FrancophonIA/ELRC3.0 huggingface dataset:
English: There were also reports of systemic hypersensitivity from post-marketing use, of which some cases were indicative of anaphylaxis.
Bulgarian: Ved brug efter markedsføringen var der også tilfælde af systemisk hypersensitivitet, hvoraf nogle tilfælde tydede på anafylaksi.
English: Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Bulgarian: Almindelig: Søvnapnø-syndrom, adenoid hypertrofi, tonsillær hypertrofi, snorken
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bulgarian: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Bulgarian: Indsprøjt INCRELEX lige under huden på din overarm, lår, maveområde (bugen) eller balle.
English: For severe hypoglycaemia, if you are not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon.
Bulgarian: Ved alvorlige tilfælde af lavt blodsukker, hvor du ikke reagerer og ikke kan drikke sukkerholdig væske, skal du give en indsprøjtning med glukagon.
English: Renal impairment No studies have been conducted in children with renal impairment.
Bulgarian: Nedsat nyrefunktion Der er ikke gennemført studier af børn med nedsat nyrefunktion.
English: The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Bulgarian: De hyppigst forekommende bivirkninger ved mercasermin er: Lavt blodsukker (hypoglykæmi), opkastning, reaktioner ved injektionsstedet, hovedpine og mellemørebetændelse.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Bulgarian: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 - 9 year old treatment naïve subjects.
Bulgarian: tryk forekom hos 4 (0,96 %) af patienterne i de kliniske forsøg og forekom hos behandlingsnaive forsøgspersoner på 7-9 år.
English: Do not give the injection if you are unable to eat shortly before or after the injection.
Bulgarian: Du må ikke give indsprøjtningen, hvis du ikke kan spise umiddelbart
English: Therapy should be discontinued if evidence of neoplasia develops.
Bulgarian: Behandlingen skal seponeres, hvis der opstår tegn på neoplasi.
English: Table 1: Adverse reactions
Bulgarian: Tabel 1: Bivirkninger
English: Tonsillar hypertrophy
Bulgarian: Tonsillær hypertrofi
English: Increased pressure in the brain (intracranial hypertension) INCRELEX can sometimes cause a temporary increase in pressure within the brain.
Bulgarian: INCRELEX kan nogle gange medføre et midlertidigt forhøjet tryk i hjernen.
English: Such containers should be sealed and disposed of properly in the way your doctor described.
Bulgarian: skal lukkes og kasseres på korrekt vis, som lægen har vist dig.
English: Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Bulgarian: Infektioner Mellemørebetændelse er observeret hos børn i behandling med mercasermin.
English: The dose of INCRELEX should not be doubled to make up for one or more omitted doses.
Bulgarian: INCRELEX-dosis må aldrig fordobles for at erstatte en eller flere glemte doser.
English: During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.
Bulgarian: 300 patienter, blev der rapporteret lokal og/eller systemisk hypersensivitet hos 8% af patienterne.
English: Mecasermin therapy should be discontinued if pregnancy occurs.
Bulgarian: Behandling med mercasermin skal afbrydes i tilfælde af graviditet.
English: If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Bulgarian: Hvis du tager INCRELEX, skal du undgå at deltage i høj-risiko-aktiviteter (såsom voldsom fysisk aktivitet) 2-3 timer efter en INCRELEX-indsprøjtning.
English: 4.8 Undesirable effects
Bulgarian: 4.8 Bivirkninger
English: Mecasermin may lower blood sugar levels.
Bulgarian: Mercasermin kan sænke blodsukkeret.
English: In this case INCRELEX cannot help you grow and should not be used.
Bulgarian: ikke hjælpe dig med at vokse og det bør derfor
English: For the 21 treatment naïve subjects with near-adult height, the mean (± SD) of the difference between observed increase in height versus that expected from Laron was approximately 13 cm (± 8 cm) after an average of 11 years of treatment.
Bulgarian: For de 21 behandlingsnaive patienter med næsten voksenhøjde var middelforskellen (± SD) mellem observeret højdeforøgelse versus den, der forventes i henhold til Larons syndrom, ca.
English: Other adverse reactions have been identified during post approval use of INCRELEX.
Bulgarian: Der er blevet identificeret andre bivirkninger under brug af INCRELEX efter markedsføringen.
English: Studies have not been conducted with mecasermin in breast-feeding mothers.
Bulgarian: ikke gennemført studier med mecasermin hos ammende mødre.
English: Hypoglycaemia
Bulgarian: Hypoglykæmi
English: - INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
Bulgarian: - INCRELEX er en væske, der indeholder mecasermin, som er en menneskeskabt insulinlignende vækstfaktor-1 (IGF-1), som ligner den IGF-1, som din krop
English: Annual results for height velocity, height velocity SDS, and height SDS until year 8 are shown in Table 2.
