qanastek/EMEA-V3 huggingface dataset:
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Protaphane buvo tiriamas keturių pagrindinių klinikinių tyrimų metu, kuriuose iš viso dalyvavo 557 pacientai: sergantys I tipo diabetu pacientai, kurių kasa negali gaminti insulino (du tyrimai, 81 pacientas), ir sergantys II tipo diabetu pacientai, kurių organizmas nepajėgia veiksmingai panaudoti insulino (du tyrimai, 476 pacientai).
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
(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 Daugumai pacientų buvo palygintas Protaphane veikimas su kitų žmogaus insulino ar insulino analogo rūšių veikimu.
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.
Tyrimų metu buvo tiriamas gliukozės kiekis kraujyje nevalgius arba kraujyje esančios medžiagos, vadinamos glikuotu hemoglobinu HbA1c, rodiklis, pagal kurį sprendžiama, ar veiksmingai kontroliuojamas gliukozės kiekis kraujyje.
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).
Tolesniuose tyrimuose, kuriuose dalyvavo 225 pacientai, buvo lyginamas Protaphane švirkštimas įprastu švirkštu arba naudojant užpildytą švirkštimo priemonę (InnoLet, NovoPen arba FlexPen).
What benefit has Protaphane shown during the studies?
Kokia Protaphane nauda atsiskleidė tyrimų metu?
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 sumažino HbA1c lygį, o tai rodo, kad gliukozės kiekis kraujyje buvo reguliuojamas panašiai, kaip ir vartojant kitą žmogaus insulino rūšį.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Protaphane buvo veiksmingas gydant abiejų – ir I, ir II – tipų diabetą, kai naudojami įprastiniai švirkštai arba viena iš švirkštimo priemonių.
What is the risk associated with Protaphane?
Kokia su Protaphane vartojimu siejama rizika?
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
Kaip ir visi insulinai Protaphane gali sukelti hipoglikemiją (sumažėjęs cukraus kiekis kraujyje).
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Išsamų visų šalutinių reiškinių, apie kuriuos pranešta gydant Protaphane, sąrašą galima rasti pakuotės lapelyje.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Protaphane negalima skirti žmonėms, kurie gali būti ypač jautrūs (alergiški) žmogaus insulinui, rDNR, arba kuriai nors kitai sudedamajai vaisto daliai.
Protaphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Protaphane dozes gali prireikti koreguoti, jei vartojami kiti vaistai, galintys daryti poveikį gliukozės kiekiui kraujyje.
Why has Protaphane been approved?
Kodėl Protaphane buvo patvirtintas?
The Committee for Medicinal products for Human Use (CHMP) decided that Protaphane’ s benefits are greater than its risks for the treatment of diabetes.
Žmonėms skirtų vaistų komitetas (CHMP) nusprendė, kad gydant diabetą Protaphane teikiama nauda yra didesnė už jo keliamą riziką.
The Committee recommended that Protaphane be given marketing authorisation.
Komitetas rekomendavo suteikti rinkodaros teisę.
Other information about Protaphane:
Kita informacija apie Protaphane:
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Europos Komisija 2002 m. spalio 7 d. bendrovei „ Novo Nordisk A/ S “. suteikė visoje Europos Sąjungoje galiojančią Protaphane rinkodaros teisę.
The full EPAR for Protaphane is available here.
Išsamų Protaphane EPAR galima rasti čia.
Invented Name
Sugalvotas Pavadinimas
Protaphane Protaphane
40 TV/ ml
40 IU/ ml 40 IU/ ml
40 TV/ ml
Suspension for injection Suspension for injection
Injekcinė suspensija
Subcutaneous use Subcutaneous use
Injekcinė suspensija
Vial (glass) Vial (glass)
Buteliukas (stiklo)
1 vial 5 vials
5 buteliukai
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
100 TV/ ml
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Injekcinė suspensija
Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
Užtaisas (stiklo)
1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
10 užtaisų
Protaphane NovoLet 100 IU/ ml Suspension for injection
100 TV/ ml
Subcutaneous use
Injekcinė suspensija
Protaphane InnoLet 100 IU/ ml Suspension for injection
100 TV/ ml
Protaphane FlexPen 100 IU/ ml Suspension for injection
100 TV/ ml
Protaphane 40 IU/ ml Suspension for injection Protaphane 100 IU/ ml Suspension for injection
100 TV/ ml
vial (glass) vial (glass)
Buteliukas (stiklo)
5 x (1 x 10 ml) vials 5 x (1 x 10 ml) vials
5 x 1 buteliukai
Protaphane 40 IU/ ml suspension for injection in a vial.
