natgillin/translations-raw huggingface dataset:
Hos børn i alderen 6-35 måneder (n = 51), som fik to doser a 0,25 ml (halv voksendosis) med et interval på tre uger, sås efter den anden dosis en øget hyppighed af reaktioner på administrationsstedet og generelle symptomer (se pkt. 
In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8).
antistof 
antibody
Gastrointestinale symptomer Hovedpine 
Gastrointestinal Headache
Pandemrix bør kun bruges, hvis de anbefalede årlige trivalente/tetravalente sæsoninfluenzavacciner ikke er tilgængelige, og hvis immunisering mod (H1N1)v vurderes at være nødvendig (se pkt. 
Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Seroprotektionsraten seks måneder efter første dosis var følgende: 
Six months after the first dose, the seroprotection rate was as follows:
En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Pandemrix. 
In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Vaccinen forventes kun at beskytte mod influenza forårsaget af A/California/07/2009 (H1N1)vlignende stammer. 
The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)vlike strains.
I et klinisk studie (D-Pan-H1N1-009) med raske børn i alderen 6-35 måneder (stratificeret i aldersgrupperne fra 6-11 måneder, 12-23 måneder og 24-35 måneder) var anti-HA-antistofresponset 21 dage efter første og anden halve voksendosis (dvs. 0,25 ml) eller voksendosis (dvs. 0,5 ml) Pandemrix følgende: 
In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
Inkluderede personer i alt n = 120 
Total enrolled subjects N=120
• reaktioner, hvor indsprøjtningen blev givet, f.eks. smerte, rødme, blå mærker, hævelse og varmefølelse (vævsirritation), hård knude. 
• Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
2procent af de vaccinerede, som initialt var seronegative og opnåede en antistoftiter ≥ 32 1/dil efter vaccination, eller som initialt var seropositive og opnåede en antistoftiter ≥ 4 gange antistoftiteren før vaccination. 
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
Doseringen kan være i overensstemmelse med anbefalingerne for voksne. 
Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
De rapporterede bivirkninger pr. dosis er opstillet i henhold til følgende frekvenser: 
Adverse reactions reported are listed per dose according to the following frequency: Very common (≥1/10)
Efter 1 dosis af 0,5 ml 
After 1 dose of 0.5 ml
• generel utilpashed 
• Generally feeling unwell
• influenzalignende symptomer. 
• Flu-like symptoms
Sådan virker Pandemrix 
How Pandemrix works
Hjælpestof, som behandleren skal være opmærksom på Vaccinen indeholder 5 mikrogram thiomersal. 
The vaccine contains 5 micrograms thiomersal
Inkluderede personer i alt n = 66 
Total enrolled subjects N=66
• hårdhed og varmefølelse, hvor indsprøjtningen blev givet 
• A hard lump and warmth at the injection site
A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme i.m. 
A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
Adjuvansen består af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg). 
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret) 
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Sådan får du Pandemrix 
How to store Pandemrix
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme > 80 år 12 måneder efter 2 doser af 0,5 ml 
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Voksendosis 
Adult dose
Se produktinformationen for Pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret). 
Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme halv dosis (D-Pan-H1N1-023) 
Immune response to A/California/7/2009 (H1N1)v-like Half dose (D-Pan-H1N1-023)
Efter 2. dosis 
Post dose 2
Efter sammenblandingen, skal den færdige vaccine anvendes inden for 24 timer, og den må ikke opbevares over 25 °C. 
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Meget sjælden Vaskulitis med forbigående nyrepåvirkning 1 Hyppighed baseret på estimeret risiko ud fra epidemiologiske studier i flere europæiske lande (se pkt. 
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
• hvis du tidligere har haft en pludselig, livstruende overfølsomhedsreaktion (allergisk reaktion) over for et eller flere af indholdsstofferne i denne vaccine (angivet i punkt 6), eller over for nogle af følgende stoffer, som kan være til stede i meget små mængder: ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat. 
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Pandemrix suspension og emulsion til injektionsvæske, emulsion Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret) 
Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Spørg lægen eller sygeplejersken, hvis du har yderligere spørgsmål til anvendelsen af denne vaccine. 
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
seroprotektionsrate: andelen af personer med hæmagglutinationshæmningstiter (HI-titer) ≥ 1:40. 
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Inkluderede personer i alt n = 59 
Total enrolled subjects N=59
Efter 1. dosis 
Post dose 1
I to kliniske studier, hvor børn i alderen 3-9 år fik to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix, var anti-HA-antistofresponset 21 dage efter henholdsvis første og anden dosis følgende: 
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:
Forbigående trombocytopeni 
Transient thrombocytopenia
En pakke indeholder: - en pakke med 50 hætteglas (type I-glas), hver indeholdende 2,5 ml suspension og forsynet med prop (butylgummi) - to pakker med 25 hætteglas (type I-glas), hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi). 
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 Efter 2 doser af 0,5 ml 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
Inkluderede personer i alt n = 24 
Total enrolled subjects N=24
fuld dosis (D-Pan-H1N1-010) 
Full dose (D-Pan-H1N1-010)
Inkluderede personer i alt4 
Half adult dose4
Efter 2. dosis n = 34 n = 32 n = 33 n = 31 n = 16 n = 17 n = 15 n = 16 
N=60 N=56 N=53 N=52 N=65 N=63 N=57 N=57
Meget almindelig (≥ 1/10) 
Very rare (<1/10,000)
• hvis du har haft en overfølsomhedsreaktion, som ikke var livstruende, over for et eller flere af indholdsstofferne i denne vaccine (angivet i punkt 6), thiomersal, ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat 
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Børn i alderen 10 år og derover 
Children from the age of 10 years onwards
Blod og lymfesystem Ikke almindelig Lymfadenopati Psykiske forstyrrelser 
Clinical trials Blood and lymphatic system disorders
Måned 6 n = 22 
Month 6 N=22
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af indholdsstofferne eller over for spor af reststoffer (ægge- og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine. 
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.
seroprotektionsrate: andelen af personer med hæmagglutinationshæmningstiter (HI-titer) ≥ 1:40. serokonverteringsrate: andelen af personer, som enten var seronegative før vaccination og opnåede en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnåede en firdobbelt stigning i titer. 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme 3,75 mikrogram** pr. 0,5 ml dosis 
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
Måned 12 n = 31 
Month 12 N=31
Dag 21 n = 22 
Day 21 N=22
• ømme muskler, ledsmerter. 
• Aching muscles, joint pain
Måned 12 n = 28 
Month 12 N=28
Hvis der skal gives yderligere en dosis, skal denne gives mindst tre uger efter den første vaccination. 
If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Dag 42 n = 22 
Day 42 N=22
Feber > 38 °C 10,0 % 14,3 % 5,7 % 32,6 % 4,6 % 6,4 % 1,8 % 12,3 % Feber > 39 °C 1,7 % 5,4 % 0,0 % 3,8 % 0,0 % 3,2 % 0,0 % 1,8 % Diarré 
NA NA NA NA 27.7% 20.6% 35.1% 49.1%
Halv voksendosis (D-Pan-H1N1-023) 
Half adult dose (D-Pan-H1N1-023)
Dag 42 n = 17 
Day 42 N=17
Vaskulære sygdomme 
Vaccine Response
Måned 12 n = 7 
Month 12 N=7
Dag 21 n = 17 
Day 21 N=17
Måned 12 n = 5 
Month 12 N=5
1antigen svarende til A/California/7/2009 (H1N1)v-lignende stamme. 
1antigenically similar to A/California/7/2009 (H1N1)v-like
Inkluderede personer i alt n = 40 
Total enrolled subjects N=40
Ikke almindelige: kan forekomme hos op til 1ud af 100 personer 
Uncommon: may affect up to 1 in 100 people
Måned 6 n = 17 
Month 6 N=17
Måned 6 n = 18 
Month 6 N=18
• reaktioner i huden, f.eks. hævelse af ansigt og nældefeber (udslæt) 
• Generalised skin reactions including facial swelling and urticaria (hives)
Inkluderede personer i alt n = 60 
Total enrolled subjects N=60
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme > 80 år 
Immune response to A/California/7/2009 (H1N1)v-like >80 years
Seronegative personer før vaccination [95 % CI] 
Seronegative subjects prior to vaccination [95% CI]
Dag 21 n = 18 
Day 21 N=18
Dag 42 n = 18 
Day 42 N=18
Måned 6 n = 15 
Month 6 N=15
Voksendosis5 (D-Pan-H1N1-010) 
Adult dose5 (D-Pan-H1N1-010)
Hævelse Aksillær feber (> 38 °C) Aksillær feber (> 39 °C) Døsighed Irritabilitet Appetitmangel 
Redness Swelling Fever (>38°C) axillary
Inkluderede personer i alt n = 67 [95 % CI] 
Total enrolled subjects N=67 [95% CI]
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Indhold: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg) 
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
I kliniske studier, hvor reaktogeniciteten blev evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået enten to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix (H1N1)v (med 21 dages mellemrum), var hyppigheden pr. dosis af nedennævnte bivirkninger som anført i tabellen: 
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:
• svimmelhed 
• Dizziness
12 måneder efter 2 doser af 0,5 ml 
Month 12 after 2 doses of 0.5 ml
Måned 12 n = 14 
Month 12 N=14
• smerter og hævelse, hvor indsprøjtningen blev givet 
• Pain and swelling at the injection site
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 12-23 måneder 
Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Måned 6 n = 13 
Month 6 N=13
Sero konverterings -rate2 
Seroconversio n rate2
Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SYGEPLEJERSKEN. 
- If you have any further questions, ask your doctor or nurse.
Seronegative personer før vaccination n = 15 
Seronegative subjects prior to vaccination N=35
6 måneder efter 2 doser af 0,5 ml 
Month 6 after 2 doses of 0.5 ml
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 24-35 måneder 
Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 Halv dosis 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 Half dose
Suspension til Pandemrix injektionsvæske, emulsion Influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret) 
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pandemrix Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Pandemrix suspension og emulsion til injektionsvæske, emulsion. 
NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Det er ikke sikkert, at du skal vaccineres, eller måske skal vaccinationen udsættes. 
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
• søvnighed 
• Sleeplessness
Måned 12 n = 13 
Month 12 N=13
Seronegative personer før vaccination n = 48 [95 % CI] 
Seronegative subjects prior to vaccination N=48 [95% CI]
6 måneder efter 1 dosis af 0,5 ml 
Month 6 after 1 dose of 0.5 ml
12 måneder efter 1 dosis af 0,5 ml 
Month 12 after 1 dose of 0.5 ml
Seronegative personer før vaccination n = 42 
Seronegative subjects prior to vaccination N=43
Efter 2. dosis n = 34 n = 32 
N=34 N = 32 N=30
Lægen vil normalt anbefale en anden vaccine (årlig trivalent/tetravalent sæsoninfluenzavaccine) i stedet for Pandemrix. 
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).
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 12-23 måneder 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Inkluderede personer i alt2 n = 2 [95 % CI] 
Total enrolled subjects2 N=2 [95% CI]
Se information i pkt. 
INFORMATION IN BRAILLE
• træthed 
Drowsiness
Inkluderede personer i alt n = 40 [95 % CI] 
Total enrolled subjects N=40 [95% CI]
Inkluderede personer i alt n = 41 [95 % CI] 
Total enrolled subjects N=41 [95% CI]
Sero konverte ringsfaktor3 
Seroconversio n factor3
Seronegative personer før vaccination n = 26 [95 % CI] 
Seronegative subjects prior to vaccination N=26 [95% CI]
Seronegative personer før vaccination n = 29 [95 % CI] 
Seronegative subjects prior to vaccination N=29 [95% CI]
Seronegative personer før vaccination n = 1 [95 % CI] 
Seronegative subjects prior to vaccination N=1 [95% CI]
Seronegative personer før vaccination n = 37 [95 % CI] 
Seronegative subjects prior to vaccination N=37 [95% CI]
Seronegative personer før vaccination n = 19 [95 % CI] 
Seronegative subjects prior to vaccination N=19 [95% CI]
Seronegative personer før vaccinatio n n = 36 [95 % CI] 
Seronegative subjects prior to vaccination N=36 [95% CI]
Serumneutraliserende antistof 
Serum neutrali-sing antibody
• rødme og kløe, hvor indsprøjtningen blev givet 
• Redness and itching at the injection site
Voksendosis (D-Pan-H1N1-010) 
Adult dose (D-Pan-H1N1-010)
Inkluderede personer i alt n = 52 [95 % CI] 
Total enrolled subjects N=52 [95% CI]
Seronegative personer før vaccination n = 32 [95 % CI] 
Seronegative subjects prior to vaccination N=32 [95% CI]
Efter 2. dosis n = 33 
Post dose N=32
Seronegative personer før vaccination n = 3 [95 % CI] 
Seronegative subjects prior to vaccination N=3 [95% CI]
Seronegative personer før vaccination n = 15 [95 % CI] 
Seronegative subjects prior to vaccination N=15 [95% CI]
Inkluderede personer i alt n = 3 [95 % CI] 
Total enrolled subjects N=3 [95% CI]
Seronegative personer før vaccination n = 16 
Seronegative subjects prior to vaccination N=32
Seronegative personer før vaccination n = 7 [95 % CI] 
Seronegative subjects prior to vaccination N=7 [95% CI]
Inkluderede personer i alt n = 51 [95 % CI] 
Total enrolled subjects N=51 [95% CI]
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 6-11 måneder 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme 6-9 år 
Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Amning 
GMT.
Appetitmangel 
Loss of appetite
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 3-5 år 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 3-5 years
Inkluderede personer i alt n = 28 [95 % CI] 
Total subjects4 N=28 [95% CI]
Inkluderede personer i alt n = 30 [95 % CI] 
Total subjects4 N=30 [95% CI]
Inkluderede personer i alt n = 5 [95 % CI] 
Total enrolled subjects N=5 [95% CI]
Børn 6-35 måneder 
24-35 months
Hvis samtidig vaccination med andre vacciner er nødvendigt, gives vaccinerne i hver sin arm. Du skal være opmærksom på, at bivirkningerne kan blive kraftigere. 
However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Immunrespons mod A/Netherlands/602/9 (H1N1)v-lignende stamme 1 6-9 år 
Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Måned 12 n = 24 
Month N=24
Inkluderede personer i alt n = 55 [95 % CI] 
Total subjects4 N=55 [95% CI]
(AESI). 
A.
I kliniske studier, hvor reaktogeniciteten blev evalueret hos børn i alderen 10-17 år, som havde fået enten to doser 0,5 ml (voksendosis) eller to doser 0,25 ml (halv voksendosis) Pandemrix (H1N1)v 
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:
Mave-tarm-kanalen 
hard lump (mass)
Inkluderede personer i alt n = 51 [95% CI] 
Total subjects4 N=51 [95% CI]
I et klinisk studie, hvor reaktogeniciteten blev vurderet hos børn i alderen 6-35 måneder, som fik enten to doser 0,25 ml (halv voksendosis) eller to doser 0,5 ml (voksendosis) Pandemrix (H1N1)v (med 21 
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).
Måned 6 n = 16 
Month N=16
Seroprotektionsraten tolv måneder efter første dosis var følgende: 
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 Twelve months after the first dose, the seroprotection rate was as follows:
Yderligere ændring af produktinformationen vil bidrage til bedre oplysning af sundhedspersoner og kvinder om risikoen for tromboemboli, 
Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk
Disse stoffer kombineres med forskellige doser ethinylestradiol (EE) eller med estradiol (E2). 
These are combined with varying doses of ethinylestradiol
Da risikofaktorerne for venøs tromboemboli ændrer sig med tiden, bemærkede PRAC, at en persons individuelle risiko bør revurderes med jævne mellemrum. 
Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should
Derudover påbød PRAC en sikkerhedsundersøgelse efter markedsføringstilladelse til bedre karakterisering af den relative risiko for tromboemboliske hændelser med chlormadinon i forhold til produkter indeholdende levonorgestrel. 
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
PRAC fastslog den kendte risiko for tromboemboli ved lægemidler indeholdende kombinerede hormonale kontraceptiva og anbefalede tydelig mærkning med symptomerne på og risikofaktorerne for tromboemboliske hændelser, 
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
• PRAC fandt behov for flere data om kombinerede hormonale kontraceptiva indeholdende chlormadinon og påbød en sikkerhedsundersøgelse efter markedsføringsgodkendelse (PASS) til vurdering af den relative risiko for tromboemboliske hændelser betinget af disse produkter i forhold til produkter indeholdende levonorgestrel, 
• 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
• For kombinerede hormonale kontraceptiva indeholdende chlormadinon, dienogest og nomegestrol er de foreliggende data utilstrækkelige til at bestemme risikoen i forhold til de 
• For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for lægemidlerne Evra, Ioa og Zoely i indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen samt supplerende risikominimeringsforanstaltninger. 
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
• udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for 
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.