natgillin/translations-raw huggingface dataset:
Insert the short injection needle into the pinched skin, holding the syringe like a pencil, use a quick “dart like” motion to insert the injection needle either straight up and down (90 degrees angle) or at a slight angle (45 degrees angle) into the skin, as shown by your health care professional (7).
Z drugo roko primite brizgo, kakor bi držali ● svinčnik in kratko injekcijsko iglo potisnite v kožno gubo s hitrim gibom, podobnim metu pri pikadu, strogo naravnost (pod kotom 90°) ali pod rahlim kotom (45°), kot vam je pokazal vaš zdravstveni strokovnjak (7).
● Inject the solution by gently pushing the plunger all the way down. ● Pull the injection needle straight out of the skin. ● Press on the injection site with a small bandage or sterile gauze for several seconds. ● Do not massage the injection site.
S počasnim pritiskom bata navzdol injicirajte raztopino. ● Injekcijsko iglo iz kože potegnite naravnost. ● Na mesto injiciranja pritisnite majhen ovoj ali sterilno gazo in jo držite nekaj sekund. ● Mesta injiciranja ne masirajte.
Any bleeding may be covered with an adhesive bandage.
Če pride do krvavitve, pokrijte z obližem. ●
Disposal The syringe, needles and all injection materials are intended for single use and must be discarded after the injection.
Odstranjevanje Injekcijska brizga, igla in vsi injekcijski materiali so namenjeni enkratni uporabi in morajo biti po injiciranju uničeni.
Dispose of the syringe and needles safely in a closed container.
V zaprt vsebnik varno spravite injekcijsko brizgo in iglo.
Medicines should not be disposed of via via wastewater or household waste.
Zdravila ne smete odvreči v odpadno vodo ali med gospodinjske odpadke.
247 PACKAGE LEAFLET:
247 NAVODILO ZA UPORABO
MIRCERA 30 micrograms/0.3 ml solution for injection in pre -filled syringe 40 micrograms/0.3 ml solution for injection in pre-filled syringe 50 micrograms/0.3 ml solution for injection in pre-filled syringe 60 micrograms/0.3 ml solution for injection in pre-filled syringe 75 micrograms/0.3 ml solution for injection in pre-filled syringe 100 micrograms/0.3 ml solution for injection in pre-filled syringe 120 micrograms/0.3 ml solution for injection in pre-filled syringe 150 micrograms/0.3 ml solution for injection in pre-filled syringe 200 micrograms/0.3 ml solution for injection in pre-filled syringe 250 micrograms/0.3 ml solution for injection in pre-filled syringe 360 micrograms/0.6 ml solution for injection in pre-filled syringe 400 micrograms/0.6 ml solution for injection in pre-filled syringe 600 micrograms/0.6 ml solution for injection in pre-filled syringe 800 micrograms/0.6 ml solution for injection in pre-filled syringe
MIRCERA 30 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 40 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 50 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 60 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 75 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 100 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 120 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 150 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 200 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 250 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 360 mikrogramov/ 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 400 mikrogramov/ 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 600 mikrogramov/ 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 800 mikrogramov/ 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
248 2.
248 2.
other ingredients of MIRCERA (see section 6)
zdravila MIRCERA (glejte poglavje 6);
- if you have high blood pressure that cannot be controlled
- če imate visok krvni tlak, ki ni obvladljiv.
Take special care with MIRCERA
Bodite posebno pozorni pri uporabi zdravila MIRCERA
- A condition called Pure Red Cell Aplasia (stopped or reduced production of red blood cells) due
- Pri nekaterih bolnikih, zdravljenih z drugimi zdravili za spodbujanje eritropoeze, so opazili
to anti -erythropoietin antibodies was observed in some patients treated with other ESAs.
stanje - imenovano čista aplazija rdečih krvnih celic (prekinjeno ali zmanjšano nastajanje rdečih krvnih celic), ki nastane zaradi protiteles proti eritropoetinu.
- If your doctor suspects or confirms that you have these antibodies in your blood you must not be
- Če vaš zdravnik sumi ali potrdi, da imate ta protitelesa v svoji krvi, se ne smete zdraviti z
treated with MIRCERA.
zdravilom MIRCERA.
- Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl
- Vaš zdravnik lahko uvede zdravljenje z zdravilom MIRCERA, če je vaša koncentracija
(6.21 mmol/l) or less.
hemoglobina 10 g/ dl (6, 21 mmol/ l) ali manj.
After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
Po začetku zdravljenja bo zdravnik skušal vzdrževati vašo koncentracijo hemoglobina med 10 in 12 g/ dl (7, 45 mmol/ l).
- Your doctor will check the amount of iron in your blood before and during MIRCERA
- Zdravnik bo pred in med zdravljenjem z zdravilom MIRCERA preverjal količino železa v vaši
treatment.
krvi.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
249 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
249 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
If you use more MIRCERA than you should Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be necessary to perform some blood tests and interrupt your treatment.
250 Če ste uporabili večji odmerek zdravila MIRCERA, kot bi smeli Prosimo, posvetujte se s svojim zdravnikom ali farmacevtom, če ste uporabili večji odmerek zdravila MIRCERA, kot bi smeli.
250 If you stop using MIRCERA Treatment with MIRCERA is normally long-term.
Če ste prenehali uporabljati zdravilo MIRCERA Zdravljenje z zdravilom MIRCERA je običajno dolgotrajno.
- hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing;
preobčutljivost (alergična reakcija, ki lahko povzroči nenavadno piskanje ali težave z dihanjem;
Do not use MIRCERA after the expiry date which is stated on the outer carton and pre-filled syringe label after ‘EXP’.
Zdravila MIRCERA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in napolnjeni injekcijski brizgi poleg oznake EXP.
Store in a refrigerator (2 °C – 8 °C).
251 Shranjujte v hladilniku (2 °C − 8 °C).
You may remove MIRCERA from the refrigerator and store it at a room temperature not above 25 °C for a single period of one month.
Zdravilo MIRCERA lahko vzamete iz hladilnika samo enkrat in ga shranite pri sobni temperaturi do 25 °C za obdobje enega meseca.
During this period when you have stored MIRCERA at a room temperature not above 25 °C you may not put MIRCERA back in the refrigerator before use.
V tem času, ko ste svoje zdravilo hranili pri sobni temperaturi do 25 °C, pred uporabo zdravila ne smete vrniti nazaj v hladilnik.
251 Ask your pharmacist how to dispose of medicines that are no longer required.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
One pre-filled syringe with
Ena napolnjena injekcijska brizga
0.3 ml or 0.6 ml contains 30, 40, 50, 60, 75, 100, 120, 150, 200, 250 micrograms or 360, 400, 600, 800 micrograms.
z 0, 3 ml ali 0, 6 ml vsebuje 30, 40, 50, 60, 75, 100, 120, 150, 200, 250 mikrogramov ali 360, 400, 600, 800 mikrogramov učinkovine.
What MIRCERA looks like and contents of the pack MIRCERA 0.3 ml or 0.6 ml is a solution for injection in pre-filled syringe.
Izgled zdravila MIRCERA in vsebina pakiranja Napolnjena injekcijska brizga z 0, 3 ml ali 0, 6 ml raztopine za injiciranje zdravila MIRCERA.
MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
Zdravilo MIRCERA je na voljo v napolnjenih injekcijskih brizgah z laminiranim zamaškom in batom ter pokrovom na vrhu in eno injekcijsko iglo 27G1/ 2.
Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Vsaka napolnjena injekcijska brizga vsebuje 0, 3 ali 0, 6 ml raztopine.
One pack contains 1 pre-filled syringe.
Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo.
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Izdelovalec Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Nemčija
Česká republika Roche s. r. o.
252 Malta Česká republika (See United Kingdom) Roche s. r. o.
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
Eesti Österreich Roche Eesti OÜ Tel: + 372 - 6 117 380
253 ---------------------------------------------------------------------------------------------------------------------------
253 Navodilo je bilo odobreno {MM/ LLLL}
HOW TO SELF INJECT MIRCERA
KAKO SI SAMOSTOJNO INJICIRATE ZDRAVILO MIRCERA
The MIRCERA pre-filled syringe is ready for use and can be self-injected by yourself either under the skin or if you are on haemodialysis, through the haemodialysis line according to your doctor’s advice.
Napolnjene injekcijske brizge MIRCERA so pripravljene za uporabo in si jih lahko daste sami pod kožo, če pa se zdravite s hemodializo, boste zdravilo prejeli preko hemodializne krvne linije po zdravnikovih navodilih.