Bulgarian: De årlige resultater for væksthastighed, væksthastighed-SDS og højde-SDS indtil år 8 er vist i tabel 2. Der var væksthastighedsdata fra før behandlingen
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Bulgarian: indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: If the patient is not awake or alert enough to drink sugarcontaining fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar.
Bulgarian: ikke er vågen nok til at kunne drikke sukkerholdig væske, kan det være nødvendigt at indsprøjte glukagon i musklen for at afhjælpe det lave blodsukker.
English: Baseline characteristics for the 81 patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years): 6.8  3.8; age range (years): 1.7 to 17.5; height (cm): 84.1  15.8; height standard deviation score (SDS): -6.9  1.8; height velocity (cm/yr): 2.6  1.7; height velocity SDS: -3.4  1.6; IGF-1 (ng/ml): 24.5  27.9; IGF-1 SDS: -4.2  2.0; and bone age (years): 3.8  2.8.
Bulgarian: i de primære og sekundære effektanalyser fra de kombinerede studier, var (middel ± SD): kronologisk alder (år): 6,8  3,8; aldersinterval (år): 1,7 til 17,5; højde (cm): 84,1  15,8; højde standardafvigelse score (SDS):
English: No data are available.
Bulgarian: ingen data.
English: Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Bulgarian: tilbage, og træk den korrekte dosis op i sprøjten (se figur 5).
English: There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients.
Bulgarian: Der er begrænsede data vedrørende farmakokinetikken for mecasermin hos børn med nedsat leverfunktion i denne specifikke population af patienter med svær primær IGFD.
English: 65, quai Georges Gorse 92100 Boulogne-Billancourt France
Bulgarian: 65, quai Georges Gorse 92100 Boulogne-Billancourt Frankrig
English: 2D barcode carrying the unique identifier included
Bulgarian: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: The doctor should regularly examine your tonsils/adenoids.
Bulgarian: Lægen skal undersøge dine mandler/polypper med regelmæssige mellemrum.
English: Date of latest renewal: 03 August 2017
Bulgarian: august 2007 Dato for seneste fornyelse: 3.
English: Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Bulgarian: Mecasermin er en human, insulinlignende vækstfaktor-1 (rhIGF-1), fremstillet ved hjælp af rekombinant DNA-teknologi.
English: Ipsen SpA
Bulgarian: Italia Ipsen SpA
English: • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Bulgarian: Rapportering af halthed eller smerter i hofte eller knæ til lægen, så dette kan evalueres.
English: 4.7 Effects on ability to drive and use machines
Bulgarian: 4.7 Virkning på evnen
English: Common: Thymus hypertrophy
Bulgarian: Almindelig: Thymushypertrofi
English: What INCRELEX looks like and contents of the pack INCRELEX is a clear and colourless solution for injection (injection) supplied in a glass vial closed with a stopper and a seal.
Bulgarian: INCRELEX er en klar og farveløs injektionsvæske, leveret i et hætteglas, der er lukket med en prop og forseglet.
English: This leaflet was last revised in
Bulgarian: Denne indlægsseddel blev senest ændret
English: Common: Papilloedema
Bulgarian: Almindelig: Papilødem
English: - The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 "INCRELEX contains benzyl alcohol and sodium").
Bulgarian: - Øvrige indholdsstoffer: Benzylalkohol, natriumchlorid, polysorbat 20, koncentreret eddikesyre, natriumacetat og vand til injektionsvæsker (se punkt 2 ”INCRELEX
English: INCRELEX should be administered using sterile disposable syringes and injection needles.
Bulgarian: INCRELEX skal indgives med sterile engangssprøjter og injektionskanyler.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Bulgarian: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: A. LABELLING
Bulgarian: ETIKETTERING
English: PHARMACEUTICAL FORM Solution for injection (injection).
Bulgarian: LÆGEMIDDELFORM Injektionsvæske, opløsning (injektion).
English: For further information ask the doctor.
Bulgarian: Spørg lægen, hvis du ønsker yderligere oplysninger.
English: Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Bulgarian: Systemisk hypersensitivitet omfatter symptomer så som anafylaksi, generaliseret urticaria, angioødem og dyspnø.
English: The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases.
Bulgarian: Det samlede IGF-1-fordelingssvolumen (middel ± SD) efter subkutan indgivelse af INCRELEX hos 12 patienter med svær primær IGFD anslås til at være 0,257 (± 0,073) l/kg ved en mecasermindosis på 0,045 mg/kg, og det anslås, at denne værdi øges i takt med, at mecasermin-dosis øges. Der er begrænsede oplysninger
English: Aqueous, clear and colourless solution.
Bulgarian: Vandig, klar og farveløs væske.
English: Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration.
Bulgarian: Der er rapporter om intrakraniel hypertension (IH) med papilødem, synsforstyrrelser, hovedpine, kvalme og/eller opkastning hos patienter i behandling med mecasermin, ligesom det også er rapporteret ved terapeutisk GH-indgivelse.
