FrancophonIA/ELRC3.0 huggingface dataset:
English: INVEGA should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).
Icelandic: Nota skal INVEGA með varúð handa sjúklingum með þekktan hjarta- og æðasjúkdóm (t.d. hjartabilun, hjartadrep eða blóðþurrð í hjartavöðva, leiðslutruflanir), heilaæðasjúkdóm eða eitthvert það ástand sem eykur hættu á lágþrýstingi (t.d. vessaþurrð og blóðmagnsskortur).
English: Blood and lymphatic system disorders white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased agranulocytosis c,
Icelandic: Blóð og eitlar fækkun hvítra blóðkorna, blóðflagnafæð, blóðleysi, lækkun á hematókrít kyrningahrap c,
English: Eye problems during cataract surgery may also occur.
Icelandic: Einnig geta komið fram augnvandamál meðan á dreraðgerð (augnaðgerð til að fjarlægja ský á augasteini) stendur.
English: In addition, the difference in the percentage of patients demonstrating ≥ 20% improvement in PANSS total score at week 26 between the two treatment groups was numerically similar.
Icelandic: heildarskori á PANSS-mælikvarða tölulega svipaður eftir viku 26 hjá báðum meðferðarhópunum.
English: It takes 2-3 weeks for full induction to be achieved and upon discontinuation of the inducer the effect wears off over a similar time period.
Icelandic: Þegar meðferð með karbamazepíni er aftur á móti hætt skal endurmeta skammta INVEGA og minnka ef þörf er á. Full áhrif örvans nást á 2-3 vikum og þegar meðferð hans er hætt tekur það svipaðan tíma fyrir áhrifin að dvína.
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Icelandic: INVEGA og fylgjast með hvítfrumnafjölda hjá sjúklingum með alvarlega daufkyrningafæð (heildarfjöldi daufkyrninga < 1 x 10
English: Each prolonged-release tablet contains 12 mg of paliperidone.
Icelandic: Hver forðatafla inniheldur 12 mg af paliperidoni.
English: The recommended dose of INVEGA for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning.
Icelandic: Ráðlagður skammtur af INVEGA til meðferðar við geðhvarfaklofa hjá fullorðnum er 6 mg einu sinni á sólarhring, að morgni.
English: Other medicines and INVEGA
Icelandic: Notkun annarra lyfja samhliða INVEGA
English: Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness.
Icelandic: Geðklofi er sjúkdómur sem hefur einkenni á borð við ofheyrnir, ofsýnir og ofskynjanir, ranghugmyndir, ofsóknarkennd, einangrun frá samfélaginu, samhengislaust tal, áhugaleysi og tilfinningalega deyfð.
English: syncope,
Icelandic: Í safngreiningu
English: LOCF endpoint change from baseline
Icelandic: LOCF (last observation carried forward) endapunktur, breyting frá grunnlínu
English: Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Icelandic: Ekki er mælt með neinni skammtaaðlögun INVEGA á grundvelli kyns, kynþáttar eða þess hvort sjúklingurinn reykir.
English: Iron oxide (black) (E172) Propylene glycol Hypromellose
Icelandic: Járnoxíð (svart) (E172) Própýlenglýkól Hýprómellósi
English: Elderly Your doctor may reduce your dose of medicine if your kidney function is reduced.
Icelandic: Aldraðir Ef þú ert með skerta nýrnastarfsemi er hugsanlegt að læknirinn minnki skammtinn af lyfinu.
English: Schizoaffective disorder (adults)
Icelandic: Geðhvarfaklofi (fullorðnir)
English: The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning.
Icelandic: Ráðlagður skammtur af INVEGA til meðferðar við geðklofa hjá fullorðnum er 6 mg einu sinni á sólarhring, að morgni.
English: Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Icelandic: Hver INVEGA 6 mg forðatafla inniheldur paliperidon 6 mg.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicinal products.
Icelandic: Geðrofslyf hafa verið tengd röskun á getu til að lækka líkamshita.
English: Each prolonged-release tablet contains 9 mg of paliperidone.
Icelandic: Hver forðatafla inniheldur 9 mg af paliperidoni.
English: Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
Icelandic: Hver INVEGA 12 mg forðatafla inniheldur paliperidon 12 mg.
English: - if you have difficulty controlling core body temperature or overheating.
Icelandic: - Ef þú ert með óstöðugan eða mjög háan líkamshita.
English: Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Icelandic: Stoðkerfi og bandvefur verkir frá stoðvef og stoðkerfi, bakverkur, liðverkir hækkun kreatínfosfókínasa í blóði, vöðvakrampar, stirðleiki í liðum, liðbólga, vöðvamáttleysi, verkur í hálsi rákvöðvalýsa c, óeðlileg líkamsstaða
English: Patients with kidney problems Your doctor may adjust your dose of this medicine based upon your kidney function.
Icelandic: Hugsanlegt er að læknirinn stilli lyfjaskammtinn sem þú tekur með hliðsjón af því hvernig nýrnastarfsemi þín er.
English: This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumour.
Icelandic: Komi slík áhrif fyrir hjá mönnum geta þau dulið einkenni ofskömmtunar sumra lyfja auk þess sem þau geta dulið ástand á borð við teppu í meltingarvegi, Reyes-heilkenni og heilaæxli.
English: Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release
Icelandic: Einni viku eftir inntöku staks 1 mg skammts
English: • blurry vision
Icelandic: • brisbólga
English: See section 4.
Icelandic: Fyrstu verkunargildi.
English: Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Carnauba wax
Icelandic: Hýprómellósi Títantvíoxíð (E171) Pólýetýlenglýkól 400 Járnoxíð (gult) (E172) Carnaubavax
English: Additional side effects in adolescents
Icelandic: Viðbótaraukaverkanir hjá unglingum
English: Response defined as decrease from baseline in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2
Icelandic: ≥ 30% og CGI-C-skori
English: Each prolonged-release tablet contains 3 mg of paliperidone.
Icelandic: Hver forðatafla inniheldur 3 mg af paliperidoni.
English: Fertility There were no relevant effects observed in the non-clinical studies.
Icelandic: Frjósemi Í forklínískum rannsóknum komu ekki fram áhrif sem skiptu máli.
English: PHARMACEUTICAL FORM
Icelandic: • þrymlabólur
English: 30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Icelandic: 30 forðatöflur - EU/1/07/395/057 350 forðatöflur - EU/1/07/395/058
English: How to take INVEGA
Icelandic: Hvernig geyma á
English: Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Icelandic: Hver INVEGA 3 mg forðatafla inniheldur paliperidon 3 mg.
English: Each prolonged-release tablet contains 6 mg of paliperidone.
Icelandic: Hver forðatafla inniheldur 6 mg af paliperidoni.
English: Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (red) (E172) Carnauba wax
Icelandic: Hýprómellósi Títantvíoxíð (E171) Pólýetýlenglýkól 400 Járnoxíð (rautt) (E172) Carnaubavax
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Icelandic: Tafarlaust skal hefja eftirlit með hjarta og æðakerfi, þ.m.t. hjartalínuritssívöktun með tilliti til hugsanlegra hjartsláttartruflana.
English: dyspepsia, dry mouth, toothache swollen tongue, gastroenteritis, dysphagia,
Icelandic: Nýru og þvagfæri þvagleki, tíð þvaglát, þvagteppa, þvagtregða
English: The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Icelandic: Sjúklingar þurfa ekki að hafa áhyggjur af því þótt þeir taki stöku sinnum eftir einhverju sem líkist töflu í hægðum.
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Icelandic: • færð blóðtappa í bláæð, sérstaklega í fótleggjum (einkenni eru m.a. bólga, verkur og roði í fótlegg).
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Icelandic: Veita skal meðferð við blóðþrýstingslækkun og blóðrásarbilun með viðeigandi hætti, t.d. með gjöf vökva í æð og/eða með adrenvirkum lyfjum.
