natgillin/translations-raw huggingface dataset:
EU/ 1/ 01/ 184/ 047 1- pakning id
EU/ 1/ 01/ 184/ 047 1 pack EU/ 1/ 01/ 184/ 059 4 pack ct
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN Læ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION du
242 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
242 Adult patients with chronic renal failure
243 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
243 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
244 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
245 4.4 Special warnings and precautions for use
246 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
246 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
4. 6 Graviditet og amning
247 4.6 Pregnancy and lactation
248 Cancerpatienter
248 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
249 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
249 in vivo activity.
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
250 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
251 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
251 effect (decreased tissue perfusion due to increased blood viscosity).
252 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M
Pakningen indeholder en eller fire fyldt( e) pen( ne) med 30 µg Nespo injektionsvæske, opløsning i 0, 3 ml (100 µg/ ml).
Package containing one or four pre-filled pens of a 30 µg Nespo solution for injection in 0.3 ml (100 µg/ ml).
lg sa 6. 6 Regler for destruktion
252 6.6 Special precautions for disposal
Ikke anvendt lægemiddelanvendte lægemidler samt affald heraf bør destrueres i henhold til lokale ng
ed Rotate the injection sites to avoid discomfort at the site of injection.
retningslinier. læ
is Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 01/ 184/ 048 1- pakning EU/ 1/ 01/ 184/ 060 4- pakning id m
EU/ 1/ 01/ 184/ 048 1 pack EU/ 1/ 01/ 184/ 060 4 pack ct
254 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
254 Adult patients with chronic renal failure
255 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
255 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
256 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
257 4.4 Special warnings and precautions for use
258 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
258 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
4. 6 Graviditet og amning
259 4.6 Pregnancy and lactation
260 Cancerpatienter
260 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
261 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
261 in vivo activity.
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
262 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
263 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
263 effect (decreased tissue perfusion due to increased blood viscosity).
264 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M
Pakningen indeholder en eller fire fyldt( e) pen( ne) med 40 µg Nespo injektionsvæske, opløsning i 0, 4 ml (100 µg/ ml).
Package containing one or four pre-filled pens of a 40 µg Nespo solution for injection in 0.4 ml (100 µg/ ml).
lg sa 6. 6 Regler for destruktion
264 6.6 Special precautions for disposal
Lad den fyldte pen få stuetemperatur før injektion. au Benyt forskellige injektionssteder for at undgå ubehag ved injektionsstedet. e er
ed Rotate the injection sites to avoid discomfort at the site of injection.
EU/ 1/ 01/ 184/ 049 1- pakning EU/ 1/ 01/ 184/ 061 4- pakning id m
EU/ 1/ 01/ 184/ 049 1 pack EU/ 1/ 01/ 184/ 061 4 pack ct
266 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
266 Adult patients with chronic renal failure
267 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
267 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
268 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
269 4.4 Special warnings and precautions for use
270 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
270 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
4. 6 Graviditet og amning
271 4.6 Pregnancy and lactation
272 Cancerpatienter
272 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
273 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
273 in vivo activity.
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
274 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
275 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
275 effect (decreased tissue perfusion due to increased blood viscosity).
276 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M
Pakningen indeholder en eller fire fyldt( e) pen( ne) med 50 µg Nespo injektionsvæske, opløsning i 0, 5 ml (100 µg/ ml).
Package containing one or four pre-filled pens of a 50 µg Nespo solution for injection in 0.5 ml (100 µg/ ml).
lg sa 6. 6 Regler for destruktion
276 6.6 Special precautions for disposal
EU/ 1/ 01/ 184/ 050 1- pakning le
EU/ 1/ 01/ 184/ 050 1 pack EU/ 1/ 01/ 184/ 062 4 pack ct
278 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
278 Adult patients with chronic renal failure
279 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
279 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
280 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
281 4.4 Special warnings and precautions for use
282 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
282 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
4. 6 Graviditet og amning
283 4.6 Pregnancy and lactation
284 Cancerpatienter
284 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Forekomsten af bivirkninger, der betragtes som relaterede til behandling med Nespo udfra kontrollerede kliniske studier, er:
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Forekomst hos forsøgsperson
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
Bivirkning
Adverse Drug Reaction Rash/ Erythema
sa Hud og subkutane væv Vaskulære sygdomme
Vascular disorders
Almindelig (≥ 1/ 100 til < 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
Udslæt- erytem Tromboemboliske hændelser, herunder lungeembolisme
Thromboembolic events, including pulmonary embolism
til Almene symptomer og reaktioner på
General Disorders and Administration Site Conditions
is Erfaring efter markedsføring
ed Postmarketing Experience
or De følgende uønskede reaktioner blev identificeret ved brug af Nespo efter markedsføring:
is The following adverse reactions have been identified during postmarketing use of Nespo:
t • au Erythroblastopenia.
or th • Pure Red Cell Aplasia.
I tilfælde af at er
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
PRCA diagnosticeres, skal behandling med Nespo afbrydes, og patienterne skal ikke skifte til et andet gensplejset erytropoietisk protein (se afsnit 4. 4). ng
In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
• Overfølsomhedsreaktioner, herunder anafylaktiske reaktioner, angioødem, hududslæt og læ
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
urticaria.
4.9 Overdose no
ikke observeret nogle symptomer på overdosering.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
Hvis klinisk indiceret kan le
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
phlebotomi udføres. id m
If clinically indicated, phlebotomy may be performed. ro lp
FARMAKOLOGISKE EGENSKABER ge
PHARMACOLOGICAL PROPERTIES a
285 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
285 in vivo activity.
lg I en prospektiv, randomiseret dobbeltblindt, placebokontrolleret undersøgelse med 314
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
til Kliniske studier har vist, at darbepoetin alfa havde lignende effekt, når denne blev givet som enkelt injektion enten én gang hver tredje uge, én gang hver anden uge eller ugentligt uden øgning i totalt
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
er Sikkerheden og effektiviteten af behandling med Nespo indgivet én gang hver tredje uge med det
ed The safety and effectiveness of once every three weeks dosing of Nespo therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a
is formål at reducere behovet for transfusion af røde blodlegemer hos patienter, som får kemoterapi, blev undersøgt i en randomiseret, dobbeltblind multinational undersøgelse.
is randomised, double-blind, multinational study.
or anæmiske patienter med ikke- myeloide maligniteter, som modtog kemoterapi med flere cyklusser.
or non-myeloid malignancies receiving multi-cycle chemotherapy.
t Patienterne blev randomiseret til at modtage en dosis på 500 μg Nespo én gang hver tredje uge eller au 2, 25 μg/ kg én gang om ugen.
In both groups, the dose was
I begge grupper blev dosis reduceret med 40% i forhold til den tidligere dosis (f. eks. var første dosisreduktion en reduktion til 300 μg i gruppen, der modtog dosis én gang hver tredje uge, og til 1, 35 μg/ kg i gruppen, der modtog dosis én gang om ugen), hvis e hæmoglobintallet steg med mere end 1 g/ dl over en periode på 14 dage.
th reduced by 40% of the previous dose (e. g., for first dose reduction, to 300 μ g in the once every three weeks group and 1.35 μ g / kg in the once weekly group) if haemoglobin increased by more than 1 g/ dl
I gruppen, som modtog dosis er
au in a 14-day period.
én gang om ugen, krævede 75% af patienterne dosisreduktioner.
In the once weekly group, 75% of patients required dose reductions.
i perioden fra uge 5 til slutningen af behandlingsforløbet. e
This study supports 500 μ g once
Der blev ligeledes ri
er every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase. ng In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic lo patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001). no
fundet en reduktion i træthed, målt ved hjælp af ” Functional Assessment of Cancer Therapy- fatigue (FACT- fatigue) ” skala. te
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
Erytropoietin er en vækstfaktor, der hovedsagelig stimulerer dannelsen af røde blodlegemer. le
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
Erytropoietin- receptorer kan være udtrykt i overfladen på en række forskellige tumorceller. id
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Overlevelse og tumorprogression er blevet undersøgt i fem store kontrollerede studier, som omfatter i m
Survival and tumour progression have been examined in five large controlled studies involving a total ro
Heraf var de fire dobbeltblinde placebokontrollerede studier, mens ét var et ublindet- studie.
