FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Spectrila for adults is 5,000 U per m² body surface area (BSA) given every third day.
Danish: Den anbefalede dosis af Spectrila for voksne er 5.000 E pr. m² legemsoverfladeareal (BSA), der gives hver tredje dag.
English: The diluted solution of asparaginase should be infused over 0.5 to 2 hours.
Danish: Den fortyndede opløsning med asparaginase infunderes i løbet af 0,5 til 2 timer.
English: No allergic reactions were observed in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Danish: Der blev ikke observeret nogen allergiske reaktioner hos nogen af de 12 spædbørn < 1 år i løbet af behandlingen med Spectrila (studie MC-ASP.6/INF).
English: In case of hyperammonaemia with severe clinical symptoms, therapeutic and pharmacological measures that rapidly reduce plasma ammonia levels (e.g. protein restriction and haemodialysis), reverse catabolic states and increase removal of nitrogen wastes should be initiated and expert advice sought.
Danish: I tilfælde af hyperammonæmi med svære kliniske symptomer bør der tages terapeutiske og farmakologiske forholdsregler, der hurtigt reducerer ammoniakniveauet i plasma (f.eks. proteinrestriktion og hæmodialyse), revertering af kataboliske tilstande og øget elimination af nitrogenaffald bør påbegyndes, og der skal søges ekspertrådgivning.
English: • Medicines which may suppress bone marrow function as these effects may be enhanced by concomitant use of asparaginase.
Danish: • Lægemidler, som kan undertrykke knoglemarvsfunktionen, da disse virkninger kan være forstærket ved samtidig anvendelse af asparaginase.
English: Before and during treatment with Spectrila your doctor will carry out blood tests.
Danish: Din læge vil tage blodprøver før og under behandlingen med Spectrila.
English: • high blood sugar level (hyperglycaemia).
Danish: • højt blodsukker (hyperglykæmi).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001 (1 vial)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1072/001 (1 hætteglas)
English: Asparaginase may induce hyperglycaemia as a consequence of decreased insulin production.
Danish: Asparaginase kan inducere hyperglykæmi som følge af en nedsat insulinproduktion.
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) has been observed during therapy with asparaginase-containing regimens.
Danish: I sjældne tilfælde er der blevet observeret et reversibelt posteriort leukoencefalopatisyndrom (RPLS) i løbet af behandlingsprogrammer indeholdende asparaginase.
English: Increase in transaminases, blood bilirubin, blood alkaline phosphatase, blood cholesterol, blood triglyceride, very low density lipoprotein (VLDL), lipoprotein lipase activity, blood urea, ammonia, blood lactate dehydrogenase (LDH), Decrease in antithrombin III, blood fibrinogen, blood cholesterol, low density lipoprotein (LDL), total protein
Danish: Forhøjede transaminaser, blod-bilirubin, blod-basisk fosfatase, blod-kolesterol, blod-triglycerid, very-low-density-lipoprotein (VLDL), lipoprotein-lipaseaktivitet, blod-urinstof, ammoniak, blod-laktatdehydrogenase (LDH) Nedsat antitrombin III, blod-fibrinogen, blod-kolesterol, lowdensity-lipoprotein (LDL), totalt protein
English: Allergic reactions can manifest as flushing, rash, pain (joint pain, back pain and abdominal pain), hypotension, oedema/angioedema, urticaria, dyspnoea, bronchospasm up to anaphylactic shock.
Danish: Allergiske reaktioner kan manifestere sig som rødme, udslæt, smerter (ledsmerter, rygsmerter og mavesmerter), hypotension, ødem/angioødem, urticaria, dyspnø, bronkospasme op til anafylaktisk shock.