English: Infections and infestations bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, influenza pneumonia, respiratory tract infection, cystitis, ear infection, tonsillitis eye infection, onychomycosis, cellulitis, acarodermatitis
Icelandic: Sýkingar af völdum sýkla og sníkjudýra berkjubólga, sýking í efri hluta öndunarvegar, skútabólga, þvagfærasýking, inflúensa lungnabólga, sýking í öndunarvegi, blöðrubólga, sýking í eyra, sýking í hálskirtlum sýking í auga, naglsveppir, húðbeðsbólga, maurahúðbólga (acarodermatitis)
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets paliperidone
Icelandic: INVEGA 3 mg forðatöflur INVEGA 6 mg forðatöflur INVEGA 9 mg forðatöflur INVEGA 12 mg forðatöflur paliperidon
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in 2% of subjects.
Icelandic: Greint var frá aukaverkunum, sem gætu bent til hækkunar á prólaktíngildum (t.d. tíðateppa, mjólkurflæði, truflun á tíðablæðingum, brjóstastækkun hjá körlum), hjá alls 2% einstaklinga.
English: Both studies included subjects who received INVEGA either as monotherapy or in combination with mood stabilisers and/or antidepressants.
Icelandic: INVEGA ýmist sem einlyfjameðferð eða til viðbótar við geðsveiflulyf og/eða þunglyndislyf.
English: What you need to know before you take INVEGA
Icelandic: Áður en byrjað er að nota INVEGA
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Icelandic: Engrar skammtaaðlögunar er þörf hjá sjúklingum með vægt til í meðallagi skerta lifrarstarfsemi.
English: 30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
Icelandic: 30 forðatöflur - EU/1/07/395/063 350 forðatöflur - EU/1/07/395/064
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products.
Icelandic: Í tengslum við inntöku forðalyfja í lyfjaformum, sem ekki leysast upp, hefur verið greint frá mjög sjaldgæfum tilvikum um teppueinkenni hjá sjúklingum með þekktar þrengingar.
English: The ADRs that appeared to be dose-related included headache, sedation/somnolence, parkinsonism, akathisia, tachycardia, dystonia, dizziness, tremor, upper respiratory tract infection, dyspepsia, and musculoskeletal pain.
Icelandic: Aukaverkanir, sem virtust vera skammtaháðar, voru höfuðverkur, slæving/svefnhöfgi, parkinsonsheilkenni, hvíldaróþol, hraðsláttur, vöðvaspennutruflun, sundl, skjálfti, sýking í efri hluta öndunarvegar, meltingartruflanir og verkir frá stoðvef og stoðkerfi.
English: Neuroleptic malignant syndrome
Icelandic: INVEGA samhliða geðörvunarlyfjum
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti INVEGA og pakkningastærðir
English: 30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Icelandic: 30 forðatöflur - EU/1/07/395/061 350 forðatöflur - EU/1/07/395/062
English: General disorders pyrexia, asthenia, fatigue face oedema, oedema e, chills, body temperature increased, gait abnormal, thirst, chest pain, chest discomfort, malaise hypothermia c, body temperature decreased c, drug withdrawal syndrome induration
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað sótthiti, þróttleysi, þreyta andlitsbjúgur, bjúgur e, kuldahrollur, hækkaður líkamshiti, óeðlilegt göngulag, þorsti, brjóstverkur, óþægindi fyrir brjósti, lasleiki lágur líkamshiti lækkaður líkamshiti c,
English: Immune system disorders anaphylactic reaction,
Icelandic: Ónæmiskerfi bráðaofnæmisviðbrögð, ofnæmi
English: However, there was no discernable effect of age in the population pharmacokinetic analysis involving schizophrenia subjects after correction of age-related decreases in CrCl.
