FrancophonIA/ELRC3.0 huggingface dataset:
English: For other doses vials with 2 or 4 mg somatropin are available.
Icelandic: Hægt er að fá hettuglös með 2 eða 4 mg af sómatrópíni fyrir aðra skammta.
English: Somatropin Biopartners is a powder and solvent for prolonged-release suspension for injection.
Icelandic: Somatropin Biopartners er stungulyfsstofn og leysir, forðadreifa.
English: There is no relevant use of Somatropin Biopartners 4 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Icelandic: Notkun Somatropin Biopartners 4 mg á ekki við hjá börnum til langtímameðferðar við vaxtarbresti vegna ónógrar seytingar innræns vaxtarhormóns.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
Icelandic: Eitt hettuglas veitir 2 mg af sómatrópíni* (sem jafngildir 6 a.e.).
English: The vial contains an overfill of somatropin powder to allow the withdrawal of up to 2 mg (0.2 mL suspension) of somatropin when reconstituted.
Icelandic: Hettuglasið er fullt af sómatrópín stofni sem gefur allt að 2 mg (0,2 ml dreifa) af sómatrópíni við blöndun.
English: One powder vial delivers 20 mg of somatropin (60 IU).
Icelandic: Eitt hettuglas með stofni veitir 20 mg af sómatrópíni (60 a.e.).
English: There is no relevant use of Somatropin Biopartners 7 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Icelandic: Notkun Somatropin Biopartners 7 mg á ekki við hjá börnum til langtímameðferðar við vaxtarbresti vegna ónógrar seytingar innræns vaxtarhormóns.
English: - Somatropin Biopartners 10 mg: 10 mg (30 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Icelandic: - Somatropin Biopartners 10 mg:10 mg (30 a.e.) sómatrópín sem stofn í hettuglasi úr gleri sem lokað er með gúmmítappa (bútýl) og ljósgrænu afrífanlegu loki (ál og plast) og 1,5 ml leysir (miðlungskeðju þríglýseríð) í hettuglasi úr gleri með gúmmítappa (bútýl).
English: Immune system disorders Common: Formation of antibodies against growth hormone
Icelandic: Myndun mótefna gegn vaxtarhormónum
English: Pack size of 4 vials of powder and 4 vials of solvent.
Icelandic: Pakkningastærð með 4 hettuglösum með stofni og 4 hettuglösum með leysi.
English: Somatropin Biopartners 2 mg should be reconstituted with 0.4 mL solvent.
Icelandic: Somatropin Biopartners 2 mg skal blanda við 0,4 ml af leysi.
English: After preparation, 0.5 mL of suspension contains 10 mg somatropin (20 mg/mL).
Icelandic: Eftir blöndun innihalda 0,5 ml af dreifu 10 mg af sómatrópíni (20 mg/ml).
English: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Icelandic: Bráð ofskömmtun gæti leitt til blóðsykursfalls til að byrja með og síðan til hás blóðsykurs.
English: Common: Haematuria, increased blood uric acid, increased blood creatinine Reproductive system and breast disorders
Icelandic: Blóðmiga, hækkun þvagsýru í blóði, hækkun kreatíníns í blóði
English: Paediatric patients with endocrine disorders, including GHD, may develop slipped capital femoral epiphyses more frequently.
Icelandic: Börn með innkirtlaraskanir, m.a. vaxtarhormónsskort, kunna að fá oftar kastlos í lærleggshöfði.
English: Skin and subcutaneous tissue disorders Common: pigmentation disorder (1.1%)
Icelandic: Uppköst (1,1%), kviðverkir (1,1%)
English: Somatropin may induce insulin resistance.
Icelandic: Sómatrópín getur aukið insúlínþol.
English: One powder vial delivers 4 mg of somatropin (12 IU).
Icelandic: Eitt hettuglas með stofni veitir 4 mg af sómatrópíni (12 a.e.).
English: After preparation, 0.7 mL of suspension contains 7 mg somatropin (10 mg/mL).
Icelandic: Eftir blöndun innihalda 0,7 ml af dreifu 7 mg af sómatrópíni (10 mg/ml).
English: If you use more Somatropin Biopartners than you should
Icelandic: Ef notaður er stærri skammtur Somatropin Biopartners en mælt er fyrir um
English: After reconstitution, 0.4 mL of suspension contains 4 mg (10 mg/mL).
Icelandic: Eftir blöndun innihalda 0,4 ml af dreifu 4 mg (10 mg/ml).
English: General disorders and administration site conditions Very common: injection site swelling (30.8%)
Icelandic: Þroti á stungustað (30,8%)
English: After reconstitution, 0.2 mL of suspension contains 2 mg (10 mg/mL).
