natgillin/translations-raw huggingface dataset:
Der er rapporteret om hjerteinsufficiens under anvendelse af pioglitazon post-marketing oghyppigere, når pioglitazon bruges i kombination med insulin og hos patienter med tidligere hjerteinsufficiens (se pkt.
Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure (see section 4.4).
Deres læge vil råde Dem til at stoppe med at tage denne medicin., hvis De ønsker at blive gravid.Tag ikke Competact, hvis De ammer eller ønsker at amme (se afsnittet ”Tag ikke Competact”).
- do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”).
Competact bør ikke anvendes hos patienter med nedsat leverfunktion (se pkt.
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
dehydrering svær infektion shock - intravaskulær administration af iodholdige kontrastmidler (se pkt.
- Acute conditions with the potential to alter renal function such as: Dehydration Severe infection Shock - Intravascular administration of iodinated contrast agents (see section 4.4) - Breast-feeding (see section 4.6)
Man.
Mon.
6.1e - svigtende hjertefunktion eller en anamnese med hjertesvigt (NYHA-klasse I til IV) - blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi - akut eller kronisk sygdom, som kan medføre vævshypoxi såsom hjerte- eller respirationsinsufficiens, nyligt myokardieinfarkt, shock - nedsat leverfunktion - akut alkoholforgiftning, alkoholisme - enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose) - diabetisk prækoma - svær nyreinsufficiens (GFR < 30 ml/min) - akutte tilstande, der muligvis kan forværre nyrefunktionen, såsom:
recent myocardial infarction, shock - Hepatic impairment - Acute alcohol intoxication, alcoholism - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR < 30 mL/min)
Patienterne skal informeres om at stoppe med at tage Competact og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktatacidose.
In case of suspected symptoms, the patient should stop taking Competact and seek immediate medical attention.
Blod og lymfesystem
Blood and lymphatic system disorders anaemia common
6I en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, komparatorkontrollerede, dobbeltblindede kliniske forsøg af op til 3,5 års varighed med over 8.100 patienter i den pioglitazonbehandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe blev der observeret en øget hyppighed af frakturer hos kvinder, der fik pioglitazon (2,6 %) sammenlignet med komparator (1,7 %).
6 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Indlægsseddel: Information til patienten Competact 15 mg/850 mg filmovertrukne tabletter pioglitazon/metforminhydrochlorid
Package leaflet: Information for the patient Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Undersøgelser vægtøgning7
Investigations weight increased8
De gastrointestinale symptomer forbundet med metformin kan reduceres, hvis Competact tages i forbindelse med eller umiddelbart efter et måltid.
Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Der bør udvises særlig forsigtighed i situationer, hvor nyrefunktionen kan blive forringet.
Dose reduction may be considered in relation to declining renal function.
Kontakt lægen, hvis Deres vægt stiger.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
(højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se afsnittet ”Risiko for laktatacidose”) eller ketoacidose.
- if you have uncontrolled diabetes, with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section“Risk of lactic acidosis”) or ketoacidosis.
Competact 15 mg/850 mg tabletter pioglitazon/metforminhydrochlorid
Competact 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Tal med lægen, da De skal holde op med at tage Competact i en periode før og efter undersøglsen.
- if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you must stop taking Competact for a certain period of time before and after the examination.
Ikke almindelige(kan ramme op til 1 ud af 100 behandlede) - bihulebetændelse - luft i maven - søvnløshed
Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia)
I en poolet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, kontrollerede, dobbeltblindede kliniske forsøg blev der set en øget hyppighed af frakturer hos kvinder.
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8)
dehydrering (væskemangel se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Urticaria meget sjælden meget sjælden
Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Competact 15 mg/850 mg filmovertrukne tabletter pioglitazon/metforminhydrochlorid
Competact 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
såsom ibuprofen og celecoxib) - visse lægemidler, der nedsætter blodtrykket (angiotensinkonverterende enzym (ACE)-hæmmere og angiotensin II-receptorantagonister)
(ACE) inhibitors and angiotensin II receptor antagonists)
Mave-tarm-kanalen4
Gastrointestinal disorders4
De skal også kontakte Deres læge hurtigst muligt, hvis De allerede har sløret syn, og symptomerne forværres.
Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible.
Andre bivirkninger såsom knoglefraktur, vægtøgning og ødem er almindeligt forekommende (≥ 1/100 til < 1/10) (se pkt.
Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Det skal De vide, før De begynder at tage Competact Sådan skal De tage Competact Bivirkninger
What Competact is and what it is used for What you need to know before you take Competact How to take Competact
Hvis De har taget for mange Competact
If you take more Competact than you should
Appetitløshed meget almindelig meget almindelig
abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common
Hovedpine almindelig smagsforstyrelser almindelig almindelig
Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Pakningsstørrelser og yderligere oplysninger
5 How to store Competact Contents of the pack and other information
Risiko for laktatacidose
How to store Competact
4.2 og 4.4.
Wed. 2
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BELANETTE OG TILKNYTTEDE NAVNE (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BELANETTE AND ASSOCIATED NAMES (see Annex I)
Belanette-blisteren er limet i en pakning, som efterfølgende foldes, så den får form som et omslag.
The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration.
143, Avenue Louise 1050 Brussel Belgien
143, Avenue Louise 1050 Brussel
Aida
Germany aida
• Hvis det sker, kan du muligvis mærke disse stykker på tungen.
• If this happens, you may be able to feel these pieces on your tongue.
Dato for første markedsføringstilladelse: 20. juli 2011 Dato for seneste fornyelse: 18. februar 2016
Date of first authorisation: 20 July 2011 Date of latest renewal: 18 February 2016
4.4 og 5.1 vedrørende data for forskellige aldersgrupper.
See sections 4.4 and 5.1 regarding data in different age groups.
Ukendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data)
Not known (frequency cannot be estimated from the available data)
Data fra forskellige aldersgrupper
Data in different age groups
Tag de resterende 3 kapsler på samme måde.
Take the other 3 capsules in the same way.
Denne analyse viste ikke køns- eller aldersrelaterede farmakokinetiske forskelle.
This analysis did not show gender or age-related pharmacokinetic differences
Nogle får først denne infektion senere i livet, mens andre får den meget tidligt.
Some people do not get this infection until later on in their lives, while others get it very young.
Ellers vent til næste dosis.
Otherwise, wait for your next dose.
Der foreligger ikke tilstrækkelige data om denne population til at støtte en anbefaling for eller imod dosisjustering.
There are insufficient data in this population to support a recommendation for or against dose adjustment.
• Tryk ikke på perforeringsknappen mere end en gang ad gangen.
• Do not press the piercing button more than once at a time.
• Du er nu klar til at inhalere kapslen i to separate åndedrag (trin 8 og 9).
• You are now ready to inhale the capsule in 2 separate breaths (Steps 8 and 9).
• 7 kapselkort (et kort til hver dag i ugen).
• 7 capsule cards (one card for each day of the week).
Der blev noteret en aldersmæssig forskel i FEV1-respons.
A difference in FEV1 response by age was noted.
Hvad er Pseudomonas aeruginosa
What is Pseudomonas aeruginosa
Skulle hosten forblive uændret, skal andre antibiotika overvejes.
Should cough remain unchanged, other antibiotics should be considered.
Frekvenserne i Tabel 1 er baseret på rapporteringshyppigheder fra det aktiv-kontrollerede studie.
The frequencies in Table 1 are based on the reporting rates from the active-controlled study.
Tal med din læge, hvis hosten bliver ved og er en belastning for dig.
Talk to your doctor if the cough is persistent and is a burden for you.
Brug den, hvis din ugentlige inhalator ikke fungerer korrekt, er våd eller har været tabt på jorden.
Use this if your weekly inhaler is not functioning correctly, is wet, or has dropped on the ground.
Undertiden kan meget små stykker af kapslen passere gennem nettet og ind i munden.
Occasionally, very small pieces of the capsule can get past the screen and get into your mouth.
De hårde kapsler leveres i PVC/PA/Alu/PVC- PET/Alu-blisterpakninger.
The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
Dosis er den samme for alle fra 6 år og opefter.
The dose is the same for everyone aged 6 years and older.
Dosis af TOBI Podhaler er den samme for alle patienter indenfor de godkendte aldersgrupper, uanset alder og vægt.
The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight.
Lad være med at tage kapslerne ud af kortet på forhånd.
Do not take the capsules out of the card in advance.
Derefter starter du forfra.
You then start another course.
Gentag fra trin 5 med de resterende tre kapsler af dosis.
Repeat, starting at step 5, for the remaining three capsules of the dose.
De observerede MIC-stigninger var for en stor dels vedkommende reversible i de behandlingsfrie perioder.
MIC increases observed were in large part reversible during offtreatment periods.
• Der skal helst være tæt på 12 timer mellem to doser, men der skal være mindst 6 timer imellem.
• It is best to leave close to 12 hours between doses, but this must be at least 6 hours
Sig det til din læge, hvis du nogensinde har haft følgende:
Tell your doctor if you have ever had any of the following conditions:
Kravene for indsendelse af periodiske, opdaterede sikkerhedsindberetninger dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Patienterne i dette studie havde ikke været eksponeret for inhaleret tobramycin i mindst 4 måneder forud for studiets start.
Patients in this study had no exposure to inhaled tobramycin for at least 4 months prior to study start.
• Det er ikke farligt at sluge eller inhalere disse stykker.
• It is not harmful if these pieces are swallowed or inhaled.
Ingen anden inhalator må anvendes.
No other inhaler may be used.
De kan stadig forekomme, mens du tager TOBI Podhaler, men de må ikke være hyppigere eller værre end før.
These may still happen while taking TOBI Podhaler, but should not be any more frequent or seem worse than before.
Man ved ikke, om inhalation af dette lægemiddel under graviditet har bivirkninger.
It is not known whether inhaling this medicine when you are pregnant causes side effects.
Vask hænderne, og tør dem fuldstændigt.
Wash and fully dry your hands.
I de åbne forlængelsesstudier resulterede hver yderligere 6 måneders behandling i øgede stigninger af samme størrelsesorden som der blev observeret i de 6 måneder af de placebo-kontrollerede studie.
In the open label extensions, each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of placebo-controlled studies.
• 1 inhalator (Podhaler) og dens opbevaringshylster.
• 1 inhaler (the Podhaler device) and its storage case.
Officiel vejledning angående hensigtsmæssig brug af antibakterielle lægemidler bør tages i betragtning.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
• Ophostning af blod (meget almindelig)
• Coughing up blood (very common)
I det aktiv-kontrollerede studie blev der blev foretaget audiologisk undersøgelse i udvalgte centre svarende til omkring en fjerdedel af forsøgspopulationen.
In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population.
Resistens over for tobramycin involverer forskellige mekanismer.
Resistance to tobramycin involves different mechanisms.
Alvorlige maternelle toksiske doser hos kaniner (dvs. nefrotoksicitet) medfører spontane aborter og død.
Severely maternally toxic doses to female rabbits (i.e. nephrotoxicity) lead to spontaneous abortions and death.
Patienter med cystisk fibrose har mange symptomer på sygdommen.
People with cystic fibrosis have many symptoms of the disease.
Åbnes her.
Lift here to open.
Sikkerhed og effekt er ikke undersøgt hos patienter med et forventet forceret ekspirationsvolumen i 1. sekund (FEV1) på <25 % eller >75 % eller patienter koloniseret med Burkholderia cepacia.
Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
• høreproblemer (herunder støj i ørerne og svimmelhed)
• hearing problems (including noises in the ears and dizziness)
Hvis kapslen er perforeret, men stadig indeholder noget pulver:
If the capsule is pierced but still contains some powder:
TOBI Podhaler må ikke gives til børn under 6 år.
TOBI Podhaler should not be given to children less than 6 years old.
Der kan ikke gives nogen anbefaling for eller imod dosisjustering for organtransplanterede patienter.
No recommendation for or against dose adjustment can be made for patients after organ transplantation.
Det er vigtigt, at du fortsætter med at bruge produktet to gange daglig i den 28 dages behandlingsperiode, og at du overholder skiftet mellem 28 dage med behandling og 28 dage uden.
It is important that you keep using the product twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle.
• muskelsvaghed, der varer ved eller bliver værre med tiden, et symptom, der som oftest er relateret til sygdomme som myasteni eller Parkinsons sygdom.
• muscle weakness that lasts or becomes worse over time, a symptom mostly related to conditions such as myasthenia or Parkinson's disease.
De vigtigste resistensmekanismer er efflux af lægemidlet og inaktivering af lægemidlet ved modificerende enzymer.
The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes.
Den er en af de mest skadelige bakterier for patienter med cystisk fibrose.
It is one of the most damaging bacteria for people with cystic fibrosis.
Det virker primært ved at forstyrre proteinsyntese, hvilket medfører ændret cellemembranpermeabilitet, fremadskridende nedbrydning af cellemembranen og til slut celledød.
It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Selvom omfanget af forbedringer i lungefunktionen var mindre i dette studie, kan dette forklares ved denne patientpopulations tidligere behandling med inhaleret tobramycin.
Although the magnitude of improvements in lung function was smaller in this study, this is explained by the previous exposure of this patient population to treatment with inhaled tobramycin.
• Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller kapselkortet efter EXP.
• Do not use this medicine after the expiry date which is stated on the box or capsule card.
Det er baktericidt i koncentrationer, der svarer til eller er en smule større end hæmmende koncentrationer.
It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
FEV1 skal måles før og efter inhalation af TOBI Podhaler.
FEV1 should be measured before and after inhalation of TOBI Podhaler.
Din læge vil overvåge din første dosis TOBI Podhaler og kontrollere din lungefunktion før og efter dosis.
Your doctor will supervise your first dose of TOBI Podhaler and check your lung function before and after dosing.
Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed med de hyppigste bivirkninger først.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Den maksimalt tolererede daglige dosis af TOBI Podhaler er ikke fastslået.
The maximum tolerated daily dose of TOBI Podhaler has not been established.
Ellers skal patienten vente til næste dosis og ikke inhalere flere kapsler for at indhente den glemte dosis.
Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.
Fingerprik-blodprøvetagning anbefales ikke på grund af risikoen for forurening af prøven.
Finger prick blood sampling is not recommended due to the risk of contamination of the sample.
Det betyder, at TOBI Podhaler med tiden måske ikke virker så godt, som det burde.
This means that TOBI Podhaler may not work as well as it should over time.
• Hvis kapslen herefter stadig er fuld og ikke ser ud til at være punkteret, skiftes inhalatoren ud med reserveinhalatoren, og trin 2, 3, 6, 7, 8, 9 og 10 gentages.
• After this if the capsule is still full and appears not to be pierced, replace the inhaler with the reserve inhaler and repeat Steps 2, 3, 6, 7, 8, 9 and 10.
Aminoglykosider kan dog forårsage fosterskader (f.eks. medfødt døvhed), når der nås høje systemiske koncentrationer hos en gravid kvinde.
However, aminoglycosides can cause foetal harm (e.g. congenital deafness) when high systemic concentrations are achieved in a pregnant woman.
Hvis det ser ud til, at kapslen ikke er perforeret:
If the capsule does not look pierced:
Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Irland
Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland
I begge studier var der en tendens til en genopretning af P. aeruginosa densiteten efter perioden på 28 dage uden behandling, hvilket blev vendt efter yderligere 28 dage med behandling.
In both studies, there was a trend for a recovery of P. aeruginosa density after the 28 days off-treatment period, which was reversed after a further 28 days on-treatment.
• Anden medicin, der kan skade dine nyrer eller din hørelse.
• Other medicines which may harm your kidneys or hearing.
Hoste var den hyppigst rapporterede bivirkning i begge kliniske studier.
Cough was the most frequently reported adverse reaction in both clinical studies.
Hver Podhaler med hylster anvendes i syv dage, hvorefter den kasseres og erstattes med en ny.
Each Podhaler device and its case are used for seven days and then discarded and replaced.
Podhaleren og dens opbevaringshylster er fremstillet af plastmaterialer (polypropylen).
The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
Se på den brugte kapsel.
Look at the used capsule.
Langt størstedelen af de rapporterede bivirkninger for TOBI Podhaler var lette eller moderate, og sværhedsgraden syntes ikke at afvige mellem cyklusserne eller mellem hele studiet og perioderne med behandling.
The vast majority of adverse reactions reported with TOBI Podhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods.
Intervallet mellem inhalering af de to doser (på hver 4 kapsler) skal være så tæt som muligt på 12 timer og ikke under 6 timer.
The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.
Organtransplanterede patienter
Patients after organ transplantation
Sådanne stoffer kan øge aminoglykosidtoksiciteten ved at ændre antibiotikakoncentrationerne i serum og væv.
Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
• Nedsat hørelse (ringen for ørerne er et potentielt advarselstegn på høretab), støj (fx susen) i ørerne (almindelig).
• Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common).
Bivirkningerne i Tabel 1 er angivet efter systemorganklasserne i MedDRA.
Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA.
Aminoglykosider kan forværre muskelsvaghed på grund af en potentiel curare-lignende effekt på den neuromuskulær funktion.
Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
• Opbevares i den originale pakning for at beskytte mod fugt.
• Store in the original packaging in order to protect from moisture.
• Hoste, produktiv hoste, stemmeændring (hæshed)
• Cough, productive cough, voice alteration (hoarseness)
56 kapsler og 1 inhalator
56 capsules and 1 inhaler
Der foreligger ikke tilstrækkelige data om brug af tobramycin via inhalation hos gravide kvinder.
There are no adequate data on the use of tobramycin via inhalation in pregnant women.
Hosten var ikke relateret til bronkospasme.
Cough was not related to bronchospasm.
Tobramycin viste intet genotoksisk potentiale i et batteri af genotoksicitetstests.
Tobramycin showed no genotoxic potential in a battery of genotoxicity tests.
Tag inhalatoren ud af munden, og hold vejret i ca. 5 sekunder.
Remove the inhaler from your mouth, and hold your breath for about 5 seconds.
Inhalatoren må aldrig vaskes med vand.
The inhaler should never be washed with water.