natgillin/translations-raw huggingface dataset:
Brug ikke SoloStar hvis insulinen er tåget, farvet eller indeholder partikler. • Insulinsuspensionerne (Insulin Human Winthrop Basal eller Insuman blandinger) skal blandes ved at vende SoloStar på hovedet mindst 10 gange, for at opslæmme insulinet igen.
Do not use this SoloStar if insulin is cloudy, coloured or has particles. • The insulin suspensions (Insulin Human Winthrop Basal or Insulin Human Winthrop mixtures) should be mixed by turning SoloStar up and down at least 10 times to resuspend the insulin.
Trin 2.
57 Step 2.
Vælg en dosis på 2 enheder.
Select a dose of 2 units.
56 Hvis der afgives insulin ved nålespidsen, virker pennen og nålen korrekt.
If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
Hvis der kræves en dosis på mere end 80 enheder, skal det gives som to eller flere injektioner.
If you need a dose greater than 80 units, you should give it as two or more injections.
Dette forhindrer smitte og/ eller infektion, at at der kommer luftbobler i insulinen eller lækage af insulin.
This helps prevent contamination and/ or infection, entry of air into the insulin reservoir and leakage of insulin.
Nåle må ikke genbruges.
Needles mut not be reused.
MARKEDSFØRINGSTILLADELSESNUMRE EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX
EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX EU/ 1/ 06/ 368/ XXX
57 1.
59 1.
Insulin Human Winthrop Basal 100 IE/ ml injektionsvæske, suspension, i hætteglas
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a vial
Human insulin i Insulin Human Winthrop Basal fremstilles med rekombinant DNA- teknologi i af Escherichia coli.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Injektionsvæske, suspension i hætteglas.
Suspension for injection in a vial.
Efter opblanding, mælkehvid suspension.
After re-suspension, milky white suspension.
Efter omstilling fra animalsk til human insulin vil dosisreduktion især være påkrævet hos patienter, der:
60 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Insulin Human Winthrop Basal indeholder 100 IE insulin pr. ml suspension.
Insulin Human Winthrop Basal contains 100 IU of insulin per ml suspension.
Insulin Human Winthrop Basal må ikke gives intravenøst og må ikke anvendes i infusionspumper og i eksterne eller implanterede insulinpumper.
Insulin Human Winthrop Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.
Patienter, der er overfølsomme over for Insulin Human Winthrop Basal, men hvor et bedre behandlingsalternativ ikke findes, må kun fortsætte behandlingen under særlig nøje kontrol og - om nødvendigt - i forbindelse med samtidig anti- allergisk behandling.
Patients hypersensitive to Insulin Human Winthrop Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
Hos patienter med nedsat nyrefunktion kan insulinbehovet være reduceret på grund af nedsat insulinmetabolisme.
61 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
59 Hos patienter med svært nedsat leverfunktion kan insulinbehovet mindskes på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Interkurrente sygdomme
62 Intercurrent illness
60 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Stoffer, som kan nedsættee den blodsukkersænkende virkning, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener (f. eks. orale kontraceptiver), phenthiazinderivater, somatropin, sympatomimetika (fx adrenalin, salbutamol, terbutalin) og thyreoideahormoner, proteasehæmmere samt atypisk antipsykotisk medicin (f. eks. olanzapin og clozapin).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Insulin Human Winthrop Rapid kan anvendes under amning.
Insulin Human Winthrop Basal can be used during breastfeeding.
Patienter bør rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel.
63 Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
61 4. 8 Bivirkninger
4.8 Undesirable effects
I kliniske forsøg og anvendelse efter markedsføring varierer hyppigheden mellem patientpopulation og doseringsregimer.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Derfor kan specifik frekvens ikke angives.
Therefore, no specific frequency can be presented.
62 Sygdomme i hud og subkutane væv
64 Skin and subcutaneous tissue disorders
Insulin og insulin- analoger, middellangt virkende, ATC kode:
Insulins and analogues, intermediate-acting, ATC Code:
63 5. 2 Farmakokinetiske egenskaber
65 5.2 Pharmacokinetic properties
Protaminsulphat, metacresol, phenol, zinkklorid, natriumdihydrogenphosphatdihydrat, glycerol, natriumhydroxid, saltsyre (til pH justering), vand til injektionsvæsker.