Icelandic: Eftir blöndun innihalda 0,2 ml af dreifu 2 mg (10 mg/ml).
English: There is no relevant use of Somatropin Biopartners 2 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Icelandic: Notkun Somatropin Biopartners 2 mg á ekki við hjá börnum til langtímameðferðar við vaxtarbresti vegna ónógrar seytingar innræns vaxtarhormóns.
English: Special populations
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI
English: Somatropin Biopartners 10 mg should be reconstituted with 0.7 mL solvent.
Icelandic: Somatropin Biopartners 10 mg skal blanda við 0,7 ml af leysi.
English: Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Icelandic: Sómatrópín örvar umbrot fitu; það eykur fitusýrur og HDL kólesteról í blóðvökva, en dregur úr heildarkólesteróli í blóðvökva.
English: The appropriate volume should be withdrawn in a sterile syringe via a sterile 26-gauge needle: The vial should be turned upside down, with the syringe in, and the tip of the needle should be placed in the suspension which is then slowly withdrawn.
Icelandic: Snúa skal hettuglasinu á hvolf með sprautuna í því þannig að oddur nálarinnar sé í dreifunni en hann er svo dreginn hægt upp.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/002 4 vials of powder and 4 vials of solvent
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/849/002 4 hettuglös með stofni og 4 hettuglös með leysi
English: INFORMATION IN BRAILLE Somatropin Biopartners 20 mg
Icelandic: TEXI Á YTRI UMBÚÐUM SOMATROPIN BIOPARTNERS 20 MG
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous.
Icelandic: Vatnsfrítt natríum tvívetnisfosfat Vatnsfrítt tvínatríum fosfat.
English: After preparation, 0.4 mL of suspension contains 4 mg somatropin (10 mg/mL).
Icelandic: Eftir blöndun innihalda 0,4 ml af dreifu 4 mg af sómatrópíni (10 mg/ml).
English: Sodium hyaluronate
Icelandic: Fyrir fullorðna sómatrópín
English: INFORMATION IN BRAILLE Somatropin Biopartners 4 mg
Icelandic: MEÐ BLINDRALETRI Somatropin Biopartners 4 mg
English: After accidental intramuscular injection, hypoglycaemia may occur.
Icelandic: Í kjölfar inndælingar í vöðva fyrir slysni kann að verða vart við blóðsykursfall.
English: Powder and solvent for prolonged-release suspension for injection 20 mg powder in a vial and 1.5 mL solvent in a vial 1 vial of 20 mg powder
Icelandic: 20 mg af stofni í hettuglasi og af 1,5 ml leysi í hettuglasi 1 hettuglas með 20 mg af stofni 1 hettuglas með 1,5 ml af leysi 4 hettuglös með 20 mg af stofni 4 hettuglös með 1,5 ml af leysi
English: Somatropin Biopartners 10 mg powder for prolonged-release suspension for injection.
Icelandic: Somatropin Biopartners 10 mg stungulyfsstofn, forðadreifa.
English: Eye disorders Common: Conjunctivitis, visual acuity reduced
Icelandic: Sýkingar af völdum sýkla og sníkjudýra
English: It is recommended to monitor thyroid function following an overdose.
Icelandic: Mælt er með því að hafa eftirlit með skjaldkirtilsstarfsemi í kjölfar ofskömmtunar.
English: After preparation, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Icelandic: Eftir blöndun innihalda 0,2 ml af dreifu 2 mg af sómatrópíni (10 mg/ml).
English: Each vial of powder delivers 20 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Icelandic: Hvert hettuglas með stofni veitir 20 mg af sómatrópíni; hvert hettuglas með leysi inniheldur 1,5 ml af vökva.
English: Conversion from required dose to injection volume and vial strength Somatropin dose vials and solvent required for preparation of
Icelandic: Umreikningur nauðsynlegs skammts yfir í inndælingarrúmmál og styrk hettuglass Sómatrópín
English: Somatropin Biopartners 7 mg powder for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 7 mg stungulyfsstofn, forðadreifa sómatrópín s.c.
English: Holding the needle against the inside vial wall, the entire contents of the syringe should be injected into the powder vial.
Icelandic: Halda skal nálinni að innra borði hettuglassins og sprauta innihaldi sprautunnar í heild í hettuglasið með stofninum.
English: General disorders and administration site conditions Very common: Oedema peripheral, oedema (local and generalised)* Common: Fatigue, pain, asthenia, face oedema, local swelling, oedema, thirst, malaise, chest pain, increased weight, injection site pain
Icelandic: Útlimabjúgur, bjúgur (staðbundinn og almennur)* Algengar: Þreyta, verkur, þrottleysi, bjúgur í andliti, staðbundinn þroti, bjúgur, þorsti, vanlíðan, verkur fyrir brjósti, þyngdaraukning, verkur á stungustað
English: The solvent vial should be warmed to room temperature and the powder vial should be tapped and shaken to ensure the powder is moving freely.
Icelandic: Hettuglasið með leysinum skal hita að stofuhita og slá skal í hettuglasið með stofninum og hrista það til að tryggja að stofninn dreifist um í því.
English: Female (not on oral oestrogen)
Icelandic: Kvenkyns (ekki á estrógeni til inntöku) 2 mg (6 a.e.) Kvenkyns (á estrógeni til inntöku)
English: Skin and subcutaneous tissue disorders Common: Swelling face, acne, allergic dermatitis, hyperhidrosis, urticaria, rash
Icelandic: Þroti í andliti, þrymlabólur, ofnæmishúðbólga, mikil svitamyndun, ofsakláði, útbrot
English: The vial should be turned upside down, with the syringe in and the tip of the needle should be placed in the solvent.
Icelandic: Snúa skal hettuglasinu á hvolf með sprautuna í því þannig að oddur nálarinnar sé í leysinum.
English: INFORMATION IN BRAILLE Somatropin Biopartners 10 mg
Icelandic: TEXI Á YTRI UMBÚÐUM SOMATROPIN BIOPARTNERS 10 MG
English: INFORMATION IN BRAILLE Somatropin Biopartners 2 mg
Icelandic: MEÐ BLINDRALETRI Somatropin Biopartners 2 mg
English: Vascular disorders Rare: hypertension*
Icelandic: Góðkynja innankúpuháþrýstingur*
English: To remove any bubbles, the syringe should be tapped gently.
Icelandic: Til þess að fjarlægja loftbólur skal slá varlega í sprautuna.
English: Somatropin Biopartners 4 mg powder for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 4 mg stungulyfsstofn og leysir, forðadreifa sómatrópín
English: Somatropin Biopartners is indicated in children and adolescents aged 2 to 18 years for long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Icelandic: 12 til 18 ára til langtímameðferðar við vaxtarhormónsskorti vegna ónógrar seytingar innræns vaxtarhormóns.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/001 4 vials of powder and 4 vials of solvent
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/849/001 4 hettuglös með stofni og 4 hettuglös með leysi
English: Each vial of powder delivers 7 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Icelandic: Hvert hettuglas með stofni veitir 7 mg af sómatrópíni; hvert hettuglas með leysi inniheldur 1,5 ml af vökva.
English: Common: Paraesthesia, hypoaesthesia, carpal tunnel syndrome, dizziness, somnolence Rare: Benign intracranial hypertension*
Icelandic: Náladofi, skert snertiskyn, úlnliðsgangaheilkenni, sundl, svefnhöfgi Mjög sjaldgæfar:
English: Excessive glucocorticoid therapy will inhibit the growth-promoting effect of hGH.
Icelandic: Of mikil sykursterameðferð hamlar vaxtarörvandi áhrifum vaxtarhormóns manna.
English: Each vial of powder delivers 2 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Icelandic: Hvert hettuglas með stofni veitir 2 mg af sómatrópíni; hvert hettuglas með leysi inniheldur 1,5 ml af vökva.
English: After reconstitution: From a microbiological point of view, the product must be used immediately.
Icelandic: Frá örverufræðilegu sjónarmiði þarf að nota lyfið tafarlaust.
English: Common: Decreased or increased white blood cell count, increased glycosylated haemoglobin, decreased haemoglobin
Icelandic: Fækkun eða fjölgun hvítra blóðkorna, hækkun glýkósýleraðs blóðrauða, lækkun blóðrauða,
English: Somatropin Biopartners 20 mg powder for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 20 mg stungulyfsstofn, forðadreifa sómatrópín s.c.
English: Benign intracranial hypertension
Icelandic: Góðkynja innankúpuháþrýstingur
English: Common: Hyperbilirubinaemia, cholecystitis, liver test abnormal Skin and subcutaneous tissue disorders
Icelandic: Gallrauðadreyri, gallblöðrubólga, óeðlileg lifrarpróf
English: Each vial of powder delivers 10 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Icelandic: Hvert hettuglas með stofni veitir 10 mg af sómatrópíni; hvert hettuglas með leysi inniheldur 1,5 ml af vökva.
English: Malignancies
Icelandic: Hryggskekkja
English: For dosage instruction, see table below.
Icelandic: Sjá leiðbeiningar um skömmtun á töflunni hér á eftir.
English: Insert the needle straight through the centre of the vial's rubber stopper into the suspension.
Icelandic: Stinga skal nálinni beint gegnum miðju gúmmítappa hettuglassins í dreifuna.
English: Somatropin Biopartners 2 mg powder for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 2 mg stungulyfsstofn og leysir, forðadreifa sómatrópín
English: The amino acid sequence of the active substance is identical to that of hGH of pituitary origin.
Icelandic: Sómatrópín hlutinn í lyfinu er fjölpeptíðahormón upprunnið úr raðbrigða DNA.
English: - Somatropin Biopartners 7 mg: 7 mg (21 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-blue flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Icelandic: 7 mg (21 a.e.) sómatrópín sem stofn í hettuglasi úr gleri sem lokað er með gúmmítappa (bútýl) og ljósbláu afrífanlegu loki (ál og plast) og 1,5 ml leysir (miðlungskeðju þríglýseríð) í hettuglasi úr gleri með gúmmítappa (bútýl).
English: Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 20 mg stungulyfsstofn og leysir, forðadreifa sómatrópín
English: Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection somatropin
Icelandic: Somatropin Biopartners 10 mg stungulyfsstofn og leysir, forðadreifa sómatrópín
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-blue flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og ljósbláu afrífanlegu loki (ál og plast).
English: Each vial of powder delivers 4 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Icelandic: Hvert hettuglas með stofni veitir 4 mg af sómatrópíni; hvert hettuglas með leysi inniheldur 1,5 ml af vökva.
English: Gastrointestinal disorders
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og gulu afrífanlegu loki (ál og plast).
English: - Somatropin Biopartners 20 mg: 20 mg (60 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Icelandic: 20 mg (60 a.e.) sómatrópín sem stofn í hettuglasi úr gleri sem lokað er með gúmmítappa (bútýl) og grænu afrífanlegu loki (ál og plast) og 1,5 ml leysir (miðlungskeðju þríglýseríð) í hettuglasi úr gleri með gúmmítappa (bútýl).
English: Because hGH may induce a state of insulin resistance, an adjustment of the insulin dose may be required.
Icelandic: Þar sem vaxtarhormón manna kann að valda insúlínþoli getur reynst þörf á því að aðlaga skammtinn af insúlíni.
English: What is in this leaflet
Icelandic: Til notkunar undir húð
English: Solvent: Vial (Type I glass) closed with a rubber stopper (butyl) and a flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og afrífanlegu loki (ál og plast).
English: NAME OF THE MEDICINAL PRODUCT
Icelandic: Í rannsóknum á eiturverkunum
English: - Somatropin Biopartners 2 mg: 2 mg (6 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in a glass vial with a rubber stopper (butyl).
Icelandic: 2 mg (6 a.e.) sómatrópín sem stofn í hettuglasi úr gleri sem lokað er með gúmmítappa (bútýl) og gulu afrífanlegu loki (ál og plast) og 1,5 ml leysir (miðlungskeðju þríglýseríð) í hettuglasi úr gleri með gúmmítappa (bútýl).
English: What you need to know before you use Somatropin Biopartners
Icelandic: Áður en byrjað er að nota Somatropin Biopartners
English: 4 vials of 1.5 mL solvent
Icelandic: 4 hettuglös með 4 mg af stofni 4 hettuglös með 1,5 ml af leysi
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og bleiku afrífanlegu loki (ál og plast).
English: 4 vials of powder and 4 vials of solvent.
Icelandic: 4 hettuglös með stofni og 4 hettuglös með leysi.
English: Common: Nausea
Icelandic: Illkynja mein
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og grænu afrífanlegu loki (ál og plast).
English: Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection
Icelandic: Somatropin Biopartners 20 mg stungulyfsstofn og leysir, forðadreifa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF POWDER 20 MG
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 20 mg (60 a.e.)
English: 1 vial of powder and 1 vial of solvent.
Icelandic: 1 hettuglös með stofni og 1 hettuglös með leysi.
English: Psychiatric disorders Common: Insomnia
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic).
Icelandic: Hettuglas (gler af gerð I) sem lokað er með gúmmítappa (bútýl) og ljósgrænu afrífanlegu loki (ál og plast).
English: Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection
Icelandic: Somatropin Biopartners 10 mg stungulyfsstofn og leysir, forðadreifa
English: Somatropin Biopartners is not recommended during pregnancy.
Icelandic: Somatropin Biopartners er ætlað börnum og unglingum á aldrinum
English: Hypothyroidism may develop in patients with central subclinical hypothyroidism after initiating therapy with growth hormone.
Icelandic: Vanstarfsemi skjaldkirtils getur þróast eftir að meðferð með vaxtarhormóni er hafin hjá sjúklingum með miðlæga vanstarfsemi skjaldkirtils án sýnilegra einkenna.
English: Pack size of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 4 mg (12 a.e.)
English: Lot
Icelandic: Kyn
English: Very common: Headache
Icelandic: Mjög algengar:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF POWDER 10 MG
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 10 mg (30 a.e.)
English: 10 bottles
Icelandic: 10 flöskur
English: Strength Pharmaceutical Form Route of Administration
Icelandic: Styrkur Lyfjaform
English: EU Number
Icelandic: EMEA verkefnisnúmer
English: Tell your doctor immediately if you:
Icelandic: Segðu lækninum samstundis frá því ef þú:
English: It is also recommended to alternate between left and right sides (see below).
Icelandic: Einnig er mælt með að skipta á milli vinstri og hægri hliðar (sjá hér fyrir neðan).
English: This list is indicative and not exhaustive.
Icelandic: Þessi listi er leiðbeinandi en ekki tæmandi.
English: It is important not to miss your scheduled dose.
Icelandic: Mikilvægt er að þú missir ekki úr áætlaðan skammt.
English: Your doctor will tell you when you need your next injection.
Icelandic: Læknirinn segir þér hvenær þú þarft að fá næstu lyfjagjöf.
English: Day 1
Icelandic: Dagur 1
English: Immediate medical treatment may be needed.
Icelandic: Þú gætir þarfnast læknismeðferðar tafarlaust.
English: Select the appropriate needle.
Icelandic: Veljið viðeigandi nál.
English: B-2340 Beerse Belgium
Icelandic: B-2340 Beerse Belgía
English: Weight should be monitored regularly.
Icelandic: Fylgjast skal reglulega með þyngd.
English: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg)
Icelandic: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
English: Elderly Efficacy and safety in elderly > 65 years have not been established.
Icelandic: Aldraðir Verkun og öryggi hjá öldruðum > 65 ára hefur ekki verið staðfest.
English: Dosing adjustments were only allowed in the first 12 weeks of the maintenance period.
Icelandic: Breytingar á skömmtunum voru aðeins leyfðar á fyrstu 12 vikum viðhaldstímabilsins.
English: Xeplion can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Icelandic: Xeplion getur hjálpað til við að draga úr einkennum sjúkdómsins og komið í veg fyrir að einkennin komi til baka.
English: It must not be administered by any other route.
Icelandic: Ekki má gefa það með öðrum leiðum.
English: Children and adolescents This medicine is not for people who are under 18 years old.
Icelandic: Lyfið er ekki fyrir einstaklinga undir 18 ára aldri.
English: For that reason, it is important to discuss with your doctor any of the following conditions which can potentially worsen during treatment with this medicine:
Icelandic: Þess vegna er mikilvægt að ræða við lækninn um alla eftirfarandi sjúkdóma, sem geta hugsanlega versnað við meðferð með lyfinu:
English: This medicine is administered by your doctor or other health care professional.
Icelandic: Lyfið er gefið af lækni eða öðrum heilbrigðisstarfsmanni.
English: Significant weight gain may adversely affect your health.
Icelandic: Umtalsverð þyngdaraukning getur haft slæm áhrif á heilsuna.
English: Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Icelandic: Mjög algengar aukaverkanir: geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum • erfiðleikar við að sofna eða svefnörðugleikar.
English: This is called priapism.
Icelandic: Þetta er kallað sístaða reðurs.
English: Functioning was evaluated using the Personal and Social Performance (PSP) scale.
Icelandic: Virkni var metin með PSP-mælikvarðanum (Personal and Social Performance).
English: • are a man and experience prolonged or painful erection.
Icelandic: • ert karlmaður og færð langa og sársaukafulla standpínu.
English: Missed monthly maintenance dose (> 6 months)
Icelandic: Mánaðarlegum viðhaldsskammti sleppt (> 6 mánuðir)
English: Schizophrenia is a disease with “positive” and “negative” symptoms.
Icelandic: Geðklofi er sjúkdómur með „jákvæð“ og „neikvæð“ einkenni.
English: Your doctor should regularly measure your body weight.
Icelandic: Læknirinn ætti að fylgjast reglulega með líkamsþyngd þinni.
English: Caution is recommended if paliperidone is used in such patients.
Icelandic: Gæta skal varúðar ef paliperidon er notað handa slíkum sjúklingum.
English: • decreased oxygen in parts of your body (because of decreased blood flow)
Icelandic: • minna súrefni í sumum líkamshlutum (vegna minnkaðs blóðflæðis)