FrancophonIA/ELRC3.0 huggingface dataset:
English: An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13.
Slovenian: Pri otrocih, starejših od 12 mesecev, so med osnovnim cepljenjem s cepivom Prevenar 13 pogosteje poročali o reakcijah na mestu cepljenja kot pri dojenčkih.
English: • Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site;
Slovenian: • razdražljivost; bolečina, občutljivost, rdečina, otekanje ali zatrdlina na mestu cepljenja,
English: In infants and children there have been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose.
Slovenian: Pri dojenčkih in otrocih obstajajo poročila o prevelikem odmerjanju cepiva Prevenar 13 v smislu dajanja zaporednih odmerkov cepiva v krajšem časovnem obdobju od priporočenega.
English: Immune responses in preterm and term infants were compared using the proportion of subjects achieving a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 μg/mL 1 month after the infant series, the approach used for immunogenicity comparisons of Prevenar 13 to Prevenar based on WHO guidelines.
Slovenian: Imunske odzive nedonošenčkov in donošenčkov so primerjali z deležem preskušancev, ki so dosegli koncentracijo protiteles IgG, ki se vežejo na pnevmokokne polisaharide, ki je ≥ 0,35 μg/ml 1 mesec po shemi za dojenčke; to je pristop, ki je bil za primerjavo imunogenosti cepiva Prevenar 13 in cepiva Prevenar uporabljen skladno s priporočili SZO.
English: Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the course of injections.
Slovenian: Pri dojenčkih in otrocih, ki so predhodno že prejeli odmerek cepiva Prevenar, se cepljenje lahko dokonča s cepivom Prevenar 13.
English: Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or with a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis.
Slovenian: Pri otrocih z napadi krčev ali z anamnezo vročinskih krčev in vseh otrocih, ki prejmejo cepivo Prevenar 13 skupaj s cepivom proti oslovskemu kašlju s celimi celicami, je treba uvesti zdravljenje vročine v skladu z nacionalnimi smernicami.
English: Headaches
Slovenian: glavoboli
English: EU/1/09/590/012 - pack of 1 multidose container EU/1/09/590/013- pack of 5 multidose containers EU/1/09/590/014- pack of 10 multidose containers EU/1/09/590/015 - pack of 25 multidose containers EU/1/09/590/016- pack of 50 multidose containers
Slovenian: EU/1/09/590/012 - pakiranje po 1 večodmerni vsebnik EU/1/09/590/013 - pakiranje po 5 večodmernih vsebnikov EU/1/09/590/014 - pakiranje po 10 večodmernih vsebnikov EU/1/09/590/015 - pakiranje po 25 večodmernih vsebnikov EU/1/09/590/016 - pakiranje po 50 večodmernih vsebnikov
English: Pneumococcal polysaccharide serotype 7F
Slovenian: 4,4 µg pnevmokokni polisaharid serotipa 7F
English: A fourth (booster) dose of Prevenar 13 was administered 6 months after the third dose.
Slovenian: Cepljenje s četrtim (obnovitvenim) odmerkom so prejeli 6 mesecev po tretjem odmerku.
English: Number needed to vaccinate
Slovenian: Število ljudi, ki jih je treba cepiti
English: Incidence rate reduction (95% CI)
Slovenian: Zmanjšanje incidence (95 % IZ)
English: 7-valent Prevenar serotypes
Slovenian: Serotipi 7-valentnega cepiva Prevenar
English: Adults with HIV infection had similar side effects however the frequencies were very common for fever, vomiting and common for nausea.
Slovenian: Odrasli z okužbo s HIV so imeli podobne neželene učinke, vendar sta bila vročina in bruhanje zelo pogosta, slabost s siljenjem na bruhanje pa pogost.
English: In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml.
Slovenian: Pri nedonošenčkih priporočeno shemo cepljenja sestavljajo štirje odmerki po 0,5 ml.
