FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in women who are pregnant or breastfeeding, or in patients with severe kidney disease.
Danish: Det må ikke anvendes til kvinder, der er gravide eller ammer, eller til patienter med svær nyresygdom.
English: Results showed that between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin.
Danish: Resultaterne viste, at mellem 95 % og 97 % af de patienter, der fik Cetrotide, ikke oplevede nogen LH-stigning, sammenlignet med 98 % for buserelin og 97 % for triptorelin.
English: What measures are being taken to ensure the safe and effective use of Cetrotide?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cetrotide?
English: Sudden, severe allergic reactions have been reported with Cetrotide and may affect between 1 and 10 patients in 1,000.
Danish: Pludselige alvorlige allergiske reaktioner er indberettet for Cetrotide, og disse kan forekomme hos mellem 1 og 10 patienter ud af 1.000.
English: What is Cetrotide and what is it used for?
Danish: Hvad er Cetrotide, og hvad anvendes det til?
English: Why is Cetrotide authorised in the EU?
Danish: Hvorfor er Cetrotide godkendt i EU?
English: The European Medicines Agency therefore decided that Cetrotide's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Cetrotide opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Cetrotide are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Cetrotide vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Cetrotide and why it is authorised in the EU
Danish: En oversigt over Cetrotide, og hvorfor det er godkendt i EU
English: Further injections may be given by the patient herself, as long as she is made aware of the signs of allergic reaction and what to do if they appear.
Danish: De efterfølgende injektioner kan udføres af patienten selv, forudsat at hun er gjort opmærksom på, hvilke symptomer der kunne tyde på en allergisk reaktion, og hvad man skal gøre, hvis en sådan opstår.
English: Cetrotide contains the active substance cetrorelix.
Danish: Cetrotide indeholder det aktive stof cetrorelix.
English: For more information about using Cetrotide, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Cetrotide, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: What are the risks associated with Cetrotide?
Danish: Hvilke risici er der forbundet med Cetrotide?
English: Treatment starts usually on day 5 or 6 of ovarian stimulation, continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.
Danish: Behandlingen startes normalt på dag 5 eller 6 efter ovariestimulationen og fortsættes i hele ovariestimulationsperioden indtil aftenen før eller morgenen den dag, hvor ovulationsinduktionen (ægløsning) er planlagt.
English: The studies involved 814 women and compared Cetrotide with buserelin nasal spray and triptorelin depot injection.
Danish: Studiet omfattede 814 kvinder, og Cetrotide blev sammenlignet med buserelin næsespray og triptorelin depotinjektion.
English: In three main studies, Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH.
Danish: Tre hovedstudier viste, at Cetrotide var lige så effektivt som sammenligningsbehandlingerne til at forhindre en kraftig stigning i produktionen af LH.
English: Cetrotide is given by injection under the skin of the lower abdomen (belly).
Danish: Cetrotide gives som en injektion under huden i den nederste del af maven (abdomen).
English: The most common side effects with Cetrotide (which may affect between 1 and 10 patients in 100) are mild to moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation procedure itself) and reactions at the injection site, such as redness, swelling and itching.
Danish: De hyppigste bivirkninger ved Cetrotide (som kan forekomme hos mellem 1 og 10 patienter ud af 100) er mild til moderat overstimulation af æggestokkene (hvilket kan forekomme som en bivirkning af selve ovariestimulationsproceduren) og reaktioner på injektionsstedet, f.eks. rødme, hævelse og kløe.
English: Cetrotide must not be used in people who are hypersensitive (allergic) to any hormones that are chemically similar to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone medicines similar to Cetrotide).
Danish: Cetrotide må ikke anvendes til personer, der er overfølsomme (allergiske) over for hormoner, som kemisk svarer til gonadotropinfrigørende hormon, eller over for ekstrinsiske peptidhormoner (hormonlægemidler svarende til Cetrotide).
English: Cetrotide is an effective alternative to existing treatments for the prevention of premature ovulation and its side effects are manageable.
Danish: Cetrotide er et effektivt alternativ til de eksisterende behandlinger til forebyggelse af for tidlig ægløsning, og bivirkningerne er håndterbare.
English: LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation.
Danish: LHRH kontrollerer produktionen og frigivelsen af et andet hormon kaldet luteiniserende hormon (LH), som forårsager ægløsning.
English: The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing hormone (LHRH) in the body.
Danish: Det aktive stof i Cetrotide, cetrorelix, blokerer virkningen af luteiniserende hormonfrigivende hormon (LHRH) i kroppen.
English: These medicines also act on the secretion of LH, but work by overstimulating the production of LHRH, so that the body in response reduces and stops making LH.
Danish: Disse lægemidler påvirker også udskillelsen af LH, men virker ved at overstimulere produktionen af LHRH, således at kroppen som reaktion nedbringer og standser produktionen af LH.
English: By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).
Danish: Ved at blokere virkningen af LHRH standser Cetrotide produktionen af LH og forhindrer således for tidlig ægløsning, som kan medføre ægløsning af æg, der er umodne og uegnede til anvendelse inden for teknikker som invitrobefrugtning (IVF).
English: During fertility treatment, ovarian stimulation is used to make the ovaries produce more eggs.
Danish: Under fertilitetsbehandling anvendes ovariestimulation til at få ovarierne til at producere flere æg.
English: For the full list of side effects and restrictions with Cetrotide, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cetrotide fremgår af indlægssedlen.
English: It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).
Danish: Det gives til kvinder, som får ovariestimulation (fertilitetsbehandling, hvor æggestokkene bliver stimuleret til at producere flere æg).
English: Cetrotide is a medicine used to prevent premature ovulation (early release of eggs from the ovary).
Danish: Cetrotide er et lægemiddel, der anvendes til forebyggelse af præmatur ægløsning (for tidlig ægløsning fra æggestokkene).
English: How does Cetrotide work?
Danish: Hvordan virker Cetrotide?
English: What benefits of Cetrotide have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cetrotide?
English: How is Cetrotide used?
Danish: Hvordan anvendes Cetrotide?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cetrotide have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cetrotide.
English: It is important that you take PritorPlus every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager PritorPlus hver dag, så længe din læge ikke siger andet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 22. april 2002 Dato for seneste fornyelse: 14. maj 2007
English: See also information under the heading “Do not take PritorPlus”.
Danish: Se også information under overskriften ”Tag ikke PritorPlus”
English: Exacerbation or activation of systemic lupus erythematosus
Danish: Forværring eller aktivering af systemisk lupus erythematosus
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig mile pæl (lægemiddelovervågning eller risikominimering) er nået.
English: If PritorPlus is used during breast feeding, doses should be kept as low as possible.
Danish: Hvis PritorPlus anvendes under amning, skal dosis holdes så lav som muligt.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take PritorPlus” and “Warnings and precautions”).
Danish: - Hvis du samtidig tager en ACE-hæmmer eller aliskiren - se også information under overskriften ”Tag ikke PritorPlus” og ”Advarsler og forsigtighedsregler”.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for PritorPlus.
Danish: En øget forekomst af sepsis er kun set med telmisartan, men kan ikke udelukkes for PritorPlus.
English: Talk to your doctor before taking PritorPlus:
Danish: Kontakt lægen, før du tager PritorPlus:
English: Protect your skin from sun exposure and UV rays while taking PritorPlus.
Danish: Beskyt huden mod sollys og UVstråler, mens du tager PritorPlus.
English: PritorPlus can have influence on the ability to drive and use machines.
Danish: PritorPlus kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: If you forget to take PritorPlus
Danish: Hvis du har glemt at tage PritorPlus
English: Some people feel dizzy or tired when taking PritorPlus.
Danish: Man kan føle sig svimmel eller blive træt, når man tager PritorPlus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/215/015-021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/02/215/015-021
English: Possible side effects of PritorPlus:
Danish: Bivirkninger ved PritorPlus:
English: Do not take PritorPlus
Danish: Tag ikke PritorPlus
English: PritorPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Danish: PritorPlus administreret én gang dagligt giver en effektiv og jævn reduktion i blodtrykket i hele det terapeutiske dosisinterval.
English: Your doctor will normally advise you to stop taking PritorPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of PritorPlus.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage PritorPlus, før du bliver gravid eller så snart du ved, du er gravid.
English: Remove your PritorPlus tablet from the blister only directly prior to intake.
Danish: Tag først din PritorPlus-tablet ud af blisteren lige før indtagelse.
English: The safety and efficacy of PritorPlus in children and adolescents aged below 18 have not been established.
Danish: PritorPlus' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with PritorPlus in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med PritorPlus i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: (It is also better to avoid PritorPlus in early pregnancy
Danish: (Du skal desuden helst undgå at bruge PritorPlus tidligt i graviditeten - se afsnittet om Graviditet)
English: PritorPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Danish: PritorPlus er en kombination af to aktive stoffer - telmisartan og hydrochlorthiazid - i én tablet.
English: Such conditions should be corrected before the administration of PritorPlus.
Danish: Sådanne tilstande bør korrigeres, før behandling med PritorPlus initieres.
English: PritorPlus contains milk sugar (lactose) and sorbitol.
Danish: PritorPlus indeholder mælkesukker (laktose) og sorbitol.
English: PritorPlus may be less effective in lowering the blood pressure in black patients.
Danish: PritorPlus kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: **Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Danish: **Tilfælde af tiltagende arvævsdannelse i lungerne er blevet rapporteret ved indtagelse af telmisartan.
English: Experience with PritorPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Erfaringer med PritorPlus er begrænsede hos patienter med let til moderat nedsat nyrefunktion, og derfor anbefales periodisk kontrol af serumværdierne for kalium, kreatinin og urinsyre.
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i PritorPlus (angivet i punkt 6).
English: There are no adequate data from the use of PritorPlus in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af telmisartan til gravide kvinder.
English: In addition, PritorPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Desuden skal PritorPlus anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske- og elektrolytbalancen kan udløse hepatisk coma.
English: Hydrochlorothiazide: Following oral administration of PritorPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Danish: Hydrochlorthiazid: Ved oral administration af PritorPlus nås peak-koncentrationerne af hydrochlorthiazid i løbet af 1,0-3,0 time efter indgift.
English: 3: For further description, please see sub-section “Description of selected adverse reactions” Hydrochlorothiazide:
Danish: 3: For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger” Hydrochlorthiazid:
English: PritorPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: PritorPlus skal opbevares i den forseglede blister på grund af tabletternes hygroskopiske egenskaber.
English: If any of the above applies to you, tell your doctor or pharmacist before taking PritorPlus.
Danish: Hvis et af ovennævnte punkter gælder for dig, skal du tale med din læge eller apoteket om det, inden du tager PritorPlus.
English: Therefore, the use of PritorPlus is not recommended.
Danish: Derfor frarådes brug af PritorPlus.
English: Co-administration of lithium and PritorPlus is not recommended (see section 4.4).
Danish: Samtidig administration af lithium og PritorPlus kan ikke anbefales (se pkt.
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking PritorPlus.
Danish: Før en operation eller bedøvelse bør du fortælle din læge, at du tager PritorPlus.
English: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with PritorPlus.
Danish: Bivirkninger, der er kendt for de enkelte komponenter, men som ikke er forekommet i de kliniske forsøg, kan forekomme ved behandling med PritorPlus.
English: PritorPlus tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: PritorPlus tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: PritorPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: PritorPlus er en kombination af en angiotensin II-receptorantagonist, telmisartan og thiazidet hydrochlorthiazid.
English: PritorPlus may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Danish: PritorPlus kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
Danish: I sjældne tilfælde er dette også set ved behandling med angiotensin II-receptorantagonister (som PritorPlus).
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Danish: Hvis du har taget for mange PritorPlus tabletter Hvis du har taget for mange tabletter, kan du få symptomer såsom lavt blodtryk og hjertebanken.
English: The concomitant use of PritorPlus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: Samtidig brug af PritorPlus og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Talk to your doctor before taking PritorPlus if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager PritorPlus, hvis du har eller har haft en medicinsk lidelse eller sygdom, især hvis det er en af dem, der er nævnt nedenfor:
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking PritorPlus.
Danish: Dette kan være symptomer på forhøjet tryk i øjet og kan udvikles indenfor få timer til uger, efter behandling med PritorPlus er startet.
English: Although clinically significant hyperkalaemia has not been documented with PritorPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart failure, and diabetes mellitus.
Danish: Skønt der ikke er set nogen klinisk signifikant hyperkaliæmi i forbindelse med PritorPlus, så omfatter risikofaktorerne for udvikling af hyperkaliæmi blandt andet nyreinsufficiens og/eller hjertesvigt samt diabetes mellitus.
English: In patients with mild to moderate hepatic impairment the posology should not exceed PritorPlus 40 mg/12.5 mg once daily.
Danish: Hos patienter med let eller moderat nedsat leverfunktion bør dosis ikke overskride PritorPlus 40 mg/12,5 mg én gang daglig.
English: Precautions to be taken before handling or administering the medicinal product PritorPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet PritorPlus skal forblive i den forseglede blister pga. hygroskopiske egenskaber.
English: PritorPlus 80 mg/12.5 mg tablets EU/1/02/215/006-010, 012, 014
Danish: PritorPlus 80 mg/12.5 mg tabletter EU/1/02/215/006-010, 012, 014
English: If you are intolerant to some sugars, consult your doctor before taking PritorPlus.
Danish: Hvis du ikke tåler disse sukkerarter, bør du kontakte din læge, før du tager PritorPlus.
English: There is no experience regarding the administration of PritorPlus in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af PritorPlus til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: PritorPlus should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Danish: PritorPlus gives, hvis blodtrykket ikke kan reguleres tilfredsstillende med telmisartan alene.
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 28 x 1 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter 28 x 1 tabletter
English: Dizziness or drowsiness may occasionally occur when taking PritorPlus.
Danish: Der kan lejlighedsvis forekomme svimmelhed eller døsighed ved behandling med PritorPlus.
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Danish: Symptomer: De mest udtalte symptomer ved telmisartan-overdosering var hypotension og takykardi; også bradykardi, svimmelhed, opkastning, forhøjelse i serum-kreatinin og akut nyresvigt er set.
English: PritorPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Danish: PritorPlus bruges til at sænke forhøjet blodtryk (essentiel hypertension) hos voksne, hvis blodtryk ikke er sænket tilstrækkeligt med telmisartan.
English: PritorPlus is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Det frarådes at anvende PritorPlus under graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: There is no clinical experience with PritorPlus in patients with hepatic impairment.
Danish: Der er ingen klinisk erfaring med brug af PritorPlus til patienter med nedsat leverfunktion.
English: Sialadenitis
Danish: Sialoadenit
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 brugere): Tiltagende arvævsdannelse i lungerne (interstitiel lungesygdom)**
English: PritorPlus must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Danish: PritorPlus må ikke anvendes til patienter med svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min).
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with PritorPlus (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumsupplementer eller kaliumholdige saltsubstitutter skal indgives med forsigtighed sammen med PritorPlus (se pkt.
English: Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Danish: Hos patienter, der kun får hydrochlorthiazid, er der, i tillæg til de bivirkninger, som er nævnt for PritorPlus, set følgende bivirkninger:
English: Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy and telmisartan treatment.
Danish: Thiazidbehandling kan svække glucosetolerancen, mens hypoglykæmi kan forekomme hos diabetikere, der får insulin- eller antidiabetisk behandling.
English: The tablets should be swallowed with some water or other nonalcoholic drink.
Danish: Tabletten synkes sammen med vand eller en anden væske.