Protaphane 40 TV/ ml injekcin suspensija buteliuke.
Protaphane is a suspension of isophane (NPH) insulin.
Protaphane yra izofano (NPH) insulino suspensija.
Protaphane is a long-acting insulin.
Protaphane yra ilgai veikiantis insulinas.
Protaphane may be used alone or mixed with fast-acting insulin.
Protaphane gali b ti vartojamas vienas ar sumaišytas su greitai veikian iu insulinu.
Protaphane is administered subcutaneously in the thigh.
Protaphane švirkš iamas po oda, šlaun.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Protaphane parduodami su pakuot s lapeliu vartotojui, kuriame yra išsami vaisto vartojimo instrukcija, ja reikia vadovautis.
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.
Prad jus vartoti Protaphane, jei reikia, doz galima sureguliuoti iš karto arba per pirmas kelet savai i ar m nesi.
On rare occasions, injection site reactions may require discontinuation of Protaphane.
Retais atvejais reikia nutraukti Protaphane vartojim, d l injekcijos vietos reakcij.
Protaphane contains metacresol, which may cause allergic reactions.
Protaphane sud tyje yra metakrezolio, kuris gali sukelti alergines reakcijas.
However, the Protaphane dosage may need to be adjusted.
Ta iau Protaphane doz gali reik ti koreguoti.
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
Klinikini tyrim metu nustatytas nepageidaujam reakcij dažnis, susij s su Protaphane vartojimu, pateikiamas žemiau.
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
Dažnis apib dinamas kaip: nedažni (1/ 1000, iki < 1/ 100).
5 4.9 Overdose
5 4. 9 Perdozavimas
6 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
5.3 Preclinical safety data
6 5. 3 Ikiklinikini saugumo tyrim duomenys
7 6.6 Special precautions for disposal and other handling
6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
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.
7 Iš mus Protaphane buteliuk iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti buteliuk kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane 100 IU/ ml suspension for injection in a vial.
Protaphane 100 TV/ ml injekcin suspensija buteliuke.
12 4.9 Overdose
12 4. 9 Perdozavimas
13 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
5.3 Preclinical safety data
13 5. 3 Ikiklinikini saugumo tyrim duomenys
14 6.6 Special precautions for disposal and other handling
6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
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.
14 Iš mus Protaphane buteliuk iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti buteliuk kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
Protaphane Penfill 100 TV/ ml injekcin suspensija užtaise.
Protaphane is administered subcutaneously in the thigh.
Protaphane paprastai švirkš iamas po oda, šlaun.
17 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.
17 Keletas pacient, kuriems pasireišk hipoglikemija, pakeitus gyvulin insulin kitu, praneš, kad ankstyvieji sp jamieji hipoglikemijos požymiai buvo silpnesni ar kitokie, negu vartojant ankstesnio insulino.
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
Dažnis apib dinamas kaip: nedažni (1/ 1000 iki < 1/ 100).
Isolated spontaneous cases are presented as very rare defined as < 1/ 10,000 including isolated reports.
Pavieniai, spontaniniai atvejai pateikiami kaip labai reti ir apib dinami kaip < 1/ 10000, skaitant pavienius pranešimus.
20 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Pašalinimas Galutin pusin s eliminacijos period nulemia absorbcijos iš poodini audini greitis.
5.3 Preclinical safety data
20 5. 3 Ikiklinikini saugumo tyrim duomenys
21 6.6 Special precautions for disposal and other handling
6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
Užtaisai turi b ti naudojami tik su jais deran iais produktais, leidžian iais veikti saugiai ir efektyviai.
Protaphane Penfill is for single person use only.
21 Protaphane Penfill skirtas vartoti tik vienam asmeniui.
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.
Iš mus Protaphane Penfill iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti Penfill kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane NovoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Protaphane NovoLet is designed to be used with NovoFine needles.
Protaphane NovoLet skirtas naudoti su NovoFine adatomis.
25 4.7 Effects on ability to drive and use machines
4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
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.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
27 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
5.3 Preclinical safety data
27 5. 3 Ikiklinikini saugumo tyrim duomenys
28 6.5 Nature and contents of container
6. 5 Pakuot ir jos turinys
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
Stikliniame užtaise (1 tipo) yra guminis bromobutilo st moklis ir guminis bromobutilo/ poliizopreno kamštis.
6.6 Special precautions for disposal and other handling
28 6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
Protaphane NovoLet is for single person use only.
Protaphane NovoLet skirtas vartoti tik vienam asmeniui.
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.
Iš mus Protaphane NovoLet iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti NovoLet kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane InnoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane InnoLet skirtas naudoti su 8 mm ilgio ar trumpesn mis NovoFine adatomis su dangteliu.
32 4.7 Effects on ability to drive and use machines
4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
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.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
4.9 Overdose
33 4. 9 Perdozavimas
However, hypoglycaemia may develop over sequential stages: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Ta iau galimos šios hipoglikemijos stadijos: • Silpni hipoglikemijos epizodai gali b ti gydomi skiriant geriamosios gliukoz s ar cukraus produkt.
34 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
5.3 Preclinical safety data
34 5. 3 Ikiklinikini saugumo tyrim duomenys
35 6.5 Nature and contents of container
6. 5 Pakuot ir jos turinys
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
Stikliniame (1 tipo) užtaise yra guminis bromobutilo st moklis ir guminis bromobutilo/ poliizopreno kamštis.
6.6 Special precautions for disposal and other handling
35 6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
Protaphane InnoLet is for single person use only.
Protaphane InnoLet skirtas vartoti tik vienam asmeniui.
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.
Iš mus Protaphane InnoLet iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti InnoLet kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane FlexPen 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je.
Protaphane FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane FlexPen skirtas naudoti su 8 mm ilgio ar trumpesn mis NovoFine adatomis su dangteliu.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Protaphane parduodami su pakuot s lapeliu vartotojui, kuriame yra išsami vartojimo instrukcija, ja reikia vadovautis.
39 4.7 Effects on ability to drive and use machines
4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
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.
Generalizuoti padid jusio jautrumo simptomai apima bendr odos išb rim, niež jim, prakaitavim, virškinamojo trakto sutrikim, angioneurozin edem, sunkum kv puoti, širdies plakim, kraujo spaudimo maž jim ir s mon s praradim.
4.9 Overdose
40 4. 9 Perdozavimas
41 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolizmas Pranešama, kad žmogaus insulin skaldo insulino proteaz ar insulin skaldantys enzimai ir galb t proteino disulfido izomeraz.
5.3 Preclinical safety data
41 5. 3 Ikiklinikini saugumo tyrim duomenys
42 6.5 Nature and contents of container
6. 5 Pakuot ir jos turinys
6.6 Special precautions for disposal and other handling
42 6. 6 Special s reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
Protaphane FlexPen is for single person use only.
Protaphane FlexPen skirtas vartoti tik vienam asmeniui.
Insulin preparations which have been frozen must not be used.
Talpykl s iš naujo užpildyti negalima.
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.
Iš mus Protaphane FlexPen iš šaldytuvo, prieš suplakant pagal instrukcijas, kaip nurodyta pirm kart vartojant insulin, rekomenduojama palaikyti FlexPen kambario temperat roje (ne aukštesn je kaip 25 °C), kad sušilt.
Protaphane Penfill and FlexPen
Protaphane Penfill ir FlexPen:
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 TV/ ml injekcin suspensija buteliuke Insulinum humanum (rDNA)
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Laikyti buteliuk išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
Protaphane vial 40 IU/ ml
Protaphane buteliukas, 40 TV/ ml
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 40 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 TV/ ml injekcin suspensija buteliuke Insulinum humanum (rDNA)
Protaphane vial 100 IU/ ml
Protaphane buteliukas, 100 TV/ ml
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 TV/ ml injekcin suspensija buteliuke Žmogaus insulinas (rDNA)
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Laikyti buteliukus išorin je d žut je, kad preparatas b t apsaugotas nuo šviesos.
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Protaphane Penfill 100 TV/ ml injekcin suspensija užtaise Insulinum humanum (rDNA)
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 skirtas vartoti tik vienam asmeniui.
Protaphane Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane Penfill 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane NovoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Insulinum humanum (rDNA)
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
Protaphane NovoLet skirtas vartoti tik vienam asmeniui.
Protaphane NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane NovoLet 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Insulinum humanum (rDNA)
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 skirtas vartoti tik vienam asmeniui.
Protaphane InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane InnoLet 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane FlexPen 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Insulinum humanum (rDNA)
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
Protaphane FlexPen skirtas vartoti tik vienam asmeniui.
EXP/ During use: use within 6 weeks
71 Prad jus vartoti: sunaudoti per 6 savaites.
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
Vartojimo metu: negalima šaldyti ar laikyti aukštesn je kaip 30
Protaphane FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane FlexPen 100 TV/ ml injekcin suspensija Insulinum humanum (rDNA) s. c.
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 TV/ ml injekcin suspensija buteliuke Žmogaus insulinas (insulinum humanum), (rDNR)
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
KAS YRA PROTAPHANE IR KAM JIS VARTOJAMAS
Protaphane is human insulin to treat diabetes.
Protaphane yra žmogaus insulinas, skirtas diabetui gydyti.
Protaphane is often given in combination with fast-acting insulin products.
Protaphane yra dažnai skiriamas kartu su greitai veikian iais insulino preparatais.
BEFORE YOU USE PROTAPHANE
KAS ŽINOTINA PRIEŠ VARTOJANT PROTAPHANE
Do not use Protaphane
Protaphane vartoti negalima
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
7 skyri Kita informacija).
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Daugiau apie hipoglikemij žr.
Take special care with Protaphane
Speciali atsargumo priemoni vartojant Protaphane reikia
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
jei yra inkst, kepen ar antinks i, hipofiz s ar skydliauk s liauk veiklos sutrikim; jei geriate alkohol: steb kite hipoglikemijos simptomus ir niekada negerkite alkoholio nevalg; jei sportuojate daugiau nei paprastai, ar norite pakeisti prast diet; jei sergate: nenutraukite insulino vartojimo; jei vykstate užsien: laiko juost pasikeitimas gali daryti tak J s insulino poreikiui ir švirkštimo laikui.
75 Pregnancy and breast-feeding
75 Vairavimas ir mechanizm valdymas Jei vairuojate ar valdote mechanizmus: steb kite hipoglikemijos simptomus.
If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
J s sugeb jimas susikoncentruoti ar reaguoti gali sumaž ti, esant hipoglikemijai.
Your ability to concentrate or to react will be less during a hypo.
Niekada nevairuokite ir nevaldykite mechanizm, jei jau iate art jan i hipoglikemij.
HOW TO USE PROTAPHANE
KAIP VARTOTI PROTAPHANE
Before using Protaphane
Prieš vartojant Protaphane
Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Dezinfekuokite gumin membran medicinine šluoste.
Do not use Protaphane
Protaphane nevartokite
In insulin infusion pumps If the protective cap is loose or missing.
insulino infuzij pompose; jei apsauginis dangtelis pažeistas, arba jei jo išvis n ra.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyri Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
Protaphane is for injection under the skin (subcutaneously).
Protaphane skirtas injekcijoms po oda.
Protaphane vials are for use with insulin syringes with the corresponding unit scale.
Protaphane buteliukai skirti naudoti insulino švirkštais su atitinkama vienet skale.
To inject Protaphane on its own
Vartojant vien tik Protaphane
To mix Protaphane with fast-acting insulin
Protaphane maišant su greitai veikian iu insulinu
Roll the vial of Protaphane between your hands.
Paritinkite Protaphane buteliuk tarp deln tol, kol skystis bus tolygiai baltas ir drumstas.
Resuspending is easier if the insulin has reached room temperature 2.
76 2. švirkšt pritraukite tiek oro, kiek užima Jums reikalinga Protaphane doz.
Draw as much air into the syringe as the dose of Protaphane you need.
Suleiskite or Protaphane buteliuk, po to ištraukite adat.
Inject the air into the Protaphane vial, then pull out the needle 3.
3. švirkšt pritraukite tiek oro, kiek užima Jums reikalinga greitai veikian io insulino doz.
Now push the needle into the vial of Protaphane.
Dabar adat durkite Protaphane buteliuk.
Draw the right dose of Protaphane into the syringe.
Pritraukite švirkšt reikiam Protaphane doz.
Inject the insulin under the skin.
Suleiskite insulin po oda.
Use the injection technique advised by your doctor or diabetes nurse Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Adat po oda laikykite mažiausiai 6 sekundes, kad sitikintum te, jog buvo suleista visa doz.
They must not give you any food or drink as it could choke you.
Jie turi neduoti Jums jokio maisto ar g rimo, nes J s galite uždusti.
77 Causes of a hypo
Taip gali atsitikti: • jei vartojate per daug insulino; 77 • jei per mažai valgote ar praleidžiate valg; • jei J s fizinis kr vis yra didesnis nei paprastai.
You get a hypo if your blood sugar gets too low.
Jei cukraus kiekis kraujyje tampa per didelis
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
Protaphane, kaip ir kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
Protaphane may cause hypoglycaemia (low blood sugar).
Protaphane gali sukelti hipoglikemij (sumaž j s cukraus kiekis kraujyje).
You may have a very rare serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction).
Jums gali b ti labai reta rimta alergin reakcija Protaphane ar kuriai nors iš pagalbini medžiag (vadinamoji sistemin alergin reakcija).
See also warning in 2 Before you use Protaphane.
Ži r kite sp jim 2 skyriuje Kas žinotina prieš vartojant Protaphane.
This soon disappears.
Prad jus gydytis insulinu, vandens susilaikymas gali sukelti kulkšnies ar kit s nari patinimus.
78 Side effects reported very rarely (in less than 1 patient in 10,000)
Paprastai šis poveikis netrukus praeina.
Vision problems.
Labai retas šalutinis poveikis (re iau nei 1 pacientui iš 10000) 78 Reg jimo sutrikimai.
HOW TO STORE PROTAPHANE
KAIP LAIKYTI PROTAPHANE
Do not use Protaphane after the expiry date which is stated on the label and the carton.
Ant etiket s ar d žut s po „ EXP “ ir „ Tinka iki “ nurodytam tinkamumo laikui pasibaigus, Protaphane vartoti negalima.
See 3 How to use Protaphane.
3 skyri Kaip vartoti Protaphane.
Protaphane must be protected from excessive heat and sunlight.
Protaphane privalo b ti apsaugotas nuo didelio karš io ir saul s spinduli.
Protaphane should not be disposed of via wastewater or household waste.
Protaphane negalima išpilti kanalizacij arba išmesti kartu su buitin mis atliekomis.
What Protaphane contains
Protaphane sud tis
Protaphane is an isophane insulin suspension (NPH).
Veiklioji medžiaga yra rekombinantin s biotechnologijos b du pagamintas žmogaus insulinas. – Protaphane yra izofano (NPH) insulino suspensija.
What Protaphane looks like and contents of the pack
Protaphane išvaizda ir kiekis pakuot je
79 Marketing Authorisation Holder and Manufacturer
79 Rinkodaros teis s tur tojas ir gamintojas
80 PACKAGE LEAFLET:
80 PAKUOT S LAPELIS:
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 TV/ ml injekcin suspensija buteliuke Žmogaus insulinas (insulinum humanum), (rDNR)
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is asymptom of low blood sugar).
Daugiau apie hipoglikemij žr.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyriuje Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
Resuspending is easier if the insulin has reached room temperature 82 2.
82 2. švirkšt pritraukite tiek oro, kiek užima Jums reikalinga Protaphane doz.
Side effects reported very rarely (in less than 1 patient in 10,000)
Labai retas šalutinis poveikis (re iau nei 1 pacientui iš 10000) 84 Reg jimo sutrikimai.
Protaphane Protaphane should not be disposed of via wastewater or household waste.
Protaphane negalima išpilti kanalizacij arba išmesti kartu su buitin mis atliekomis.
Protaphane is an isophane insulin suspension (NPH).
Protaphane sud tis Veiklioji medžiaga yra rekombinantin s biotechnologijos b du pagamintas žmogaus insulinas. – Protaphane yra izofano (NPH) insulino suspensija.
The suspension for injection comes as a cloudy, white, aqueous suspension.
Protaphane išvaizda ir kiekis pakuot je Injekcin suspensija yra drumsta, balta, vandenin suspensija.
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Danija
85 PACKAGE LEAFLET:
86 PAKUOT S LAPELIS:
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Protaphane Penfill 100 TV/ ml injekcin suspensija užtaise Žmogaus insulinas (insulinum humanum), (rDNR)
Do not use Protaphane
Protaphane vartoti negalima:
Take special care with Protaphane
Speciali atsargumo priemoni vartojant Protaphane reikia:
Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper).
Visada patikrinkite Penfill užtais, taip pat ir gumin st mokl.
See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination.
Visada naudokite nauj adat kiekvienai injekcijai, kad išvengtum te užteršimo.
In insulin infusion pumps If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyriuje Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
Do not refill Protaphane Penfill.
Pakartotinai neužpildykite Protaphane Penfill.
If you are treated with Protaphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jei J s gydot s Protaphane Penfill ir kitu insulinu Penfill užtaisuose, tuomet turite naudoti dvi insulino švirkštimo sistemas, po vien kiekvienam insulino tipui.
Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
Patikrinkite, ar užtaise yra lik bent 12 vienet insulino, kad gal tum te sumaišyti.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store Protaphane without the needle attached.
Laikykite Protaphane be adatos.
88 as soon as you are conscious.
Jei gliukagonas nepadeda, J s
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
89 turite b ti gydomas ligonin je.
Diabetic retinopathy (eye background changes).
90 Diabetin retinopatija (aki pagrindo poky iai).
Protaphane is an isophane insulin suspension (NPH).
Protaphane yra izofano (NPH) insulino suspensija.
The suspension for injection comes as a cloudy, white, aqueous suspension.
91 Protaphane išvaizda ir kiekis pakuot je Injekcin suspensija yra drumsta, balta, vandenin suspensija.
90 Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Danija
– If the second and third characters are W5, S6, P5, K7, or ZF Novo Nordisk A/ S, Novo Allé, DK-2880 Bagsværd, Denmark is the manufacturer
- Jei antras ir tre ias simboliai yra W5, S6, P5, K7 ar ZF, tuomet gamintojas yra Novo Nordisk
91 PACKAGE LEAFLET:
92 PAKUOT S LAPELIS:
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane NovoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Žmogaus insulinas (insulinum humanum), (rDNR)
What Protaphane is and what it is used for 2.
Kas yra Protaphane ir kam jis vartojamas 2..
Before you use Protaphane 3.
Kas žinotina prieš vartojant Protaphane 3..
How to use Protaphane 4.
Kaip vartoti Protaphane 4..
How to store Protaphane 7.
Kaip laikyti Protaphane 7.
Protaphane is human insulin to treat diabetesProtaphane is a long-acting insulin.
Protaphane yra ilgai veikiantis insulinas.
92 Using other medicines
93 Kit vaist vartojimas
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
Visada naudokite nauj adat kiekvienai injekcijai, kad išvengtum te užteršimo.
Do not use Protaphane
Protaphane nevartokite:
In insulin infusion pumps If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyriuje Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
The NovoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
96 Prad t vartoti NovoLet ar nešiojam atsargai nereikia laikyti šaldytuve.
After removing the NovoLet from the refrigerator it is recommended to let it reach room
Žr.
It is supplied in packs of 5 or 10 pre-filled pens of 3 ml.
Pakuojama po 1, 5 ar 10 užpildytas švirkštimo priemones po 3 ml.
96 Information on how to use Protaphane NovoLet
97 Informacija kaip naudoti Protaphane NovoLet
Please read the following instructions carefully before using your Protaphane NovoLet.
Prašome atidžiai perskaityti instrukcij prieš naudojant Protaphane NovoLet.
Protaphane NovoLet is a simple, compact pre-filled pen.
Protaphane NovoLet yra paprasta, kompaktiška, insulinu užpildyta švirkštimo priemon.
Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin.
Patikrinkite etiket je, kad sitikintum te, ar J s Protaphane NovoLet yra teisingas insulino tipas.
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
Jei liko • mažiau nei 12 vienet, naudokite nauj Protaphane NovoLet.
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
Š veiksm atlikite mažiausiai 20 kart.
The movement must always be repeated, until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Protaphane NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
B pav.). • Nuimkite didij išorin ir vidin adatos dangtelius.
To avoid injection of air and ensure proper dosing: • Hold Protaphane NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Laikydami adat nukreipt virš, pasukite užtais rodykl s kryptimi per vien • spragtel jim (žr.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Protaphane NovoLet horizontally.
Laikykite Protaphane NovoLet horizontaliai.
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
• sid m kite skai i ant dangtelio ties doz s rodykle. • sid m kite didžiausi matom skai i ant st moklio skal s. • Sud j šiuos du skai ius gausite nustatytos doz s dyd. • Jei nustat te klaiding doz, papras iausiai pasukite dangtel pirmyn arba atgal tol, kol gausite reikiam vienet skai i.
The maximum dose is 78 units • Don’ t try to set a dose higher than 78 units.
100 Didžiausia doz yra 78 vienetai. • Nebandykite nustatyti didesn s nei 78 vienet doz s.
Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Užd kite užpildytos švirkštimo priemon s dangtel ant Protaphane NovoLet taip, kad ties doz s rodykle b t 0.
Dispose of your used Protaphane NovoLet carefully without the needle attached.
Panaudot Protaphane NovoLet išmeskite atsargiai, be adatos.
Your Protaphane NovoLet is designed to work accurately and safely.
J s Protaphane NovoLet pagamintas veikti tiksliai ir saugiai.
Do not refill Protaphane NovoLet.
Pakartotinai neužpildykite Protaphane NovoLet.
You can clean the exterior of your Protaphane NovoLet by wiping it with a medicinal swab.
J s galite valyti Protaphane NovoLet medicinine šluoste.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Žmogaus insulinas (insulinum humanum), (rDNR)
How to store Protaphane 7.
Kaip laikyti Protaphane 7..
Using other medicines
102 Kit vaist vartojimas
Talk to your 102 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Pasakykite savo gydytojui ar vaistininkui, jeigu vartojate ar vartojote kit vaist, skaitant sigytus be recepto, ar jeigu pakeit te j dozes.
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyriuje Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
103 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
103 sp jamieji hipoglikemijos simptomai gali pasireikšti staiga ir tai gali b ti: šaltas prakaitas; šalta, blyški oda; galvos skausmas; dažnas širdies plakimas; šleikštulio jausmas; alkio jausmas; laikini reg jimo poky iai; mieguistumas; ne prastas nuovargis ir silpnumas; nervingumas ar drebulys; neramumo, orientacijos sutrikimo jausmas; sunku susikaupti.
The InnoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
105 Prad t vartoti InnoLet ar nešiojam atsargai nereikia laikyti šaldytuve.
105 Protaphane should not be disposed of via wastewater or household waste.
Protaphane negalima išpilti kanalizacij arba išmesti kartu su buitin mis atliekomis.
106 Information on how to use Protaphane InnoLet
106 Informacija kaip naudoti Protaphane InnoLet
Please read the following instructions carefully before using your Protaphane InnoLet.
Prašome atidžiai perskaityti instrukcij prieš naudojant Protaphane InnoLet.
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Protaphane InnoLet yra paprasta, kompaktiška, insulinu užpildyta švirkštimo priemon, kuria galima sušvirkšti 1 - 50 vienet dozes, didinant doz po 1 vienet.
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Protaphane InnoLet skirtas naudoti su 8 mm ar trumpesn mis NovoFine S adatomis.
Check the label to make sure that your Protaphane InnoLet contains the correct type of insulin.
Patikrinkite etiket je, kad sitikintum te, ar J s Protaphane InnoLet yra teisingas insulino tipas.
If there are less than 12 units left, use a new Protaphane InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Š veiksm atlikite mažiausiai 20 kart.
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Protaphane InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
Nuimkite didij išorin ir vidin adatos dangtelius.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Protaphane InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C) • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
1C pav.). • Laikydami adat nukreipt virš, iki galo nuspauskite st moklio mygtuk ir doz s parink jas rodys nul. • Ant adatos galo privalo pasirodyti insulino lašas.
108 If a drop of insulin still does not appear, the device is defective and must not be used.
108 Jei insulino lašas vis dar nepasirodo, prietaisas yra sugadintas ir jo naudoti negalima.
Dispose of your used Protaphane InnoLet carefully without the needle attached.
Panaudot Protaphane InnoLet išmeskite atsargiai, be adatos.
Your Protaphane InnoLet is designed to work accurately and safely.
J s Protaphane InnoLet pagamintas veikti tiksliai ir saugiai.
Do not refill Protaphane InnoLet.
Pakartotinai neužpildykite Protaphane InnoLet.
You can clean your Protaphane InnoLet by wiping it with a medicinal swab.
J s galite valyti Protaphane InnoLet medicinine šluoste.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane FlexPen 100 TV/ ml injekcin suspensija užpildytoje švirkštimo priemon je Žmogaus insulinas (insulinum humanum), (rDNR)
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
KAS YRA PROTAPHANE IR NUO KO JIS VARTOJAMAS
Using other medicines
111 Kit vaist vartojimas
Talk to your 111 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Pasakykite savo gydytojui ar vaistininkui, jeigu vartojate ar vartojote kit vaist, skaitant sigytus be recepto, ar jeigu pakeit te j dozes.
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
6 skyriuje Kaip laikyti Protaphane); jei jis n ra tolygiai baltas ir drumstas po sumaišymo.
112 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
112 sp jamieji hipoglikemijos simptomai gali pasireikšti staiga ir tai gali b ti: šaltas prakaitas; šalta, blyški oda; galvos skausmas; dažnas širdies plakimas; šleikštulio jausmas; alkio jausmas; laikini reg jimo poky iai; mieguistumas; ne prastas nuovargis ir silpnumas; nervingumas ar drebulys; neramumo, orientacijos sutrikimo jausmas; sunku susikaupti.
113 Side effects reported uncommonly (in less than 1 patient in 100)
Nedažnas šalutinis poveikis (re iau nei 1 pacientui iš 100)
Do not use Protaphane the expiry date which is stated on the label and the carton.
Ant etiket s ar d žut s po „ EXP “ ir „ Tinka iki “ nurodytam tinkamumo laikui pasibaigus, Protaphane vartoti negalima.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
114 Prad t vartoti FlexPen ar nešiojam atsargai nereikia laikyti šaldytuve.
After removing the FlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Žr.
114 Protaphane should not be disposed of via wastewater or household waste.
Protaphane negalima išpilti kanalizacij arba išmesti kartu su buitin mis atliekomis.
Please read the following instructions carefully before using your Protaphane FlexPen.
Prašome atidžiai perskaityti instrukcij prieš naudojant Protaphane FlexPen.
Protaphane FlexPen Pen cap
Protaphane FlexPen Užpildytos švirkštimo priemon s dangtelis
Rubber
Liku io
Cartridge
Rodykl
Residual
Doz s St moklio
Pointer
rutuliukas
Dose
skal
Needle
Apsaugin
tab
plokštel
Preparing your Protaphane FlexPen
Protaphane FlexPen paruošimas
A Let the insulin reach room temperature before you use it.
A Prieš naudojim, leiskite insulinui sušilti iki kambario temperat ros..
116 Pull off the pen cap.
116 Nuimkite užpildytos švirkštimo priemon s dangtel.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
Jei insulino lašas vis dar nepasirodo, prietaisas yra sugadintas ir J s turite naudoti kit prietais.
What is PROTELOS?
Kas yra PROTELOS?
PROTELOS is a medicine containing the active substance strontium ranelate.
PROTELOS – tai vaistinis preparatas, kurio sudėtyje yra veikliosios medžiagos stroncio ranelato.
It is available as 2-g sachets containing yellow granules, which are made up into an oral suspension.
Jis tiekiamas 2 g maišeliais, kuriuose yra geltonos kapsulės geriamajai suspensijai ruošti.
What is PROTELOS used for?
Kam vartojamas PROTELOS?