natgillin/translations-raw huggingface dataset:
HEXAVAC should be injected into the quadriceps or deltoid muscle preferably at alternating sites for subsequent injections.
Zaželeno je izmenjevanje mest vbrizganja pri naslednjih injekcijah.
If you forget to take HEXAVAC:
Če ste pozabili cepiti otroka s HEXAVAC- om:
Following the widespread use of HEXAVAC, additional undesirable effects have been reported:
Po začetku splošne uporabe HEXAVAC- a so poročali o dodatnih neželenih učinkih:
Very rarely there may be allergic reaction; chills; fatigue; malaise; oedema; swelling of the entire limb(s); Guillain Barré Syndrome; hypotonic hyporesponsive episode; pallor; convulsions (with or without fever); brain inflammation, acute brain swelling; eyes rolling; decrease in muscle tone; neuritis; nausea; abdominal gas and/ or pain; low platelet count; purple or red brown spots visible through the skin; agitation; difficulty sleeping; breathing difficulty; wheezing; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; rash; skin redness; generalized hives; generalized itching; flushing; temporary swelling of local lymph nodes.
Zelo redko se lahko pojavi alergijska reakcija; mrazenje; utrujenost; splošna slabost; edem; otekanje celotnega uda ali udov; sindrom Guillain Barré; epizoda hipotoničnosti hipoodzivnosti; bledica; krči (ki jih spremlja vročina ali pa ne); vnetje možganov, akutno otekanje možganov; vrtenje oči; zmanjšanje mišičnega tonusa; nevritis; slabost; vetrovi in/ ali bolečine v trebuhu; nizke vrednosti trombocitov; vijolične ali rdečerjave pege vidne skozi kožo; vznemirjenje; težave pri spanju; oteženo dihanje; sopihanje; otekanje obraza, ustnic, ust, jezika ali grla, ki lahko povzroči oteženo požiranje in dihanje; izpuščaj; rdečina na koži; generaliziran izpuščaj; generalizirana srbečica; rdečina; začasno otekanje lokalnih limfnih vozljev.
Store at 2 °C – 8 °C (in a refrigerator) Do not freeze Do not use after the expiry date stated on the label.
Ne zamrzujte!
Eesti Norge AS Oriola – Tallinn Tel:
Eesti AS Oriola – Tallinn Tel:
Sanofi Pasteur MSD sa/ nv Tlf: +32.2.726.95.84
Norge Sanofi Pasteur MSD sa/ nv Tlf: +32. 2. 726. 95. 84
Κύπρος XANTOS LYSSIOTIS AND SON Τηλ:
42 Κύπρος XANTOS LYSSIOTIS AND SON Τηλ:
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN RAZLOGI ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
INTRODUCTION The EMEA published its initial review on the benefit/ risk profile of hexavalent vaccines (EMEA/ 8519/ 03, EMEA/ CHMP/ 5889/ 03) in April and December 2003, concluding that there was no change to the benefit/ risk profile and therefore no changes to the conditions of use were recommended, for, among others, the following reasons:
UVOD Evropska agencija za zdravila (EMEA) je aprila in decembra 2003 objavila svojo prvo revizijo profila koristnih učinkov in tveganj heksavalentnih cepiv (EMEA/ 8519/ 03, EMEA/ CHMP/ 5889/ 03), kjer je zaključila, da ni sprememb razmerja med koristmi in tveganji, zato ni priporočila sprememb pogojev uporabe, med drugim zaradi naslednjih razlogov:
- Vaccination offers benefits to the individual child and to the general population.
- Cepljenje je koristno za posameznega otroka in za splošno populacijo.
The CHMP
Odbor za zdravila za uporabo
considered that the benefits of vaccination far outweighed possible risks of existing vaccines, including hexavalent vaccines, and that vaccination should be continued according to national vaccination schedules.
v humani medicini (CHMP) je menil, da so koristni učinki cepljenja večji od možnih tveganj obstoječih cepiv, vključujoč heksavalentna cepiva, in da naj se cepljenje nadaljuje po nacionalnih programih cepljenja.
