FrancophonIA/ELRC3.0 huggingface dataset:
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > - 1 (i.e. standardised to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account gender and ethnicity) is one of the therapeutic objectives during the transition period.
Danish: Et af de terapeutiske mål i overgangsperioden er vedligeholdelse af normal maksimal knoglemasse, defineret som en T score > -1 (dvs. standardiseret til gennemsnitlig voksen maksimal knoglemasse målt ved Dual Energy X-ray Absorptiometri (DXA), hvor der tages højde for køn og etnisk oprindelse).
English: Excessive glucocorticoid therapy will inhibit the growth-promoting effect of hGH.
Danish: Øget glukokortikoidbehandling vil hæmme den vækstfremmende virkning af hGH.
English: Common: Paraesthesia, hypoaesthesia, carpal tunnel syndrome, dizziness, somnolence Rare: Benign intracranial hypertension*
Danish: Almindelig: Paræstesi, hypæstesi, karpaltunnelsyndrom, svimmelhed, somnolens Sjælden: Benign intrakraniel hypertension*
English: If you use more Somatropin Biopartners than you should, you should consult your doctor.
Danish: Hvis du bruger for meget Somatropin Biopartners, skal du kontakte din læge.
English: After reconstitution the injection should be administered immediately.
Danish: Efter rekonstitution skal injektionen indgives omgående.
English: Rare, may affect up to 1 in 100 people - abnormal sensation such as prickling, tingling and itchiness - high blood pressure
Danish: Sjælden, kan påvirke op til 1 ud af 100 personer - unormal fornemmelse, f.eks. prikken, snurren og kløe - højt blodtryk
English: EXP After reconstitution, use immediately.
Danish: EXP Anvendes straks efter rekonstitution.
English: Common: headache (4.4%), lethargy (1.1%), dizziness (2.6%) Rare: paraesthesia*
Danish: Almindelig: hovedpine (4,4%), letargi (1,1%), svimmelhed (2,6%) Sjælden: Paræstesi*
English: Apply gentle pressure to the injection site with a dry gauze or cotton pad.
Danish: Tryk forsigtigt på injektionsstedet med en tør gaze eller en vattampon.
English: After reconstitution the medicinal product should be used immediately before the suspension settles.
Danish: Efter rekonstitution skal lægemidlet anvendes omgående, inden suspensionen bundfælder sig.
English: Treatment should be discontinued if there is evidence of tumour
Danish: Behandlingen skal seponeres, hvis der opstår tegn på tumorvækst.
English: Patients receiving concomitant glucocorticoid therapy should have their dose carefully adjusted.
Danish: Patienter i samtidig glukokortikoidbehandling bør have deres dosis nøje justeret.
English: Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD).
Danish: Somatropin Biopartners er indiceret til substitutionsbehandling for endogent væksthormon hos voksne med væksthormonmangel (GHD) med debut i barndommen eller i voksenalderen.
English: 2 mg (6 IU)
Danish: 2 mg (6 IE)
English: Animal studies are insufficient with respect to reproductive toxicity (see section
Danish: Data fra dyreforsøg er utilstækkelige hvad angår reproduktionstoksicitet (se pkt 5.3).
English: Metabolism and nutrition disorders Common: Mild hyperglycaemia* Not known: Insulin resistance*
Danish: Almindelig: Mild hyperglykæmi* Ikke kendt: Insulinresistens*
English: Intracranial tumours must be inactive and antitumour therapy must be completed prior to the initiation of growth hormone therapy.
Danish: Intrakranielle tumorer skal være inaktive, og antitumorbehandling skal være afsluttet, før behandling med væksthormon iværksættes.
English: If necessary, your doctor will gradually increase this dose according to your individual response to the treatment and your blood levels of a growth factor called IGF-I.
Danish: Hvis det er nødvendigt, vil din læge gradvist øge dosis i henhold til din individuelle reaktion på behandlingen og niveauerne i blodet af en vækstfaktor kaldet IGF-I. Niveauerne i blodet af IGF-I kræver regelmæssig overvågning, således at de kan holdes inden for det normale område for din alder og dit køn.
