natgillin/translations-raw huggingface dataset:
Humalog is used to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.
Zdravilo Humalog se uporablja za zdravljenje odraslih in otrok s sladkorno boleznijo, ki potrebujejo insulin za nadzor sladkorja v krvi, vključno z bolniki, katerim je bila sladkorna bolezen šele diagnosticirana.
The medicine is only available with a prescription.
Zdravilo se dobi samo na recept.
Humalog, Humalog NPL and Humalog Mix may be given subcutaneously (under the skin) by injection into the upper arms, thighs, buttocks, or abdomen (tummy).
Zdravila Humalog, Humalog NPL in Humalog Mix se dajejo subkutano (pod kožo) z injekcijo v nadlaket, stegno, zadnjico ali trebuh.
Humalog may also be given by continuous infusion using an insulin pump or intravenously (into a vein).
Zdravilo Humalog se lahko daje tudi s kontinuirano infuzijo z insulinsko črpalko ali intravensko (v veno).
Humalog and Humalog Mix products are normally given shortly before a meal and may be given soon after a meal if necessary.
Izdelki Humalog in Humalog Mix se običajno dajejo tik pred obrokom, po potrebi pa se lahko dajejo tudi kmalu po obroku.
Humalog can be used with a longer-acting insulin or oral diabetic medicines (sulphonylureas).
Zdravilo Humalog se lahko uporablja v kombinaciji z insulinom z dolgotrajnejšim delovanjem ali peroralnimi antidiabetiki (sulfonilsečnino).
Humalog NPL can be mixed with or given in conjunction with Humalog.
Zdravilo Humalog NPL je mogoče zmešati ali dati v kombinaciji z zdravilom Humalog.
Humalog is a replacement insulin which very similar to the insulin made by the pancreas.
Zdravilo Humalog je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
The active ingredient of Humalog, insulin lispro, is produced by a method known as ‘ recombinant DNA technology’.
Učinkovina zdravila Humalog, insulin lispro, se proizvaja po metodi, ki jo imenujemo » tehnologija rekombinantne DNA «.
Insulin lispro products are available in various forms: as Humalog in the soluble form, which acts 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Proizvaja ga bakterija, ki je prejela gen 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged quickly (more or less immediately after injection), and as Humalog NPL in the protamine suspension form which is absorbed much more slowly during the day; and give a longer duration of action.
Insulin lispro se le malo razlikuje od humanega insulina, ta sprememba pa mu omogoča hitrejšo absorpcijo v telesu, zaradi česar lahko učinkuje hitreje kot običajni humani insulin.
Humalog Mix is a mixture between these both formulations.
Humalog Mix je mešanica teh dveh formulacij.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Nadomestni insulin učinkuje na enak način kot naravno proizvedeni insulin ter omogoča, da lahko glukoza vstopi iz krvi v celice.
By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced.
Z nadzorovanjem sladkorja v krvi se zmanjšajo simptomi in zapleti, povezani s sladkorno boleznijo.
Humalog was originally studied in eight clinical trials including 2951 diabetic patients with type 1 or type 2 diabetes.
Zdravilo Humalog je bilo prvotno preučevano v okviru osmih kliničnih preizkušanj, v katere je bilo vključenih 2951 bolnikov s sladkorno boleznijo tipa 1 ali tipa 2.
The effectiveness of Humalog was compared to Humulin R (a soluble recombinant DNA human insulin), when added to one or two daily doses of long-acting insulins.
Učinkovitost zdravila Humalog so primerjali z učinkovitostjo Humulina R (topnega humanega insulina, pridobljenega z rekombinantno DNA), kadar je dodan enemu ali dvema odmerkoma insulina z dolgotrajnim delovanjem.
The studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and fasting glucose levels.
V okviru raziskav so merili koncentracijo glikoziliranega hemoglobina (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana, ter ravni glukoze na tešče.
Further studies were also done looking at the use of Humalog in 542 children and adolescents (aged 2 to 19), and the use of Humalog in combination with sulphonylureas (oral anti-diabetes medicines).
