FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, the systemic exposures AUC from zero to infinity (AUCinf of free (non-liposome associated) MTP-PE in mild or moderate renal insufficiency were similar to those observed in healthy adult subjects with normal renal function.
Croatian: Dodatno, sistemska izloženost AUC od nule do beskonačno (AUCinf) slobodnom (ne-liposomalnom) MTP-PE u ispitanika s blagim do umjerenim oštećenjem bubrega bila je slična onoj opaženoj u zdravih odraslih ispitanika s normalnom funkcijom bubrega.
English: It is not known whether MEPACT passes to human milk.
Croatian: Nije poznato izlučuje li se MEPACT u majčino mlijeko kod ljudi.
English: 50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide.
Croatian: Staklena bočica (staklo tipa I) od 50 ml sa sivim čepom od butilne gume, aluminijskim prstenom i plastičnom flip-off kapicom koja sadrži 4 mg mifamurtida.
English: Administration of mifamurtide was commonly associated with transient neutropenia, usually when used in conjunction with chemotherapy.
Croatian: Primjena mifamurtida bila je često povezana s prolaznom neutropenijom, obično kad se je koristio istodobno s kemoterapijom.
English: Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Croatian: Za mifamurtid se, stoga, ne očekuju interakcije s metabolizmom tvari koje su supstrat za jetreni citokrom P450.
English: Musculoskeletal and connective tissue disorders Low grade pain was very common in patients receiving mifamurtide, including myalgia (31%), back pain (15%), extremity pain (12%) and arthralgia (10%).
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol niske razine bila je vrlo česta kod bolesnika koji primaju mifamurtid, uključujući mijalgiju (31%), bol u leđima (15%), bol u ekstremitetima (12%) i artralgiju (10%).
English: Very common side effects (may affect more than 1 in 10 people): - fever, shaking/shivering, weakness, tiredness or general discomfort - nausea and/or vomiting, diarrhoea or constipation - headache or dizziness - rapid beating of the heart - high blood pressure or low blood pressure - no appetite for food - sweating - pain, including general pain, pain in your muscles and/or joints and pain in back, chest,
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 ljudi): - vrućica, tresavica/drhtanje, slabost, umor, opća nelagoda - mučnina i/ili povraćanje, proljev ili zatvor - glavobolja ili omaglica - ubrzan rad srca - povišen krvni tlak ili snižen krvni tlak - gubitak teka - znojenje - bol, uključujući opću bol, bol u mišićima i/ili zglobovima i bol u leđima, prsnom košu, trbuhu,
English: It is unknown whether mifamurtide is excreted in human milk.
Croatian: Nije poznato izlučuje li se mifamurtid u majčino mlijeko kod ljudi.
English: Based upon the review of the cases, a causal association between mifamurtide and the occurrence of pericardial effusion is considered likely in view of cases with a plausible TTO, absence of other causative factors, and positive dechallenge.
Croatian: Temeljem ocjene slučajeva utvrđena je vjerojatna uzročno-posljedična veza između mifamurtida i pojave perikardijalnog izljeva, s obzirom na slučajeve u kojima je vrijeme do nastupa bilo vjerojatno, odsutnost drugih uzročnih čimbenika te povlačenje nuspojave nakon ukidanja primjene lijeka (pozitivan dechallenge).
English: Episodes of neutropenic fever should be monitored and managed appropriately.
Croatian: Epizode febrilne neutropenije treba pratiti i primjereno zbrinjavati.
English: Haemorrhage was observed in animals at very high doses.
Croatian: Pri vrlo visokim dozama kod životinja je primijećeno krvarenje.
English: In the SmPC of mifamurtide, pericarditis is mentioned in section 4.4.
Croatian: U sažetku opisa svojstava lijeka za mifamurtid perikarditis se navodi u dijelu 4.4.
English: Other generalised symptoms that were typically mild to moderate and very common included hypothermia (23%), malaise (13%), pain (15%), asthenia (13%) and chest pain (11%).
Croatian: Drugi opći simptomi koji su tipično bili blagi do umjereni i vrlo česti uključivali su hipotermiju (23%), malaksalost (13%), bol (15%), asteniju (13%) i bol u prsištu (11%).
English: • Sodium chloride 9 mg/mL (0.9%) solution for injection, 100 mL bag
Croatian: • 0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju, vrećica od 100 ml
English: Metabolism and nutritional disorders Anorexia (21%) was very commonly reported in phase I and II studies of mifamurtide
Croatian: Poremećaji metabolizma i prehrane Anoreksija (21%) je bila vrlo često prijavljivana u ispitivanjima
English: Sepsis, Cellulitis, Nasopharyngitis, Catheter site infection, Upper respiratory tract infection, Urinary tract infection, Pharyngitis, Herpes simplex infection
Croatian: Sepsa, celulitis, nazofaringitis, infekcija na mjestu katetera, infekcije gornjih dišnih puteva, infekcije mokraćnih puteva, faringitis, Herpes simplex infekcija
English: Paraesthesia, Hypoaesthesia, Tremor, Somnolence, Lethargy
Croatian: Parestezija, hipoestezija, tremor, somnolencija, letargija
English: • MEPACT powder for concentrate for dispersion for infusion (vial)
Croatian: • MEPACT prašak za koncentrat za disperziju za infuziju (bočica)
English: Talk to your doctor before using MEPACT: if you have or have had problems with your heart or blood vessels, like blood clots (thrombosis), bleeding (haemorrhage) or inflammation of the veins (vasculitis).
Croatian: Upozorenja i mjere opreza Obavijestite svog liječnika prije primjene lijeka MEPACT: - ako imate ili ste imali problema sa srcem ili krvnim žilama, poput krvnih ugrušaka (tromboze), krvarenja (hemoragije) ili upale vena (vaskulitis)- trebat će Vas pažljivije nadzirati dok primate terapiju s lijekom MEPACT.
English: The filter luer connector cap should not be removed at this time.
Croatian: U ovom trenutku se ne smije skidati poklopac s luer spojnice.
English: MEPACT is administered by intravenous infusion over a period of 1 hour.
Croatian: Način primjene MEPACT se primjenjuje intravenskom infuzijom tijekom razdoblja od 1 sata.
English: Respiratory distress
Croatian: Smetnje disanja
English: The cap of the vial should be removed and the stopper cleaned using an alcohol pad.
Croatian: S bočice treba ukloniti kapicu i čep očistiti jastučićem od vate natopljenom alkoholom.
English: Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders.
Croatian: Stoga je sažetak opisa svojstava lijeka za mifamurtid potrebno ažurirati kako bi se perikardijalni izljev uvrstio kao nuspojava unutar klasifikacije organskih sustava u dijelu 4.8., pod „Srčani poremećaji”.
English: General disorders and administration site conditions The majority of patients experience chills (89%), fever (85%) and fatigue (53%).
Croatian: Većina bolesnika iskusila je zimicu (89%), vrućicu (85%) i umor (53%).
English: In vivo administration of mifamurtide resulted in the inhibition of tumour growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma.
Croatian: In vivo primjena mifamurtida rezultirala je inhibicijom tumorskog rasta kod miševa i štakora s metastazama na plućima, s karcinomom kože i jetre te s fibrosarkomom.
English: The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection according to the detailed instructions shown below.
Croatian: Volumen rekonstituirane suspenzije koji odgovara izračunatoj dozi izvuče se kroz priloženi filtar i dalje razrijedi s dodatnih 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju prema detaljnim uputama u nastavku.
English: Each vial contains 4 mg mifamurtide*.
Croatian: Jedna bočica sadrži 4 mg mifamurtida*.
English: Skin and subcutaneous disorders Hyperhidrosis (11%) was very common in patients receiving mifamurtide in uncontrolled studies.
Croatian: Hiperhidroza (11%) je bila vrlo česta kod bolesnika koji su mifamurtid primali u nekontroliranim ispitivanjima.
English: The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (figure 4).
Croatian: Mjesto ubrizgavanja na vrećici treba prebrisati jastučićem od vate natopljenom alkoholom i ubrizgati suspenziju iz štrcaljke u izvornu vrećicu s preostalih 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (slika 4).
English: However, no specific subset analyses for efficacy are available in patients < 18 years of age and ≥ 18 years of age.
Croatian: < 18 godina starosti i ≥ 18 godina starosti.
English: The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe.
Croatian: 11. Štrcaljku zatim treba odvojiti od filtra i na štrcaljku sa suspenzijom staviti novu iglu.
English: The freeze-dried powder has to be reconstituted into a liquid suspension, filtered using the filter provided and further diluted before use.
Croatian: Od praška osušenog smrzavanjem treba pripremiti tekuću suspenziju, profiltrirati ju kroz priloženi filtar i dodatno razrijediti prije primjene.
English: What MEPACT looks like and contents of the pack MEPACT is a white to off-white homogeneous cake or powder for concentrate for dispersion for infusion.
Croatian: Mepact je bijeli do bjelkasti homogeni kolačić ili prašak za koncentrat za disperziju za infuziju.
English: Chemical and physical stability has been demonstrated for 6 hours up to 25 ºC.
Croatian: Rekonstituirana suspenzija Kemijska i fizikalna stabilnost u primjeni dokazane su tijekom 6 sati na temperaturi do 25ºC.
English: The most frequent adverse reactions are chills, pyrexia, fatigue, nausea, tachycardia and headache.
Croatian: Najčešće nuspojave su zimica, pireksija, umor, mučnina, tahikardija i glavobolja.
English: Upper abdominal pain, Dyspepsia, Abdominal distension, Lower abdominal pain
Croatian: Bol u gornjem dijelu abdomena, dispepsija, distenzija abdomena, bol u donjem dijelu abdomena
English: Adverse reactions are classified according to system organ class and frequency.
Croatian: Nuspojave su razvrstane prema klasifikaciji organskih sustava i učestalosti.
English: As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended.
Croatian: Nema farmakokinetičkih podataka o mifamurtidu kod bolesnika s teškim oštećenjem bubrega ili jetre te je kod tih bolesnika pri primjeni mifamurtida potreban oprez.
English: Vertigo, Tinnitus, Hearing loss
Croatian: Vrtoglavica, tinitus, gubitak sluha
English: Mifamurtide treatment was continued for the remainder of the study without seizure recurrence.
Croatian: U preostalom vremenu ispitivanja, liječenje mifamurtidom nastavljeno je bez ponovne pojave epileptičkog napadaja.
English: How to use MEPACT
Croatian: Kako primjenjivati MEPACT
English: The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (Child-Pugh class A; n = 9) or moderate (Child-Pugh class B; n = 8) hepatic impairment and in age, sex-, and weight-matched healthy adults with normal hepatic function (n = 19).
Croatian: Farmakokinetika jednostruke doze od 4 mg mifamurtida nakon jednosatne intravenske infuzije ispitana je u odraslih dobrovoljaca s blagim (Child-Pugh stadij A, n=9) ili umjerenim (Child-Pugh stadij B, n=8) oštećenjem jetre i u zdravih odraslih s normalnom jetrenom funkcijom (n=19) usklađenih po dobi, spolu i tjelesnoj težini.
English: Each mL reconstituted suspension contains 0.08 mg mifamurtide.
Croatian: Jedan ml rekonstituirane suspenzije sadrži 0,08 mg mifamurtida.
English: From a microbiological point of view, immediate use is recommended.
Croatian: S mikrobiološkog stajališta, preporučuje se odmah primijeniti pripremljenu suspenziju.
English: Do not use MEPACT: - if you are allergic to mifamurtide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primati MEPACT: - ako ste alergični na mifamurtid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako uzimate lijekove koji sadrže ciklosporin ili druge inhibitore kalcineurina ili visoke doze nesteroidnih protuupalnih lijekova (pogledajte „Uzimanje drugih lijekova“ u nastavku).
English: Myalgia, Arthralgia, Back pain, Pain in extremity
Croatian: Mialgija, artralgija, bol u leđima, bol u ekstremitetima
English: Powder for concentrate for dispersion for infusion
Croatian: Prašak za koncentrat za disperziju za infuziju.
English: If you have long-lasting or worsening symptoms, you should contact your doctor, as MEPACT treatment may need to be delayed or discontinued.
Croatian: Ako imate dugotrajne simptome ili se oni pogoršavaju, obratite se liječniku, jer možda će trebati odgoditi ili prekinuti liječenje lijekom MEPACT. - ako u anamnezi imate astmu ili druge poremećaje disanja.
English: How MEPACT is given
Croatian: Kako se MEPACT primjenjuje
English: Pleural effusion, Exacerbated dyspnoea, Productive cough, Haemoptysis, Wheezing, Epistaxis, Exertional dyspnoea, Sinus congestion, Nasal congestion, Pharyngolaryngeal pain
Croatian: Pleuralni izljev, pogoršanje dispneje, produktivni kašalj, hemoptiza, piskanje, epistaksa, dispneja u naporu, začepljenje sinusa, začepljenje nosa, faringolaringealna bol
English: You should use effective contraception if you are being treated with MEPACT.
Croatian: Za vrijeme liječenja lijekom MEPACT morate koristiti učinkovitu kontracepciju.
English: Powder for concentrate for dispersion for infusion 4 mg mifamurtide
Croatian: Prašak za koncentrat za disperziju za infuziju 4 mg mifamurtida
English: The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (n = 9) or moderate (n = 8) renal impairment and in age-, sex-, and weight-matched healthy adults with normal renal function (n = 16).
