natgillin/translations-raw huggingface dataset:
Den rekonstituerede vaccine må ikke anvendes, hvis der bemærkes synlige partikler, eller hvis den ikke ser ud som beskrevet ovenfor.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the vaccine differs from that described above.
3 HVORDAN ProQuad ANVENDES.
55 See also section 3 HOW TO USE ProQuad.
Protaphane er en række suspensioner af insulin til injektion.
Protaphane is a range of insulin suspensions for injection.
Protaphane leveres i hætteglas, cylinderampuller (Penfill) eller i fyldte penne (InnoLet, NovoLet og FlexPen).
Protaphane is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Protaphane indeholder det aktive stof insulin human (rDNA).
Protaphane contains the active substance insulin human (rDNA).
Protaphane anvendes til patienter med sukkersyge.
Protaphane is used in patients with diabetes.
Protaphane indsprøjtes subkutant (under huden), sædvanligvis i låret.
Protaphane is given subcutaneously (under the skin) by injection, usually in the thigh.
Hvis det passer bedre, kan det også gives i bugvæggen (maven), i sædemuskelregionen (ballerne) eller i deltamuskelregionen (skulderen).
If convenient it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Protaphane er et langtidsvirkende insulin, der kan indgives som injektion en eller to gange dagligt med eller uden hurtigtvirkende insulin (ved spisetid) efter lægens anvisninger.
Protaphane is a long-acting insulin, it can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Protaphane er et erstatningsinsulin, der er identisk med det insulin, der produceres af bugspytkirtlen.
Protaphane is a replacement insulin which identical to the insulin made by the pancreas.
Det aktive stof i Protaphane, insulin human (rDNA), produceres via en metode, der er kendt som "rekombinant teknologi".
The active substance in Protaphane, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’:
Protaphane indeholder insulin blandet med et andet stof, protamin, i en form, der kaldes "isofan", som optages langsommere dagen igennem Det giver Protaphane en længerevarende virkning.
This gives Protaphane a longer duration of action.
Ved at holde blodglukosen under kontrol mindskes sukkersygesymptomerne og - komplikationerne.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hos størstedelen af patienterne blev Protaphane sammenlignet med andre typer humant insulin eller insulinanaloger.
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
I undersøgelserne målte man blodglukosen i fastende tilstand eller mængden af et stof (glykosyleret hæmoglobin, HbA1c), der viser, hvor godt blodsukkeret reguleres.
The studies measured the level of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Der blev også gennemført yderligere undersøgelser af 225 patienter, hvor man sammenlignede injektion af Protaphane med kanyle eller med brug af en fyldt pen (InnoLet, NovoPen eller FlexPen).
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Hvilken fordel viser undersøgelserne, at der er ved Protaphane?
What benefit has Protaphane shown during the studies?
Protaphane har bevirket et fald i indholdet af HbA1c som tegn på, at blodglukosen er blevet reguleret til et niveau svarende til det, der opnås med andre humane insuliner.
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Protaphane var effektiv til såvel type 1 - som type 2- diabetes og ved anvendelsen af en standardinjektion eller en af pennene.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Protaphane kan medføre hypoglykæmi (for lav blodglukose).
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
Den fuldstændige liste over alle de indberettede bivirkninger ved Protaphane fremgår af indlægssedlen.
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Protaphane bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for insulin human (rDNA) eller et af de øvrige stoffer.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Det kan også være nødvendigt at justere doseringen af Protaphane, når det gives sammen med en række andre lægemidler, der kan indvirke på blodglukosen (den fuldstændige liste fremgår af indlægssedlen).
The full list is available in the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Protaphane er større end risiciene ved behandling af diabetes.
The Committee for Medicinal products for Human Use (CHMP) decided that Protaphane’ s benefits are greater than its risks for the treatment of diabetes.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Protaphane.
The Committee recommended that Protaphane be given marketing authorisation.
Andre oplysninger om Protaphane:
Other information about Protaphane:
Europa- Kommissionen udstedte en markedsføringstilladelse for Protaphane med gyldighed i hele Den Europæiske Union til Novo Nordisk A/ S den 7. oktober 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Den fuldstændige EPAR for Protaphane findes her.
The full EPAR for Protaphane is available here.