Izvedene so bile tudi nadaljnje raziskave, ki so preučevale uporabo zdravila Humalog pri 542 otrocih in mladostnikih (starosti 2 do 19 let) ter uporabo zdravila Humalog v kombinaciji s sulfonilsečnino (peroralni antidiabetik).
What benefit has Humalog shown during the studies?
Kakšne koristi je zdravilo Humalog izkazalo med raziskavami?
There were no statistical differences between Humalog and Humulin on diabetic control measured by glycosylated haemoglobin or fasting glucose levels.
Med zdraviloma Humalog in Humulin ni bilo statističnih razlik z vidika nadzora sladkorne bolezni, merjenega z ravnjo glikoziliranega hemoglobina in glukoze na tešče.
Humalog may cause hypoglycaemia (low blood glucose).
Zdravilo Humalog lahko povzroči hipoglikemijo (nizko raven glukoze v krvi).
For the full description of the side effects reported with Humalog, please see the Package Leaflet.
Celovit opis stranskih učinkov, o katerih so poročali pri uporabi zdravila Humalog, najdete v Navodilih za uporabo.
Humalog should not be used in people who may be hypersensitive to any of the ingredients.
Zdravila Humalog ne smejo uporabljati osebe, ki utegnejo biti preobčutljive na katerokoli sestavino.
Humalog doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Odmerke zdravila Humalog bo morda potrebno prilagoditi, če se zdravilo jemlje istočasno s katerim od drugih zdravil, ki lahko vplivajo na sladkor v krvi (celoten seznam najdete v Navodilih za uporabo).
Under no circumstances should Humalog Mix or Humalog NPL be given intravenously.
V nobenem primeru se zdravil Humalog Mix ali Humalog NPL ne sme dajati intravensko.
The Committee for Medicinal products for Human Use (CHMP) decided that Humalog’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Humalog pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
They recommended that Humalog be given marketing authorisation.
Zato je priporočil, da se za zdravilo Humalog podeli dovoljenje za promet z zdravilom.
Other information about Humalog:
Druge informacije o zdravilu Humalog:
The European Commission granted marketing authorisations valid throughout the European Union, for Humalog to Eli Lilly Netherland B. V. on 30 April 1996.
Evropska komisija je dovoljenje za promet z zdravilom Humalog, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Netherland B. V. dne 30. aprila 1996.
This was renewed on 30 April 2001.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 30. aprila 2001.
The full EPAR for Humalog is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Humalog je na voljo tukaj.
This summary was last updated in 1-2006
Ta povzetek je bil nazadnje posodobljen 1- 2006.
100 U/ ml
100 i. e. / ml
Subcutaneous or intravenous use
subkutana ali intravenska uporaba
5 pens
5 peresnikov
5 x 1 vial
5 x 1 viala
2 x 5 cartridges
2 x 5 vložkov
2x 5 pens
2 x 5 peresnikov
2 x 5 pens
2 x 5 peresnikov
2 x 5 cartridges
2 x 5 peresnikov
Humalog 100 U/ ml, solution for injection in vial
Humalog 100 i. e. / ml raztopina za injiciranje v viali
One ml contains 100U (equivalent to 3.5mg) insulin lispro (recombinant DNA origin produced in E. coli).
(ekvivalentno 3, 5 mg) insulina lispro (izdelanega s pomočjo rekombinantne DNA v E. coli).
Each container includes 10ml equivalent to 1000U insulin lispro.
Vsak vsebnik vsebuje 10 ml, kar je ekvivalentno 1000 i. e. insulina lispro.
Humalog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Pripravke zdravila Humalog dajemo s subkutano injekcijo ali s kontinuirno subkutano infuzijsko črpalko (glejte poglavje 4. 2), lahko pa tudi z intramuskularno injekcijo, čeprav to ni priporočljivo.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
Po nasvetu zdravnika se lahko zdravilo Humalog uporabi hkrati s humanim insulinom z dolgotrajnejšim delovanjem ali peroralnimi pripravki s sulfonilsečnino.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
2 Za infundiranje insulina lispro lahko uporabljamo samo določene insulinske infuzijske črpalke, označene s CE.
Change the infusion set every 48 hours.
Infuzijski sistem vsakih 48 ur zamenjajte.
Use aseptic technique when inserting the infusion set.
Pri vstavitvi infuzijskega sistema uporabite aseptične metode.
Infusion systems at concentrations from 0.1U/ ml to 1.0U/ ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours.
Infuzijski sistemi s koncentracijami od 0, 1 i. e. / ml do 1, 0 i. e. / ml insulina lispro v 0, 9% raztopini natrijevega klorida ali v 5% dekstrozi so pri sobni temperaturi obstojni 48 ur.
Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal, human, human insulin analogue), and/ or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
V primeru spremembe jakosti, blagovne znamke (izdelovalca), tipa (navadni, NPH, lente itd.), vrste (živalski, humani, analog humanega insulina) in/ ali načina izdelave (s pomočjo rekombinantne DNA v primerjavi z insulinom živalskega izvora) bo morda treba spremeniti odmerjanje insulina.
For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/ fasting glucose control.
Pri insulinih s hitrim delovanjem morajo bolniki, ki uporabljajo tudi bazalni insulin, optimizirati odmerjanje obeh insulinov, da bi dosegli nadzor ravni glukoze preko celega dneva, zlasti nadzor nočne ravni glukoze/ ravni glukoze na na tešče.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced
Potrebe po insulinu so lahko zmanjšane tudi pri bolnikih z jetrno okvaro zaradi zmanjšane zmogljivosti za glukoneogenezo in
3 insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
3 zmanjšane razgradnje insulina, vendar pa lahko pri bolnikih s kronično jetrno okvaro povečanje rezistence na insulin vodi v povečano potrebo po insulinu.
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Potrebe po insulinu lahko zmanjšajo zdravila s hipoglikemičnim delovanjem, kot so peroralni antidiabetiki, salicilati (na primer acetilsalicilna kislina), sulfonamidi, nekateri antidepresivi (zaviralci monoamin- oksidaze), nekateri zaviralci angiotenzin- konvertaze (kaptopril, enalapril), blokatorji receptorjev angiotenzina II, beta blokatorji, oktreotid ali alkohol.
The physician should be consulted when using other medications in addition to Humalog.
Pri sočasni uporabi zdravila Humalog in drugih zdravil se je potrebno posvetovati z zdravnikom.
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
Podatki zbrani na velikem številu nosečnic ne kažejo na možnost škodljivih vplivov insulina lispro na nosečnost ali zdravje zarodka/ novorojenca.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Zaradi hipoglikemije se lahko bolnikova sposobnost koncentracije in odzivanja zmanjša.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
V okoliščinah, v katerih so take sposobnosti še posebej pomembne (npr. vožnja avtomobila ali upravljanje strojev), je to lahko nevarno.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
To je še posebno pomembno pri tistih, ki se manj ali sploh ne zavedajo opozorilnih znakov hipoglikemije ali imajo pogoste hipoglikemije.
No
Huda hipoglikemija lahko vodi v izgubo zavesti, v skrajnih primerih pa celo v smrt.
4 specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e. g. a patient`s level of diet and exercise.
Pogostnost hipoglikemije ni navedena, hipoglikemija je namreč rezultat tako odmerka insulina kot drugih faktorjev, kot so bolnikova prehrana in telesna dejavnost.
Local allergy in patients is common (1/ 100 to < 1/ 10).
4 Lokalna alergijska reakcija je pogost (> 1/ 100, < 1/ 10) neželen učinek.
Systemic allergy, which is rare (1/ 10,000 to < 1/ 1,000) but potentially more serious, is a generalised allergy to insulin.
Sistemska alergijska reakcija, ki je redka (> 1/ 10. 000, < 1/ 1. 000), a potencialno nevarnejša, je generalizirana alergija na insulin.
Lipodystrophy at the injection site is uncommon (1/ 1,000 to < 1/ 100).
Na mestu injiciranja insulina občasno (> 1/ 1. 000, < 1/ 100) pride do lipodistrofije.
Fast-acting human insulin analogue.
Analog humanega insulina s hitrim delovanjem.
