FrancophonIA/ELRC3.0 huggingface dataset:
English: Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems.
Icelandic: Trobalt getur valdið alvarlegum aukaverkunum, m.a. þvagteppu og geðvandamálum.
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Icelandic: + 44 (0)800 221441 customercontactuk@gsk.com
English: Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Icelandic: Sýnt hefur verið fram á að retigabín truflar klínískar mælingar á bílírúbíni í sermi og þvagi sem getur valdið óeðlilega háum niðurstöðum.
English: Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Icelandic: Á þéttnibilinu 0,1 til 2 míkróg/ml eru um 80% retigabíns bundin plasmapróteinum.
English: INFORMATION IN BRAILLE trobalt 200 mg
Icelandic: trobalt 200 mg
English: Memory impairment
Icelandic: Minnisleysi Málstol
English: Disturbance in attention
Icelandic: Áttavilla Kvíði
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Icelandic: D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ
English: Further, based on pooled data, there were no clinically significant effects of the following antiepileptic medicinal products on retigabine pharmacokinetics: - lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproate.
Icelandic: Að auki, samkvæmt heildargreiningu á niðurstöðum, höfðu eftirtalin flogaveikilyf ekki áhrif af klínískri þýðingu á lyfjahvörf retigabíns: - lamótrigín, levetírasetam, oxkarbazepín, tópíramat, valpróat.
English: This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts.
Icelandic: á hvíldarspennu himnunnar og heldur raförvun í taugafrumum undir þröskuldi, sem hindrar að boðspenna fyrir flogavirkni náist.
English: Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Icelandic: Fjólubláar, kringlóttar, filmuhúðaðar töflur 5,6 mm, merktar „RTG 50“ á annarri hliðinni.
English: Keep out of the sight and reach of children.
Icelandic: Geymið lyfið þar sem börn hvorki ná til né sjá.
English: Study 205 (n=396; n=303)
Icelandic: Rannsókn 205 (n=396; n=303) Heildartíðni hlutafloga (miðgildi) % breyting Svörunartíðni (annar endapunktur)
English: In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis (n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine (100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
Icelandic: Eftir gjöf staks skammts af retigabíni (100 mg), til lækkunar á þéttni retigabíns í plasma um 52% að miðgildi, frá upphafi til loka skilunar.
English: Each tablet contains 50 mg retigabine
Icelandic: Hver tafla inniheldur 50 mg retigabín
English: There were no treatment-related effects of retigabine on fertility in animal studies.
Icelandic: Í dýrarannsóknum komu ekki fram nein áhrif tengd meðferð með retigabíni á frjósemi.
English: • drowsiness
Icelandic: • svefnhöfgi
English: Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Icelandic: Retigabín getur aukið lengd svæfingar af völdum sumra svæfingalyfja (t.d. tíópentalnatríums).
English: Nervous system disorders
Icelandic: Hægðatregða Meltingartruflanir Munnþurrkur
English: INFORMATION IN BRAILLE trobalt 300 mg
Icelandic: trobalt 300 mg
English: Polyvinyl alcohol
Icelandic: Milliverkun við áfengi
English: GROUDS FOR ONE ADDITIONAL RENEWAL
Icelandic: Ástæður fyrir einni endurnýjun markaðsleyfis til viðbótar
English: 400 mg tablets:
Icelandic: 400 mg töflur:
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com
Icelandic: + 357 22 39 70 00 gskcyprus@gsk.com
English: In rats, retigabine increased the sleep time induced by thiopental sodium from approximately 4 min to 53 min, and the propofol-induced sleep time from approximately 8 min to 12 min.
Icelandic: Retigabín lengdi svefntíma hjá rottum, sem framkallaður var með tíópentalnatríum, úr u.þ.b. 4 mín.
English: Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina.
Icelandic: Augnkvillar hafa komið fram við notkun Trobalt, litabreytingar í sjónu þar meðtaldar.