English: • decreased function of the thyroid gland or the parathyroid glands
Danish: • nedsat funktion af skjoldbruskkirtlen eller biskjoldbruskkirtlerne
English: Other medicines and Spectrila
Danish: Brug af anden medicin sammen med Spectrila
English: • low blood sugar level (hypoglycaemia)
Danish: • lavt blodsukker (hypoglykæmi)
English: Hypersensitivity including flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea Common
Danish: Overfølsomhed, herunder rødme, udslæt, hypotension, ødem/angioødem, urticaria, dyspnø
English: • inflammation of the salivary glands (parotitis)
Danish: • betændelse i spytkirtlerne (parotitis)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Spectrila 10.000 E, pulver til koncentrat til infusionsvæske, opløsning Asparaginase
English: Hypersensitivity reactions range from transient flushing or rash and urticaria to bronchospasm, angioedema and anaphylaxis.
Danish: Overfølsomhedsreaktioner varierer fra forbigående rødme eller udslæt og urticaria til bronkospasme, angioødem og anafylaksi.
English: These patients should no longer be treated with any asparaginase preparation (see also sections 4.3 and 4.8).
Danish: Disse patienter bør ikke længere blive behandlet med noget asparaginasepræparat (se også pkt.
English: As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase (see section 4.4).
Danish: Som følge af en hæmmet proteinsyntese falder niveauet af serumprotein (især albumin) meget hyppigt hos patienter i behandling med asparaginase (se pkt.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Danish: BILAG IV VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation.
Danish: Da der ikke kan udelukkes en indirekte interaktion mellem komponenterne i den orale kontraception og asparaginase, anses oral kontraception ikke for at være tilstrækkelig sikker i en sådan klinisk situation.
English: • high blood levels of ammonia (hyperammonaemia)
Danish: • højt niveau af ammoniak i blodet (hyperammonæmi)
English: Most serious side effects of Spectrila include severe hypersensitivity reactions such as anaphylactic shock (rare), thromboembolic events (common), acute pancreatitis (common), and severe hepatotoxicity, e.g. jaundice, hepatic necrosis, hepatic failure (rare).
Danish: De mest alvorlige bivirkninger af Spectrila omfatter svære overfølsomhedsreaktioner, såsom anafylaktisk shock (sjælden), tromboemboliske hændelser (almindelig), akut pankreatitis (almindelig) og svær hepatotoksicitet, f.eks. gulsot, levernekrose, leversvigt (sjælden).
English: • feeling of tiredness
Danish: • træthedsfølelse
English: Common Hypoglycaemia, decreased appetite, weight loss
Danish: Hypoglykæmi, nedsat appetit, vægttab Ikke almindelig
English: • pseudocysts of the pancreas (collections of fluid after acute inflammation of the pancreas)
Danish: • pseudocyster i bugspytkirtlen (ophobning af væske efter akut betændelse i bugspytkirtlen)
English: Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Danish: Leversvigt med muligt dødeligt udfald, levernekrose, kolestase, gulsot
English: • liver problems,
Danish: • problemer med leveren,
English: Thrombosis especially cavernous sinus thrombosis or deep vein thrombosis, haemorrhage
Danish: Trombose, især kavernøs sinustrombose eller dyb venetrombose, blødning
English: In rare cases, haemorrhagic or necrotising pancreatitis occurs.
Danish: I sjældne tilfælde opstår der blødende eller nekrotiserende pankreatitis.
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation (see section 4.6).
Danish: Da der ikke kan udelukkes en indirekte interaktion mellem komponenterne i den orale kontraception og asparaginase, anses oral kontraception ikke for at være tilstrækkelig sikker i en sådan klinisk situation (se pkt.
English: • If you have any further questions, ask your doctor or nurse.
Danish: • Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer):
English: The probability of the occurrence of allergic reactions increases with the number of administered doses; however, in very rare cases reactions can occur at the first dose of asparaginase.
Danish: Sandsynligheden for, at der opstår allergiske reaktioner, øges med antallet af administrerede doser.
English: No anti-asparaginase antibodies were detected in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Danish: Der blev ikke observeret nogen anti-asparaginase-antistoffer hos nogen af de 12 spædbørn < 1 år i løbet af behandlingen med Spectrila (studie MC-ASP.6/INF).