- The causes of death remain unexplained and on the basis of the available data, it is not possible to
- Vzroki smrti ostajajo nerazloženi in na podlagi dostopnih podatkov za heksavalentna cepiva ni
establish a cause and effect association with the hexavalent vaccines.
možno določiti povezave vzrok- učinek.
- The temporal relationship identified between 4 Sudden Unexpected Death (SUD) cases and
- Odkrita časovna povezava med štirimi primeri nenadne nepričakovane smrti (SUD) in
hexavalent vaccination raises a possible signal for Hexavac vaccination and SUD, but there are some inevitable limitations of the data sources and methods used to calculate the expected numbers.
heksavalentnim cepljenjem je vzbudila možen signal povezave med cepljenjem s Hexavac in SUD, vendar obstaja nekaj neizogibnih omejitev virov podatkov in metod, ki se uporabljajo za izračun pričakovanih vrednosti.
In any case, the signal only raised a suspicion and did not prove a cause and effect relationship.
V vseh primerih je signal povzročil sum, a ni bilo mogoče dokazati povezave vzrok- učinek.
Further studies are needed to establish whether or not there is a risk.
Da bi ugotovili ali tveganje obstaja ali ne, so potrebne dodatne raziskave.
On 28 January 2005, Germany requested the suspension of the Marketing Authorisation for Hexavac (EU/ 1/ 00/ 147/ 001-8) based on the Article 18 of Council Regulation 2309/ 93 (EC).
Nemčija je 28. januarja 2005 zahtevala umik dovoljenja za promet z zdravilom Hexavac (EU/ 1/ 00/ 147/ 001- 8) na podlagi člena 18 Uredbe Sveta 2309/ 93 (ES).
Therefore, on 15 February 2005, the European Commission (EC) triggered the review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93 for reasons related to the occurrence of Sudden Unexplained Deaths after administration of Hexavac in the 2nd year of life.
2309/ 93 zaradi razlogov, povezanih s pojavom nenadnih nerazloženih smrti po uporabi zdravila Hexavac v drugem letu življenja.
The CHMP was requested to give an opinion as to whether the Marketing Authorisation (MA) for Hexavac should be maintained, varied, suspended or withdrawn.
Zaprosila je CHMP za mnenje o ohranitvi, spremembi, umiku ali ukinitvi dovoljenja za promet z zdravilom Hexavac.
The CHMP started the review procedure on 15 February 2005.
CHMP je začel revizijski postopek 15. februarja 2005.
An expert meeting was convened on 21 March 2005 to scrutinise all available data and analyses on the occurrence of Sudden Infant Death Syndrome (SIDS) and SUD after administration of Hexavac and to discuss whether the administration of Hexavac can be considered as safe.
Dne 21. marca 2005 je bila sklicana strokovna seja, da bi temeljito preverili dostopne podatke in analize o pojavu sindroma nenadne otroške smrti (SIDS) in SUD po uporabi zdravila Hexavac in da bi razpravljali o varnosti uporabe zdravila Hexavac.
The risk assessment focused on epidemiological analyses of the cases of SUD, autopsy reports of the individual cases, all available data from the previous review and the results from the observed/ expected analysis of Prof.
Vrednotenje tveganja se je osredotočilo na epidemiološke analize primerov SUD, obdukcijska poročila za posamezne primere, vse dostopne podatke iz prejšnje revizije in rezultate iz analize opaženih/ pričakovanih podatkov, ki jo je izvedel prof.
Von Kries, as published in the European Journal of Paediatrics, 2005 (Eur J Pediatr 2005 Feb; 164(2):61-69, Epub 2004 Dec 16).
Von Kries in je bila objavljena v European Journal of Paediatrics, 2005 (Eur J Pediatr 2005 Feb; 164( 2): 61- 69, Epub 2004 Dec 16).
Safety Issue
Vprašanje varnosti
The CHMP had previously concluded that there is a statistical signal of an excess occurrence of cases of SUD within 24 hours of a booster vaccination with Hexavac during the 2nd year of life.
