natgillin/translations-raw huggingface dataset:
Hvis du ønsker praktisk vejledning om anvendelsen af Palonosetron Hospira, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Palonosetron Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Det kan gives sammen med et corticosteroid (en anden type lægemiddel, der kan anvendes til
It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect.
Hvorfor blev Palonosetron Hospira godkendt?
Why is Palonosetron Hospira approved?
Virksomheden fremlagde data fra faglitteraturen om palonosetron.
The company provided data from the published literature on palonosetron.
Hvordan er Palonosetron Hospira blevet undersøgt?
How has Palonosetron Hospira been studied?
Hvordan anvendes Palonosetron Hospira?
How is Palonosetron Hospira used?
Hvordan virker Palonosetron Hospira?
How does Palonosetron Hospira work?
Dato for første markedsføringstilladelse: 10. januar 2008 Dato for seneste fornyelse: 20. september 2012
Date of first authorisation: 10 January 2008 Date of latest renewal: 20 September 2012
Det er vigtigt at forblive på den diæt og motion, som lægen anbefaler, mens De tager TESAVEL.
It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL.
På grund af mangel på humane data bør TESAVEL ikke anvendes under graviditet.
Due to lack of human data, TESAVEL should not be used during pregnancy.
Lægen vil måske bede Dem om at stoppe med at tage TESAVEL.
Your doctor may ask you to stop TESAVEL.
- Allergisk reaktion over for TESAVEL (se punkt 4).
- an allergic reaction to TESAVEL (see section 4).
TESAVEL bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Da der er dosisjustering på baggrund af nyrefunktionen, anbefales det at vurdere nyrefunktionen før initiering af TESAVEL og med mellemrum derefter.
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of TESAVEL and periodically thereafter.
Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager TESAVEL.
The level of digoxin in your blood may need to be checked if taking with TESAVEL.
Administration TESAVEL kan tages med eller uden mad.
Method of administration TESAVEL can be taken with or without food.
Hvis en dosis TESAVEL glemmes, bør den tages, så snart patienten kommer i tanke om det.
If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
Eftersom samtidig administration af et fedtrigt måltid sammen med sitagliptin ikke havde nogen effekt på farmakokinetikken, kan TESAVEL administreres med eller uden mad.
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
TESAVEL indeholder:
What TESAVEL contains
Hvis der er mistanke om pankreatitis, bør TESAVEL og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med TESAVEL ikke genoptages.
If pancreatitis is suspected, TESAVEL and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, TESAVEL should not be restarted.
Ved anvendelse sammen med metformin og/eller en PPAR-agonist bør dosis af metformin og/eller PPAR-agonisten opretholdes, og TESAVEL administreres samtidigt.
When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and TESAVEL administered concomitantly.
Aktiviteten af GLP-1 og GIP begrænses af DPP4-enzymet, som hurtigt hydrolyserer inkretinhormonerne til inaktive produkter.
The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Plasma AUC for sitagliptin øgedes proportionalt med dosis.
Plasma AUC of sitagliptin increased in a dose-proportional manner.
Hvis De holder op med at tage TESAVEL
If you stop taking TESAVEL
Hvis De har glemt at tage TESAVEL
If you forget to take TESAVEL
Bivirkningsfrekvens identificeret i placebokontrollerede kliniske undersøgelser med sitagliptin-monoterapi og efter markedsføring
The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin monotherapy and post-marketing experience
Desuden bør patienterne være opmærksomme på risikoen for hypoglykæmi, når TESAVEL anvendes sammen med et sulfonylurinstof eller sammen med insulin.
In addition, patients should be alerted to the risk of hypoglycaemia when TESAVEL is used in combination with a sulphonylurea or with insulin.
TESAVEL er også indiceret som tillægsbehandling til insulin (med eller uden metformin), når diæt og motion plus stabil dosering af insulin ikke giver tilstrækkelig glykæmisk kontrol.
TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får TESAVEL (se punkt 4).
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4).
Dosisjustering af TESAVEL er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
No dose adjustment for TESAVEL is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Tag ikke TESAVEL - hvis De er allergisk over for sitagliptin eller et af de øvrige indholdsstoffer i TESAVEL
Do not take TESAVEL - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6)
Behandling med GLP-1 eller DPP-4-hæmmere i dyremodeller af type 2-diabetes har vist sig at forbedre betacellernes reaktion på glucose og at stimulere syntesen samt frigivelsen af insulin.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
TESAVEL påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
TESAVEL has no or negligible influence on the ability to drive and use machines.
Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
Ask your pharmacist how to throw away medicines no longer use.
Det skal De vide, før De begynder at tage TESAVEL
What you need to know before you take TESAVEL
HbA1c resultater i placebokontrollerede monoterapi-og kombinationsterapiundersøgelser*
HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Meget almindelig (kan berøre flere end 1 ud af 10) : Lavt blodsukker.
Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation
Hvis De har taget for meget TESAVEL Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
If you take more TESAVEL than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
TESAVEL bør ikke anvendes under amning.
TESAVEL should not be used during breast-feeding.
som dual oral terapi sammen med
as dual oral therapy in combination with
TESAVEL tilhører en klasse af orale anti-hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase-4-(DPP-4)-hæmmere.
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Når TESAVEL anvendes i kombination med et sulfonylurinstof eller sammen med insulin, kan en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Når lægemidlet tages sammen med et sulfonylurinstof eller sammen med insulin kan lavt blodsukker (hypoglykæmi) forekomme.
However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med TESAVEL hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with TESAVEL in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Til patienter med svær nyreinsufficiens (GFR ≥15 til <30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR <15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg TESAVEL en gang dagligt.
For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
TESAVEL er ikke undersøgt hos patienter med svær leverinsufficiens, og der bør udvises forsigtighed (se pkt.
TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Hvis der er mistanke om en overfølsomhedsreaktion, skal Tesavel seponeres.
If a hypersensitivity reaction is suspected, TESAVEL should be discontinued.
Sådan skal De tage TESAVEL
How to take TESAVEL
Yderligere oplysninger om TESAVEL findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Til patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) er dosis 50 mg TESAVEL en gang dagligt.
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
som tripel oral behandling terapi sammen med
as triple oral therapy in combination with
STOP med at tage TESAVEL og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger: Svære og vedvarende smerter i maven, som kan stråle ud i ryggen, med eller uden kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pankreatitis).
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas
TESAVEL indeholder det aktive stof sitagliptin, som tilhører en klasse af lægemidler, som kaldes DPP-4-hæmmere (dipeptylpeptidase-4-hæmmere).
TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Behandling med sitagliptin 100 mg en gang dagligt som monoterapi gav signifikante forbedringer i HbA1c, i faste-plasma-glucose, (FPG) og 2-timers postprandial glucose (2-timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvoraf den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Efter 54 uger var den gennemsnitlige reduktion i forhold til baseline i HbA1c -0,76% med sitagliptin og -0,64% med glipizid (Per Protocol Analysis).
After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (PerProtocol Analysis).
Hvis der er mistanke om bulløs pemfigoid, skal TESAVEL seponeres.
If bullous pemphigoid is suspected, TESAVEL should be discontinued.
Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af TESAVEL som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist).
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Nogle patienter har oplevet følgende bivirkninger, efter at sitagliptin er blevet føjet til metformin: Almindelige (kan berøre op til 1 ud af 10): lavt blodsukker, kvalme, øget luftafgang fra tarmen, opkastning.
Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
MSD Α.Φ.Β.Ε.Ε Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com
Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
TESAVEL er indiceret til at forbedre den glykæmiske kontrol:
For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control:
For at opnå den samme plasmakoncentration for sitagliptin som hos patienter med normal nyrefunktion bør patienter med GFR <45 ml/min samt ESRD-patienter med behov for hæmodialyse eller peritonealdialyse have lavere doser (se pkt.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Det skal De vide, før De begynder at tage TESAVEL Sådan skal De tage TESAVEL Bivirkninger
What TESAVEL is and what it is used for What you need to know before you take TESAVEL How to take TESAVEL
De kliniske data der er beskrevet nedenfor tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administrres samtidigt.
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
Brug af anden medicin sammen med TESAVEL Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Peakplasmakoncentrationer (median Tmax) forkeom 1-4 timer efter dosering, gennemsnitlig plasma-AUC for sitagliptin var 8,52 µM•hr, Cmax var 950 nM. Sitagliptins absolutte biotilgængelighed er ca. 87%.
Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
TESAVEL 25 mg tabletter sitagliptin
TESAVEL 25 mg tablets Sitagliptin
TESAVEL 100 mg tabletter sitagliptin
TESAVEL 100 mg tablets Sitagliptin
TESAVEL 50 mg tabletter sitagliptin
TESAVEL 50 mg tablets Sitagliptin
Reduktionen i HbA1c i forhold til de gennemsnitlige baseline værdier på 7,2% var -0,43% for sitagliptin og -0,57% for metformin (Per Protocol Analysis).Overordnet var incidensen for gastrointestinale bivirkninger, som blev anset for at være lægemiddelrelaterede, 2,7% hos patienter, der fik sitagliptin, sammenlignet med 12,6% hos de patienter, der fik metformin.
The overall incidence of gastrointestinal adverse reactions considered as drug-related in patients treated with sitagliptin was 2.7 % compared with 12.6 % in patients treated with metformin.
EU/1/07/435/013 14 filmovertrukne tabletter EU/1/07/435/014 28 filmovertrukne tabletter EU/1/07/435/023 30 filmovertrukne tabletter EU/1/07/435/015 56 filmovertrukne tabletter EU/1/07/435/016 84 filmovertrukne tabletter EU/1/07/435/024 90 filmovertrukne tabletter EU/1/07/435/017 98 filmovertrukne tabletter EU/1/07/435/018 50 x 1 filmovertrukne tabletter
EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
EU/1/07/435/001 14 filmovertrukne tabletter EU/1/07/435/002 28 filmovertrukne tabletter EU/1/07/435/019 30 filmovertrukne tabletter EU/1/07/435/003 56 filmovertrukne tabletter EU/1/07/435/004 84 filmovertrukne tabletter EU/1/07/435/020 90 filmovertrukne tabletter EU/1/07/435/005 98 filmovertrukne tabletter EU/1/07/435/006 50 x 1 filmovertrukne tabletter
EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
EU/1/07/435/007 14 filmovertrukne tabletter EU/1/07/435/008 28 filmovertrukne tabletter EU/1/07/435/021 30 filmovertrukne tabletter EU/1/07/435/009 56 filmovertrukne tabletter EU/1/07/435/010 84 filmovertrukne tabletter EU/1/07/435/022 90 filmovertrukne tabletter EU/1/07/435/011 98 filmovertrukne tabletter EU/1/07/435/012 50 x 1 filmovertrukne tabletter
EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
The TECOS was a randomised in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
- Lægen har ordineret TESAVEL til Dem personligt.
- This medicine has been prescribed for you only.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ€
Driving and using machines
TESAVEL 100 mg filmovertrukne tabletter sitagliptin
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 25 mg filmovertrukne tabletter
TESAVEL 25 mg film-coated tablets
TESAVEL 100 mg filmovertrukne tabletter
TESAVEL 100 mg film-coated tablets
TESAVEL 25 mg filmovertrukne tabletter sitagliptin
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 50 mg filmovertrukne tabletter sitagliptin
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg filmovertrukne tabletter
TESAVEL 50 mg film-coated tablets
Børn Der er ikke udført undersøgelser med anvendelse af TESAVEL til børn.
Paediatric No studies with TESAVEL have been performed in paediatric patients.
Udseende og pakningsstørrelser
What TESAVEL looks like and contents of the pack
Sitagliptin 100 mg en gang dagligt som supplement til igangværende behandling med pioglitazon + metforminbehandling
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Lægemiddelform Administrati on
Pharmaceutical form
1 hætteglas + 1 injektionssprøjte + 1 kanyle + 1 renseserviet
1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab
12 hætteglas + 72 injektionssprøjter med påsat kanyle + 144 renseservietter
12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
2 hætteglas + 12 injektionssprøjter med påsat kanyle + 24 renseservietter
2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
1 hætteglas + 6 injektionssprøjter med påsat kanyle + 12 renseservietter
1 vial + 6 injection syringes with attached needle + 12 cleansing swabs
Særnavn Styrke Lægemidde l¬form
Strength Pharmaceutical Form
Tilbageho ldelsestid
Withdrawal period
Indhold Pakningsstør relse
Content Package size
Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*: A/Brisbane/02/2018 (H1N1)pdm09- lignende stamme (A/Idaho/07/2018) 15 mikrogram HA** A/Kansas/14/2017 (H3N2)- lignende stamme (A/Indiana/08/2018) 15 mikrogram HA** B/Colorado/06/2017 - lignende stamme (B/Iowa/06/2017) 15 mikrogram HA** B/Phuket/3073/2013 - lignende stamme (B/Singapore/INFTT-16-0610/2016) 15 mikrogram HA**
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
1 Hver 0,5 ml-dosis indeholder:
--¹ 1 Each 0.5 ml dose contains:
* opformeret i Madin Darby Canine Kidney (MDCK)-celler.
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
pr. 0,5 ml-dosis
per 0.5 ml dose
Fyldt injektionssprøjte (glas) uden kanyle
Intramuscular use Pre-filled syringe (glass) without needle
De kan også have episoder med depression.
They may also have episodes of depression.
Aripiprazole Zentiva aripiprazol
Aripiprazole Zentiva aripiprazole
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aripiprazole Zentiva den 25. juni 2015.
The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Zentiva anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Udvalget anbefalede, at Aripiprazole Zentiva godkendes til anvendelse i EU.
The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Aripiprazole Zentiva fås som tabletter (5, 10, 15 og 30 mg) og som tabletter, der opløses i munden (smeltetabletter) (10, 15 and 30 mg).
Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Andre oplysninger om Aripiprazole Zentiva
Other information about Aripiprazole Zentiva
Den virksomhed, der markedsfører Aripiprazole Zentiva, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år.
In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
• bipolar lidelse type I, en psykisk sygdom, hvor patienterne skiftevis har episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør.
• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Zentiva i kroppen.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.