FrancophonIA/ELRC3.0 huggingface dataset:
English: Dr. Falk Pharma Österreich GmbH Tel: +43 (1) 577 3516 0 office@drfalkpharma.at
Bulgarian: Falk Pharma Österreich GmbH Tel: +43 (1) 577 3516 0 office@drfalkpharma.at
English: If you stop taking Jorveza
Bulgarian: Ако сте спрели приема на Jorveza
English: However, only minor effects on the breast-fed child are anticipated after oral use of Jorveza within the therapeutic range.
Bulgarian: След перорална употреба на Jorveza в рамките на терапевтичния обхват, обаче, се очакват само незначителни ефекти при кърмачето.
English: Jorveza 1 mg orodispersible tablets budesonide
Bulgarian: Jorveza 1 mg таблетки, диспергиращи се в устата будезонид (budesonide)
English: Each orodispersible tablet contains 1 mg of budesonide.
Bulgarian: Всяка таблетка, диспергираща се в устата, съдържа 1 mg будезонид (budesonide).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medicalprescription .
Bulgarian: И УПОТРЕБА Лекарственият продукт се отпуска по ограничено лекарско предписание.
English: Dr. Falk Pharma Benelux Tel: +31-(0)76-5244200 info@drfalkpharma-benelux.eu
Bulgarian: Falk Pharma Benelux Tel: +31-(0)76-5244200 info@drfalkpharma-benelux.eu
English: Alu / Alu-blister.
Bulgarian: И ЛЕНТИТЕ Блистери
English: Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH
Bulgarian: Falk Pharma GmbH
English: − mood changes, such as depression, irritability or euphoria
Bulgarian: - забавен растеж при децата - промени в настроението като депресия, раздразнителност или еуфория - безпокойство с повишена физическа активност, тревожност, агресия
English: Swallow the dissolved material with saliva little by little, as the orodispersible tablet breaks up.
Bulgarian: Малко по малко поглъщайте разтвореното вещество заедно със слюнката, докато таблетката, диспергираща се в устата, се разпада.
English: Cushing's syndrome, adrenal suppression, growth retardation in children Metabolism and nutrition disorders Hypokalaemia, hyperglycaemia Psychiatric disorders
Bulgarian: Синдром на Кушинг, потискане на надбъбречната функция, забавяне на растежа при деца
English: Kidney and liver problems
Bulgarian: Проблеми с черния дроб и бъбреците
English: Tell your doctors that you are taking Jorveza before you have any tests.
Bulgarian: Jorveza преди да Ви бъдат направени каквито и да са изследвания.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Bulgarian: Дата на първо разрешаване:
English: Hepatic impairment
Bulgarian: Сърдечни гликозиди
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets
Bulgarian: Jorveza 1 mg таблетки, диспергиращи се в устата
English: Method of administration Take the orodispersible tablet after a meal.
Bulgarian: Вземайте таблетката, диспергираща се в устата, след хранене.
English: − tiredness
Bulgarian: Кърмене
English: − tingling or numbness in your mouth
Bulgarian: Таблетка, диспергираща се в устата
English: − weakening of the bones (osteoporosis), bone damage due to poor circulation of blood
Bulgarian: кожни реакции като контактен дерматит, синини - болки в ставите и мускулите, мускулна слабост, потрепване на мускулите - отслабване на костите (остеопороза), увреждане на костите поради лоша циркулация на кръвта (остеонекроза) - общо чувство за неразположение.
English: − rash, red spots from bleeding in the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising
Bulgarian: - възпаление на панкреаса, което причинява силна болка в корема и гърба - кожен обрив, червени петна от кървене под кожата, забавено заздравяване на рани,
English: − tuberculosis
Bulgarian: Дозировка
English: Dr. Falk Pharma GmbH Tél: +49 761 1514 0 zentrale@drfalkpharma.de
Bulgarian: Falk Pharma GmbH Tél: +49 761 1514 0 zentrale@drfalkpharma.de
English: Cardiac glycosides
Bulgarian: contact@galenica.gr
English: − heartburn
Bulgarian: НА БРАЙЛОВА
English: Dr. Falk Pharma GmbH Teл: +49 761 1514 0 zentrale@drfalkpharma.de
Bulgarian: Falk Pharma GmbH Teл: +49 761 1514 0 zentrale@drfalkpharma.de
English: Dr. Falk Pharma GmbH Sími: +49 761 1514 0 zentrale@drfalkpharma.de
Bulgarian: Falk Pharma GmbH Sími: +49 761 1514 0 zentrale@drfalkpharma.de
English: Gastrointestinal disorders
Bulgarian: Безводен мононатриев цитрат
English: GALENICA A.E Tηλ: +30 210 52 81 700 contact@galenica.gr
Bulgarian: Tηλ: +30 210 52 81 700
English: Dr. Falk Pharma GmbH Tel: +49 761 1514 0 zentrale@drfalkpharma.de
Bulgarian: Falk Pharma GmbH Tel: +49 761 1514 0 zentrale@drfalkpharma.de
English: Package size l t o r
Bulgarian: Перорално приложение блистер (PVC/alu) 28 cкапсули
English: - if you have cancer.
Bulgarian: - Hvis du har kræft.
English: The potential risk for humans is unknown.
Bulgarian: Den potentielle risiko for mennesker er ukendt.
English: • At the request of the European Medicines Agency;
Bulgarian: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Do not freeze.
Bulgarian: ikke nedfryses.
English: Children under 2 years old
Bulgarian: Børn under 2 år
English: 3 years
Bulgarian: 3 år.
English: After opening
Bulgarian: Efter åbning
English: There was no death during the studies.
Bulgarian: Der var ingen dødsfald under studierne.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Bulgarian: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab.
English: An updated RMP should be submitted:
Bulgarian: En opdateret RMP skal fremsendes:
English: Upon re-administration, symptoms did not re-occur in all patients.
Bulgarian: Ved re-administration, opstod symptomerne ikke igen hos alle patienter.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Bulgarian: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Bulgarian: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: This medicinal product should not be used during pregnancy unless clearly necessary.
Bulgarian: Dette lægemiddel bør ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: Severe Primary IGFD is defined by:
Bulgarian: Svær primær IGFD defineres ved:
English: • Risk Management Plan (RMP)
Bulgarian: Risikostyringsplan (RMP)
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Bulgarian: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: Some patients required hospitalization.
Bulgarian: Nogle patienter krævede hospitalsindlæggelse.
English: ANNEX II
Bulgarian: BILAG II
English: DATE OF REVISION OF THE TEXT
Bulgarian: DATO FOR ÆNDRING AF TEKSTEN
English: 4.9 Overdose
Bulgarian: 4.9 Overdosering
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/402/001
Bulgarian: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/402/001
English: This will allow quick identification of new safety information.
Bulgarian: Dermed kan der hurtigt tilvejebringes nye oplysninger om sikkerheden.
English: Systemic/local hypersensitivity
Bulgarian: Systemisk/lokal hypersensitivitet
English: Store in a refrigerator (2C - 8°C).
Bulgarian: Opbevares i køleskab (2C - 8°C).
English: In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
Bulgarian: I nogle tilfælde, når det skønnes nødvendigt, kan lægen beslutte at bekræfte diagnosen ved at udføre en IGF-I-generationstest.
English: • height standard deviation score  -3.0 and
Bulgarian: • højde standardafvigelse score  -3,0 og
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Bulgarian: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (not known).
Bulgarian: Eftersom disse reaktioner er rapporteret af frivillige fra en befolkningsgruppe af ukendt størrelse er det umuligt med sikkerhed at estimere reaktionernes hyppighed (ikke kendt).
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Bulgarian: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Other sources of information
Bulgarian: Andre informationskilder
English: No interaction studies have been performed.
Bulgarian: ikke udført interaktionsstudier.
English: - in premature babies or neonates because it contains benzyl alcohol.
Bulgarian: - Til præmature spædbørn eller nyfødte, da det indeholder benzylalkohol.
English: Carcinogenic potential
Bulgarian: Karcinogent potentiale
English: You are now ready to inject (see Figure 7).
Bulgarian: Du er nu klar til at indsprøjte (se figur 7).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Bulgarian: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Bulgarian: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Post-marketing reports
Bulgarian: Post-marketing rapporter
English: You should have examinations periodically.
Bulgarian: De skal undersøges med regelmæssige mellemrum.
English: Package leaflet: Information for the user
Bulgarian: Indlægsseddel: Information til brugeren
English: This medicine is subject to additional monitoring.
Bulgarian: Dette lægemiddel er underlagt supplerende overvågning.
English: The height velocities for years 2 through 8 remained statistically greater than baseline.
Bulgarian: Væksthastigheden for år 2 og op til år 8 forblev statistisk større end baseline.
English: Call the doctor should these symptoms bother you.
Bulgarian: Tal med lægen, hvis disse symptomer generer dig.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Bulgarian: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten efter Exp.
English: This condition is called primary IGF-1 deficiency.
Bulgarian: Denne tilstand kaldes primær IGF-1-mangel.
English: If you develop any of these events, please follow the advice given for each event in the sections below.
Bulgarian: Hvis du oplever noget af dette, skal du følge vejledningen for hver hændelse i afsnittene herunder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Bulgarian: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Snoring This occurred generally in the first year of treatment, and was reported in 30 subjects (7%).
Bulgarian: Snorken Dette startede generelt i det første år af behandlingen og blev rapporteret hos 30 patienter (7 %).
English: Long-term overdose may result in enlargement of certain body parts (e.g., hands, feet, parts of the face) or excessive growth of the whole body.
Bulgarian: Længerevarende overdoseringer kan medføre forstørrelse af visse kropsdele (f.eks. hænder, fødder, dele af ansigtet) eller voldsom vækst af hele kroppen.
English: This medicine has been authorised under ‘exceptional circumstances'.
Bulgarian: Dette lægemiddel er godkendt under “særlige vilkår”.
English: Surgical and medical procedures
Bulgarian: Kirurgiske og medicinske procedurer
English: • basal IGF-1 levels below the 2.5th percentile for age and gender and
Bulgarian: basale IGF-1-niveauer under 2,5 percentilen for alder og køn og
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Bulgarian: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: System Organ Class
Bulgarian: Systemorganklasse
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Bulgarian: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er i det væsentlige ”natriumfrit”.
English: Release the skin (see Figure A).
Bulgarian: Slip huden (se figur A).
English: Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score
Bulgarian: Pre-Tx = Før behandling; SD = Standardafvigelse; SDS = Standardafvigelse Score
English: The next dose should be taken as usual, with a meal or snack.
Bulgarian: Den næste dosis skal tages som sædvanligt med et måltid eller mellemmåltid.
English: 28100 Dreux
Bulgarian: 28100 Dreux Frankrig
English: Not known: alopecia
Bulgarian: Ikke kendt: Alopeci
English: Clinical efficacy and safety
Bulgarian: Klinisk virkning og sikkerhed
English: Forty-six (57%) of the subjects were male; 66 (81%) were Caucasian.
Bulgarian: 46 (57 %) af patienterne var af hankøn; 66 (81 %) var kaukasiske.
English: Frequency not known (frequency cannot be estimated from the available data) Serious allergic reactions (anaphylaxis)
Bulgarian: Ukendt hyppighed (hyppigheden kan ikke vurderes ud fra de tilgængelige data) Alvorlige allergiske reaktioner (anafylaksi)
English: Only use INCRELEX that is clear and colourless.
Bulgarian: Brug kun INCRELEX, der er klar og farveløs.
English: Your doctor may perform an echocardiogram before, during and after mecasermin treatment.
Bulgarian: Din læge kan foretage et ekkokardiogram inden, under og efter behandling med mecasermin.
English: Manufacturer:
Bulgarian: Fremstiller:
English: See the package leaflet for further information.
Bulgarian: Se indlægssedlen for yderligere information.
English: The dose should be individualised for each patient.
Bulgarian: Doseringen skal bestemmes individuelt for hver enkelt patient.
English: IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
Bulgarian: IGF-1 består af 70 aminosyrer i en enkelt kæde med tre intramolekylære disulfid-broer og en molekylvægt på 7649 dalton.
English: Toxicity to reproduction
Bulgarian: Toksicitet i forbindelse med reproduktion
English: Lightly pinch the skin.
Bulgarian: Knib huden let sammen.
English: Lonza AG Lonzastrasse CH-3930 Visp Switzerland
Bulgarian: Lonza AG Lonzastrasse CH-3930 Visp Schweiz
English: No attenuation of growth was observed as a consequence of the development of antibodies.
Bulgarian: Der blev ikke observeret væksthæmning som følge af antistofudvikling.
English: [1] P-values for comparison versus pre-Tx values were computed using paired t-tests.
Bulgarian: [1] P-værdier for sammenligning kontra pre-Tx-værdier blev beregnet ved hjælp af parvise t-tests.
English: This reaction occurred in 71 (17%) subjects from the clinical trials and was generally associated with lack of proper rotation of injections.
Bulgarian: Denne reaktion forekom hos 71 patienter (17 %) fra de kliniske forsøg og var oftest forbundet med mangel på korrekt rotation af injektionssted.
English: INCRELEX should not be administered intravenously.
Bulgarian: INCRELEX bør ikke indgives intravenøst.
English: These conditions should be monitored during INCRELEX treatment.
Bulgarian: Disse tilstande skal monitoreres under behandling med INCRELEX.
English: If the patient is unable to eat, for any reason, this medicinal product should be withheld.
Bulgarian: Hvis patienten af en eller anden årsag ikke kan spise, bør dette lægemiddel
English: 4.6 Fertility, pregnancy and lactation
Bulgarian: 4.6 Fertilitet, graviditet og amning
English: Subcutaneous use.
Bulgarian: Til subkutant brug.
English: P-value for change from pre-Tx [1]
Bulgarian: P-værdi for ændring fra pre-Tx [1]
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Bulgarian: ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Description
Bulgarian: Beskrivelse
English: If a dose is skipped, the next dose should not be made larger to compensate.
Bulgarian: Hvis du glemmer en dosis skal den næste dosis ikke laves større for at kompensere.
English: Uncommon: Depression, nervousness
Bulgarian: Ikke almindelig: Depression, nervøsitet
English: Table 1 contains very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000, < 1/100) adverse reactions which occurred in clinical trials.
Bulgarian: Tabel 1 indeholder meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10) og ikke almindelige (≥ 1/1.000 til < 1/100) bivirkninger, som er forekommet i kliniske forsøg.
English: Chemical and physical in-use stability has been demonstrated for 30 days at 2C to 8C.
Bulgarian: Den kemiske og fysiske holdbarhed under brug er påvist for 30 dage ved 2C
English: Figure 1: Wipe top with alcohol
Bulgarian: Figur 1: Tør toppen af med alkohol
English: Warnings and precautions
Bulgarian: Advarsler og forsigtighedsregler
English: 4.1 Therapeutic indications
Bulgarian: 4.1 Terapeutiske indikationer
English: Some patients may develop antibodies to mecasermin.
Bulgarian: Nogle patienter kan udvikle antistoffer over for mecasermin.
English: Data was also collected from post-marketing sources.
Bulgarian: Data blev også indsamlet efter markedsføringen.
English: These studies did not indicate direct or indirect harmful effects with respect to fertility and pregnancy, but due to the different route of application the relevance of these findings is unclear.
Bulgarian: skadelige virkninger med hensyn til fertilitet og graviditet, men på grund af den anderledes indgivelsesvej er relevansen af disse resultater uklar.
English: The effects of mecasermin on the unborn child have not been studied.
Bulgarian: Virkningen af mecasermin på det ufødte barn er ikke blevet undersøgt.
English: Eighty-three (83) out of 92 patients were naïve to INCRELEX at baseline and 81 completed at least one year of INCRELEX treatment.
Bulgarian: 83 ud af 92 patienter var INCRELEX-naive ved baseline, og 81 gennemførte mindst et års behandling med INCRELEX.
English: Common: Melanocytic naevus
Bulgarian: Almindelig: Melanocytisk naevus
English: These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during mecasermin treatment.
Bulgarian: Disse tilstande og andre symptomer og tegn, som generelt er forbundet med GH-behandling, skal monitoreres under behandling med mecasermin.
English: Special Populations
Bulgarian: Særlige populationer
English: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux France
Bulgarian: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux Frankrig
English: Final report by
Bulgarian: Sidste rapport i
English: Name and address of the manufacturer of the biological active substance
Bulgarian: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Paediatric population
Bulgarian: Pædiatrisk population
English: This includes any possible side effects not listed in this leaflet.
Bulgarian: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: Treatment with mecasermin is a long-term therapy.
Bulgarian: Behandling med mecasermin er en længerevarende behandling.
English: Of these, 72 (89%) had Laron syndrome-like phenotype; 7 (9%) had GH gene deletion, 1 (1%) had neutralizing antibodies to GH and 1 (1%) had isolated genetic GH deficiency.
Bulgarian: Ud af disse havde 72 (89 %) Larons syndrom-lignende fænotype; 7 (9 %) havde GHgentab, 1 (1 %) havde neutraliserende antistoffer over for GH, og 1(1 %) havde isoleret genetisk GH-mangel.
English: 5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Bulgarian: 5 ml hætteglas (type I glas) lukket med en prop (bromobutyl/isoprenpolymer) og en forsegling (lakeret plast).
English: • Additional risk minimisation measures
Bulgarian: Yderligere risikominimeringsforanstaltninger
English: Seventy-four (91%) of the subjects were prepubertal at baseline.
Bulgarian: 74 (91 %) af patienterne var præpubertale ved baseline.
English: Of the 115 (28%) subjects who experienced one or more episode of hypoglycaemia, 6 subjects experienced a hypoglycaemic seizure on one or more occasion.
Bulgarian: Af de 115 patienter (28 %), som havde en eller flere episoder med hypoglykæmi, oplevede 6 patienter hypoglykæmiske krampeanfald ved en eller flere lejligheder.
English: Figure 6: Remove air bubbles and refill syringe
Bulgarian: Figur 6: Fjern luftbobler og fyld sprøjten op igen
English: Long-term overdose may result in signs and symptoms of acromegaly or gigantism.
Bulgarian: Overdosering over længere tid kan medføre tegn og symptomer på akromegali eller gigantisme.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Bulgarian: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: 6.6 Special precautions for disposal and other handling INCRELEX is supplied as a multi-dose solution.
Bulgarian: 6.6 Regler for bortskaffelse og anden håndtering INCRELEX leveres som en opløsning til flergangsbrug.
English: • Physician information about INCRELEX (information card, dosing guide, and a dose calculator)
Bulgarian: Lægeinformation om INCRELEX (informationskort, doseringsvejledning og en dosisberegner)
English: IGF-1 has inhibitory effects on insulin secretion.
Bulgarian: IGF-1 har en hæmmende effekt på insulinsekretionen.
English: Mean (SD) for change from pre-Tx
Bulgarian: Middel (SD) for ændring fra pre-Tx
English: Mean (SD)
Bulgarian: Middel (SD)
English: All cases were mild or moderate in severity and none was serious.
Bulgarian: Alle tilfælde var milde eller moderate i
English: INCRELEX should be administered using sterile disposable syringes and injection needles which could be provided by your doctor, pharmacist or nurse.
Bulgarian: INCRELEX skal indgives ved brug af sterile engangssprøjter og injektionskanyler, som kan fås af din læge, farmaceut eller sygeplejerske.
English: Reactions at the injection site
Bulgarian: Reaktioner ved injektionsstedet
English: Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1.
Bulgarian: Personer, som får allergiske reaktioner over for injiceret IGF-1, som har uventede høje blodværdier af IGF-1 efter injektion, eller som ikke udviser et respons i vækst, uden nogen identificeret årsag, kan have et antistofrespons på injiceret IGF-1.
English: Mecasermin should not be used for growth promotion in patients with closed epiphyses.
Bulgarian: Mecasermin må ikke anvendes til vækststimulering hos patienter med lukkede epifyser.
English: Figure 5: Extract correct dose
Bulgarian: Figur 5: Træk den korrekte dosis op
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Bulgarian: Data fra dyrestudier er utilstrækkelige hvad angår reproduktionstoksicitet (se pkt.
English: Injecting the dose:
Bulgarian: Indsprøjtning af dosis:
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Bulgarian: inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Figure A: Lightly pinch the skin and inject as instructed
Bulgarian: Figur A: Knib huden let sammen, og indsprøjt
English: Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth.
Bulgarian: Organvækst: behandling af IGF-1-insufficiente rotter med rhIGF-1 medfører hel krops- og organvækst.
English: Placental transfer of mecasermin was not studied.
Bulgarian: Placental overførsel af mecasermin er ikke undersøgt.
English: The expiry date refers to the last day of the month.
Bulgarian: sidste dag i den nævnte måned.