CHMP je v prejšnjem primeru zaključil, da obstaja statistični signal za čezmerno pojavnost SUD v 24 urah po obnovitvenem cepljenju z zdravilom Hexavac v drugem letu življenja.
The signal had been identified in the observed/ expected analysis (see above).
Signal so odkrili v analizi opaženih/ pričakovanih podatkov (glejte zgornje besedilo).
They find that chance is a very unlikely explanation of the finding, given the
Raziskovalci so menili, da njihovi podatki dokazujejo,, močen signal tveganja SUD po obnovitvenih cepljenjih z zdravilom Hexavac v drugem letu življenja “.
1 fact that the lower confidence limits for both day 1 and day 2 were greater than unity, i. e.
Ugotavljajo, da je naključje zelo neverjetna razlaga tega odkritja, če upoštevamo dejstvo, da sta bili spodnji meji intervalov zaupanja za prvi in drugi dan večji od spodnje meje intervala zaupanja za združena dneva (tj.
3.8 and 4.8, respectively.
3, 8 za prvi dan in 4, 8 za drugi dan).
The absolute risk (reporting rate) would correspond to 1 death due to SUD in 300,000- 400,000 children in the 2nd year of life.
Absolutno tveganje (poročana stopnja) ustreza 1 smrti zaradi SUD na 300. 000- 400. 000 otrok v 1 drugem letu življenja.
On the basis of extensive analyses showing a remaining excess risk, i. e. sensitivity analyses, it was concluded that the findings were unlikely to be attributed solely to limitations of the data sources.
Na podlagi obsežnih analiz, ki kažejo preostalo čezmerno tveganje, tj. analize občutljivosti, so zaključili, da odkritij ni mogoče pripisati izključno omejitvam virov podatkov.
However, it is acknowledged that the calculations are based on a number of assumptions and may be affected by bias in the data, but the finding of an excess statistical occurrence of SUD seems to remain after testing for the influence of new and different assumptions.
Vendar priznavajo, da izračuni temeljijo na številnih predpostavkah, zato nanje lahko vplivajo napake v podatkih, vendar se odkritje čezmerne statistične pojavnosti SUD ohranja po preskusih za vpliv novih in drugačnih domnev.
The CHMP concluded, that the absolute risk was considered to be very small.
Zato je bil CHMP mnenja, da je absolutno tveganje zelo majhno.
In addition, the observed/ expected analysis could not provide evidence for a cause and effect relationship between SUDs and vaccination with Hexavac.
Poleg tega analiza opaženih/ pričakovanih podatkov ni mogla ponuditi dokazov za povezavo vzrok- učinek med SUD in cepljenjem z zdravilom Hexavac.
Additionally, there is no biologic explanation so far to support a causal link.
Prav tako ni biološke razlage vzročne povezave.
Meticulous expert scrutiny of individual reports of all known cases (3 cases from Germany and 1 case from Austria) of SUD in the 2nd year of life did not reveal any circumstantial evidence of a biological and causal link between Hexavac and the occurrence of SUD.
Natančno strokovno preverjanje posameznih poročil o vseh znanih primerih SUD (3 primeri iz Nemčije in 1 primer iz Avstrije) v drugem letu življenja ni odkrilo posrednih dokazov o biološki in vzročni povezavi med zdravilom Hexavac in pojavnostjo SUD.
Neither is there any hypothetical explanation regarding possible effects on the immune or autonomous nervous systems, on pro- convulsive mechanisms or by means of quality defects in the production of the multivalent vaccines.
Niti ne obstaja hipotetična razlaga možnih učinkov na imunski sistem ali avtonomno živčevje, na konvulzije vzbujevalne mehanizme ali preko napak v kakovosti pri proizvodnji multivalentnih cepiv.
The updated review of the individual cases did not identify any new safety issue for Hexavac.
Posodobljena revizija posameznih primerov ni odkrila nobenega novega vprašanja o varnosti zdravila Hexavac.
Additionally, no specific underlying mechanism could be identified to explain a causal link between Hexavac and an increased occurrence of SUD.
Prav tako ni bilo možno odkriti specifičnega osnovnega mehanizma, s katerim bi bilo mogoče razložiti povezavo med zdravilom Hexavac in zvišano pojavnostjo SUD.
Different experts had previously assessed and discussed the quality aspects of Hexavac and no mechanistic support for an increased risk of SUD was identified.
Različni strokovnjaki so predhodno ocenili kakovostne vidike zdravila Hexavac in o njih razpravljali, pri čemer niso odkrili mehanistične podlage za povečano tveganje SUD.
There is no inconsistency between batches and no quality deficiencies were identified.
Niso odkrili nedoslednosti med serijami zdravila niti pomanjkljive kakovosti.
Based on the available data, there is no possible link between an immunological reaction caused by the hexavalent vaccines and an increase of SUD occurrence.
Na podlagi dostopnih podatkov možna povezava med imunološko reakcijo, ki jo vzbudijo heksavalentna cepiva, in zvišano pojavnostjo SUD ne obstaja.
Animal studies and animal models were thoroughly reviewed to analyse a possible relationship between SUD and Hexavac.
Podrobno so bile preverjene raziskave na živalih in živalskih modelih z namenom analize možne povezave med SUD in zdravilom Hexavac.
However, there was currently no animal model available to investigate SUDs.
Vendar trenutno ni na voljo živalskega modela, ki bi bil primeren za raziskovanje SUD.
Furthermore, the fact that no significant effects had been observed in the telemetry animal studies indicates that there is no support for a hypothesis that disturbances in the autonomic nervous system are responsible for the SUD occurrence associated with Hexavalent vaccines.
Ravno tako v telemetričnih raziskavah na živalih niso odkrili pomenljivih učinkov, kar nakazuje odsotnost osnove za domnevo, da je za pojav SUD, povezan s heksavalentnimi cepivi, odgovorno avtonomno živčevje.
Furthermore the EEG monitoring did not show proconvulsive effects related to the administration of vaccines.
Hkrati pa spremljanje EEG ni pokazalo konvulzije vzbujevalnih učinkov, ki bi bili povezani z uporabo cepiv.
In summary, it was found that no new relevant data has become available since previous discussions/ conclusions by/ of the CHMP.
Povzeto na kratko je bilo ugotovljeno, da od zadnje razprave/ zaključkov CHMP ni novih pomembnih podatkov.
The CHMP, upon review of the safety of Hexavac, acknowledged the finding of a statistical signal of an excess occurrence of SUD after Hexavac booster vaccination in the 2nd year of life, but also the inability to identify a biological mechanism in spite of meticulous expert considerations, and the initiation of epidemiological studies.
Na podlagi revizije varnosti zdravila Hexavac je CHMP priznal odkritje statističnega signala čezmerne pojavnosti SUD po obnovitvenem cepljenju z zdravilom Hexavac v drugem letu življenja, vendar tudi nezmožnost odkritja biološkega mehanizma navkljub natančni strokovni obravnavi in začetku epidemioloških raziskav.
The CHMP reviewed the data submitted by the MAHs in relation to the signal of SUD in children and toddlers.
CHMP je pregledal podatke, ki so jih v zvezi s signalom SUD pri otrocih in malčkih predložili imetniki dovoljenj za promet z zdravili.
The CHMP concluded that a signal does exist based on a statistical relationship, which may represent an artefact in the data, a random cluster of events, or a true biological effect.
Na podlagi statistične povezave, ki morda predstavlja artefakt v podatkih, naključno gručo dogodkov ali resničen biološki učinek, CHMP meni, da signal obstaja.
However, the strength of this signal is, in the absence of a convincing biological and causal link, weak, therefore the benefit-risk balance for Hexavac remains positive and no further regulatory action is necessary at this point in time.
Vendar je moč signala v odsotnosti prepričljive biološke ali vzročne povezave šibka, zato razmerje med koristmi in tveganji za zdravilo Hexavac ostaja pozitivno, zato v tem trenutku ni potrebe po dodatnih regulatornih ukrepih.