English: Common: Back pain, pain in extremities, arthralgia, shoulder pain, musculoskeletal stiffness, bone pain, muscular weakness, sensation of heaviness, tendonitis, joint swelling, arthritis, musculosceletal pain, myalgia*
Danish: Almindelig: Rygsmerter, smerter i ekstremiteter, artralgi, skuldersmerter, muskuloskeletal stivhed, knoglesmerter, muskelsvækkelse, tunghedsfornemmelse, tendonitis, hævelse af led, artritis, muskuloskeletale smerter, myalgi*
English: Inject the entire contents of the syringe into the vial of powder, holding the syringe against the vial wall.
Danish: Injicer hele indholdet af sprøjten i hætteglasset med pulver, og hold sprøjten mod hætteglassets væg.
English: In patients with hypopituitarism receiving thyroxin replacement therapy, hyperpituitarism may develop.
Danish: Hos patienter med nedsat hypofysefunktion, som får thyroxinsubstitutionsbehandling, kan forøget hypofysefunktion udvikles.
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.
Danish: Hætteglasset med solvens skal opvarmes til stuetemperatur, og hætteglasset med pulver skal bankes let og rystes for at sikre, at pulveret bevæger sig frit.
English: Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Solvent: Medium chain triglycerides.
Danish: Solvens: Mellemkædede triglycerider.
English: Immune system disorders Common: Formation of antibodies against growth hormone
Danish: Almindelig: Dannelse af antistoffer mod væksthormonet
English: Any child with the onset of a limp during growth hormone therapy should be evaluated.
Danish: Børn, som halter under væksthormonbehandling, bør evalueres.
English: No clinical studies have been conducted with Somatropin Biopartners in breast-feeding women.
Danish: Der er ikke udført kliniske studier med Somatropin Biopartners hos ammende kvinder.
English: Remove the needle guard and fill the syringe with a volume of air equal to the required volume of the solvent for injection, making it easier to withdraw the solvent:
Danish: Fjern kanylebeskyttelsen og fyld sprøjten med en luftmængde, der er lig med den nødvendige mængde solvens til injektionsvæske, hvilket gør det lettere at udtrække solvensen:
English: Collect the following items before you begin: - supplied in the pack - Somatropin Biopartners vial containing active substance - Somatropin Biopartners vial containing 1.5 mL solvent for suspension for injection - not supplied in the pack - one sterile injection syringe with 19 (19G) or wider Gauge needle to withdraw the solvent - one sterile injection syringe with 26 Gauge (26G) needle for the injection
Danish: Indsaml følgende genstande, før du begynder: - medfølger i pakningen - Somatropin Biopartners hætteglas med aktivt stof - Somatropin Biopartners hætteglas med 1,5 ml solvens til injektionsvæske, suspension - medfølger ikke i pakningen - en steril injektionssprøjte med en 19 (19G) eller bredere kanyle til udtrækning af solvensen - en steril injektionssprøjte med en 26 Gauge (26G) kanyle til injektionen - spritservietter - tør gaze eller vattampon - et hæfteplaster - affaldsbeholder til brugte sprøjter og kanyler
English: For the treatment of children and adolescents aged 2 to 18 years vials with 10 mg and 20 mg somatropin should be used.
Danish: Til behandling af børn og unge i alderen 2-18 år skal der anvendes hætteglas med 10 mg og 20 mg somatropin.
English: Investigations Common: Increased blood phosphorus, increased or decreased IGF
Danish: Almindelig: Øget fosfor i blodet, nedsat eller øget IGF
English: Common: Impaired fasting glucose, hyperlipidaemia, increased blood insulin, increased blood cholesterol, decreased blood sodium, increased blood triglycerides, increased blood glucose, increased or decreased HDL, increased LDL
Danish: Almindelig: Nedsat glukosetolerans, hyperlipidæmi, øget insulin i blodet, øget kolesterol i blodet, nedsat natrium i blodet, øgede triglycerider i blodet, øget glukose i blodet, øget eller nedsat HDL, øget LDL
English: Therefore, if you weigh more than 40 kg the overall injection volume must be divided into equal parts between two injection sites, as more than 1 mL of suspension is required.
Danish: Hvis du vejer over 40 kg, skal den samlede injektionsvolumen derfor deles i lige dele mellem to injektionssteder, da det vil være nødvendigt med mere end 1 ml suspension.
English: Somatropin promotes cellular protein synthesis and nitrogen retention.
Danish: Somatropin fremmer cellernes proteinsyntese og nitrogenretenton.
English: Only stop swirling the vial once the suspension appears uniform, white and all the powder on the bottom is dispersed.
Danish: Hold ikke op med at svinge hætteglasset, før suspensionen ser ensartet ud, er hvid og alt pulveret i bunden er opløst.
English: Tel: +49 (0)7121 948 7756 Fax: +49 (0)7121 346 255 e-mail: info@biopartners.de
Danish: Tlf.: +49 (0)7121 948 7756 Fax: +49 (0)7121 346 255 e-mail: info@biopartners.de
English: Tumours must be inactive and cancer therapy complete before you can start your treatment with growth hormone.
Danish: Svulster skal være inaktive, og du skal have afsluttet kræftbehandlingen, før du starter behandlingen med væksthormon.
English: Remove the needle guard.
Danish: Fjern kanylebeskyttelsen.
English: The adverse reactions most commonly reported were injection site related reactions, peripheral oedema, headache, myalgia, arthralgia, paraesthesia, hypothyroidism and decreased free thyroxine.
Danish: De mest almindelige bivirkninger var reaktioner på injektionsstedet, perifert ødem, hovedpine, myalgi, artralgi, paræstesi, hypothyroidisme og nedsat frit thyroxin.
English: Common: Adrenal insufficiency, decreased free thyroxine, decreased free tri-iodothyronine, increased blood TSH, hypothyroidism*
Danish: Almindelig: Binyreinsufficiens, nedsat frit thyroxin, nedsat frit triiodothyronin, øget TSH i blodet, hypothyroidisme*
English: The syringe should be held upright and gentle pressure applied to the plunger until a small drop of suspension appears at the end of the needle.
Danish: Sprøjten skal holdes opret, og der trykkes let på stemplet, indtil en lille dråbe suspension kommer til syne for enden af kanylen.
English: Vascular disorders Rare: hypertension*
Danish: Sjælden: Hypertension*
English: Somatropin Biopartners is not recommended in women of childbearing potential not using contraception.
Danish: Somatropin Biopartners anbefales ikke til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: The plunger should be pushed up gently, until all bubbles are removed from the syringe and needle.
Danish: Stemplet skal trykkes forsigtigt op, indtil alle bobler er fjernet fra sprøjten og kanylen.
English: In order to reach the defined treatment goal, men may need lower growth hormone doses than women.
Danish: Mænd kan have behov for lavere doser af væksthormon end kvinder for at nå det definerede behandlingsmål.
English: Common, may affect up to 1 in 10 people - virus infection known as Herpes simplex - skin tag (a form of harmless skin growth) - tiredness - weakness, feeling unwell - face swelling - thirst - pain, chest pain, pain at the injection site - pain in the back, arms, legs, shoulders, bones, joints - sleeplessness - decreased sensation, numbness and tingling in fingers and palm of the hand due to squeezed nerve at wrist (carpal tunnel syndrome) - dizziness, sleepiness - muscular or bone stiffness, weakness of the muscles, muscle pain, feeling of heaviness - inflammation of the tendons, joint swelling, joint inflammation - reddening of the eyes, reduced vision, vertigo (a feeling of dizziness or spinning) - increased or irregular heart rate - high blood pressure - nosebleed - nausea - increased level of bilirubin, a substance produced by the liver - inflammation of the gall bladder - acne, increased sweating, skin rash - allergic skin reactions such as redness, irritation, itching - blood in the urine - nipple pain - reduced function of the adrenal gland (which could show as tiredness) - reduced function of the thyroid gland - increased fat levels in the blood - weight gain - development of substances (antibodies) in the blood that bind to growth hormone - changes in blood test results such as a change in the number of white blood cells or increased levels of insulin, sugar, sodium or certain fatty substances in the blood - changes in liver test results - a type of benign brain tumour called craniopharyngioma
Danish: Almindelig, kan påvirke op til 1 ud af 10 personer - virusinfektion kendt som Herpes simplex - hudpapillom (en slags uskadelig hudvækst) - træthed - svækkelse, utilpashed - ansigtshævelse - tørst - smerte, brystsmerte, smerte på injektionsstedet - smerte i ryggen, armene, benene, skuldrene, knoglerne, leddene - søvnløshed - nedsat følesans, følelsesløshed og snurren i fingrene og håndfladen pga. en klemt nerve ved håndleddet (karpaltunnelsyndrom) - svimmelhed, søvnighed - stivhed i muskel eller knogle, muskelsvækkelse, muskelsmerter, tunghedsfornemmelse - senebetændelse, ledhævelse, ledbetændelse - øjenrødme, nedsat syn, vertigo (en følelse af svimmelhed eller at det hele kører rundt) - øget eller uregelmæssig hjertefrekvens - højt blodtryk - næseblødning - kvalme - øget bilirubinniveau, et stof, der produceres af leveren - galdeblærebetændelse - acne, øget svedtendens, hududslæt - allergiske hudreaktioner, f.eks. rødmen, irritation, kløe - blod i urinen - ømme brystvorter - nedsat binyrefunktion (hvilket kan vise sig som træthed) - nedsat skjoldbruskkirtelfunktion - øgede fedtniveauer i blodet - vægtstigning - udvikling af stoffer (antistoffer) i blodet, der binder til væksthormonet - ændringer i blodprøveresultater, f.eks. en ændring i antallet af hvide blodlegemer eller øgede niveauer af insulin, sukker, natrium eller fedtstoffer i blodet - ændringer i leverprøveresultater - en slags godartet hjernetumor kaldet kraniofaryngeom
English: - 0.7 mL in a 1 mL graduated syringe for Somatropin Biopartners 10 mg - 1.2 mL in a 2 mL graduated syringe for Somatropin Biopartners 20 mg
Danish: - 0,7 ml i en 1 ml gradueret sprøjte for Somatropin Biopartners 10 mg - 1,2 ml i en 2 ml gradueret sprøjte for Somatropin Biopartners 20 mg
English: Gently pinch the skin that has been cleaned, to make a fold.
Danish: Klem forsigtigt den rensede hud, så der dannes en fold.
English: Tel: +49 (0) 7121 948 7756 Fax:+49 (0) 7121 346 255 e-mail: info@biopartners.de
Danish: Tlf. +49 (0) 7121 948 7756 Fax.+49 (0) 7121 346 255 e-mail: info@biopartners.de
English: Rare, may affect up to 1 in 1,000 people - symptoms of increased pressure in the skull such as severe and recurrent headache, visual changes, nausea and/or vomiting
Danish: Sjælden, kan påvirke op til 1 ud af 1.000 personer - symptomer på øget tryk i kraniet, f.eks. svær og tilbagevendende hovedpine, synsforstyrrelser,
English: Therefore, in children weighing more than 40 kg the overall injection volume must be divided into equal parts between two injection sites, as more than 1 mL of suspension is required.
Danish: Hos børn, der vejer over 40 kg, skal den samlede injektionsvolumen derfor deles i lige dele mellem to injektionssteder, da det vil være nødvendigt med mere end 1 ml suspension.
English: Do not use Somatropin Biopartners
Danish: Brug ikke Somatropin Biopartners
English: The syringe should be filled with a volume of air equal to the required volume of the solvent for injection and the air injected into the solvent vial to make it easier to withdraw the solvent.
