natgillin/translations-raw huggingface dataset:
Handling of the pen Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
Ravnanje z injekcijskim peresnikom Pred uporabo OptiSeta natančno preberite navodila za ravnanje z OptiSetom v navodilu za uporabo.
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
Optiset uporabljajte kot je priporočeno v navodilih za ravnanje z OptiSetom (glejte poglavje 6. 6).
37 It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Ni znano, ali se insulin glulisin izloča v materinem mleku, a praviloma insulin ne prehaja v materino mleko in se po peroralni uporabi ne absorbira.
4.7 Effects on ability to drive and use machines
37 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritus.
Splošne težave Občasni: sistemske preobčutljivostne reakcije Sistemske preobčutljivostne reakcije lahko vključujejo urtikarijo, tiščanje v prsih, dispnejo, alergijski dermatitis in srbenje.
38 There are no specific data available concerning overdose with insulin glulisine.
Specifičnih podatkov o prevelikem odmerjanju insulina glulisin ni.
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
38 Blage hipoglikemije je mogoče zdraviti z zaužitjem glukoze ali sladkih izdelkov.
A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 U/ kg, at different times in relation to a 15-minute standard meal.
Študija faze I pri bolnikih z diabetesom mellitusom tipa 1 je ocenjevala znižanje glukoze z insulinom glulisin in navadnim humanim insulinom, apliciranima subkutano v odmerku 0, 15 enot/ kg ob različnih časih glede na 15- minutni standardni obrok.
When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the
Insulin glulisin, uporabljen 2 minuti pred obrokom, je zagotovil boljšo postprandialno urejenost kot navadni humani insulin, uporabljen 2 minuti pred obrokom.
39 meal.
39
GLULISINE - pre REGULAR - 30 min
GLULISIN - po
GLULISINE REGULAR -
NAVADNI - pred
- pre pre
NAVADNI - pred
2 3
234 5
6
234 ČAS - ure
Obesity A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
Študija faze I, opravljena z insulinom glulisin, insulinom lispro in navadnim humanim insulinom pri populaciji debelih preiskovancev, je pokazala, da insulin glulisin ohrani svoje hitro delovanje.
40 Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/ m²) has demonstrated that rapid action is generally maintained across a wide range of body mass indices, while total glucose lowering effect decreases with increasing obesity.
Druga študija faze I, izvedena z insulinom glulisin in insulinom lispro pri skupini 80 oseb brez diabetesa s širokim razponom indeksov telesne mase (18- 46 kg/ m²) je pokazala, da se hitro delovanje običajno ohrani preko širokega razpona indeksov telesne mase, medtem ko se skupni učinek na znižanje glukoze z večanjem telesne mase zmanjšuje.
A phase I study in 18 obese patients with type 2 diabetes mellitus (BMI between 35 and 40 kg/ m2) with insulin glulisine and insulin lispro [90% CI:
Študija faze I, izvedena pri 18 bolnikih s prekomerno telesno maso in diabetesom mellitusom tipa 2 (indeks telesne mase med 35 in 40 kg/ m2) z insulinom glulisin in insulinom lispro [90% interval zaupanja:
0.81, 0.95 (p= < 0.01)] has shown that insulin glulisine effectively controls diurnal post-prandial blood glucose excursions.
0, 81; 0, 95 (p = < 0, 01)] je pokazala, da insulin glulisin učinkovito nadzira dnevno postprandialno nihanje glukoze v krvi.
41 In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Rasa in spol V kontroliranih kliničnih preizkušanjih pri odraslih se varnost in učinkovitost insulina glulisin v analizah podskupin po starosti in spolu nista razlikovali.
5.2 Pharmacokinetic properties
41 5. 2 Farmakokinetične lastnosti
42 Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/ m²) has demonstrated that rapid absorption and total exposure is generally maintained across a wide range of body mass indices.
Druga študija faze I, izvedena z insulinom glulisin in insulinom lispro pri skupini 80 oseb brez diabetesa s širokim razponom indeksov telesne mase (18- 46 kg/ m²) je pokazala, da se hitra absorpcija in celotna izpostavljensot običajno ohranita preko širokega razpona indeksov telesne mase.
The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
42 Z insulinom lispro je bila 10% skupna INS izpostavljenost dosežena približno 5- 6 minut hitreje.
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated
Metakrezol, natrijev klorid, trometamol, polisorbat 20, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
43 Sodium hydroxide Water for injections
43 zdravili razen s humanim insulinom NPH.
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Rok uporabnosti po prvi uporabi injekcijskega peresnika Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
The pen cap must be put back on the pen after each injection in order to protect from light.
Po vsakem injiciranju dajte pokrovček injekcijskega peresnika nazaj na injekcijski peresnik za zagotovitev zaščite pred svetlobo..
Not in-use pens Store in a refrigerator (2°C - 8°C).
Injekcijski peresniki, ki jih ne uporabljate Shranjujte v hladilniku (2 °C - 8 °C).
In use pens For storage precautions, see section 6.3.
Injekcijski peresniki, ki jih uporabljate Za navodila za shranjevanje glejte poglavje 6. 3.
3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).
3 ml raztopine v vložku (iz brezbarvnega stekla) z batom (iz elastomerne gume) in s prirobljeno zaporko (iz aluminija) z zamaškom (iz elastomerne gume).
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Na voljo so pakiranja z 1, 3, 4, 5, 6, 8, 9 in 10 injekcijskimi peresniki.
Empty pens must never be used and must be properly discarded.
Praznih injekcijskih peresnikov se nikdar ne sme uporabiti in jih je treba ustrezno zavreči.
Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
Ravnanje z injekcijskim peresnikom Pred uporabo OptiSeta natančno preberite navodila za ravnanje z OptiSetom v navodilu za uporabo. ime telo peresnika igla peresnika (ni priložena) pokrovček peresnika insulina
Schematic diagram of the pen
gumijast barvna črta
Important information for use of OptiSet: • Always attach a new needle before each use.
Pomembne informacije za uporabo OptiSeta: • Pred vsako uporabo vedno namestite novo iglo.
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Uporabljajte le igle, primerne za uporabo z OptiSetom. • Pred vsakim injiciranjem opravite varnostni preizkus. • Če uporabljate nov OptiSet, morate prvi varnostni preizkus narediti z odmerkom 8 enot, ki ga je nastavil že izdelovalec. • Izbirnik odmerka je mogoče vrteti le v eno smer. • Ko je gumb za injiciranje izvlečen, izbirnika odmerka ne smete več obračati (tj. ne smete več spreminjati odmerka). • Ta injekcijski peresnik uporabljajte le vi sami.
45 • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
Ne delite ga z nikomer drugim. • Če vam injekcijo da druga oseba, je treba posebej paziti, da se ta oseba po naključju ne poškoduje z iglo in da ne prenese okužbe. • Ne uporabljajte OptiSeta, če je poškodovan ali če niste prepričani, da deluje pravilno. • Vedno imejte na zalogi rezerven OptiSet, če injekcijski peresnik izgubite ali se poškoduje.
Please check section 6.4 of this leaflet for instructions on how to store OptiSet.
Za navodila o shranjevanju OptiSeta glejte poglavje 6. 4 tega navodila za uporabo.
If you are concerned that your OptiSet may be damaged, use a new one.
Če vas skrbi, da je vaš OptiSet poškodovan, uporabite novega.
Check the Insulin
Preverite insulin
In-use OptiSet, select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
45 Pri OptiSetu, ki ga uporabljate, izberite odmerek 2 enoti tako, da izbirnik odmerka zavrtite naprej, dokler odmerna puščica ne pokaže 2.
Pull out the injection button completely in order to load the dose.
Da boste napolnili odmerek, popolnoma izvlecite gumb za injiciranje.
Never turn the dosage selector after injection button has been pulled out.
Ko je gumb za injiciranje izvlečen, izbirnika odmerka ne smete več obračati.
Keep the outer cap to remove the used needle.
Shranite zunanji pokrovček, da boste z njim odstranili uporabljeno iglo.
46 If no insulin appears at the needle tip, step 3 should be repeated two more times until insulin appears at the needle tip.
Če se na konici ne prikaže insulin, ponovite točko 3 še dvakrat, dokler na konici igle ne zagledate kapljice insulina.
Check if you have enough insulin for the dose.
Preverite, ali imate dovolj insulina za odmerek.
The injection
Napolnite odmerek
button should be pulled out as far as it will go in order to load the pen.
Gumb za injiciranje je treba izvleči, kolikor gre, da se injekcijski peresnik napolni.
Step 6.
Korak 6
This ensures that the full dose of insulin has been delivered..
To zagotovi, da je bil dan celoten odmerek insulina.
The needle should be removed after each injection and discarded.
46 Po vsakem injiciranju je treba iglo odstraniti in zavreči.
This helps prevent contamination and/ or infection as well as entry of air into the insulin reservoir and leakage, of the insulin, which can cause inaccurate dosing.
To pomaga preprečiti onesnaženje in/ ali okužbo, pa tudi vstopanje zraka v rezervoar z insulinom in iztekanje insulina, kar lahko povzroči nenatančno odmerjanje.
SoloStar.
Raztopina za injiciranje v napolnjenem injekcijskem peresniku SoloStar.
Mixing with insulins
48 Mešanje z insulini
49 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Zaradi pomanjkanja študij kompatibilnosti, insulina glulisin ne smemo mešati z drugimi zdravili razen s humanim insulinom NPH.
Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6).
Pred uporabo SoloStarja natančno preberite navodila za ravnanje z injekcijskim peresnikom v navodilu za uporabo (glejte poglavje 6. 6).
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za insulin glulisin ali katerokoli pomožno snov.
50 When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
49 Po injiciranju hitrodelujočih analogov se lahko hipoglikemija, če do nje pride, pojavi bolj zgodaj kot po topnem humanem insulinu.
Handling of the pen Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.
Ravnanje z injekcijskim peresnikom Pred uporabo SoloStarja natančno preberite navodila za ravnanje z injekcijskim peresnikom v navodilu za uporabo.
SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).
SoloStar uporabljajte kot je priporočeno v navodilih za ravnanje z injekcijskim peresnikom (glejte poglavje 6. 6).
51 It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Ni znano, ali se insulin glulisin izloča v materinem mleku, a praviloma insulin ne prehaja v materino mleko in se po peroralni uporabi ne absorbira.
4.7 Effects on ability to drive and use machines
50 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000), not known (cannot be estimated from the available data).
Naslednji povezani neželeni učinki, ugotovljeni v kliničnih raziskavah, so navedeni spodaj po organskem sistemu in razvrščeni po padajoči incidenci (zelo pogosti: ≥ 1/ 10; pogosti: ≥ 1/ 100 do < 1/ 10; občasni: ≥ 1/ 1. 000 do < 1/ 100; redki: ≥ 1/ 10. 000 do, < 1/ 1. 000; zelo redki: < 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
52 There are no specific data available concerning overdose with insulin glulisine.
Specifičnih podatkov o prevelikem odmerjanju insulina glulisin ni.
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
51 Blage hipoglikemije je mogoče zdraviti z zaužitjem glukoze ali sladkih izdelkov.
Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/ m²) has demonstrated that rapid action is generally maintained across a wide range of body mass indices, while total glucose lowering effect decreases with increasing obesity.
Druga študija faze I, izvedena z insulinom glulisin in insulinom lispro pri skupini 80 oseb brez diabetesa s širokim razponom indeksov telesne mase (18- 46 kg/ m²) je pokazala, da se hitro delovanje
54 The average total GIR AUC between 0– 1 hour was 102±75 mg/ kg and 158±100 mg/ kg with 0.2 and 0.4 U/ kg insulin glulisine, respectively, and was 83.1±72.8 mg/ kg and 112.3±70.8 mg/ kg with 0.2 and 0.4 U/ kg insulin lispro respectively.
Pri odmerku 0, 2 enot/ kg insulina lispro je bila 83, 1 ±72, 8 mg/ kg, pri odmerku 0, 4 enot/ kg insulina lispro pa 112, 3 ± 70, 8 mg/ kg.
Race and Gender In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
54 V kontroliranih kliničnih preizkušanjih pri odraslih se varnost in učinkovitost insulina glulisin v analizah podskupin po starosti in spolu nista razlikovali.
55 In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favors more rapid absorption.
V insulinu glulisin je aminokislina asparagin na položaju B3 humanega insulina nadomeščena z lizinom, lizin na položaju B29 pa z glutaminsko kislino; to zagotavlja hitrejšo absorpcijo.
Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/ m²) has demonstrated that rapid absorption and total exposure is generally maintained across a wide range of body mass indices.
55 Druga študija faze I, izvedena z insulinom glulisin in insulinom lispro pri skupini 80 oseb brez diabetesa s širokim razponom indeksov telesne mase (18- 46 kg/ m²) je pokazala, da se hitra absorpcija in celotna izpostavljenost običajno ohranita preko širokega razpona indeksov telesne mase.
56 The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
Z insulinom lispro je bila 10% skupna INS izpostavljenost dosežena približno 5- 6 minut hitreje.
6.2 Incompatibilities
56 6. 2 Inkompatibilnosti
Shelf life after first use of the pen The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Rok uporabnosti po prvi uporabi injekcijskega peresnika Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
Not in-use pens Store in a refrigerator (2°C-8°C).
Neuporabljeni injekcijski peresniki Shranjujte v hladilniku (2 °C – 8 °C).
Keep the pre-filled pen in the outer carton in order to protect from light.
Napolnjeni injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo..
In use pens For storage precautions, see section 6.3.
Uporabljeni injekcijski peresniki Za navodila za shranjevanje glejte poglavje 6. 3.
58 Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using SoloStar.
57 Ravnanje z injekcijskim peresnikom Pred uporabo SoloStarja natančno preberite navodila za ravnanje z injekcijskim peresnikom v navodilu za uporabo.
Schematic diagram of the pen
pokrovček peresnika
Important information for use of SoloStar:
igla peresnika (ni priložena)
Before each use, a new needle must always be carefully attached and a safety test must be performed.
izbirnik odmerka
Only use needles that are compatible for use with SoloStar.
Shematični prikaz injekcijskega peresnika
Always have a spare SoloStar in case your SoloStar is lost or damaged.
Pomembne informacije za uporabo SoloStarja: • Pred vsako uporabo morate natančno namestiti novo iglo in opraviti varnostni preizkus. • Uporabljajte le igle, primerne za uporabo s SoloStarjem. • Posebej morate paziti, da boste preprečili naključne poškodbe z iglo in prenos okužbe. • Ne uporabljajte SoloStarja, če je poškodovan ali če niste prepričani, da deluje pravilno. • Vedno imejte na zalogi rezerven SoloStar, če injekcijski peresnik izgubite ali se poškoduje.
Please check section 6.4 for instructions on how to store SoloStar.
Za navodila o shranjevanju SoloStarja glejte poglavje 6. 4 tega navodila.
The outside of SoloStar can be cleaned by wiping it with a damp cloth.
Zunanjost SoloStarja lahko očistite tako, da ga obrišete z vlažno krpico.
Situations where SoloStar might be damaged must be avoided.
Izogibajte se okoliščinam, v katerih se SoloStar lahko poškoduje.
the pen should be checked to make sure it contains the correct insulin.
Preveriti morate oznako na injekcijskem peresniku in se tako prepričati, da vsebuje pravi insulin.
The Apidra
Apidra SoloStar je modre barve.
Only needles
Namestitev igle
that are compatible for use with SoloStar should be used.
Uporabljajte le igle, primerne za uporabo s SoloStarjem.
Prior to each injection a safety test has to be performed.
Pred vsakim injiciranjem morate opraviti varnostni preizkus.
Select a dose of 2.
Nastavite odmerek 2.
be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units.
Odmerek lahko nastavite v korakih po 1 enoto, od najmanj 1 enote do največ 80 enot.
If a dose 80 units is required, it should be given as two or more injections.
Če je potrebni odmerek večji od 80 enot, ga je treba dati z dvema ali več injiciranji.
The dose window must show “ 0 ” following the safety test.
Po varnostnem preizkusu mora okence odmerka kazati "0".
This helps prevent contamination and/ or infection, entry of air into the insulin reservoir and leakage of insulin.
To pomaga preprečiti onesnaženje in/ ali okužbo, vstopanje zraka v rezervoar z insulinom in iztekanje insulina.
Follow recommended safety measures for removal and disposal of needles (e. g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Upoštevajte priporočene varnostne ukrepe, ko igle odstranjujete in zavržete (npr. tehniko pokrivanja z eno roko), da boste zmanjšali tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
Mixing with insulins When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
V primeru mešanja s humanim insulinom NPH, je treba insulin Apidra v brizgo potegniti najprej.
61 ANNEX II
60 DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Germany
Sanofi- Aventis Deutschland GmbH Industriepark Höchst, D- 65926 Frankfurt Nemčija
PSURs The Marketing Authorisation Holder will submit PSURs every six months starting June 2008 until the next renewal application.
Periodična poročila o varnosti zdravila Imetnik dovoljenja za promet z zdravilom bo od junija 2008 do naslednjega podaljšanja dovoljenja za promet predložil PSURje vsakih šest mesecev.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 14-Mar-2008, of the Risk Management Plan (RMP) and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom je dolžan izvesti študije in dodatne farmakovigilančne aktivnosti, kot je razloženo v sprejetem farmakovigilančnem načrtu v okviru Načrta upravljanja tveganja (RMP – Risk Management Plan) verzija 1, 14.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
V skladu s CHMP smernico Guideline on Risk Management System for medicinal products for human use mora biti vsaka posodobitev RMP- ja predložena istočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega mora biti vsaka posodobitev vložena: • če je prejeta informacija, ki vpliva na varnostne specifikacije, farmakovigilančni načrt ali na aktivnosti za zmanjšanje tveganja • v 60- ih dneh od doseženega pomembnega mejnika (farmakovigilanca ali zmanjšanje tveganja) • na zahtevo EMEA
LABELLING
64 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Apidra 100 Units/ ml, solution for injection in a vial Insulin glulisine.
Apidra 100 enot/ ml raztopina za injiciranje v viali insulin glulisin
Each ml contains 100 Units (equivalent to 3.49 mg) insulin glulisine.
Vsak ml vsebuje 100 enot (kar ustreza 3, 49 mg) insulina glulisin.
Also contains: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Vsebuje tudi: metakrezol, natrijev klorid, trometamol, polisorbat 20, koncentrirano klorovodikovo kislino, natrijev hidroksid, vodo za injekcije.
EXP (MM/ YYYY)
Uporabno do MM/ LLLL
Unopened vials Store in a refrigerator.
Neodprte viale Shranjujte v hladilniku.
After first use: the product may be stored for a maximum of 4 weeks not above 25°C.
Po prvi uporabi: zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C.
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, Nemčija
EU/ 1/ 04/ 285/ 001 1 vial of 10ml EU/ 1/ 04/ 285/ 002 2 vials of 10ml.
EU/ 1/ 04/ 285/ 002 2 viali z 10 ml.
EU/ 1/ 04/ 285/ 003 4 vials of 10ml EU/ 1/ 04/ 285/ 004 5 vials of 10ml.
EU/ 1/ 04/ 285/ 004 5 vial z 10 ml.
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Apidra 100Units/ ml Solution for injection in a vial Insulin glulisine.
Apidra 100 enot/ ml raztopina za injiciranje v viali insulin glulisin
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI