FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation due to genital mycotic infections occurred in 1.2%, 1.1% and 0.8% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Danish: Seponering på grund af genitale svampeinfektioner forekom hos 1,2 %, 1,1 % og 0,8 % af de patienter, der blev behandlet med henholdsvis sotagliflozin 200 mg, sotagliflozin 400 mg og placebo.
English: Drug/Laboratory test interference
Danish: Interferens mellem lægemiddel og laboratorietest
English: CKD Stage II (eGFR ≥60 and <90 mL/min/1.73 m2) and CKD Stage IIIa (eGFR ≥45 and <60
Danish: stadie IIIb (eGFR ≥30 og <45 ml/min/1,73 m2) og CKD-stadie IV (eGFR ≥15 og <30 ml/min/1,73 m2)
English: BMI is a measure of your weight in relation to your height.Type 1 diabetes is a disease where your body's immune system destroys the insulin-producing cells in the pancreas and the body produces little to no insulin, the hormone that normally controls the level of your blood sugar.
Danish: Type 1-diabetes er en sygdom, hvor kroppens immunforsvar ødelægger de insulindannende celler i bugspytkirtlen.
English: Effects of sotagliflozin on other medicinal products There is an increase in AUC0-inf and Cmax of digoxin (27% and 52% respectively) when coadministered with sotagliflozin 400mg, due to inhibition of P-gp by sotagliflozin.
Danish: Samtidig administration af digoxin og sotagliflozin 400 mg medførte en stigning i AUC0-inf og Cmax (henholdsvis 27 % og 52 %) på grund af sotagliflozins hæmning af P-gp.
English: Rate of documented hypoglycaemia† (events per patient year) at thresholds of ≤3.1 or ≤3.9 mmol/L
Danish: Hyppighed af natlig‡ dokumenteret hypoglykæmi† (hændelser pr. patientår) ved grænseværdier på ≤3,1 eller
English: This treatment is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with T1DM with a BMI ≥27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Danish: Behandlingen er indiceret som supplement til insulinbehandling for at forbedre den glykæmiske kontrol hos voksne med type 1-diabetes mellitus med et Body Mass Index (BMI) ≥ 27 kg/m2, som ikke har opnået tilstrækkelig glykæmisk kontrol på trods af optimal insulinbehandling.
English: Discontinuation due to genital mycotic infections occurred in 0%, 0.4% and 0.4% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Danish: Seponering på grund af genitale svampeinfektioner forekom hos 0 %, 0,4 % og 0,4 % af de patienter, der blev behandlet med henholdsvis sotagliflozin 200 mg, sotagliflozin 400 mg og placebo.
English: • yeast infection (thrush) of the vagina (signs may include irritation, itching, unusual discharge or odour)
Danish: • svampeinfektion (trøske) i skeden (symptomerne kan være irritation, kløe, usædvanligt udflåd eller lugt)
English: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA, sotagliflozin should be discontinued.
Danish: • Patienter med euglykæmisk DKA skal have tilført glucose, insulin og væske til behandling af DKA.
English: Foot care
Danish: * Se pkt.
English: The proportion of patients with A1C <7.0% at 24 weeks was 19.0% for placebo, 35.1% for sotagliflozin 200mg, 40.4% for sotagliflozin 400mg and at 52 weeks was 18.3%, 28.6% and 31.6% for placebo, sotagliflozin 200 mg and 400 mg respectively.
Danish: I slutningen af uge 24 var reduktion i HbA1c -0,36 % og -0,38 %, og i slutningen af uge 52 var reduktion i HbA1c -0,23 % og -0,32 % med henholdsvis sotagliflozin 200 mg og 400 mg. Andelen af patienter med A1C <7,0 % ved uge 24 var 19,0 % for placebo, 35,1 % for sotagliflozin 200 mg, 40,4 % for sotagliflozin 400 mg, og ved uge 52 var den 18,3 %, 28,6 % og 31,6 % for henholdsvis placebo, 200 mg og 400 mg sotagliflozin.
English: If a dose is missed, it should be taken as soon as you remember the missed dose.
Danish: Hvis du glemmer en dosis, skal du tage den, så snart du kommer i tanke om det. Du må ikke tage en dobbeltdosis Zynquista som erstatning for den glemte dosis.
English: How to take Zynquista
Danish: Sådan skal du tage Zynquista
English: Difference from insulin alone, LS mean [95%CI]
Danish: Forskel i forhold til insulin alene, MKmiddelændring [95 % KI]
English: LS mean % Difference from insulin alone, adjusted mean [95%CI]
Danish: Forskel i forhold til insulin alene, justeret gennemsnit [95 % KI]
English: Baseline, mean in units/day % change from baseline, LS mean % difference from insulin alone, LS mean
Danish: Baseline, gennemsnit i enheder/dage % ændring fra baseline, MKmiddelændring % forskel i forhold til insulin alene, MKmiddelændring
English: Zynquista 200 mg tablets sotagliflozin
Danish: Zynquista 200 mg tabletter sotagliflozin
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment, as sotagliflozin exposure is increased in these patients (see sections 4.2 and 5.2).
Danish: Da eksponeringen for sotagliflozin er øget hos patienter med moderat og svært nedsat leverfunktion, anbefales sotagliflozin ikke til denne patientgruppe (se pkt.
English: The mean eGFR was 87 mL/min/1.73 m2 and 5.7% of patients had eGFR between 45 and 60 mL/min/1.73 m2.
Danish: Gennemsnitligt eGFR var 87 ml/min/1,73 m2, og 5,7 % af patienterne havde eGFR mellem 45 og 60 ml/min/1,73 m2.
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Sotagliflozin bør ikke anvendes til patienter med moderat og svært nedsat leverfunktion (se pkt.
English: Baseline, mean in units % change from baseline, LS mean % difference from insulin alone, LS mean
Danish: Baseline, gennemsnit i enheder % ændring fra baseline, MKmiddelændring % forskel i forhold til insulin alene, MKmiddelændring
English: Date of first authorisation: 26 April 2019
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}
English: • Counsel the patient and evaluate their adherence to ketone monitoring while establishing their baseline ketone level 1 to 2 weeks before treatment initiation and ensure the patient o Has received education/training in ketone testing and interpreting/acting upon test results.
Danish: • Patienten skal vejledes, overholdelse af ketonmonitorering skal vurderes, og patientens baselineniveau af ketoner skal fastsættes 1-2 uger før behandlingen påbegyndes.
English: Talk to your doctor, pharmacist or nurse before taking Zynquista, and during treatment: • if you have the following symptoms, which may be a sign of a serious condition, diabetic ketoacidosis (see also section 4):
Danish: Fortæl det til enhver læge, sundhedsperson eller apotekspersonalet, hvis du skal i gang med en behandling, uanset hvilken type behandling det er. Du kan også hente patientkortet ved at scanne QR-koden eller besøge følgende hjemmeside:
English: Zynquista 200 mg film-coated tablets sotagliflozin
Danish: Zynquista 200 mg filmovertrukne tabletter sotagliflozin
English: In patients where DKA is suspected or diagnosed, treatment with sotagliflozin should be discontinued immediately.
Danish: Behandlingen med sotagliflozin skal straks seponeres hos patienter med mistænkt eller diagnosticeret DKA.
English: A.
Danish: DKA.
English: Blood ketone body increased, serum lipids increasede, haematocrit increasedf
Danish: Forhøjet indhold af ketonstoffer i blodet, forhøjede serumlipidere, forhøjet hæmatokritf
English: Zynquista 200 mg film coated tablets:
Danish: Zynquista 200 mg filmovertrukne tabletter:
English: Baseline, mean in mmHg Change from baseline, LS mean Difference from insulin alone, adjusted mean [95% CI]
Danish: Baseline, MK-middelændring Ændring fra baseline, gennemsnit Forskel i forhold til insulin alene, MKmiddelændring [95 % KI]
English: Urinary glucose excretion
Danish: Udskillelse af glucose i urinen
English: Zynquista 200 mg film-coated tablets
Danish: Zynquista 200 mg filmovertrukne tabletter
English: The mean eGFR was 92 mL/min/1.73 m2 and 3.3% had eGFR between 45 and 60 mL/min/1.73 m2.
Danish: Gennemsnitligt eGFR var 92 ml/min/1,73 m2, og 3,3 % af patienterne havde eGFR mellem 45 og 60 ml/min/1,73 m2.
English: The mean eGFR was 92 mL/min/1.73 m2 and 5 % had eGFR between 45 and 60 mL/min/1.73 m2.
Danish: Gennemsnitligt eGFR var 92 ml/min/1,73 m2, og 5 % af patienterne havde eGFR mellem 45 og 60 ml/min/1,73 m2.
English: Before initiating treatment with sotagliflozin 200 mg and before increasing dose to sotagliflozin 400 mg:
Danish: Før behandling med sotagliflozin 200 mg initieres, og før dosis øges til sotagliflozin 400 mg: - Risikofaktorer for diabetisk ketoacidose (DKA) bør vurderes, og ketonniveauet bør være normalt.
English: In the 3 Phase 3 randomized clinical studies in patients with type 1 diabetes, patients with eGFR < 45 mL/min/1.73 m2 were excluded, 79 patients exposed to sotagliflozin had an eGFR < 60 mL/min/1.73 m2 and 841 patients had an eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2.
Danish: 79 patienter, der fik sotagliflozin havde eGFR < 60 ml/min/1,73 m2 og 841 patienter havde eGFR ≥ 60 til ≤ 90 ml/min/1,73 m2.
English: Male genital mycotic infections*,b, † urinary tract infections*' †
Danish: Svampeinfektioner i de mandlige kønsorganer*,b,
English: Sotagliflozin may cause intravascular volume contraction (see section 4.8).
Danish: Sotagliflozin kan medføre nedsat intravaskulært volumen (se pkt.
English: No overall differences in safety were observed with sotagliflozin treatment as compared to insulin alone in subjects with eGFR between 45 and 60 mL/min/1.73 m2.
Danish: Hos forsøgspersoner med eGFR mellem 45 og 60 ml/min/1,73 m2 blev der ikke observeret nogen overordnet forskel i sikkerhed mellem sotagliflozin-behandling og insulin alene.
English: • flatulence
Danish: Bolusinsulin
English: ≤3.9 mmol/L: 81.3
Danish: ≤3,1 mmol/l: 14,9 ≤3,9 mmol/l: 81,3
English: If you take more Zynquista tablets than you should, talk to a doctor or go to a hospital immediately.
Danish: Kontakt straks lægen eller skadestuen, hvis du har taget mere Zynquista, end der står i denne information, eller mere end lægen har foreskrevet.
English: Posology
Danish: Fodpleje
English: Baseline (after 6-week insulin optimisation), mean Change from baseline, LS mean Difference from insulin alone, LS mean (p-value)
Danish: HbA1c (%) Baseline (efter 6 ugers insulinoptimering), gennemsnit Ved uge 24, gennemsnit Ændring fra baseline, MK*middel-ændring *MK = beregnet ved mindste kvadraters metode Forskel fra insulin alene, MK-middelændring [95 % KI]
English: 7.0% at week 24, n (%) Body Weight (kg) Baseline, mean
Danish: HbA1c < 7,0 % ved uge 24, n (%) Legemsvægt (kg) Baseline, gennemsnit Ændring fra baseline, MKmiddel-ændring Forskel fra insulin alene, MK-middelændring [95 % KI]
English: ≤3.9 mmol/L: 11.1
Danish: ≤3,1 mmol/l: 2,3 ≤3,9 mmol/l: 11,1
English: ≤3.9 mmol/L: 11.0
Danish: ≤3,1 mmol/l: 2,3 ≤3,9 mmol/l: 11,0
English: If you take more Zynquista than you should
Danish: Hvis du har taget for meget Zynquista
English: Stage IV (eGFR ≥15 and <30 mL/min/1.73 m2) sotagliflozin exposures were 1.95 and 2.25 fold higher compared to subjects with normal renal function.
Danish: En farmakokinetisk populationsmodel, der integrerede data fra patienter med nedsat nyrefunktion og raske forsøgspersoner, estimeret for forsøgspersoner med CKD-stadie II (eGFR ≥60 og <90 ml/min/1,73 m2) og CKD-stadie IIIa (eGFR ≥45 og <60 ml/min/1,73 m2), viste, at sotagliflozin-eksponering var 1,5 gange højere end hos forsøgspersoner med normal nyrefunktion.
English: ≤3.9 mmol/L: 83.7
Danish: ≤3,1 mmol/l: 15,0 ≤3,9 mmol/l: 83,7
English: 2-hour postprandial glucose following a standardized mixed meal, mmol/L
Danish: 2-timers postprandial glucose efter et blandet standardmåltid, mmol/l Baseline (efter 6 ugers insulinoptimering), MKmiddelændring Ændring fra baseline, MK-middelændring Forskel i forhold til insulin alene, MK-middelændring (pværdi)
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 December 2017
Danish: Dato for første markedsføringstilladelse: 13. marts 2013 Dato for seneste fornyelse: 8. december 2017
English: Elderly The elderly population has been studied in clinical studies.
Danish: Ældre Den ældre population er blevet undersøgt i kliniske studier.
English: Ethnicity Experience is limited in groups other than Caucasians.
Danish: Etnicitet Der er begrænset erfaring med andre grupper end kaukasiske
English: Proper aseptic injection techniques must always be used.
Danish: Der skal altid bruges korrekte aseptiske injektionsteknikker.
English: This is generally reversible and will usually disappear without treatment.
Danish: Den er almindeligvis forbigående og forsvinder normalt uden behandling.
English: Population with no or limited data
Danish: Population med begrænsede eller manglende data
English: Most of these events occurred during or after vitrectomy in both groups.
Danish: De fleste af disse hændelser forekom under eller efter vitrektomi i begge grupper.
English: If an overdose occurs, close monitoring is recommended.
Danish: Hvis en overdosis forekommer anbefales nøje monitorering.
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved within 2 to 3 weeks.
Danish: Størstedelen af disse reaktioner var ikke-alvorlige, milde til moderate i intensitet og ophørte inden for 2 til 3 uger.
English: At the end of this period the product must be used or discarded.
Danish: I slutningen af denne periode skal produktet anvendes eller kasseres.
English: The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces.
Danish: Macula sørger for det centrale syn, som man bruger ved udførelsen af dagligdags opgaver, såsom at køre bil, læse og genkende ansigter.
English: Routine observation is recommended in all above situations.
Danish: Rutinemæssig monitorering anbefales i alle ovennævnte situationer.
English: Your doctor will be aware of this and will take it into account when monitoring your eye.
Danish: Din læge vil være opmærksom på dette og tage hensyn til det ved øjenundersøgelser.
English: It remains unclear if this haemorrhage is related to the injection procedure itself or administration of ocriplasmin.
Danish: Det er fortsat uklart, om denne blødning er knyttet til selve injektionsproceduren eller til administration af ocriplasmin.
English: Caution should be exercised when treating such patients.
Danish: Der skal udvises forsigtighed ved behandling af sådanne patienter.
English: It is unknown whether JETREA is excreted in human milk.
Danish: Det er ukendt, om Jetrea udskilles i human mælk.
English: A difference was maintained through the end of the studies (Month 6).
Danish: En forskel blev opretholdt til og med studiernes afslutning (6. måned).
English: Combined Placebo
Danish: Kombineret Placebo
English: No systemic interactions are anticipated.
Danish: Der forventes ingen systemiske interaktioner.
English: The new in-use expiry date should be calculated and noted on the carton before it is placed in the refrigerator.
Danish: Den nye udløbsdato skal beregnes og skrives på kartonen, inden denne anbringes i køleskabet.
English: This should be taken into consideration when using these tests for the diagnosis or monitoring of other conditions (see section 4.8).
Danish: Der skal tages højde for dette, når disse tests anvendes til diagnosticering eller monitorering af andre tilstande (se pkt.
English: Ellipsoid Zone disruption within and outside the central area has been reported in non-interventional studies and post-marketing reports.
Danish: Rifter i den ellipsoide zone i og uden for det centrale område er blevet rapporteret i ikkeinterventionelle studier og indberetninger efter markedsføring.
English: The use of Jetrea is therefore not recommended in this patient group.
Danish: Brug af Jetrea anbefales derfor ikke til denne patientgruppe.
English: Only a clear, colourless solution without visible particles should be used.
Danish: Der må kun bruges en klar, farveløs opløsning uden synlige partikler.
English: The patient information pack should be provided in printed and in audio format, and contain the following key elements:
Danish: Patientinformationspakken skal udgives på tryk og i lydformat og skal indeholde følgende hovedelementer:
English: Each vial should only be used once and for the treatment of a single eye.
Danish: Hvert hætteglas må kun anvendes én gang og til behandling af et enkelt øje.
English: 2) including scotoma
Danish: 2) herunder skotom
English: You will not be given Jetrea more than once into the same eye.
Danish: Du vil ikke få Jetrea mere end én gang i det samme øje.
English: Combined JETREA
Danish: Kombineret JETREA
English: No dose adjustment is required.
Danish: Der kræves ingen dosisjusteringer.
English: • Key signs and symptoms of serious adverse events
Danish: • Vigtige tegn og symptomer på bivirkninger
English: Treatment is not recommended in such patients.
Danish: Behandling anbefales ikke hos sådanne patienter.
English: Jetrea should not be used during pregnancy or breast-feeding unless your doctor/ophthalmologist thinks it is clearly necessary.
Danish: Jetrea må ikke bruges under graviditet eller amning, medmindre din læge/øjenlæge mener, det er klart nødvendigt.
English: You will not be given Jetrea into both eyes at the same time.
Danish: Du vil ikke få Jetrea i begge øjne samtidigt.
English: Intravenous administration of 10 mg/kg was generally well tolerated in both rat and dog whether administered as single dose or as repeated dose.
Danish: Intravenøs administration af 10 mg/kg blev generelt tolereret vel hos både rotter og hunde, uanset om det blev administreret som enkeltdosis eller som gentagne doser.
English: - A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea treatment.
Danish: - En alvorlig synsforringelse er rapporteret i op til 1 ud af 10 patienter inden for en uge efter behandling med Jetrea.
English: Also the proportion of patients gaining ≥ 2 or
Danish: Desuden viste andelen af patienter med en forøgelse på ≥ 2 eller
English: In the majority of cases recovery occurred within 6 months.
Danish: I størstedelen af tilfældene forekom normalisering inden for 6 måneder.
English: Active or suspected ocular or periocular infections.
Danish: Aktive eller formodede okulære eller periokulære infektioner.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/ophthalmologist for advice before being given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge/øjenlæge til råds, før du får dette lægemiddel.
English: VMT can cause symptoms such as distorted or decreased vision.
Danish: VMT kan give symptomer i form af forvrænget eller svækket syn.
English: Intraocular inflammation/infection may be assessed using biomicroscopy between 2 and 7 days following the injection.
Danish: Intraokulær inflammation/infektion kan vurderes ved hjælp af biomikroskopi mellem 2 og 7 dage efter injektionen.
English: Administration in close temporal association with other medicinal products in the same eye may affect the activity of both medicinal products and is therefore not recommended.
Danish: Tidsmæssig tæt administration af andre lægemidler med samme administrationsvej kan påvirke aktiviteten af begge lægemidler og kan derfor ikke anbefales.
English: In these cases, patients should not drive or use machines until the visual disturbances have resolved.
Danish: I sådanne tilfælde må patienten ikke føre motorkøretøj eller betjene maskiner, før synsforstyrrelserne er ophørt.
English: The clinical data on the effects of JETREA overdose are limited.
Danish: De kliniske data om virkningen af en overdosis af Jetrea er begrænsede.
English: The following table summarises the adverse reactions reported in the treated eye in clinical studies and/or from post-marketing experience.
Danish: Følgende tabel sammenfatter de bivirkninger, der blev indberettet for det behandlede øje i forbindelse med kliniske studier og/eller efter markedsføring.
English: The difference continued to be statistically significant through Month 6 in each study (p≤0.024).
Danish: Forskellen fortsatte med at være statistisk signifikant til og med måned 6 i hvert studie (p ≤ 0,024).
English: If this happens, do not drive or use any tools or machines until your vision improves.
Danish: Hvis det sker, må du ikke køre bil eller arbejde med værktøj eller maskiner, før dit syn er klart igen.
English: Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions' section.
Danish: Information om normalisering af specifikke hændelser så som kromatopsi og ændringer i ERG kan findes i de relevante afsnit i sektionen ”beskrivelse af udvalgte bivirkninger”.
English: This information will be taken into account to evaluate if and when Jetrea can be injected into the same eye.
Danish: Der vil blive taget hensyn til disse oplysninger for at vurdere, om Jetrea kan injiceres i samme øje.
English: The median time to resolution was 22 days.
Danish: Den mediane tid til normalisering var 22 dage.
English: The inactive ocriplasmin/α2-antiplasmin complex is cleared from the circulation with a half-life (t1/2) of several hours.
Danish: Det inaktive ocriplasmin/α2antiplasmin kompleks udgår af cirkulationen med en halveringstid (t1/2) på flere timer.
English: The medicinal product should be diluted and used immediately.
Danish: Lægemidlet skal fortyndes og anvendes med det samme.
English: Visual symptoms perceived in the contralateral eye or bilaterally have also been reported.
Danish: Der er også indberettet visuelle symptomer i det kontralaterale øje eller bilateralt.
English: No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.
Danish: Der findes ingen karcinogenicitetsdata, mutagenicitetsdata eller reproduktive og udviklingsmæssige toksicitetsdata.
English: Your doctor/ophthalmologist will decide if treatment with Jetrea is right for you.
Danish: Din læge/øjenlæge vil beslutte, om behandling med Jetrea er det rigtige for dig.
English: EXP Use immediately after dilution.
Danish: EXP Anvendes umiddelbart efter fortynding.
English: Most of the adverse reactions occurred within the first week after the injection.
Danish: De fleste bivirkninger forekom inden for den første uge efter injektionen.
English: This effect appeared to be dose-related and was observed in all animals administered intravitreal ocriplasmin more than once.
Danish: Denne effekt forekom at være dosisrelateret og blev observeret hos alle dyr, som fik indgivet intravitreal ocriplasmin mere end en gang.
English: When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or α2-macroglobulin.
Danish: Når ocriplasmin administreres intravenøst, går det ind i den endogene proteinkatabolisme, hvor det hurtigt inaktiveres gennem dets interaktioner med protease-hæmmere α2antiplasmin eller α2makroglobulin.
English: At Month 24, the proportions were 48/145 (33.3%) and 32/73 (43%), respectively.
Danish: Ved måned 24 var andelene henholdsvis 48/145 (33,3 %) og 32/73 (43 %).
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where JETREA will be marketed, at launch and after launch, all healthcare professionals who are expected to use JETREA are provided with the following items:
Danish: Indehaveren af markedsføringstilladelsen skal sørge for efter diskussioner og aftale med de relevante myndigheder i hver enkelt medlemsstat, hvor Jetrea vil blive markedsført, såvel ved lanceringen som efter lanceringen, at sundhedspersonale, som forventes at anvende Jetrea, får udleveret følgende materiale:
English: Fertility There are no data on the effect of JETREA on fertility.
Danish: Fertilitet Der er ingen data vedrørende Jetreas virkning på fertiliteten.
English: Days Post-Injection
Danish: Dage efter injektion