Icelandic: Hins vegar hafði aldur engin greinileg áhrif í þýðisgreiningunni á lyfjahvörfum, þar sem var um að ræða sjúklinga með geðklofa, að teknu tilliti til aldurstengdrar minnkunar CrCl.
English: Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Icelandic: á PANSS-mælikvarðanum frá grunnlínu í rannsóknum R076477-SCA-3001 og R076477-SCA-3002:
English: Class effects
Icelandic: Flokkstengd áhrif
English: depression, anxiety sleep disorder,
Icelandic: Geðræn vandamál: átröskun í svefni
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis), abnormal posture
Icelandic: • niðurbrot vöðvaþráða og vöðvaverkir (rákvöðvalýsa), óeðlileg líkamsstaða
English: 9/L) should discontinue INVEGA and have their WBC followed until recovery.
Icelandic: 9/l), þangað til hvítfrumnafjöldi er orðinn eðlilegur á ný.
English: Psychiatric disorders: sleep-related eating disorder Nervous system disorders: cerebrovascular disorder Eye disorders: floppy iris syndrome (intraoperative) Respiratory, thoracic and mediastinal disorders: rales
Icelandic: Augu: heilkenni spennuleysis í lithimnu (í aðgerð) (Intraoperative Floppy Iris Syndrome (IFIS))
English: 30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
Icelandic: 30 forðatöflur - EU/1/07/395/059 350 forðatöflur - EU/1/07/395/060
English: Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”
Icelandic: Þriggja laga, bleikar, hylkislaga töflur, sem eru 11 mm langar og 5 mm í þvermál og með áletruninni „PAL 9“.
English: Prolonged-release tablet
Icelandic: Úthreinsun paliperidons eftir inntöku
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets
Icelandic: INVEGA 3 mg forðatöflur INVEGA 6 mg forðatöflur INVEGA 9 mg forðatöflur INVEGA 12 mg forðatöflur
English: The safety and efficacy of INVEGA in the treatment of schizophrenia in adolescents between 12 and 14 years old has not been established.
Icelandic: INVEGA meðferðar við geðklofa hjá unglingum á aldrinum 12-14 ára.
English: • development of breasts in men, enlargement of the glands in your breasts, discharge from the breasts, vaginal discharge
Icelandic: • brjóstamyndun hjá körlum, stækkun kirtla í brjóstum, útferð úr brjóstum, útferð úr leggöngum
English: Cerebrovascular adverse reactions
Icelandic: Síðkomnar ranghreyfingar/utanstrýtueinkenni
English: Refer to ‘Hyperprolactinaemia' below.
Icelandic: Sjá upplýsingar um „prólaktínhækkun í blóði“ hér að neðan.
English: • shortness of breath, wheezing, nosebleeds
Icelandic: • mæði, hvæsandi öndun, blóðnasir
English: The effects of this medicine may be affected if you are taking medicines that affect the speed of movement in the gut (e.g., metoclopramide).
Icelandic: Notkun lyfja sem hafa áhrif á hraða þarmahreyfinga (t.d. metoclopramid) getur haft áhrif á virkni þessa lyfs.
English: Hyperglycemia and diabetes mellitus
Icelandic: Blóðsykurshækkun og sykursýki
English: 98 prolonged-release tablets - EU/1/07/395/030 - WHITE
Icelandic: - GEGNSÆJAR 30 forðatöflur - EU/1/07/395/017
English: 14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
Icelandic: 14 forðatöflur - EU/1/07/395/070 28 forðatöflur - EU/1/07/395/045 49 forðatöflur - EU/1/07/395/046 56 forðatöflur - EU/1/07/395/047 98 forðatöflur - EU/1/07/395/048
English: An antiemetic effect was observed in preclinical studies with paliperidone.
Icelandic: Í forklínískum rannsóknum á paliperidoni sáust uppsöluhemjandi áhrif.
English: Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only) Polyethylene Oxide 7000K Ferric Oxide (Red) (E172)
Icelandic: Bútýlhýdroxýtólúen (E321) Járnoxíð (gult) (E172) (einungis 3 mg og 12 mg töflur)
English: The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 mL/min).
Icelandic: Meðaltalsgildi lokahelmingunartíma brotthvarfs paliperidons var 24 klst. hjá sjúklingum með vægt skerta nýrnastarfsemi, 40 klst. hjá sjúklingum með í meðallagi skerta nýrnastarfsemi og 51 klst.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Icelandic: Hins vegar er hugsanlegt að aldraðir sjúklingar með vitglöp, sem fá meðferð með svipuðum lyfjum, séu í aukinni hættu á að fá heilablóðfall eða deyja (sjá kafla 4 Hugsanlegar aukaverkanir).
English: Respiratory, thoracic and mediastinal disorders pharyngolarynge al pain, cough, nasal congestion dyspnoea, wheezing, epistaxis sleep apnoea syndrome, hyperventilation, pneumonia aspiration, respiratory tract congestion, dysphonia pulmonary congestion
Icelandic: Öndunarfæri, brjósthol og miðmæti verkir í koki og barka, hósti, nefstífla andnauð, hvæsandi öndun, blóðnasir kæfisvefn, oföndun, lungnabólga vegna ásvelgingar, teppa og bólga í öndunarvegi, raddtruflun blóðsókn í lungum (pulmonary congestion)
English: Coated tablet core:
Icelandic: *Hópurinn sem fékk miðlungsskammt:
English: 14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE
Icelandic: 14 forðatöflur - EU/1/07/395/075 - HVÍTAR 28 forðatöflur - EU/1/07/395/036 - HVÍTAR 30 forðatöflur - EU/1/07/395/037 - HVÍTAR 49 forðatöflur - EU/1/07/395/038 - HVÍTAR 56 forðatöflur - EU/1/07/395/039 - HVÍTAR 98 forðatöflur - EU/1/07/395/040 - HVÍTAR
English: Overall mortality
Icelandic: Heildarhætta á dauðsföllum
English: 14 prolonged-release tablets - EU/1/07/395/067 28 prolonged-release tablets - EU/1/07/395/041 49 prolonged-release tablets - EU/1/07/395/042 56 prolonged-release tablets - EU/1/07/395/043 98 prolonged-release tablets - EU/1/07/395/044
Icelandic: 14 forðatöflur - EU/1/07/395/067 28 forðatöflur - EU/1/07/395/041 49 forðatöflur - EU/1/07/395/042 56 forðatöflur - EU/1/07/395/043 98 forðatöflur - EU/1/07/395/044
English: Schizophrenia
Icelandic: • skjálfti
English: 14 prolonged-release tablets - EU/1/07/395/076 28 prolonged-release tablets - EU/1/07/395/053 49 prolonged-release tablets - EU/1/07/395/054 56 prolonged-release tablets - EU/1/07/395/055 98 prolonged-release tablets - EU/1/07/395/056
Icelandic: 14 forðatöflur - EU/1/07/395/076 28 forðatöflur - EU/1/07/395/053 49 forðatöflur - EU/1/07/395/054 56 forðatöflur - EU/1/07/395/055 98 forðatöflur - EU/1/07/395/056
English: • chest pain, chest discomfort, feeling unwell
Icelandic: verkur fyrir brjósti, ónot fyrir brjósti, vanlíðan
English: 14 prolonged-release tablets - EU/1/07/395/066 - WHITE 28 prolonged-release tablets - EU/1/07/395/021 - WHITE 30 prolonged-release tablets - EU/1/07/395/022 - WHITE 49 prolonged-release tablets - EU/1/07/395/023 - WHITE 56 prolonged-release tablets - EU/1/07/395/024 - WHITE 98 prolonged-release tablets - EU/1/07/395/025 - WHITE
Icelandic: 14 forðatöflur - EU/1/07/395/066 - HVÍTAR 28 forðatöflur - EU/1/07/395/021 - HVÍTAR 30 forðatöflur - EU/1/07/395/022 - HVÍTAR 49 forðatöflur - EU/1/07/395/023 - HVÍTAR 56 forðatöflur - EU/1/07/395/024 - HVÍTAR 98 forðatöflur - EU/1/07/395/025
English: Skin and subcutaneous tissue disorders pruritus, rash urticaria, alopecia, eczema, acne angioedema, drug eruption c, hyperkeratosis, dry skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff
Icelandic: Húð og undirhúð kláði, útbrot ofsakláði, hárlos, exem, þrymlabólur ofsabjúgur, lyfjaútbrot c, siggmein, húðþurrkur, hörundsroði, litarbreytingar í húð, flösuexem, flasa
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Iron oxide (black) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Icelandic: Bútýlhýdroxýtólúen (E321) Pólýetýlenoxíð 7000K Járnoxíð (rautt) (E172) Járnoxíð (svart) (E172) Hýdroxýetýlsellulósi Pólýetýlenglýkól 3350
English: 14 prolonged-release tablets - EU/1/07/395/072 - WHITE 28 prolonged-release tablets - EU/1/07/395/031 - WHITE 30 prolonged-release tablets - EU/1/07/395/032 - WHITE 49 prolonged-release tablets - EU/1/07/395/033 - WHITE 56 prolonged-release tablets - EU/1/07/395/034 - WHITE 98 prolonged-release tablets - EU/1/07/395/035 - WHITE
Icelandic: 14 forðatöflur - EU/1/07/395/072 - HVÍTAR 28 forðatöflur - EU/1/07/395/031 - HVÍTAR 30 forðatöflur - EU/1/07/395/032 - HVÍTAR 49 forðatöflur - EU/1/07/395/033 - HVÍTAR 56 forðatöflur - EU/1/07/395/034 - HVÍTAR 98 forðatöflur - EU/1/07/395/035 - HVÍTAR
English: 14 prolonged-release tablets - EU/1/07/395/065 - CLEAR 28 prolonged-release tablets - EU/1/07/395/001 - CLEAR 30 prolonged-release tablets - EU/1/07/395/002 - CLEAR 49 prolonged-release tablets - EU/1/07/395/003 - CLEAR 56 prolonged-release tablets - EU/1/07/395/004 - CLEAR 98 prolonged-release tablets - EU/1/07/395/005 - CLEAR
Icelandic: 14 forðatöflur - EU/1/07/395/065 - GEGNSÆJAR 28 forðatöflur - EU/1/07/395/001 - GEGNSÆJAR 30 forðatöflur - EU/1/07/395/002 - GEGNSÆJAR 49 forðatöflur - EU/1/07/395/003 - GEGNSÆJAR 56 forðatöflur - EU/1/07/395/004 - GEGNSÆJAR 98 forðatöflur - EU/1/07/395/005
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including INVEGA, should be considered.
Icelandic: Komi fram einkenni síðkominna ranghreyfinga skal íhuga að hætta allri meðferð með geðrofslyfjum, þ.m.t. INVEGA.
English: 14 prolonged-release tablets - EU/1/07/395/068 - CLEAR 28 prolonged-release tablets - EU/1/07/395/006 - CLEAR 30 prolonged-release tablets - EU/1/07/395/007 - CLEAR 49 prolonged-release tablets - EU/1/07/395/008 - CLEAR 56 prolonged-release tablets - EU/1/07/395/009 - CLEAR 98 prolonged-release tablets - EU/1/07/395/010 - CLEAR
Icelandic: 14 forðatöflur - EU/1/07/395/068 - GEGNSÆJAR 28 forðatöflur - EU/1/07/395/006 - GEGNSÆJAR 30 forðatöflur - EU/1/07/395/007 - GEGNSÆJAR 49 forðatöflur - EU/1/07/395/008 - GEGNSÆJAR 56 forðatöflur - EU/1/07/395/009 - GEGNSÆJAR 98 forðatöflur - EU/1/07/395/010