Croatian: Farmakokinetika jednostruke doze od 4 mg mifamurtida nakon jednosatne intravenske infuzije ispitana je u odraslih dobrovoljaca s blagim (n=9) ili umjerenim (n=8) oštećenjem bubrega i u zdravih odraslih s normalnom bubrežnom funkcijom (n=16) usklađenih po dobi, spolu i tjelesnoj težini.
English: - The other ingredients are 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS).
Croatian: - Druge pomoćne tvari su 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC) i 1,2-dioleoil sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS).
English: Each vial contains 4 mg of mifamurtide.
Croatian: Jedna bočica sadrži 4 mg mifamurtida.
English: 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Croatian: 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC) 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
English: Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold
Croatian: Periferni edem, edem, upala sluznice, eritem na mjestu infuzije, reakcije na mjestu infuzije, bol na mjestu katetera, nelagoda u prsištu, osjećaj hladnoće
English: You may experience more severe side effects, including fever, chills, fatigue, nausea, vomiting, headache and high blood pressure or low blood pressure.
Croatian: Ako primite više lijeka MEPACT nego što ste trebali Možete imati teže nuspojave, uključujući vrućicu, zimicu, umor, mučninu, povraćanje, glavobolju i povišeni ili sniženi krvni tlak.
English: MEPACT 4 mg powder for concentrate for dispersion for infusion
Croatian: MEPACT 4 mg prašak za koncentrat za disperziju za infuziju.
English: The lyophilised powder should be allowed to reach a temperature between approximately 20 C-25 °C prior to reconstitution, filtering using the filter provided and dilution.
Croatian: Liofilizirani prašak mora prije rekonstitucije, filtriranja kroz priloženi filtar i razrjeđivanja doseći temperaturu od oko 20°C do 25°C.
English: Inflammatory response
Croatian: Upalni odgovor
English: Volume to withdraw = [12.5 x calculated dose (mg)] mL
Croatian: Volumen suspenzije koji treba izvući za određenu dozu računa se na sljedeći način: Potrebni volumen = [12,5 x izračunata doza (mg)] ml Za jednostavniji izračun može poslužiti sljedeća tablica.
English: MEPACT 4 mg powder for concentrate for dispersion for infusion mifamurtide
Croatian: MEPACT 4 mg prašak za koncentrat za disperziju za infuziju mifamurtid
English: The sodium chloride 9 mg/mL (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger.
Croatian: 7. 0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju se dodaje u bočicu sporim, čvrstim pritiskom klipa štrcaljke.
English: Excipients: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Croatian: Pomoćne tvari: 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC), 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
English: How to store MEPACT
Croatian: Kako čuvati MEPACT
English: Significant enhancement of disease-free survival was also demonstrated in the treatment of dog osteosarcoma and hemangiosarcoma with mifamurtide as adjuvant therapy.
Croatian: Mifamurtid kao adjuvanta terapija značajno je produžio preživljavanje bez bolesti kod pasa s osteosarkomom i hemangiosarkomom.
English: Vomiting, Diarrhoea, Constipation, Abdominal pain, Nausea
Croatian: Povraćanje, proljev, konstipacija, bol u abdomenu, mučnina
English: The filter should be removed from the blister pack, and the cap removed from the filter spike.
Croatian: 2. Filtar treba izvaditi iz blister pakiranja i s njegovog šiljka skinuti kapicu.
English: - corticosteroids, used to treat inflammations, allergies or asthma.
Croatian: MEPACT se ne smije koristiti istodobno s visokim dozama NSAIL-a. - kortikosteroide, kojima se liječe upala, alergije ili astma.
English: Headache, Dizziness
Croatian: Glavobolja, omaglica
English: The site of the sodium chloride 9 mg/mL (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad.
Croatian: 4. Mjesto na vrećici 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju gdje će se umetnuti igla, treba prebrisati jastučićem od vate natopljenom alkoholom.
English: A higher percentage of objective and subjective hearing loss was observed overall in patients who received MEPACT and chemotherapy (12% and 4%, respectively) in the phase III study (see section 5.1 for a description of the study) compared to those patients that received only chemotherapy (7% and 1%).
Croatian: Iako se gubitak sluha može pripisati ototoksičnoj kemoterapiji, poput cisplatina, nejasno je može li MEPACT zajedno s polikemoterapijom pojačati gubitak sluha.U ispitivanju faze III (vidjeti dio 5.1 za opis ispitivanja) kod bolesnika koji su primali MEPACT i kemoterapiju zabilježen je viši postotak objektivnog i subjektivnog gubitka sluha (12% i 4%) u odnosu na bolesnike koji su primali samo kemoterapiju (7% i 1%).
English: The 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack).
Croatian: 3. Raspakirati vrećicu sa 100 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju, iglu i štrcaljku (nisu priloženi u pakiranju).
English: Each vial should be reconstituted with 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Jednu bočicu treba rekonstituirati s 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju.
English: if you have a history of inflammatory or autoimmune disease or have been treated with corticosteroids or other medicines that may affect your immune system.
Croatian: - ako ste bolovali od upalnih ili autoimunih bolesti ili ste liječeni kortikosteroidima ili drugim lijekovima koji mogu utjecati na imunološki sustav. - ako imate bilo kakve alergijske reakcije na lijekove, kao što su osip, nedostatak zraka i visoki krvi tlak.
English: because this may be a sign of an infection, or - if you experience rash or have any problems breathing (wheezing), or - if you experience any stomach problems.
Croatian: Odmah se javite liječniku: - ako vrućica ili zimica traju dulje od 8 sati nakon primjene doze lijeka MEPACT, jer to može biti znak infekcije ili - ako se pojavi osip ili imate bilo kakvih teškoća s disanjem (piskanje) ili - ako osjećate bilo kakve želučane poteškoće.
English: Muscle spasms, Neck pain, Groin pain, Bone pain, Shoulder pain, Chest wall pain, Musculoskeletal stiffness
Croatian: Grčevi mišića, bol u vratu, bol u preponama, bol u kostima, bol u ramenu, bol u stijenci prsišta, mišićno-koštana ukočenost
English: Treatment with MEPACT can often cause stomach problems such as nausea, vomiting and loss of appetite when used with chemotherapy.
Croatian: Ukoliko se koristi s kemotrapijom, liječnje lijekom MEPACT može često uzrokovati želučane poteškoće kao što su mučnina, povraćanje i gubitak teka.
English: Mild-moderate tachycardia (50%), hypertension (26%) and hypotension (29%) were very commonly reported in uncontrolled studies of mifamurtide.
Croatian: U nekontroliranim ispitivanjima mifamurtida vrlo često su prijavljene blaga do umjerena tahikardija (50%), hipertenzija (26%) i hipotenzija (29%).
English: Using the needle and syringe, 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection should be withdrawn from the bag.
Croatian: 5. Korištenjem igle i štrcaljke izvući iz vrećice 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju.
English: Fever, Chills, Fatigue, Hypothermia, Pain, Malaise, Asthenia, Chest pain
Croatian: Vrućica, zimica, umor, hipotermija, bol, malaksalost, astenija, bol u prsištu
English: After reconstitution, each mL of suspension contains 0.08 mg of mifamurtide.
Croatian: Nakon pripreme jedan ml suspenzije sadrži 0,08 mg mifamurtida.
English: Phlebitis, Flushing, Pallor
Croatian: Flebitis, navale crvenila, bljedilo
English: After reconstitution, each mL of suspension in the vial contains 0.08 mg mifamurtide.
Croatian: Nakon rekonstitucije, jedan ml suspenzije u bočici sadrži 0,08 mg mifamurtida.
English: *fully synthetic analogue of a component of Mycobacterium sp. cell wall.
Croatian: *potpuno sintetski analog sastojka iz stanične stijenke Mycobacterium sp. Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Unopened vial of powder
Croatian: Neotvorena bočica s praškom 30 mjeseci
English: Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension.
Croatian: Na vrećicu s rekonstituiranom, profiltriranom i razrijeđenom liposomalnom suspenzijom treba napisati podatke o bolesniku, vrijeme i datum.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Nuspojava (preporučeni pojam)
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za pripremu MEPACT intravenske infuzije
English: • 1 vial of MEPACT (mifamurtide)
Croatian: Oprema priložena u jednom pakiranju• 1 bočica lijeka MEPACT (mifamurtid)
English: • 1 Filter for MEPACT
Croatian: • Jedan sterilni filtar za MEPACT u blisteru.
English: If you have worsening symptoms, you should contact your doctor, as these may have been caused by MEPACT.
Croatian: Ako Vam se simptomi pogoršavaju, trebate se obratiti svom liječniku, jer to može biti uzrokovano lijekom MEPACT - ako imate želučane poteškoće kao što su mučnina, povraćanje i nedostatak teka.
English: Marketing Authorisation Holder Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Takeda France SAS
English: Aerius has also been studied in 416 patients with urticaria.
Croatian: Aerius je također ispitivan u 416 bolesnika s urtikarijom.