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Se pkt 6. 6.
Concerning mixing or incompatibility with other insulins see section 6.6.
64 6. 5 Emballagetype og pakningsstørrelser.
66 6.5 Nature and contents of container
5 ml suspension i et hætteglas (type 1 farveløs glas) med ombøjet hætte (aluminium), en prop (chlorbutylgummi (type 1)) og aftageligt låg (polypropylen).
5 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
Insulinet skal rystes op umiddelbart før, det trækkes fra hætteglasset op i injektionssprøjten.
Immediately before withdrawal from the vial into the injection syringe, the insulin must be re- suspended.
Hætteglasset må ikke rystes så kraftigt, at det kan ændre suspensionen (giver injektionsvæsken et rimfrostagtigt udseende, se nedenfor) og forårsage skumdannelse.
Do not shake the vial vigorously as this may lead to changes in the suspension (giving the vial a frosted appearance; see below) and cause frothing.
Dette er tilfældet, hvis fx suspensionen forbliver klar, eller klumper, så partikler eller fnug findes i insulinet eller sætter sig på glassets væg eller bund.
Insulin Human Winthrop Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the vial.
Insulin Human Winthrop Basal må i lighed med andre insulinpræparater ikke blandes med opløsninger, der indeholder reducerende stoffer som thioler og sulfitter.
As with all insulin preparations, Insulin Human Winthrop Basal must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Opmærksomheden henledes på, at protamininsulinkrystaller opløses i sur pH.
It must also be remembered that insulin protamine crystals dissolve in an acid pH range.
Insulin Human Winthrop Basal kan blandes med alle humane insuliner fra Sanofi- Aventis, men IKKE med dem der er designet til anvendelse i insulinpumper.
Insulin Human Winthrop Basal may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Basal må heller IKKE blandes med insuliner af animalsk oprindelse eller med insulinanaloger.
Insulin Human Winthrop Basal must also NOT be mixed with insulins of animal origin or with insulin analogues.
Når to forskellige insulinformer skal trækkes op i i samme injektionssprøjte, tilrådes det at trække det korttidsvirkende insulin op først, så dets hætteglas ikke kontamineres med det langtidsvirkende præparat.
If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
65 9.
67 9.
66 1.
68 1.
Insulin Human Winthrop Basal 40 IE/ ml injektionsvæske, suspension, i hætteglas
Insulin Human Winthrop Basal 40 IU/ ml suspension for injection in a vial
Hver ml indeholder 40 IE human insulin (svarende til1, 4 mg) af det aktive stof insulin human.
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
Human insulin fremstilles med rekombinant DNA- teknologi i af Escherichia coli K.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Efter omstilling fra animalsk til human insulin vil dosisreduktion især være påkrævet hos patienter, der:
69 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
67 Omhyggelig metabolisk kontrol er nødvendig ved præparatomstilling og i de første uger lige efter.
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Insulin Human Winthrop Basal indeholder 40 IE insulin pr. ml suspension.
Insulin Human Winthrop Basal contains 40 IU of insulin per ml suspension.
6. 6.
Fur further details on handling, see section 6.6.
Hos patienter med nedsat nyrefunktion kan insulinbehovet være reduceret på grund af nedsat insulinmetabolisme.
70 In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
68 I tilfælde af utilstrækkelig glukosekontrol eller ved tendens til udvikling af hyper - eller hypoglykæmi skal følgende vurderes inden en eventuel dosisjustering: hvorvidt patienten har overholdt den ordinerede behandlingsforskrift, har fulgt forskrifterne for injektionssteder, anvendt korrekt injektionsteknik, samt hvorvidt øvrige relevante faktorer er opfyldt.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Interkurrente sygdomme
71 Intercurrent illness
69 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Stoffer, som kan forstærke den blodsukkersænkende virkning og som kan øge risikoen for hypoglykæmi, omfatter perorale antidiabetika, angiotensin converting enzym (ACE) - hæmmere, disopyramid, fibrater, fluoxetin, monoamin oxidase (MAO) - hæmmere, pentoxifyllin, propoxyfen, salicylater og sulfonamidantibiotika.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Stoffer, kan nedsætte den blodsukkersænkende virkning, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener (f. eks orale kontraceptiver), phenthiazinderivater, somatropin, sympatomimetika (fx adrenalin, salbutamol, terbutalin) og thyreoideahormoner, proteasehæmmere samt atypisk antipsykotisk medicin (f. eks. olanzapin og clozapin).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Insulin Human Winthrop Basal kan anvendes under amning.
