natgillin/translations-raw huggingface dataset:
Hos den unge population (13 til 17 år) med skizofreni, der blev eksponeret for 5 mg 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 to 17 years) schizophrenia population with aripiprazole exposure of 5 mg 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.
• mindre hyppig eller træg afføring,
• decreased number of or difficulty making bowel movements,
Hjælpestof, som behandleren skal være opmærksom på 186,54 mg lactose (som monohydrat) per tablet
Excipient with known effect 186.54 mg lactose (as monohydrate) per tablet
ABILIFY 10 mg tabletter er rektangulære og lyserøde mærket med ”A-008” og ”10” på den ene side.
ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008' and ‘10' on one side.
ABILIFY 30 mg smeltetabletter: Dette lægemiddel indeholder 6 mg aspartam pr. tablet.
ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg aspartame in each tablet.
• spjættende eller rykkende bevægelser, der ikke kan kontrolleres, uro i benene,
• uncontrollable twitching, jerking or writhing movements, restless legs,
Sådan skal du tage ABILIFY
How to take ABILIFY
Smeltetabletten opløses hurtigt i mundvandet.
Tablet disintegration occurs rapidly in saliva.
ABILIFY indeholder natrium
ABILIFY contains sodium
Hver ml indeholder 1 mg aripiprazol.
Each mL contains 1 mg of aripiprazole.
Virkning og anvendelse Det skal du vide, før du får ABILIFY Sådan skal vil du få ABILIFY Bivirkninger
What ABILIFY is and what it is used for What you need to know before you take ABILIFY How to take ABILIFY Possible side effects 5 How to store ABILIFY Contents of the pack and other information
Hjælpestof, som behandleren skal være opmærksom på 6 mg aspartam (E 951) og 0,225 mg lactose per smeltetablet
6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet
ABILIFY 15 mg smeltetabletter: Dette lægemiddel indeholder 3 mg aspartam pr. tablet.
ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame in each tablet.
Maniske episoder ved bipolær lidelse type I med oral aripiprazol I to, 3-ugers placebokontrollerede enkeltstof-forsøg med fleksible doser til patienter med manisk eller blandet episode af bipolær lidelse type I, viste aripiprazol bedre effekt end placebo til reduktion af de maniske symptomer over 3 uger.
Manic episodes in Bipolar I Disorder with oral aripiprazole In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
ABILIFY 7,5 mg/ml injektionsvæske, opløsning aripiprazol
ABILIFY 7.5 mg/mL solution for injection aripiprazole
ABILIFY 7,5 mg/ml injektionsvæske, opløsning
ABILIFY 7.5 mg/mL solution for injection
ABILIFY 10 mg smeltetabletter: Dette lægemiddel indeholder 2 mg aspartam pr. tablet.
ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame in each tablet.
Hvis du ophører med at få ABILIFY
If you stop receiving ABILIFY
ABILIFY leveres i perforerede endosis-blisterpakninger i æsker indeholdende 14 × 1, 28 × 1, 49 × 1, 56 × 1 eller 98 × 1 tabletter.
ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, 49 × 1, 56 × 1, or 98 × 1 tablets.
Aluminium-blisterstrips i æsker med 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tabletter.
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
ABILIFY 30 mg tabletter:
ABILIFY 30 mg tablets:
EU/1/04/276/033 (1 mg/ml, 50 ml flaske) EU/1/04/276/034 (1 mg/ml, 150 ml flaske) EU/1/04/276/035 (1 mg/ml, 480 ml flaske)
EU/1/04/276/033 (1 mg/mL, 50 mL per bottle) EU/1/04/276/034 (1 mg/mL, 150 mL per bottle) EU/1/04/276/035 (1 mg/mL, 480 mL per bottle)
I tre kortere varende (4 til 6 uger), placebokontrollerede undersøgelser med 1228 skizofrene, voksne patienter med positive eller negative symptomer var oral aripiprazol forbundet med statistisk signifikant, større forbedring i psykotiske symptomer sammenlignet med placebo.
