FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term administration of somatropin to growth hormone deficient patients with osteopenia results in an increase in bone mineral content and density at weight-bearing sites.
Icelandic: Þegar sómatrópín er gefið til langframa sjúklingum með skort á vaxtarhormóni og beinrýrnun, veldur það aukningu á steinefnainnihaldi beina og þéttni á álagspunktum.
English: Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn Omnitrope 10 mg/1,5 ml stungulyf, lausn
English: Injecting Omnitrope
Icelandic: Omnitrope
English: However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Icelandic: Hins vegar bendir ekkert til þess að nýgengi hvítblæðis sé aukið hjá þeim sem fá vaxtarhormón og eru án áhættuþátta.
English: In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
Icelandic: Hjá sjúklingum með Prader-Willi heilkenni á meðferð ávallt að vera í tengslum við hitaeiningasnautt fæði.
English: 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
Icelandic: 0,025-0,035 mg/kg líkamsþyngdar á dag eða 0,7-1,0 mg/m2 líkamsyfirborðs á dag.
English: After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) for a maximum of 28 days.
Icelandic: Eftir fyrstu notkun á rörlykjan að verða eftir í sprautupennanum og verður að geyma hann í kæli (2°C - 8°C) að hámarki 28 daga.
English: Children with chronic renal (kidney) insufficiency:
Icelandic: Börn með langvinna nýrnabilun:
English: A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively.
Icelandic: 5 mg skammtur af Omnitrope 15 mg/1,5 ml stungulyfi, lausn, gefinn heilbrigðum einstaklingi undir húð leiðir til gildanna Cmax 52 ± 19 µg/l og tmax 3,7 ± 1,2 klst.
English: However, after subcutaneous administration of Omnitrope 15 mg/1.5 ml solution for injection, a half life of 2.76 hours is achieved.
Icelandic: Eftir gjöf á Omnitrope 15 mg/1,5 ml stungulyfi, lausn undir húð er helmingunartíminn hins vegar 2,76 klst.
English: Clean the injection site with an alcohol swab and administer Omnitrope by subcutaneous injection.
Icelandic: Hreinsið stungustað með þurrku vættri alkóhóli og gefið Omnitrope með inndælingu undir húð.
English: Adults - Replacement therapy in adults with pronounced growth hormone deficiency.
Icelandic: - Uppbótarmeðferð hjá fullorðnum með áberandi skort á vaxtarhormóni.
English: Pack sizes of 1, 5 and 10.
Icelandic: Pakkningastærðir með 1,5 og 10 rörlykjum.
English: Inject the solvent slowly.
Icelandic: Sprautið leysinum hægt í hettuglasið.
English: - Hold the syringe with the needle in the vial pointing up and remove the syringe from the vial.
Icelandic: - Haldið sprautunni þannig að nálin í hettuglasinu bendi upp og takið sprautuna úr hettuglasinu.
English: - Push the needle through the rubber stopper of the vial with the reconstituted solution.
Icelandic: - Stingið nálinni gegnum gúmmítappann á hettuglasinu með blandaðri lausninni.
English: After reconstitution, one cartridge contains 5 mg somatropin (corresponding to 15 IU) per ml.
Icelandic: Eftir blöndun inniheldur ein rörlykja 5 mg sómatrópín (sem jafngildir 15 a.e.) á ml.
English: - The residual solution, vials, and injection materials intended for single use must be discarded.
Icelandic: - Farga verður afgangslausn, hettuglösum og inndælingarefni sem er einnota.
English: Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá færri en 1 af hverjum 100 sjúklingum) eru meðal annars:
English: A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively.
Icelandic: 5 mg skammtur af Omnitrope 5 mg/1,5 ml stungulyfi, lausn, gefinn heilbrigðum einstaklingi undir húð leiðir til gildanna Cmax 72 ± 28 µg/l og tmax 4,0 ± 2,0 klst.
English: Leukaemia†
Icelandic: Hvítblæði†
English: After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml.
Icelandic: Eftir blöndun inniheldur eitt hettuglas 1,3 mg sómatrópín* (sem jafngildir 4 a.e.) á ml.
English: Replacement therapy in adults with growth hormone deficiency System Organ
Icelandic: Uppbótarmeðferð hjá fullorðnum með skort á vaxtarhormóni Flokkun eftir líffærum
English: A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively.
Icelandic: 5 mg skammtur af Omnitrope 10 mg/1,5 ml stungulyfi, lausn, gefinn heilbrigðum einstaklingi undir húð leiðir til gildanna Cmax 74 ± 22 µg/l og tmax 3,9 ± 1,2 klst.
English: After reconstitution, one vial contains 5 mg somatropin* (corresponding to 15 IU) per ml.
Icelandic: Eftir blöndun inniheldur eitt hettuglas 5 mg sómatrópín* (sem jafngildir 15 a.e.) á ml.
English: Flip off the plastic protective cap from the vial.
Icelandic: Rífið plasthlífðarhettuna af hettuglasinu.
English: In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Icelandic: á öðru æxli hjá sjúklingum sem lifðu af krabbamein í bernsku og voru meðhöndlaðir með sómatrópíni eftir fyrsta æxlið.
English: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Icelandic: 0,045-0,050 mg/kg líkamsþyngdar á dag eða 1,4 mg/m2 líkamsyfirborðs á dag.
English: Uncommo n ≥ 1/1,000 to < 1/100
Icelandic: Algengar ≥ 1/100 til
English: In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Icelandic: Í rannsóknum með Omnitrope á meðalbráðum eituráhrifum og því hvernig lyfið þolist staðbundið hefur ekki orðið vart við nein áhrif sem hafa klínískt vægi.
English: However, after subcutaneous administration of Omnitrope 5 mg/ml powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Icelandic: Eftir gjöf á Omnitrope 5 mg/ml stungulyfsstofni og leysi, lausn undir húð er helmingunartíminn 3 klst.
English: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
Icelandic: 0,035 mg/kg líkamsþyngdar á dag eða 1,0 mg/m2 líkamsyfirborðs á dag.
English: Indication mg/kg body weight dose per day mg/m² body surface area dose per day
Icelandic: Dagsskammtur miðað við mg/m2 líkamsyfirborðs
English: After reconstitution, one vial contains 1.3 mg somatropin (corresponding to 4 IU) per ml.
Icelandic: Eftir blöndun inniheldur eitt hettuglas 1,3 mg af sómatrópíni (sem jafngildir 4 a.e.) á ml.
English: In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
Icelandic: Hjá sjúklingum með miklar líkur á viðvarandi skorti vaxtarhormóns, þ.e. af meðfæddum ástæðum eða skort vaxtarhormóns sem fylgikvilla undirstúku-heiladingulssjúkdóms eða áverka, telst insúlínlíkur vaxtarþáttur-I (IGF-I)
English: Omnitrope is a clear and colourless solution for injection.
Icelandic: Omnitrope er tært og litlaust stungulyf, lausn
English: Leukaemia
Icelandic: Taugakerfi
English: Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Icelandic: Omnitrope 10 mg/1,5 ml í rörlykju fyrir SurePal 10 er ætlað til notkunar í fleiri en eitt skipti.
English: Powder: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
Icelandic: Stofn: glýcín tvínatríum hýdrógen fosfat heptahýdrat natríum tvíhýdrógen fosfat tvíhýdrat
English: Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Icelandic: Stofn: glýcín, tvínatríum hýdrógen fosfat heptahýdrat, natríum tvíhýdrógen fosfat tvíhýdrat Leysir: vatn fyrir stungulyf
English: Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into SurePal following the instructions for use provided with the pen.
Icelandic: Setjið rörlykjuna inn í SurePal og fylgið notkunarleiðbeiningum sem fylgja pennanum.
English: Clinical trials in children with chronic renal insufficiency Table 3
Icelandic: Klínískar rannsóknir á börnum með skort á vaxtarhormóni Tafla 1
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.
Icelandic: Önnur innihaldsefni: tvínatríum hýdrógen fosfat heptahýdrat, natríum tvíhýdrógen fosfat tvíhýdrat, mannítól, poloxamer 188, benzýl alkóhól, vatn fyrir stungulyf.
English: Long-term treatment of children with growth disturbance due to insufficient secretion of growth hormone
Icelandic: Langtímameðferð á börnum með vaxtartruflun vegna ónógrar seytingar á vaxtarhormóni
English: One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
Icelandic: Ein rörlykja inniheldur 1,5 ml sem jafngildir 15 mg sómatrópín (45 a.e.).
