natgillin/translations-raw huggingface dataset:
Saccharomyces cerevisiae by recombinant DNA technology.
Saccharomyces cerevisiae z rekombinantno DNA tehnologijo.
sachet
blazinica
SACHET
VREČICA
SACHET
VREČKA
sachet
vrečica
Sachet
vrečka
sachet (alu)
vrečka (alu)
sachet (alu/PET/PE)
Vrečka (alu/PET/PE)
sachet (coated paper/alu/LLDPE)
vrečica (prevlečen papir/aluminij/LLDPE)
SACHET (Contains 1 transdermal patch)
VREČKA (vsebuje 1 transdermalni obliž)
Sachet (LDPE
Vrečka (LDPE)
Sachet (LDPE)
EU/1/09/521/003
sachet (LDPE)
Vrečica (LDPE)
Sachet (LDPE)
Vrečka (LDPE)
sachet (LDPE/alu/PET)
vrečka (LDPE/alu/PET)
sachet (LDPE/paper laminate)
vrečica (laminat iz LDPE/papirja)
sachet (Paper/LDPE/alu/ LDPE)
vrečka (papir/LDPE/alu/LDPE)
sachet (paper/LDPE/alu/ET copolymer PE/Alu/ ET copolymer/paper)
Zaščitna vrečka (papir/polietilen majhne gostote/aluminij/etilenski kopolimer polietilen/aluminij/etilenski kopolimer/papir)
sachet (paper/LDPE/alu/ET copolymer PE/Alu/ET copolymer/paper)
Zaščitna vrečka (papir/polietilen majhne gostote/aluminij/etilenski kopolimer polietilen/aluminij/etilenski kopolimer/papir)
sachet (paper/LDPE/Alu/ethylene methacrylic acid copolymer)
Zaščitna vrečka (papir/LDPE/aluminij/kopolimer etilena in metakrilne kisline)
Sachet (paper/PE/A lu/PE)
Vrečke (papir/PE/a
Sachet (paper/PE/A lu/PE)
Vrečke (papir/PE/a lu/PE),
sachet (paper/PE/alu)
vrečka (papir/PE/alu)
Sachet (paper/PE/Alu/PE)
Vrečke (papir/PE/alu/PE),
sachet (paper/polyester/alu/ polyacrylonitrile)
vrečka (papir/poliester/aluminij/ poliakrilonitril)
Sachet (PE/alu/PET)
vrečka (PE/alu/PET)
Sachet (penta- laminate)
vrečka (pentalaminat)
sachet (PET/alu/LLDPE)
vrečica (PET/alu/LLDPE)
Sachet (PET/Alu/LLDPE)
vrečka (PET/Alu/LLDPE)
Sachet (PET/alu/PE)
vrečica (PET/alu/PE)
sachet (PET/OPA/alu/LDPE)
vrečica (PET/OPA/alu/LDPE)
sachet (PET/PE/alu/PE/PVDC)
vrečica (PET/PE/alu/PE/PVDC)
sachet (polyester/alu)
Blazinica
sachet (polyester/Alu)
vrečica (poliester/Al)
SACHET CARTON
KARTONSKA ŠKATLA ZA VREČKE
SACHET FOIL
FOLIJA VREČKE
SACHET FOR 2 G GRANULES
VREČICE ZA 2 G ZRNC
SACHET FOR 3 G GRANULES
VREČICE ZA 3 G ZRNC
SACHET LABEL
BESEDILO NA VREČKI
SACHET LABEL
NALEPKA NA VREČKI
SACHET LABEL
NALEPKA ZA VREČKO
SACHET LABEL
OZNAKA NA VREČKI
SACHET LABEL TEXT
BESEDILO NA NALEPKI NA VREČKI
SACHET LABELLING
OZNAČEVANJE NA VREČICI
Sachet of ethylene methacrylic acid copolymer, polyester, low density polyethylene and aluminium foil laminate, with a heat seal.
Vrečica iz kopolimera etilena in metakrilne kisline, poliestra, polietilena nizke gostote in laminata aluminijeve folije, toplotno zavarjena.
Sachet of ethylene methacrylic acid copolymer, polyester, low density polyethylene and aluminium foil laminate, with a heat seal.
Vrečka iz kopolimera etilena in metakrilne kisline, poliestra, polietilena nizke gostote in laminata aluminijeve folije, toplotno zavarjena.
Sachet of ethylene methacrylic acid copolymer, polyester, low density polyethylene and aluminium foil laminate, with a heat seal.
Vrečka iz kopolimera etilena in metakrilne kisline, poliestra, polietilena nizke gostote in laminata aluminijeve folije, toplotno zavarjena..
SACHET TEXT
BESEDILO NA VREČICI
SACHET TEXT
BESEDILO NA VREČKI
Sachet: 5.6 g
Blazinica: 5.6 g
Sachet: 5.6 g
EU/1/03/263/003
SACHETS
VREČICE
SACHETS
ZLOŽENKA ZA VREČICE
SACHETS (3, 9 and 18 gram)
VREČKE (3, 9 in 18 gramov)
Sachets are made with a composite paper/aluminium/polyethylene film.
Vrečke so izdelane iz kompozita papir/aluminij/polietilenski film.
Sachets are packaged in a cardboard carton.
Zunanja ovojnina
Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.
Vrečke iz papirja/polietilena nizke gostote/aluminijaste folije/prevleke/polietilena nizke gostote.
Sachets should not be re-used once opened.
Ko je vrečka enkrat odprta, je ne smete ponovno uporabiti.
Sachets should not be re-used once opened.
Ko so enkrat vrečke odprte, se ne smejo ponovno uporabiti.
Sacs of fluid within the ovaries (ovarian cysts)
vrečke s tekočino znotraj jajčnikov (ciste jajčnikov)
Sacs of fluid within the ovaries (ovarian cysts)
vrečke s tekočino znotraj jajčnikov (ciste jajčnikov);
Sad mood (depression)
žalostno razpoloženje (depresija),
Safe handling of the suspension
Varno ravnanje s suspenzijo
Safe use, storage and disposal of EFFENTORA.
Varna uporaba, shranjevanje in odstranjevanje zdravila EFFENTORA.
Safely dispose of the ring.
Varno odstranite obroček.
Safely throw away the Relistor pre-filled syringe after use (Step 4).
Napolnjeno injekcijsko brizgo zdravila Relistor po uporabi varno odstranite (korak 4).
Safety advice for men
varnostne nasvete za moške
Safety advice for men
varnostne nasvete za moške:
Safety advice for women of childbearing potential
varnostne nasvete za ženske v rodni dobi
Safety advice for women of childbearing potential
varnostne nasvete za ženske v rodni dobi:
Safety advice relevant to all patients
Varnostne nasvete, pomembne za vse bolnike
Safety advice relevant to all patients
varnostne nasvete, primerne za vse bolnike:
Safety and diagnostic accuracy in persons under 21 years of age have not been established.
Varnost in diagnostična natančnost pri osebah, mlajših od 21 let, nista bili določeni.
Safety and effectiveness in the paediatric population have not been established.
Varnost in učinkovitost zdravila Respreeza pri pediatrični populaciji nista bili dokazani.
Safety and effectiveness of 99mTc-depreotide were established using investigational material shown to have a radiochemical purity of at least 90% by ITLC prior to administration to patients in clinical studies.
Varnost in učinkovitost 99mTc-depreotida so ugotovili v kliničnih študijah z uporabo raziskovalnega materiala, ki je imel pred dajanjem bolniku z ITLC določeno radiokemijsko čistoto najmanj 90%.
Safety and effectiveness of JEVTANA have not been established in children and adolescents below 18 years of age.
Varnost in učinkovitost zdravila JEVTANA pri otrocih in mladostnikih do 18 let nista ugotovljeni.
Safety and effectiveness of Pelzont in paediatric patients under the age of 18 years have not been established.
Varnost in učinkovitost zdravila Pelzont pri pediatričnih bolnikih, mlajših od 18 let, nista bili dokazani.
Safety and effectiveness of Pergoveris in elderly patients have not been established.
Varnost in učinkovitost zdravila Pergoveris pri starejših bolnikih nista bili dokazani.
Safety and efficacy beyond 6 injections with Xofigo have not been studied.
Varnosti in učinkovitosti za več kot 6 injekcij zdravila Xofigo niso preučevali.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL’s inactivated vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno aplicirati na isti dan ampak na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini.>
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL’s inactivated vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko daje isti dan toda ne mešano s cepivi serije Canigen za intranazalno dajanje imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebujejo bakterijo Bordetella bronchiseptica seva B-C2 in/ali virus pasje parainfluence seva Cornell za intranazalno dajanje, kjer so registrirana.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko daje isti dan toda ne mešano s cepivi serije Canigen za intranazalno dajanje istega imetnika dovoljenja za promet (krajevne podružnice), ki vsebujejo bakterijo Bordetella bronchiseptica seva B-C2 in/ali virus parainfluence seva Cornell za intranazalno dajanje, kjer so registriran .
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar ne zmešano z Merialovim adjuviranim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar ne zmešano z Merialovim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim adjuviranim cepivom proti steklini
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim adjuviranim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in aplicira z Merialovimi neadjuviranimi cepivi (različne kombinacije komponent virusnega rinotraheitisa mačk, kaliciviroze, panleukopenije in klamidioze).
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z Merialovimi neadjuviranimi cepivi (različne kombinacije komponent virusnega rinotraheitisa mačk, kaliciviroze, panleukopenije in klamidioze).
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or intranasal/ocular administration to commercial chicks from one day of age onwards.
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da se ta cepiva lahko mešajo in dajejo s cepivom Nobilis IB Ma5 za pršilo ali intranazalno/okularno dajanje komercialnim piščancem od enega dneva starosti dalje.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da se to cepivo lahko meša in daje s cepivom Nobililis IB Ma5 za pršenje ali za okulonazalno dajanje.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Canigen istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebujejo virus pasje kuge seva Onderstepoort, pasji adenovirus seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva Cornell za subkutano dajanje, kjer so registrirana.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components for subcutaneous administration.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Nobivac za subkutano dajanje, ki vsebujejo virus pasje kuge, pasji adenovirusa tipa 2, pasji parvovirus in/ali virus pasje parainfluence.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim adjuviranim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim cepivom proti steklini.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim’s Ingelvac MycoFLEX and administered at one injection site.
Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da lahko to cepivo zmešamo s cepivom Ingelvac MycoFLEX družbe Boehringer Ingelheim in ga uporabimo na istem injekcijskem mestu.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with FELIGEN CRP and FELIGEN RCP.
Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da se to cepivo lahko zmeša z FELIGEN CRP in FELIGEN RCP.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with FELIGEN CRP or FELIGEN RCP.
Razpoložljivi podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko zmeša z zdravilom FELIGEN CRP ali FELIGEN RCP.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial attenuated vaccines against Marek’s disease Rispens strain.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim atenuiranim cepivom proti Marekovi bolezni, sev Rispens.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z Merialovimi neadjuviranimi cepivi (različne kombinacije komponent virusnega rinotraheitisa mačk, kaliciviroze, panleukopenije in klamidioze) in/ali varno dajati isti dan, vendar ne zmešano z Merialovimi adjuviranimi cepivi proti steklini.
Safety and efficacy data are very limited in liver transplant patients.
Podatki o varnosti in učinkovitosti pri bolnikih s presajenimi jetri so zelo omejeni.
Safety and efficacy have been assessed in controlled studies for up to 24 weeks. (see section 5.1).
Varnost in učinkovitost so ocenili v kontroliranih študijah, ki so trajale do 24 tednov (glejte poglavje 5.1).
Safety and efficacy have not been established for children and adolescents up to 18 years.
Varnost in učinkovitost pri otrocih in mladostnikih do 18 let nista bili dokazani.
Safety and efficacy have not been established for use of Tybost with either atazanavir or darunavir when used in any other dosing regimen.
Varnost in učinkovitost uporabe zdravila Tybost z bodisi atazanavirjem ali darunavirjem, če se uporabljata v drugih režimih odmerjanja, nista bili dokazani.
Safety and efficacy have not been established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C infection.
Varnost in učinkovitost ni bila ugotovljena pri sočasni uporabi z direktno delujočimi protivirusnimi zdravili, odobrenimi za zdravljenje kroničnih okužb s hepatitisom C.
Safety and efficacy have not been established in the following:
Pri naslednjih stanjih varnosti in učinkovitosti niso dokazali:
Safety and efficacy have not been evaluated in older people and the use of dexrazoxane in such patients is not recommended.
Varnosti in učinkovitosti zdravila pri starostnikih niso preučevali, zato uporaba dekstrazoksana pri teh bolnikih ni priporočljiva.
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Varnost in učinkovitost zdravila pri bolnicah s hudo ledvično okvaro (kreatininski očistek ≤ 30 ml/min) nista bili ugotovljeni in zato je pri teh bolnicah potrebna previdnost (glejte poglavje 4.4).
Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Varnosti in učinkovitosti zdravila niso proučevali pri bolnikih z vrednostjo forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) manj kot 25 % ali več kot 75 % napovedane vrednosti, ali pri bolnikih, okuženih z bakterijo Burkholderia cepacia.
Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
Varnost in učinkovitost pri bolnikih z nevrogenim vzrokom za čezmerno aktivnost detruzorja še nista bili ugotovljeni.
Safety and efficacy in children aged under 18 years have not been established.
Varnost in učinkovitost pri otrocih, mlajših od 18 let, še nista bili dokazani.
Safety and efficacy in children and adolescents below 18 years of age have not yet been established.
Varnost in učinkovitost pri otrocih in mladostnikih do 18. leta starosti še nista ugotovljeni.
Safety and efficacy in Philadelphia chromosome-positive patients has not been established.
Varnost in učinkovitost pri bolnikih s kromosomom Philadelphia nista bili dokazani.
Safety and efficacy of ataluren in patients with renal and hepatic impairment have not been established (see section 4.4).
Varnost in učinkovitost atalurena pri bolnikih z okvaro ledvic in jeter nista bili dokazani (glejte poglavje 4.4).
Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Varnost in učinkovitost zdravila Epclusa pri bolnikih s cirozo jeter stopnje B po CPT nista bili ocenjeni (glejte poglavji 4.8 in 5.1).
Safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older.
Varnost in učinkovitost insulina glargin sta bili ugotovljeni pri otrocih, starih 2 leti in starejših.
Safety and efficacy of insulin glargine have not been established in children below the age of 2 years.
Varnost in učinkovitost insulina glargin pri otrocih, mlajših od 2 let, nista bili ugotovljeni.
Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older (see section 5.1).
Varnost in učinkovitost zdravila Lantus sta ugotovljeni pri mladostnikih in otrocih, starih 2 leti in več (glejte poglavje 5.1).
Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin’s lymphoma.
Varnosti in učinkovitosti zdravila MabThera v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over.
Varnost in učinkovitost zdravila Myocet so ocenjevali pri 61 bolnicah z metastatskim rakom dojke, starih 65 let ali več.
Safety and efficacy of raltegravir in infants below 4 weeks of age have not yet been established.
Varnost in učinkovitost raltegravirja pri dojenčkih, mlajših od 4 tednov, še nista bili dokazani.
Safety and efficacy of Toujeo have been established in adolescents and children aged 2 years and older (see section 5.1).
Varnost in učinkovitost zdravila Toujeo sta ugotovljeni pri mladostnikih in otrocih, starih 2 leti in več (glejte poglavje 5.1).
Safety and efficacy of Xarelto have not been established in breast feeding women.
Varnost in učinkovitost zdravila Xarelto pri doječih materah nista bili dokazani.
Safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that Xarelto 20 mg (15 mg in patients with moderate or severe renal impairment) provides adequate anticoagulation in this patient population.
Varnosti in učinkovitosti zdravila Xarelto niso preučevali pri bolnikih z umetnimi srčnimi zaklopkami, zato ni podatkov, ki bi potrdili da uporaba zdravila Xarelto 20 mg (15 mg pri bolnikih z zmerno do hudo okvaro ledvic) zagotavlja ustrezno antikoagulacijsko zaščito pri tej populaciji bolnikov.
Safety and efficacy of Xofigo have not been studied in patients with hepatic impairment.
Varnosti in učinkovitosti zdravila Xofigo pri bolnikih z jetrno okvaro niso preučevali.
Safety and efficacy of Xofigo in patients with Crohn’s disease and with ulcerative colitis have not been studied.
Varnosti in učinkovitosti zdravila Xofigo pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom niso preučevali.
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e.g. children with another congenital or acquired splenic dysfunction, HIV- infected, malignancy, nephrotic syndrome).
Podatki o varnosti in imunogenosti tega cepiva pri otrocih v drugih posebnih skupinah z visokim tveganjem za invazivne pnevmokokne okužbe še niso na voljo (kot so: otroci z drugo prirojeno ali pridobljeno motnjo delovanja vranice, otroci z okužbo s HIV, otroci z malignomi, nefrotskim sindromom).
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e.g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome).
Podatki o imunogenosti in varnosti cepiva pri otrocih z visokim specifičnim tveganjem za invazivne pnevmokokne okužbe še niso na voljo (npr. otroci z drugo prirojeno ali pridobljeno motnjo delovanja vranice, z okužbo s HIV, z malignimi boleznimi, nefrotskim sindromom).
Safety and immunogenicity data are not yet available in children above 5 years of age.
Podatkov o varnosti in imunogenosti za otroke po 5. letu starosti še ni.
Safety and immunogenicity data in children with increased risk for pneumococcal infections (e.g. sickle cell disease, congenital and acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome) are not yet available for Synflorix.
Podatkov o varnosti in imunogenosti cepiva Synflorix pri otrocih z večjim tveganjem za pnevmokokne okužbe (npr. pri otrocih z boleznijo srpastih celic, prirojeno ali pridobljeno motnjo delovanja vranice, okužbo s HIV, malignomom, nefrotskim sindromom) še ni.