natgillin/translations-raw huggingface dataset:
Niraparib er ikke et substrat for MATE 1 eller 2, 
Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both.
Seponer Zejula, hvis neutrofiltallet og/eller hæmoglobin ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt. 
• Discontinue Zejula if neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Farmakokinetikken for niraparib hos patienter med svært nedsat leverfunktion er ikke undersøgt (se pkt. 
The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer CYP-enzymer (f.eks. itraconazol, ritonavir og clarithromycin) eller inducerer CYP-enzymer (f.eks. rifampicin, carbamazepin og phenytoin). 
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Lave blodtal Zejula giver lave blodtal, f.eks. et lavt antal røde blodlegemer (blodmangel (anæmi)), hvide blodlegemer (neutropeni) eller blodplader (trombocytopeni). 
Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia).
Diarré, obstipation, slimhindebetændelse (herunder mucositis), stomatitis, mundtørhed 
Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth
Hvis bivirkningen varer ved ud over en dosisafbrydelse på 28 dage, bør Zejula seponeres. 
If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
PFS-median (95 %-KI*) 
PFS median (95% CI*)
Kvalme, obstipation, opkastning, mavesmerter, dyspepsi 
Nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia
Reproduktionstoksicitet 
Reproductive toxicology
Bekræftet diagnose på myelodysplastisk syndrom (MDS) eller akut myeloid leukæmi (AML) 
Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia
Zejula indeholder tartrazin (E 102) 
Zejula contains tartrazine (E 102)
kriterierne), der varer i mere end 28 dage, mens patienten får Zejula 100 mg/dag 
CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
I det kliniske program blev trombocytopeni håndteret ved hjælp af laboratorieovervågning, dosisjustering og trombocyttransfusion, hvor det var relevant (se pkt. 
In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Seponer Zejula, hvis trombocyttallet ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt. 
• Discontinue Zejula if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Ca. 60 % af de patienter, som fik Zejula, oplevede trombocytopeni af alle grader, og 34 % af patienterne oplevede trombocytopeni af grad 3/4. 
Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Tilfældene var typiske for sekundært myelodysplastisk syndrom/akut myeloid leukæmi relateret til kræftbehandling. 
The cases were typical of secondary, cancer therapy-related MDS/AML.
• 56 × 1 hårde kapsler 
• 56 × 1 hard capsules
Sådan skal du tage Zejula 
How to take Zejula
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER 
STATEMENT OF ACTIVE SUBSTANCE(S)
Den mediane varighed af neutropeni af alle grader var 26 dage og 13 dage for hændelser af grad 3/4. 
The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
• 28 × 1 hårde kapsler 
• 28 × 1 hard capsules
Virkning og anvendelse Det skal du vide, før du begynder at tage Zejula Sådan skal du tage Zejula Bivirkninger 
What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Der kræves derfor ingen dosisjustering af Zejula, når det administreres sammen med lægemidler, der hæmmer P-gp (f.eks. amiodaron, verapamil) eller BCRP (f.eks. osimertinib, velpatasvir og eltrombopag). 
Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag).
Rygsmerter, artralgi, myalgi 
Back pain, arthralgia, myalgia
Den mediane tid til starten af neutropeni af alle grader var 27 dage og 29 dage for hændelser af grad 3/4. 
The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
• 84 × 1 hårde kapsler 
• 84 × 1 hard capsules
Der var flere patienter i niraparibgruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 34,2 % og 
More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (34.2 % and 21.1 %, respectively).
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OAT1 (f.eks. probenecid), OAT3 (f.eks. probenecid, diclofenac) eller OCT2 (f.eks. cimetidin, quinidin). 
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Kapselindhold Magnesiumstearat Lactosemonohydrat 
Capsule content Magnesium stearate
De systemiske eksponeringer for niraparib (Cmax og AUC) steg proportionalt med dosis, når niraparibdosis blev øget fra 30 mg til 400 mg. Niraparibs absolutte biotilgængelighed er ca. 73 %, hvilket peger på en minimal first-pass effekt. 
The systemic exposures (Cmax and AUC) to niraparib increased in a dose-proportional manner when the dose of niraparib increased from 30 mg to 400 mg.
Den mediane tid til starten af anæmi af alle grader var 42 dage og 85 dage for hændelser af grad 3/4. 
The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OATP1B1 eller 1B3 (f.eks. gemfibrozil, ritonavir) eller OCT1 (f.eks. dolutegravir). 
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Den mediane varighed af anæmi af alle grader var 63 dage og 8 dage for hændelser af grad 3/4. 
The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Kapslerne skal synkes hele sammen med vand. 
Swallow the capsules whole, with some water.
Niraparib metaboliseres primært af carboxylesteraser (CE'er) og danner en væsentlig inaktiv metabolit, M1. I et massebalancestudie var M1 og M10 (de efterfølgende dannede M1-glucuronider) de væsentligste cirkulerende metabolitter. 
In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites.
Anvendes med forsigtighed til disse patienter (se pkt. 
There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2).
Hæmning af hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er en hæmmer af organisk aniontransportpolypeptid 1B1 (OATP1B1) eller 1B3 (OATP1B3). 
Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl. 
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL.
Hvis du har taget for meget Zejula 
If you take more Zejula than you should
Der er ikke udført studier af niraparibs reproduktions- og udviklingstoksicitet. 
Reproductive and developmental toxicity studies have not been conducted with niraparib.
• Næseblod 
• Nose bleed
Efter den første måned bør det komplette blodtal overvåges månedligt og derefter med jævne mellemrum (se pkt. 
After the first month, it is recommended to monitor CBCs monthly and periodically after this time (see section 4.4).
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) • Nedsat antal hvide blodlegemer (leukopeni) 
Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects.
Niraparib som et substrat for renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 er et substrat for organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2). 
Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
PRAC konkluderede derfor, at febril neutropeni bør tilføjes som en ny bivirkning under pkt. 
Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Hæmning af renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 hæmmer organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2). 
Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Træthed, asteni 
Fatigue, asthenia
Alle blødningshændelser, der var samtidige med trombocytopeni, var af sværhedsgrad 1 eller 2, med undtagelse af ét tilfælde af petekkier og hæmatom af grad 3, der blev observeret samtidig med et alvorligt tilfælde af pancytopeni. 
In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia.
• Vægttab 
• Dizziness
Dosisændringer ved hæmatologiske bivirkninger 
Dose modifications for haematologic adverse reactions
Rygsmerter, artralgi 
Back pain, arthralgia
Der foreligger ingen data om patienter med svært nedsat nyrefunktion eller nyresygdom i slutfasen, som får hæmodialyse. 
There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2).
I det kliniske program blev anæmi håndteret ved hjælp af laboratorieovervågning, dosisjustering (se pkt. 
In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Tilbagehold Zejula i maksimalt 28 dage, og overvåg det komplette blodtal ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl. 
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to
• Oppustet mave 
• Stomach pain
• Øjenbetændelse 
• Pink eye
Lave blodtal kan i sjældne tilfælde være tegn på alvorligere problemer med knoglemarven, såsom "myelodysplastisk syndrom" (MDS) eller "akut myeloid leukæmi" (AML). 
Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as
Dosisjusteringer ved bivirkninger 
Dose adjustments for adverse reactions
Niraparib som et substrat for hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er et substrat for organisk aniontransportpolypeptid 1B1 (OATP1B1), 1B3 (OATP1B3) eller organisk kationtransportør 1 (OCT1). 
Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
• Svaghed 
• Feeling of weakness
Europa-Kommissionen traf en afgørelse den 10. juni 2016. 
The European Commission issued a decision on 10 June 2016.
10. juni 2016 
10 June 2016
Virksomheden ønskede at få godkendelsen anerkendt i Bulgarien, Kroatien, Frankrig, Tyskland, Irland, Italien, Nederlandene, Polen, Portugal, Rumænien, Slovenien, Spanien og Det Forenede Kongerige (de "berørte medlemsstater"). 
The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den belgiske sundhedsstyrelse indbragte sagen til CVMP med henblik på voldgift den 29. september 2015. 
However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Den 17. marts 2016 gennemførte Det Europæiske Lægemiddelagentur (Agenturet) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet CattleMarker IBR Inactivated, emulsion til injektion til kvæg (herefter kaldet CattleMarker IBR Inactivated). 
On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Hvad er CattleMarker IBR Inactivated? 
What is CattleMarker IBR Inactivated?
Zoetis Belgium SA indsendte en ansøgning om gensidig anerkendelse af CattleMarker IBR Inactivated på grundlag af den oprindelige godkendelse udstedt af Belgien. 
Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Hvorfor blev CattleMarker IBR Inactivated vurderet? 
Why was CattleMarker IBR Inactivated reviewed?
CattleMarker IBR Inactivated fremstilles i samme bovine cellelinje og tilføres den samme højpotente adjuvans som PregSure BVD. 
CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.
På grundlag af evalueringen af de nuværende tilgængelige data og den videnskabelige diskussion i Komitéen konkluderede CVMP, at markedsføringstilladelsen for CattleMarker IBR Inactivated skal udstedes i alle berørte medlemsstater, forudsat at der gennemføres supplerende studier og yderligere foranstaltninger som angivet i risikostyringsplanen. 
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Årsagerne til indbringelsen var bekymringer, som Tyskland gav udtryk for, hvad angår den immunologiske sikkerhed ved CattleMarker IBR Inactivated, fordi produktet har samme sammensætning og fremstilling som PregSure BVD, en Zoetis-vaccine, som man har påvist inducerer langvarig allogen antistofrespons, hvilket har været forbundet med bovin neonatal pancytopeni (BNP), en neonatal alloimmun sygdom hos afkommet fra vaccinerede moderdyr. 
The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Spørgsmål og svar om CattleMarker IBR Inactivated, emulsion til injektion til kvæg (inaktiveret gE bovin herpesvirus type 1 (BoHv-1), Difivac stamme EMA/290855/2016 
Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac) EMA/290855/2016
Produktet er indiceret til aktiv immunisering af seronegative kalve i alderen 2 uger og derover med henblik på at reducere de kliniske tegn på IBR (pyreksi og depression) og spredning af virus, der skyldes BoHV-1-infektion. 
The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
CattleMarker IBR Inactivated er en inaktiveret infektiøs bovin rhinotracheitis (IBR)-vaccine, der indeholder glykoprotein E (gE)-negativ bovin herpesvirus type 1 (BoHV-1) af Difivac-stammen. 
CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Aktiv immunisering af kviekalve i alderen 6 måneder og derover er også indiceret med henblik på at reducere de kliniske tegn på IBR (pyreksi og varigheden af dyspnø) og spredning af virus, der skyldes BoHV-1-infektion og med henblik på at reducere forekomsten af aborter i forbindelse med BoHV-1-infektion, typisk i drægtighedsperiodens andet trimester, efter eksponering. 
Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Spørgsmål og svar om CattleMarker IBR Inactivated, emulsion til injektion til kvæg (inaktiveret gE bovin herpesvirus type 1 (BoHv-1), Difivac stamme 
Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at markedsføringstilladelsen udstedt i Belgien for CattleMarker IBR Inactivated kan anerkendes i andre medlemsstater af EU, forudsat at betingelser i forbindelse med risikostyring og overvågning imødekommes. 
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Tyskland mener imidlertid, at den foreslåede håndtering af risiciene er utilstrækkelig, og at Zoetis bør iværksætte en omfattende undersøgelse efter tilladelse til markedsføring. 
The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Emballage Indhold Pakningsstørrelse 
Packaging Content Package size
Du kan få brug for det igen. 
You may need it again.
Dato for seneste fornyelse: 20. oktober 2010. 
Date of latest renewal: 20 October 2010.
Jo større dosis, jo længere vil det tage at injicere. 
The larger the dose, the longer it will take to inject.
• Det er vigtigt, at dine hænder og de ting, som du anvender er så rene som muligt. 
• It is important that your hands and the items you use be as clean as possible.
Behovet for at øge dosis (%) 
Need to increase the dose (%)
•Vask dine hænder med sæbe og vand. 
•Wash your hands with soap and water.
• Giv dig selv injektionen på samme tidspunkt hver dag. 
• Give yourself the injection at the same time each day.
Vask dine hænder og find et rent område 
Wash your hands and find a clean area
E - 28760 Tres Cantos (Madrid) Spanien 
E - 28760 Tres Cantos (Madrid) Spain
Følg proceduren nøje, da den kan være forskellig fra din tidligere anvendelse. 
Follow the procedure exactly, as it may differ from your past experience.
• Et godt sted er et rent bord eller køkkenbord. 
• A good place is a clean table or kitchen surface.
EXP Opbevaringstid efter første anvendelse: 28 dage 
EXP Shelf-life after first use: 28 days
Sæt den til side til senere brug. 
Put it aside for later use.
•Hvis du er mand: med beskadigede testikler, som ikke kan kureres. 
• If you are a man: with damaged testicles that cannot be healed.
Et eksempel på en dagbog over behandlingen: 
An example of a treatment diary:
Efter subkutan anvendelse er den absolutte biotilgængelighed ca. 70%. 
Following subcutaneous administration, the absolute bioavailability is about 70 %.
Den næste injektion skal gives på samme tidspunkt næste dag. 
The next injection should be done at the same time the next day.
• Registrer nummeret på behandlingsdagen (1), dato (2) og tidspunkt (3) for din injektion. 
• Record the treatment day number (1), date (2) and time (3) of your injection.
Den følgende tabel angiver det volumen, der skal administreres, for at give den ordinerede dosis: 
The following table states the volume to be administered to deliver the prescribed dose:
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20. oktober 1995. 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 1995.
Pga. en lokal reaktion over for benzylalkohol, skal det samme injektionssted ikke anvendes på hinanden følgende dage. 
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Udfør en delvis injektion (kun ved behov) 
Complete a partial injection (only when needed).
Tag en ny kanyle. 
Get a new needle.
• GONAL-f gives normalt dagligt. 
• GONAL-f is usually given every day.
Derfor skal patienten følges i mindst 2 uger efter hCG administration. 
Therefore patients should be followed for at least two weeks after hCG administration.
Følgende definitioner gælder for den herefter anvendte terminologi for hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000). 
The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Medfølger ikke i pakningen: 
Not provided in the pack:
Gonadotropiner har indvirkning på reproduktion og fertilitet. 
Gonadotropins are involved in reproduction and fertility.
Produktet skal kasseres, hvis det ikke er anvendt inden 3 måneder. 
The product must be discarded if it has not been used after 3 months.
Advarsel: Sørg altid for at anvende en ny kanyle til hver injektion. 
Warning: Always make sure to use a new needle for each injection.
Injicer ikke direkte ind i en vene. 
Do not inject directly into a vein.
Du kan nedsætte risikoen for flerfoldsgraviditet ved at tage den rette dosis GONAL-f på de rette tidspunkter. 
You can reduce the risk of multiple pregnancy by using the right dose of GONAL-f at the right times.
Til engangsbrug umiddelbart efter åbning og rekonstitution. 
For immediate and single use following first opening and reconstitution.
•Find et rent område og en flad overflade. 
•Find a clean area and aflat surface.