qanastek/EMEA-V3 huggingface dataset:
If you may have taken more Inovelon than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
Ja esat lietojis Inovelon vairāk nekā noteikts, nekavējoties pastāstiet par to savam aprūpētājam (radiniekam vai draugam), ārstam vai farmaceitam vai griezieties neatliekamās palīdzības nodaļā, līdzi ņemot savas zāles.
You may become sleepy and could lose consciousness.
Jūs varat kļūt miegains vai zaudēt samaņu.
Do not drive at this time.
Šajā laikā Jūs nedrīkstat vadīt transportlīdzekli.
If you forget to take Inovelon
Ja esat aizmirsis lietot INOVELON
If you forget to take a dose, continue taking your medicine as normal.
Ja esat aizmirsis lietot vienu devu, turpiniet lietot zāles kā parasti.
Do not take a double dose to make up for forgotten dose.
Nelietojiet dubultu devu, lai aizvietotu aizmirsto devu.
If you miss more than one dose, seek advice from your doctor.
Ja esat izlaidis vairāk kā vienu devu, griezieties pie sava ārsta
If you stop taking Inovelon
Ja Jūs pārtraucat lietot INOVELON
If your doctor advises you to stop treatment, follow your doctor’ s instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
Ja ārsts iesaka pārtraukt ārstēšanu, ievērojiet ārsta norādījumus pakāpeniskai Inovelon devu mazināšanai, lai novērstu lēkmju biežākas atkārtošanās risku.
Like all medicines, Inovelon can cause side effects, although not everybody gets them.
Tāpat kā citas zāles, Inovelon var izraisīt blakusparādības, kaut arī ne visiem tās izpaužas.
Tell your doctor if you have any of the following and if they are too uncomfortable for you:
Pastāstiet ārstam, ja Jums izpaužas kāda no turpmāk minētajām blakusparādībām, un ja tās ir Jums pārāk nepatīkamas.
Very common (more than 1 in 10 patients) side effects of Inovelon are:
Ļoti bieži (vairāk kā 1 no 10 pacientiem) Inovelon blakusparādības ir:
Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
reibonis, galvassāpes, nelabums, vemšana, miegainība, nogurums.
Less commonly reported (more than 1 in a 100 patients) side effects of Inovelon are:
Retāk minētās (vairāk kā 1 no 100 pacientiem) Inovelon blakusparādības ir:
Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/ seizures, unusual eye movements, blurred vision, trembling.
Ar nerviem saistītas problēmas: pārvietošanās grūtības, anormālas kustības, krampji/ lēkmes, savādas acu kustības, neskaidra redze, trīsas.
Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Ar vēderu saistītas problēmas: sāpes vēderā, aizcietējums, gremošanas traucējumi, mīksta vēdera izeja( caureja), izmainīta apetīte vai apetītes zudums, svara zudums.
Ear infection, flu, nasal congestion, chest infection.
Infekcijas: auss infekcijas, gripa, aizlikts deguns, krūšu kurvja infekcijas.
In addition patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury.
Vēl pacientiem bija: nemiers, bezmiegs, deguna asiņošana, pūtītes, izsitumi, sāpes mugurā, retas menstruācijas, sasitumi, galvas traumas.
48 Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are:
Retākas (diapazonā 1 no 100 pacientiem un 1 no 1000 pacientiem) Inovelon blakusparādības ir:
Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
alerģiskas reakcijas un paaugstināti aknu funkciju marķieri (palielināti aknu fermentu rādītāji).
HOW TO STORE INOVELON
KĀ UZGLABĀT INOVELON
Keep Inovelon out of the reach and sight of children.
Uzglabāt bērniem nepieejamā un neredzamā vietā.
Do not use Inovelon after the expiry date which is stated on the blister and carton.
48 Nelietot Inovelon pēc derīguma termiņa beigām, kas norādīts uz blistera un kastītes.
Do not use Inovelon if you notice a change in colour of the tablets.
Nelietojiet Inovelon, ja pamanāt tablešu krāsas maiņu.
What Inovelon contains
Ko Inovelon satur
- The active substance is rufinamide.
- Aktīvā viela ir rufinamīds
Each Inovelon 100 mg film-coated tablet contains 100 mg of rufinamide.
Katra Inovelon 100 mg apvalkotā tablete satur 100 mg rufinamīda.
Each Inovelon 200 mg film-coated tablet contains 200 mg of rufinamide.
Katra Inovelon 200 mg apvalkotā tablete satur 200 mg rufinamīda.
Each Inovelon 400 mg film-coated tablet contains 400 mg of rufinamide.
Katra Inovelon 400 mg apvalkotā tablete satur 400 mg rufinamīda.
croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Citas sastāvdaļas ir laktozes monohidrāts, mikrokristāliskā celuloze, kukurūzas ciete, kroskarmelozes nātrija sāls, hipromeloze, magnija stearāts, nātrija laurilsufāts, koloidālais bezūdens silīcija dioksīds.
The film-coating consists of Opadry 00F44042 [hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172)].
Tabletes apvalks sastāv no Opadry 00F44042 [hipermellozes, makrogola (8000), titāna dioksīda (E171), talka, sarkanā dzelzs oksīda (E172)].
What Inovelon looks like and contents of the pack
Inovelon ārējais izskats un iepakojums:
• Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 261’ on one side and blank on the other side.
• Inovelon 100 mg tabletes ir sārtas, ovālas, nedaudz izliektas apvalkotas tabletes ar dalījuma līniju abās pusēs un marķējumu ‘ Є261 ’ vienā tabletes pusē, otra puse bez marķējuma.
They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Tās ir pieejamas iepakojumos pa 10, 30, 50, 60 un 100 apvalkotām tabletēm.
• Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 262’ on one side and blank on the other side.
• Inovelon 200 mg tabletes ir sārtas, ovālas, nedaudz izliektas apvalkotas tabletes ar dalījuma līniju abās pusēs un marķējumu ‘ Є262 ’ vienā tabletes pusē, otra puse bez marķējuma.
• Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є 263’ on one side and blank on the other side.
• Inovelon 400 mg tabletes ir sārtas, ovālas, nedaudz izliektas apvalkotas tabletes ar dalījuma līniju abās pusēs un marķējumu ‘ Є263 ’ vienā tabletes pusē, otra puse bez marķējuma.
They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Tās ir pieejamas iepakojumos pa 10, 30, 50, 60, 100 un 200 apvalkotām tabletēm.
Eisai Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, UK.
Eisai Ltd., Mosquito Way, Hatfield, Herts, AL10 9SN, Lielbritānija.
49 Manufacturer:
Ražotājs:
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom
Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts, AL10 9SN, Lielbritānija
Detailed information on this product is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu
Sīkāka informācija par šo produktu ir pieejama Eiropas Zāļu aģentūras (EMEA) mājas lapā http: // www. emea. europa. eu
What is Insulatard?
Kas ir Insulatard?
Insulatard is a range of insulin suspensions for injection.
Insulatard ir insulīna injekcijas suspensijas.
Insulatard is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Insulatard piegādā pudelītēs, kasetnēs (Penfill) vai iepriekš uzpildītos pildspalvinjektoros (InnoLet, NovoLet un FlexPen).
Insulatard contains the active substance insulin human (rDNA).
Insulatard aktīvā viela ir cilvēka insulīns (rDNS).
What is Insulatard used for?
Kāpēc lieto Insulatard?
Insulatard is used in patients with diabetes.
Insulatard lieto diabēta slimnieki.
How is Insulatard used?
Kā lieto Insulatard?
Insulatard is given subcutaneously (under the skin) by injection, usually in the thigh.
Insulatard ievada subkutāni (zem ādas), parasti injicējot augšstilbā.
If convenient, it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Ērtības labad to var ievadīt arī vēdera sienā, sēžas muskulī vai deltveida muskulī pleca apvidū.
It can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Insulatard ir ilgas darbības insulīns, to var ievadīt kā injekciju vienreiz vai divreiz dienā kopā ar ātras darbības insulīnu (ēdienreizēs) vai bez tā, ievērojot ārsta ieteikumus.
How does Insulatard work?
Kā Insulatard darbojas?
Insulatard is a replacement insulin which identical to the insulin made by the pancreas.
Insulatard ir insulīna aizvietotājs, kas ir identisks insulīnam, ko ražo aizkuņģa dziedzeris.
The active substance in Insulatard, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Insulatard aktīvo vielu, cilvēka insulīnu (rDNS), ražo, izmantojot tā dēvēto „ rekombinanto tehnoloģiju ”: to producē rauga šūnas, kurās ir ievadīts gēns (DNS), kas nodrošina insulīna sintēzi.
Insulatard contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Insulatard „ izofāna ” formā satur insulīnu maisījumā ar citu vielu, protamīnu; Insulatard uzsūcas lēnāk, visas dienas garumā.
This gives Insulatard a longer duration of action.
Tas nodrošina Insulatard ilgāku iedarbību.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Insulīna aizvietotājs darbojas tāpat kā dabīgais insulīns, palīdzot glikozei no asinīm iekļūt šūnās.
How has Insulatard been studied?
Kā noritēja Insulatard izpēte?
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Insulatard izmantoja četros klīniskajos pamatpētījumos, kas kopā aptvēra 557 pacientus ar 1. tipa diabētu, kad aizkuņģa dziedzeris nespēj ražot insulīnu (2 pētījumi, 81 pacients), vai 2. tipa diabētu, kad organisms nespēj efektīvi izmantot insulīnu (2 pētījumi, 476 pacienti).
In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Vairākumā gadījumu Insulatard tika salīdzināts ar citiem cilvēka insulīna tipiem vai insulīna analogiem.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged labi tiek regulēts glikozes līmenis asinīs.
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Vēl tika veikti salīdzinoši pētījumi ar 225 pacientiem, kam injicēja Insulatard ar šļirci vai pildspalvinjektoru (InnoLet, NovoPen vai FlexPen).
What benefit has Insulatard shown during the studies?
Kāds ir Insulatard iedarbīgums šajos pētījumos?
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Insulatard pazemināja HbA1c līmeni, kas norāda uz to, ka cukura līmenis asinīs ir līdzīgā līmenī, kādu novēroja pēc citu cilvēka insulīnu lietošanas.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Insulatard bija efektīvs kā 1., tā arī 2. tipa diabēta ārstēšanā, gan izmantojot šļirci, gan kādu no injektoriem.
What is the risk associated with Insulatard?
Kāds pastāv risks, lietojot Insulatard?
As with all insulins, Insulatard may cause hypoglycaemia (low blood glucose).
Tāpat kā visi insulīni, Insulatard var izraisīt hipoglikēmiju (zemu glikozes līmeni asinīs).
For the full list of all side effects reported with Insulatard, see the Package Leaflet.
Pilns Insulatard izraisītu blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
Insulatard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Insulatard nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģiju) pret cilvēka insulīnu (rDNS) vai kādu citu šo zāļu sastāvdaļu.
Insulatard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Ievadot tās kopā ar dažām citām zālēm, kas var ietekmēt cukura līmeni asinīs, Insulatard deva ir jāpielāgo.
The full list is available in the Package Leaflet.
Pilns zāļu saraksts ir atrodams lietošanas pamācībā.
Why has Insulatard been approved?
Kāpēc Insulatard tika apstiprināts?
The Committee for Medicinal products for Human Use (CHMP) decided that Insulatard’ s benefits are greater than its risks for the treatment of diabetes.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka ieguvumi, ārstējot diabētu ar Inslatard, ir lielāki nekā to radītais risks.
The Committee recommended that Insulatard be given marketing authorisation.
Komiteja ieteica izsniegt Insulatard reģistrācijas apliecību.
Other information about Insulatard:
Cita informācija par Insulatard Eiropas Komisija 2002. g.
The marketing authorisation was renewed on 7 October 2007.
7. oktobrī izsniedza Insulatard reģistrācijas apliecību, kas ir derīga visā Eiropas Savienībā, uzņēmumam Novo Nordisk A/ S.
The full EPAR for Insulatard is available here.
Pilns Insulatard EPAR teksts ir atrodams šeit.
Invented Name
Izgudrotais nosaukums
EU/ 1/ 02/ 233/ 001 EU/ 1/ 02/ 233/ 002 EU/ 1/ 02/ 233/ 003 EU/ 1/ 02/ 233/ 004 EU/ 1/ 02/ 233/ 005 EU/ 1/ 02/ 233/ 006 EU/ 1/ 02/ 233/ 007
EU/ 1/ 02/ 233/ 001 EU/ 1/ 02/ 233/ 002 EU/ 1/ 02/ 233/ 003 EU/ 1/ 02/ 233/ 004 EU/ 1/ 02/ 233/ 005 EU/ 1/ 02/ 233/ 006 EU/ 1/ 02/ 233/ 007 EU/ 1/ 02/ 233/ 008
Insulatard Insulatard Insulatard Insulatard Insulatard Penfill Insulatard Penfill Insulatard Penfill
Insulatard Insulatard Insulatard Insulatard Insulatard Penfill Insulatard Penfill Insulatard Penfill Insulatard NovoLet
40 IU/ ml 40 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml 100 IU/ ml
40 SV/ ml 40 SV/ ml 100 SV/ ml 100 SV/ ml 100 SV/ ml 100 SV/ ml 100 SV/ ml 100 SV/ ml
Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection
Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām Suspensija injekcijām
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai Subkutānai lietošanai
Vial (glass) Vial (glass) Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
Flakons (stikls) Flakons (stikls) Flakons (stikls) Flakons (stikls) Kārtridžs (stikls) Kārtridžs (stikls) Kārtridžs (stikls) Kārtridžs (stikls) pildspalvveida pilnšļircē
10ml (1.4 mg/ ml) 10 ml (1.4 mg/ ml) 10 ml (3.5 mg/ ml) 10 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml)
10 ml (1. 4 mg/ ml) 10 ml (1. 4 mg/ ml) 10 ml (3. 5 mg/ ml) 10 ml (3. 5 mg/ ml) 3 ml (3. 5 mg/ ml) 3 ml (3. 5 mg/ ml) 3 ml (3. 5 mg/ ml) 3 ml (3. 5 mg/ ml)
1 vial 5 vials 1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
1 flakons 5 flakoni 1 flakons 5 flakoni 1 kārtridžs 5 kārtridži 10 kārtridži 5 pildspalvveida pilnšļirces
Cartridge (glass) in 3 ml (3.5 mg/ ml) pre-filled pen
3 ml (3. 5 mg/ ml)
Cartridge (glass) in 3 ml(3.5 mg/ ml) pre-filled pen
3 ml (3. 5 mg/ ml)
EU/ 1/ 02/ 233/ 015
1/ 2 EU/ 1/ 02/ 233/ 015
EU/ 1/ 02/ 233/ 016
EU/ 1/ 02/ 233/ 016 EU/ 1/ 02/ 233/ 017
Insulatard
Insulatard Insulatard
40 IU/ ml
40 SV/ ml 100 SV/ ml
Suspension for injection
Suspensija injekcijām Suspensija injekcijām
Subcutaneous use
Subkutānai lietošanai Subkutānai lietošanai
vial (glass) 10 ml (1.4 mg/ ml)
Flakons (stikls) Flakons (stikls)
vial (glass) 10 ml (3.5 mg/ ml)
10 ml (1. 4 mg/ ml) 10 ml (3. 5 mg/ ml)
5 x (1 x 10 ml) vials
5 x 1 flakons 5 x 1 flakons
SUMMARY OF PRODUCT CHARACTERISTICS
Z U APRAKSTS
NAME OF THE MEDICINAL PRODUCT
U NOSAUKUMS
Insulatard 40 IU/ ml suspension for injection in a vial.
Insulatard 40 SV/ ml suspensija injekcij m flakon
QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITAT VAIS UN KVANTITAT VAIS SAST VS
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Cilv ka insul ns (insulinum humanum), rDNS (ieg ts ar rekombinantas DNS tehnolo ijas pal dz bu no Saccharomyces cerevisiae).
1 ml contains 40 IU of insulin human.
1 ml satur 40 SV cilv ka insul na.
1 vial contains 10 ml equivalent to 400 IU.
1 flakon ir 10 ml, kas atbilst 400 SV.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Viena SV (starptautisk vien ba) atbilst 0, 035 mg bez dens cilv ka insul na.
Insulatard is a suspension of isophane (NPH) insulin.
Insulatard ir izof na (NPH) insul na suspensija.
For a full list of excipients, see section 6.1.
Pilnu pal gvielu sarakstu skat t apakšpunkt 6. 1.
PHARMACEUTICAL FORM
U FORMA
Suspension for injection in a vial.
Suspensija injekcij m flakon.
Cloudy, white, aqueous suspension.
Du aina, balta dens suspensija.
CLINICAL PARTICULARS
KL NISK INFORM CIJA
4.1 Therapeutic indications
4. 1 Terapeitisk s indik cijas
Treatment of diabetes mellitus.
Cukura diab ta rst šana.
Insulatard is a long-acting insulin.
Insulatard ir ilgstošas darb bas insul na prepar ts.
Dosage Dosage is individual and determined in accordance with the needs of the patient.
Devas Devas ir individu las un tiek noz m tas, emot v r pacienta nepieciešam bu p c insul na.
The individual insulin requirement is usually between 0.3 and 1.0 IU/ kg/ day.
Individu l nepieciešam ba p c insul na parasti ir robež s no 0, 3 l dz 1, 0 SV / kg dien.
The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Dien nepieciešamais insul na daudzums var b t liel ks pacientiem, kuriem ir rezistence pret insul nu (piem ram, pubert tes laik vai aptaukošan s d), un maz ks pacientiem, kuriem ir saglab jusies endog n insul na produkcija.
The physician determines whether one or several daily injections are necessary.
rsts nosaka, vai dien nepieciešama viena vai vair kas injekcijas.
Insulatard may be used alone or mixed with fast-acting insulin.
Insulatard var lietot vienu pašu vai sajaucot kop ar tras darb bas insul na prepar tu.
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
Intensific t s insul nterapijas ietvaros suspensiju var izmantot par baz lo insul nu (vakara un/ vai r ta injekcija) ar tras darb bas insul na prepar tu, ko ievada saist b ar dienreiz m.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
Pacientiem ar cukura diab tu laba vielmai as kompens cija aizkav v l no diab ta komplik ciju rašanos.
Close blood glucose monitoring is therefore recommended.
T d ieteicams prec zi kontrol t glikozes l meni asin s.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Devas piel gošana Vienlaic gas citas slim bas, paši infekcijas un drudža gad jum, pacientam nepieciešam ba p c insul na parasti palielin s.
Renal or hepatic impairment may reduce insulin requirement.
2 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.
Iesp jams, deva b s j piel go ar pacientiem, kuriem main s fizisk aktivit te vai kuri maina šanas paradumus.
2 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).
Administration For subcutaneous use.
Lietošanas veids Subkut nai lietošanai.
Insulin suspensions are never to be administered intravenously.
Insul na suspensijas nek d gad jum nedr kst ievad t intravenozi.
Insulatard is administered subcutaneously in the thigh.
Insulatard ievada subkut ni augšstilb.
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
Ja ir rti, var injic t ar v dera priekš j sien, s žas vai deltveida musku a apvid.
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
P c subkut nas injekcijas augšstilb uzs kšan s ir l n ka un maz k main ga nek p c ievad šanas cit s injekciju viet s.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Injic šana pacelt das krok mazina neparedz tas intramuskul ras injic šanas risku.
The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Paturiet adatu zem das vismaz 6 sekundes, lai b tu droši, ka visa deva ir injic ta.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
Lai izvair tos no lipodistrofijas, injekcijas vietas viena anatomisk apvidus robež s j maina.
The vials are for use with insulin syringes with a corresponding unit scale.
Flakoni paredz ti lietošanai kop ar insul na š irc m, kam ir atbilstoša vien bu skala.
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Sajaucot kop divu veidu insul na prepar tus, vispirms š irc ievelciet nepieciešamo tras darb bas insul na daudzumu, bet p c tam – ilgstošas darb bas insul nu.
Insulatard is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulatard iepakojum ir lietošanas instrukcija ar detaliz tiem nor d jumiem, kas j em v r.
4.3 Contraindications
4. 3 Kontrindik cijas
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Paaugstin ta jut ba pret akt vo vielu vai jebkuru no pal gviel m (skat t apakšpunktu 6. 1).
Hypoglycaemia.
Hipoglik mija.
4.4 Special warnings and precautions for use
4. 4 paši br din jumi un piesardz ba lietošan
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Nepietiekamu devu lietošana vai terapijas p rtraukšana, paši 1. tipa cukura diab ta pacientiem, var izrais t hiperglik miju.
Usually, the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Pirmie hiperglik mijas simptomi parasti att st s pak peniski vair ku stundu vai dienu laik.
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.
Var b t sl pes, biež ka urin cija, slikta d ša, vemšana, miegain ba, pies rtusi, sausa da, sausuma saj ta mut, stgribas zudums, k ar acetona smarža elp.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Ne rst ta hiperglik mija 1. tipa cukura diab ta slimniekam izraisa diab tisko ketoacidozi, kas var beigties let li.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Hipoglik mija var rasties, ja insul na deva attiec b pret nepieciešam bu ir p r k liela (skat t apakšpunktu 4. 8 un 4. 9). dienreizes izlaišana vai nepl nota, liela fiziska slodze var izrais t hipoglik miju.
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 accordingly.
Pacientiem, kuru glikozes l me a kontrole asin s ir stipri uzlabojusies, piem ram, intensific tas insul nterapijas d, var main ties hipoglik mijas br din juma simptomi un pacienti par to j br dina.
Usual warning symptoms may disappear in patients with longstanding diabetes.
Pacientiem, kuriem cukura diab ts ir ilgstoši, parastie br din juma simptomi var izzust.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Cita tipa vai cita z mola insul ns pacientam j s k lietot stingr medi u uzraudz b.
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.
Mainot lietojam insul na koncentr ciju, z molu (ražot ju), tipu (tras darb bas, div j das darb bas, ilgstošas darb bas insul na prepar ts utt.), izcelsmi (dz vnieku, cilv ka vai insul na analogs) un/ vai ražošanas metodi (rekombinants DNS pret dz vnieku cilmes insul nu), var rasties vajadz ba main t t devu.
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.
Ja, s kot lietot Insulatard, nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai p ris pirmo ned u vai m nešu laik.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
3 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 samazin t vai nov rst š s reakcijas.
Reactions usually resolve in a few days to a few weeks.
Reakcijas parasti izz d dažu dienu vai ned u laik.
On rare occasions, injection site reactions may require discontinuation of Insulatard.
Retos gad jumos reakcijas injekcijas viet var pras t Insulatard terapijas p rtraukšanu.
3 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.
Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Pirms ce ošanas pacientam v lams konsult ties ar rstu, jo laika zonu starp ba daž d s valst s iespaidos insul na ievad šanas un dienreižu laiku.
Insulin suspensions are not to be used in insulin infusion pumps.
Insul na suspensijas nedr kst lietot insul na inf zijas s k os.
Insulatard contains metacresol, which may cause allergic reactions.
Insulatard sast v ir metakrezols, kas var izrais t aler iskas reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
Zin mi daudzi medikamenti, kas mijiedarbojas ar glikozes vielmai u, t d rstam j em v r iesp jam mijiedarb ba un vienm r j izvaic pacients par vis m lietotaj m z l m.
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
Nepieciešam bu p c insul na var mazin t š das vielas: peror lie hipoglikemiz jošie l dzek i (PHL), monoam noksid zes inhibitori (MAOI), neselekt vie beta blokatori, angiotens na konvert još enz ma (AKE) inhibitori, salicil ti, alkohols, anabolie stero di un sulfonam di.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Nepieciešam bu p c insul na var palielin t š das vielas: peror lie pretapaug ošan s l dzek i, tiaz di, glikokortiko di, vairogdziedzera hormoni un beta simpatomim tiskie l dzek i, augšanas hormons un danazols.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
Beta blokatori var mask t hipoglik mijas simptomus un kav t atlabšanu p c hipoglik mijas.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
Oktreot ds/ lanreot ds var gan mazin t, gan palielin t nepieciešam bu p c insul na.
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
Alkohols var pastiprin t un paildzin t insul na hipoglik misko darb bu.
4.6 Pregnancy and lactation
4. 6 Gr tniec ba un z d šana
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Nav ierobežojumu diab ta rst šanai ar insul nu gr tniec bas laik, jo insul ns neš rso placent ro barjeru.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero.
Gan hipoglik mija, gan hiperglik mija, kas var rasties nepietiekami kontrol tas diab ta terapijas laik, palielina iedzimtu kropl bu un n ves in utero risku.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
T d sieviet m ieteicama pastiprin ta diab ta rst šanas kontrole visu gr tniec bas laiku un tad, ja pl no gr tniec bu.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
Nepieciešam ba p c insul na parasti mazin s pirmaj trimestr un p c tam palielin s otraj un trešaj trimestr.
After delivery, insulin requirements return rapidly to pre-pregnancy values.
P c dzemd b m nepieciešam ba p c insul na tri atjaunojas l men, k ds bijis pirms gr tniec bas.
Insulin treatment of the nursing mother presents no risk to the baby.
M tes rst šana ar insul nu nerada risku b rnam, ko baro ar m tes pienu.
However, the Insulatard dosage may need to be adjusted.
Tom r var b t nepieciešams piel got Insulatard devu.
4.7 Effects on ability to drive and use machines
4. 7 Ietekme uz sp ju vad t transportl dzek us un apkalpot meh nismus
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Hipoglik mijas d var pav jin ties pacienta koncentr šan s un reakcijas sp ja.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Tas var rad t risku situ cij s, kad š s sp jas ir paši svar gas (piem ram, vadot transportl dzekli vai apkalpojot meh nismus).
4 hypoglycaemia or have frequent episodes of hypoglycaemia.
4 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.
The advisability of driving should be considered in these circumstances.
J izlemj, vai š dos apst k os b tu v lams vad t transportl dzekli.
4.8 Undesirable effects
4. 8 Nev lam s blakuspar d bas
As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
T pat k citiem insul niem, biež k sastopam blakuspar d ba ir hipoglik mija.
It may occur if the insulin dose is too high in relation to the insulin requirement.
T var rasties, ja insul na deva ir p r k liela sal dzinot ar insul na nepieciešam bu.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Kl niskos p t jumos un p cre istr cijas nov rojumos t s biežums vari starp pacientu grup m un dozešanas rež miem, t d noteikts hipoglik mijas rašan s biežums nevar b t uzr d ts.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Smaga hipoglik mija var rad t bezsama u un/ vai krampjus, k ar p rejošus vai past v gus smadze u darb bas trauc jumus vai pat n vi.
Frequencies of adverse drug reactions from clinical trials that are considered related to Insulatard are listed below.
Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuri ir attiecin ti uz Insulatard, uzskait tas t l k.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Biežums tiek defin ts š di: ret k (> 1/ 1000, < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Atseviš i spont ni gad jumi tiek defin ti k oti reti (< 1/ 10 000), ieskaitot atseviš us zi ojumus.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Katr sastopam bas biežuma grup nev lam s blakuspar d bas sak rtotas to nopietn bas samazin juma sec b.
Nervous system disorders Very rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
Nervu sist mas trauc jumi oti reti - perif r neirop tija. tra glikozes l me a asin s kontroles uzlabošan s var apvienoties ar st vokli, ko sauc par ak tu s pju neirop tiju, kas parasti ir p rejoša.
Eye disorders Very rare - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
Uzs kot insul nterapiju iesp jami refrakcijas trauc jumi.
These symptoms are usually of transitory nature.
Parasti šie simptomi ir p rejoši.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Ilgstoši uzlabota glik misk kontrole samazina diab tisk s retinop tijas progres šanas risku.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Tom r insul nterapijas intensifik cija ar p kš u glik mijas kontroles uzlabošanos var b t saist ta ar slaic gu diab tisk s retinop tijas pasliktin šanos.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Ja nemaina injekciju vietu anatomisk apvidus robež s, injekcijas viet var att st ties lipodistrofija.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Visp r ji trauc jumi un reakcijas ievad šanas viet Ret k – reakcijas injekcijas viet. rst šanas laik ar insul nu iesp jamas reakcijas injekcijas viet (aps rtums, piet kums, nieze, s p gums un hematoma injekcijas viet).
Most reactions are transitory and disappear during continued treatment.
P rsvar reakcijas ir p rejošas un, turpinot rst šanu, izz d.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
Šie simptomi parasti ir p rejoši.
These symptoms are usually of transitory nature.
Im n s sist mas trauc jumi Ret k - n trene, izsitumi.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
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.
Generalised hypersensitivity reactions are potentially life- threatening.
Visp r j s paaugstin tas jut bas reakcijas var b t dz v bai b stamas.
4.9 Overdose
4. 9 P rdoz šana
5 A specific overdose of insulin cannot be defined.
5 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.
Tom r hipoglik mijai var b t vair kas pak pes: • Vieglu hipoglik miju var rst t, peror li lietojot glikozi vai produktus, kuru sast v ir cukurs.
It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice. • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
T d diab ta pacientiem iesaka n s t l dzi dažus cukurgraudus, saldumus, cepumus vai ar cukuru saldin tu aug u sulu. • Smagu hipoglik miju, kad pacients zaud sama u, var rst t ar glikagonu (0, 5 – 1 mg), ko apm c ta persona ievada intramuskul ri vai subkut ni, vai ar glikozi, ko medic nas darbinieks ievada intravenozi.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glikoze intravenozi j ievada ar tad, ja 10 – 15 min šu laik nav atbildes reakcijas uz glikagonu.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Atg stot sama u, pacientam ieteicams peror li lietot og hidr tus, lai izvair tos no atk rtotas hipoglik mijas.
PHARMACOLOGICAL PROPERTIES
FARMAKOLO ISK S PAŠ BAS
5.1 Pharmacodynamic properties
5. 1 Farmakodinamisk s paš bas
Insulins and analogues for injection, intermediate-acting, insulin (human).
Farmakoterapeitisk grupa: insul ni un analogi injekcij m, vid jas darb bas, insul ns (cilv ka).
ATC code:
AT kods:
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Insul ns pazemina glikozes l meni asin s, jo tas saist s ar musku š nu un taukš nu receptoriem, veicinot glikozes nok šanu audos un vienlaikus nom cot glikozes izdal šanos no akn m.
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
Darb ba s kas 1 ½ stundas laik, maksimumu sasniedz 4 – 12 stundu laik un kop jais darb bas ilgums ir aptuveni 24 stundas.
5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
Insulin in the blood stream has a half-life of a few minutes.
Insul na elimin cijas pusperiods asin s ir dažas min tes.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
T tad insul na prepar tu darb bas laiku raksturo tikai t uzs kšan s.
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
Šo procesu ietekm vair ki faktori (piem ram, insul na deva, injekcijas veids un vieta, zem das tauku sl a biezums, cukura diab ta tips), t d nov ro b tiskas insul na prepar tu farmakokin tikas atš ir bas vienam un tam pašam pacientam, k ar, sal dzinot vair kus pacientus.
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.
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Izplat šan s Nav nov rota izteikta saist šan s ar plazmas olbaltumiem, iz emot asinsrit cirkul još s insul na antivielas (ja t das ir).
Metabolism 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.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Neviens no metabol tiem, kas rodas p c š elšan s, nav akt vs.
Elimination 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.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of
T p c termin lais elimin cijas pusperiods (t1/ 2) vair k ir uzs kšan s, nevis pašas insul na elimin cijas no plazmas funkcija (asinsrit insul na t1/ 2 ir dažas min tes).
Trials have indicated a t½ of about 5-10 hours.
P t jumos nov rots, ka t1/ 2 ir aptuveni 5 – 10 stundas.
5.3 Preclinical safety data
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.
6 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.
PHARMACEUTICAL PARTICULARS
FARMACEITISK INFORM CIJA
6.1 List of excipients
6. 1 Pal gvielu saraksts
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
Cinka hlor ds Glicer ns Metakrezols Fenols N trija hidrog nfosf ta dihidr ts N trija hidroks ds (pH korekcijai) S lssk be (pH korekcijai) Protam na sulf ts dens injekcij m
6.2 Incompatibilities
6. 2 Nesader ba
Insulin products should only be added to compounds with which it is known to be compatible.
Insul na prepar tus dr kst pievienot tikai tiem mais jumiem, kas ir zin mi k savietojami.
Insulin suspensions should not be added to infusion fluids.
Insul na suspensijas nedr kst pievienot inf ziju š idrumiem.
6.3 Shelf life
6. 3 Uzglab šanas laiks
30 months when stored between 2°C - 8°C.
30 m neši, uzglab jot temperat r 2°C - 8°C.
4 weeks when used or stored at room temperature (below 25°C).
4 ned as lietojot vai uzglab jot istabas temperat r (l dz 25°C).
6.4 Special precautions for storage
6. 4 paši uzglab šanas nosac jumi
Before use: store in a refrigerator (2°C - 8°C).
Pirms lietošanas: uzglab t ledusskap (2°C – 8°C).
Do not store them in or too near the freezer section or cooling element.
Neuzglab t sald tavas nodal jum vai p r k tuvu tam, vai aukstuma elementam.
Do not freeze.
Nesasald t.
During use: do not refrigerate.
Lietošanas laik: neatdzes t.
Do not store above 25°C.
Uzglab t temperat r l dz 25°C.
Keep the vial in the outer carton in order to protect from light.
Flakonu uzglab t r j iepakojum, lai pasarg tu no gaismas.
Protect from excessive heat and sunlight.
Sarg t no p rm r ga karstuma un saules gaismas.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
10 ml stikla (1. klase) flakons, kas aizv kots ar brombutila/ poliizopr na gumijas aizb zni un plastmasas aizsargv ci u.
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 vai 5 flakoni x 10 ml un daudzdevu iepakojumi pa 5 x (1 x 10 ml) flakoniem.
Not all pack sizes may be marketed.
Visi iepakojuma lielumi tirg var neb t pieejami.
6.6 Special precautions for disposal and other handling
6. 6 paši nor d jumi atkritumu likvid šanai un nor d jumi par sagatavošanu lietošanai
Insulin preparations which have been frozen must not be used.
Insul na prepar tus, kas bijuši sasaluši, nedr kst lietot.
7 After removing Insulatard vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
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.
7 Insul na suspensijas nedr kst lietot, ja p c saskalošanas t s nav vienm r gi baltas un du ainas.
Any unused product or waste material should be disposed of in accordance with local requirements.
Neizlietot s z les vai izlietotos materi lus j izn cina atbilstoši viet j m pras b m.
MARKETING AUTHORISATION HOLDER
RE ISTR CIJAS APLIEC BAS PAŠNIEKS
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Alle DK- 2880 Bagsværd D nija
MARKETING AUTHORISATION NUMBER(S)
RE ISTR CIJAS NUMURS( I)
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
RE ISTR CIJAS / P RRE ISTR CIJAS DATUMS
Date of first authorisation:
Pirm s re istr cijas datums:
Date of latest renewal:
2002. gada 7. oktobris P rre istr cijas datums:
DATE OF REVISION OF THE TEXT
TEKSTA P D J S P RSKAT ŠANAS DATUMS
Insulatard 100 IU/ ml suspension for injection in a vial.
Insulatard 100 SV/ ml suspensija injekcij m flakon
1 vial contains 10 ml equivalent to 1000 IU.
1 ml satur 100 SV cilv ka insul na 1 flakon ir 10 ml, kas atbilst 1000 SV
Renal or hepatic impairment may reduce insulin requirement.
9 Nieru vai aknu darb bas trauc jumi var mazin t vajadz bu p c insul na.
9 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 is administered subcutaneously in the thigh.
Insulatard parasti ievada subkut ni augšstilb.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
10 T pat k pie jebkuras insul na terapijas, injekcijas viet var b t reakcijas, ieskaitot s pes, niezi, n treni, piet kumu un iekaisumu.
10 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
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.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
11 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.
12 4.9 Overdose
4. 9 P rdoz šana
A specific overdose of insulin cannot be defined.
12 Insul nam nav specifiskas p rdoz šanas defin cijas.
13 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.
The terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
T p c termin lais elimin cijas pusperiods (t1/ 2) vair k ir uzs kšan s, nevis pašas insul na elimin cijas no plazmas funkcija (asinsrit insul na t1/ 2 ir dažas min tes).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
13 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.