English: Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Icelandic: Omnitrope 10 mg/1,5 ml stungulyf, lausn tvínatríum hýdrógen fosfat heptahýdrat natríum tvíhýdrógen fosfat tvíhýdrat glýsín poloxamer 188 fenól vatn fyrir stungulyf
English: What Omnitrope 10 mg/1.5 ml contains
Icelandic: Omnitrope 10 mg/1,5 ml inniheldur
English: 5 cartridges for SurePal 5 10 cartridges for SurePal 5
Icelandic: Stungulyf, lausn 1 rörlykja fyrir SurePal 5 5 rörlykjur fyrir SurePal 5 10 rörlykjur fyrir SurePal 5
English: and injection needle (e.g. 0.25 mm x 8 mm) for subcutaneous injection (not supplied in the pack).
Icelandic: - dauðhreinsaða, einnota sprautu af réttri stærð (t.d. 1 ml sprautu) og nál til inndælingar (t.d. 0,25 mm x 8 mm) til inndælingar undir húð (fylgja ekki með í pakkanum).
English: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
Icelandic: - Vaxtartruflun vegna ónógrar seytingar vaxtarhormóns (skorts á vaxtarhormóni).
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Icelandic: Omnitrope 15 mg/1,5 ml í rörlykju fyrir SurePal 15 er ætlað til notkunar í fleiri en eitt skipti.
English: Paraesthesia* Benign intracranial hypertension
Icelandic: Náladofi* Góðkynja innankúpuþ rýstingur
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Icelandic: Algengar aukaverkanir (geta komið fyrir hjá færri en 1 af hverjum 10 sjúklingum) eru meðal annars:
English: A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is recommended.
Icelandic: Ráðlagður skammtur er 0,045 - 0,050 mg/kg líkamsþyngdar á dag eða 1,4 mg/m2 líkamsyfirborðs á dag.
English: Omnitrope 15 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Icelandic: Omnitrope 15 mg/1,5 ml stungulyf, lausn tvínatríum hýdrógen fosfat heptahýdrat natríum tvíhýdrógen fosfat tvíhýdrat natríum klóríð poloxamer 188 fenól vatn fyrir stungulyf
English: Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Icelandic: Omnitrope 10 mg/1,5 ml stungulyf, lausn, er sæfð lausn, tilbúin til notkunar fyrir inndælingu undir húð, í rörlykju úr gleri.
English: Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Icelandic: Hormón framhluta heiladinguls og hliðstæður þeirra, ATC flokkur:
English: Somatropin stimulates the turnover of skeletal bone.
Icelandic: Sómatrópín örvar umbrot beina í beinagrind.
English: Omnitrope 5 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn tvínatríum hýdrógen fosfat heptahýdrat natríum tvíhýdrógen fosfat tvíhýdrat mannítól poloxamer 188 benzýl alkóhól vatn fyrir stungulyf
English: Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only.
Icelandic: Omnitrope 10 mg/1,5 ml stungulyf, lausn er aðeins ætlað til notkunar í SurePal 10.
English: Excipient(s) with known effect: One ml contains 9 mg benzyl alcohol.
Icelandic: Einn ml inniheldur 9 mg benzýl alkóhól.
English: Long-term treatment of children with growth disturbance due to chronic renal insufficiency System Organ
Icelandic: Langtímameðferð á börnum með vaxtartruflun vegna ónógrar seytingar á vaxtarhormóni Flokkun eftir líffærum
English: All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed as early as possible and treated aggressively.
Icelandic: Fylgjast á með merkjum um öndunarfærasýkingar hjá sjúklingum og þarf að greina þær eins fljótt og auðið er og meðhöndla þær af harðfylgi.
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Icelandic: Ein rörlykja inniheldur 1,5 ml sem jafngildir 5 mg sómatrópín (15 a.e.).
English: Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Icelandic: Bráð ofskömmtun getur í fyrstu valdið blóðsykurslækkun og síðar blóðsykurshækkun.
English: - Take the needle off the pen using the outer needle cap, and discard the needle.
Icelandic: - Takið nálina af pennanum með ytri nálarhlíf og fargið nálinni.
English: In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be observed.
Icelandic: Þegar sómatrópín er gefið sjúklingum með skort á vaxtarhormóni, veldur það yfirleitt lækkun á LDL og apólípópróteini B í sermi.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Icelandic: Önnur innihaldsefni: tvínatríum hýdrógen fosfat heptahýdrat, natríum tvíhýdrógen fosfat tvíhýdrat, glýsín, poloxamer 188, fenól, vatn fyrir stungulyf.
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Icelandic: Omnitrope 5 mg/1,5 ml í rörlykju fyrir SurePal 5 er ætlað til notkunar í fleiri en eitt skipti.
English: Musculoskeleta l stiffness*
Icelandic: Liðverkur* Vöðvaverk ur*
English: The clinical significance of this is unknown.
Icelandic: Ekki er vitað um klínískt vægi þessa.
English: INFORMATION IN BRAILLE Omnitrope 5 mg/ml
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Omnitrope 5 mg/ml
English: Replacement therapy in adults with growth hormone deficiency
Icelandic: Klínískar rannsóknir á fullorðnum með skort á vaxtarhormóni
English: What Omnitrope 15 mg/1.5 ml contains
Icelandic: Omnitrope 15 mg/1,5 ml inniheldur
English: Omnitrope 10 mg/1.5 ml is intended for multiple use.
Icelandic: Omnitrope 10 mg/1,5 ml er ætlað til notkunar í fleiri en eitt skipti.
English: • After the first injection, the cartridge should remain in the pen injector and has to be stored in a refrigerator (2°C-8°C) and only used for a maximum of 28 days.
Icelandic: Eftir fyrstu inndælingu á rörlykjan að verða eftir í inndælingarpennanum og á að geyma hann í kæli (2°C-8°C) og nota aðeins í hámark 28 daga.
English: Omnitrope is intended for subcutaneous use.
Icelandic: Omnitrope er ætlað til notkunar undir húð.
English: The top of the vials should be wiped with an antiseptic solution to prevent contamination of the contents.
Icelandic: Strjúkið ofan af hettuglösunum með sótthreinsilausn til þess að koma í veg fyrir að innihald mengist.
English: What Omnitrope 5 mg/1.5 ml contains
Icelandic: Omnitrope 5 mg/1,5 ml inniheldur
English: Reporting of suspected adverse reactions
Icelandic: Tilkynnt hefur verið um aukna hættu
English: Push the needle fitted to the syringe through the rubber membrane.
Icelandic: Stingið nálinni sem fest er á sprautuna gegnum gúmmíhimnuna.
English: Patients limping during treatment with somatropin should be examined clinically.
Icelandic: Gera á klíníska skoðun á sjúklingum sem haltra meðan á meðferð með sómatrópíni stendur.
English: Omnitrope 5 mg/1.5 ml solution for injection:
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn:
English: Omnitrope 15 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Icelandic: Omnitrope 15 mg/1,5 ml stungulyf, lausn, er sæfð lausn, tilbúin til notkunar fyrir inndælingu undir húð, í rörlykju úr gleri.
English: However, after subcutaneous administration of Omnitrope powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Icelandic: Omnitrope stungulyfsstofni og leysi, lausn undir húð er helmingunartíminn 3 klst.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Icelandic: Önnur innihaldsefni: tvínatríum hýdrógen fosfat heptahýdrat, natríum tvíhýdrógen fosfat tvíhýdrat, natríum klóríð, poloxamer 188, fenól, vatn fyrir stungulyf.
English: INFORMATION IN BRAILLE Omnitrope 1.3 mg/ml
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Omnitrope 1,3 mg/ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT CARTRIDGE LABEL
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
Icelandic: Hver ml af lausn inniheldur 10 mg af sómatrópíni (sem jafngildir 30 a.e.) Ein rörlykja inniheldur 15 mg (sem jafngildir 45 a.e.) af sómatrópíni á 1,5 ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS OMNITROPE VIAL LABEL
Icelandic: Mæling á skammtinum af Omnitrope sem sprauta á
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Icelandic: MARKAÐSLEYFISNÚMER EU/1/06/332/013
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Icelandic: Omnitrope 10 mg/1,5 ml stungulyf, lausn EU/1/06/332/007
English: Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn, er sæfð lausn, tilbúin til notkunar fyrir inndælingu undir húð, í rörlykju úr gleri.
English: - Select the site of injection.
Icelandic: - Veljið stungustað.
English: • Store and transport refrigerated (2°C-8°C).
Icelandic: Geymið við (2°C-8°C) (í kæli).
English: Arthralgia* Myalgia* Musculoskeletal stiffness*
Icelandic: Liðverkur* Vöðvaverkur* Stirðleiki í stoðkerfi*
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Icelandic: Omnitrope 10 mg/1,5 ml stungulyf, lausn EU/1/06/332/016
English: It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Icelandic: Það á aðeins að gefa með Omnitrope Pen 5, inndælingarbúnaðinum sem sérstaklega er hannaður til notkunar með Omnitrope 5 mg/1,5 ml stungulyfi, lausn.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Icelandic: MARKAÐSLEYFISNÚMER EU/1/06/332/016
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum, hjúkrunarfræðingnum eða lyfjafræðingi.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/06/332/010
English: Type 2 diabetes mellitus
Icelandic: Notkun annarra lyfja samhliða
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/06/332/007
English: The reconstituted solution should be administered using sterile, disposable syringes.
Icelandic: Blandaða lausnina á að gefa með sæfðum, einnota sprautum.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 1.3 mg/ml powder for solution for injection Somatropin
Icelandic: HEITI LYFS OG ÍKOMULEIÐ Omnitrope 1,3 mg/ml stungulyfsstofn, lausn Sómatrópín s.c.
English: It should only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Icelandic: Það á aðeins að gefa með SurePal 10, inndælingarbúnaðinum sem sérstaklega er hannaður til notkunar með Omnitrope 10 mg/1,5 ml stungulyfi, lausn.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn EU/1/06/332/004
English: Benign intracranial hypertension
Icelandic: Góðkynja innankúpuþrýstingur
English: Measuring the dose of Omnitrope to be injected - Take the sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm).
Icelandic: 1 ml sprautu) og inndælingarnál (t.d. 0,25 mm x 8 mm).
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Omnitrope 10 mg/1,5 ml
English: Omnitrope 5 mg/1.5 ml is intended for multiple use.
Icelandic: Omnitrope 5 mg/1,5 ml er ætlað til notkunar í fleiri en eitt skipti.
English: Clean the site of injection with an alcohol swab.
Icelandic: Hreinsið stungustað með þurrku vættri alkóhóli.
English: It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Icelandic: Það á aðeins að gefa með Omnitrope Pen 10, inndælingarbúnaðinum sem sérstaklega er hannaður til notkunar með Omnitrope 10 mg/1,5 ml stungulyfi, lausn.
English: Omnitrope 5 mg/ml powder and solvent for solution for injection
Icelandic: Omnitrope 5 mg/ml stungulyfsstofn og leysir, lausn
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Icelandic: Vaxtarhormón eykur skipti úr T4 í T3 utan skjaldkirtils sem geta leitt til minnkunar á þéttni T4 og aukningar á þéttni T3 í sermi. Þrátt fyrir að útlæg gildi skjaldkirtilshormóns hafi verið innan samanburðarmarka við heilbrigða einstaklinga kann skjaldvakabrestur að koma fram hjá einstaklingum með forklínískan skjaldvakabrest.
English: Use only with Omnitrope Pen 5.
Icelandic: Omnitrope Pen 5. Lesið fylgiseðilinn fyrir notkun.
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Icelandic: - Önnur innihaldsefni eru: tvínatríum hýdrógen fosfat natríum tvíhýdrógen fosfat natríum klóríð poloxamer 188 fenól vatn fyrir stungulyf
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Icelandic: - Önnur innihaldsefni eru: tvínatríum hýdrógen fosfat natríum tvíhýdrógen fosfat glýsín poloxamer 188 fenól vatn fyrir stungulyf
English: It should only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection.
Icelandic: Það á aðeins að gefa með SurePal 15, inndælingarbúnaðinum sem sérstaklega er hannaður til notkunar með Omnitrope 15 mg/1,5 ml stungulyfi, lausn.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Icelandic: Omnitrope 5 mg/1,5 ml stungulyf, lausn EU/1/06/332/013
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Icelandic: Omnitrope 15 mg/1,5 ml stungulyf, lausn EU/1/06/332/010
English: Medical treatment for your kidney should be continued.
Icelandic: Halda á áfram læknismeðferð vegna nýrnasjúkdómsins.