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Målkoncentrationen ge
The lp
af hæmoglobin i to af studierne var > 13 g/ dl, og i de øvrige tre studier var den 12- 14 g/ dl.
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Det ublindede studiet viste ingen forskel i den samlede overlevelsesrate hos patienter, der blev behandlet Læ
In the open-label study there was no difference in overall survival between patients treated a
med rekombineret humant erytropoietin og kontrolgruppen.
with recombinant human erythropoietin and controls.
I de fire placebokontrollerede studier lå hazard ratioen for den samlede overlevelse på mellem 1, 25 og 2, 47 i kontrolgruppens favør.
In the four placebo-controlled studies the hazard in
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
286 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
287 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
287 effect (decreased tissue perfusion due to increased blood viscosity).
288 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M
Pakningen indeholder en eller fire fyldt( e) pen( ne) med 60 µg Nespo injektionsvæske, opløsning i 0, 3 ml (200 µg/ ml).
Package containing one or four pre-filled pens of a 60 µg Nespo solution for injection in 0.3 ml (200 µg/ ml).
lg sa 6. 6 Regler for destruktion
288 6.6 Special precautions for disposal
Der må ikke administreres mere end én dosis med
Do not administer more than one dose per pen.
Kun opløsninger som er au farveløse, klare eller let opaliserede bør injiceres.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Lad den fyldte pen få stuetemperatur før injektion. e Benyt forskellige injektionssteder og injicer langsomt for at undgå ubehag ved injektionsstedet. er ng
ed Rotate the injection sites to avoid discomfort at the site of injection.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier. læ
is Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 01/ 184/ 051 1- pakning EU/ 1/ 01/ 184 / 4- pakning id m
EU/ 1/ 01/ 184/ 051 1 pack EU/ 1/ 01/ 184/ 063 4 pack ct
290 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
290 Adult patients with chronic renal failure
291 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
291 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
292 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
294 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
294 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
296 Cancerpatienter
296 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
297 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
297 in vivo activity.
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
298 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
299 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
299 effect (decreased tissue perfusion due to increased blood viscosity).
300 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M
Pakningen indeholder en eller fire fyldt( e) pen( ne) med 80 µg Nespo injektionsvæske, opløsning i 0, 4 ml (200 µg/ ml).
Package containing one or four pre-filled pens of a 80 µg Nespo solution for injection in 0.4 ml (200 µg/ ml).
lg sa 6. 6 Regler for destruktion
300 6.6 Special precautions for disposal
Ikke anvendt lægemiddelanvendte lægemidler samt affald heraf bør destrueres i overensstemmelse ng
ed Rotate the injection sites to avoid discomfort at the site of injection.
medhenhold til lokale retningslinier. læ
is Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 01/ 184/ 052 1- pakning id
EU/ 1/ 01/ 184/ 052 1 pack EU/ 1/ 01/ 184/ 064 4 pack ct
302 Behandling med Nespo er delt i to trin – korrigerings - og vedligeholdelsesfase.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
Voksne patienter med kronisk nyresvigt
302 Adult patients with chronic renal failure
303 Nespo (µg/ uge) kan bestemmes ved at dividere hele den ugentlige dosis af r- HuEPO (IE/ uge) med 200.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
303 individual variability, titration to optimal therapeutic doses is expected for individual patients.
25% lavere end den tidligere dosis.
304 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
305 4.4 Special warnings and precautions for use
306 Nespo bør bruges med forsigtighed hos patienter med epilepsi.
Nespo should be used with caution in patients with epilepsy.
Hos disse patienter bør man tilstræbe en
306 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
4. 6 Graviditet og amning
307 4.6 Pregnancy and lactation
308 Cancerpatienter
308 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
309 Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
309 in vivo activity.
lg hæmoglobinkoncentration på under 13 g/ dl, fordi de medtagne data kun indeholder få patienter med
310 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
311 farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Der var bl. a. tale om
311 effect (decreased tissue perfusion due to increased blood viscosity).
312 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container M