Danish: Sprøjten skal fyldes med en luftmængde, der er lig med den nødvendige mængde solvens til injektionsvæske og luften, der injiceres ind i hætteglasset med solvens, for at gøre det lettere at trække solvensen ud.
English: In children, Somatropin Biopartners should be administered subcutaneously at a concentration of 20 mg/mL.
Danish: Hos børn skal Somatropin Biopartners administreres subkutant ved en koncentration på 20 mg/ml.
English: The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 12-month controlled comparative clinical study in 178 treatment naïve children with growth failure due to insufficient secretion of endogenous growth hormone and in a dose finding study.
Danish: Følgende bivirkninger er observeret under behandling med Somatropin Biopartners i et 12-måneders kontrolleret, komparativt klinisk studie med 178 behandlingsnaive børn med hæmmet vækst på grund af utilstrækkelig udskillelse af endogent væksthormon og i et dosisfindende studie.
English: IGF-I SDS in the range of -1 to +1 and more than 1 SDS increase from Baseline Maintain
Danish: IGF-I SDS i området -1 til +1 og mere end 1 SDS stigning fra baseline
English: IGF-I SDS in the range of -1 to +1 and less than 1SDS increase from Baseline
Danish: IGF-I SDS i området -1 til +1 og mindre end 1 SDS stigning fra baseline
English: IGF-I SDS in the range of +1 to +2
Danish: IGF-I SDS i området +1 til +2
English: IGF-I SDS lower than -1
Danish: IGF-I SDS under -1
English: Paediatric population (below 2 years of age) Somatropin Biopartners should not be used in infants below the age of 2 years.
Danish: Somatropin Biopartners bør ikke anvendes hos spædbørn under 2 år.
English: Important information about some of the ingredients of Somatropin Biopartners
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Somatropin Biopartners
English: Tap and shake the vial of powder to make sure the powder is moving freely.
Danish: Bank hætteglasset med pulver let og ryst det for at sikre, at pulveret bevæger sig frit.
English: Common, may affect up to 1 in 10 people - tiredness or weight gain due to underactive thyroid gland - reduced function of the adrenal gland (which may show as tiredness) - mild blood sugar increase - headache, lethargy (lack of energy), dizziness - vomiting, stomach ache - discoloration of the skin - pain in joints, arms or legs - pain, discoloration, swelling, hardening, reddening or feeling of warmth at the injection site - tissue swelling - fever - changes in blood levels of certain hormones
Danish: Almindelig, kan påvirke op til 1 ud af 10 personertræthed eller vægtstigning pga. en underaktiv skjoldbruskkirtel - nedsat binyrefunktion (hvilket kan vise sig som træthed) - mild stigning i blodsukkeret - hovedpine, letargi (mangel på energi), svimmelhed - opkastning, mavesmerter - misfarvning af huden - smerter i leddene, arme og ben - smerter, misfarvning, hævelse, forhærdning, rødmen eller varmefølelse på injektionsstedet - vævshævelse - feber - ændringer i blodniveauerne af visse hormoner
English: Infections and infestations Common: Herpes simplex
Danish: Almindelig: Herpes simplex
English: Insert the needle through the centre of the rubber stopper of the solvent vial and inject all of the air into the vial.
Danish: Før kanylen gennem midten af gummiproppen på hætteglasset med solvens, og injicer al luften ind i hætteglasset.
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
Danish: Meget almindelig: Perifert ødem, ødem (lokalt og generaliseret)* Almindelig: Træthed, smerter, asteni, ansigtsødem, lokal hævelse, ødem, tørst, utilpashed, brystsmerter, øget vægt, smerte på injektionsstedet
English: Information about self-injection of Somatropin Biopartners
Danish: Information om selvinjektion af Somatropin Biopartners
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: Neoplasm progression (1 case of neoplasm progression in a female patient with a history of neurofibromatosis and radiation treatment), acrochordon, craniopharyngioma
Danish: Almindelig: Progression af neoplasmer (1 tilfælde med progression af neoplasmer hos en kvindelig patient med neurofibromatose og strålebehandling i anamnesen), acrochordon, kraniofaryngiom
English: - 0.4 mL in a 1 mL graduated syringe for Somatropin Biopartners 2 mg - 0.6 mL in a 1 mL graduated syringe for Somatropin Biopartners 4 mg - 0.9 mL in a 1 mL graduated syringe for Somatropin Biopartners 7 mg
Danish: - 0,4 ml i en 1 ml gradueret sprøjte for Somatropin Biopartners 2 mg - 0,6 ml i en 1 ml gradueret sprøjte for Somatropin Biopartners 4 mg - 0,9 ml i en 1 m gradueret sprøjte for Somatropin Biopartners 7 mg
English: The syringe should be filled with the correct volume of the solvent for injection as listed above and the syringe needle withdrawn from the vial subsequently.
Danish: Sprøjten skal fyldes med den korrekte mængde solvens til injektionsvæske som angivet ovenfor, og sprøjtekanylen skal trækkes ud af hætteglasset derefter.
English: The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 6-month controlled clinical study with 151 adult patients with GHD of adult or childhood-onset and in a 6-month extension study.
Danish: Følgende bivirkninger er observeret under behandling med Somatropin Biopartners i et 6-måneders kontrolleret klinisk studie med 151 voksne patienter med GHD med debut i voksenalderen eller barndommen og i et 6-måneders forlængelsesstudie.
English: The maximum retrievable amount of somatropin in one vial of suspension is 20 mg which is sufficient for administration in children of up to 40 kg bodyweight.
Danish: Den maksimale mængde somatropin i et hætteglas er 20 mg, hvilket er tilstrækkeligt til administration hos børn på op til 40 kg legemsvægt.
English: Withdrawing the suspension
Danish: Udtrækning af suspensionen
English: Gently tap the syringe to remove small air bubbles.
Danish: Bank let på sprøjten for at fjerne små luftbobler.
English: Leukaemia
Danish: Leukæmi
English: Common: Decreased or increased white blood cell count, increased glycosylated haemoglobin, decreased haemoglobin
Danish: Almindelig: Nedsat eller øget antal hvide blodlegemer, øget glykosyleret hæmoglobin, nedsat hæmoglobin
English: Apply gentle pressure to the plunger until a small drop of suspension appears at the end of the needle.
Danish: Tryk forsigtigt på stemplet, indtil en lille dråbe suspension kommer til syne for enden af kanylen.
English: Insert the needle straight through the centre of the vial's rubber stopper into the suspension.
Danish: Før kanylen lige ned i midten af hætteglassets gummiprop og ind i suspensionen.
English: Leukaemia has been reported in a small number of GHD patients, some of whom have been treated with somatropin.
Danish: Leukæmi er set hos et lille antal patienter med GHD.
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.
Danish: Somatropin Biopartners er indiceret til børn og unge i alderen 2-18 år til langtidsbehandling af hæmmet vækst på grund af utilstrækkelig udskillelse af endogent væksthormon.
English: Psychiatric disorders Very rare: insomnia*
Danish: Meget sjælden: Insomni
English: Somatropin Biopartners 10 mg is sufficient for use in children up to 20 kg bodyweight.
Danish: Somatropin Biopartners 10 mg er tilstrækkelig til brug til børn op til 20 kg legemsvægt.
English: Cardiac disorders Common: Tachycardia, heart rate abnormal/irregular
Danish: Almindelig: Takykardi, unormal/uregelmæssig hjertefrekvens
English: Somatropin Biopartners should be administered subcutaneously at a concentration of 10 mg/mL.
Danish: Somatropin Biopartners skal administreres subkutant ved en koncentration på 10 mg/ml.
English: Somatropin Biopartners 20 mg is sufficient for use in children up to 40 kg bodyweight.
Danish: Somatropin Biopartners 20 mg er tilstrækkelig til brug til børn op til 40 kg legemsvægt.
English: IGF-I SDS greater than +2
Danish: IGF-I SDS over +2