English: Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Icelandic: Grænar, kringlóttar, filmuhúðaðar töflur 7,1 mm, merktar „RTG 100“ á annarri hliðinni.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Icelandic: Trobalt sé áfram jákvætt en telur halda skuli áfram nánu eftirliti með öryggi af eftirfarandi ástæðum:
English: In addition, a single supplemental dose is recommended immediately after haemodialysis.
Icelandic: Auk þess er mælt með stökum viðbótarskammti strax að skilun lokinni.
English: 300 mg tablets:
Icelandic: 300 mg töflur:
English: INFORMATION IN BRAILLE trobalt 400 mg
Icelandic: trobalt 400 mg
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR
English: 200 mg tablets:
Icelandic: 200 mg töflur:
English: Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Icelandic: Gular, ílangar, filmuhúðaðar töflur 7,1 mm x 14 mm, merktar „RTG-200“ á annarri hliðinni.
English: INFORMATION IN BRAILLE trobalt 100 mg
Icelandic: trobalt 100 mg
English: Magnesium stearate
Icelandic: Algengar aukaverkanir
English: Dysphagia
Icelandic: Skammtar
English: Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Icelandic: Trobalt 100 mg filmuhúðaðar töflur eru grænar, kringlóttar og merktar „RTG 100“ á annarri hliðinni.
English: • tremors
Icelandic: • skjálfti
English: Risk related to antiepileptic medicinal products in general Specialist advice should be given to women who are of childbearing potential.
Icelandic: Konum á barneignaraldri skal veita sérfræðiráðgjöf.
English: Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Icelandic: Grænar, ílangar, filmuhúðaðar töflur 7,1 mm x 16 mm, merktar „RTG-300“ á annarri hliðinni.
English: In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance <50 ml/min), relative to healthy volunteers.
Icelandic: 100% hjá sjálfboðaliðum með miðlungs- til verulega skerta nýrnastarfsemi (kreatínínúthreinsun < 50 ml/mín.), samanborið við heilbrigða sjálfboðaliða.
English: Each tablet contains 200 mg retigabine
Icelandic: Hver tafla inniheldur 200 mg retigabín
English: INSTRUCTIONS ON USE
Icelandic: Varúð við notkun
English: 100 mg tablets:
Icelandic: 100 mg töflur:
English: Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Icelandic: Fjólubláar, ílangar, filmuhúðaðar töflur 8,1 mm x 18 mm, merktar „RTG-400“ á annarri hliðinni.
English: GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Icelandic: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Icelandic: Því er ekki líklegt að retigabín hafi hindrandi eða örvandi áhrif á lyfjahvörf hvarfefna helstu cýtókróm-P450-ísóensímanna.
English: Each tablet contains 400 mg retigabine
Icelandic: Hver tafla inniheldur 400 mg retigabín
English: Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Icelandic: Trobalt 300 mg filmuhúðaðar töflur eru grænar, ílangar og merktar „RTG-300“ á annarri hliðinni.
English: Each tablet contains 300 mg retigabine
Icelandic: Hver tafla inniheldur 300 mg retigabín
English: Withdrawal seizures
Icelandic: Pakkningar innihalda
English: Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Icelandic: Aukin hætta getur verið á aukaverkunum í miðtaugakerfi, þvagteppu og gáttatifi, hjá öldruðum sjúklingum.
English: Retigabine and its metabolites are eliminated principally by renal excretion.
Icelandic: Retigabín og umbrotsefni þess hverfa aðallega á brott með útskilnaði um nýru.
English: Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Icelandic: Trobalt 200 mg filmuhúðaðar töflur eru gular, ílangar og merktar „RTG-200“ á annarri hliðinni.
English: In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Icelandic: Til viðbótar við aukaverkanir sem komu fram við ráðlagða skammta, voru einkenni ofskömmtunar með retigabíni m.a. æsingur, árásargirni og pirringur.
English: Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration (see section 4.8).
Icelandic: Greint var frá aukaverkunum, svo sem sundli, svefnhöfga, tvísýni og þokusýn, í klínískum samanburðarrannsóknum, einkum við skammtaaðlögun (sjá kafla 4.8).
English: Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Icelandic: Meðan á klínískum rannsóknum stóð var greint frá ofskömmtun með retigabíni, umfram 2.500 mg/dag.
English: Xanthan gum
Icelandic: Glaxo Wellcome
English: Interaction with anaesthetics
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/011, EU/1/11/681/012
Icelandic: EU/1/11/681/011, EU/1/11/681/012
English: Study 301 (n=305; n=256)
Icelandic: Rannsókn 301 (n=305; n=256) Heildartíðni hlutafloga (miðgildi) % breyting Svörunartíðni
English: Each tablet contains 100 mg retigabine
Icelandic: Hver tafla inniheldur 100 mg retigabín
English: Hepatic impairment
Icelandic: Ruglástand Geðrofskvillar
English: Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Icelandic: Trobalt 400 mg filmuhúðaðar töflur eru fjólubláar, ílangar og merktar „RTG-400“ á annarri hliðinni.
English: Packs containing 21or 84 film-coated tablets.
Icelandic: 21 eða 84 filmuhúðaðar töflur.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Icelandic: Trobalt 50 mg filmuhúðaðar töflur retigabín
English: Croscarmellose sodium
Icelandic: • mikil svitamyndun
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets retigabine
Icelandic: Trobalt 200 mg filmuhúðaðar töflur retigabín
English: Peripheral oedema
Icelandic: Viðauki IV
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets
Icelandic: Trobalt Trobalt 50 mg filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets retigabine
Icelandic: Trobalt 400 mg filmuhúðaðar töflur retigabín
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Icelandic: Trobalt 300 mg filmuhúðaðar töflur retigabín
English: Therefore Trobalt is not recommended during pregnancy.You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
Icelandic: örugga getnaðarvörn til að forðast þungun meðan á meðferð með Trobalt stendur.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Icelandic: Engin sérstök fyrirmæli eru um geymsluaðstæður lyfsins
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of retigabine.
Icelandic: Hver filmuhúðuð tafla inniheldur 200 mg af retigabíni.
English: Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
Icelandic: Trobalt á móti áhættu fyrir barnið ef Tobalt er notað á meðgöngu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine.
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg af retigabíni.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
Icelandic: Trobalt 300 mg filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets
Icelandic: Trobalt 200 mg filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
Icelandic: Trobalt 400 mg filmuhúðaðar töflur
English: There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Icelandic: Engar vísbendingar voru um vansköpunarvaldandi áhrif eftir gjöf retigabíns hjá ungafullum dýrum á líffæramyndunarskeiði.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets retigabine
Icelandic: Trobalt 100 mg filmuhúðaðar töflur retigabín
English: The primary efficacy endpoints were: - percentage change in the 28-day total partial seizure frequency from baseline to the double-blind phase (titration and maintenance phases combined) in all three studies - responder rate (defined as the percentage of patients with a ≥50% reduction in 28-day total partial seizure frequency) from baseline to the maintenance phase (Studies 301 and 302 only).
Icelandic: (skammtaaðlögunar- og viðhaldstímabil sameinuð) í öllum þremur rannsóknum - svörunartíðni (skilgreind sem hlutfall sjúklinga með ≥ 50% lækkun á heildartíðni hlutafloga á
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of retigabine.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg af retigabíni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of retigabine.
Icelandic: Hver filmuhúðuð tafla inniheldur 400 mg af retigabíni.
English: The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
Icelandic: Trobalt á meðan þú ert með barn á brjósti á móti hugsanlegri áhættu fyrir barnið
English: Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
Icelandic: Blóðskilun hefur reynst lækka þéttni retigabíns og NAMR í plasma um u.þ.b.
English: Pregnancy
Icelandic: Tormæli
English: Weight increased Increased appetite
Icelandic: • þyngdaraukning; aukin matarlyst
English: NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets
Icelandic: Trobalt 100 mg filmuhúðaðar töflur
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of retigabine.
Icelandic: Hver filmuhúðuð tafla inniheldur 100 mg af retigabíni.
English: Hypokinesia
Icelandic: Taugakerfi
English: Renal impairment
Icelandic: Sundl Svefnhöfgi
English: Symptoms and signs
Icelandic: Meðganga og brjóstagjöf
English: Urinary retention Nephrolithiasis
Icelandic: Húðútbrot Ofsviti
English: Class
Icelandic: Kyn
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/009, EU/1/11/681/010
Icelandic: EU/1/11/681/009, EU/1/11/681/010
English: Very rare:
Icelandic: Mjög algengar
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172).
Icelandic: Pólývínýlalkóhól Títantvíoxíð (E171) Talkúm (E553b) Álindígókarmín (E132) Gult járnoxíð (E172) Lesitín (SOY) Xantangúmmí
English: Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Icelandic: Athyglisbrestur Truflun á göngulagi Vöðvarykkjakrampi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/681/004, EU/1/11/681/005
Icelandic: EU/1/11/681/004 EU/1/11/681/005
English: ≥ 2.69 RPU** * Antigenic Units as determined in the in vitro potency test (ELISA).
Icelandic: * Mótefnatítri ákvarðaður í samræmi við in vitro styrkleikapróf (ELISA próf) ** Einingar hlutfallslegrar virkni (Relative Potency Units) skilgreind m.t.t. viðmiðunarbóluefnis.
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥ 2828 AU* Mycoplasma hyopneumoniae inactivated
Icelandic: Mycoplasma hyopneumoniae óvirkjuð
English: Withdrawal period
Icelandic: Dýrategund
English: Strength Pharmaceutical Form Route of Administration
Icelandic: Lyfjaform Íkomuleið Umbúðir
English: Package size l t o r
Icelandic: Pakkningastærð i
English: The usual doses are:
Icelandic: Venjulegur skammtur er:
English: Please tell your doctor if you have been diagnosed with cancer.
Icelandic: Segðu lækninum frá því ef þú hefur greinst með krabbamein.
English: The recommended dosage is 100 I.U.
Icelandic: Ráðlagður skammtur er 100 a.e.
English: Treatment should be discontinued once the patient has responded and symptoms have resolved.
Icelandic: Meðferð skal hætt þegar sjúklingurinn hefur svarað meðferðinni og einkennin hafa gengið til baka.
English: In some cases, you doctor might decide to extend your treatment up to 6 months.
Icelandic: Í sumum tilvikum getur verið að læknirinn ákveði að framlengja meðferðina í allt að 6 mánuði.
English: For example, patients who are bed-bound because of a fracture.
Icelandic: Til dæmis sjúklingum sem eru rúmfastir vegna beinbrota.
English: In some cases, it may be given by injection into a vein.
Icelandic: Í sumum tilvikum er það gefið með inndælingu í bláæð.
English: - Treatment of high calcium levels in the blood (hypercalcaemia) due to cancer.
Icelandic: - Meðferð við of miklu kalsíum í blóði (blóðkalsíumhækkun) vegna krabbameins.
English: Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose.
Icelandic: Vegna vísbendinga um aukna hættu á illkynja sjúkdómum og langvarandi notkunar calcitonins (sjá kafla 4.4), skal meðferðartími við öllum ábendingum vera eins stuttur og hægt er og nota skal minnsta virka skammt.
English: The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline.
Icelandic: Fylgjast má með áhrifum calcitonins með því að mæla viðeigandi vísa um enduruppbyggingu beina, svo sem alkalískan fosfatasa í sermi, hýdroxýprolin eða deoxýpyridinolin í þvagi.
English: Your doctor will decide if calcitonin is a suitable treatment for you and for how long you can be treated.
Icelandic: Læknirinn mun ákveða hvort meðferð með calcitonini henti þér og hversu lengi þú megir fá meðferð.
English: Malignancy (with long term use), frequency: common
Icelandic: Illkynja sjúkdómur (við langvarandi notkun), tíðni: algengar
English: Paget's disease is a slowly progressing illness which can cause a change in the size and shape of certain bones.
Icelandic: Pagetssjúkdómur er hægt versnandi sjúkdómur sem getur leitt til breytinga á stærð og lögun ákveðinna beina.
English: Under exceptional circumstances, e.g. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months.
Icelandic: Í undantekningartilvikum, t.d. hjá sjúklingum með yfirvofandi sjúklegt beinbrot, má halda meðferð áfram í allt að 6 mánuði, sem er ráðlagður hámarkstími.
English: Common side effects: Cancer (following long term treatment)
Icelandic: Krabbamein (eftir langvarandi meðferð)
English: For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.
Icelandic: Til meðferðar við Pagetssjúkdómi, eingöngu hjá sjúklingum sem ekki svara annarri meðferð eða sem hentar ekki önnur meðferð, til dæmis þeim sem eru með verulega skerta nýrnastarfsemi.
English: Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations.
Icelandic: Sjúklingar í þessum rannsóknum fengu meðferð með lyfjaformum til inntöku eða til notkunar í nef en hins vegar er líklegt að aukin áhætta eigi einnig við þegar calcitonin er gefið undir húð, í vöðva eða í bláæð, sérstaklega við langvarandi notkun, vegna þess að búist er við að altæk útsetning fyrir calcitonini hjá slíkum sjúklingum sé meiri en við notkun annarra lyfjaforma.
English: The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use.
Icelandic: Ráðlagður meðferðartími er 2 vikur og skal ekki í nokkru tilviki vera lengri en 4 vikur, vegna tengsla milli aukinnar hættu á illkynja sjúkdómum og langvarandi notkunar calcitonins.
English: Your doctor will decide the correct dose and how long you should receive calcitonin treatment depending on your condition.
Icelandic: Með hliðsjón af ástandi þínu mun læknirinn ákveða réttan skammt og hversu lengi þú færð meðferð með calcitonini.
English: - Paget's disease of bone in patients who cannot take other treatments for this condition, for example patients with serious kidney problems.
Icelandic: - Pagetssjúkdómi í beinum hjá sjúklingum sem hentar ekki önnur meðferð við sjúkdómnum, til dæmis sjúklingar með alvarlega nýrnasjúkdóma.
English: Possible side effects [the wording below should be inserted]
Icelandic: Hugsanlegar aukaverkanir [bæta skal við textanum hér að neðan]
English: For prevention of bone loss: 100 IU per day or 50 IU twice daily for 2 to 4 weeks, given into the muscle or the tissue just under the skin.
Icelandic: 100 a.e. á dag eða 50 a.e. tvisvar sinnum á dag í 2 til 4 vikur, gefið í vöðva eða í vefinn rétt undir húðinni.
English: Take special care with <invented name>
Icelandic: Gæta skal sérstakrar varúðar við notkun <sérheiti>
English: For Paget's disease: 100 IU daily injected into a muscle or into the tissue just under the skin, normally for up to 3 months.
Icelandic: 100 a.e. á dag gefið í vöðva eða í vefinn rétt undir húðinni, venjulega í allt að 3 mánuði.
English: These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.
Icelandic: Þessar rannsóknir sýndu að aukning raunáhættu fyrir krabbameini hjá sjúklingum, sem fengu meðferð með calcitonini samanborið við þá sem fengu lyfleysu, var á bilinu 0,7% til 2,4% við langvarandi meðferð.
English: Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section
Icelandic: Íhuga má lotubundna endurmeðferð hjá þessum sjúklingum og taka skal tillit til hugsanlegs ávinnings og tengsla milli aukinnar hættu á illkynja sjúkdómum og langvarandi notkunar calcitonins (sjá kafla 4.4).
English: Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use.
Icelandic: Meðferðin skal venjulega ekki vara lengur en í 3 mánuði vegna vísbendinga um aukinnar hættu á illkynja sjúkdómum og langvarandi notkunar calcitonins.
English: Patient Information Leaflet
Icelandic: Pagetssjúkdómur
English: Analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that calcitonin is associated with a statistically significant increase in the risk of cancer compared to patients treated with placebo.
Icelandic: Greiningar á slembuðum samanburðarrannsóknum sem gerðar voru hjá sjúklingum með slitgigt og beinþynningu, hafa sýnt að calcitonin tengist tölfræðilega marktækt aukinni hættu á krabbameini samanborið við sjúklinga sem fengu lyfleysu.