English: Precaution to be taken before manipulating or administering the medicinal product The solution should be clear immediately after removal from the refrigerator.
Bulgarian: Opløsningen skal være klar umiddelbart efter at den tages ud af køleskabet.
English: Distribution
Bulgarian: Fordeling
English: 5.2 Pharmacokinetic properties
Bulgarian: 5.2 Farmakokinetiske egenskaber
English: • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Bulgarian: Forskudt caput femoralis epifyser og udvikling af skoliose kan forekomme hos patienter, som oplever hurtig vækst.
English: Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Bulgarian: svimmelhed, træthed, rastløshed, sult, irritabilitet, manglende koncentrationsevne, sveden, kvalme og hurtig eller uregelmæssig hjerterytme.
English: Bone/Mineral Metabolism
Bulgarian: Knogle-/mineralstofskifte
English: Do not recap the syringe.
Bulgarian: Tag ikke gummiproppen af.
English: EXP After first opening, use within 30 days.
Bulgarian: Skal anvendes senest 30 dage efter åbning.
English: Very common: Vomiting, upper abdominal pain
Bulgarian: Meget almindelig: Opkastning, øvre abdominale smerter Almindelig: Abdominalsmerter
English: Women of childbearing potential / Contraception in males and females A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Bulgarian: Kvinder i den fertile alder/kontraception til mænd og kvinder Det anbefales, at der foreligger en negativ graviditetstest for alle kvinder i den fertile alder forud for behandling med mecasermin.
English: • To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Bulgarian: Forældrene skal oplyses om tegn, symptomer og behandling af hypoglykæmi, herunder injektion af glukagon.
English: At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Bulgarian: Ved den første ordination skal lægen oplyse patienten om tegn, symptomer og behandling af hypoglykæmi, herunder injektion af glukagon.
English: 5.1 Pharmacodynamic properties
Bulgarian: 5.1 Farmakodynamiske egenskaber
English: *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Bulgarian: *Mecasermin er en rekombinant, DNA-afledt, human, insulinlignende vækstfaktor-1(IGF-1), fremstillet i Escherichia coli.
English: Leave the syringe in the vial and turn both upside down.
Bulgarian: Lad sprøjten sidde i hætteglasset, og vend bunden i vejret på dem begge.
English: Mecasermin should not be administered to a breast-feeding mother.
Bulgarian: Mercasermin må ikke gives til en ammende moder.
English: Reporting of side effects
Bulgarian: Indberetning af bivirkninger
English: Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Bulgarian: Hjælpestoffer: benzylalkohol, natriumchlorid, polysorbat 20, eddikesyre, natriumacetat og vand til injektionsvæsker.
English: Throw them away properly in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Bulgarian: til skarpe genstande (f.eks. en beholder til miljøfarligt affald), en beholder af hård plast (f.eks. en flaske, hvor der har været rengøringsmiddel i) eller en metalbeholder (f.eks. en tom kaffedåse).
English: Figure 3: Prepare for extraction
Bulgarian: Figur 3: Gør klar
English: Use a new disposable needle and syringe every time you give a dose.
Bulgarian: Brug en ny engangskanyle og en engangssprøjte, hver gang du giver en dosis. Sprøjten og kanylen må kun bruges én gang.
English: The rhIGF-1 protein is synthesised in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Bulgarian: Aminosyresekvensen i produktet er identisk med endogen human IGF-1. rhIGF-1-proteinet er syntetiseret i bakterier (E. coli), som er modificeret ved at tilføje genet for human IGF-1.
English: A swelling at the back of the eye (due to increased pressure within the brain) may be observed by a doctor or optician during mecasermin treatment.
Bulgarian: Lægen eller en optiker kan observere en hævelse bagerst i øjet (på grund af forhøjet tryk i hjernen) under behandling med mercasermin.
English: Reactions observed in the clinical trials
Bulgarian: Bivirkninger i de kliniske forsøg
English: Metabolism and nutrition disorders
Bulgarian: Thyroid- og ernæringsforstyrrelser
English: If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily.
Bulgarian: i mindst en uge, kan dosis øges i trin på 0,04 mg/kg op til den maksimale dosis på 0,12 mg/kg to gange daglig.
English: Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.
Bulgarian: Forældre og patienter skal informeres om, at systemiske allergiske reaktioner kan forekomme, og at behandlingen
English: What you need to know before you use INCRELEX
Bulgarian: Det skal du vide, før du begynder at tage INCRELEX
English: Pack size of 1 vial.
Bulgarian: Pakningsstørrelse på 1 hætteglas.
English: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Bulgarian: til 18 år med svær primær insulinlignende vækstfaktor 1-mangel (primær IGFD).
English: • Immunogenicity sampling information.
Bulgarian: Information om immunogenicitetsprøvetagning.
English: Treatment should be reconsidered if after a year patients remain non-responsive.
Bulgarian: ikke har reageret på behandlingen efter et år.
English: For subjects with bone age available for at least 6 years after treatment initiation, the mean increase in bone age was comparable to the mean increase in chronological age; for these subjects, there does not appear to be any clinically significant advance of bone age relative to chronological age.
Bulgarian: For patienter med tilgængelig knoglealder i mindst 6 år efter iværksættelse af behandling var middeløgningen i knoglealder sammenlignelig med middeløgningen i kronologisk alder.
English: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Bulgarian: 300 patienter) rapporterede 8% af patienterne en lokal og/eller systemisk hypensensivitets reaktion.
English: The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.
Bulgarian: Biotilgængeligheden af mecasermin efter subkutan indgivelse til raske personer er rapporteret
English: How to use INCRELEX 4.
Bulgarian: Sådan skal du tage INCRELEX 4. Bivirkninger
English: • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/or adenoids following the beginning of treatment with INCRELEX.
Bulgarian: Vejledning i at rapportere en begyndende eller en forværret snorken, efter behandlingsstart med INCRELEX.
English: Acute overdose could lead to hypoglycaemia (low blood sugar).
Bulgarian: En akut overdosering kan medføre lavt blodsukker (hypoglykæmi).
English: Figure 7: Ready to inject
Bulgarian: Figur 7: Klar
English: It is important that you have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
Bulgarian: Glukagon hæver blodsukkeret, når det indsprøjtes. Det er vigtigt, at du får en velafbalanceret kost med protein og fedt, herunder kød og ost, udover
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Bulgarian: HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea.
Bulgarian: Symptomerne i de tilfælde, som tydede på anfylaksi inkluderede udslæt, angioødem og dyspnø.
English: Postmarketing reports of local allergic reactions were also received.
Bulgarian: Der var også tilfælde af lokale allergiske reaktioner efter markedsføringen.
English: These have been observed both as being systemic and/or local to the injection site.
Bulgarian: systemiske reaktioner og/eller lokale reaktioner ved injektionstedet.
English: What INCRELEX contains - The active substance is mecasermin.
Bulgarian: - Aktivt stof: mecasermin.
English: The dose of 120 μg/kg given subcutaneously (SC) and twice daily (BID) was associated with the greatest growth responses.
Bulgarian: to gange daglig (BID) var forbundet med det største vækstrespons.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: This may be through the production of anti-IGF-1 IgEs, sustaining antibodies or neutralizing antibodies respectively.
Bulgarian: Dette kan skyldes produktion af anti-IGF-1 IgE'er, henholdsvis bindende antistoffer eller neutraliserende antistoffer. I sådanne tilfælde skal test for antistof
English: Figure 4: Tip in liquid
Bulgarian: Figur 4: Kanylespidsen
English: In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Bulgarian: IGF-1 bindes i blod til seks IGF-bindende proteiner (IGFBP'er) med ~80 % bundet
English: Check with your doctor or pharmacist if you are not sure.
Bulgarian: Spørg lægen eller på apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Call the doctor as soon as possible if you get a localised rash.
Bulgarian: som muligt, hvis du får et lokalt udslæt.
English: Common: Skin hypertrophy, abnormal hair texture
Bulgarian: Hypertrofi i huden, unormal hårtekstur
English: • Long-term toxicity in patients undergoing developmental changes
Bulgarian: sigt hos patienter, der ændrer
English: Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD.
Bulgarian: 413 patienter med svær primær IGFD.
English: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.
Bulgarian: Hvis du tager hul på et nyt hætteglas skal du fjerne beskyttelseshætten.
English: If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top.
Bulgarian: Hvis der er bobler i sprøjten, skal du holde hætteglasset og sprøjten med nålen helt lodret og banke let på siden af sprøjten, indtil boblerne flyder op til overfladen. Skub boblerne ud med stemplet, og træk væske tilbage, indtil du har den korrekte dosis (se figur 6).
English: Efficacy is dose dependent.
Bulgarian: Effekten er dosisafhængig.
English: Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Bulgarian: toksiske reaktioner og anafylaktoide reaktioner hos spædbørn og børn under 3 år.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bulgarian: Benigne, maligne og uspecificerede tumorer (inkl.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Bulgarian: Opbevaringsforhold efter anbrud af lægemidlet, se pkt.
English: Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX.
Bulgarian: Generelt blev symptomatisk hypoglykæmi undgået, hvis patienten indtog et måltid eller et mellemmåltid enten umiddelbart
English: Ipsen Pharma SAS Magyarországi Kereskedelmi Képviselet Árbóc utca 6.
Bulgarian: Ipsen Pharma SAS Magyarországi Kereskedelmi Képviselet