FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Bulgarian: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Do not pass it on to others.
Bulgarian: Lad derfor være med at give medicinen til andre.
English: GENERAL CLASSIFICATION FOR SUPPLY
Bulgarian: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Hair loss (alopecia)
Bulgarian: Hårtab (alopeci)
English: Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.
Bulgarian: Vækst og metabolisme i epifyseskivernes celler stimuleres direkte af GH og IGF-1.
English: Do not rub the area (see Figure B).
Bulgarian: Du må ikke gnide på stedet (se figur B).
English: That parents and caregivers should always ensure that the child has a source of sugar.
Bulgarian: skal altid sikre, at barnet har en sukkerkilde til rådighed.
English: Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Bulgarian: Behandling med mecasermin skal styres af læger med erfaring i diagnosticering og behandling af patienter med vækstforstyrrelser.
English: In some patients treated with mecasermin, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle and abnormalities of heart valve function.
Bulgarian: Hos visse patienter, der blev behandlet med mecasermin, viste en ultralydsundersøgelse af hjertet (ekkokardiogram) en forstørrelse af hjertemusklen og afvigelser i hjerteklappernes funktion.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2007
Bulgarian: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 3.
English: Breast-feeding while taking INCRELEX is not recommended, because there is insufficient information on the excretion of mecasermin in human milk.
Bulgarian: Amning anbefales ikke ved indtagelse af INCRELEX, da data for udskillelse af mecasermin i human mælk er utilstrækkelige.
English: • INCRELEX should not be administered if the patient is unable to eat for any reason.
Bulgarian: INCRELEX må ikke indgives, hvis patienten af en eller anden årsag ikke er i stand til at spise.
English: 4.4 Special warnings and precautions for use
Bulgarian: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: • The signs and symptoms of hypoglycaemia.
Bulgarian: • Tegn og symptomer på hypoglykæmi.
English: Among all subjects included for safety evaluation (n=92), 83% of the subjects reported at least one adverse event during the course of the studies.
Bulgarian: til sikkerhedsvurdering (n=92), rapporterede 83 % af patienterne mindst en bivirkning i løbet af studierne.
English: Typically these were pruritus and urticaria.
Bulgarian: Disse var typisk pruritus og urticaria.
English: See the ‘Instructions for Use' at the end of this leaflet.
Bulgarian: Se ‘Brugsanvisning' sidst i indlægssedlen.
English: • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Bulgarian: Eksklusion af sekundære former for IGF-1-mangel, såsom fejlernæring, hypotyroidisme, eller kronisk behandling med farmakologiske doser af antiinflammatoriske steroider.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Bulgarian: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: The injection site should be dry before you inject.
Bulgarian: skal være tørt, før du indsprøjter.
English: Tissue Growth
Bulgarian: Vævsvækst
English: Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
Bulgarian: Mecasermin kan, ligesom insulin, sænke sukkerniveauet i blodet (se hypoglykæmi i afsnit 4).
English: Very common (may affect more than 1 in 10 people) Low blood sugar (hypoglycaemia)
Bulgarian: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter) Lavt blodsukker (hypoglykæmi)
English: The most frequently reported adverse reactions from the clinical trials were headache (44%), hypoglycaemia (28%), vomiting (26%), injection site hypertrophy (17%), and otitis media (17%).
Bulgarian: De oftest rapporterede bivirkninger i de kliniske forsøg var hovedpine (44 %), hypoglykæmi (28 %), opkastning (26 %), hypertrofi på injektionsstedet (17 %) og otitis media (17 %).
English: Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.
Bulgarian: Patienter med et abnormt ekkokardiogram eller kardiovaskulære symptomer bør følges regelmæssigt med optagelse af ekkokardiogram.
English: A small number of cases indicative of anaphylaxis requiring hospitalisation have been reported.
Bulgarian: Et lille antal tilfælde, der indikerede anafylaksi og krævede hospitalsindlæggelse, er rapporteret.
English: - It is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF-1.
Bulgarian: - Det anvendes til at behandle børn og unge mellem 2 og 18 år, som er meget lave af vækst i forhold til deres alder, fordi deres krop
English: Keep vial in the outer carton in order to protect from light.
Bulgarian: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: Investigations
Bulgarian: Undersøgelser
English: - if you have finished growing (the bone growth plates are closed).
Bulgarian: - Hvis du er færdigudvokset (knoglevækstskiverne er lukkede).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Bulgarian: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: See section 4.8 for how to report adverse reactions.
Bulgarian: 4.8, hvordan bivirkninger indberettes.
English: Height SDS
Bulgarian: Højde SDS
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bulgarian: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists, ATC code: H01AC03
Bulgarian: Hypofyse- og hypothalamushormoner og analoger, somatropin og somatropinagonister, ATC-kode: H01AC03
English: Hypoglycaemia was the most frequently reported adverse event and a proper attention has to be given to meals in relation to dosing.
Bulgarian: Hypoglykæmi var den hyppigst rapporterede bivirkning, og det er nødvendigt at være opmærksom på måltider i forhold til dosering.
English: Wash your hands before getting INCRELEX ready for your injection.
Bulgarian: Vask hænderne, inden du gør INCRELEX klar
English: • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.
Bulgarian: INCRELEX er kontraindiceret ved aktiv eller mistænkt neoplasi, og behandlingen skal seponeres, hvis der udvikles tegn på neoplasi.
English: Never share needles and syringes.
Bulgarian: Del aldrig kanyler og sprøjter med andre.
English: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Bulgarian: ikke gennemført studier med henblik på at fastslå effekt af nedsat leverfunktion på de farmakokinetiske egenskaber ved mecasermin.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Bulgarian: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte
English: INCRELEX contains benzyl alcohol as a preservative which may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Bulgarian: INCRELEX indeholder benzylalkohol, som konserveringsmiddel, hvilket kan medføre forgiftning og allergiske reaktioner hos spædbørn og børn under 3 år.
English: There were also reports of local allergic reactions at the injection site.
Bulgarian: Der var også tilfælde af lokale allergiske reaktioner på injektionsstedet.
English: If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy.
Bulgarian: Hvis dette er tilfældet, kan lægen eventuelt beslutte midlertidigt at nedsætte dosis eller afbryde behandlingen med mecasermin.
English: Therefore, this medicinal product is not recommended in children below age of 2.
Bulgarian: Dette lægemiddel frarådes derfor til børn under 2 år.
English: Insert the needle in the way the doctor showed you.
Bulgarian: Indfør kanylen, som lægen har vist dig.
English: Blood and lymphatic system disorders
Bulgarian: Blod og lymfesystem
English: Pharmacodynamic effects The following actions have been demonstrated for endogenous human IGF-1:
Bulgarian: Farmakodynamisk virkning Følgende virkninger er påvist for endogen, human IGF-1:
English: • Product information
Bulgarian: Produktinformation
English: An enlarged thymus (a specialized organ of the immune system) has been observed with mecasermin treatment.
Bulgarian: Der er rapporteret om forstørret thymus (et specialiseret organ i immunsystemet) ved behandling med mercasermin.
English: Talk to your doctor or pharmacist before using INCRELEX - if you have a curved spine (scoliosis).
Bulgarian: Kontakt lægen eller apotekspersonalet, før du tager INCRELEX - Hvis du har en krum rygsøjle (skoliose).
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Bulgarian: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: Instructions on the treatment of hypoglycaemia.
Bulgarian: Vejledning i behandling af hypoglykæmi.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop a serious allergic reaction.
Bulgarian: Du skal øjeblikkeligt stoppe med at tage INCRELEX og straks søge læge, hvis du får en alvorlig allergisk reaktion.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Bulgarian: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Hair loss has also been reported following mecasermin use.
Bulgarian: Hårtab er også rapporteret efter brug af mecasermin.
English: Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone.
Bulgarian: Knoglevæksten opnås ved epifyseskiverne ved enderne af en knogle
English: - if you have a localised reaction at the injection site or generalised allergic reaction with INCRELEX.
Bulgarian: - Hvis du får en lokal reaktion på injektionsstedet eller en allergisk reaktion, der breder
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Bulgarian: når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller
English: Figure B: Press (don't rub) with gauze or cotton
Bulgarian: Figur B: Tryk med gaze eller vat (må ikke gnides)
English: If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced.
Bulgarian: Hvis der trods passende fødeindtag opstår hypoglykæmi ved de anbefalede doseringer, skal dosis reduceres.
English: Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth.
Bulgarian: Insulinlignende vækstfaktor-1 (IGF-1) er den primære hormonelle mediator for højdevækst.
English: If you forget to use INCRELEX
Bulgarian: Hvis du har glemt at tage INCRELEX
English: The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Bulgarian: tilstrækkeligt lille volumen til, at den ordinerede dosis kan trækkes op af hætteglasset med rimelig nøjagtighed.
English: Get medical help immediately if you have a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell).
Bulgarian: Søg straks lægehjælp, hvis du får en allergisk reaktion, der involverer hele kroppen (nældefeber, problemer med at trække vejret, besvimelse eller kollaps og en generel følelse af utilpashed).
English: Limited information is available on the concentration of unbound IGF-1 after the administration of INCRELEX.
Bulgarian: til rådighed om koncentrationen af ubundet IGF-1 efter indgivelse af INCRELEX.
English: IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
Bulgarian: IGF-1 undertrykker glukoseproduktion i leveren, stimulerer perifer glukoseudnyttelse og kan reducere blodglukose og medføre hypoglykæmi.
English: The doctor or nurse will instruct you how to give the injection.
Bulgarian: sygeplejersken vil vise dig, hvordan du skal give indsprøjtningen.
English: Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion.
Bulgarian: til studierne ud fra en meget lille højde, langsom vækst, lave IGF-1serumkoncentrationer og normal GH-sekretion.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Bulgarian: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen:
English: The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Bulgarian: De metaboliske virkninger af IGF-1 er delvist rettet mod stimulering af optagelsen af glukose, fedtsyrer og aminosyrer, således at metabolismen understøtter vævsvæksten.
English: A negative pregnancy test and adequate contraception is required in all pre-menopausal women receiving INCRELEX.
Bulgarian: En negativ graviditetstest og passende prævention er påkrævet hos alle præ-menopausale kvinder, som får INCRELEX.
English: INFORMATION IN BRAILLE INCRELEX
Bulgarian: INFORMATION I BRAILLESKRIFT INCRELEX
English: Use alcohol or soap and water to clean the skin where you are going to inject you.
Bulgarian: sæbe og vand til at rense huden, der hvor du vil sprøjte dig selv. Indgivelsesstedet
English: The MAH must ensure that, at launch, all physicians who are expected to prescribe INCRELEX are provided with a “physician information pack” containing the following:
Bulgarian: sørge for, at alle læger, der forventes at ordinere INCRELEX, får udleveret en “informationspakke
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Bulgarian: skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2
English: Skin and subcutaneous tissue disorders
Bulgarian: Hud og subkutane væv
English: 6.4 Special precautions for storage
Bulgarian: 6.4 Særlige opbevaringsforhold
English: INSTRUCTIONS FOR USE
Bulgarian: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Serious allergic reactions have also been reported with INCRELEX.
Bulgarian: tilfælde af alvorlige allergiske reaktioner med INCRELEX.
English: The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Bulgarian: Den absolutte subkutane biotilgængelighed af mecasermin hos patienter med svær primær IGFD er ikke blevet fastlagt.
English: It is also recommended that all women of childbearing potential use adequate contraception during treatment.
Bulgarian: Det anbefales også, at alle kvinder i den fødedygtige alder bruger passende prævention under behandlingen.
English: Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Bulgarian: Enhver patient, der begynder at halte eller klager over smerter i hofte eller knæ, skal evalueres.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Bulgarian: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Table 2: Annual Height Results by Number of Years Treated with INCRELEX Pre-Tx Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Bulgarian: Pre-Tx År 1 År 2 År 3 År 4 År 5 År 6 År 7 År 8
English: Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Bulgarian: Andre ikke almindelige bivirkninger under behandling med mercasermin omfatter depression og nervøsitet.
English: Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 l/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.
Bulgarian: Clearance af total IGF-1 er omvendt proportional med serum IGFBP-3-niveauer, og total systemisk IGF-1-clearance (CL/F) anslås til at være 0,04 l/t/kg ved 3 mg/l IGFBP-3 hos 12 patienter.
English: Driving and using machines
Bulgarian: til at føre motorkøretøj og betjene maskiner
English: Summary of the safety profile
Bulgarian: sikkerhedsprofilen
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40mg/4ml
Bulgarian: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mg/4 ml
English: INCRELEX should not be given to pregnant or nursing women.
Bulgarian: ikke gives til gravide eller ammende kvinder.
English: 5.3 Preclinical safety data
Bulgarian: 5.3 Prækliniske sikkerhedsdata
English: What you need to know before you use INCRELEX 3.
Bulgarian: Det skal du vide, før du begynder at tage INCRELEX 3.
English: Persons with a history of severe hypoglycemia should have glucagon available.
Bulgarian: Personer med en anamnese for svær hypoglykæmi bør have glukagon inden for rækkevidde.
English: Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Bulgarian: Ikke kendt: Systemisk hypersensitivitet (anafylaksi, generaliseret urticaria, angioødem, dyspnø), lokale allergiske reaktioner ved injektionsstedet (pruritus, urticaria)
English: Contents of the pack and other information
Bulgarian: Pakningsstørrelser og yderligere oplysninger
English: Tell the doctor if you develop hearing problems.
Bulgarian: til lægen, hvis du får problemer med hørelsen.
English: Mecasermin may be started again after the episode is over.
Bulgarian: Behandlingen med mecasermin kan startes igen, når bivirkningen er overstået.
English: Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of mecasermin treatment, until a welltolerated dose of INCRELEX has been established.
Bulgarian: Patienter skal undgå høj-risiko-aktiviteter i 2-3 timer efter doseringen, især i begyndelsen af mecasermin-behandlingen, indtil en veltolereret INCRELEX dosis er fastlagt.
English: Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Bulgarian: skal undersøges med regelmæssige mellemrum og ved forekomst af kliniske symptomer for at udelukke sådanne potentielle komplikationer eller for at iværksætte en passende behandling.
English: Hypoglycaemia is a very common adverse reaction.
Bulgarian: Hypoglykæmi er en meget almindelig bivirkning.
English: You should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of hypoglycaemia occur.
Bulgarian: Du skal altid have en sukkerkilde, såsom appelsinjuice, glukosegel, slik eller mælk, på dig, hvis der
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Bulgarian: speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy.
Bulgarian: Vejledning i at skifte og rotere injektionssted for hver injektion for at undgå udvikling af lipohypertrofi.
English: METHOD OF ADMINISTRATION
Bulgarian: ADMINISTRATIONSMETODE
English: Do not use a double dose to make up for a forgotten dose.
Bulgarian: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Biotransformation Both the liver and the kidney have been shown to metabolise IGF-1.
Bulgarian: Biotransformation Det er påvist, at både lever og nyrer metaboliserer IGF-1.
English: Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake.
Bulgarian: små børn, børn med tidligere tilfælde af hypoglykæmi og børn med uregelmæssig fødeindtag.
English: Before you take the needle out of the vial, check the syringe for air bubbles.
Bulgarian: Inden du trækker kanylen ud af hætteglasset, skal du kontrollere, om der er luftbobler i sprøjten.
English: Mecasermin is not a substitute for GH treatment.
Bulgarian: ikke en erstatning for GH-behandling.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Bulgarian: Yderligere information om INCRELEX findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Your doctor or nurse will instruct you how to give the injection of glucagon.
Bulgarian: Lægen eller sygeplejersken vil vise dig, hvordan du skal indsprøjte glukagon.
English: Acute overdose could lead to hypoglycaemia.
Bulgarian: En akut overdosering kan føre til hypoglykæmi.
English: Figure 2: Inject air into vial
Bulgarian: Figur 2: Sprøjt luft i hætteglasset
English: Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth.
Bulgarian: Forskudt caput femoralis epifyser (med risiko for at medføre avaskulær nekrose) og udvikling af skoliose kan forekomme hos patienter i hurtig vækst.
English: INCRELEX contains benzyl alcohol and sodium
Bulgarian: INCRELEX indeholder benzylalkohol og natrium
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Bulgarian: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Bulgarian: Tør gummiproppen på hætteglasset af med en spritserviet for at forhindre, at glasset forurenes med bakterier, som kan stamme fra flere kanyleindføringer (se figur 1).
English: • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Bulgarian: Patienterne skal have undersøgt, ører næse og hals undersøgt med regelmæssige mellemrum og ved forekomst af kliniske symptomer for at udelukke sådanne potentielle komplikationer eller for at iværksætte en passende behandling.
English: Name and address of the manufacturer responsible for batch release
Bulgarian: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Preparing the dose
Bulgarian: Klargøring af dosis