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Brug ikke lægemidlet efter den udløbsdato, der står på æsken og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
Hvert hætteglas indeholder 9,75 mg aripiprazol.
Each vial contains 9.75 mg aripiprazole.
Kontakt lægen eller apoteket, hvis du mener, virkningen af ABILIFY er for kraftig eller for svag.
If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
ABILIFY 30 mg tabletter
ABILIFY 30 mg tablets
Der henvises til produktresumé for ABILIFY tabletter, ABILIFY smeltetabletter eller ABILIFY oral opløsning, hvis fortsat behandling er indiceret med oral aripiprazol.
If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.
ABILIFY smeltetabletter indeholder lactose.
ABILIFY orodispersible tablets contain lactose.
Ubehag i abdomen Ubehag i maven
Abdominal discomfort Stomach discomfort
ABILIFY indeholder parahydroxybenzoater
ABILIFY contains parahydroxybenzoates
Angst Rastløshed
Renal impairment
• skaldethed,
• tiredness,
I tre kortere varende (4 til 6 uger), placebokontrollerede undersøgelser med 1228 skizofrene, voksne patienter med positive eller negative symptomer var aripiprazol forbundet med statistisk signifikant, større forbedring i psykotiske symptomer sammenlignet med placebo.
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af ABILIFY.
These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.
ABILIFY 10 mg tabletter:
ABILIFY 10 mg tablets:
Hvis du føler dig svimmel eller svag efter indsprøjtningen, skal du sige det til lægen eller sygeplejersken.
Tell the doctor or nurse if you feel dizzy or faint after the injection.
Dyspepsi Kvalme Øget spytsekretion Opkastning
Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting
Hjælpestof, som behandleren skal være opmærksom på 62,18 mg lactose (som monohydrat) per tablet
Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
14 × 1 smeltetabletter 28 × 1 smeltetabletter 49 × 1 smeltetabletter
14 × 1 orodispersible tablets 28 × 1 orodispersible tablets 49 × 1 orodispersible tablets
ABILIFY 10 mg tabletter
ABILIFY 10 mg tablets
• ængstelse,
• agitation,
ABILIFY 30 mg smeltetabletter Hver smeltetablet indeholder 30 mg aripiprazol.
ABILIFY 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Hjælpestof, som behandleren skal være opmærksom på 57 mg lactose (som monohydrat) per tablet
Excipient with known effect 57 mg lactose (as monohydrate) per tablet
ABILIFY 15 mg smeltetabletter er runde og gule mærket med ”"A" over "641"” på den ene side og ”15” på den anden side.
ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
ABILIFY 15 mg tabletter:
ABILIFY 15 mg tablets:
• triptaner, tramadol og tryptophan bruges mod lidelser som fx depression, generaliseret angst,
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
ABILIFY 10 mg smeltetabletter Hver smeltetablet indeholder 10 mg aripiprazol.
ABILIFY 10 mg tablets Each tablet contains 10 mg of aripiprazole.
ABILIFY 15 mg smeltetabletter Rund og gul, mærket med "A" over "641" på den ene side og ”15” på den anden side.
ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
ABILIFY 5 mg tabletter:
ABILIFY 5 mg tablets:
ABILIFY 15 mg smeltetabletter Hver smeltetablet indeholder 15 mg aripiprazol.
ABILIFY 15 mg tablets Each tablet contains 15 mg of aripiprazole.
Aluminium-blisterstrips i æsker med 14 × 1, 28 × 1, 49 × 1 tabletter.
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
ABILIFY 15 mg tabletter
ABILIFY 15 mg tablets
• antidepressiva eller naturmedicin mod depression og angst (fx fluoxetin, paroxetin, venlafaxin eller perikon)
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
ABILIFY 5 mg tabletter
ABILIFY 5 mg tablets
Hjælpestof, som behandleren skal være opmærksom på 67 mg lactose (som monohydrat) per tablet
Excipient with known effect 67 mg lactose (as monohydrate) per tablet
I et randomiseret, dobbeltblindet, placebokontrolleret 10-ugers studie gennemført i Sydkorea blev aripiprazols virkning hos pædiatriske patienter med Tourettes syndrom (aripiprazol: n = 32, placebo: n = 29) undersøgt inden for et fleksibelt dosisområde på 2 mg/dag til 20 mg/dag med en startdosis på 2 mg.