5 Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin.
Klinična preskušanja pri bolnikih z diabetesom tipa 1 in 2 so pokazala, da je pri uporabi insulina lispro v primerjavi s topnim humanim insulinom manj postprandialnih hiperglikemij.
As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Odvisen je od odmerka, mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
Humulin R Hypoglycaemic Activity
Humulin R Hypoglycaemic Hipoglikemična Activity aktivnost
5
Time (Hours) Čas (ure)
Time (Hours) The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Zgornji diagram ponazarja časovni potek učinkov obeh insulinov na presnovo glukoze, ki je potrebna za vzdrževanje koncentracije glukoze v polni krvi blizu ravni na tešče.
In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
V dvojno slepi navzkrižni študiji so po 12 tednih odmerjanja insulina lispro dosegli 0, 37% zmanjšanje ravni glikiranega hemoglobina v primerjavi z 0, 03% pri topnem insulinu (p = 0, 004).
The reduction of HbA1c would also be expected with other insulin products e. g. soluble or isophane insulins.
Znižanje HbA1c bi pričakovali tudi pri drugih pripravkih insulina, npr. pri topnem ali izofan insulinu.
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
Razlika v glukodinamiki med insulinom lispro in topnim humanim insulinom, merjeni s postopkom glukoznega “ clampa ”, se je ohranjala preko širokega razpona ledvične funkcije.
When considering the clinical 6 relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Za oceno kliničnega pomena te kinetike je bolj primerno upoštevati krivulji utilizacije glukoze (glejte poglavje 5. 1).
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment.
6 Insulin lispro se pri bolnikih z ledvično okvaro absorbira hitreje kot topni humani insulin.
7H2O Zinc oxide Water for injections Hydrochloric acid and sodium hydroxide maybe used to adjust pH to 7.0 – 7.8.
Metakrezol [3, 15 mg/ ml] Glicerol Natrijev hidrogenfosfat heptahidrat Cinkov oksid Voda za injekcije Za uravnavanje pH na 7, 0- 7, 8 sta morda bila uporabljena klorovodikova kislina in natrijev hidroksid.
6.3 Shelflife
6. 3 Rok uporabnosti
After first use of the vial, the solution should be used within 28 days when stored below 30°C.
Po prvi uporabi viale je treba raztopino porabiti v 28 dneh, če je shranjena pri temperaturi do 30 °C.
6.6 Special precautions for disposal and other handling
1 x 10 ml Humalog viala 2 x 10 ml Humalog viali 5 x (1 x 10 ml) Humalog viale 7 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Instructions for use and handling The vial is to be used in conjunction with an appropriate syringe (100 U markings).
Navodila za pripravo in ravnanje z zdravilom Vialo je treba uporabiti z ustrezno injekcijsko brizgo (oznake 100 enot).
a) Preparing a dose
a) Priprava odmerka
If mixing insulins, refer to the instructions for mixing that follow in Section (ii) and 6.2.
Če insuline mešate, glejte navodila za mešanje, ki sledijo v poglavju (ii) in 6. 2.
ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2)
ii) Mešanje zdravila Humalog s humanimi insulini z dolgotrajnejšim delovanjem (glejte poglavje 6. 2)
b) Injecting a dose
b) Injiciranje odmerka
c) Mixing insulins
c) Mešanje insulinov
See section 6.2.
Glejte poglavje 6. 2.
Eli Lilly Nederland B. V., Grootslag 1-5, 3991 RA Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA Houten, Nizozemska.
1 x 10 ml Humalog vial 2 x 10 ml Humalog vials 5 x (1 x 10 ml) Humalog vials
1 x 10 ml Humalog viala 2 x 10 ml Humalog viali 5 x (1 x 10 ml) Humalog viale
30th April 1996 Date of last renewal:
30. april 1996 Datum zadnjega podaljšanja dovoljenja za promet:
30th April 2006
30. april 2006
Humalog 100 U/ ml, solution for injection in cartridge
Humalog 100 i. e. / ml raztopina za injiciranje v vložku
Each container includes 3ml equivalent to 300U insulin lispro.
Vsak vsebnik vsebuje 3 ml, kar je ekvivalentno 300 i. e. insulina lispro.
The faster onset of action compared to soluble human insulin is maintained regardless of injection site As with all insulin preparations, the duration of action of Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Kakor velja za vse pripravke insulina, je trajanje delovanja zdravila Humalog odvisno od odmerka, mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
10 Za infundiranje insulina lispro lahko uporabljamo samo določene insulinske infuzijske črpalke, označene s CE.
11 Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
11 Odmerjanje je morda treba prilagoditi tudi, če bolnik poveča telesno dejavnost ali spremeni običajni način prehrane.
If the 40 U/ ml vial is the product normally prescribed, do not take insulin from a 100 U/ ml cartridge using a 40 U/ ml syringe.
Če je običajno predpisan izdelek 40 i. e. / ml viala, ne jemljite insulina iz 100 i. e. / ml vložka s 40 i. e. / ml injekcijsko brizgo.
No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e. g. a patient`s level of diet and exercise.
Pogostnost hipoglikemije ni navedena, hipoglikemija je namreč rezultat tako odmerka insulina kot drugih faktorjev, kot so bolnikova prehrana in telesna dejavnost.
12 Local allergy in patients is common (1/ 100 to < 1/ 10).
12 Lokalna alergijska reakcija je pogost (> 1/ 100, < 1/ 10) neželen učinek.
Pharmacotherapeutic group: Fast-acting human insulin analogue.
Analog humanega insulina s hitrim delovanjem.
13 As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.
Odvisen je od odmerka, mesta injiciranja, prekrvitve tkiva, temperature in telesne dejavnosti.
Time (Hours)
Time (Hours) Čas (ure)
14 The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.
Farmakokinetika insulina lispro kaže na spojino, ki se hitro absorbira in doseže najvišjo raven v krvi 30 do 70 minut po subkutanem injiciranju.
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).
Za oceno kliničnega pomena te kinetike je bolj primerno upoštevati krivulji utilizacije glukoze (glejte poglavje 5. 1).
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment.
14 Insulin lispro se pri bolnikih z ledvično okvaro absorbira hitreje kot topni humani insulin.
After insertion of the cartridge in a pen, the solution should be used in 28 days when stored below 30°C.
Po vstavitvi vložka v injekcijski peresnik je treba raztopino porabiti v 28 dneh, če je shranjena pri temperaturi do 30 °C.
Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/ or the glass cartridges.
Za obdelavo bata vložka in/ ali steklenega vložka sta lahko bili uporabljeni dimetikonska ali silikonska emulzija.
15 5 x 3 ml Humalog cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog cartridges for a 3 ml pen
5 x 3 ml Humalog vložki za 3 ml injekcijski peresnik 2 x (5 x 3 ml) Humalog vložki za 3 ml injekcijski peresnik
Instructions for use and handling Humalog cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Navodila za pripravo in ravnanje z zdravilom Vložke zdravila Humalog uporabljajte z injekcijskim peresnikom, označenim s CE, kot je priporočeno v podatkih izdelovalca pripomočka.
The manufacturer’ s instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
Pri vstavitvi vložka, pritrjevanju igle in dajanju injekcije insulina je treba upoštevati navodila izdelovalca, ki so priložena posameznim injekcijskim peresnikom.
Eli Lilly Nederland B V., Grootslag 1-5, 3991 RA Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA Houten, Nizozemska.
5 x 3 ml Humalog cartridges for a 3 ml pen 2 x (5 x 3 ml) Humalog cartridges for a 3 ml pen
5 x 3 ml Humalog vložki za 3 ml injekcijski peresnik 2 x (5 x 3 ml) Humalog vložki za 3 ml injekcijski peresnik
30th April 1996 Date of last renewal:
16 Datum zadnjega podaljšanja dovoljenja za promet:
Humalog Mix25 100 U/ ml suspension for injection in vial
Humalog Mix25 100 i. e. / ml suspenzija za injiciranje v viali
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Zdravilo Humalog Mix25 vsebuje 25% raztopine insulina lispro in 75% suspenzije insulina lispro - protamin.