Insulin Human Winthrop Basal can be used during breastfeeding.
70 4. 8 Bivirkninger
72 4.8 Undesirable effects
Lange eller alvorlige hypoglykæmiske episoder kan være livstruende. Ikke kendt (kan ikke estimeres udfra de tilgængelige data).
Prolonged or severe hypoglycaemic episodes may be life-threatening.
(< 1/ 10. 000).
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
71 Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders
Dette forsinker den lokale insulinabsorption.
73 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
72 5. 2 Farmakokinetiske egenskaber
74 5.2 Pharmacokinetic properties
Protaminsulphat, metacresol, phenol, zinkklorid, natriumdihydrogenphosphatdihydrat, glycerol, natriumhydroxid, saltsyre, (til pH justering) vand til injektionsvæsker.
Protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
73 6. 5 Emballagetype og pakningsstørrelser
75 6.5 Nature and contents of container
10 ml suspension i hætteglas (type 1 farveløs glas) med ombøjet hætte (aluminium) en prop chlorbutylgummi (type 1)) og aftageligt låg (polypropylen).
10 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
Plastbeskyttelseshætten fjernes, inden der første gang trækkes insulin opfra hætteglasset.
Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
74 9.
76 9.
75 1.
77 1.
Insulin Human Winthrop Basal 100 IE/ ml injektionsvæske, suspension, i cylinderampul
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a cartridge
Human insulin fremstilles med rekombinant DNA- teknologi i Escherichia coli.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Efter omstilling fra animalsk til human insulin vil dosisreduktion især være påkrævet hos patienter, der:
78 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
76 Omhyggelig metabolisk kontrol er nødvendig ved præparatomstilling og i de første uger lige efter.
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Insulin Human Winthrop Basal i cylinderampuller er udviklet til brug i penne af typen OptiPen.
Insulin Human Winthrop Basal in cartridges has been developed for use in the OptiPen series.
For yderligere information om håndtering, se sektion 6. 6.
For further details on handling, see section 6.6.
77 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
Hos patienter med svært nedsat leverfunktion kan insulinbehovet mindskes på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
79 In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
80 4.5 Interaction with other medicinal products and other forms of interaction
Insulin Human Winthrop Basal kan anvendes under amning..
Insulin Human Winthrop Basal can be used during breastfeeding.
79 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Alvorlige hypoglykæmiske episoder, især tilbagevendende, kan føre til neurologiske skader.
81 Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.
(< 1/ 10. 000), ikke kendt (kan ikke estimeres udfra de tilgængelige data)
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
80 Øjensygdomme
Eyes disorders
Almene lidelser og reaktioner på indgivelsesstedet.
82 General disorders and administration site conditions
81 Virkningsmekanisme
Mode of action
5. 3 Prækliniske sikkerhedsdata
83 5.3 Preclinical safety data
Opbevaringtid efter første anvendelse af cylinderampullen:
Shelf life after first use of the cartridge:
82 Pen med ampul isat må ikke opbevares i køleskab.
The pen containing a cartridge must not be stored in the refrigerator.
Insuma Rapid må ikke komme i direkte berøring med frostbokse eller fryseelementer.
Do not put Insulin Human Winthrop Basal next to the freezer compartment or a freezer pack.
6. 5 Emballagetype og pakningsstørrelser.
84 6.5 Nature and contents of container
3 ml suspension i en cylinderampul (type 1, farveløs glas), med et stempel (brombutylgummi (type 1) og ombøjet låg (aluminium) med en prop (bromobutyl eller laminate af polyisoprene og bromobutylgummi (type 1)).