The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n = 32, placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in SouthKorea.
Hver tablet indeholder 30 mg aripiprazol.
Each tablet contains 30 mg of aripiprazole.
ABILIFY 30 mg tabletter aripiprazol
ABILIFY 30 mg tablets aripiprazole
ABILIFY 10 mg tabletter aripiprazol
ABILIFY 10 mg tablets aripiprazole
I kliniske studier af ABILIFY injektionsvæske, opløsning, er der ikke rapporteret om bivirkninger, som var forbundet med tilfælde af overdosering.
No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection.
EU/1/04/276/016 (30 mg, 14 × 1 tabletter) EU/1/04/276/017 (30 mg, 28 × 1 tabletter) EU/1/04/276/018 (30 mg, 49 × 1 tabletter) EU/1/04/276/019 (30 mg, 56 × 1 tabletter) EU/1/04/276/020 (30 mg, 98 × 1 tabletter)
EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets)
ABILIFY 30 mg smeltetabletter er runde og lyserøde mærket med ”"A" over "643"” på den ene side og ”30” på den anden side.
ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
ABILIFY 10 mg smeltetabletter er runde og lyserøde mærket med ”"A" over "640"” på den ene side og ”10” på den anden side.
ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"' on one side and ‘10' on the other.
ABILIFY 30 mg smeltetabletter Rund og lyserød, mærket med "A" over "643" på den ene side og ”30” på den anden side.
ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
I den pædiatriske population (10 til 17 år) med bipolær lidelse, som fik behandling i op til 30 uger, var incidensen af lav serum-prolaktin hos piger (< 3 ng/ml) og drenge (< 2 ng/ml) henholdsvis 28,0 % og
In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %,
ABILIFY 5 mg tabletter aripiprazol
ABILIFY 5 mg tablets aripiprazole
• ubehag i maven,
• stomach discomfort,
Dyspepsi
Dysphagia
ABILIFY 10 mg smeltetabletter Rund og lyserød, mærket med "A" over "640" på den ene side og ”10” på den anden side.
ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
Mælkesyre
Haemodialysis
EU/1/04/276/030 (30 mg, 14 × 1 smeltetabletter) EU/1/04/276/031 (30 mg, 28 × 1 smeltetabletter) EU/1/04/276/032 (30 mg, 49 × 1 smeltetabletter)
EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets)
ABILIFY smeltetabletter indeholder natrium.
ABILIFY orodispersible tablets contain sodium.
Aripiprazol påvirker i mindre eller moderat grad evnen til at køre bil eller betjene maskiner som følge af den mulige indvirkning på nervesystemet og synet.
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
EU/1/04/276/011 (15 mg, 14 × 1 tabletter) EU/1/04/276/012 (15 mg, 28 × 1 tabletter) EU/1/04/276/013 (15 mg, 49 × 1 tabletter) EU/1/04/276/014 (15 mg, 56 × 1 tabletter) EU/1/04/276/015 (15 mg, 98 × 1 tabletter)
EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets)
ABILIFY 15 mg tabletter aripiprazol
ABILIFY 15 mg tablets aripiprazole
Hver tablet indeholder 10 mg aripiprazol.
Each tablet contains 10 mg of aripiprazole.
EU/1/04/276/006 (10 mg, 14 × 1 tabletter) EU/1/04/276/007 (10 mg, 28 × 1 tabletter) EU/1/04/276/008 (10 mg, 49 × 1 tabletter) EU/1/04/276/009 (10 mg, 56 × 1 tabletter) EU/1/04/276/010 (10 mg, 98 × 1 tabletter)
EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets)
Indlægsseddel: Information til brugeren ABILIFY 10 mg smeltetabletter
Package leaflet: Information for the user ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets aripiprazole
Hver tablet indeholder 15 mg aripiprazol.
