FrancophonIA/ELRC3.0 huggingface dataset:
English: No patients treated with human serum albumin-paclitaxel nanoparticles and carboplatin experienced Grade 4 peripheral neuropathy.
Icelandic: Enginn sjúklinganna sem fékk meðferð með mannasermisalbúmín-paclitaxel nanóögnum í samsettri meðferð með karbóplatíni fékk úttaugakvilla af gráðu
English: [Teva invented name]+Gemcitabine Gemcitabine arms treatment was administered until disease progression or development of an unacceptable toxicity.
Icelandic: [Teva invented name]+Gemcitabine
English: The uncommon side effects may affect up to 1 in 100 people:
Icelandic: Sjaldgæfar aukaverkanir geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum:
English: Breast-feeding must be discontinued for the duration of therapy.
Icelandic: Hætta verður brjóstagjöf meðan á meðferð stendur.
English: Return to Day 1 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 1 doses
Icelandic: Gefa skal 1. dags skammtastærðir og fylgja því eftir með vaxtarþáttum hvítra blóðkorna EÐA Minnka skammta um eitt stig frá 1. dags skömmtum
English: Dose of Pazenir
Icelandic: Pazenir inniheldur
English: Reduce 1 dose level and follow with WBC Growth Factors OR Reduce doses 2 dose levels from Day 1 doses
Icelandic: Minnka skal skammta um eitt stig og fylgja því eftir með vaxtarþáttum hvítra blóðkorna EÐA Minnka skammta um tvö stig frá 1. dags skömmtum
English: There have been reports of tumour lysis syndrome during treatment with human serum albuminpaclitaxel nanoparticles.
Icelandic: Greint hefur verið frá æxlislýsuheilkenni meðan á meðferð með mannasermisalbúmín-paclitaxel nanóögnum hefur staðið.
English: • Pain in back, bone pain
Icelandic: Verkir í baki, beinverkir
English: Table 4: Dose reductions for haematologic toxicities in patients with non-small cell lung cancer Haematologic Toxicity
Icelandic: Minnkun skammta vegna eiturverkana á blóð hjá sjúklingum með lungnakrabbamein sem ekki er af smáfrumugerð
English: If foaming or clumping occurs, the solution must stand for at least 15 minutes until foam subsides.
Icelandic: Ef froða eða kekkir myndast skal láta lausnina standa í a.m.k.
English: • Pain in a joint or joints
Icelandic: Roði eða þroti á stungustað nálar
English: Gemcitabine Dose
Icelandic: Blöðrusjónudepilsbjúgur2
English: Pazenir contains sodium
Icelandic: Pazenir inniheldur natríum
English: • Nausea, diarrhoea, constipation, sore mouth, loss of appetite
Icelandic: Ógleði, niðurgangur, hægðatregða, særindi í munni, lystarleysi
English: Withhold dose until improves to
Icelandic: Fresta skal skömmtum þar til frumum hefur fjölgað aftur
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as human serum albuminpaclitaxel nanoparticles 260 mg/m2 given as a 30 minute infusion without premedication (N = 229).
Icelandic: Þessi samanburðarrannsókn var gerð á sjúklingum með brjóstakrabbamein með meinvörpum, sem fengu paclitaxel á 3 vikna fresti, ýmist sem uppleyst paclitaxel, 175 mg/m2 gefið sem 3 klst.
English: Breast cancer
Icelandic: Krabbamein í brisi
English: Animal studies with human serum albumin-paclitaxel nanoparticles showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Icelandic: Dýrarannsóknir með mannasermisalbúmín-paclitaxel nanóögnum sýndu óafturkræfar eiturverkanir á æxlunarfæri karldýra í klínískum skömmtum.
English: Pazenir is a white to yellow powder for dispersion for infusion.
Icelandic: Pazenir er hvítur eða gulur innrennslisstofn, ördreifa.
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Icelandic: Frá örverufræðilegu sjónarmiði skal setja lyfið tafarlaust í innrennslispoka, nema sú aðferð sem notuð er við opnun/blöndun/þynningu komi í veg fyrir hættu á örverumengun.
English: For storage conditions after reconstitution, see package leaflet.
Icelandic: Geymsluskilyrði eftir blöndun lyfsins, sjá fylgiseðil.
English: Pazenir is for intravenous use.
Icelandic: Pazenir er til notkunar í bláæð.
English: Nadir ANC <500/mm3 with neutropenic fever > 38°C
Icelandic: 3, daufkyrningafæð með hita > 38°C
English: In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Icelandic: örvar paclitaxel myndun óeðlilegra fylkja eða vöndla örpípla í gegnum frumuhringinn og geislakerfi örpípla á meðan á mítósu stendur.
English: There are insufficient data available to recommend dose modifications of Pazenir in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Icelandic: Pazenir hjá sjúklingum með verulega skerta nýrnastarfsemi eða nýrnasjúkdóm á lokastigi (áætluð kreatínínúthreinsun < 30 ml/mín.
English: Rare: Extravasation
Icelandic: Skalli, útbrot
English: Confirmed complete or partial overall reponse, n 95% Cl (%)
Icelandic: Staðfest heildarsvörun, alger eða að hluta til, n (%) 95% CI pA+G/pG(95% Cl)
English: • Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood, flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells
Icelandic: þruska, alvarleg sýking í blóði sem getur verið af völdum fækkunar hvítra blóðkorna
English: Stability of the reconstituted dispersion in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Icelandic: Sýnt hefur verið fram á efna- og eðlisfræðilegan stöðugleika í 24 klst. við 2°C-8°C, varið gegn ljósi og eftir það í 4 klst.
English: 2D bar code carrying the unique identifier
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: Musculoskeletal and connective tissue disorders
Icelandic: Blóðflagnafæðarpurpuri með segamyndun
English: *Survival [95% CI] (weeks) > 1st-line therapy
Icelandic: *Lifun [95% CI] (vikur) > meðferð sem fyrsti valkostur
English: Uncommon: Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness
Icelandic: Verkur í brjóstholi, þróttleysi í vöðvum, hálsverkir, verkir í nára, vöðvakrampar, verkir í stoðkerfi, verkir í síðu, óþægindi í útlimum, þróttleysi í vöðvum
English: Dose adjustments during treatment of breast cancer
Icelandic: Aðlögun skammtastærðar meðan á meðferð við brjóstakrabbameini stendur
English: Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Icelandic: Fjöltaugakvilli, viðbragðaleysi, hreyfibilun, vanviðbrögð, taugahvot, skyntap, aðsvif, stöðusvimi, taugaverkir, skjálfti
English: In addition, Pazenir is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x
Icelandic: Auk þess er ekki mælt með notkun Pazenir hjá sjúklingum með kirtilkrabbamein í brisi með meinvörpum sem hafa miðlungsmikla eða verulega skerðingu á lifrarstarfsemi (heildarbilirubin > 1,5 föld eðlileg efri mörk og AST ≤ 10 föld eðlileg efri mörk (sjá kafla 5.2).
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Icelandic: Hósti með uppgangi, áreynslumæði, stíflur í ennisholum, minnkuð öndunarhljóð, fleiðruvökvi, ofnæmisnefkvef, hæsi, nefstíflur, nasaþurrkur, önghljóð, lungnasegarek, blóðtappi í lungum vegna segareks
English: • Reduction in the number of platelets in the blood
Icelandic: Fækkun blóðflagna í blóði
English: Common: Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis
Icelandic: Aukin táraseyting, þokusýn, augnþurrkur, glæru- og tárusigg, augnháramissir (madarosis)
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Icelandic: Í síðari rannsókninni var skammtastærðin 300 mg/m2 sem 30 mínútna innrennslislyf hjá
English: Common: Stomatitis, intestinal obstruction, colitis, dry mouth
Icelandic: Munnbólga, garnastífla, ristilbólga, munnþurrkur
English: Pazenir should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Icelandic: Pazenir á að gefa undir eftirliti krabbameinslæknis á deildum sem sérhæfðar eru til gjafar frumudrepandi lyfja.
English: Pancreatic adenocarcinoma
Icelandic: Natríumhýdroxíð
English: Pancreatic adenocarcinoma (Pazenir administered in combination with gemcitabine)
Icelandic: Kirtilfrumukrabbamein í brisi (Pazenir gefið í samsettri meðferð með gemcítabíni)
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer
Icelandic: Minnkun skammta vegna eiturverkana, annarra en á blóð, hjá sjúklingum með lungnakrabbamein sem ekki er af smáfrumugerð
English: • Dizziness
Icelandic: Þokusýn
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of human serum albumin-paclitaxel nanoparticles after > 6 courses of treatment was not evaluated and remains unknown.
Icelandic: Þróun úttaugavandamála eftir meira en 6 meðferðir með mannasermisalbúmín-paclitaxel nanóögnum var ekki metin og er því óþekkt.
English: Fir st
Icelandic: Ελλάδα
English: Uncommon: Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis
Icelandic: Óþægindi í augum, verkir í augum, óeðlileg sjón, minnkuð sjónskerpa, tárubólga, sjóntruflanir, augnkláði, glærubólga Mjög sjaldgæfar:
English: Some settling of the reconstituted dispersion may occur.
Icelandic: ördreifunnar getur sest aftur.
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Icelandic: Óþægindi í augum, verkur í augum, rauð augu, kláði í augum, tvöföld sjón, minnkuð sjón,
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Icelandic: Andnauð, blóðnasir, hósti Algengar: Lungnabólga2, nefstífla Sjaldgæfar:
English: In both study
Icelandic: Hjá sjúklingum
English: Uncommon: Chest discomfort, abnormal gait, swelling, injection site reaction
Icelandic: Óþægindi í brjósti, óeðlilegt göngulag, bólgur, svörun á inndælingarstað
English: Table 12: Overall response rate in randomized non-small cell lung cancer trial (intentto-treat population)
Icelandic: Heildartíðni svörunar í slembiraðaðri rannsókn á lungnakrabbameini sem ekki er af smáfrumugerð (hópurinn sem ætlunin var að fengi meðferð)
English: If foaming or clumping occurs, the dispersion should stand for at least 15 minutes until foam subsides.
Icelandic: Ef froða eða kekkir myndast skal láta ördreifuna standa í a.m.k.
English: Very common: Diarrhoea, vomiting, nausea, constipation Common: Stomatitis, dyspepsia, abdominal pain, dysphagia
Icelandic: Niðurgangur, uppköst, ógleði, hægðatregða Algengar: Munnbólga, meltingartruflanir, kviðverkir, kyngingarerfiðleikar
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine
Icelandic: Mannasermisalbúmín-paclitaxel nanóagnir (125 mg/m2)/ Gemcítabín
English: Powder for dispersion for infusion.
Icelandic: Truflanir á rafleiðslukerfi hjartans (gáttasleglarof).
English: Package leaflet: Information for the user Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Icelandic: Upplýsingar fyrir notanda lyfsins Pazenir 5 mg/ml innrennslisstofn, ördreifa
English: Other medicines and Pazenir
Icelandic: Notkun annarra lyfja samhliða Pazenir
English: • Increased bilirubin in the blood
Icelandic: Gallrauðahækkun í blóði
English: CNS metastases are generally not well controlled by systemic chemotherapy.
Icelandic: Meinvörp í miðtaugakerfi svara venjulega verr krabbameinslyfjameðferð.
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Icelandic: Daufkyrningafæð, blóðleysi, hvítkornafæð, blóðflagnafæð, eitilfrumnafæð, beinmergsbæling
English: • Infection in the urinary tract
Icelandic: Einkenni í meltingarvegi
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Icelandic: Hækkun aspartat amínótransferasa, bílírúbínhækkun í blóði, kreatínínhækkun í blóði
English: Central nervous system metastases
Icelandic: Mannasermisalbú mín-paclitaxel nanóagnir
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Icelandic: Breytingar á skömmtum vegna annarra aukaverkana hjá sjúklingum með kirtilfrumukrabbamein í brisi
English: • Chills
Icelandic: Paclitaxel
English: Grade 3-4
Icelandic: Tafla 3:
English: Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenzalike illness, malaise, lethargy, hyperpyrexia
Icelandic: Bjúgur á útlimum, slímhimnubólgur, verkir, stirðleiki, bjúgur, magnleysi, minnkuð hreyfigeta, verkir fyrir brjósti, flensulík einkenni, lasleiki, svefnhöfgi, sótthiti
English: Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Icelandic: Þegar úttaugavillarnir eru komnir niður í gráðu 0 eða gráðu 1 skal gefa Pazenir aftur, en í minni skömmtum (sjá kafla 4.2).
English: After reconstitution, the reconstituted dispersion in the infusion bag should be used immediately.
Icelandic: Nota skal blönduðu ördreifuna í innrennslispokanum strax eftir blöndun.
English: Based on findings in animals, male and female fertility may be compromised.
Icelandic: Dýrarannsóknir gefa til kynna að lyfið geti dregið úr frjósemi hjá bæði körlum og konum.
English: Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid.
Icelandic: 5 mínútur til að tryggja að duftið blotni nægilega vel.
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Icelandic: Skert vöðvasamhæfing eða lestrarörðugleikar, aukin eða minnkuð táramyndun, missir augnhára
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Icelandic: Skyntaugakvilli, höfuðverkur, bragðskynstruflun, sundl, hreyfitaugakvilli, hreyfiglöp, skyntruflanir, svefndrungi
English: Renal impairment
Icelandic: Aukin táraseyting
English: BATCH NUMBER
Icelandic: Log-rank próf
English: There is no relevant use of human serum albumin-paclitaxel nanoparticles in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Icelandic: Notkun mannasermisalbúmín-paclitaxel nanóagna á ekki við hjá börnum við ábendingunum brjóstakrabbamein með meinvörpum, kirtilfrumukrabbamein í brisi og lungnakrabbamein sem ekki er af smáfrumugerð.
English: Very common: Alopecia, rash Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Icelandic: Naglskemmdir, kláði, húðþurrkur, hörundsroði, litun/aflitun nagla, ofurlitun, nagllos, breytingar á nöglum
English: Platelet count (cells/mm3)
Icelandic: Heildarfjöldi daufkyrninga (frumur/mm3)
English: Common: Hypotension, hypertension
Icelandic: Þróttleysi, magnleysi, hiti
English: Patients who have baseline neutrophil counts <1500 cells/mm
Icelandic: Sjúklingar með daufkyrningafjölda < 1.500 frumur/mm3 í upphafi meðferðar.
English: Do not administer the reconstituted dispersion if particulate matter is observed in the vial.
Icelandic: Ekki liggja fyrir neinar fullnægjandi rannsóknaniðurstöður um notkun paclitaxel á meðgöngu.
English: Discontinue Treatment
Icelandic: FYRNINGARDAGSETNING
English: Common: Interstitial pneumonitis3, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Icelandic: Millivefsbjúgbólga lungna3, andnauð, blóðnasir, verkur í barkakýli og koki, hósti, nefslímubólga, nefrennsli
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Icelandic: Sveppasýking í munni, nefkoksbólga, húðbeðsbólga, áblásturssótt, veirusýking, lungnabólga, sýking við hollegg, sveppasýking, ristill, sýking á inndælingarstað, sýklasótt2, sýklasótt vegna daufkyrningafæðar2
English: D-21465 Reinbek Germany
Icelandic: D-21465 Reinbek Þýskaland
English: The potential risk to humans is unknown.
Icelandic: Ekki er vitað um hugsanlega áhættu hjá mönnum.
English: EU/1/01/173/001 EU/1/01/173/002 EU/1/01/173/003
Icelandic: EU/1/01/173/001/IS EU/1/01/173/002/IS EU/1/01/173/003/IS
English: It is important to continue using the cream.
Icelandic: Mikilvægt er að halda áfram notkun kremsins.
English: Ronda General Mitre, 151 08022 Barcelona Spain.
Icelandic: Ronda General Mitre, 151 08022 Barcelona Spánn.
English: Not all pack sizes may be marketed.
Icelandic: Ekki er víst að allar pakkningastærðir séu á markaði.
English: It may take 8 weeks before you see results.
Icelandic: Það geta liðið 8 vikur þar til árangur kemur í ljós.
English: Patient comfort in various social and work settings was also improved.
Icelandic: Líðan sjúklingsins bæði félagsleg og á vinnustað varð einnig betri.
English: The combined results of these two trials are presented below:
Icelandic: Niðurstöður þessara tveggja rannsókna eru eftirfarandi:
English: No improvement / worse * At end of therapy (Week 24).
Icelandic: Enginn árangur/versnun *Í lok meðferðarinnar (vika 24).
English: Almirall, S.A. Keep out of the sight and reach of children.
Icelandic: Almirall, S.A. Geymið þar sem börn hvorki ná til né sjá.
English: Clear / almost clear
Icelandic: Hárlaus/næstum hárlaus
English: It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.
Icelandic: Það er fáanlegt í 15 g, 30 g og 60 g túpum, en ekki er víst að allar pakkningastærðir séu á markaði.
English: In such cases they normally resolve without discontinuation of Vaniqa.
Icelandic: Í slíkum tilvikum hverfa þær yfirleitt án þess að notkun Vaniqa sé hætt.
English: EU/1/01/173/001-003
Icelandic: EU/1/01/173/001-003/IS
English: Special population Elderly: (> 65 years) no dosage adjustment is necessary.
Icelandic: Sérstakir sjúklingahópar Aldraðir: (> 65 ára) ekki er nauðsynlegt að breyta skömmtum hjá öldruðum.
English: very rare
Icelandic: Mjög sjaldgæfar
English: Cream 15 g 30 g 60 g
Icelandic: Krem 15 g 30 g 60 g
English: Vaniqa is not recommended for use in anyone younger than 18 years of age.
Icelandic: Vaniqa er ekki ráðlagt til notkunar fyrir neinn yngri en 18 ára.
English: • Use twice a day, at least 8 hours apart.
Icelandic: Notið tvisvar á dag, með minnst 8 klst. millibili.
English: Shelf-life after first opening: 6 months.
Icelandic: 3 ár. Geymsluþol eftir fyrstu opnun: 6 mánuðir.
English: Outcome*
Icelandic: Niðurstöður*
English: For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Icelandic: Hjá sjúklingum sem hættu meðferð áður en meðferðartímanum var lokið, voru síðustu athuganirnar gerðar í viku
English: Hands should be washed after applying this medicinal product.
Icelandic: Þvo skal hendur eftir að lyfið hefur verið borið á.
English: • Wash your hands after applying the cream.
Icelandic: Þvoið hendurnar eftir að kremið hefur verið borið á.
English: There are no data available.
Icelandic: Engar upplýsingar liggja fyrir.
English: Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Icelandic: Miðað við það hve lítið eflornitín frásogast frá húð (sjá kafla 5.2), er ofskömmtun mjög ólíkleg.
English: If you stop using it your original hair growth may return within 8 weeks.
Icelandic: Ef þú hættir notkuninni getur upphaflegur hárvöxtur birst á ný á 8 vikum.
English: MedDRA conventions for frequency are 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), or not known (cannot be estimated from the available data) including isolated reports.
Icelandic: MedDRA reglur fyrir tíðni eru: mjög algengar (≥1/10), algengar (≥1/100 til < 1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til 1/1.000), eða koma örsjaldan fyrir (1/10.000), eða tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum) þ.m.t. einangruð tilvik.
English: If you do not see any improvement after using it for 4 months contact your doctor.
Icelandic: Hafi engin framför komið í ljós eftir 4 mánuði hafðu þá samband við lækninn.
English: If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.
Icelandic: Ef Vaniqa kemst í augu, munn eða nef fyrir slysni skal skola vandlega með vatni.
English: The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Vaniqa hjá börnum á aldrinum 0 til 18 ára.
English: Steady state was reached within four days.
Icelandic: Stöðug plasmaþéttni náðist innan fjögurra daga.
English: Almirall, S.A. Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
Icelandic: Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
English: Tel: + 34 93 291 30 00
Icelandic: Sími: + 34 93 291 30 00
English: Subgroup analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
Icelandic: Greining á undirhópum sýndi einnig hjá 29% kvenna sem þjáðust af offitu (BMI ≥ 30) og hjá 43% kvenna í kjörþyngd (BMI < 30) greinilegan eða aukinn bata.
English: Side effects are usually limited to the skin and mild in intensity.
Icelandic: Aukaverkanir takmarkast yfirleitt við húð og eru vægar.
English: If you forget to use Vaniqa
Icelandic: Ef gleymist að nota Vaniqa
English: Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
Icelandic: Athygli er vakin á því að í þessum rannsóknum voru meira en 1350 sjúklingar meðhöndlaðir með Vaniqa í 6-12 mánuði, á meðan rétt rúmlega 200 sjúklingar voru meðhöndlaðir með kremgrunninum í 6 mánuði.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Icelandic: Dýrarannsóknir hafa leitt í ljós eiturverkun á æxlun (sjá kafla 5.3).
English: Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down's Syndrome to a 35 year old).
Icelandic: Eftir þessar 19 þunganir fæddust 9 heilbrigð börn, 5 konur völdu fóstureyðingu, 4 fósturlát urðu og fæðingargalli kom fram hjá einu barni (Downs heilkenni, hjá 35 ára móður).
English: If it persists contact your doctor.
Icelandic: Hafið samband við lækninn ef þetta heldur áfram.
English: Almirall ApS Tel.: +45 70 25 75 75
Icelandic: Almirall ApS Tel./Puh.: +45 70 25 75 75
English: • When using on the face, avoid contact with your eyes or the inside of your nose or mouth.
Icelandic: Þegar kremið er notað á andlit skal forðast snertingu við augu eða inni í nefi og munni.
English: Talk to your doctor if you need to use other medicines on the areas of skin where you are using the cream.
Icelandic: Talið við lækninn ef nota þarf önnur lyf á sama húðsvæði og kremið er notað.
English: The active substance is eflornithine.
Icelandic: Virka innihaldsefnið er eflornitín.