English: confusion, seizures and visual loss)
Danish: forvirring, krampeanfald og synstab)
English: • destruction of liver cells (liver cell necrosis)
Danish: • nedbrydning af leverceller (levercellenekrose)
English: Reporting of side effects
Danish: Tabel over bivirkninger
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase.
Danish: Reversibelt posteriort leukoencefalopatisyndrom (RPLS) kan opstå i sjældne tilfælde i løbet af behandlingen med alle asparaginaser.
English: One vial contains 10,000 units of asparaginase.
Danish: Et hætteglas indeholder 10.000 enheder asparaginase.
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM Pulver til koncentrat til infusionsvæske, opløsning.
English: Qualitatively, the same asparaginase-induced adverse drug reactions are observed in adults and children; however, some of these undesirable effects (e.g. thromboembolic events) are known to occur with a higher frequency in adult patients compared to the paediatric population.
Danish: Nogle af disse bivirkninger (f.eks. tromboemboliske hændelser) vides dog at forekomme med en større hyppighed hos voksne patienter sammenlignet med den pædiatriske population.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 January 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Difference (95 % CIa); P valueb
Danish: Kan ikke evalueres Forskel (95 % CI
English: What Spectrila is and what it is used for What you need to know before you are given Spectrila How to use Spectrila
Danish: Det skal du vide, før du begynder at få administreret Spectrila Sådan skal du bruge Spectrila
English: Anaphylactic shock
Danish: Sjælden Anafylaktisk shock
English: • jaundice
Danish: • gulsot
English: After reconstitution each ml contains 2,500 units of asparaginase.
Danish: Efter rekonstitution indeholder hver ml 2.500 enheder asparaginase.
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe.
Danish: Da der ikke kan udelukkes en indirekte interaktion mellem komponenterne i den orale kontraception(p-piller, svangerskabsforebyggende midler) og asparaginase, anses oral kontraception ikke for at være tilstrækkelig sikker.
English: To aid traceability of rASNase batches and distinction between different ASNase and rASNase products, the product information should include in section 4.4 of the SmPC and relevant section of the PL a prominent statement that the name and batch number of the administered product should be clearly recorded in the patient records.
Danish: 4.4. i produktresuméet og i det relevante punkt i indlægssedlen inkludere en fremtrædende erklæring om, at navnet og batchnummeret for det administrerede præparat skal registreres tydeligt i patientjournalen.
English: • hyperglycaemic conditions.
Danish: • hyperglykæmiske tilstande.
English: After administration of asparaginase, close monitoring of bilirubin, hepatic transaminases, of blood/urinary glucose, coagulation parameters (PTT, PT, antithrombin III, fibrinogen, and D-dimer), amylase, lipase, triglycerides, and cholesterol is recommended.
Danish: Efter administration af asparaginase rådes der til nøje overvågning af bilirubin, levertransaminaser, glucose i blod/urin, koagulationsparametre (PTT, PT, antitrombin III, fibrinogen og D-dimer), amylase, lipase, triglycerider og kolesterol.
English: What Spectrila looks like and contents of the pack Spectrila is provided as a powder for concentrate for solution for infusion.
Danish: Udseende og pakningsstørrelser Spectrila fås som et pulver til koncentrat til infusionsvæske, opløsning.
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8).
Danish: Reversibelt posteriort leukoencefalopatisyndrom (RPLS) kan opstå i sjældne tilfælde under behandlingen med alle asparaginaser (se pkt.
English: Hyperglycaemic conditions Asparaginase may induce hyperglycaemia as a consequence of decreased insulin production.
Danish: Asparaginase kan inducere hyperglykæmi som følge af nedsat insulinproduktion.
English: In rare cases severe liver impairment has been described, including cholestasis, icterus, hepatic necrosis and hepatic failure with fatal outcome (see sections 4.8 and 4.5).
Danish: I sjældne tilfælde er der blevet beskrevet svært nedsat leverfunktion, herunder kolestase, ikterus, levernekrose og leversvigt med dødelig udgang (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10,000 units of asparaginase.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 10.000 enheder asparaginase.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer):
English: Antineoplastic agents
Danish: Antineoplastiske stoffer
English: After administration of any asparaginase preparation, close monitoring of bilirubin, hepatic transaminases, blood/urinary glucose, coagulation parameters (e.g. PTT, PT, antithrombin III, fibrinogen and D-dimer), amylase, lipase, triglycerides and cholesterol is recommended.
Danish: Efter administration af alle slags asparaginasepræparater rådes der til nøje overvågning af bilirubin, levertransaminaser, glucose i blod/urin, koagulationsparametre (f.eks. PTT, PT, antitrombin III, fibrinogen og D-dimer), amylase, lipase, triglycerider og kolesterol.
English: Before initiating therapy bilirubin, hepatic transaminases and coagulation parameters (e.g. partial thromboplastin time [PTT], prothrombin time [PT], antithrombin III and fibrinogen) should be determined.
Danish: Før behandlingen påbegyndes, skal bilirubin, levertransaminaser og koagulationsparametre (f.eks. partiel tromboplastintid [PTT], protrombintid [PT], antitrombin III og fibrinogen) bestemmes.
English: • high blood levels of uric acid (hyperuricaemia)
Danish: • højt niveau af urinsyre i blodet (hyperurikæmi)
English: Common Pain (back pain, joint pain)
Danish: Almindelig Smerter (rygsmerter, ledsmerter)
English: Hyperglycaemic conditions
Danish: Hyperglykæmiske tilstande
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
English: Uncommon Hyperuricaemia, hyperammonaemia
Danish: Hyperurikæmi, hyperammonæmi Sjælden
English: As a consequence of hypoalbuminaemia oedema can occur.
Danish: Som følge af hypoalbuminæmi kan der opstå ødem.
English: • pain (back pain, joint pain, stomach ache)
Danish: • smerter (rygsmerter, ledsmerter, mavepine)
English: The ready-to-use solution may exhibit a slight opalescence.
Danish: Opløsningen, der er klar til brug, kan være let uigennemsigtig.
English: • feeling sick (nausea), being sick (vomiting), stomach ache or watery stools (diarrhoea)
Danish: • kvalme, opkastning, mavepine eller vandig afføring (diarré)
English: Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Danish: Spectrila 10.000 E, pulver til koncentrat til infusionsvæske, opløsning Asparaginase
English: After reconstitution, one ml contains 2,500 units of asparaginase.
Danish: Efter rekonstitution indeholder en ml 2.500 enheder asparaginase.
English: After reconstitution 1 ml contains 2,500 units of asparaginase.
Danish: Efter rekonstitution indeholder 1 ml 2.500 enheder asparaginase.
English: Spectrila 10,000 U powder for concentrate for solution for infusion
Danish: Spectrila 10.000 E, pulver til koncentrat til infusionsvæske, opløsning
English: Very rare
Danish: Meget sjælden Tremor
English: Very common Hyperglycaemia, hypoalbuminaemia
Danish: Hyperglykæmi, hypoalbuminæmi Almindelig
English: Handling
Danish: Håndtering
English: • allergic reactions including serious allergic reaction (anaphylactic shock), flushing, rash, low blood pressure, swelling of face and throat, hives, shortness of breath,
Danish: • allergiske reaktioner, herunder alvorlig allergisk reaktion (anafylaktisk shock), rødme, udslæt,
English: The daily amount of Spectrila needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Danish: Den daglige mængde Spectrila, som er nødvendig til hver patient, kan fortyndes i et endeligt volumen på 50 - 250 ml natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL).
Danish: 14 børn/unge (i alderen 2 - 14 år) med de novo ALL (studie MC-ASP.4/ALL).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning.
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Danish: Den beregnede mængde asparaginase opløses yderligere i 50 til 250 ml natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: Unopened vials
Danish: Lever og galdeveje
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Danish: Den beregnede mængde asparaginase opløses yderligere i 50 til 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Half-life
Danish: Halveringstid
English: Headaches
Danish: Dyslipidæmi
English: The daily amount of asparaginase needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.
Danish: Den daglige mængde asparaginase, som er nødvendig til hver patient, kan fortyndes i et endeligt volumen på 50 - 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: • accumulation of fluid (oedema)
Danish: • væskeophobning (ødem)
English: Tel.: +49 4103 8006-0
Danish: Tlf.: +49 4103 8006-0
English: Tel.: +49-4103-8006-0
Danish: Tlf.: +49-4103-8006-0
English: How to store Spectrila
Danish: Hvis du har fået for meget Spectrila
English: Asparaginase activity
Danish: Nedsat leverfunktion
English: Before initiating therapy bilirubin, hepatic transaminases, and coagulation parameters (partial thromboplastin time [PTT], prothrombin time [PT], antithrombin, fibrinogen, and D-dimer) should be determined.
Danish: Anbefalede kontrolundersøgelser og sikkerhedsforanstaltninger Før behandlingen påbegyndes, skal bilirubin, levertransaminaser og koagulationsparametre (partiel tromboplastintid [PTT], protrombintid [PT], antitrombin, fibrinogen og D-dimer) bestemmes.
English: A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase.
Danish: Mænd bør anvende sikre kontraceptionsmetoder og rådes til ikke at undfange et barn, mens de får asparaginase.
English: 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Saccharose
English: Hepatic impairment
Danish: Ikke almindelig Hovedpine
English: Breast-feeding
Danish: Leversteatose
English: For this reason, your doctor is likely to prescribe more than one [Invented name] for you.
Danish: Derfor kan din læge udskrive mere end en [særnavn] til dig.
English: Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Danish: Nogen gange er en enkelt dosis adrenalin ikke tilstrækkelig til helt at modvirke virkningerne af en alvorlig allergisk reaktion.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Hvis det er hensigtsmæssigt kan produktinformationen efterfølgende opdateres af den relevante myndighed i den enkelte medlemsstat, i samarbejde med referencemedlemsstaten, i overensstemmelse med de procedurer, der er fastlagt i Kapitel 4 artikel III i Direktiv 2001/83/EC.
English: If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Danish: Hvis dine symptomer ikke er blevet bedre indenfor 5-15 minutter efter første injektion, bør du, eller en du er sammen med, indgive endnu en injektion.
English: In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Danish: Hvis der ikke ses klinisk forbedring, eller hvis der sker en forværring, kan yderligere en injektion med [særnavn] administreres 5-15 minutter efter den første injektion.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Danish: Dette produktresumé og denne indlægsseddel er resultatet af en referral procedure.
English: A. Summary of Products Characteristics
Danish: A. Produktresume
English: Section 6 - Contents of the pack and other information
Danish: Afsnit 6 - Pakningsstørrelser og yderligere oplysninger
English: For this reason you should carry more than one [Invented name] with you at all times.
Danish: Derfor bør du altid have mere end en [særnavn] på dig.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante punkter i produktresuméet og indlægssedlen
English: It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the [Invented name] in case support is needed in the emergency situation.
Danish: Det anbefales på det kraftigste, at patientens umiddelbare pårørende - såsom forældre, plejer eller lærer - vejledes i korrekt brug af [særnavn], så de kan hjælpe i en nødsituation.
English: For EpiPen/Nepipe and associated names
Danish: [For EpiPen/Nepipe i forskellige varianter]
English: It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Danish: Din familie, plejer eller lærer bør også vejledes i at bruge [særnavn] korrekt.
English: Section 3 - How to use [Invented name]
Danish: Afsnit 3 - Sådan skal du bruge [særnavn]
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen [Afsnittet skal tilpasses følgende ordlyd]