Indgivelsesvej
Invented Name
Injektionsvæske, suspension
Route of administration Packaging
10 ml (1, 4 mg/ ml)
Content (concentration)
40 IE/ ml
40 IU/ ml 40 IU/ ml
Injektionsvæske, suspension
Suspension for injection Suspension for injection
Injektionsvæske, suspension
Subcutaneous use Subcutaneous use
10 ml (3, 5 mg/ ml)
Vial (glass) Vial (glass)
1 cylinderampul
1 vial 5 vials
EU/ 1/ 02/ 234/ 007
EU/ 1/ 02/ 234/ 003 EU/ 1/ 02/ 234/ 004 EU/ 1/ 02/ 234/ 005 EU/ 1/ 02/ 234/ 006 EU/ 1/ 02/ 234/ 007
100 IE/ ml
100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection
Injektionsvæske, suspension
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Cylinderampul (glas)
Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
10 cylinderampuller
1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
100 IE/ ml
Protaphane NovoLet 100 IU/ ml Suspension for injection
Injektionsvæske, suspension
Subcutaneous use
100 IE/ ml
Protaphane InnoLet 100 IU/ ml Suspension for injection
100 IE/ ml
Protaphane FlexPen 100 IU/ ml Suspension for injection
Protaphane
Protaphane 40 IU/ ml Suspension for injection Protaphane 100 IU/ ml Suspension for injection
5 x (1 x 10 ml) hætteglas
vial (glass) vial (glass)
10 ml (3. 5 mg/ ml)
10 ml (1.4 mg/ ml) 10 ml (3.5 mg/ ml)
5 x (1 x 10 ml) hætteglas
5 x (1 x 10 ml) vials 5 x (1 x 10 ml) vials
Protaphane 40 IE/ ml injektionsvæske, suspension i et hætteglas
Protaphane 40 IU/ ml suspension for injection in a vial.
Protaphane er en suspension af isophan( NPH) insulin.
Protaphane is a suspension of isophane (NPH) insulin.
ProtaphaneUklar, hvid, vandig suspension.
Cloudy, white, aqueous suspension.
Protaphane kan bruges alene eller blandes med hurtigtvirkende insulin.
Protaphane may be used alone or mixed with fast-acting insulin.
Protaphane administreres subkutant i låret.
Protaphane is administered subcutaneously in the thigh.
ProtaphaneHætteglassene skal anvendes med insulininjektionssprøjter med en tilsvarende enhedsskala.
The vials are for use with insulin syringes with a corresponding unit scale.
Hvis en justering er nødvendig ved skift til Protaphane, kan det vise sig ved første dosis eller inden for de første adskillige uger eller måneder.
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre ophør af behandling med Protaphane.
On rare occasions, injection site reactions may require discontinuation of Protaphane.
Protaphane indeholder metacresol, som kan forårsage allergiske reaktioner.
Protaphane contains metacresol, which may cause allergic reactions.
Det kan dog være nødvendigt at justere Protaphane- dosis.
However, the Protaphane dosage may need to be adjusted.
Frekvensen af bivirkninger fra de kliniske forsøg, som kan betragtes at være relateret til Protaphane, er angivet nedenfor.
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
Frekvenserne er defineret således: ikke almindelig (1/ 1. 000 til, < 1/ 100).
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
6. 6 Regler for destruktion og anden håndtering
7 6.6 Special precautions for disposal and other handling
Efter, at Protaphane hætteglasset er taget ud af køleskabet, bør hætteglasset opnå stuetemperatur (ikke over 25°C) inden insulinet opblandes, som beskrevet første gang.
After removing Protaphane vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
EU/ 1/ 02/ 234/ 001, 002, 016
EU/ 1/ 02/ 234/ 001-002, 016
Protaphane 100 IE/ ml injektionsvæske, suspension i et hætteglas
Protaphane 100 IU/ ml suspension for injection in a vial.
11 4. 8 Bivirkninger
4.8 Undesirable effects
12 • Mild hypoglykæmi kan behandles med oral indtagelse af glucose eller sukkerholdige produkter.
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
EU/ 1/ 02/ 234/ 003, 004, 017
EU/ 1/ 02/ 234/ 003-004, 017
Protaphane Penfill 100 IE/ ml injektionsvæske, suspension i en cylinderampul
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
ProtaphaneCylinderampullerne er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer (flergangspenne) og NovoFine nåle.
Detailed instruction accompanying the delivery system must be followed.
Den detaljerede brugervejledning, der følger med dispenseringssystemet, skal følges.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Efter, at Protaphane Penfill er taget ud af køleskabet, bør Penfill opnå stuetemperatur (ikke over 25°C) inden insulinet opblandes, som beskrevet første gang.
After removing Protaphane Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Protaphane NovoLet 100 IE/ ml injektionsvæske, suspension i en fyldt pen
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
UProtaphaneklar, hvid, vandig suspension.
Cloudy, white, aqueous suspension.
Protaphane Protaphane NovoLet er beregnet til anvendelse sammen med NovoFine nåle.
Protaphane NovoLet is designed to be used with NovoFine needles.
Dosis vælges ved at dreje dosisvælgeren, som nulstilles under injektionen.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
24 rapporteret, at de tidlige advarselssymptomer på hypoglykæmi var mindre udtalte eller forskellige fra dem, som de havde oplevet med deres tidligere insulin.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
25 4.7 Effects on ability to drive and use machines
25 4. 8 Bivirkninger
4.8 Undesirable effects
Immunsystemet Ikke almindelig - Nældefeber, udslæt Meget sjælden - Anafylaktiske reaktioner Symptomer på almen hypersensibilitet kan indbefatte hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken, blodtryksfald og besvimelse/ tab af bevidsthed.
26 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
26 4. 9 Overdosering
4.9 Overdose
Metabolisme Human insulin nedbrydes af insulinprotease eller insulinnedbrydende enzymer og muligvis af disulfidisomeraseproteinet.
27 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
27 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
6. 5 Emballagetype og pakningsstørrelser
28 6.5 Nature and contents of container
Cylinderampullen er af glas (type 1), indeholder et gummistempel af brombutyl og er lukket med en gummiskive af brombutyl/ polyisopren.
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
28 Protaphane NovoLet må kun anvendes af én person.
Protaphane NovoLet is for single person use only.
Efter, at Protaphane NovoLet er taget ud af køleskabet, bør NovoLet opnå stuetemperatur (ikke over 25°C) inden insulinet opblandes, som beskrevet første gang.
After removing Protaphane NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
EU/ 1/ 02/ 234/ 008, 009
EU/ 1/ 02/ 234/ 008-009
Protaphane InnoLet 100 IE/ ml injektionsvæske, suspension i en fyldt pen
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
ProtaphaneProtaphane Innolet er beregnet til anvendelse sammen med korte NovoFine nåle på 8 mm eller derunder.
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
32 4.7 Effects on ability to drive and use machines
Immunsystemet Ikke almindelig - Nældefeber, udslæt Meget sjælden - Anafylaktiske reaktioner Symptomer på almen hypersensibilitet kan indbefatte hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken, blodtryksfald og besvimelse/ tab af bevidsthed.
33 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Metabolisme Human insulin nedbrydes af insulinprotease eller insulinnedbrydende enzymer og muligvis af disulfidisomeraseproteinet.
34 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
6. 5 Emballagetype og pakningsstørrelser
35 6.5 Nature and contents of container
35 Protaphane InnoLet må kun anvendes af én person.
Protaphane InnoLet is for single person use only.
Efter, at Protaphane InnoLet er taget ud af køleskabet, bør InnoLet opnå stuetemperatur (ikke over 25°C) inden insulinet opblandes, som beskrevet første gang.
After removing Protaphane InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Protaphane FlexPen 100 IE/ ml injektionsvæske, suspension i en fyldt pen
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
4. 4).
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
ProtaphaneProtaphane FlexPen er beregnet til anvendelse sammen med korte NovoFine nåle på 8 mm eller derunder.
Protaphane FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
38 Nogle få patienter, som har oplevet hypoglykæmiske reaktioner efter skift fra animalsk insulin, har rapporteret, at de tidlige advarselssymptomer på hypoglykæmi var mindre udtalte eller forskellige fra dem, som de havde oplevet med deres tidligere insulin.
A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Immunsystemet Ikke almindelig - Nældefeber, udslæt Meget sjælden - Anafylaktiske reaktioner Symptomer på almen hypersensibilitet kan indbefatte hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken, blodtryksfald og besvimelse/ tab af bevidsthed.
40 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Metabolisme Human insulin nedbrydes af insulinprotease eller insulinnedbrydende enzymer og muligvis af disulfidisomeraseproteinet.
41 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
6. 5 Emballagetype og pakningsstørrelser
42 6.5 Nature and contents of container
42 Protaphane FlexPen må kun anvendes af én person.
Protaphane FlexPen is for single person use only.
Efter, at Protaphane FlexPen er taget ud af køleskabet, bør FlexPen opnå stuetemperatur (ikke over 25°C) inden insulinet opblandes, som beskrevet første gang.
After removing Protaphane FlexPen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Protaphane Penfill og FlexPen:
Protaphane Penfill and FlexPen
Protaphane 40 IE/ ml injektionsvæske, suspension i et hætteglas Insulin, human (rDNA)
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane hætteglas 40 IE/ ml
Protaphane vial 40 IU/ ml
Protaphane 40 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 100 IE/ ml injektionsvæske, suspension i et hætteglas Insulin, human (rDNA)
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane hætteglas 100 IE/ ml
Protaphane vial 100 IU/ ml
Protaphane 100 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 40 IE/ ml injektionsvæske, suspension i et hætteglas Insulin, human, rDNA
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
56 Må ikke nedfryses Opbevar hætteglasset i den ydre karton for at beskytte mod lys Efter ibrugtagning:
SPECIAL STORAGE CONDITIONS
60 Må ikke nedfryses Opbevar hætteglasset i den ydre karton for at beskytte mod lys Efter ibrugtagning:
SPECIAL STORAGE CONDITIONS
Protaphane Penfill 100 IE/ ml injektionsvæske, suspension i cylinderampul Insulin, human (rDNA)
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Subkutan anvendelse Penfill cylinderampuller er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer Opblandes som angivet i indlægssedlen Læs indlægssedlen inden brug Protaphane Penfill må kun anvendes af én person
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Protaphane Penfill is for use by one person only
Protaphane Penfill 100 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane NovoLet 100 IE/ ml injektionsvæske, suspension i en fyldt pen Insulin, human (rDNA)
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Subkutan anvendelse Protaphane NovoLet er beregnet til anvendelse sammen med NovoFine nåle Opblandes som angivet i indlægssedlen Læs indlægssedlen inden brug Protaphane NovoLet må kun anvendes af én person
Subcutaneous use Protaphane NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Protaphane NovoLet is for use by one person only
Må ikke opbevares i køleskab eller opbevares over 30°C
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
Protaphane NovoLet 100 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane InnoLet 100 IE/ ml injektionsvæske, suspension i en fyldt pen Insulin, human (rDNA)
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Subkutan anvendelse Protaphane InnoLet er beregnet til anvendelse sammen med NovoFine S nåle Opblandes som angivet i indlægssedlen Læs indlægssedlen inden brug Protaphane InnoLet må kun anvendes af én person
Subcutaneous use Protaphane InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Protaphane InnoLet is for use by one person only
Protaphane InnoLet 100 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane FlexPen 100 IE/ ml injektionsvæske, suspension i en fyldt pen Insulin, human (rDNA)
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Beregnet til brug sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm Nålene forhandles separat Opblandes som angivet i indlægssedlen Læs indlægssedlen inden brug Protaphane FlexPen må kun anvendes af én person
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Protaphane FlexPen is for use by one person only
71 Efter ibrugtagning:
EXPIRY DATE
Protaphane FlexPen 100 IE/ ml injektionsvæske, suspension Insulin, human (rDNA) s. c.
Protaphane FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Læs denne indlægsseddel grundigt, inden De begynder at bruge Deres insulin. – Gem indlægssedlen.
Protaphane Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
De kan få brug for at læse den igen. – Spørg lægen, diabetessygeplejersken eller på apoteket, hvis der er mere, De vil vide. – Lægen har ordineret Protaphane til Dem personligt.
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
VIRKNING AF PROTAPHANE, OG HVAD DE SKAL BRUGE DET TIL
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
Protaphane er human insulin til diabetesbehandling.
Protaphane is human insulin to treat diabetes.
Protaphane gives ofte i kombination med hurtigtvirkende insulinprodukter.
Protaphane is often given in combination with fast-acting insulin products.
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE PROTAPHANE
BEFORE YOU USE PROTAPHANE