Each tablet contains 15 mg of aripiprazole.
EU/1/04/276/001 (5 mg, 14 × 1 tabletter) EU/1/04/276/002 (5 mg, 28 × 1 tabletter) EU/1/04/276/003 (5 mg, 49 × 1 tabletter) EU/1/04/276/004 (5 mg, 56 × 1 tabletter) EU/1/04/276/005 (5 mg, 98 × 1 tabletter)
EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets)
Hver tablet indeholder 5 mg aripiprazol.
Each tablet contains 5 mg of aripiprazole.
• døsighed,
• seizure,
EU/1/04/276/024 (10 mg, 14 × 1 smeltetabletter) EU/1/04/276/025 (10 mg, 28 × 1 smeltetabletter) EU/1/04/276/026 (10 mg, 49 × 1 smeltetabletter)
EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets)
ABILIFY 30 mg tabletter Rød jernoxid (E 172)
ABILIFY 30 mg tablets Red iron oxide (E 172)
EU/1/04/276/027 (15 mg, 14 × 1 smeltetabletter) EU/1/04/276/028 (15 mg, 28 × 1 smeltetabletter) EU/1/04/276/029 (15 mg, 49 × 1 smeltetabletter)
EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets)
Diplopi
Hepatobiliary
ABILIFY 10 mg tabletter Rød jernoxid (E 172)
ABILIFY 10 mg tablets Red iron oxide (E 172)
Sådan vil du få ABILIFY
How to store ABILIFY
ABILIFY 10 mg smeltetabletter Rød jernoxid (E 172)
ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
• betændelse i bugspytkirtlen,
• inflammation of the pancreas,
• øget svedtendens,
• excessive sweating,
ABILIFY 30 mg smeltetabletter aripiprazol
ABILIFY 30 mg orodispersible tablets aripiprazole
ABILIFY 30 mg smeltetabletter Rød jernoxid (E 172)
ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
Hver smeltetablet indeholder 30 mg aripiprazol.
Each orodispersible tablet contains 30 mg of aripiprazole.
ABILIFY injektionsvæske, opløsning, indeholder natrium.
ABILIFY solution for injection contains sodium.
ABILIFY 10 mg smeltetabletter aripiprazol
ABILIFY 10 mg orodispersible tablets aripiprazole
gul jernoxid (E172)
Yellow iron oxide (E 172)
ABILIFY 15 mg tabletter Gul jernoxid (E 172)
ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172)
• fordøjelsesbesvær,
• indigestion,
Hver smeltetablet indeholder 10 mg aripiprazol.
Each orodispersible tablet contains 10 mg of aripiprazole.
• leverbetændelse,
• vomiting,
Hver smeltetablet indeholder 15 mg aripiprazol.
Each orodispersible tablet contains 15 mg of aripiprazole.
Hvis du har fået for meget ABILIFY
If you are given more ABILIFY than you need
• Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt i denne indlægsseddel.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Hikke
IM use
ABILIFY 15 mg smeltetabletter aripiprazol
ABILIFY 15 mg orodispersible tablets aripiprazole
ABILIFY 30 mg smeltetabletter:
ABILIFY 30 mg orodispersible tablets:
• vægttab,
• baldness,
ABILIFY 10 mg smeltetabletter:
ABILIFY 10 mg orodispersible tablets:
• ørhed,
• fainting,
• ufrivillig vandladning,
• abdominal discomfort,
Hovedpine Sedation
Hepatitis Jaundice
FARMACEUTISKE OPLYSNINGER
PHARMACOLOGICAL PROPERTIES
Tabletovertræk
Orodispersible tablets
Din læge vil drøfte dette med dig.
Your doctor will discuss this with you.
Dette kan medføre symptomer som:
This can lead to symptoms such as:
som blev efterfulgt af
which was followed by
TTP = tid til progression, "ne" betyder, at grænsen ikke kunne estimeres, eller at den endnu ikke var nået.
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Slutkoncentration
Final concentration
Hvis dette sker for dig, skal du øjeblikkeligt kontakte en læge.
If this happens to you, contact your doctor immediately.
Bivirkninger, hvor hyppigheden ikke er kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data
Side effects of not known frequency: frequency cannot be estimated from the available data
Der skal foretages en grundig risk-benefit vurdering før det besluttes, om der skal behandles med trastuzumab.
A careful risk-benefit assessment should be made before deciding to treat with trastuzumab.
Hjerteproblemer kan nogle gange forekomme under behandlingen og lejlighedsvis efter, at behandlingen er stoppet, og kan være alvorlige.
Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Hvis en anden administrationsvej er nødvendig, skal der anvendes andre trastuzumab-produkter, der tilbyder en sådan mulighed.
If an alternate route of administration is required, other trastuzumab products offering such an option should be used
• Lægen vil rådgive dig om risici og fordele ved at tage Ogivri under graviditet.
• Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
Ogivri må kun gives af en læge eller sygeplejerske.
Ogivri should only be given by a doctor or nurse.
• åndenød (herunder åndenød om natten),
• breathlessness (including breathlessness at night),
Produktet er ikke beregnet til opbevaring efter rekonstituering og fortynding, med mindre dette har fundet sted under kontrollerede og validerede aseptiske betingelser.
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Ogivri kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
Ogivri can cause breathing difficulties, especially when it is first given.
Den biologiske aktivitet af D7D og den kliniske betydning af øget eksponering for denne metabolit var uklar.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Hvis du holder op med at bruge Ogivri
If you stop using Ogivri
Derfor kan din læge beslutte at fortsætte med at undersøge din hjertefunktion, efter din behandling er stoppet.
Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Børn og unge Ogivri er frarådet til børn og unge under 18 år.
Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
*Cmin,ss - Cmin ved steady state **Cmax,ss = Cmax ved steady state *** tid til 90 % af steady-state
*Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Ogivri kan også gives én gang om ugen ved metastatisk brystkræft.
Ogivri may also be given once a week for metastatic breast cancer.
Nedenstående oplysninger er til læger og sundhedspersonale
The following information is intended for healthcare professionals only
Lægen vil kontrollere dit hjerte regelmæssigt under og efter behandlingen, men du skal øjeblikkeligt fortælle det til lægen, hvis du får nogle af ovenstående symptomer.
Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Nogle af de bivirkninger, som du oplever, kan skyldes din underliggende brystkræft.
Some of the side effects you experience may be due to your underlying breast cancer.
I dette punkt er følgende kategorier for hyppighed blevet anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Kun patienter med store mængder HER2 vil blive behandlet med Ogivri.
Only patients with a large amount of HER2 will be treated with Ogivri.
21 (mg/ml, koncentration af rekonstitueret opløsning)
21 (mg/mL, concentration of reconstituted solution)
* defineret som fravær af hvilken som helst invasiv kræft både i bryst og aksilknuder
* defined as absence of any invasive cancer both in the breast and axillary nodes
Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se afsnit 2 under ”Advarsler og forsigtighedsregler”).
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Derudover blev der foretaget en sammenligning af 2 års trastuzumab-behandling versus 1 års trastuzumab-behandling.
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Hvis produktet ikke anvendes med det samme, er opbevaringstiderne efter åbning og opbevaringsbetingelserne før anvendelse brugerens ansvar.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Ogivri er kun til engangsbrug, da produktet ikke indeholder konserveringsmidler.
Ogivri is for single-use only, as the product contains no preservatives.
Når Ogivri bindes til HER2, stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.
• øget muskeltonus eller muskelspænding (hypertoni)
• increased muscle tone or tension (hypertonia)
Andre bivirkninger kan indtræffe på ethvert tidspunkt under behandlingen med Ogivri og er ikke kun relateret til en infusion.
Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion.