natgillin/translations-raw huggingface dataset:
People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Bolesnici s bolešću MPS I imaju male količine enzima koji se zove α-L-iduronidaza i koji razgrađuje specifične tvari u organizmu (glukozaminoglikane) ili tog enzima uopće nemaju.
The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
na 17% (3/18), a srednja vrijednost mase lijeve klijetke, normalizirana prema tjelesnoj površini, smanjila se za 0,9 Z-vrijednosti (n=17).
Post-marketing experience of infusion-associated reactions revealed reporting of cyanosis, hypoxia, tachypnoea, pyrexia, vomiting, chills and erythema, in which some of these reactions were severe.
Nakon stavljanja lijeka u promet, u sklopu reakcija povezanih s infuzijom prijavljene su cijanoza, hipoksija, tahipneja, pireksija, povraćanje, zimica i eritem.
In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred.
Ako se pojavi blaga ili umjerena reakcija povezana s infuzijom, treba razmotriti primjenu antihistaminika i paracetamola/ibuprofena i/ili smanjenje brzine infuzije na polovicu brzine pri kojoj se reakcija pojavila.
A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens.
Ispitivanje faze IV provedeno je kako bi se ispitali farmakodinamički učinci različitih režima doziranja lijeka Aldurazyme na glikozaminoglikane u mokraći, volumen jetre i 6MWT.
Package leaflet: Information for the user Aldurazyme 100 U/ml concentrate for solution for infusion Laronidase
Uputa o lijeku: Informacije za korisnika Aldurazyme 100 U/ml koncentrat za otopinu za infuziju laronidaza
25 vials of concentrate for solution for infusion.
25 bočica koncentrata za otopinu za infuziju.
MedDRA Preferred term
preporučeni izraz
Infusion 12 Mean ± SD
Infuzija 12
Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus.
Pročišćena laronidaza je glikoprotein, molekularne mase od približno 83 kDa.
This medicinal product contains 1.29 mmol sodium per vial.
Jedna bočica ovog lijeka sadrži 1,29 mmol natrija.
- The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
- Drugi sastojci su natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 80, voda za injekcije.
Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study.
2 U obje je skupine nadmašena najmanja klinički značajna razlika (-0,24) Od 26 bolesnika s povećanom jetrom prije početka liječenja, jetra je postigla normalnu veličinu kod 22 bolesnika (85%) do završetka ispitivanja.
Before dilution, visually inspect each vial for particulate matter and discoloration.
Prije razrjeđivanja vizualno pregledajte svaku bočicu i provjerite sadrži li čestice i je li sadržaj promijenio boju.
Sodium chloride,
Chinese Hamster Ovary,
There are inadequate data on the use of Aldurazyme in pregnant women.
Nema odgovarajućih podataka o primjeni lijeka Aldurazyme kod trudnica.
mean 5.6median 3.0 0.009 0.9 - 8.6
srednja vrijednost medijan 3,0 0,009
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Pomiješane volumene lijeka Aldurazyme dodajte u 0,9% otopinu natrijeva klorida za infuziju (9 mg/ml).
Angioneurotic edema, swelling face, urticaria, pruritus, cold sweat, alopecia, hyperhidrosis
Poremećaji kože i potkožnog tkiva osip angioneurotski edem, oticanje lica, urtikarija, pruritus, hladan znoj, alopecija, hiperhidroza eritrem, edem lica, laringealni edem, periferni edem
A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype).
Provedeno je jednogodišnje otvoreno ispitivanje faze II u kojemu su se uglavnom ocjenjivale sigurnost i farmakokinetika lijeka Aldurazyme kod 20 bolesnika koji su u trenutku uključenja bili mlađi od
Infusion 26 Mean± SD
Infuzija 26
Mix the solution for infusion gently.
Lagano promiješajte otopinu za infuziju.
Nausea, abdominal pain Vomiting, diarrhoea
Poremećaji probavnog sustava mučnina, bol u abdomenu povraćanje, proljev
The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks.
Bolesnici su svaki tjedan tijekom ukupno 52 tjedana primali infuziju lijeka Aldurazyme u dozi od 100 U/kg.
Some of the IARs were severe.
Neke od tih reakcija bile su teške.
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Koncentrat za otopinu za infuziju mora se razrijediti s 0,9% otopinom natrijeva klorida za infuziju (9 mg/ml)
Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Laronidaza je rekombinantni oblik humane α-L-iduronidaze i dobiva se tehnologijom rekombinantne
Cyanosis, hypoxia, tachypnoea, bronchospasm, respiratory arrest
Poremećaji dišnog sustava, prsišta i sredoprsja respiratorni distres, dispneja, kašalj cijanoza, hipoksija, tahipneja, bronhospazam, respiratorni arest
Musculoskeletal pain
• bolovi u mišićima
To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%).
Zbog heterogenih manifestacija bolesti kod različitih bolesnika, odgovor na liječenje mjeren je kompozitnom mjerom ishoda koja je objedinila klinički značajne promjene u pet varijabli djelotvornosti (postotak predviđenog normalnog FVC-a, udaljenost prijeđena u šestominutnom testu, raspon pokretljivosti ramena u fleksiji, indeks apneja/hipopneja i oštrina vida).
The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles.
Otopina mora biti bistra do blago opalescentna te bezbojna do blijedožuta i ne smije sadržavati vidljive čestice.
Psychiatric disorders
Psihijatrijski poremećaji nemir
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
If you are given more Aldurazyme than needed No case of overdose of Aldurazyme has been reported.
Ako primite više lijeka Aldurazyme nego što ste trebali
10 vials of concentrate for solution for infusion.
10 bočica koncentrata za otopinu za infuziju.
In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks.
U ispitivanju faze IV su 33 bolesnika oboljela od MPS I primala lijek prema jednom od sljedeća četiri režima doziranja: 100 U/kg intravenski svaki tjedan (preporučena doza), 200 U/kg i.v. svaki tjedan,
median 38.5 0.066 -2.0 - 79.0
srednja vrijednost medijan 38,5 0,066
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
Very common oxygen saturation decreased Very common
Pretrage povišen krvni tlak vrlo često smanjena zasićenost kisikom vrlo često
Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8).
Aldurazyme se mora primjenjivati uz oprez kod bolesnika u kojih su se razvila protutijela ili simptomi reakcije povezane s infuzijom (vidjeti dijelove 4.3 i 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
KUTIJA (1 BOČICA, 10 BOČICA, 25 BOČICA)
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion laronidase
Aldurazyme 100 U/ml koncentrat za otopinu za infuziju laronidaza
Method of administration Aldurazyme is to be administered as an intravenous infusion.
Aldurazyme se primjenjuje intravenskom infuzijom.
• paleness
• omaglica
Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG.
Kod bolesnika bez protutijela ili s niskom razinom protutijela opaženo je snažno smanjenje glikozaminoglikana (GAG) u mokraći, dok je kod bolesnika s visokim titrom protutijela smanjenje
How Aldurazyme is given
Kako primjenjivati Aldurazyme
Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22.
GAG-a u mokraći u 22. tjednu četvorici je bolesnika doza u posljednjih 26 tjedana povećana na
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80
natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat polisorbat 80 voda za injekcije
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
Aldurazyme je dostupan u obliku koncentrata za otopinu za infuziju.
One ml of the solution in the vial contains 100 U of laronidase.
Jedan mililitar otopine u bočici sadrži 100 U laronidaze.
Dosage
MedDRA
To be taken into consideration by patients on a controlled sodium diet.
O tome treba voditi računa kod bolesnika koji su na režimu prehrane s ograničenjem unosa natrija.
ADRs were all mild to moderate in severity.
Sve su nuspojave bile blage do umjerene težine.
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva artropatija, artralgija,
It is a solution that is clear to slightly opalescent, and colourless to pale yellow.
Ta je otopina bistra do blago opalescentna te bezbojna do blijedožuta.
• tingling
• trnci
Any unused solution should be discarded.
Neupotrijebljenu otopinu nužno je zbrinuti.
Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels.
Vrijednost GAG-a u mokraći smanjila se za 77% u placebo/Aldurazyme skupini, odnosno za 66% u
The following information is intended for healthcare professionals only:
Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Jedna bočica lijeka Aldurazyme namijenjena je isključivo za jednokratnu uporabu.
• swelling of the neck
• proljev • oticanje vrata
• redness of the skin
• ubrzano disanje • crvenilo kože
ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below.
20 bolesnika mlađih od 5 godina i uglavnom teškog fenotipa koji su liječeni najviše 12 mjeseci.
6MWT (meters)
Šestominutni test hodanja (metri)
Severe IARs have been reported in patients with pre-existent severe underlying upper airway involvement and therefore specifically these patients should continue to be closely monitored and only be infused with Aldurazyme in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Prijavljene su teške reakcije povezane s infuzijom kod bolesnika s postojećim teškim podležećim poremećajem gornjih dišnih puteva pa te bolesnike treba i dalje pomno nadzirati, a infuziju lijeka
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase.
1 ml sadrži 100 U laronidaze.
What Aldurazyme contains - The active substance is laronidase.
- Djelatna tvar je laronidaza.
A clear to slightly opalescent, and colourless to pale yellow solution.
Bistra do blago opalescentna te bezbojna do blijedožuta otopina.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial
EU/1/03/253/001 1 bočica EU/1/03/253/002 10 bočica EU/1/03/253/003 25 bočica
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ujedinjeno Kraljevstvo Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion
Aldurazyme 100 U/ml koncentrat za otopinu za infuziju
Arthropathy, arthralgia, back pain, pain in extremity
bol u leđima, bol u ekstremitetima mišićno-koštana bol
Тел.
CHO).
Respiratory distress, dyspnoea, cough
Poremećaji živčanog sustava glavobolja parestezija, omaglica
A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face.
javile su se teške reakcije, uključujući bronhospazam (stezanje dišnih puteva), zastoj disanja i oticanje lica.
Intravenous use
Način primjene
Elderly
Aldurazyme.
Vistor hf.
Primjena u venu.
Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Iz infuzijske vrećice izvucite i bacite volumen 0,9% otopine natrijeva klorida za infuziju
Hypotension, pallor, peripheral coldness
Krvožilni poremećaji crvenilo praćeno osjećajem užarenosti hipotenzija, bljedoća, periferna hladnoća
General disorders and administration site conditions pyrexia
Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često zimica vrlo često
This is done once and is called the ‘activation' process.
To se radi samo jednom, a naziva se postupkom ‘aktivacije'.
This is used in exactly the same way.
Ona se upotrebljava na posve isti način.
Thereafter, they progressively decreased during the following weeks.
Nakon toga se njihova učestalost narednih tjedana progresivno smanjivala.
Using the wrong medicine could be harmful to your health.
Uporaba pogrešnog lijeka može naškoditi Vašem zdravlju.
If it is orange, go to Section 2.
Ako je narančaste boje, idite na dio 2.
Your dose has now been given.
Sada ste primili svoju dozu.
Steps 1 to 5 below show you how to do this.
Koraci 1 do 5 navedeni u nastavku prikazuju kako se to radi.
For your first injection go directly to Section 3 - Step C.
Za prvu injekciju idite odmah na dio 3 - korak C.
The most important points are:
Najvažnije su sljedeće:
Small air bubbles in the container are normal - they will not harm you.
Mali mjehurići zraka u spremniku normalna su pojava - oni Vam neće naškoditi.
After first use: 14 days
Nakon prve primjene: 14 dana
Printed on the inside:
Otisnuto na unutarnjoj strani:
Both pens are used in the same way.
Obje brizgalice upotrebljavaju se na isti način.
Section 1 - IMPORTANT INFORMATION
Dio 1 - VAŽNE INFORMACIJE
Your dose will be correct and you can keep following the instructions.
Doza koju ćete primijeniti je točna pa možete nastaviti slijediti upute.
Do not take two doses at the same time to make up for a forgotten injection.
Nemojte primijeniti dvije doze u isto vrijeme kako biste nadoknadili zaboravljenu injekciju.
Do this even if there is some medicine left in the pen.
Učinite to čak i ako je u brizgalici ostala mala količina lijeka.
What if there are air bubbles in the container?
Što ako u spremniku ima mjehurića zraka?
Specific recommendations regarding intake of such medicinal products are given in section 4.5.
Posebne preporuke o uzimanju takvih lijekova navedene su u dijelu 4.5.
Check the liquid.
Pregledajte tekućinu.
There is no need to measure each dose.
Nema potrebe za odmjeravanjem svake pojedine doze.
• a basal insulin, a type of insulin which works all day.
• bazalni inzulin, vrsta inzulina koja djeluje cijeli dan.
A treatment initiation pack is also available for use during the first 28 days of treatment.
Dostupno je i pakiranje za početak liječenja namijenjeno za uporabu tijekom prvih 28 dana liječenja.
The arrow will now be pointing towards the needle.
Strelica je sada usmjerena prema igli.
Stop taking Lyxumia and contact a doctor immediately if you notice any of the following serious side effects:
Prestanite uzimati lijek Lyxumia i odmah kontaktirajte liječnika ako primjetite neku od sljedećih ozbiljnih nuspojava:
• If you cannot follow all the instructions completely on your own, or are not able to handle the pen
• Ako ne možete potpuno sami slijediti sve upute ili ne možete rukovati brizgalicom (primjerice,
Do not try to repair the pen.
Nemojte pokušavati popraviti brizgalicu.
Insulin glulisine TID
Insulin glulizin TID
In the example above, the dose number shows there are 13 injections left.
U gornjem primjeru broj doze pokazuje da je preostalo još 13 injekcija.
The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment.
Većina reakcija bila je blagog intenziteta i obično nije rezultirala prekidom liječenja.
Similar HbA1c decreases were observed regardless of which meal was the main meal (breakfast, lunch or dinner).
Zabilježeno je slično smanjenje vrijednosti HbA1c neovisno o tome koji je obrok bio glavni obrok (doručak, ručak ili večera).
• Before injecting a dose - before injecting you must first remove excess liquid from your new pen.
• Prije injiciranja doze - prije injiciranja morate prvo izbaciti višak tekućine iz nove brizgalice.
You must first use all 14 doses from this pen.
Morate primijeniti svih 14 doza iz te brizgalice.
(-2.593 to -1.396)*
(-2,593 do -1,396)*
Attach a new needle and repeat Steps D and E only.
Pričvrstite novu iglu i ponovite samo korake D i E.
The pen can be used for 14 days when stored at a temperature below 30°C.
Brizgalica se može upotrebljavati 14 dana ako se čuva na temperaturi ispod 30°C.
Frequencies of adverse reactions are defined as: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Učestalost nuspojava definirana je kao: vrlo često: ≥ 1/10, često: ≥ 1/100 i < 1/10, manje često: ≥ 1/1000 i < 1/100, rijetko: ≥ 1/10 000 i < 1/1000, vrlo rijetko: < 1/10 000).
You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing.
Odmah zatražite liječničku pomoć ako primijetite simptome poput oticanja lica, jezika ili grla koji uzrokuju teškoće pri disanju.
It is an injectable medicine used to help your body to control your blood sugar level when it is too high.
To je lijek u obliku injekcije koji se koristi kako bi pomogao Vašem tijelu kontrolirati razinu šećera u krvi kada je ona previsoka.
Before first use Store in a refrigerator.
Prije prve uporabe Čuvati u hladnjaku.
Coronary revascularization 368 (12.1%) 356 (11.7%) procedure
Postupak koronarne 368 (12,1%) 356 (11,7%) revaskularizacije
10 microgram ___ / ___ / ___ ___ / ___ / ___ 20 microgram ___ / ___ / ___ ___ / ___ / ___
20 mikrograma ___ / ___ / ___
• Flu (influenza)
• gripa (influenca)
The pen is activated and ready for injections.
Brizgalica je aktivirana i spremna za injiciranje.
Section 2 - GETTING STARTED
Dio 2 - POČETNA PRIPREMA
Your doctor will tell you what to do if you get a low blood sugar.
Liječnik će Vam reći što morate napraviti ako Vam se spusti razina šećera u krvi.
If you use more Lyxumia than you should, talk to your doctor immediately.
Ako primijenite više lijeka Lyxumia nego što ste trebali, odmah se obratite svom liječniku.
Lixisenatide has a moderate level of binding (55%) to human proteins.
Liksisenetid ima umjerenu razinu vezivanja (55%) za ljudske proteine.
The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weak, dizzy, confused or irritable, feeling hungry, fast heart beat and feeling jittery.
Upozoravajući znakovi niske razine šećera u krvi mogu uključivati hladan znoj, hladnu blijedu kožu, glavobolju, omamljenost, slabost, omaglicu, smetenost ili razdražljivost, glad, ubrzane otkucaje srca i osjećaj treme.
The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established.
Sigurnost primjene i djelotvornost liksisenatida u djece i adolescenata u dobi do 18 godina nisu još ustanovljeni.
It is used in adults with type 2 diabetes.
Koristi se u odraslih osoba sa šećernom bolešću tipa 2.
What Lyxumia is and what it is used for
Što je Lyxumia i za što se koristi
Other important information about using the pre-filled pens There is more information on how to use the pens in the “Instructions for Use”.
Druge važne informacije o uporabi napunjenih brizgalica Dodatne informacije o uporabi brizgalica navode se u "Uputama za uporabu".
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013
Datum prvog odobrenja: 01 veljače 2013.
In the table, write the date when you activated your pen and the date to throw it away 14 days later.
U tablicu upišite datum kada ste aktivirali brizgalicu i datum kada je morate baciti 14 dana kasnije.
It is not known if Lyxumia may harm your unborn child.
Nije poznato može li Lyxumia naškoditi nerođenom djetetu.
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
Follow all steps in Section
Slijedite sve korake navedene u dijelu 2.
Check the number of doses in the pen.
Provjerite broj doza u brizgalici.
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology and toxicology.
Neklinički podaci ne upućuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksikologije.
• Always use the pen as described in the “Instructions for Use”.
• Uvijek rukujte brizgalicom kako je opisano u "Uputama za uporabu".
Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 only.
Uklonite iglu s brizgalice, pričvrstite novu iglu i ponovite samo korake 4 i 5.
Pen ready for injections (white window)
Brizgalica spremna za injiciranje (bijeli prozorčić)
If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection.
Ako ste si injicirali lijek prije aktivacije brizgalice, nemojte to pokušati ispraviti dajući si drugu injekciju.
It is important to avoid dehydration by drinking plenty of fluids, especially when starting treatment with Lyxumia
Važno je spriječiti dehidraciju pijenjem veće količine tekućine, osobito na početku liječenja lijekom Lyxumia