2 The CHMP concluded that serious adverse events, particularly cases of SUD, shall be continuously and carefully monitored and assessed.
CHMP meni, da je treba hude neželene učinke, zlasti primere SUD, neprekinjeno in natančno spremljati ter vrednotiti.
Therefore the CHMP members recommended follow-up measures to further investigate the known cases and to initiate further studies
Zato člani CHMP priporočajo spremljanje, da bi dodatno raziskali znane primere in začeli nove raziskave.
On the basis of the current data, the CHMP concluded that the safety profile of Hexavac is in line with the current SPC.
Na podlagi trenutnih podatkov CHMP meni, da je varnostni profil zdravila Hexavac v skladu s trenutnim SPC.
GROUNDS FOR MAINTAINING THE MARKETING AUTHORISATION OF HEXAVAC
2 RAZLOGI ZA OHRANITEV DOVOLJENJA ZA PROMET ZA ZDRAVILO HEXAVAC
• The CHMP came to the conclusion that after the review of available data, the causes of death remain unexplained and it is not possible to establish a causal association with Hexavac.
• CHMP je po pregledu dostopnih podatkov zaključil, da vzroki smrti ostajajo nerazloženi in da ni možno določiti vzročne povezave z zdravilom Hexavac.
• The CHMP members have, in line with the previous reviews, come to the conclusion that the signal does exist based on a statistical relationship, which may represent an artefact in the data, a random cluster of events, or a true biological effect.
• Člani CHMP so v skladu s prejšnjimi revizijami zaključili, da na podlagi statistične povezave, ki morda predstavlja artefakt v podatkih, naključno gručo dogodkov ali resničen biološki učinek, signal obstaja.
However, the strength of this signal is, in the absence of a convincing biological and causal link, weak.
Vendar je moč signala v odsotnosti prepričljive biološke ali vzročne povezave šibka.
• The CHMP concluded that no scientific rationale or convincing ethical considerations to take regulatory action have been presented.
• CHMP meni, da ni bilo predstavljene znanstvene podlage ali prepričljivih etičnih zadržkov za regulatorne ukrepe.
Therefore the benefit-risk balance for Hexavac remains positive and no further regulatory action is necessary at this point in time.
Zato razmerje med koristmi in tveganji za zdravilo Hexavac ostaja pozitivno in v tem trenutku ni potrebe po dodatnih regulatornih ukrepih.
• The CHMP concluded that serious adverse events, particularly cases of SUD, shall be continuously and carefully monitored and assessed.
• CHMP meni, da je treba hude neželene učinke, zlasti primere SUD, neprekinjeno in natančno spremljati ter vrednotiti.
Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, polio virus and Haemophilus influenzae type b.
Hexavac je heksavalentno cepivo, ki vsebuje kombinirane antigene, pridobljene iz Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virusa hepatitisa B, poliovirusa in Haemophilus influenzae tipa b.
This combined vaccine is indicated for primary and booster vaccination of children against the viruses and bacteria mentioned above.
To kombinirano cepivo je indicirano za primarno in obnovitveno cepljenje otrok proti zgoraj omenjenim virusom in bakterijam.
On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
Odbor za zdravila za uporabo v humani medicini je 26. maja 2005 soglašal s tem, da je potrebno sklicati sestanek ad hoc izvedenske skupine za kratkotrajno in dolgotrajno zaščito pred hepatitisom, ki jo omogočajo rekombinantna cepiva proti hepatitisu B.
The CHMP expressed concerns that there is evidence of unpredictable variability in Hepatitis B antibody response following vaccination with Hexavac.
Odbor za zdravila za uporabo v humani medicini je izrazil zaskrbljenost, ker obstajajo dokazi o nepredvidljivi variabilnosti odziva protiteles hepatitisa B po cepljenju s Hexavacom.
On 14 September 2005, the European Commission (EC) triggered the procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Hexavac.
2309/ 93, kot je bila spremenjena.
