacion r.
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
P c glikagona injekcijas mekl jiet medic nisku padomu, lai konstat tu hipoglik mijas c loni un nov rstu t s atk rtošanos.
Causes of a hypo
Hipoglik mijas c lo i
77 You get a hypo if your blood sugar gets too low.
Jums ir hipoglik mija, ja glikozes l menis asin s ir p r k zems.
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
Tas var notikt: • ja esat ievad jis p r k daudz insul na, • ja esat par maz dis vai dienreize ir izlaista, • ja fizisk slodze ir liel ka nek parasti.
If your blood sugar gets too high
Ja glikozes l menis j su asin s stipri paaugstin s
Your blood sugar may get too high (this is called hyperglycaemia).
Glikozes l menis j su asin s var stipri paaugstin ties (to sauc par hiperglik miju).
The warning signs appear gradually.
Br din juma paz mes par d s pak peniski.
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
T s ir š das: biež ka urin cija, sl pes, stgribas zudums, slikta pašsaj ta (slikta d ša vai vemšana), miegain ba vai nogurums, pies rtusi, sausa da, sausuma saj ta mut un aug u (acetona) smarža elp.
Then seek medical advice straight away.
Ja jums rodas k da no š m paz m m, p rbaudiet glikozes l meni asin s; ja iesp jams, nosakiet ketonvielu kl tb tni ur n; nekav joties mekl jiet medic nisku pal dz bu.
These may be signs of a very serious condition called diabetic ketoacidosis.
T s var b t oti nopietna st vok a, ko sauc par diab tisko ketoacidozi, paz mes.
If you don’ t treat it, this could lead to diabetic coma and death.
Ja j s to ne rst siet, var iest ties diab tisk koma un n ve.
Causes of hyperglycaemia
Hiperglik mijas c lo i
• 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.
• Aizmirstat ievad t insul nu. • Atk rtoti ievad t maz k insul na nek jums nepieciešams. • Infekcijas slim ba vai drudzis. • dat vair k nek parasti. • Fizisk slodze ir maz ka nek parasti.
POSSIBLE SIDE EFFECTS
IESP JAM S BLAKUSPAR D BAS
Like all medicines, Insulatard can cause side effects, although not everybody gets them.
T pat k citas z les, Insulatard var izrais t blakuspar d bas, kaut ar ne visiem t s izpaužas.
Insulatard may cause hypoglycaemia (low blood sugar).
Insulatard var izrais t hipoglik miju (zems glikozes l menis asin s).
See the advice in 4 What to do in an emergency.
K r koties neatliekam situ cij.
Side effects reported uncommonly (in less than 1 patient in 100)
(maz k nek 1 pacientam no 100)
Changes at the injection site (Lipodystrophy).
Izmai as injekcijas viet (lipodistrofija).
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Ja injekciju izdar t pats, p r k bieži injic jot vien un taj paš viet, taukaudi zem das šaj viet var sarukt (lipoatrofija) vai sabiez t (lipohipertrofija).
Changing the site with each injection may help to prevent such skin changes.
Mainot injekcijas vietu katrai injekcijai, var pal dz t izvair ties no š d m das izmai m.