FrancophonIA/ELRC3.0 huggingface dataset:
English: Vasculitis with transient renal involvement 1frequency based on estimated attributable risk from epidemiological studies in several European countries (see section 4.4) 2Reported in patients with narcolepsy and as a temporary event following vaccination
Slovenian: Žilne bolezni zelo redki vaskulitis s prehodno prizadetostjo ledvic 1 Pogostnost temelji na ocenjenem pripisljivem tveganju iz epidemioloških študij v več evropskih državah (glejte poglavje 4.4).
English: 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Slovenian: 2odstotek cepljenih oseb, ki so po cepljenju dosegle titer protiteles ≥ 32 1/DIL (razmerje razredčenja), če so bile uvodoma seronegativne, ali ki so dosegle ≥ 4-kraten titer protiteles kot je bil pred cepljenjem, če so bile uvodoma seropozitivne
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C).
Slovenian: Vklinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 6 do 35 mesecev, ki so dobili ali dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, so opazili več reakcij na mestu injiciranja in splošnih simptomov po drugem odmerku v primerjavi s prvim odmerkom, zlasti deleža zvišane aksilarne temperature (> 38 °C).
English: 23.3% 17.9% 15.1% 28.8% NA NA NA NA
Slovenian: 23,3 % 17,9 % 15,1 % 28,8 % np np np np
English: Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Slovenian: Pandemrix suspenzija in emulzija za emulzijo za injiciranje cepivo proti gripi (H1N1)v z delci virionov, inaktivirano (z adjuvansom)
English: Very common Headache Uncommon Paraesthesia, dizziness
Slovenian: Bolezni živčevja zelo pogosti glavobol občasni parestezije, omotica
English: If they persist, CONSULT YOUR DOCTOR.
Slovenian: POSVETUJTE Z ZDRAVNIKOM.
English: • Pain and swelling at the injection site
Slovenian: • bolečina in oteklina na mestu injiciranja,
English: Very rare: may affect up to 1 in 10,000 people
Slovenian: Zelo redki: pojavijo se lahko pri največ 1 od 10.000 cepljenih oseb
English: NA NA NA NA 15.4% 14.3% 14.0% 22.8%
Slovenian: Artralgija np np np np 15,4 % 14,3 % 14,0 % 22,8 %
English: Rare: may affect up to 1 in 1,000 people
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 cepljenih oseb
English: How to store Pandemrix
Slovenian: Kako uporabljati cepivo Pandemrix
English: Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Slovenian: Vsebina: Adjuvans AS03, sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
English: 5all subjects seronegative prior to vaccination anti-HA
Slovenian: 5 Vsi preiskovanci so bili pred cepljenjem seronegativni.
English: Talk to your doctor or nurse before you receive Pandemrix:
Slovenian: Opozorila in previdnostni ukrepi Preden dobite cepivo Pandemrix, se posvetujte s svojim zdravnikom ali z medicinsko sestro:
English: Injection site reactions (such as inflammation, mass, ecchymosis)
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (na primer vnetje, masa, ekhimoze)
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Slovenian: Anafilaktična reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A
Slovenian: razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev NYMC X-179A pridobljen iz seva A/California/07/2009 (H1N1)
English: Month 12 N=28
Slovenian: 12. mesec n=28
English: Month 6 N=22
Slovenian: 6. mesec n=22
English: Contents of the pack and other information
Slovenian: Shranjevanje cepiva Pandemrix Vsebina pakiranja in dodatne informacije
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).
Slovenian: Po mešanju je količina cepiva Pandemrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Pandemrix").
English: Serum neutralising antibody
Slovenian: Nevtralizi rajoča protitelesa v serumu
English: In two clinical studies in which children aged 3 to 9 years old received two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) of Pandemrix, the anti-HA antibody responses 21 days after the first and the second dose were as follows:
Slovenian: V dveh kliničnih študijah, v katerih so otroci, stari od 3 do 9 let dobili dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) cepiva Pandemrix, so bili odzivi anti-HA protiteles 21 dni po prvem in drugem odmerku naslednji:
English: Very common Swelling and pain at the injection site, fatigue, shivering
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti oteklost in bolečina ne mestu injiciranja,
English: Month 12 N=31
Slovenian: 12. mesec n=31
English: • Redness and itching at the injection site
Slovenian: • pordelost in srbenje na mestu injiciranja,
English: Month 6 N=18
Slovenian: 6. mesec n=18
English: Month 12 N=7
Slovenian: 12.mesec n=7
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Slovenian: 1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition) ≥1:40
English: Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders
Slovenian: utrujenost, drgetanje pogosti pordelost in srbenje na mestu injiciranja, zvišana telesna temperatura občasni zatrdelo in toplo mesto injiciranja, gripi podobna bolezen, splošno slabo počutje
English: 20.0% 17.9% 15.1% 32.7% NA NA NA NA
Slovenian: Izguba apetita 20,0 % 17,9 % 15,1 % 32,7 % np np np np
English: Month 6 N=15
Slovenian: 6. mesec n=15
English: Full dose (D-Pan-H1N1-010)
Slovenian: Polni odmerek (D-Pan-H1N1-010)
English: anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)vpodobnemu sevu >80 let 12. mesec po 2 odmerkih po 0,5 ml
English: Month 6 N=17
Slovenian: 6. mesec n=17
English: 1antigenically similar to A/California/7/2009 (H1N1)v-like
Slovenian: 1antigensko podoben A/California/7/2009 (H1N1)v-podobnemu sevu
English: Adverse reactions reported are listed per dose according to the following frequency: Very common (≥1/10)
Slovenian: Opisani neželeni učinki so navedeni na odmerek po naslednjih skupinah pogostnosti:
English: Month 6 after 1 dose of 0.5 ml
Slovenian: 6. mesec po 1 odmerku 0,5 ml
English: Total enrolled subjects N=25
Slovenian: Skupno vklju čeni preiskovanci n=25
English: Total enrolled subjects N=33
Slovenian: Skupno vklju čeni preiskovanci n=33
English: In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
Slovenian: (H1N1)v, so več poročali o bolečini, rdečini in oteklosti na mestu injiciranja ter o zvišani telesni temperaturi (> 38 °C), zaspanosti, razdražljivosti in izgubi apetita po drugem odmerku v primerjavi s prvim odmerkom.
English: Seroconversio n rate2
Slovenian: Delež serokonverz ije2
English: Adult dose5 (D-Pan-H1N1-010)
Slovenian: Odmerek za odrasle5 (D-Pan-H1N1-010)
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
Slovenian: Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 Po 2 odmerkih po 0,5 ml
English: Immune response to A/California/7/2009 (H1N1)v-like >80 years
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu >80 let
English: Total enrolled subjects N=15
Slovenian: Skupno vklju čeni preiskovanci n=15
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose *propagated in eggs **expressed in microgram haemagglutinin
Slovenian: uporabljenemu sevu NYMC X-179A pridobljenemu iz seva A/California/07/2009 (H1N1) 3,75°mikrogramov** na 0,5 ml odmerek
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Slovenian: V skladu z uradnimi priporočili vas bo cepil zdravnik ali medicinska sestra.
English: Day 21 N=18
Slovenian: 21. dan n=18
English: Month 6 N=13
Slovenian: 6. mesec n=13
English: Total enrolled subjects N=24
Slovenian: Skupno vključe ni preiskovanci n =24
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
Slovenian: haemagglutination inhibition) ≥1:40 anti-HA protitelesa
English: In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Slovenian: V kliničnih študijah, s katerimi so ocenili reaktogenost pri otrocih, starih od 10 do 17 let, ki so dobili ali dva 0,5 ml odmerka (odmerek za odrasle) ali dva 0,25 ml odmerka (polovični odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, je bila pogostnost naslednjih neželenih učinkov na odmerek, kot je prikazano v preglednici:
English: Vaccine Response
Slovenian: Delež odziva na cepivo2
English: Month 12 N=13
Slovenian: 12. mesec n=13
English: Total enrolled subjects N=40
Slovenian: Skupno vklju čeni preiskovanci n=40
English: • Severe stabbing or throbbing pain along one or more nerves
Slovenian: • hujša zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev, • znižanje števila trombocitov s posledičnim pojavom krvavitev ali modric.
English: In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Slovenian: V kliničnih študijah, s katerimi so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so dobili ali dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, je bila pogostnost naslednjih neželenih učinkov na odmerek, kot je prikazano v preglednici:
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Slovenian: KG Zirkustraße 40, D-01069 Dresden
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Navodila za mešanje in injiciranje cepiva: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti na sobni temperaturi.
English: Total enrolled subjects N=67 [95% CI]
Slovenian: Skupno vključeni preiskovanci n = 67 [95 % IZ]
English: Total subjects4 N=30 [95% CI]
Slovenian: Vsi preiskovanci4 n=30 [95% IZ]
English: Day 21 N=22
Slovenian: 21.dan n=22
English: Day 42 N=18
Slovenian: 42. dan n=18
English: Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 12-23 mesecev
English: Total subjects4 N=51 [95% CI]
Slovenian: Vsi preiskovanci4 n=51 [95% IZ]
English: • A hard lump and warmth at the injection site
Slovenian: • trda bula na mestu injiciranja in toplo mesto injiciranja,
English: Total subjects4 N=28 [95% CI]
Slovenian: Vsi preiskovanci4 n=28 [95% IZ]
English: Day 21 N=17
Slovenian: 21. dan n=17
English: Total subjects5 [95% CI]
Slovenian: Vsi preiskovanci5 [95% IZ]
English: Month 12 after 2 doses of 0.5 ml
Slovenian: 12. mesec po 2 odmerkih po 0,5 ml
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Slovenian: Neželeni učinki, našteti spodaj, so se pojavili po začetku trženja cepiva Pandemrix (H1N1)v.: • alergijske reakcije z nevarnim znižanjem krvnega tlaka, ki lahko brez zdravljenja povzročijo šok;
English: Total subjects4 N=55 [95% CI]
Slovenian: Vsi preiskovanci4 n=55 [95% IZ]
English: Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 24-35 mesecev
English: Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).
Slovenian: V primeru, da trivalentnih/štirivalentnih cepiv ni na voljo, je mogoče uporabiti cepivo Pandemrix, če potrebujete zaščito proti gripi A(H1N1)v (glejte poglavje Bodite posebno pozorni pri cepljenju s cepivom Pandemrix).
English: Month 12 after 1 dose of 0.5 ml
Slovenian: 12. mesec po 1 odmerku po 0,5 ml
English: NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Slovenian: Izgled cepiva Pandemrix in vsebina pakiranja suspenzija in emulzija za emulzijo za injiciranje
English: Day 42 N=22
Slovenian: 42. dan n=22
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pandemrix Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Slovenian: Suspenzija za emulzijo za injiciranje za Pandemrix cepivo proti gripi (H1N1)v z delci virionov, inaktivirano (z adjuvansom)
English: Day 42 N=17
Slovenian: 42. dan n=17
English: The anti-HA antibody responses were as follows: anti-HA antibody
Slovenian: 0,5 ml) naslednji: anti-HA protitelesa
English: Month 6 after 2 doses of 0.5 ml
Slovenian: 6. mesec po 2 odmerkih po 0,5 ml
English: There are no data with Pandemrix using the subcutaneous route.
Slovenian: Podatkov o subkutani uporabi cepiva Pandemrix ni.
English: Seronegative subjects prior to vaccination N=48 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=48 [95% IZ]
English: Seronegative subjects prior to vaccination N=37 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=37 [95% IZ]
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, mialgija
English: Total subjects4 [95% CI]
Slovenian: Vsi preiskovanci4 [95% IZ]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Slovenian: Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 12-23 mesecev
English: • Dizziness
Slovenian: • drgetanje,
English: Total enrolled subjects N=40 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=40 [95% IZ]
English: N=2 [95% CI]
Slovenian: seronegativni n=19 [95% IZ]
English: Immune response to A/California/7/2009 (H1N1)v-like
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu
English: Seronegative subjects prior to vaccination [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni [95% IZ]
English: Adult dose (D-Pan-H1N1-010)
Slovenian: Odmerek za odrasle (D-Pan-H1N1-010)
English: Total enrolled subjects N=51 [95% CI]
Slovenian: Skupno vključeni preiskovanci n =51 [95 % IZ]
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Pandemrix je na voljo v dveh vsebnikih:
English: Seronegative subjects prior to vaccination N=36 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=36 [95% IZ]
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 2all subjects seronegative prior to vaccination
Slovenian: haemagglutination inhibition) ≥1:40 2delež preiskovancev, ki so bili pred cepljenjem seronegativni
English: Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Slovenian: Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite naslednji:
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 cepljenih oseb
English: Other side effects:
Slovenian: Drugi neželeni učinki
English: Seronegative subjects prior to vaccination N=26 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=26 [95% IZ]
English: Seronegative subjects prior to vaccination N=42 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=42 [95% IZ]
English: Antigen suspension for Pandemrix Influenza vaccine
Slovenian: Shranjevanje cepiva Pandemrix
English: Seronegative subjects prior to vaccination N=19 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =19 [95 % IZ]
English: Uncommon Insomnia
Slovenian: Psihiatrične motnje občasni nespečnost
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =23 [95 % IZ]
English: Seronegative subjects prior to vaccination N=32 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=32 [95% IZ]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1
Slovenian: Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1
English: Total enrolled subjects N=52 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=52 [95% IZ]
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =43 [95 % IZ]
English: Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age.
Slovenian: (0,5 ml) cepiva Pandemrix za odrasle pri zdravih otrocih, starih od 10 do 17 let.
English: Post dose N=37
Slovenian: Po 2. odmerku n=33
English: Seronegative subjects prior to vaccination N=7 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =7 [95 % IZ]
English: Total enrolled subjects2 N=2 [95% CI]
Slovenian: Skupno vključeni preiskovanci2 n =2 [95 % IZ]
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 cepljenih oseb
English: Seronegative subjects prior to vaccination N=1 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =1 [95 % IZ]
English: Total enrolled subjects N=3 [95% CI]
Slovenian: Skupno vključeni preiskovanci n =3 [95 % IZ]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Slovenian: Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 6 do 11 mesecev
English: Seronegative subjects prior to vaccinatio n N=15 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n =15 [95 % IZ]
English: Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 6-9 let
English: Thiomersal
Slovenian: urtikarija
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Slovenian: Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 6-9 let
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Slovenian: Po mešanju je količina cepiva Pandemrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
English: Serum neutrali-sing antibody
Slovenian: Nevtra-lizira-joča protitelesa v serumu
English: Febrile convulsions
Slovenian: Delež serokonverzije
English: Nervous system disorders
Slovenian: Bolezni živčevja febrilne konvulzije zelo redki1
English: Pandemrix may be administered in lactating women.
Slovenian: Cepivo Pandemrix se lahko uporabi v obdobju dojenja.
English: Do not freeze
Slovenian: Če ne prenehajo, SE
English: tection rate1 92.7%
Slovenian: serokonverzije2 97,1% Faktor serokonverzije3
English: • Generally feeling unwell
Slovenian: • srbenje, izpuščaj, • splošno slabo počutje,
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk
Slovenian: Dodatne spremembe informacij o zdravilu bodo prispevale k temu, da bodo zdravstveni delavci in uporabnice bolje seznanjeni s tveganjem za trombembolijo;
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should
Slovenian: Glede na to, da se dejavniki tveganja za VTE sčasoma spremenijo, je PRAC izpostavil, da je treba tveganje pri posameznicah redno ocenjevati.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk
Slovenian: PRAC je potrdil že znano tveganje za trombembolijo, povezano z zdravili, ki vsebujejo kombinirane hormonske kontraceptive, in priporočil, naj se jasno označijo simptomi trombemboličnih dogodkov ter tudi dejavniki tveganja za trombembolične dogodke;
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel
Slovenian: Poleg tega je PRAC zahteval, da se opravi študija varnosti zdravila v obdobju trženja, s katero bi podrobneje opredelili, kakšno je relativno tveganje za trombembolične dogodke zaradi klormadinona v primerjavi z zdravili, ki vsebujejo levonorgestrel.
English: These are combined with varying doses of ethinylestradiol
Slovenian: Ti so kombinirani z različnimi odmerki etinilestradiola (EE) ali z estradiolom (E2).
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the
Slovenian: • PRAC je menil, da so za kombinirane hormonske kontraceptive, ki vsebujejo klormadinon, potrebni dodatni podatki, in zahteval, da se opravi študija varnosti zdravila v obdobju trženja (PASS), s katero se bo ocenilo, kakšno je relativno tveganje za trombembolične dogodke zaradi teh zdravil v primerjavi s tistimi, ki vsebujejo levonorgestrel.