The CHMP was requested to give an opinion as to whether the marketing authorisation for Hexavac should be maintained, varied, suspended or withdrawn in the context of an Article 18 of Council Regulation (EEC) No 2309/ 93, as amended, procedure.
2309/ 93, kot je bila spremenjena.
Additional concerns were raised by the recent finding that children primary immunised with Hexavac apparently respond to a booster dose of a monovalent Hepatitis B vaccine as a function of the geometric mean titres (GMTs) achieved upon completion of the primary immunisation series.
Dodatno zaskrbljenost je povzročila nedavna ugotovitev, da pri otrocih, ki so bili primarno cepljeni s Hexavacom, očitno pride do odziva na obnovitveni odmerek monovalentnega cepiva proti hepatitisu B in sicer v odvisnosti od titrov geometričnih povprečij (GMT), doseženih po zaključku serij primarnega
1 number of infants but raised concerns because the findings of a challenge ‘ weaker ’ than priming with or without booster dose are unexpected.
Pri otrocih, pri katerih se je začetni imunski odziv nahajal med 10 in 100 mIE/ ml proti HbsAg, je v primerjavi z otroki, pri katerih so se začetni titri nahajali med 100 in 1000 mIE/ ml, po enkratnem odmerku monovalentnega cepiva proti hepatitisu B, danega pri starosti 7 do 9 let, prišlo do manj učinkovitega odziva ali pa odziva sploh ni bilo.
The CHMP considered that clinical alternatives exist, i. e. hexavalent vaccines or equivalent combinations of vaccines containing the same components as Hexavac.
Odbor za zdravila za uporabo v humani medicini meni, da klinične alternative obstajajo, in sicer heksavalentna cepiva ali enakovredne kombinacije cepiv, ki vsebujejo enake sestavine kot Hexavac.
2 GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATION OF HEXAVAC
2 PODLAGA ZA UKINITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM HEXAVAC
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
• Odbor za zdravila za uporabo v humani medicini je ugotovil, da je zmanjšana imunogenost HepB sestavine, ki jo je na tržišče dal imetnik dovoljenja za promet z zdravilom, posledica razlik v postopku izdelave te sestavine.
• The CHMP considered that the benefit/ risk balance of Hexavac for primary and booster vaccination of children against diphtheria, tetanus, pertussis, Hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b, was not favourable.
• Odbor za zdravila za uporabo v humani medicini je mnenja, da razmerje med koristmi in tveganji uporabe Hexavaca za primarno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, ki ga povzročajo vse znane podvrste virusov, poliomielitisu in invazivnim okužbam, ki jih povzroča Haemophilus influenzae tipa b, ni ugodno.
Humalog is a range of solutions and suspensions for injection.
Zdravilo Humalog je vrsta raztopin in suspenzij za injiciranje.
Humalog is supplied in vials, cartridges or in prefilled pens (Humalog Pen, Humaject).
Zdravilo Humalog se dobi v vialah, vložkih ali predhodno napolnjenih injekcijskih peresnikih (Humalog Pen, Humaject).
Humalog contains the active ingredient insulin lispro.
Zdravilo Humalog vsebuje učinkovino insulin lispro.
The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog NPL), and combination of both in various proportions (Humalog Mix):
Izdelki Humalog vsebujejo raztopine insulinov s hitrim delovanjem (Humalog), suspenzije insulinov z dolgotrajnejšim delovanjem (Humalog NPL) ter kombinacijo obeh v različnih razmerjih (Humalog Mix):
Humalog: insulin lispro solution Humalog NPL: insulin lispro protamine suspension Humalog Mix25:
Humalog: raztopina insulina lispro Humalog NPL: suspenzija insulina lispro- protamin Humalog Mix25:
25% insulin lispro solution and 75% insulin lispro protamine suspension Humalog Mix50:
25% raztopine insulina lispro in 75% suspenzije insulina lispro- protamin Humalog Mix50:
50% insulin lispro solution and 50% insulin lispro protamine suspension
50% raztopine insulina lispro in 50% suspenzije insulina lispro- protamin