FrancophonIA/ELRC3.0 huggingface dataset:
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Slovenian: Na voljo so pakiranja z 1, 3, 4, 5, 6, 8, 9 in 10 vložki.
English: 8 pens of 3 ml.
Slovenian: 8 vložkov s 3 ml.
English: EU/1/04/285/001 1 vial of 10ml EU/1/04/285/002 2 vials of 10ml.
Slovenian: EU/1/04/285/001 1 viala z 10 ml. EU/1/04/285/002 2 viali z 10 ml. EU/1/04/285/003 4 viale z 10 ml. EU/1/04/285/004 5 vial z 10 ml.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen 3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v vložku (iz brezbarvnega stekla) z batom (iz elastomerne bromobutilne gume) in s prirobljeno zaporko (iz aluminija) z zamaškom (iz elastomerne bromobutilne gume).
English: After its first use, the product may be stored for a maximum of 4 weeks below 25°C.
Slovenian: Po prvi uporabi lahko zdravilo shranjujete največ 4 tedne pri temperaturi do 25 °C.
English: 4 vials of 10ml.
Slovenian: 4 viale z 10 ml.
English: How to handle an infusion pump system
Slovenian: Ravnanje s sistemom z insulinsko črpalko
English: When administered as a subcutaneous injection, Apidra must not be mixed with other medicinal products except NPH human insulin.
Slovenian: Če se zdravilo Apidra uporablja v subkutani injekciji, se ne sme mešati z ostalimi zdravili razen z NPH (nevtralni protamin hagedorn) insulinom.
English: Apidra 100 Units/ml solution for injection in a vial is a clear, colourless, aqueous solution with no particles visible.
Slovenian: Apidra 100 enot/ml, raztopina za injiciranje v viali, je bistra, brezbarvna, vodna raztopina brez vidnih delcev.
English: Marketing Authorisation Holder: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany
Slovenian: Imetnik dovoljenja za promet: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Nemčija
English: Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Slovenian: Vsak vložek vsebuje 3 ml raztopine za injiciranje, kar ustreza 300 enotam.
English: Do not use this medicine after the expiry date, which is stated on the carton and on the label of the pen after “EXP”.
Slovenian: Zdravila Apidra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki vložka poleg oznake“EXP”.
English: The product may be stored for a maximum of 4 weeks below 25°C.
Slovenian: Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C.
English: The product may be stored for a maximum of 4 weeks below 25°C away from direct heat or direct light.
Slovenian: Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25°C zaščiteno pred neposredno toploto ali svetlobo.
English: Sodium chloride Trometamol
Slovenian: Metakrezol, natrijev klorid, trometamol, polisorbat 20,
English: In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displayed dose-proportional glucose lowering effect in the therapeutic relevant dose range 0.075 to 0.15 Units/kg, and less than proportional increase in glucose lowering effect with 0.3 Units/kg or higher, like human insulin.
Slovenian: V študiji z 18 osebami moškega spola z diabetesom mellitusom tipa 1, starimi od 21 do 50 let, je bil učinek insulina glulisin na znižanje glukoze v krvi v razponu terapevtsko pomembnih odmerkov od 0,075 do 0,15 enot/kg sorazmeren z odmerkom.
English: 5 vials of 10ml.
Slovenian: 5 vial z 10 ml.
English: Please check section 6.4 of this SPC for instructions on how to store SoloStar.
Slovenian: Za navodila o shranjevanju SoloStarja glejte poglavje 6.4 tega navodila.
English: The effect will be slightly quicker if the insulin is injected into your abdomen.
Slovenian: Če insulin injicirate v trebuh, bo učinek nekoliko hitrejši.
English: Apidra 100 Units/ml solution for injection in a cartridge 3 ml solution in a cartridge (type I colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v vložku 3 ml raztopine v vložku (iz brezbarvnega stekla tipa 1) z batom (iz elastomerne bromobutilne gume) in s prirobljeno zaporko (iz aluminija) z zamaškom (iz elastomerne bromobutilne gume).
English: Measure your blood sugar level regularly to make sure you get the benefit of the insulin infusion and to make sure that the pump is working properly.
Slovenian: Da vam bo infundiranje insulina koristilo in da boste zagotovili pravilno delovanje črpalke, si morate redno meriti krvni sladkor.
English: When used with a subcutaneous insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Slovenian: Če je zdravilo Apidra uporabljeno v črpalki za subkutano infundiranje, se ga ne sme mešati z redčili in tudi ne s kakšnim drugim insulinom.
English: 10 secs
Slovenian: 10 sek
English: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light.
Slovenian: Injekcijske peresnike, ki jih uporabljate ali jih imate pri sebi za rezervo, lahko shranjujete največ 4 tedne pri temperaturi do 25°C in zaščitene pred neposredno toploto ali svetlobo.
English: What Apidra contains
Slovenian: Kaj vsebuje zdravilo Apidra
English: Before insertion of the cartridge into the reusable pen, the cartridge must be stored at room temperature for 1 to 2 hours.
Slovenian: Pred vstavitvijo v injekcijski peresnik za večkratno uporabo mora biti vložek od 1 do 2 uri na sobni temperaturi.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Slovenian: Uporabiti se ga sme le, če je raztopina bistra, brezbarvna, vodi podobne konsistence in v njej ni vidnih trdnih delcev.
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Slovenian: Na voljo so pakiranja z 1, 3, 4, 5, 6, 8, 9 in 10 injekcijskimi peresniki.
English: You must always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
Slovenian: Da bi se izognili zamenjavi med zdravilom Apidra in drugimi insulini, vedno pred vsakim injiciranjem preverite nalepko insulina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak ml vsebuje 100 enot insulina glulisin (kar ustreza 3,49 mg).
English: Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Slovenian: Lipodistrofija na mestu injiciranja se lahko pojavi, če bolnik mest injiciranja na posameznem predelu ne menja krožno.
English: - The other ingredients are: metacresol (see section 2 under “Apidra contains metacresol”), sodium chloride (see section 2 under “Important information about some of the ingredients of Apidra”), trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Slovenian: - Pomožne snovi so: metakrezol (glejte poglavje 2 Apidra vsebuje metakrezol), natrijev klorid, (glejte poglavje 2 Pomembne informacije o nekaterih sestavinah zdravila Apidra) trometamol, polisorbat 20, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
English: Once in use, the vial may be stored for a maximum of 4 weeks in the outer carton below 25°C away from direct heat or direct light.
Slovenian: Ko vialo začnete uporabljati, jo lahko shranjujete največ 4 tedne pri temperaturi do 25°C zaščiteno pred neposredno toploto ali svetlobo v zunanji ovojnini.
English: To prevent any kind of contamination, the re-usable pen should be used by a single patient only.
Slovenian: Da preprečimo kakršnokoli onesnaženje, sme injekcijski peresnik za večkratno uporabo uporabljati samo en bolnik.
English: EU/1/04/285/011 9 cartridges of 3ml.
Slovenian: EU/1/04/285/011 9 vložkov s 3ml.
English: 5 pens of 3 ml.
Slovenian: 5 vložkov s 3 ml.
English: It must only be used if the solution is clear, colourless, with no solid particles visible.
Slovenian: Uporabiti se ga sme le, če je raztopina bistra, brezbarvna in v njej ni vidnih trdnih delcev.
English: Instruction for intravenous administration
Slovenian: Navodilo za intravensko uporabo
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available.
Slovenian: Na voljo so pakiranja z 1, 3, 4, 5, 6, 8, 9 in 10 napolnjenimi injekcijskimi peresniki.
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - sulphonamide antibiotics.
Slovenian: Med zdravili, ki lahko povzročijo znižanje koncentracije krvnega sladkorja (hipoglikemija) so: vsa druga zdravila za zdravljenje sladkorne bolezni, zaviralci angiotenzinske konvertaze (ACE - angiotensin converting enzyme) (uporabljajo se za zdravljenje določenih bolezenskih stanj srca ali visokega krvnega tlaka), dizopiramid (uporablja se za zdravljenje določenih bolezenskih stanj srca), fluoksetin (uporablja se za zdravljenje depresije), fibrati (uporabljajo se za znižanje visokih koncentracij krvnih lipidov), zaviralci monoaminooksidaze (MAO) (uporabljajo se za zdravljenje depresije), pentoksifilin, propoksifen, salicilati (na primer acetilsalicilna kislina, uporabljajo se za lajšanje bolečine in znižanje zvišane telesne temperature), sulfonamidni antibiotiki.
English: Changing the injection site with each injection may help to prevent such skin changes.
Slovenian: Takšne kožne spremembe lahko preprečite z menjavanjem mesta injiciranja.
English: Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
Slovenian: Če opazite, da se urejenost vašega krvnega sladkorja nepričakovano poslabša, vedno uporabite nov injekcijski peresnik.
English: How to store Apidra
Slovenian: Shranjevanje zdravila Apidra
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik vsebuje 3 ml raztopine za injiciranje, kar ustreza 300 enotam.
English: However, insulin requirements may be reduced in the presence of renal impairment.
Slovenian: Lahko pa se pri okvari ledvic zmanjša potreba po insulinu.
English: Apidra 100 Units/ml solution for injection in a vial Subcutaneous use
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali Subkutana uporaba
English: Hypoglycaemia is also more likely to occur if: - you have just begun insulin treatment or changed to another insulin preparation, - your blood sugar levels are almost normal or are unstable,
Slovenian: Hipoglikemija je verjetnejša tudi, če: - ste zdravljenje z insulinom pravkar začeli ali ste prešli na drug pripravek insulina, - je koncentracija vašega krvnega sladkorja skoraj normalna ali ni stabilna, - zamenjate predel kože, kamor injicirate insulin (na primer s stegna na nadlaket), - imate hudo bolezen ledvic ali jeter ali kakšno drugo bolezen, npr. nezadostno delovanje ščitnice.
English: For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Slovenian: Informacije o zdravljenju hiperglikemije najdete v okvirju na koncu tega navodila za uporabo.
English: Apidra 100 Units/ml solution for injection in a cartridge Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v vložku Vsak vložek vsebuje 3 ml raztopine za injiciranje, kar ustreza 300 enotam.
English: Then the injection button should be pressed in completely.
Slovenian: Potem morate gumb za injiciranje pritisniti do konca.
English: Apidra 100 Units/ml solution for injection in a vial Shelf life after first use of the vial
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali Rok uporabnosti po prvi uporabi viale:
English: Talk to your doctor, pharmacist or nurse before using Apidra.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: 10 pens of 3 ml.
Slovenian: 10 vložkov s 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial 10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric chlorobutyl rubber) and a polypropylene tear-off cap.
Slovenian: 10 ml raztopine v viali (iz brezbarvnega stekla tipa 1) z zaporko (prekriti prirobljen aluminij, elastomerna klorobutilna guma) in s polipropilenskim pokrovčkom, ki se odtrga.
English: 1 vial of 10ml.
Slovenian: 1 viala z 10 ml.
English: 1 pen of 3 ml.
Slovenian: 1 vložek s 3 ml.
English: 9 cartridges of 3ml.
Slovenian: 9 vložkov s 3ml.
English: 4 pens of 3 ml.
Slovenian: 4 vložki s 3 ml.
English: Rubber seal
Slovenian: Okvara jeter
English: Apidra 100 Units/ml solution for injection in a cartridge is a clear, colourless, aqueous solution with no particles visible.
Slovenian: Apidra SoloStar 100 enot/ml, raztopina za injiciranje v napolnjenem injekcijskem peresniku je bistra, brezbarvna vodna raztopina brez vidnih delcev.
English: Shelf life for intravenous use
Slovenian: Rok uporabnosti za intravensko uporabo
English: EU/1/04/285/012 10 cartridges of 3ml.
Slovenian: EU/1/04/285/012 10 vložkov s 3 ml.
English: 6 pens of 3 ml.
Slovenian: 6 vložkov s 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial Insulin glulisine
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali insulin glulisin
English: Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks below 25°C, away from direct heat or direct light and must not be stored in a refrigerator.
Slovenian: Vložke, ki jih uporabljate (v insulinskem injekcijskem peresniku) lahko shranjujete največ 4 tedne pri temperaturi do 25°C zaščitene pred neposredno toploto ali svetlobo.
English: Keep the cartridge inserted in the pen protected from light.
Slovenian: Injekcijski peresnik z vstavljenim vložkom shranjujte zaščiteno pred svetlobo.
English: NAME OF THE MEDICINAL PRODUCT Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali Apidra 100 enot/ml raztopina za injiciranje v vložku Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: EU/1/04/285/007 4 cartridges of 3ml.
Slovenian: EU/1/04/285/007 4 vložki s 3 ml.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Insulin glulisine
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glulisin
English: Apidra 100 Units/ml solution for injection in a cartridge Pens to be used with Apidra 100 units/ml solution for injection in a cartridge Apidra 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen.
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v vložku Peresniki, ki se uporabljajo z zdravilom Apidra 100 enot/ml raztopina za injiciranje v vložku Zdravilo Apidra 100 enot/ml v vložku je primerno samo za podkožno injiciranje z injekcijskim peresnikom za večkratno uporabo.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.
Slovenian: Da bi se izognili napakam zdravljenja zaradi zamenjave med insulinom glulisin in drugimi insulini, je potrebno nalepko insulina vedno preveriti pred vsakim injiciranjem.
English: Store in a refrigerator (2°C - -8°C).
Slovenian: Shranjujte v hladilniku (2ºC - 8ºC).
English: NAME OF THE MEDICINAL PRODUCT Apidra 100 Units/ml, solution for injection in a vial Insulin glulisine
Slovenian: IME ZDRAVILA Apidra 100 enot/ml raztopina za injiciranje v viali insulin glulisin
English: 3 pens of 3 ml.
Slovenian: 3 vložki s 3 ml.
English: Pen needle (not included)
Slovenian: NALEPKA (vložek)
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Not in-use pens
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Neuporabljeni injekcijski peresniki
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Solution for injection in a pre-filled pen.
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: EU/1/04/285/009 6 cartridges of 3ml.
Slovenian: EU/1/04/285/009 6 vložkov s 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial Unopened vials
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali Neodprte viale
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone),
Slovenian: Med zdravili, ki lahko povzročijo zvišanje koncentracije krvnega sladkorja (hiperglikemija) so: kortikosteroidi (na primer "kortizon", uporabljajo se za zdravljenje vnetja), danazol (zdravilo, ki deluje na ovulacijo), diazoksid (uporablja se za zdravljenje visokega krvnega tlaka), diuretiki (uporabljajo se za zdravljenje visokega krvnega tlaka ali za prekomerno zadrževanje tekočin), glukagon (hormon, ki ga izloča trebušna slinavka, uporablja pa se za zdravljenje hude hipoglikemije), izoniazid (uporablja se zdravljenje tuberkuloze), estrogeni in progestogeni (na primer kontracepcijske tablete, uporabljajo se za načrtovanje rojstva), fenotiazinski derivati (uporabljajo se za zdravljenje psihiatričnih motenj), somatropin (rastni hormon), simpatikomimetična zdravila (na primer adrenalin ali salbutamol, terbutalin, uporabljajo se za zdravljenje astme), ščitnični hormoni (uporabljajo se za zdravljenje motenj v delovanju žleze ščitnice), netipična antipsihotična zdravila (kot sta olanzapin in klozapin), zaviralci proteaz (uporabljajo se za zdravljenje HIV).
English: carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Apidra").
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi hidrati), - izgubljate ogljikove hidrate zaradi bruhanja ali driske, - pijete alkohol (zlasti če ne jeste dosti), - ste bolj dejavni kot navadno ali je telesna dejavnost drugačna kot ponavadi, - okrevate po poškodbi, operaciji ali drugem stresu, - okrevate po bolezni ali po vročini, - uporabljate ali ste nehali uporabljati določena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo Apidra").
English: - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - protease inhibitors (used to treat HIV), - atypical antipsychotic medicines (such as olanzapine and clozapine).
Slovenian: diazoksid (uporablja se za zdravljenje visokega krvnega tlaka), diuretiki (uporabljajo se za zdravljenje visokega krvnega tlaka ali za prekomerno zadrževanje tekočin), glukagon (hormon, ki ga izloča trebušna slinavka, uporablja pa se za zdravljenje hude hipoglikemije), izoniazid (uporablja se za zdravljenje tuberkuloze), estrogeni in progestogeni (na primer kontracepcijske tablete, uporabljajo se za načrtovanje rojstva), fenotiazinski derivati (uporabljajo se za zdravljenje psihiatričnih motenj), somatropin (rastni hormon), simpatikomimetična zdravila (na primer adrenalin ali salbutamol, terbutalin, uporabljajo se za zdravljenje astme), ščitnični hormoni (uporabljajo se za zdravljenje motenj v delovanju žleze ščitnice), netipična antipsihotična zdravila (kot sta olanzapin in klozapin), zaviralci proteaz (uporabljajo se za zdravljenje HIV).
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for subcutaneous injections.
Slovenian: Apidra SoloStar 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Apidra SoloStar 100 enot/ml v napolnjenem injekcijskem peresniku je primerno samo za podkožno injiciranje.
English: Discard
Slovenian: Lipodistrofija
English: Remove and discard the needle
Slovenian: 6. korak; Iglo odstranite in zavrzite
English: 8 cartridges of 3ml.
Slovenian: 8 injekcijskih peresnikov s 3 ml.
English: Keep the cartridge in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini, da zagotovite zaščito pred svetlobo.
English: In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycaemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint.
Slovenian: V 26-tedenski klinični študiji faze III so primerjali insulin glulisin in insulin lispro pri bolnikih z diabetesom mellitusom tipa 1, ki so kot bazalni insulin uporabljali insulin glargin.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Shelf life after first use of the pen
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v vložku Rok uporabnosti po prvi uporabi vložka
English: EU/1/04/285/008 5 cartridges of 3ml.
Slovenian: EU/1/04/285/008 5 vložkov s 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v viali
English: Apidra 100 Units/ml solution for injection in a cartridge Insulin glulisine
Slovenian: Apidra 100 enot/ml raztopina za injiciranje v vložku insulin glulisin
English: EU/1/04/285/010 8 cartridges of 3ml.
Slovenian: EU/1/04/285/010 8 vložkov s 3 ml.
English: Keep the pen protected from light.
Slovenian: Injekcijski peresnik shranjujte zaščiteno pred svetlobo.
English: Solution for injection in a cartridge.
Slovenian: Raztopina za injiciranje v vložku.
English: EU/1/04/285/033 6 pens of 3 ml.
Slovenian: EU/1/04/285/006 3 vložki s 3 ml.
English: EU/1/04/285/029 1 pen of 3 ml.
Slovenian: EU/1/04/285/029 1 injekcijski peresnik s 3 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Apidra 100 Units/ml solution for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Apidra 100 enot/ml raztopina za injiciranje insulin glulisin
English: EU/1/04/285/030 3 pens of 3 ml.
Slovenian: EU/1/04/285/030 3 injekcijski peresniki s 3 ml.