English: Nervous system disorders: Common:
Slovenian: Bolezni živčnega sistema: Pogosti:
English: EU/1/09/590/002 - pack of 1 with separate needle EU/1/09/590/001 - pack of 1 without needle EU/1/09/590/004 - pack of 10 with separate needles EU/1/09/590/003 - pack of 10 without needle EU/1/09/590/006 - pack of 50 with separate needles EU/1/09/590/005 - pack of 50 without needle
Slovenian: EU/1/09/590/002 - pakiranje po 1 s priloženo injekcijsko iglo EU/1/09/590/001 - pakiranje po 1 brez injekcijske igle EU/1/09/590/004 - pakiranje po 10 s priloženimi injekcijskimi iglami EU/1/09/590/003 - pakiranje po 10 brez injekcijskih igel EU/1/09/590/006 - pakiranje po 50 s priloženimi injekcijskimi iglami EU/1/09/590/005 - pakiranje po 50 brez injekcijskih igel
English: Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa (see section 4.8).
Slovenian: Pri sočasni uporabi cepiva Prevenar 13 s cepivom Infanrix hexa so opazili zvečano stopnjo poročanja konvulzij (z vročino ali brez nje) ter epizod hipotonije in zmanjšane odzivnosti (glejte poglavje 4.8).
English: • Seizures (or fits), including those caused by a high temperature
Slovenian: • krči (konvulzije), vključno z vročinskimi krči
English: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common.
Slovenian: Pogostnost neželenih učinkov pri odraslih z okužbo s HIV je bila podobna, z izjemo pireksije in bruhanja, ki sta bila zelo pogosta, in navzee, ki je bila pogosta.
English: The vaccine should be shaken well to obtain a homogeneous white suspension and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration.
Slovenian: Pred cepljenjem morate cepivo pregledati glede prisotnosti kakršnihkoli vidnih delcev in/ali neobičajne spremembe videza.
English: EU/1/09/590/007 - pack of 1 vial EU/1/09/590/008 - pack of 5 vials EU/1/09/590/009 - pack of 10 vials EU/1/09/590/010 - pack of 25 vials EU/1/09/590/011 - pack of 50 vials
Slovenian: EU/1/09/590/007 - pakiranje po 1 vialo EU/1/09/590/008 - pakiranje po 5 vial EU/1/09/590/009 - pakiranje po 10 vial EU/1/09/590/010 - pakiranje po 25 vial EU/1/09/590/011 - pakiranje po 50 vial
English: Unvaccinated infants and children ≥ 7 months of age
Slovenian: Predhodno necepljeni dojenčki in otroci, stari 7 mesecev ali več
English: Prevenar 13 significantly reduced NP carriage of the 6 additional serotypes (and serotype 6C) combined and individual serotypes 6C, 7F, 19A when compared with Prevenar.
Slovenian: Cepivo Prevenar 13 je v primerjavi s cepivom Prevenar pomembno zmanjšalo nosilstvo v nosnožrelnem prostoru za 6 dodatnih serotipov (in serotip 6C) v celoti ter za posamezne serotipe 6C, 7F, 19A.
English: As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.
Slovenian: Kot velja tudi za druga cepiva, je možno, da cepivo Prevenar 13 pred prevmokoknimi boleznimi ne bo zaščitilo vseh cepljenih oseb.
English: The other ingredients are sodium chloride, succinic acid, polysorbate 80, 2- phenoxyethanol and water for injections.
Slovenian: Druge sestavine zdravila so natrijev klorid, jantarna kislina, polisorbat 80, 2-fenoksietanol in voda za injekcije.
English: Pneumococcal polysaccharide serotype 23F
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 23F
English: The vaccine should be shaken well to obtain a homogeneous white suspension prior to expelling air from the syringe, and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration.
Slovenian: Cepivo morate pred uporabo najprej dobro pretresti, da nastane homogena, bela suspenzija, šele nato iz injekcijske brizge odstranite zrak.
English: The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections.
Slovenian: Druge sestavine zdravila so natrijev klorid, jantarna kislina, polisorbat 80 in voda za injekcije.
English: Adults with an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common.
Slovenian: Pogostnost neželenih učinkov pri odraslih s presadkom hematopoetskih matičnih celic je bila podobna, z izjemo pireksije in bruhanja, ki sta bila zelo pogosta.
English: The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13.
Slovenian: Odzivi na vse tri antigene TIV ob sočasnem dajanju cepiva TIV in cepiva Prevenar 13 so bili primerljivi z odzivi ob dajanju cepiva TIV samega.
English: Sodium chloride, succinic acid, polysorbate 80, 2-phenoxyethanol and water for injections
Slovenian: Natrijev klorid, jantarna kislina, polisorbat 80, 2-fenoksietanol in voda za injekcije.
English: Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).
Slovenian: Otrokom, ki so prejeli ustrezno osnovno cepljenje s cepivom Prevenar 13 (skladno z lokalnimi priporočili), lahko med 12. in 23. mesecem cepivo Prevenar 13 dajemo tudi sočasno s polisaharidnim cepivom proti meningokokom seroloških skupin A, C, W in Y, konjugiranim na tetanusni toksoid.
English: Adults ≥ 18 years of age, and the elderly
Slovenian: Odrasli, stari 18 let in več, ter starejši
English: Skin and subcutaneous tissue disorders: Common:
Slovenian: Bolezni kože in podkožja: Pogosti:
English: Pneumococcal polysaccharide serotype 19A
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 19A
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born  28 weeks of gestation), and particularly for those with a previous history of respiratory immaturity.
Slovenian: Pri osnovnem cepljenju veliko prezgodaj rojenih nedonošenčkov (rojenih pred ali v 28. tednu nosečnosti), še posebej tistih z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48-urnem do 72-urnem spremljanju pljučne funkcije.
English: The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone.
Slovenian: Imunski odzivi na cepivo Prevenar 13 so bili, ob sočasnem dajanju cepiva Prevenar 13 in cepiva QIV, enakovredni odzivom ob samostojnem dajanju cepiva Prevenar 13.
English: interfering with arm movement (severe pain or tenderness at vaccination-site for those 18-39 years of age and severe limitation of arm movements for those 18 to 39 years of age)
Slovenian: starih od 18 do 39 let, in močno omejeno gibanje roke pri osebah, starih od 18 do 39 let)
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET S CEPIVOM
English: Prevenar 13 suspension for injection Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Slovenian: Prevenar 13 suspenzija za injiciranje cepivo proti pnevmokokom, polisaharidno, konjugirano (13-valentno, adsorbirano)
English: Hypotonic-hyporesponsive episode
Slovenian: epizoda hipotonije in zmanjšane odzivnosti
English: 84,496 subjects, 65 years and older received a single vaccination of either Prevenar 13 or placebo in a 1:1 randomisation.
Slovenian: Eno cepljenje s cepivom Prevenar 13 ali placebom v razmerju randomizacije 1:1 je prejelo 84.496 preskušancev, starih 65 let in več.
English: Sodium chloride, succinic acid, polysorbate 80 and water for injections
Slovenian: Natrijev klorid, jantarna kislina, polisorbat 80 in voda za injekcije.
English: Prevenar 13 Effectiveness
Slovenian: Učinkovitost cepiva Prevenar 13
English: Pneumococcal polysaccharide serotype 19F
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 19F
English: Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 odmerkov cepiva) so:
English: Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197.
Slovenian: Shema cepljenja s cepivom Prevenar 13 za dojenčke in otroke, ki so bili predhodno cepljeni s cepivom Prevenar (7-valentno) (serotipi Streptococcus pneumoniae 4, 6B, 9V, 14, 18C, 19F in 23F)
English: Prevenar 13 suspension for injection in single dose vial Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Slovenian: Prevenar 13 suspenzija za injiciranje v enoodmerni viali cepivo proti pnevmokokom, polisaharidno, konjugirano (13-valentno, adsorbirano)
English: Acute Otitis Media
Slovenian: Akutno vnetje srednjega ušesa
English: Pneumococcal polysaccharide serotype 6B
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 6B
English: Prevenar 13 suspension for injection in multidose container Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Slovenian: Prevenar 13 suspenzija za injiciranje v večodmernem vsebniku cepivo proti pnevmokokom, polisaharidno, konjugirano (13-valentno, adsorbirano)
English: In addition, OPA GMTs between subjects receiving Prevenar 13 with or without 2-PE were compared.
Slovenian: Poleg tega so primerjali titre funkcionalnih protiteles (OPA) GMT med preskušanci, ki so prejeli cepivo Prevenar 13 s konzervansom 2-PE, in preskušanci, ki so prejeli cepivo Prevenar 13 brez tega konzervansa.
English: In a head-to-head, comparative trial conducted in adults aged 60-64 years, subjects received a single dose of either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine.
Slovenian: Odrasli, ki predhodno niso bili cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom V preskušanju, ki je potekalo po načelu neposredne primerjave in je bilo izvedeno pri odraslih osebah, starih od 60 do 64 let, so posamezniki prejeli en sam odmerek bodisi cepiva Prevenar 13 bodisi 23-valentnega pnevmokoknega polisaharidnega cepiva.
English: The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.
Slovenian: Imunski odzivi na vse štiri seve cepiva QIV so bili, ob sočasnem dajanju cepiva Prevenar 13 in cepiva QIV, enakovredni odzivom ob samostojnem dajanju cepiva QIV.
English: • Decreased appetite; headaches; diarrhoea; vomiting (for those 18 to 49 years of age) • Chills; tiredness; rash; pain, redness, swelling hardness or tenderness at the vaccination-site,
Slovenian: • zmanjšan apetit, glavoboli, driska, bruhanje (pri osebah, starih od 18 do 49 let)
English: As per general recommendations, a single dose of 23-valent pneumococcal polysaccharide vaccine was administered 1 month after the fourth dose of Prevenar 13.
Slovenian: En mesec po četrtem odmerku cepiva Prevenar 13 so skladno s splošnimi priporočili prejeli enkratni odmerek 23-valentnega pnevmokoknega polisaharidnega cepiva.
English: Immune system disorders: Uncommon:
Slovenian: Bolezni imunskega sistema: Občasni:
English: How to store Prevenar 13
Slovenian: Shranjevanje cepiva Prevenar 13
English: Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months), 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Slovenian: Šestinštirideset od teh otrok je pri starosti 15-18 mesecev prejelo tudi 23-valentno pnevmokokno polisaharidno cepivo.
English: This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1).
Slovenian: Cepivo se sme dati subkutano, če je korist cepljenja znatno večja od možnega tveganja (glejte poglavje 5.1).
English: Pneumococcal polysaccharide serotype 6A
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 6A
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine.
Slovenian: Otroci z večjim tveganjem, stari  24 mesecev, morajo prejeti 23-valentno pnevmokokno polisaharidno cepivo kadarkoli je to potrebno, tudi če so že bili cepljeni s cepivom Prevenar 13.
English: NCKP: Vaccine-serotype IPD
Slovenian: NCKP: invazivne pnevmokokne bolezni, povzročene s serotipom, ki ga vsebuje cepivo
English: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given.
Slovenian: Če se cepivo Prevenar 13 uporablja v okviru rutinskega programa cepljenja dojenčkov, lahko pride v poštev tudi shema cepljenja s tremi odmerki po 0,5 ml. Cepljenje s prvim odmerkom se lahko opravi od starosti 2 mesecev naprej, cepljenje z drugim odmerkom pa 2 meseca po cepljenju s prvim odmerkom.
English: Prevenar 13 suspension for injection in single dose vial IM
Slovenian: Prevenar 13 suspenzija za injiciranje v enoomerni viali i.m.
English: Each injection will be given at least one month apart.
Slovenian: Med dvema odmerkoma mora miniti vsaj en mesec.
English: N VE
Slovenian: navzea
English: Pre-filled syringe
Slovenian: Vnetje srednjega ušesa
English: Prevenar 13.
Slovenian: - Navodilo shranite.
English: 6A 6B 7F
Slovenian: 6B 3.212 7F
English: Rash; urticaria or urticaria-like rash
Slovenian: izpuščaj, urtikarija ali urtikariji podoben izpuščaj
English: The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Slovenian: Cepljenje s prvim odmerkom se običajno opravi pri starosti 2 mesecev.
English: After the second
Slovenian: Po protokolu
English: What Prevenar 13 contains
Slovenian: Kaj vsebuje cepivo Prevenar 13
English: - If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če pri sebi ali pri svojem otroku opazite katerikoli neželeni učinek, se posvetujte z zdravnikom,
English: OPA GMT levels at baseline
Slovenian: Ravni GMT OPA na začetku
English: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Slovenian: Dva odmerka, vsak po 0,5 ml.
English: Booster responses following two-dose and three-dose primary infant series
Slovenian: Odzivi na obnovitveni odmerek po osnovnem cepljenju dojenčkov z dvema odmerkoma in s tremi odmerki
English: • Irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; drowsiness;
Slovenian: • mrzlica, utrujenost, izpuščaj; bolečina, rdečina, oteklina, zatrdlina ali občutljivost na mestu cepljenja, ki ovira gibanje roke (huda bolečina ali občutljivost na mestu cepljenja pri osebah,
English: However, talk to your doctor, pharmacist, or nurse first.
Slovenian: farmacevtom ali medicinsko sestro.
English: Prevenar 13 group
Slovenian: Skupina s cepivom Prevenar 13
English: Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 odmerkov cepiva) so:
English: Suspension for injection in multidose container (4 doses).
Slovenian: suspenzija za injiciranje v večodmernem vsebniku (4 odmerki) Cepivo je homogena, bela suspenzija.
English: Pneumococcal polysaccharide serotype 5
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 5
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode)
Slovenian: • kolaps ali šoku podobno stanje (epizoda hipotonije in zmanjšane odzivnosti) • alergijska (preobčutljivostna) reakcija, vključno z oteklino obraza in/ali ustnic, težko dihanje
English: Pneumococcal polysaccharide serotype 14
Slovenian: 2,2 µg pnevmokokni polisaharid serotipa 14
English: Patients can inject themselves with this medicine if they have been trained appropriately.
Slovenian: Bolniki si lahko to zdravilo vbrizgajo sami, če so bili za to ustrezno usposobljeni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humalog on 30 April 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Humalog, veljavno po vsej Evropski uniji, izdala 30. aprila 1996.
English: What measures are being taken to ensure the safe and effective use of Humalog?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Humalog?
English: Humalog Mix is a mixture of these two formulations.
Slovenian: Humalog Mix je mešanica teh dveh pripravkov.
English: The full EPAR for Humalog can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Humalog je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Humalog
Slovenian: Druge informacije o zdravilu Humalog
English: This is a summary of the European public assessment report (EPAR) for Humalog.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Humalog.
English: Studies also looked at the use of Humalog in 542 patients aged between two and 19 years, and the use of Humalog in combination with sulphonylureas.
Slovenian: V študijah so proučevali tudi uporabo zdravila Humalog pri 542 bolnikih, starih od dve do 19 let, in uporabo zdravila Humalog v kombinaciji s sulfonilsečninami.
English: What benefit has Humalog shown during the studies?
Slovenian: Kakšne koristi je zdravilo Humalog izkazalo med študijami?
English: • Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Slovenian: • Humalog: raztopina insulina lispro, na voljo v standardni ali višji jakosti (100 ali 200 enot/ml);
English: Humalog and Humalog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Slovenian: Zdravili Humalog in Humalog Mix se običajno dajeta tik pred obrokom, po potrebi pa se lahko jemljeta tudi kmalu po obroku.
English: A risk management plan has been developed to ensure that Humalog is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Humalog je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Humalog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Humalog preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In addition, the company that makes Humalog has provided information to patients and healthcare professionals to remind them that there are two strengths of Humalog and to advise them on how to use them safely to avoid medication errors.
Slovenian: Poleg tega je družba, ki izdeluje zdravilo Humalog, bolnikom in zdravstvenim delavcem zagotovila informacije, ki jih opominjajo, da obstajata dve jakosti zdravila Humalog in nasvete o tem, kako ju varno uporabljati v izogib napačni uporabi.
English: What is the risk associated with Humalog?
Slovenian: Kakšna tveganja so povezana z zdravilom Humalog?
English: • Humalog Basal: insulin lispro protamine suspension;
Slovenian: • Humalog Basal: suspenzija insulina lispro-protamin;
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Humalog.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.