The pre-filled syringe does not contain any preservative and is to be used for one single injection only.
Napolnjena injekcijska brizga ne vsebuje konzervansov in jo lahko uporabimo le za enkratno injiciranje.
More than one dose must not be administered per pre-filled syringe.
Z eno injekcijsko brizgo ne smemo dati več kot enega odmerka.
Store the pre-filled syringe in the outer carton box.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini.
Safety tips ● Make sure that the pre-filled syringe has not been removed from the fridge for more than a single period not extending 1 month. ● Do not use a pre-filled syringe that has been frozen and do not expose it to temperatures above 25°C. ● Do not use a pre-filled syringe after the expiry date stated on the label. ● Only use the pre-filled syringe if the solution is clear, colourless (slightly yellow in colour is acceptable) and is free of visible particles. ● Do not shake the pre-filled syringe, if the solution has been shaken and appears foamy, do not use it (shaking MIRCERA or exposing it to light may damage the medicine). ● When handling the syringe, do not touch the needle. ● Do not use a syringe more than once
Varnostni napotki • Napolnjena injekcijska brizga ne sme biti zunaj hladilnika več kot en mesec in je ne smete vzeti iz hladilnika več kot enkrat. • Ne uporabljajte napolnjene injekcijske brizge, če je bila zmrznjena; poleg tega ne izpostavljajte napolnjenih injekcijskih brizg temperaturi nad 25 °C. • Ne uporabljajte napolnjenih injekcijskih brizg po preteku roka uporabnosti, ki je označen na ovojnini. • Napolnjeno injekcijsko brizgo lahko uporabite le, če je raztopina bistra, brezbarvna (rahlo rumena barva je sprejemljiva) in brez vidnih delcev. • Napolnjene injekcijske brizge ne stresajte in je ne uporabite, če je bila raztopina stresena in je spenjena (stresanje ali izpostavitev zdravila MIRCERA svetlobi lahko poškoduje zdravilo). • Pri ravnanju z brizgo pazite, da se ne boste dotaknili igle. • Brizgo lahko uporabite samo enkrat.
Setting up for an injection Assemble all of the supplies you will need for an injection on a clean surface:
Ovojnina vsebuje: • napolnjeno injekcijsko brizgo z zdravilom MIRCERA in ločeno injekcijsko iglo.
Included in the pack: ● A pre-filled syringe of MIRCERA and a separate injection needle Not included in the pack: ● Cleansing alcohol swabs ● Sterile gauze ● A container for the waste material
V ovojnini ni: • dezinfekcijske krpice, • sterilne gaze, • vsebnika za odpadni material.
The following instructions explain how to use MIRCERA pre-filled syringes to inject yourself.
Naslednja navodila opisujejo, kako si lahko zdravilo MIRCERA z napolnjeno injekcijsko brizgo dajete sami.
Remove the box containing MIRCERA from the refrigerator.
Zdravilo pustite zunaj hladilnika vsaj 30 minut, da se segreje na sobno temperaturo.
Keep the medicine in the box to protect it from light and allow it to reach room temperature for at least 30 minutes
Zdravilo pustite v škatli, da ga zavarujete pred svetlobo.
Remove the plastic tray of MIRCERA from the box without peeling back the protective film.
Iz škatle vzemite plastični omot z zdravilom MIRCERA, vendar zaščitne prevleke še ne odstranjujte.
Wash your hands well with soap and warm water.
Preden boste začeli, si skrbno umijte roke z milom in toplo vodo.
● Peel back plastic foil from plastic tray and remove syringe and needle
• Odlepite plastično folijo s plastičnega omota in vzemite brizgo ter iglo.
Preparing the MIRCERA pre-filled syringe and the needle for injection
254 Priprava napolnjene injekcijske brizge MIRCERA in igle za injiciranje
Grasp the needle firmly in both hands.
Z obema rokama trdno primite iglo.
Break seal of the needle, using a twisting motion and remove the cap.
Z zasukom pretrgajte zaščitno oznako in odstranite pokrovček.
Do not remove the needle shield.
Zaščite na igli ne odstranite.
254 Picture 2.
Slika 2.
Remove the rubber tip cap from the syringe (bend and pull)
Z brizge odstranite gumijasti pokrovček (upognite in povlecite).
Attach the needle to the syringe by pushing firmly together.
Na brizgo pritrdite iglo, tako da ju trdno pritisnete skupaj.
Choose one of the recommended injection sites, arm abdomen or thigh (exept the navel or waistline).
Izberite priporočeno mesto injiciranja na roki, trebuhu ali stegnu (razen področja popka in pasu).
Do not inject MIRCERA into an area that is tender or healing
Zdravila MIRCERA ne injicirajte v mesta, ki so boleča ali se celijo.
Picture 5.
Slika 5.
Clean the site with a new alcohol swab and wait for the area to dry.
Z novo alkoholno krpico očistite mesto injiciranja in počakajte, da se posuši.
Grab syringe and needle shield and pull firmly to remove shield.
Odstranite zaščito na igli, tako da primete brizgo in zaščito na igli ter močno povlecite.
To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Držite brizgo z iglo obrnjeno navzgor, da boste odstranili zračne mehurčke iz brizge.
Tap the syringe gently to bring any bubbles to the top.
Rahlo potrkajte po brizgi, da se bodo mehurčki dvignili proti vrhu.
Push the plunger up slowly to the correct dose, as shown to you by a health care professional.
Bat počasi potisnite navzgor do pravilnega odmerka, kot vam je pokazal zdravstveni strokovnjak.
Injecting the solution If your doctor has advised you to inject MIRCERA through the haemodialysis line or into a vein, please administer your dose as shown by your health care professional.
Injiciranje raztopine Če vam je zdravnik svetoval dajanje zdravila MIRCERA preko hemodializne krvne linije ali v veno, si odmerek injicirajte tako, kot vam je pokazal zdravstveni strokovnjak.
Picture 6.
255 Slika 6.
Insert the needle in a quick, “dart-like” motion.
Kožo stisnite v gubo in vanjo potisnite iglo s hitrim gibom, podobnim metu pri pikadu.
255 Picture 7.
Slika 7.
Slowly push the plunger all the way down until all the medicine is injected.
Bat počasi potiskajte navzdol, dokler ne injicirate celotnega odmerka.
Do not release plunger.
Bata ne sprostite.
Picture 8 Take the needle out of the skin without releasing the plunger.
Pri tem bata še ne smete sprostiti.
Picture 9.
Slika 9.
Release the plunger allowing the needle guard to protect the needle.
Sprostite bat in s tem bo varovalo za iglo zaščitilo iglo.
Place a cotton ball over the injection site.
Na mesto injiciranja pritisnite bombažno blazinico.
Any bleeding may be covered with an adhesive bandage.
Če začne krvaveti, si nanj prilepite obliž.
Disposal The syringe is intended for single use and must be thrown away after the injection.
Odstranjevanje Injekcijska brizga je namenjena enkratni uporabi in jo je treba po injiciranju zavreči.
Dispose of the syringe in a puncture-proof disposal container..
Vrzite jo v vsebnik za odpadke, ki ga igle ne morejo prebosti.
Mixtard is a range of insulin suspensions for injection.
Zdravilo Mixtard obsega različne suspenzije insulina za injiciranje.
Mixtard is supplied in vials, cartridges (PenFill) or pre-filled pens (NovoLet, FlexPen or InnoLet).
Mixtard je na voljo je v vialah, injekcijskih vložkih (PenFill) ali napolnjenih injekcijskih peresnikih (NovoLet, FlexPen ali InnoLet).
Mixtard contains the active substance insulin human (rDNA).
Zdravilo Mixtard vsebuje zdravilno učinkovino humani insulin (rDNA).
Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin: • Mixtard 10: soluble insulin 10% and isophane insulin 90%, • Mixtard 20: soluble insulin 20% and isophane insulin 80%, • Mixtard 30: soluble insulin 30% and isophane insulin 70%, • Mixtard 40: soluble insulin 40% and isophane insulin 60%, • Mixtard 50: soluble insulin 50% and isophane insulin 50%.
50% topnega insulina in 50% insulina izofan
Mixtard is used in patients with diabetes.
Zdravilo Mixtard se uporablja pri bolnikih z diabetesom.
Mixtard is given subcutaneously (under the skin) by injection, usually in the abdominal wall (tummy).
Mixtard se injicira subkutano (pod kožo), navadno v trebušno steno.
If convenient it may also be given in the gluteal region (buttocks) or the deltoid region (shoulder).
Če je primerno, se lahko daje tudi v 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 najnižjega učinkovitega odmerka je potrebno redno spremljati bolnikovo raven glukoze (sladkorja) v krvi.
The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Običajni odmerek je med 0, 3 in 1, 0 mednarodnih enot (i. e.) na kilogram telesne mase na dan.
Mixtard is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Mixtard se navadno daje enkrat ali dvakrat dnevno, kadar je zaželen hiter začetni učinek ob hkratnem dolgotrajnejšem učinku.
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Diabetes je bolezen, pri kateri telo ne tvori dovolj insulina za uravnavanje glukoze v krvi.
Mixtard is a replacement insulin which is identical to the insulin made by the pancreas.
Zdravilo Mixtard je nadomestni insulin, ki je enak insulinu, ki ga proizvaja trebušna slinavka.
The active substance in Mixtard, insulin human (rDNA), is produced by a method known as ‘ recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Zdravilna učinkovina zdravila Mixtard je humani insulin (rDNA), ki je pridobljen z metodo, imenovano „ rekombinantna tehnologija “: pri tej metodi insulin izdelajo kvasovke, ki so prejele ustrezni gen (DNA), s pomočjo katerega postanejo sposobne tvoriti insulin.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Mixtard vsebuje insulin v dveh oblikah: v topni obliki, ki učinkuje hitro (v 30 minutah po injiciranju), ter v „ izofan “ obliki, ki se 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 This gives Mixtard a longer duration of action.
(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 absorbira veliko počasneje v teku dneva, zaradi česar učinkovanje zdravila Mixtard traja dlje časa.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Z nadzorovanjem sladkorja v krvi se zmanjšajo simptomi in zapleti, povezani z diabetesom.
Mixtard has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Zdravilo Mixtard so preučevali pri 294 bolnikih z diabetesom tipa 1, pri katerem trebušna slinavka ne more tvoriti insulina, in z diabetesom tipa 2, pri katerem telo ne more učinkovito izrabiti insulina.
About one- third of the patients had type 1 diabetes and the remainder had type 2 diabetes.
Približno ena tretjina bolnikov je imela diabetes tipa 1, ostali so imeli diabetes tipa 2.
The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Študija je primerjala zdravilo Mixtard 30 s podobno mešanico, ki pa je bila sestavljena iz analognega insulina (insulina aspart).
The study measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 12 weeks, which gives an indication of how well the blood glucose is controlled.
V okviru študije so merili raven glikoziliranega hemoglobina (HbA1c) v krvi po 12 tednih, ki kaže, kako dobro je glukoza v krvi nadzorovana.
What benefit has Mixtard shown during the studies?
Kakšne koristi je zdravilo Mixtard izkazalo med raziskavami?
Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Zdravilo Mixtard je povzročilo znižanje ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kakor pri drugih humanih insulinih.
Mixtard was effective for both type 1 and type 2 diabetes.
Zdravilo Mixtard se je izkazalo kot učinkovito tako za diabetes tipa 1 kot tudi tipa 2.
As with all insulins, Mixtard may cause hypoglycaemia (low blood glucose).
Tako kot vsi insulini tudi zdravilo Mixtard lahko povzroči hipoglikemijo (nizko raven glukoze v krvi).
For the full list of all side effects reported with Mixtard, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mixtard, glejte Navodilo za uporabo.
Mixtard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Zdravila Mixtard se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) humani insulin (rDNA) ali katero koli drugo sestavino zdravila.
Mixtard 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 Mixtard bo morda potrebno prilagoditi, če se zdravilo daje sočasno z drugimi zdravili, ki vplivajo na raven glukoze v krvi.
The Committee for Medicinal products for Human Use (CHMP) decided that Mixtard’ s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Mixtard pri zdravljenju diabetesa večje od z njim povezanih tveganj.
The Committee recommended that Mixtard be given marketing authorisation.
Zato je priporočil, da se za zdravilo Mixtard podeli dovoljenje za promet.
Other information about Mixtard:
Druge informacije o zdravilu Mixtard:
The European Commission granted a marketing authorisation valid throughout the European Union, for Mixtard to Novo Nordisk A/ S on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Mixtard, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 7. oktobra 2002.
The full EPAR for Mixtard can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mixtard je na voljo tukaj.
Route of administration Packaging
Način aplikacije
Content (concentration)
Pakiranje