FrancophonIA/ELRC3.0 huggingface dataset:
English: The reconstituted dispersion in the intravenous drip may be stored for up to 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Croatian: Pripremljenu disperziju u intravenskom dripu može se čuvati do 24 sata na temperaturi od 2°C do 8°C,
English: Common: Vertigo Uncommon: Ear pain, tinnitus
Croatian: Često: vrtoglavica Manje često: bol u uhu, tinitus
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Croatian: Ako dođe u dodir sa sluznicama, potrebno ih je temeljito isprati vodom.
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Croatian: Skraćenica: ABN = apsolutni broj neutrofila
English: Febrile neutropenia occurred in four patients on human serum albuminpaclitaxel nanoparticles.
Croatian: Febrilna neutropenija javila se u četiri bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: However, a subsequent analysis in 981 patients receiving human serum albumin-paclitaxel nanoparticles monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Croatian: Međutim, kasnija analiza provedena u 981 bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma kao monoterapiju za metastatski rak dojke, od kojih je 15% bilo u dobi od ≥ 65 godina te 2% u dobi od ≥ 75 godina,
English: The uncommon side effects may affect up to 1 in 100 people:
Croatian: Manje česte nuspojave mogu se pojaviti u do 1 na 100 osoba:
English: Confirmed complete or partial overall reponse, n 95% Cl (%)
Croatian: Potvrđeni potpuni ili djelomični sveukupni odgovor, n (%) 95% CI pA+G/pG(95% Cl) P-vrijednost (hi-kvadrat test)
English: Survival, months (95% CI)
Croatian: Medijan sveukupnog preživljenja (95% CI) (mjeseci)
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood
Croatian: • snižena razina fosfora u krvi, zadržavanje tekućine, niska razina albumina u krvi, pojačana žeđ,
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine at a dose of 1000 mg/m2
Croatian: Opis odabranih nuspojava Slijede najčešće i najvažnije incidencije nuspojava u 421 bolesnika s metastatskim adenokarcinomom pankreasa koji su bili liječeni sa 125 mg/m2 paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom, u dozi od 1000 mg/m2, davanoj 1., 8. i 15. dana svakog 28-dnevnog ciklusa u fazi III kliničkog ispitivanja.
English: human serum albuminpaclitaxel nanoparticles were administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Croatian: 40 minuta u dozi od 125 mg/m2, nakon čega je primijenjen gemcitabin kao intravenska infuzija u trajanju od 30 do 40 minuta, u dozi od 1000 mg/m2 davanoj 1., 8. i 15. dana svakog 28-dnevnog ciklusa.
English: • Pazenir is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Croatian: • Ako imate metastatski rak gušterače (karcinom pankreasa), Pazenir se koristi zajedno s lijekom koji se naziva gemcitabin.
English: Reduce 1 dose level and follow with WBC Growth Factors OR Reduce doses 2 dose levels from Day 1 doses
Croatian: Smanjenje doza za 1 razinu i zatim primjena čimbenika rasta bijelih krvnih stanica ILI smanjenje razine doza 1. dana za 2 razine
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as human serum albuminpaclitaxel nanoparticles 260 mg/m2 given as a 30 minute infusion without premedication (N = 229).
Croatian: 175 mg/m2 u obliku trosatne infuzije s premedikacijom za sprječavanje preosjetljivosti (N = 225) ili paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma u dozi od 260 mg/m2 u obliku 30-minutne infuzije bez premedikacije (N = 229).
English: There was a statistically significant improvement in PFS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Croatian: U bolesnika liječenih kombinacijom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabina zabilježeno je statistički značajno poboljšanje u preživljenju bez progresije bolesti nasuprot onima koji su bili liječeni samo gemcitabinom, uz povećanje medijana preživljenja bez progresije bolesti od 1,8 mjeseci.
English: Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Jedna bočica sadrži 100 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: Teva Pharma B.V. Swensweg 5
Croatian: Teva Pharma B.V.
English: Uncommon: Mucosal inflammation, infusion site extravasation, infusion site inflammation, infusion site rash
Croatian: Manje često: upala sluznice, ekstravazacija na mjestu infuzije, upala na mjestu infuzije, osip na mjestu infuzije
English: Stability of the reconstituted dispersion in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Croatian: Kemijska i fizikalna stabilnost disperzije u primjeni dokazana je tijekom 24 sata na temperaturi od 2°C do 8°C, uz zaštitu od svjetlosti, te nakon toga tijekom 4 sata na temperaturi od 15°C do 25°C.
English: There was no difference in ORR between the treatment arms in patients with non-squamous histology (N=602, 26% vs 25%, p=0.808).
Croatian: 26% naspram 25%, p = 0,808).
English: • Dry mouth, difficulty in swallowing
Croatian: • iskašljavanje krvi • suha usta, otežano gutanje
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Croatian: Manje često: hemolitički uremijski sindrom
English: Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Croatian: Često: pneumonija, bronhitis, infekcija gornjeg dijela dišnog sustava,
English: Gemcitabine dose (mg/m2)
Croatian: Doza lijeka Pazenir (mg/m2) Doza gemcitabina (mg/m2)
English: Uncommon: Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face
Croatian: fotosenzitivna reakcija, poremećaj pigmentacije, pruritički osip, poremećaj kože, hiperhidroza, onihomadeza, eritematozni osip, generalizirani osip, dermatitis, noćno znojenje, makulopapularni osip,
English: 100mg/20ml
Croatian: Prašak za disperziju za infuziju 100 mg/20 ml
English: Platelet count (cells/mm3)
Croatian: Trombociti (stanice/mm3)
English: For any other Grade 3 or 4 non-haematologic toxicity, interrupt treatment until the toxicity improves to ≤ Grade 2, then restart treatment according to the guidelines in Table 5.
Croatian: U idućim ciklusima liječenje se može nastaviti pri sljedećoj nižoj razini doze prema smjernicama u tablici 5. Za svaku drugu nehematološku toksičnost 3. ili 4. stupnja, prekinite liječenje dok se toksičnost ne poboljša na ≤ 2. stupnja, a zatim liječenje ponovno započnite prema smjernicama u tablici 5.
English: • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight, skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face
Croatian: promjena boje kože, pojačano znojenje, noćna znojenja, bijela područja kože, ranice, otečeno lice
English: • Bruising
Croatian: • omaglica
English: Bone marrow suppression (primarily neutropenia) occurs frequently with human serum albuminpaclitaxel nanoparticles.
Croatian: Supresija koštane srži (primarno neutropenija) česta je pojava u liječenju paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with Pazenir.
Croatian: Prije početka liječenja lijekom Pazenir žene reproduktivne dobi moraju obaviti test na trudnoću.
English: • Anxiety
Croatian: • nemir
English: Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G(95% Cl)a
Croatian: Broj smrti (%) Medijan sveukupnog preživljenja, mjeseci (95% CI)
English: • Acute kidney failure
Croatian: Često: akutno zatajenje bubrega
English: Common: Vision blurred
Croatian: Često: zamućeni vid
English: If foaming or clumping occurs, the dispersion should stand for at least 15 minutes until foam subsides.
Croatian: disperzija mora odstajati najmanje 15 minuta dok se pjena ne slegne.
English: Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population) Human serum albumin-paclitaxel nanoparticles (125 mg/m2)/gemcitabine (N=431)
Croatian: Paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma (125 mg/m2)/gemcitabin (N = 431)
English: Preparation and administration precautions
Croatian: Priprema i mjere opreza kod primjene
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Croatian: Vrlo često: periferna neuropatija, neuropatija, hipoestezija, parestezije Često: periferna senzorna neuropatija, glavobolja, disgeuzija, omaglica,
English: Dose of carboplatin (AUC mg•min/mL
Croatian: Preporučena doza karboplatina je AUC = 6 mg•min/ml,
English: 1On Day 1 of the 21-day cycle reduce the dose of Pazenir and carboplatin simultaneously.
Croatian: Prekinuti liječenje 1Dozu lijeka Pazenir i karboplatina smanjite istodobno 1. dana 21-dnevnog ciklusa.
English: Sími: + 354 550 3300
Croatian: Actavis Pharmaceutical Iceland ehf. Sími: + 354 550 3300
English: Dose of Pazenir
Croatian: Doza lijeka Pazenir
English: • Pain in the breast
Croatian: • bol u udovima
English: Lung cancer
Croatian: Rak gušterače
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: otopina ljudskog albumina (koja sadrži natrij, natrijev kaprilat i N-acetil DL
English: Uncommon: Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis
Croatian: Često: pojačano suzenje, zamućeni vid, suho oko, keratokonjunktivitis sicca, madaroza Manje često: iritacija oka, bol u oku, abnormalni vid, smanjena vidna oštrina, konjunktivitis, poremećaji vida, svrbež oka, keratitis
English: Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Croatian: Potvrđen potpuni ili djelomični ukupni odgovor, n (%) 95% CI (%) PA/pT (95,1% CI) P-vrijednosta
English: • Pain in extremities
Croatian: • bol u dojkama
English: Very common: Dyspnoea, epistaxis, cough Common: Pneumonitis2, nasal congestion Uncommon: Dry throat, nasal dryness
Croatian: Vrlo često: dispneja, epistaksa, kašalj Često: pneumonitis2, nazalna kongestija
English: It is not known if paclitaxel is excreted in human milk.
Croatian: Nije poznato izlučuje li se paklitaksel u majčino mlijeko.
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving human serum albumin-paclitaxel nanoparticles.
Croatian: Poremećaji živčanog sustava Općenito, u bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma, učestalost i težina neurotoksičnosti bile su ovisne o dozi.
English: Tel: +421 2 5726 7911
Croatian: Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911
English: Thus patients receiving Pazenir should be vigilantly monitored by physicians for the occurrence of cardiac events.
Croatian: Stoga liječnici trebaju posebno obratiti pozornost na pojavu srčanih tegoba u bolesnika koji primaju Pazenir.
English: Very common: Alopecia, rash Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Croatian: Često: poremećaji noktiju, svrbež, suha koža, eritem, pigmentacija noktiju/promjena boje, hiperpigmentacija kože, oniholiza, promjene na noktima Manje često: osjetljivost ležišta nokta, urtikarija, bolna koža,
English: Of the 229 patients in the randomized study who received human serum albumin-paclitaxel nanoparticles monotherapy for breast cancer, 13% were at least 65 years of age and < 2% were 75 years and older.
Croatian: Od 229 ispitanika koji su u randomiziranom ispitivanju primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma kao monoterapiju za rak dojke, 13% ih je imalo najmanje
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine
Croatian: Tablica 8: Hematološke abnormalnosti ustanovljene laboratorijskim pretragama u ispitivanju adenokarcinoma pankreasa
English: Uncommon: Drug hypersensitivity, hypersensitivity
Croatian: Poremećaji imunološkog sustava Manje često: preosjetljivost na lijek, preosjetljivost
English: Very common: Pain in extremity, arthralgia, myalgia Common: Muscular weakness, bone pain
Croatian: Vrlo često: bol u udovima, artralgija, mijalgija
English: (PT at Risk) ABX/GEM:
Croatian: (bolesnici pod rizikom) Paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma /GEM: GEM:
English: Common: Lacrimation increased Uncommon: Cystoid macular oedema
Croatian: Manje često: cistoidni makularni edem
English: Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Croatian: Često: infekcija, infekcija mokraćnog sustava, folikulitis, infekcija gornjeg dijela dišnog sustava, kandidijaza, sinusitis Manje često: oralna kandidijaza, nazofaringits, celulitis, herpes simplex,
English: Single-arm open-label studies
Croatian: Otvorena ispitivanja s jednom skupinom
English: There have been reports of tumour lysis syndrome during treatment with human serum albuminpaclitaxel nanoparticles.
Croatian: Tijekom liječenja paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma zabilježen je sindrom lize tumora.
English: Table 6: Adverse reactions reported with human serum albumin-paclitaxel nanoparticlesmonotherapy at any dose in clinical studies
Croatian: Tablica 6: Nuspojave zabilježene u kliničkim ispitivanjima uz bilo koju dozu paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma primijenjenog kao monoterapija
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Croatian: U bolesnika s umjerenim (ukupni bilirubin od > 1,5 do ≤ 3 x GGN) ili teškim (ukupni bilirubin od > 3 do ≤ 5 x
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of human serum albumin-paclitaxel nanoparticles.
Croatian: Tijekom postmarketinškog praćenja paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma prijavljeni su paraliza kranijalnih živaca, pareza glasnica i rijetki slučajevi teških reakcija preosjetljivosti.
English: Uncommon: Hepatomegaly
Croatian: Često: pancitopenija
English: Solvent-based paclitaxel(200 mg/m2 every 3 weeks)+ carboplatin (N=531)
Croatian: 3 tjedna) + karboplatin (N = 531)
English: Fir st
Croatian: I DOHVATA
English: Reconstituted Pazenir dispersion should be administered intravenously using an infusion set incorporating a 15 µm filter.
Croatian: Da biste izbjegli unos tih vlakana, primjenjujte Pazenir s pomoću kompleta za infuziju opremljenog filtrom od 15 µm.
English: The usual dose for breast cancer is 260 mg/m of body surface area given over a 30 minute period.
Croatian: 260 mg/m2 tjelesne površine i daje se tijekom 30 minuta.
English: • Pain in a joint or joints
Croatian: • bol u zglobu ili zglobovima
English: • Obstruction in the gut, inflammation of the large bowel, inflammation of the bile duct
Croatian: • začepljenje crijeva, upala debelog crijeva, upala žučnog kanala
English: Very common: Rash, alopecia Common: Pruritus, nail disorder Uncommon: Skin exfoliation, dermatitis allergic, urticaria
Croatian: Manje često: eksfolijacija kože, alergijski dermatitis, urtikarija
English: Hepatobiliary disorders Common: Cholangitis
Croatian: Često: kolangitis
English: Very common: Fatigue, asthenia, pyrexia
Croatian: Često: hemoptiza, epistaksa, kašalj
English: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Croatian: MedDRA = skraćenica za Medical Dictionary for Regulatory Activities; Rječnik medicinskih pojmova za regulatorne poslove; SMQ =Standardizirani MedDRA upit (engl.
English: Very common: Diarrhoea, vomiting, nausea, constipation Common: Stomatitis, dyspepsia, abdominal pain, dysphagia
Croatian: Često: periferni edem, upala sluznice, bol, tresavica, edem, slabost,
English: More information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine.
Croatian: Više informacija o lijeku Myalepta možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine.
English: Your pharmacist will give you detailed instructions on how to do this.
Croatian: Ljekarnik će Vam dati detaljne upute kako se to radi.
English: • You must then inject the medicine under the skin.
Croatian: • Lijek morate ubrizgati pod kožu.
English: Patients should be reviewed every 6 months to ensure that their injection technique is correct.
Croatian: Bolesnike je potrebno pregledati svakih šest mjeseci kako bi se osiguralo da je njihova tehnika ubrizgavanja pravilna.
English: Weight of child
Croatian: Tjelesna težina djeteta
English: Information for patients and their parents or carers
Croatian: Informacije za bolesnike i njihove roditelje ili njegovatelje
English: Syringe
Croatian: Štrcaljka
English: This might result in the patient receiving too much or too little of the active substance.
Croatian: Bolesnik tako može primiti preveliku ili premalenu količinu djelatne tvari.
English: The dose should be prescribed in both milligrams and milliliters:
Croatian: Dozu je potrebno propisati i u miligramima i mililitrima:
English: Maximum daily dose (injection volume)
Croatian: Najveća dnevna doza (volumen injekcije)
English: In addition giving the medicine in the muscle instead of under the skin could lead to the medicine being absorbed faster than recommended which can change the effects of the medicine.
Croatian: Uz to, ako lijek ubrizgate u mišić umjesto potkožno, možda će se apsorbirati brže nego što je to preporučeno, što može promijeniti učinke lijeka.
English: • The dose depends on your body weight and may be different for men than women.
Croatian: • Doza ovisi o tjelesnoj težini i može se razlikovati za muškarce i žene.
English: It will be adjusted by your doctor according to your response to treatment.
Croatian: Liječnik će dozu prilagoditi u skladu s Vašim odgovorom na liječenje.
English: It is important that you follow the instructions given to you by your doctor, pharmacist or nurse.
Croatian: Važno je da se pridržavate uputa koje ste dobili od liječnika, ljekarnika ili medicinske sestre.
English: Rounded amount of solution
Croatian: Zaokružena količina otopine
English: Starting daily dose
Croatian: Početna dnevna doza
English: They must however always prepare and give the first dose under supervision of the doctor or nurse.
Croatian: Međutim, prvu dozu moraju pripremiti i primijeniti pod nadzorom liječnika ili medicinske sestre.
English: • Your pharmacist will also give you a second syringe (the size of syringe to use varies depending on the dose prescribed and is either 0.3 mL, 1.0 mL or 2.5 mL ) that you must use to give the injection.
Croatian: • Ljekarnik će Vam također dati drugu štrcaljku (veličina štrcaljke ovisi o propisanoj dozi i može biti 0,3 ml, 1,0 ml ili 2,5 ml ) koju morate upotrijebiti za ubrizgavanje.
English: For daily doses > 1.5 mg - 5 mg (0.3 - 1.0 mL)
Croatian: 0,3 ml 100 UI inzulina za svakodnevne doze > 1,5 mg - 5 mg (0,3 - 1,0 ml)
English: With every prescription of Myalepta the pharmacist should dispense:
Croatian: Uz svaki recept za lijek Myalepta ljekarnik treba izdati:
English: Any remaining solution should be discarded.
Croatian: Svu preostalu otopinu bacite.
English: Once you have made up the solution you must draw the amount prescribed by your doctor (this may be in units or in ml depending on the syringe) using the second syringe.
Croatian: Nakon što pripremite otopinu, morate izvući količinu koju je propisao liječnik (to može biti u jedinicama ili u ml, ovisno o štrcaljki) s pomoću druge štrcaljke.
English: Water for injection to reconstitute the powder (2.2 ml of water for injection are needed);
Croatian: vodu za injekciju za rekonstituciju praška (potrebna su 2,2 ml vode za injekciju)
English: The size of the syringe depends on the dose prescribed and is determined as follows:
Croatian: Veličina štrcaljke ovisi o propisanoj dozi te se utvrđuje na način naveden u nastavku:
English: Material will include training video on how to prepare and give medicine
Croatian: Materijal će sadržavati videozapis o načinu pripreme i primjene lijeka
English: Healthcare professionals must carefully explain to the patient or carer how the solution for injection is prepared and how the prescribed dose should be measured (in ml or units).
Croatian: Zdravstveni radnici moraju bolesniku ili njegovatelju pažljivo objasniti način pripreme otopine za injekciju i način mjerenja propisane doze (u ml ili jedinicama).
English: ‘Unit' measurement volume in 0.3 mL syringe to inject
Croatian: Volumen mjernih jedinica u štrcaljki od 0,3 ml za ubrizgavanje
English: To avoid medication errors, healthcare professionals and patients will be given educational material with detailed instructions on how to prepare the solution and how to inject the correct dose.
Croatian: Kako bi izbjegli pogreške prilikom primjene lijeka, zdravstveni radnici i bolesnici primit će edukacijski materijal s detaljnim uputama o načinu pripreme otopine i ubrizgavanja ispravne doze.
English: A 3 ml syringe (21 gauge and 40 mm) to draw up the water for injection and reconstitute the powder.
Croatian: štrcaljku od 3 ml (veličine 21G i 40 mm) za povlačenje vode za injekciju i rekonstituciju praška.
English: Patients, their parents or carers can inject the medicine once they have been trained by their doctor or nurse.
Croatian: Bolesnici, njihovi roditelji ili njegovatelji mogu sami ubrizgati lijek nakon što ih obuči liječnik ili medicinska sestra.
English: Educational materials will be provided to patients and healthcare professionals to ensure that the medicine Myalepta (metreleptin) is prepared and injected correctly, and to prevent the risk of medication errors.
Croatian: Edukacijski materijali bit će stavljeni na raspolaganje bolesnicima i zdravstvenim radnicima kako bi se osigurala pravilna priprema i pravilno ubrizgavanje lijeka Myalepta (metreleptin) te kako bi se spriječio rizik od pogrešaka pri primjeni lijeka.
English: Dose of Myalepta in mg
Croatian: Doza lijeka Myalepta u mg