natgillin/translations-raw huggingface dataset:
Ved samtidig administration af ketoconazol og aripiprazol bør dosis af aripiprazol halveres.
When concomitant administration of ketoconozole with aripiprazole occurs, aripiprazole dose should be reduced to approximately one-half of its prescribed dose.
I to længerevarende forsøg med unge patienter i alderen 13-17 år med skizofreni og bipolær lidelse, der blev behandlet med aripiprazol, var forekomsten af lavt serumprolaktin hos piger (< 3 ng/ml) og drenge (< 2 ng/ml) henholdsvis 37,0 % og 59,4 %.
In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Hjælpestof, som behandleren skal være opmærksom på Hver 10 mg tablet indeholder 59 mg lactose (som monohydrat).
Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Hos den unge population (13-17 år) med skizofreni, der blev eksponeret for 5 til 30 mg aripiprazol i op til 72 måneder, var incidensen af lavt serumprolaktin hos pigerne (< 3 ng/ml) og drengene (< 2 ng/ml) henholdsvis 25,6 % og 45,0 %.
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
Aripiprazole Accord 10 mg/30 mg tabletter
Aripiprazole Accord 10 mg/ 30 mg tablets
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1045/017 30 tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Aripiprazole Accord 15 mg tabletter er gule, bikonvekse, runde tabletter med facetslebne kanter, uden overtræk, ca. 7,14 mm i diameter, præget med “A15” på den ene side og jævne på den anden.
Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
• serotoninsyndrom (en bivirkning, der kan forårsage unormal opstemthed, døsighed, klodsethed,
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
I et korterevarende, placebo-kontrolleret klinisk forsøg, der involverede 302 unge (13-17 år) med skizofreni, var bivirkningsfrekvensen og -typen lig den for voksne undtagen for følgende bivirkninger, der blev rapporteret hyppigere hos unge, der fik aripiprazol end hos voksne, der fik aripiprazol (og hyppigere end med placebo): døsighed/sedation og ekstrapyramidale forstyrrelser blev meget almindeligt rapporteret (≥ 1/10) og tør mund, øget appetit og ortostatisk hypotension blev almindeligt rapporteret (≥ 1/100 til < 1/10).
Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Andre lægemidler, der kan påvirkes af aripiprazol
Other medicines and Aripiprazole Accord
Hjælpestof, som behandleren skal være opmærksom på Hver 5 mg tablet indeholder 63 mg lactose (som monohydrat).
Each 5 mg tablet contains 63 mg lactose (as monohydrate).
EU/1/15/1045/018 100 tabletter
EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
Aripiprazole Accord 30 mg tabletter
Aripiprazole Accord 30 mg tablets
Aripiprazole Accord 5 mg tabletter er blå, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A5” på den ene side og jævne på den anden.
Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
INFORMATION I BRAILLESKRIFT Aripiprazole Accord 30 mg
INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Hos langsomme CYP2D6-omsættere kan samtidig brug af stærke CYP3A4-hæmmere medføre højere plasmakoncentrationer af aripiprazol end hos ekstensive CYP2D6-omsættere.
In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
INFORMATION I BRAILLESKRIFT Aripiprazole Accord 5 mg
INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
- 100 dage (HDPE-flaske med 100 tabletter).
- 30 day (for HDPE 30's count) - 100 day (for HDPE 100's count)
Maniske episoder ved bipolær lidelse type I hos børn og unge Aripiprazol blev undersøgt i et 30-ugers placebokontrolleret forsøg med 296 børn og unge (10-17 år),
Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10-17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score  20 at baseline.
Det skal du vide, før du begynder at tage Aripiprazole Accord Sådan skal du tage Aripiprazole Accord Bivirkninger
What Aripiprazole Accord is and what it is used for What you need to know before you take Aripiprazole Accord How to take Aripiprazole Accord Possible side effects 5 How to store Aripiprazole Accord Contents of the pack and other information
Aripiprazole Accord 10 mg tabletter er lyserøde, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A10” på den ene side og jævne på den anden.
Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Lyserøde, bikonvekse, runde tabletter med facetslebne kanter, uden overtræk, ca. 9,1 mm i diameter, præget med “A30” på den ene side og jævne på den anden.
Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Aripiprazole Accord 5 mg tabletter
Aripiprazole Accord 5 mg tablets
Aripiprazole Accord 10 mg tabletter
Aripiprazole Accord 10 mg tablets
Forhøjet gammaglutamyltransferase (GGT)
Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Brug af Aripiprazole Accord sammen med mad, drikke og alkohol Dette lægemiddel kan tages uafhængigt af måltider.
Aripiprazole Accord with food, drink and alcohol
Aripiprazole Accord 30 mg tabletter: Hver tablet indeholder 30 mg aripiprazol.
Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole.
INFORMATION I BRAILLESKRIFT Aripiprazole Accord 10 mg
INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Det skal du vide, før du begynder at tage Aripiprazole Accord Tag ikke Aripiprazole Accord
What you need to know before you take Aripiprazole Accord
• Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Aripiprazole Accord 30 mg tabletter Hver tablet indeholder 30 mg aripiprazol.
Aripiprazole Accord 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Aripiprazole Accord 15 mg tabletter
Aripiprazole Accord 15 mg tablets
Gule, bikonvekse, runde tabletter med facetslebne kanter, uden overtræk, ca. 7,14 mm i diameter, præget med “A15” på den ene side og jævne på den anden.
Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Aripiprazole Accord 10 mg tabletter Hver tablet indeholder 10 mg aripiprazol.
Aripiprazole Accord 10 mg tablets Each tablet contains 10 mg of aripiprazole.
Aripiprazole Accord 15 mg tabletter Hver tablet indeholder 15 mg aripiprazol.
Aripiprazole Accord 15 mg tablets Each tablet contains 15 mg of aripiprazole.
Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af Aripiprazole Accord.
These medicines may increase the risk of side effects or reduce the effect of ARIPIPRAZOLE ACCORD; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD you should see your doctor.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 30 mg aripiprazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Aripiprazole Accord 10 mg tabletter: Hver tablet indeholder 10 mg aripiprazol.
Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Aripiprazole Accord 5 mg tabletter: Hver tablet indeholder 5 mg aripiprazol.
Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Aripiprazole Accord 30 mg tabletter er lyserøde, bikonvekse, runde tabletter med facetslebne kanter, uden overtræk, ca. 9,1 mm i diameter, præget med “A30” på den ene side og jævne på den anden.
Aripiprazole Accord 30 mg tablets are pink colored, approximately 9.1 mm in diameter, round shaped,
LÆGEMIDLETS NAVN Aripiprazole Accord 30 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg aripiprazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Aripiprazole Accord 15 mg tabletter: Hver tablet indeholder 15 mg aripiprazol.
Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg aripiprazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg aripiprazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
LÆGEMIDLETS NAVN Aripiprazole Accord 15 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
LÆGEMIDLETS NAVN Aripiprazole Accord 5 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
LÆGEMIDLETS NAVN Aripiprazole Accord 10 mg tabletter aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Lyserøde, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A10” på den ene side og jævne på den anden.
Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
• hikke.
• hiccups.
Blå, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A5” på den ene side og jævne på den anden.
Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
EU/1/15/1045/019 14x1 tabletter EU/1/15/1045/020 28x1 tabletter EU/1/15/1045/026 49x1 tabletter EU/1/15/1045/021 56x1 tabletter EU/1/15/1045/022 98x1 tabletter
EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
EU/1/15/1045/001 14x1 tabletter EU/1/15/1045/002 28x1 tabletter EU/1/15/1045/023 49x1 tabletter EU/1/15/1045/003 56x1 tabletter EU/1/15/1045/004 98x1 tabletter
EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
EU/1/15/1045/013 14x1 tabletter EU/1/15/1045/014 28x1 tabletter EU/1/15/1045/025 49x1 tabletter EU/1/15/1045/015 56x1 tabletter EU/1/15/1045/016 98x1 tabletter
EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
EU/1/15/1045/007 14x1 tabletter EU/1/15/1045/008 28x1 tabletter EU/1/15/1045/024 49x1 tabletter EU/1/15/1045/009 56x1 tabletter EU/1/15/1045/010 98x1 tabletter
EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Hyponatriæmi Anoreksi
Hyponatremia Anorexia Weight decreased Weight gain
Den 11. april 2012
11 April 2012
Brevet om tilbagetrækningen kan ses her.
The withdrawal letter can be found here.
Ca. halvdelen af patienterne brugte kapslerne, og halvdelen depotplastret, i en periode på 76 uger.
About half of the patients took the capsule, and half were tre for 76 weeks.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser?
es this withdrawal have for patients in clinical trials?
Udvalget fandt derfor, at de farmakokinetiske data ikke er tilstrækkelige til at drage konklusioner om effektiviteten af plastret, og at det vil være nødvendigt med supplerende oplysninger.
The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required.
Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
What did the company present to support its application?
Den fuldstændige europæiske offentlige vurderingsrapport for Prometax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Det betyder, at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Exelon og Prometax er lægemidler, der indeholder det aktive stof rivastigmin.
Exelon and Prometax are medicines containing the active substance rivastigmine.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Exelon eller Prometax.
y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax.
Den fuldstændige europæiske offentlige vurderingsrapport for Exelon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Hvad anbefalede CHMP på daværende tidspunkt?
What was the recommendation of the CHMP at that tim
Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene, var der stadig nogle uafklarede punkter.
uated the er the CHMP had o the questions, there were still some unresolved issues.
Virksomheden havde fremlagt farmakokinetiske data, der viste, at koncentrationen af rivastigmin ved brug af depotplasteret var den samme hos patienter med Parkinsons sygdom som hos patienter med Alzheimers sygdom, men CHMP bemærkede, at demens ved de to sygdomme er forskellig og kan reagere forskelligt på behandlingen.
The company had presented pharmacokinetic data showing that, when using the patch, rivastigmine levels in patients with Parkinson's disease were similar to the levels seen in patients with Alzheimer's, but the CHMP noted that the dementia in the two diseases was different and could respond differently to treatment.
Hvis du deltager i en klinisk undersøgelse med Exelon eller Prometax og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
a clinical trial and need more information about your treatment, contact the doctor who is
Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
How far into the evaluation was the applicatio
Alle former af lægemidlet kan anvendes til behandling af let til middelsvær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Exelon/Prometax, depotplaster, til behandling af let til middelsvær demens ved Parkinsons sygdom er usikre og ikke er større end risiciene.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks.
Exelon og Prometax, depotplastre, forventedes også anvendt til behandling af let til middelsvær demens ved Parkinsons sygdom, som i forvejen kan behandles med kapslerne og den orale opløsning.
The transdermal patches of Exelon and Prometax were also expected to be used to treat mild to moderately severe dementia associated with Parkinson's disease, which can already be treated using the capsules and oral solution.
Virksomheden fremlagde resultaterne af en undersøgelse af de langsigtede virkninger af kapslen og depotplastret hos 583 patienter med let til middelsvær demens ved Parkinsons sygdom.
The company presented the results of a study designed to assess the long-t and transdermal patch in 583 patients with mild to moderately severe dementia ass Parkinson's disease.
Det aktive stof i Exelon og Prometax, rivastigmin, blokerer de enzymer, der nedbryder acetylcholin: acetylcholinesterase og butyrylcholinesterase.
The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl
Hvad er Exelon og Prometax?
What are Exelon and Prometax?
Exelon og Prometax har været godkendt i EU siden maj 1998.
capsules, an oral solution and transdermal patches (patches tha Exelon and Prometax have been authorised in the EU since May 1998.
Afgørelsen vil ikke få konsekvenser for anvendelsen af Exelon eller Prometax til de godkendte indikationer.
There are no consequences on the use of Exelon and Prometax in their author
Hvordan forventes Exelon og Prometax at virke?
How are Exelon and Prometax expected to work?
Den 14. marts 2012 meddelte Novartis Europharm Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om udvidelse af indikationen for Exelon og Prometax, depotplaster, til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
On 14 March 2012, Novartis Europ and Prometax, to add the use of the transdermal patch for the treatment of mild to dementia in patients with Parkinson's disease.
Hvad sker der med Exelon og Prometax til de godkendte indikationer?
What is happening with Exelon and Prometax in their authorised ised indications.
Hvad forventedes Exelon og Prometax anvendt til?
What were Exelon and Prometax expected to be used for?
Derved mindskes symptomerne på demens ved Parkinsons sygdom.
choline to be increased in the brain, helping to reduce the symptoms of dementia in patients with Parkinson's disease.
I sit officielle brev erklærede virksomheden, at den ville trække ansøgningen tilbage, efter at CHMP havde meddelt, at godkendelse ville kræve fremlæggelse af supplerende oplysninger, hvilket ikke var muligt inden for den fastlagte frist.
The Committee was concerned that the new study was not sufficient to conclude on of the patch in patients with dementia associated with Pa e the reasons given by the company for withdrawing the d that it decided to withdraw the application after the CHMP de on a favourable approval additional data was required, which could not be generated within the allowed timeframe.
De leveres som kapsler, oral opløsning og depotplaster (et plaster, der afgiver et lægemiddel gennem huden).
They are available as t deliver the medicine across the skin).
Undersøgelsen var oprindeligt sat i gang for at vurdere sikkerheden af kapslerne på langt sigt, men virksomheden udvidede senere formålet, så den også omfattede fordele og risici ved depotplastret til behandling af demens ved Parkinsons sygdom.
erm effects of the capsule ociated with ated with the patch, he capsules, but the company later extended its aim to include the assessment of the benefits and risks of the ase.
Virksomheden fremlagde desuden en ”farmakokinetisk” analyse af, hvordan rivastigmin optræder i kroppen, når det gives til patienter med demens ved Parkinsons sygdom, sammenlignet med forholdene hos patienter med Alzheimers demens.
The company also presented a ‘pharmacokinetic' analysis of the way rivastigmine from the patch is handled in the body th what is seen n when it was withdrawn?
Efter gennemgang af de foreliggende oplysninger og virksomhedens besvarelse af CHMP's spørgsmål havde udvalget visse betænkeligheder.
Based on the review of the data and the company's response to the CHMP lists time of the withdrawal, the CHMP had some concerns and was of the provisional o transdermal patch could not have been approved for the treatment of mild to
Tilbagetrækning af ansøgningen om ændring af markedsføringstilladelsen for Exelon ogPrometax (rivastigmin)
Withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax harm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for an extension of indication for Exelon moderately severe
rotransmitteren acetylcholin (et signalstof, som anvendes af nervecellerne til indbyrdes kommunikation).
The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other).
For alle epoetiner
For all epoetins
Vedtaget på PRAC's møde 3.-6. juli 2017
Adopted at the 3-6 July 2017 PRAC
Ingen handling er påkrævet for topiske formuleringer.
For topical formulations, no action is required.
For alle epoetiner - 4.4.
For all epoetins - 4.4.
• Lægemidler, der stimulerer frigivelsen af vasopressin, omfatter:
• Drugs stimulating vasopressin release include:
<Lægemidlets navns> tonicitet: XXX
<Product name> tonicity: XXX
Ordlyden nedenfor skal tilpasses for de enkelte lægemidler, og derfor skal den type ændring, der skal indsendes, aftales med den relevante nationale kompetente myndighed (NCA) inden indsendelsen.
The wording below should be adapted at an individual product level and therefore, the type of variation to be submitted should be agreed with the relevant National Competent Authority (NCA) prior to the submission.
Blodtrykket og nyrefunktionen (S-kreatinin) bør således kontrolleres regelmæssigt.
Blood pressure and renal function (s-creatinine) should therefore be routinely checked.
Lægen kan råde dig til at få dit blodtryk og din urin kontrolleret regelmæssigt.
The doctor may advise that you have your blood pressure and urine regularly checked.
Punktet "Advarsler og forsigtighedsregler" - Vær særligt forsigtig med <lægemidlets navn>:
Section Warnings and precautions - Take special care with <product name>:
Kontakt lægen, før du tager <lægemidlets navn>, hvis du har:
Talk to your doctor before taking <product name>, if you have:
Tegn på sklerodermisk nyrekrise omfatter forhøjet blodtryk og nedsat urinproduktion.
Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.