natgillin/translations-raw huggingface dataset:
Andre bivirkninger, som meget sjældent er set (set ved mindre end 1 ud af 10000 vaccinationer) hos børn, som har fået andre vacciner indeholdende MenC: Kollaps eller chok, at barnet efter vaccinationen ikke reagerer på kontakt fra forældrene, besvimelse, feberkramper eller kramper hos børn, som tidligere har haft kramper, nedsat eller øget følesans (f.eks. smerter, sovende legemsdele eller kløen ved indsprøjningsstedet), ledsmerter, eller blå/violette pletter eller områder under huden. 
They include: Collapse or shock, the child not responding to his or her parents for a time after vaccination, fainting, convulsions in children who have had them before, lack of sensation or an increased sensation (for example pain, pins and needles or itching at the injection site), joint pain, or purple spots or patches under the skin.
- bedømmelsesrapporten fra rapportøren og medrapportøren - ansøgerens/indehaveren af markedsføringstilladelsens svar på spørgsmål fra CHMP - den faglige drøftelse i udvalget anbefalede CHMP udstedelse af markedsføringstilladelse for Menitorix med ændringer i de relevante afsnit af patientinformationen og med forpligtelser, som skal opfyldes. 
Based on - the Rapporteur's and Co-Rapporteur's assessment reports, - the Applicant/MAH response to the CHMP questions, - the Scientific discussion within the Committee,
som ikke er nævnt her. 
Not relevant.
Brug af anden medicin 
Using other medicines or vaccines
Børn eksponeret med 3 doser af godkendt Meningitec** eller Menjugate** N = 96 
Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
Indehaveren af markedsføringstilladelsen [Se Bilag I - Udfyldes nationalt] 
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Procentdelen af børn med en antistoftitre ≥ ”assay cut-off” en måned efter boostervaccination med Menitorix administreret samtidig med en mæslinge-fåresyge-røde-hunde-vaccine (MFR)* var følgende: 
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
På grund af manglende data for sikkerhed og effekt bør Menitorix ikke bruges til børn over 2 år. 
Menitorix is not recommended for use in children above 2 years of age due to a lack of data on safety and efficacy.
Hvis dit barn får et af følgende symptomer, skal du straks kontakte din læge eller nærmeste skadestue for at få undersøgt dit barn: Nakkesmerter, nakkestivhed eller modvilje mod lys, bliver sløv eller konfus, får røde eller blålige mærker, som ikke falmer ved tryk. 
If your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or confusion, or red or purple bruise-like spots that do not fade under pressure you should contact your doctor or local accident and emergency department immediately to rule out other causes.
Procentdelen af børn med antistoftitre ≥ ”assay cut off” en måned efter primærvaccination med Menitorix givet samtidig med en DTPa-IPV*- eller DTPa-HBV-IPV*-vaccine var følgende: 
Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
For at holde øje med, om dit barn får en hurtigt indtrædende overfølsomhedsreaktion, kan du og dit barn blive bedt om, at blive et lille stykke tid efter vaccination i konsultationen eller det sted, vaccinationen er foregået. 
Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction.
Hib boostervaccination skal gives før 2-års alderen til børn, som i det primære børnevaccinationsprogram tidligere har fået en kombineret acellulær pertussis-vaccine indeholdende Hib. 
In children who received an acellular pertussis combination vaccine containing Hib in the primary infant immunisation series the Hib booster dose should be given before the age of 2 years.
I et forsøg med primær vaccination sås sammenlignelige immunrespons ved samtidig administration af en undersøgelsesvaccine, der indeholdt samme mængde konjugeret Hib og MenC saccharid som i Menitorix med DTPa- HBV-IPV*, og en godkendt, konjugeret pneumokoksaccharid-vaccine (de tre injektioner blev givet på anatomisk fjerntliggende steder). 
In a trial of primary vaccination, concomitant administration of an investigational vaccine containing the same amount of conjugated Hib and MenC saccharides as in Menitorix with DTPa-HBV-IPV* and a licensed pneumococcal saccharide conjugated vaccine (the three injections were made into anatomically distant sites) gave similar immune responses to the seven pneumococcal serotypes as achieved in a group that received DTPa-HBV-IPV* concomitantly with Hib (conjugated to tetanus toxoid) and a licensed pneumococcal saccharide conjugated vaccine.
Procentdelen af børn med en antistoftitre ≥ ”assay cut-off” en måned efter boostervaccination med Menitorix administreret alene eller samtidig med en DTPa-HBV-IPV*-vaccine var følgende: 
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:
1 hætteglas: Pulver 1 fyldt injektionssprøjte: Solvens 2 kanyler 
1 vial: Powder 1 pre-filled syringe: Solvent 2 needles
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Menitorix, og associerede navne (se Bilag I) solvens til injektionsvæske, opløsning [Se Bilag IUdfyldes nationalt] i.m. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menitorix and associated names (see Annex I) solvent for solution for injection [See Annex I - To be completed nationally]
Aktiv immunisering af spædbørn og børn i alderen fra 2 måneder op til 2 år til forebyggelse af invasive sygdomme forårsaget af Haemophilus influenzae type b (Hib) og Neisseria meningitis serogruppe C (MenC). 
Active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Denne indlægsseddel blev senest godkendt november 2007 [Udfyldes nationalt] 
This leaflet was last approved in {MM/YYYY} [To be completed nationally]
Antistof efter to doser N = 111 
After two doses N=111
Primærvaccination af børn fra 2 måneder op til 12-måneders alderen: Tre injektioner á 0,5 ml gives med mindst 1 måneds interval. 
Primary vaccination in infants from 2 months up to 12 months of age:
♦ Sjælden (det sker ved mindre end 1 ud af 1000, men ved flere end 1 ud af 10000 vaccinationer) 
♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
• Følelse af utilpashed 
• Generally feeling unwell
Menitorix, og associerede navne (se Bilag I) pulver og solvens til injektionsvæske, opløsning Konjugeret Haemophilus type b- og Meningokok gruppe C-vaccine [Se Bilag I - Udfyldes nationalt] 
Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally]
Derudover mener CHMP ikke, at man alene på baggrund af data om persistens af SBA-titre i op til 5 år efter boosting med Menitorix kan forudsige, at vaccinationen har en beskyttende effekt på længere sigt. 
Furthermore the CHMP considers that data on the persistence of SBA titres for up to 5 years after boosting with Menitorix alone cannot predict the longer-term protective effect of vaccination, which can only be estimated by detailed surveillance of disease and therefore agrees with the proposed revised SPC which accurately and comprehensively reflects the extensive body of data that has already been accumulated with respect to the immunity afforded by this vaccine.
Immunresponset for antigen for begge vacciner ved samtidig administration blev ikke påvirket sammenlignet med de to kontrolgrupper, som modtog enten Menitorix eller MFR alene (se pkt. 
Compared to the two control groups that received either Menitorix or MMR alone the immune responses to the antigens in both vaccines were not affected by concomitant administration.
Anti-PRP-antistoffer mikrogram/ml ≥ 1 mikrogram/ml 100 % GMC (mikrogram/ml) 
Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml)
N = antal børn med tilgængelige resultater % = procentdel af børn med en titer lig med eller over “the cut-off” PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer † = børn ≤ 18 uger ved tredje dosis af Menitorix 
N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Antistofresponset er i kliniske forsøg vurderet en måned efter to doser og igen efter afslutningen af det primære 3-dosis-vaccinationsprogram med Menitorix (administreret sammen med DTPa-HBV-IPV eller DTPa-IPV vacciner). 
Clinical trials have evaluated the antibody responses at one month after two doses and after completion of a 3-dose primary vaccination course of Menitorix (co-administered with DTPa-HBVIPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
Grunden til, at den udleverede database blev accepteret, var dels størrelsen af sikkerhedsdatabasen fra de kliniske undersøgelser, dels lighederne imellem denne nye vaccine og allerede godkendte produkter. 
The size of the safety database derived from clinical studies and the similarity of this new vaccine to already licensed products were both reasons to accept the database provided, which is supported by the fact that that the available safety data do not indicate any unusual problems.
Trometamol 
Menitorix
Det er nødvendigt, at give børn en boostervaccination af Hib og MenC efter den primære vaccination. 
After primary vaccination in infancy, booster doses of Hib and MenC must be administered.
Menitorix, pulver og solvens til injektionsvæske, opløsning [Se Bilag I - Udfyldes nationalt] 
Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I - To be completed nationally]
Hvis Menitorix gives som boostervaccination mod Hib eller MenC. 
If Menitorix is used to boost protection against Hib and MenC:
Når hele vaccinationsprogrammet mod Hib og MenC er afsluttet, skal der gives en boostervaccination. 
After the first course of vaccinations against Hib and MenC has been completed a booster dose of Hib and MenC should be given, usually at some time in the second year of life.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Menitorix, og associerede navne (se Bilag I) pulver til injektionsvæske, opløsning Konjugeret Haemophilus type b- og Meningokok gruppe C-vaccine [Se Bilag I - Udfyldes nationalt] i.m. 
NAME OF THE MEDICINAL PRODUCT Menitorix and associated names (see Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally]
PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer % = procentdel af børn med en titer lig med eller over “the cut-off” * = samtidig administration med DTPa-IPV vacciner ** = samtidig administration med DTPa-Hib-TT vacciner 
GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines
Lægemiddelform Indgivelsesv ej 
Pharmaceutical form
[Udfyldes nationalt] 
[See Annex I - To be completed nationally]
% = procentdel af børn med en titer lig med eller over ”the cut-off” PRP = polyribosylribitolphosphat rSBA-MenC = serumbaktericid antistof mod meningokok polysaccharid C ved kaninkomplement GMC eller GMT = geometrisk middelantistofkoncentration eller titer 
PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
(tetanustoksin), eller et af de øvrige indholdsstoffer (se afsnit 6). 
For a full list of excipients, see section 6.1.
Markedsføringstilladelse under særlige omstændigheder 
Marketing authorisation under exceptional circumstances
BILAG IV 
<ANNEX IV
KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER SÆRLIGE OMSTÆNDIGHEDER OG <SIMILARITET> <OG> <UNDTAGELSE> <OG> <ANMODNING OM <MARKEDSFØRINGSBESKYTTELSE> <DATABESKYTTELSE> I ET ÅR> FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR 
CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
[ For the status on marketing authorisation under exceptional circumstances and, where appropriate, for similarity and derogation, please select the statement(s) as provided below.] 
[ For the status on marketing authorisation under exceptional circumstances and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]
<<Markedsføringsbeskyttelse><Databeskyttelse> i et år> 
<one-year <marketing protection> <data exclusivity>>
<ansøgeren kan i sin ansøgning påvise, at lægemidlet, selv om det er similært med {det godkendte lægemiddel til sjældne sygdomme}, er sikrere, mere effektivt eller på anden vis klinisk overlegent (som defineret i artikel 3 i Kommissionens forordning (EC) nr. 847/2000) ved den samme terapeutiske indikation> <og> 
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
<Efter at have vurderet ansøgningen er CHMP af den opfattelse, at risk/benefit-forholdet er positivt for anbefaling af udstedelse af markedsføringstilladelse under særlige omstændigheder. 
<The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.>
<CHMP er af den opfattelse, at «lægemidlets navn» er similært med allerede godkendte lægemidler til sjældne sygdomme i henhold til artikel 3 i Kommissionens forordning (EC) nr. 847/2000. 
<The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Disse bivirkninger fortager sig uden behandling i løbet af 2-5 dage. 
These reactions resolve without treatment in 2 to 5 days.
Der kan gives en enkelt boosterinjektion hver 6. måned for at opretholde immuniteten. 
A single booster injection can be given every 6 months to maintain immunity.
Beskyttelsen begynder i starten af drægtighedsperioden og varer i 6 måneder. 
Protection starts at the beginning of pregnancy and lasts for 6 months.
Hvis dyret kommer i kontakt med virusset, vil immunsystemet reagere hurtigt. 
If the animals come into contact with the virus the immune system will be able to respond quickly.
Yderligere information om ReproCyc ParvoFLEX findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex. 
Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
Det indledende vaccinationsforløb omfatter to indsprøjtninger med 3 ugers mellemrum, hvor den anden injektion gives mindst 3 uger før parring. 
The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating.
En stigning i kropstemperaturen kan forekomme efter vaccination (hos op til 1 ud af 10 dyr), men fortager sig inden for 24-48 timer. 
An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
Tilbageholdelsestiden for kød fra grise, der behandles med ReproCyc ParvoFLEX, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid. 
The withdrawal period for meat from pigs treated with ReproCyc ParvoFLEX is ‘zero' days, which means that there is no mandatory waiting time.
ReproCyc ParvoFLEX fik en markedsføringstilladelse med gyldighed i hele EU den 26/04/2019. 
ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019.
Vaccinen indeholder et porcint parvovirusprotein, som ikke forårsager sygdom. 
The vaccine contains a porcine parvovirus protein that does not cause disease.
Den hyppigste bivirkning ved ReproCyc ParvoFLEX (som kan forekomme hos mere end 1 ud af 10 dyr) er kortvarig rødme eller hævelse (op til 4 cm) på injektionsstedet. 
The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved ReproCyc ParvoFLEX opvejer risiciene, og det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that ReproCyc ParvoFLEX's benefits are greater than its risks and it can be authorised for use in the EU.
Hvis du ønsker flere oplysninger om anvendelsen af ReproCyc ParvoFLEX, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek. 
For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
ReproCyc ParvoFLEX indeholder også adjuvansen (indholdsstof, der styrker immunreaktionen) carbomer. 
ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer.
Dette vil bidrage til at beskytte fostrene mod infektioner med porcin parvovirus under graviditeten. 
This will help protect the unborn piglets against porcine parvovirus infections during pregnancy.
ReproCyc ParvoFLEX er en vaccine. 
ReproCyc ParvoFLEX is a vaccine.
En feltundersøgelse i Spanien viste, at når ReproCyc ParvoFLEX blev givet til søer, var den lige så effektiv som en godkendt porcin parvovirusvaccine, Parvoseng, målt ved fertiliteten hos vaccinerede dyr, antallet af dødsfødsler og kuldstørrelsen. 
A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters.
Når ReproCyc ParvoFLEX gives til søer, genkender dyrenes immunsystem virusproteinet som "fremmed" og danner antistoffer mod det. 
When ReproCyc ParvoFLEX is given to female pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it.
Tre laboratoriestudier viste, at ReproCyc ParvoFLEX beskytter mod transplacental porcin parvovirusinfektion, eftersom mere end 95 % af pattegrisene fra vaccinerede søer var beskyttet mod infektion, og der ingen forekomst var af parvovirus. 
Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus.
Andre oplysninger om ReproCyc ParvoFLEX 
Other information about ReproCyc ParvoFLEX
ReproCyc ParvoFLEX (inaktiveret porcin parvovirusvaccine) 
ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine)
Oversigt over ReproCyc ParvoFLEX, og hvorfor det er godkendt i EU 
An overview of ReproCyc ParvoFLEX and why it is authorised in the EU
ReproCyc ParvoFLEX (inaktiveret porcin parvovirusvaccine) EMA/245834/2019 
ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine) EMA/153444/2019
Porcin parvovirus er årsag til ufrugtbarhed, dødsfødsler og små kuld hos søer. 
Porcine parvovirus causes infertility, still births and small litters in female pigs.
ReproCyc ParvoFLEX indeholder inaktiveret (dræbt) porcin parvovirus, stamme 27a, viralt protein 2. 
ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2.
ReproCyc ParvoFLEX er en veterinærvaccine, der gives til søer for at beskytte deres fostre mod porcin parvovirusinfektion via placenta. 
ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta.
ReproCyc ParvoFLEX udleveres kun efter recept og fås som injektion. 
ReproCyc ParvoFLEX can only be obtained with a prescription and is available as an injection.
Hvad er ReproCyc ParvoFLEX, og hvad anvendes det til? 
What is ReproCyc ParvoFLEX and what is it used for?
Hvorfor blev ReproCyc ParvoFLEX godkendt i EU? 
Why is ReproCyc ParvoFLEX authorised in the EU?
Hvilken risiko er der forbundet med ReproCyc ParvoFLEX? 
What are the risks associated with ReproCyc ParvoFLEX?
Hvordan anvendes ReproCyc ParvoFLEX? 
How is ReproCyc ParvoFLEX used?
Det gives til søer fra 5-måneders alderen som en injektion i en muskel. 
It is given into the muscle of female pigs from 5 months of age.
Hvilke fordele viser studierne, at der er ved ReproCyc ParvoFLEX? 
What benefits of ReproCyc ParvoFLEX have been shown in studies?
Hvordan virker ReproCyc ParvoFLEX? 
How does ReproCyc ParvoFLEX work?
Den anbefalede startdosis er 1 mg pr. kilogram kropsvægt dagligt. 
The recommended starting dose is 1 mg per kilogram body weight per day.
Yderligere information vedrørende Nityr findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nityr (nitisinon) 
Nityr (nitisinone)
Nityr (nitisinon) EMA/396203/2018 
Nityr (nitisinone) EMA/396203/2018
Andre oplysninger om Nityr 
Other information about Nityr
Virksomheden har desuden udført et studie, der viser, at det er "bioækvivalent" med referencelægemidlet. 
The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Behandlingen bør indledes hurtigst muligt, og dosis af Nityr tilpasses patientens behandlingsrespons og legemsvægt. 
Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient's response and body weight.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nityr? 
What measures are being taken to ensure the safe and effective use of Nityr?
Som for alle lægemidler bliver data vedrørende brugen af Nityr løbende overvåget. 
As for all medicines, data on the use of Nityr are continuously monitored.
En oversigt over Nityr, og hvorfor det er godkendt i EU 
An overview of Nityr and why it is authorised in the EU
Hvad er Nityr, og hvad anvendes det til? 
What is Nityr and what is it used for?
Hvilke fordele og risici er der forbundet med Nityr? 
What are the benefits and risks of Nityr?
Da Nityr er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet. 
Because Nityr is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Som for ethvert andet lægemiddel har virksomheden fremlagt studier af kvaliteten af Nityr. 
As for every medicine, the company provided studies on the quality of Nityr.
For mere information om brug af Nityr se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist.