FrancophonIA/ELRC3.0 huggingface dataset:
English: Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ml.
Danish: Bovin, koncentreret valle med et indhold af specifik immunglobulin-G mod E.coli F5 (K99) adhesin på ≥2.8* log10/ml.
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO UDL.D.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥2.8 log10/ml.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Bovin, koncentreret valle med et indhold af specifik immunglobulin-G mod E.coli F5 (K99) adhesin på ≥ 2.8 log10/ml.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥2.8* log10/ml.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Bovin, koncentreret valle med et indhold af specifik immunglobulin-G mod E.coli F5 (K99) adhesin på ≥2.8* log10/ml.
English: 6.3 Shelf life
Danish: 6.1 Fortegnelse over hjælpestoffer
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Bovine concentrated lactoserum containing specific immunoglobulin G against E. coli F5(K99) adhesin >2.8 log10/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Bovin, koncentreret valle med et indhold af specifik immunglobulin-G mod E.coli F5 (K99) adhesinpå ≥ 2.8 log10/ml.
English: Subsequently, it may increase and become too high.
Danish: Dernæst kan det stige og blive for højt.
English: This usually takes approximately 60 seconds but can take up to 90 seconds.
Danish: Dette tager sædvanligvis ca. 60 sekunder, men kan tage op til 90 sekunder.
English: Contact your doctor if this happens.
Danish: Kontakt din læge, hvis dette sker.
English: Side effects can occur with the following frequencies:
Danish: Bivirkninger kan forekomme med følgende frekvens:
English: Effects were maintained throughout the 6-month follow-up period.
Danish: Virkningen blev opretholdt under hele opfølgningsperioden på 6 måneder.
English: The minimum effective dose should be used.
Danish: Den effektive minimumsdosis bør anvendes.
English: This helps to prevent infection.
Danish: Det hjælper med at forhindre infektion.
English: It is important to use each dose at the scheduled time.
Danish: Det er vigtigt at bruge hver dosis på det fastlagte tidspunkt.
English: White or almost white powder.
Danish: Hvidt eller næsten hvidt pulver.
English: No effect on safety or efficacy was observed.
Danish: Der blev ikke observeret nogen effekt på sikkerhed eller virkning.
English: Treatment is symptomatic and supportive.
Danish: Behandlingen skal være symptomatisk og understøttende.
English: It is indicated in children and adolescents for long-term use.
Danish: Det er indiceret hos børn og unge til langvarig brug.
English: The clinical significance of this is unknown.
Danish: Den kliniske betydning af dette kendes ikke.
English: IGF-I levels should be acted upon, as indicated below.
Danish: IGF-I niveauer skal håndteres som anført herunder.
English: Storage conditions of the unopened product
Danish: Opbevaringsforhold for det uåbnede produkt
English: Once weekly
Danish: En gang ugentligt
English: Injections should always be given on the same day of the week and at the same time of day because it is easier to remember.
Danish: Injektionerne bør altid gives på samme ugedag og på samme tidspunkt af dagen, fordi det er lettere at huske.
English: Your dose should be checked every 6 months by your doctor.
Danish: Din dosis bør kontrolleres hver 6. måned af din læge.
English: Samples should be drawn 4 days after the previous dose (Day 4).
Danish: Prøver skal tages 4 dage efter den foregående dosis (dag 4).
English: figure 3b
Danish: figur 3b
English: It is not known how often this may occur, but if you suspect that this is the case, contact your doctor since the treatment may have to be stopped.
Danish: Det er ukendt, hvor ofte dette forekommer, men hvis du har mistanke om, at det er tilfældet, skal du kontakte din læge, da behandlingen muligvis skal stoppes.
English: Your doctor may decide upon a lower starting dose.
Danish: Din læge kan træffe beslutning om en lavere startdosis.
English: Follow the instructions carefully step by step.
Danish: Følg omhyggeligt instruktionerne punkt for punkt.
English: Dose requirements may decline with increasing age.
Danish: Dosisbehov kan mindskes med stigende alder.
English: The suspension should appear uniform and white.
Danish: Suspensionen skal fremstå ensartet og hvid.
English: Children below 2 years of age
Danish: Børn under 2 år
English: For adults
Danish: Til voksne
English: - If you have had a tumour your doctor will examine you before and regularly during treatment.
Danish: - Hvis du har haft en svulst, vil din læge undersøge dig før og regelmæssigt under behandlingen.
English: There are no data on the use of this medicinal product in pregnant women.
Danish: Der er ingen data fra anvendelse af dette lægemiddel til gravide kvinder.
English: Growth hormone regulates the growth and development of cells.
Danish: Væksthormonet regulerer cellernes vækst og udvikling.
English: Ask your doctor for advice before stopping treatment.
Danish: Spørg din læge til råds, før du stopper behandlingen.
English: Wash your hands thoroughly with soap and water and dry them with a clean towel before preparing your injection.
Danish: Vask hænderne grundigt med sæbe og vand og tør dem med et rent håndklæde, før du tilbereder injektionen.
English: Do not use this medicine if you notice that it cannot be properly mixed.
Danish: Brug ikke dette lægemiddel, hvis du bemærker, at det ikke kan blandes ordentligt.
English: Thyroxine replacement therapy may therefore need to be initiated or adjusted.
Danish: Thyroxinsubstitutionsbehandling skal derfor påbegyndes eller justeres.
English: Number of injections per dose
Danish: Antal injektioner pr. dosis
English: The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Danish: Nøjagtigheden af væksthormondosis bør derfor kontrolleres hver 6. måned.
English: Repeated adjustments in dose may be required, dependent on patients' IGF-I response.
Danish: Det kan være nødvendigt med gentagne dosisjusteringer, afhængigt af patientens IGF-I respons.
English: Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poland
Danish: Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Polen
English: Patients with prior malignancies should be examined routinely for progression or recurrence.
Danish: Patienter med tidligere maligniteter skal undersøges rutinemæssigt for progression eller recidiv.
English: Progression of scoliosis can occur in patients who experience rapid growth.
Danish: Progression af skoliose kan forekomme hos patienter, der oplever hurtig vækst.
English: Remove the carton from the refrigerator.
Danish: Tag kartonen ud af køleskabet.
English: Monitoring during treatment
Danish: Overvågning under behandling
English: It has 191 amino acid residues and a molecular weight of 22,125 Daltons.
Danish: Det har 191 aminosyrerester og en molekylevægt på 22.125 dalton.
English: Individual doses may vary and your doctor will always prescribe the minimum effective dose based on your specific need.
Danish: Individuelle doser kan variere, og din læge vil ordinere den effektive minimumsdosis på grundlag af dit specifikke behov.
English: Oral oestrogen administration increases the dose requirements in women.
Danish: Oral administration af østrogen øger dosisbehovene hos kvinder.
English: Slowly withdraw the required volume of solvent.
Danish: Træk langsomt den nødvendige mængde solvens ud.
English: For children and adolescents (2 to 18 years)
Danish: Til børn og unge (2-18 år)
English: The patient or carer should receive training to ensure understanding of the administration procedure before being allowed to (self-) inject.
Danish: Patienten eller omsorgspersonen skal instrueres, så det sikres, at administrationsproceduren er forstået, inden patienten kan få tilladelse til at (selv) injicere.
English: If you have used too much of this medicine, initially your blood sugar may decrease and become too low.
Danish: Hvis du har brugt for meget af denne medicin, kan dit blodsukker først falde og blive for lavt.
English: Thyroid function should therefore be closely monitored in all patients.
Danish: Thyroideafunktionen bør derfor nøje monitoreres hos alle patienter.
English: After the injection, growth hormone is slowly released into your body over a period of about a week.
Danish: Efter injektionen frigives væksthormonet langsomt i kroppen over en periode på ca. en uge.
English: To avoid this, always change the injection site between injections.
Danish: For at undgå det skal du altid skifte injektionssted mellem injektioner.
English: None or -0.5 mg (all patients)
Danish: Ingen eller -0,5 mg (alle patienter)
English: If you miss a dose, contact your doctor who will help establish a new dosing schedule.
Danish: Hvis du glemmer en dosis, skal du kontakte din læge, som vil hjælpe dig med at fastlægge en ny dosisplan.
English: After reconstitution: From a microbiological point of view, the product must be used immediately.
Danish: Efter rekonstitution: Fra et mikrobiologisk synspunkt skal produktet anvendes omgående.
English: This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place.
Danish: Det giver din hud og området under din hud tid til at komme sig efter en injektion, før den får endnu en injektion samme sted.
English: Because it is a thick mixture, the syringe might fill slowly.
Danish: Da det er en tyk blanding, vil sprøjten muligvis fyldes langsomt.
English: (the median nerve) becomes squeezed, resulting in hand numbness and pain - following use of the medicine over an extended period of time, particularly in men.
Danish: (medianusnerven) bliver klemt, hvilket resulterer i følelsesløshed og smerte i hånden - efter brug af medicinen over en længerevarende periode, især hos mænd.
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: This medicine is used once a week.
Danish: Denne medicin bruges en gang ugentligt.
English: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do South Korea
Danish: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do Sydkorea
English: D-72764 Reutlingen Germany
Danish: D-72764 Reutlingen Tyskland
English: Accidental injection of this medicine into the muscle instead of under the skin may result in blood sugar levels becoming too low.
Danish: Utilsigtet injektion af denne medicin i musklen i stedet for under huden kan medføre, at sukkerniveauerne i blodet bliver for lave.
English: Animal studies with this medicinal product are not sufficient to fully assess the reproductive toxicity potential.
Danish: Dyreforsøg med dette lægemiddel er utilstrækkelige til fuldt ud at vurdere potentialet for reproduktionstoksicitet.
English: Do not inject this medicine yourself unless you have received training and you understand the procedure.
Danish: Du må ikke selv injicere denne medicin, medmindre du er instrueret heri, og du forstår proceduren.
English: The dose will be calculated by your doctor as described below.
Danish: Dosis vil blive beregnet af din læge som beskrevet herunder.
English: These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.
Danish: Disse patienter bør have foretaget en enkelt dynamisk test for at diagnosticere eller udelukke GHD.
English: The doctor will carefully monitor you during treatment as the effect of insulin may be reduced.
Danish: Lægen vil omhyggeligt overvåge din behandling, da insulinens virkning kan reduceres.
English: The dose may be reduced in steps of 0.5 mg at a time.
Danish: Dosis kan nedsættes i trin på 0,5 mg ad gangen.
English: Please also see the required adjustments described in section 2, ‘Other medicines and Somatropin Biopartners'.
Danish: Se venligst også de nødvendige justeringer beskrevet i punkt 2, ‘Brug af anden medicin sammen med Somatropin Biopartners'.
English: Take a new syringe with a 26G needle.
Danish: Tag en ny sprøjte med en 26G kanyle.
English: Very limited data on exposure to other somatropin preparations during early pregnancy did not indicate an adverse pregnancy outcome.
Danish: Meget begrænsede data om eksponering for andre somatropinpræparater i den tidlige graviditet indikerede ikke nogen graviditetskomplikationer.
English: The suspension is for immediate single use only.
Danish: Suspensionen er kun til umiddelbar engangsbrug.
English: Benign intracranial hypertension
Danish: Benign intrakraniel hypertension
English: This medicine should not be used in infants below the age of 2 years.
Danish: Dette lægemiddel bør ikke bruges hos spædbørn under 2 år.
English: These patients should be counselled on risks before initiating therapy.
Danish: Disse patienter bør rådgives om risikoen inden indledning af behandling.
English: Common: Epistaxis
Danish: Almindelig: Epistaxis
English: Reconstitution and dilution should be performed using aseptic techniques to ensure the sterility of the prepared suspension.
Danish: Rekonstitution og fortynding skal foretages med aseptiske teknikker for at sikre, at den tilberedte suspension er steril.
English: Some patients may develop antibodies to this medicinal product.
Danish: Nogle patienter kan udvikle antistoffer mod dette lægemiddel.
English: Injection volume (mL)
Danish: Injektionsvolumen (ml)
English: Not known, frequency cannot be estimated from the available data - a reduced response to insulin (insulin resistance)
Danish: Ikke kendt, kan ikke estimeres ud fra forhåndenværende data - en nedsat respons på insulin (insulinresistens)
English: - Your doctor may check the level of sugar in your urine or blood since it may be affected by this
Danish: - Din læge vil muligvis kontrollere sukkerniveauet i din urin eller dit blod, da det kan påvirkes af denne medicin.
English: Do not use any remaining solvent for a second preparation!
Danish: Brug ikke eventuel resterende solvens til en ny tilberedning!
English: Do not touch the needle or allow it to come into contact with any surface prior to the injection.
Danish: Rør ikke ved kanylen, og lad den ikke få kontakt med nogen overflader før injektionen.
English: If you are injecting this medicine yourself you will be shown how to prepare and give the injection.
Danish: Hvis du selv injicerer denne medicin, vil du få vist, hvordan du skal tilberede og indgive injektionen.
English: - Inform the doctor if you begin to limp during treatment.
Danish: - Underret lægen, hvis du begynder at halte under behandlingen.
English: • Somatropin must not be used for growth promotion in children with closed epiphyses.
Danish: • Somatropin må ikke anvendes til vækstfremmelse hos børn med lukkede epifyser.
English: This medicinal product is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of GHD.
Danish: Dette lægemiddel er ikke indiceret til behandling af patienter med vækstforstyrrelser på grund af Prader-Willi syndrom, medmindre de også har en diagnosticeret GHD.
English: The metabolic fate of hGH involves classical protein catabolism in both the liver and kidney.
Danish: Den metaboliske skæbne for hGH involverer klassisk proteinkatabolisme i både lever og nyre.
English: During normal pregnancy, levels of pituitary growth hormone fall markedly after 20 weeks of gestation, being replaced almost entirely by placental growth hormone by 30 weeks.
Danish: Under en normal graviditet falder niveauerne af hypofysevæksthormon markant efter 20 ugers gestation og bliver næsten helt erstattet af placentavæksthormon efter 30 uger.
English: Prolonged overdose may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone.
Danish: Langvarig overdosering kan forårsage en større vækst end normalt af ører, næse, læber, tunge og kindben.
English: Treatment with this medicinal product should be continued until final height has been reached or until epiphyseal closure.
Danish: Behandling med dette lægemiddel bør fortsættes, indtil den endelige højde er nået eller indtil hypofyselukning.
English: This is because the doctor will stop the treatment should a tumour occur.
Danish: Det er fordi, lægen vil stoppe behandlingen, hvis en svulst opstår.
English: +1.5 mg (female on oral oestrogen) +1.0 mg (all other patients)
Danish: +1,5 mg (kvinde i behandling med oralt østrogen) +1,0 mg (alle andre patienter)
English: Safety and efficacy in adults with GHD was assessed in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study.
Danish: Sikkerhed og virkning hos voksne med GHD blev vurderet i et dobbeltblindet, randomiseret, placebokontrolleret, parallelgruppe, multicenter, fase III-studie.
English: Any remaining solvent should not be used for a second preparation.
Danish: Eventuel resterende solvens må ikke anvendes til en ny tilberedning.
English: If the thyroid is not working properly, this medicine may not work as well as it should.
Danish: Hvis skjoldbruskkirtlen ikke fungerer korrekt, vil denne medicin muligvis ikke virke så godt, som den skal.
English: It is recommended to monitor thyroid function following an overdose.
Danish: Det anbefales at overvåge thyroideafunktionen efter overdosering.
English: The solvent is a clear, oily liquid.
Danish: Solvensen er en klar, olieholdig væske.
English: Long term over-dosing could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of hGH excess.
Danish: Langvarig overdosering kan resultere i tegn og symptomer på gigantisme og/eller akromegali i overensstemmelse med den kendte virkning af overskud af hGH.
English: Other precautions
Danish: Andre forholdsregler
English: -0.5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score.
Danish: -0,5 mg (alle patienter) IGF-I = insulinlignende vækstfaktor-I, SDS = standardafvigelsesscore.
English: Interruption or early stopping of treatment with this medicine may impair the success of the therapy.
Danish: Afbrydelse eller tidligt ophør af behandling med denne medicin kan gøre behandlingen med denne medicin mindre vellykket.
English: Common: Vertigo
Danish: Almindelig: Vertigo
English: In rabbits and monkeys no adverse effects were observed.
Danish: Der blev ikke observeret bivirkninger hos kaniner og aber.
English: Slowly release the skin during the injection.
Danish: Slip langsomt huden under injektionen.
English: After preparation, the product must be used immediately.
Danish: Efter tilberedning skal produktet anvendes omgående.
English: An increasing sensitivity to growth hormone (expressed as change in IGF-I per growth hormone dose) over time may be observed, particularly in men.
Danish: Der kan observeres en øget følsomhed for væksthormonet (udtrykt som en ændring i IGF-I pr. væksthormondosis) med tiden, især hos mænd.
English: Initially, patients should have their IGF-I levels assessed at 3- to 4-weekly intervals until IGF-I SDS is in the target range of -0.5 to +1.5.
Danish: Indledningsvist bør patienter få deres IGF-I niveauer vurderet ved 3 til 4 ugentlige intervaller, indtil IGF-I SDS er i målområdet på -0,5 til +1,5.
English: Inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
Danish: Utilstrækkelig behandling af hypothyroidisme kan forhindre optimalt respons på somatropin.
English: Some patients may develop antibodies to rhGH.
Danish: Nogle patienter kan udvikle antistoffer mod rhGH.
English: Clinical trials included approximately 530 patients treated with Somatropin Biopartners.
Danish: Kliniske forsøg inkluderede ca. 530 patienter behandlet med Somatropin Biopartners.
English: Few patients discontinued treatment due to injections site reactions, see section 4.8.
Danish: Få patienter seponerede behandling på grund af reaktioner på injektionsstedet, se punkt 4.8.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virking på evnen til at føre motorkøretøj og betjene maskiner
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: After the powder is evenly mixed with the solvent provided, this medicine is injected under the skin.
Danish: Efter pulveret er godt blandet med den medfølgende solvens, injiceres denne medicin under huden.
English: When it stimulates the growth of cells in the long bones of the legs and spine, it causes an increase in height.
Danish: Når det stimulerer cellernes vækst i de lange knogler i benene og rygsøjlen, øges højden.
English: In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Danish: I lyset af dette er det usandsynligt, at fortsat substititionsbehandling med somatropin ville være nødvendigt hos kvinder med væksthormonmangel i graviditetens 3. semester.
English: The maximum injection volume per injection site should not exceed 1 mL.
Danish: Den maksimale injektionsvolumen pr. injektionssted bør ikke overskride 1 ml.
English: Somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Danish: Administration af somatropin kan øge clearance af stoffer, som metaboliseres af cytokrom P450 isoenzymer.
English: No accumulation of hGH following multiple dosing of this medicinal product has been observed.
Danish: Der er ikke observeret akkumulering af hGH efter flere doser af dette lægemiddel.
English: Hold the fold between the thumb and the forefinger during the entire injection.
Danish: Hold folden mellem tommel- og pegefinger under hele injektionen.
English: Detailed information on how to administer this medicinal product is provided in section 3 of the patient leaflet.
Danish: Der gives detaljeret information om administration af dette lægemiddel i punkt 3 i indlægssedlen.
English: Female (not on oral oestrogen)
Danish: Kvinde (ikke i behandling med oral østrogen)
English: If you are breast-feeding only use this medicine if your doctor indicates it is clearly necessary.
Danish: Hvis du ammer, må du kun bruge denne medicin, hvis din læge angiver, at det er absolut nødvendigt.
English: Injection site related reactions, mostly swelling at the injection site, were reported in approximately 43% of the paediatric patients.
Danish: Reaktioner relateret til injektionsstedet, hovedsageligt hævelse på injektionsstedet, blev rapporteret hos ca. 43% af pædiatriske patienter.
English: Patient bodyweight (kg)
Danish: Patientlegemsvægt (kg)
English: Not known: Insulin resistance*
Danish: Ikke kendt: Insulinresistens*
English: Additionally, it promotes cellular protein synthesis and nitrogen retention.
Danish: Derudover fremmer det cellernes proteinsyntese og nitrogenretention.
English: Insulin sensitivity
Danish: Insulinfølsomhed
English: The most prominent effect of somatropin in children is the stimulation of the growth plates of long bones.
Danish: Somatropins mest fremherskende effekt hos børn er, at det stimulerer de lange knoglers vækstplader.
English: The active substance is somatropin.
Danish: Aktivt stof: somatropin.
English: If the symptom reappears after the dose increase, then the dose should be maintained at the previous lower dose.
Danish: Hvis symptomet genopstår efter dosisoptrapning, bør dosis vedligeholdes på den tidligere lavere dosis.
English: After removal of the protective caps from the top of both vials the rubber stoppers should be cleaned with an alcohol swab.
Danish: Efter fjernelse af de beskyttende låg fra toppen af begge hætteglas skal gummipropperne rengøres med en spritserviet.