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
Fremstillerens instruktioner for anvendelse af pennen skal følges nøje for isætning af cylinderampul, påsætning af injektionsnål og administration af insulin injektionen.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.
Hvis insulin- pennen er skadet eller ikke virker ordentligt (pga.. mekaniske fejl) må den kasseres, og en ny insulin pen tages i brug.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Hvis pennen ikke fungerer tilfredsstillende (se instruktionen for brug af pennen), kan suspensionen fra cylinderampullen trækkes op i en injektionssprøjte (der passer til insulin med 100 IE/ ml) og derefter injiceres.
If the pen malfunctions (see instructions for using the pen), the suspension may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ ml) and injected.
Cylinderampuller Insulin Human Winthrop Basal skal før det sættes ind i pennen opbevares ved stuetemperatur i 1
Cartridges Before insertion into the pen, Insulin Human Winthrop Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents.
cylinderampullen frem og tilbage (mindst 10 gange).
This is best done by gently tilting the cartridge back and forth (at least ten times).
Dette er tilfældet, hvis fx suspensionen forbliver klar eller klumper, så partikler eller fnug findes i insulinet eller sætter sig på cylinderampullens væg eller bund.
Insulin Human Winthrop Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.
83 Luftbobler skal så vidt muligt fjernes fra cylinderampullen inden injektionen (se brugsanvisningen for pennen).
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Blandning af insulin
Mixing of insulins
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
85 Any unused product or waste material should be disposed of in accordance with local requirements.
84 1.
86 1.
Insulin Human Winthrop Basal 100 IE/ ml injektionsvæske, suspension i en fyldt pen
Insulin Human Winthrop Basal 100 IU/ ml suspension for injection in a pre-filled pen.
Human insulin i Insulin Human Winthrop Basal fremstilles med rekombinant DNA- teknologi i Escherichia coli.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Injektionsvæske, suspension, i en fyldt pen. OptiSet
OptiSet.
Efter opblanding, mælkehvid suspension..
After re-suspension, milky white suspension.
85 Efter omstilling fra animalsk til human insulin vil dosisreduktion især være påkrævet hos patienter, der:
87 Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Patienter, der er overfølsomme over for Insulin Human Winthrop Basal, men hvor et bedre behandlingsalternativ ikke findes, må kun fortsætte behandlingen under særlig nøje kontrol og – om nødvendigt – i forbindelse med samtidig anti- allergisk behandling.
Patients hypersensitive to Insulin Human Winthrop Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
86 I tilfælde af utilstrækkelig glukosekontrol eller ved tendens til udvikling af hyper - eller hypoglykæmi skal følgende vurderes inden en eventuel dosisjustering: hvorvidt patienten har overholdt den ordinerede behandlingsforskrift, har fulgt forskrifterne for injektionssteder, anvendt korrekt injektionsteknik, samt hvorvidt øvrige relevante faktorer er opfyldt.
88 In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Anvendelse af pennen
89 Handling of the pen
87 Brugsanvisningen i indlægssedlen skal læses omhyggeligt før Optiset anvendes.
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
88 4. 8 Bivirkninger
90 4.8 Undesirable effects
(< 1/ 10. 000), ikke kendt (kan ikke estimeres udfra de tilgængelige data..
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
89 Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders
Dette forsinker den lokale insulinabsorption.
91 As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
90 Farmakodynamiske karakteristika
Pharmacodynamic characteristics
5. 2 Farmakokinetiske egenskaber
92 5.2 Pharmacokinetic properties
91 Penne som er taget i brug:
In-use pens:
6. 5 Emballagetype og pakningsstørrelser (art og indhold)
93 6.5 Nature and contents of container
3 ml suspension i en cylinderampul (type1 farveløs glas) med et stempel (brombutylgummi (type 1)) og ombøjet låg (aluminium) med en prop (bromobutyl eller laminate af polyisoprene og brombutylgummi (type I)).
3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).
Insulin Human Winthrop Basal må ikke anvendes, hvis dette ikke er tilfældet, fx hvis suspensionen forbliver klar eller klumper, så partikler eller fnug findes i insulinet eller sætter sig på cylinderampullens væg eller bund.
Insulin Human Winthrop Basal must not be used if this cannot be achieved, i. e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge.