natgillin/translations-raw huggingface dataset:
Keep the vial in the outer carton in order to protect from light.
Viala naj ostane v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Do not use ProQuad after the expiry date which is stated on the outer carton after EXP.
Ne uporabljajte cepiva ProQuad po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake EXP.
What ProQuad contains
Po pripravi en odmerek (0, 5 ml) vsebuje:
Measles virus1 Enders’ Edmonston strain (live, attenuated).................. not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)............. not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)......................... not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated).............................. not less than 3.99 log10 PFU**
Virus ošpic1, sev Enders 'Edmonston (živ, oslabljen).......................... najmanj 3, 00 log10 CCID50 * Virus mumpsa1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen)............... najmanj 4, 30 log10 CCID50 * Virus rdečk2, sev Wistar RA 27/ 3 (živ, oslabljen).............................. najmanj 3, 00 log10 CCID50 * Virus noric3, sev Oka/ Merck (živ, oslabljen)...................................... najmanj 3, 99 log10 PFU **
*50% cell culture infectious dose ** plaque-forming units
* 50- odstotni infektivni odmerek na celični kulturi (CCID = cell culture infectious dose) ** enote, ki tvorijo plak (PFU = plaque- forming units)
(3) Produced in human diploid cells (MRC-5).
(3) Pridobljen iz človeških diploidnih celic (MRC- 5).
Powder Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.
Prašek Saharoza, hidrolizirana želatina, sečnina, natrijev klorid, sorbitol, mononatrijev glutamat, natrijev fosfat, natrijev hidrogenkarbonat, kalijev fosfat, kalijev klorid, medij 199 s Hanksovimi solmi, MEM, neomicin, fenol rdeče, klorovodikova kislina in natrijev hidroksid.
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, Nizozemska
48 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
49 Za vse informacije o tem zdravilu se lahko obrnete na lokalnega predstavnika imetnika dovoljenja za promet.
Sanofi Pasteur MSD, SA, Tel: +351.21.470.45.50 România:
470. 45. 50 România:
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the vaccine differs from that described above.
50 Pripravljenega cepiva ne uporabite, če v njem opazite delce snovi ali če se njegov videz razlikuje od zgornjega opisa.
49 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno cepivo ali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
See also section 3 HOW TO USE ProQuad.
Glejte tudi poglavje 3 KAKO UPORABLJATI CEPIVO ProQuad.
ProQuad Powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
ProQuad prašek in vehikel za suspenzijo za injiciranje cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
When a person is given the vaccine, the immune system (the body’ s natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Po cepljenju začne imunski sistem (naravna obramba telesa) izdelovati protitelesa proti virusom ošpic, mumpsa, rdečk in noric.
51 Take special care with ProQuad
Bodite posebno pozorni pri cepljenju s cepivom ProQuad
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:
52 Če je pri osebi, ki naj bi bila cepljena, prišlo do kateregakoli od naštetih pojavov, o tem pred cepljenjem s cepivom ProQuad povejte zdravniku ali farmacevtu:
After vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you otherwise.
Po cepljenju s cepivom ProQuad cepljena oseba 1 mesec ne sme dobiti imunoglobulinov ali imunoglobulina proti virusu varicella - zoster, razen če se zdravnik ne odloči drugače.
52 Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Ženske, ki dojijo ali nameravajo dojiti, morajo to povedati zdravniku.
Important information about some of the ingredients of ProQuad
53 Pomembne informacije o nekaterih sestavinah cepiva ProQuad
These included: allergic reactions (hives); seizures with a fever; cough and bronchiolitis (difficulty breathing with or without cough); and unsteadiness with walking.
Ti vključujejo: alergijske reakcije (koprivnico); vročinske krče; kašelj in bronhiolitis, (težko dihanje, s kašljem ali brez); nestabilnost pri hoji.
Store and transport refrigerated (2°C-8°C).
54 Shranjujte in prevažajte v hladilniku (2 °C do 8 °C).
Measles virus1 Enders’ Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)... not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated).................... not less than 3.99 log10 PFU**
Virus ošpic1, sev Enders 'Edmonston (živ, oslabljen).......................... najmanj 3, 00 log10 CCID50 * Virus mumpsa1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen)............... najmanj 4, 30 log10 CCID50 * Virus rdečk2, sev Wistar RA 27/ 3 (živ, oslabljen).............................. najmanj 3, 00 log10 CCID50 * Virus noric3, sev Oka/ Merck (živ, oslabljen)...................................... najmanj 3, 99 log10 PFU **
Solvent Water for injections.
Vehikel Voda za injekcije
What ProQuad looks like and contents of the pack The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided with the vial of powder.
Cepivo je prašek za suspenzijo za injiciranje v enoodmerni viali, ki ga je treba zmešati z vehiklom, priloženim viali s praškom.
54 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
55 Za vse informacije o tem zdravilu se lahko obrnete na lokalnega predstavnika imetnika dovoljenja za promet.
. Inject the entire content of the syringe into the vial containing the powder.
Izbrizgajte celotno vsebino napolnjene injekcijske brizge z vehiklom v vialo s praškom.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the vaccine differs from that described above.
Pripravljenega cepiva ne uporabite, če v njem opazite delce snovi ali če se njegov videz razlikuje od zgornjega opisa.
56
56 Neuporabljeno cepivo ali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
Protaphane is a range of insulin suspensions for injection.
Zdravilo Protaphane obsega različne suspenzije insulina za injiciranje.
Protaphane is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet, NovoLet in FlexPen).
Protaphane contains the active substance insulin human (rDNA).
Zdravilo Protaphane vsebuje zdravilno učinkovino humani insulin (rDNA).
What is Protaphane used for?
Za kaj se uporablja zdravilo Protaphane?
Protaphane is used in patients with diabetes.
Zdravilo Protaphane se uporablja za zdravljenje sladkorne bolezni.
Protaphane is given subcutaneously (under the skin) by injection, usually in the thigh.
Zdravilo Proptaphane se daje s subkutano (podkožno) injekcijo, ponavadi v stegno.
If convenient it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Če je prikladno, se lahko daje tudi v trebušno steno (trebuh), glutealni predel (zadnjico) ali deltoidni predel (rame).
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Za določitev najmanjšega učinkovitega odmerka je potrebno redno spremljati koncentracijo glukoze v krvi bolnika.
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.
Lahko se daje enkrat dnevno ali dvakrat dnevno, z ali brez hitrodelujočega insulina (ob obrokih) v skladu s priporočili zdravnika.
Protaphane is a replacement insulin which identical to the insulin made by the pancreas.
Zdravilo Protaphane je nadomestni insulin, ki je enak insulinu iz trebušne slinavke.
The active substance in Protaphane, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’:
Zdravilna učinkovina zdravila Protaphane je humani insulin (rDNA), ki je izdelan z metodo, imenovano „ rekombinantna tehnologija “: pri tej metodi insulin izdela kvasovka, ki je prejela gen (DNA), s pomočjo katerega lahko tvori insulin.
The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Zdravilo Protaphane vsebuje insulin v zmesi z drugo snovjo, protaminom, v obliki „ izofan “, ki se čez dan veliko počasneje absorbira, kar se odraža v daljšem trajanju delovanja.
Protaphane contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Nadomestni insulin deluje enako kot insulin, ki se tvori naravno, ter omogoča prenos glukoze iz krvi v celice.
This gives Protaphane a longer duration of action.
Z uravnavanjem ravni glukoze v krvi se simptomi in zapleti sladkorne bolezni zmanjšajo.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Zdravilo Protaphane so preučevali v štirih glavnih kliničnih prizkušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa I, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, ki sta vključevali 81 bolnikov), in bolnikov s sladkorno boleznijo tipa II, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, ki sta vključevali 476 bolnikov).
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Pri večini bolnikov so zdravilo Protaphane primerjali z drugimi vrstami humanega insulina ali analogi insulina.
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
(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 V študijah so merili raven sladkorja v krvi na tešče ali snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže učinkovitost uravnavanja ravni glukoze v krvi.
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).
V dodatnih študijah zdravila Protaphane, izvedenih na 225 bolnikih, so delali primerjavo med injiciranjem zdravila Protaphane z brizgo in injiciranjem napolnjenega injekcijskega peresnika (InnoLet, NovoPen ali FlexPen).
What benefit has Protaphane shown during the studies?
Kakšne koristi je zdravilo Protaphane izkazalo med raziskavami?
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.
Zdravilo Protaphane je povzročilo znižanje ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kakor pri drugih humanih insulinih.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Zdravilo Protaphane je bilo učinkovito tako za sladkorno bolezen tipa I kot za sladkorno bolezen tipa II in pri uporabi standardne injekcije ali enega izmed injekcijskih peresnikov.
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
Tako kot vsi insulini, lahko tudi zdravilo Protaphane povzroči hipoglikemijo (nizko raven glukoze v krvi).
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Protaphane, glejte Navodilo za uporabo.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Zdravila Protaphane se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) humani insulin (rDNA) ali katerokoli drugo sestavino zdravila.
Protaphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Odmerke zdravila Protaphane je morda treba prilagoditi, če se dajejo sočasno z drugimi zdravili, ki lahko vplivajo na raven glukoze v krvi.
The Committee for Medicinal products for Human Use (CHMP) decided that Protaphane’ s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Protaphane pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
The Committee recommended that Protaphane be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Protaphane odobri dovoljenje za promet.
Other information about Protaphane:
Druge informacije o zdravilu Protaphane:
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Protaphane, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 7. oktobra 2002.
The full EPAR for Protaphane is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protaphane je na voljo tukaj.
Route of administration Packaging
Vsebnost (koncentracija)
Content (concentration)
uporabo viala (steklena) za subkutano
Protaphane Protaphane
40 i. e. / ml
40 IU/ ml 40 IU/ ml
10 ml (1, 4 mg/ ml)
Suspension for injection Suspension for injection
100 i. e. / ml
Subcutaneous use Subcutaneous use
suspenzija za injiciranje
Vial (glass) Vial (glass)
uporabo viala (steklena) za subkutano uporabo
1 vial 5 vials
5 vial
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 i. e. / ml
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
suspenzija za injiciranje
Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
uporabo injekcijski vložek za subkutano
1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
1 injekcijski vložek
EU/ 1/ 02/ 234/ 008
EU/ 1/ 02/ 234/ 006
Protaphane NovoLet 100 IU/ ml Suspension for injection
100 i. e. / ml
Cartridge (glass) in pre-filled pen
uporabo injekcijski vložek za subkutano
5 pre-filled pens
5 injekcijskih vložkov
EU/ 1/ 02/ 234/ 009
EU/ 1/ 02/ 234/ 007
Cartridge (glass) in pre-filled pen
suspenzija za injiciranje
10 pre-filled pens
10 napolnjenih injekcijskih
EU/ 1/ 02/ 234/ 010
EU/ 1/ 02/ 234/ 009
Protaphane InnoLet 100 IU/ ml Suspension for injection
100 i. e. / ml
Cartridge (glass) in pre-filled pen
uporabo peresniku injekcijski vložek v napolnjenem injekcijskem
EU/ 1/ 02/ 234/ 011
EU/ 1/ 02/ 234/ 010
5 pre-filled pens
5 napolnjenih injekcijskih
EU/ 1/ 02/ 234/ 012
EU/ 1/ 02/ 234/ 011
Cartridge (glass) in pre-filled pen
uporabo peresniku injekcijski vložek v
EU/ 1/ 02/ 234/ 013
EU/ 1/ 02/ 234/ 012
Protaphane FlexPen 100 IU/ ml Suspension for injection
100 i. e. / ml
EU/ 1/ 02/ 234/ 014
EU/ 1/ 02/ 234/ 013
EU/ 1/ 02/ 234/ 015
EU/ 1/ 02/ 234/ 014
Cartridge (glass) in pre-filled pen
uporabo peresniku
Protaphane 40 IU/ ml Suspension for injection Protaphane 100 IU/ ml Suspension for injection
40 i. e. / ml
vial (glass) vial (glass)
uporabo za subkutano uporabo
5 x (1 x 10 ml) vials 5 x (1 x 10 ml) vials
5 x 1 viala
Protaphane 40 IU/ ml suspension for injection in a vial.
Protaphane 40 i. e. / ml suspenzija za injiciranje v viali
Protaphane is a suspension of isophane (NPH) insulin.
Protaphane je suspenzija insulina izofan (NPH) za injiciranje.
Protaphane is a long-acting insulin.
Protaphane je dolgodelujo i insulin.
Protaphane may be used alone or mixed with fast-acting insulin.
Protaphane se lahko uporablja sam ali mešan s hitrodelujo im insulinom.
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
Protaphane se aplicira subkutano v stegno. e je prikladno, je mogo e uporabiti tudi trebušno steno, glutealni predel ali deltoidni predel.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Insulinu Protaphane je priloženo navodilo za uporabo s podrobnimi napotki za uporabo, ki jih je treba upoštevati.
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.
Spremembe jakosti, znamke (izdelovalec), vrste (hitro -, dvojno -, dolgodelujo i insulin itd.), izvora (živalski, humani ali analogni insulin) in/ ali na ina izdelave (rekombinantna DNA ali živalski vir insulina) imajo lahko za posledico spremembo odmerjanja. e je po prehodu bolnikov na Protaphane potrebna prilagoditev, je to lahko potrebno že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
On rare occasions, injection site reactions may require discontinuation of Protaphane.
V redkih primerih utegne biti zaradi reakcij na mestu injiciranja potrebna prekinitev uporabe insulina Protaphane.
Protaphane contains metacresol, which may cause allergic reactions.
Protaphane vsebuje metakrezol, ki lahko povzro i alergijske reakcije.
However, the Protaphane dosage may need to be adjusted.
Potrebna pa utegne biti prilagoditev odmerjanja zdravila Protaphane.
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
Spodaj so navedene pogostnosti neželenih reakcij, ki so po splošni presoji povezane z zdravilom Protaphane.
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
Pogostnosti so opredeljene kot: ob asni (1/ 1. 000 do < 1/ 100).
6 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Izlo anje Kon ni razpolovni as je dolo en s hitrostjo absorpcije iz podkožnega tkiva.
5.3 Preclinical safety data
6 5. 3 Predklini ni podatki o varnosti
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.
Potem ko vialo insulina Protaphane vzamete iz hladilnika, jo je priporo ljivo pustiti, da doseže sobno temperaturo (do 25°C), preden insulin resuspendirate po navodilu za prvo uporabo.
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
7 Suspenzij insulina se ne sme uporabiti, e po resuspendiranju niso enakomerno bele in motne.
Protaphane 100 IU/ ml suspension for injection in a vial.
Protaphane 100 i. e. / ml suspenzija za injiciranje v viali
13 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Izlo anje Kon ni razpolovni as je dolo en s hitrostjo absorpcije iz podkožnega tkiva.
5.3 Preclinical safety data
13 5. 3 Predklini ni podatki o varnosti
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 Potem ko vialo insulina Protaphane vzamete iz hladilnika, jo je priporo ljivo pustiti, da doseže sobno temperaturo (do 25°C), preden insulin resuspendirate po navodilu za prvo uporabo.
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
Protaphane Penfill 100 i. e. / ml suspenzija za injiciranje v injekcijskem vložku
20 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Izlo anje Kon ni razpolovni as je dolo en s hitrostjo absorpcije iz podkožnega tkiva.
5.3 Preclinical safety data
20 5. 3 Predklini ni podatki o varnosti
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
Vložke se sme uporabljati samo z izdelki, s katerimi so kompatibilni in ki omogo ajo varno in u inkovito delovanje vložkov.
Protaphane Penfill is for single person use only.
Protaphane Penfill je namenjen uporabi ene same osebe.
Insulin preparations which have been frozen must not be used.
21 Pripravkov insulina, ki so bili zamrznjeni, se ne sme uporabiti.
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.
Potem ko Protaphane Penfill vzamete iz hladilnika, je priporo ljivo Penfill pustiti, da doseže sobno temperaturo (do 25°C), preden insulin resuspendirate po navodilu za prvo uporabo.
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane NovoLet 100 i. e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku
Protaphane NovoLet is designed to be used with NovoFine needles.
Protaphane NovoLet je namenjen za uporabo z iglami NovoFine.
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.
Spremembe jakosti, znamke (izdelovalec), vrste (hitro -, dvojno -, dolgodelujo i insulin itd.), izvora (živalski, humani ali analogni insulin) in/ ali na ina izdelave (rekombinantna DNA ali živalski vir insulina) imajolahko za posledico spremembo odmerjanja. e je po prehodu bolnikov na Protaphane potrebna prilagoditev, je to lahko potrebno že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
25 4.7 Effects on ability to drive and use machines
25 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
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 tlaka in omedlevica/ izguba zavesti.
27 Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Presnova Opisano je, da se humani insulin razgradi z insulinsko proteazo ali encimi za razgradnjo insulina in morda s proteinsko disulfid- izomerazo.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
27 Izlo anje Kon ni razpolovni as je dolo en s hitrostjo absorpcije iz podkožnega tkiva.
28 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Protaphane NovoLet is for single person use only.
Protaphane NovoLet je namenjen uporabi ene same osebe.
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.
Potem ko Protaphane NovoLet vzamete iz hladilnika, je priporo ljivo NovoLet pustiti, da doseže sobno temperaturo (do 25°C), preden insulin resuspendirate po navodilu za prvo uporabo.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane InnoLet 100 i. e. / ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane InnoLet je namenjen za uporabo z iglami NovoFine s kratkim pokrov kom, dolgimi 8 mm ali manj.