FrancophonIA/ELRC3.0 huggingface dataset:
English: FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g.
Croatian: FIRMAGON može ometati djelovanje nekih lijekova za liječenje tegoba sa srčanim ritmom (npr. kinidin, prokainamid, amiodaron i sotalol) ili drugih lijekova koji mogu utjecati na srčani ritam (npr. metadon (koristi se za ublažavanje bolova te kao dio detoksikacije, tj. čišćenja organizma kod ovisnosti o drogama),
English: Pack-size of 2 trays containing: 2 vials with 120 mg degarelix (powder) 2 pre-filled syringes with 3 ml solvent 2 plunger rods
Croatian: Pakiranje od 2 podloška koje sadrži: 2 bočice sa 120 mg degareliksa (prašak) 2 napunjene štrcaljke s 3 ml otapala 2 klipa štrcaljke
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se pojaviti u do 1 na 100 osoba)
English: Name and address of the manufacturer responsible for batch release Ferring GmbH
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: The pack contains two vials of powder and two pre-filled syringes with solvent that must be prepared for subcutaneous injection.
Croatian: • NE TRESITE BOČICE Pakiranje sadrži dvije bočice praška i dvije štrcaljke napunjene otapalom koje se mora pripremiti za supkutanu injekciju.
English: Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics ).
Croatian: moksifloksacin (antibiotik), antipsihotici).
English: Inject 4 ml of FIRMAGON 80 mg slowly,
Croatian: Polako injicirajte 4 ml lijeka FIRMAGON 80 mg odmah nakon rekonstitucije.*
English: Each vial contains 120 mg degarelix (as acetate).
Croatian: Svaka bočica sadrži 120 mg degareliksa (u obliku degareliksacetata).
English: hypotension)
Croatian: hipoestezija
English: Inject 3 ml of FIRMAGON 120 mg slowly,
Croatian: Polako injicirajte 3 ml lijeka FIRMAGON 120 mg odmah nakon rekonstitucije.*
English: Hot flush*
Croatian: Krvožilni poremećaji navale vrućine*
English: Markedly abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Croatian: U bolesnika koji su prije liječenja imali normalne vrijednosti, primijećene su izrazito poremećene vrijednosti kalija (≥5,8 mmol/l) i to u 6% bolesnika liječenih degareliksom i 3% liječenih leuprorelinom, kreatinina (≥177 μmol/l) u 2% bolesnika liječenih degareliksom i 2% bolesnika liječenih leuprorelinom i dušika iz ureje u krvi (BUN) (≥10,7 mmol/l) u 15% bolesnika liječenih degareliksom i 14% bolesnika liječenih leuprorelinom.
English: Worsening or onset of diabetes may occur.
Croatian: Može doći do pogoršanja postojeće šećerne bolesti ili razvoja šećerne bolesti u osoba koje je nemaju.
English: The site of injection is likely to vary within the abdominal region.
Croatian: Injekcija se obično daje u različita mjesta u predjelu trbuha.
English: Markedly abnormal (>3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with normal values prior to treatment, following treatment with both medicinal products.
Croatian: Nakon liječenja s oba lijeka, u 2-6% bolesnika koji su prije liječenja imali normalne vrijednosti, primijećene su izrazito poremećene (>3 puta iznad gornje granice normale) vrijednosti jetrenih transaminaza (ALT, AST i GGT).
English: − reduced size of testicles, breast swelling, impotence
Croatian: − bol i nelagoda u mišićima i kostima − smanjena veličina testisa, oticanje dojki, impotencija
English: The solvent is a clear, colourless solution.
Croatian: Otapalo: bistra, bezbojna otopina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FIRMAGON 80 mg prašak i otapalo za otopinu za injekciju
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FIRMAGON 120 mg prašak i otapalo za otopinu za injekciju
English: Each vial contains 80 mg degarelix (as acetate).
Croatian: Svaka bočica sadrži 80 mg degareliksa (u obliku degareliksacetata).
English: The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v.
Croatian: Odsutnost intrinzičnog učinka degareliksa na srčanu repolarizaciju (QTcF), srčanu frekvenciju, AV provodljivost, srčanu depolarizaciju ili morfologiju T ili
English: 1 injection needle
Croatian: 1 iglu za injekciju
English: FIRMAGON 120 mg powder for injection degarelix
Croatian: FIRMAGON 120 mg prašak za injekciju degareliks
English: Plunger rod
Croatian: Klip štrcaljke
English: The recommended starting dose is two consecutive injections of 120 mg After that, you will receive a monthly 80 mg injection.
Croatian: Preporučenu početnu dozu čine dvije uzastopne injekcije od 120 mg.
English: FIRMAGON 80 mg powder for injection degarelix
Croatian: FIRMAGON 80 mg prašak za injekciju degareliks
English: Pack-size of 3 trays containing 3 vials with 80 mg degarelix (powder) 3 pre-filled syringe with 4.2 ml solvent 3 plunger rod
Croatian: Pakiranje od 3 podloška koje sadrži: 3 bočice s 80 mg degareliksa (prašak) 3 napunjene štrcaljke s 4,2 ml otapala 3 klipa štrcaljke
English: 1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.
Croatian: Pakiranje od 1 podloška sadrži: 1 bočicu s praškom koji sadrži 80 mg degareliksa i 1 napunjenu štrcaljku s 4,2 ml otapala;
English: Constipation, vomiting, abdominal pain, abdominal discomfort, dry mouth
Croatian: bol u trbuhu, nelagoda u trbuhu, suha usta
English: Changes in laboratory values seen during one year of treatment in the confirmatory phase III study (N=409) were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
Croatian: U potvrdnom ispitivanju faze III (N=409), promjene laboratorijskih vrijednosti ustanovljene tijekom liječenja u trajanju od jedne godine kretale su se u istom rasponu i za degareliks i za agonist GnRH-a
English: Pack-size of 1 tray containing 1 vial with 80 mg degarelix (powder) 1 pre-filled syringe with 4.2 ml solvent 1 plunger rod
Croatian: Pakiranje od 1 podloška koje sadrži: 1 bočicu s 80 mg degareliksa (prašak) 1 napunjenu štrcaljku s 4,2 ml otapala 1 klip štrcaljke
English: − The solvent is water for injections.
Croatian: Otapalo je voda za injekcije.
English: Package leaflet: Information for the user FIRMAGON 80 mg powder and solvent for solution for injection
Croatian: Uputa o lijeku: Informacija za korisnika FIRMAGON 80 mg prašak i otapalo za otopinu za injekciju degareliks
English: Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 ferring@ferring.hu
Croatian: Tel: +36 1 236 3800 ferring@ferring.hu
English: Package leaflet: Information for the user FIRMAGON 120 mg powder and solvent for solution for injection
Croatian: Uputa o lijeku: Informacija za korisnika FIRMAGON 120 mg prašak i otapalo za otopinu za injekciju degareliks
English: Transfer all solvent to the powder vial.
Croatian: Istisnite svu količinu otapala u bočicu s praškom.
English: Pack-size of 1 tray containing: 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 needle.
Croatian: FIRMAGON je dostupan u 2 veličine pakiranja: pakiranje od 1 podloška koje sadrži: 1 bočicu s praškom, 1 štrcaljku napunjenu otapalom, 1 klip za štrcaljku, 1 nastavak za bočicu i 1 iglu;
English: Tel: +385 1 2396 900
Croatian: Clinres farmacija d.o.o. Tel: +385 1 2396 900
English: • for the degarelix 240/80 mg treatment group 19.8 ng/ml (interquartile range: P25 9.4 ng/ml, P75
Croatian: Na početku ispitivanja medijan PSA bio je: • 19,8 ng/ml za skupinu liječenu degareliksom 240/80 mg (interkvartilni raspon: P25 9,4 ng/ml,
English: Tel: +48 22 246 06 80 ferring@ferring.pl
Croatian: Ferring Pharmaceuticals Poland Sp. z o.o. Tel: +48 22 246 06 80 ferring@ferring.pl
English: FIRMAGON 120 mg powder and solvent for solution for injection
Croatian: FIRMAGON 120 mg prašak i otapalo za otopinu za injekciju
English: 1 ml of the reconstituted solution contains 20 mg degarelix.
Croatian: Nakon rekonstitucije 1 ml rekonstituirane otopine sadrži 20 mg degareliksa.
English: Ferring Pharmaceuticals Ltd. Tel: +44 844 931 0050 contact2@ferring.com
Croatian: Tel: +44 844 931 0050 contact2@ferring.com
English: Patients with renal impairment
Croatian: Posebne populacije Bolesnici s oštećenjem funkcije bubrega
English: Elderly, hepatically or renally impaired patients:
Croatian: Posebne populacije Bolesnici starije dobi, bolesnici s oštećenjem funkcije jetre ili bubrega:
English: FIRMAGON 80 mg powder and solvent for solution for injection
Croatian: FIRMAGON 80 mg prašak i otapalo za otopinu za injekciju
English: 1 ml of the reconstituted solution contains 40 mg degarelix.
Croatian: Nakon rekonstitucije 1 ml rekonstituirane otopine sadrži 40 mg degareliksa.
English: After reconstitution, each ml solution contains 40 mg of degarelix.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži 40 mg degareliksa.
English: Osteoporosis/osteopenia, arthralgia muscular weakness, muscle spasms, joint swelling/stiffness
Croatian: artralgija, mišićna slabost, grčevi mišića, oticanje/ukočenost zglobova rabdomioliza
English: 2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.
Croatian: 2 bočice s praškom koji sadrži 120 mg degareliksa i 2 napunjene štrcaljke s 3 ml otapala; 2 klipa za štrcaljku, 2 nastavka za bočice i 2 igle za injekciju.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL FOR FIRMAGON 120 mg powder for solution for injection
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA ZA FIRMAGON 120 mg prašak i otapalo za otopinu za injekciju
English: After reconstitution, each ml of solution contains 20 mg of degarelix.
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži 20 mg degareliksa.
English: Pollakiuria, micturition urgency, dysuria, nocturia, renal impairment, incontinence
Croatian: Opći poremećaji i reakcije na mjestu primjene nuspojave na mjestu primjene injekcije zimica, pireksija, umor*, bolest nalik gripi malaksalost, periferni edem
English: 3 vials with powder containing 80 mg of degarelix and 3 pre-filled syringes with 4.2 ml of solvent.
Croatian: 3 bočice s praškom koji sadrži 80 mg degareliksa i 3 napunjene štrcaljke s 4,2 ml otapala; 3 klipa za štrcaljku, 3 nastavka za bočicu i 3 igle za injekciju.
English: Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection
Croatian: Bočica od stakla (tip I) s čepom od bromobutilne gume i aluminijskim „flip-off“ zatvaračem, koja sadrži
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL FOR FIRMAGON 80 mg powder for solution for injection
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA ZA FIRMAGON 80 mg prašak i otapalo za otopinu za injekciju
English: − blurred vision
Croatian: (inkontinencija) − zamagljen vid
English: Very common (may affect more than 1 in 10 people) Hot flushes, injection site pain and redness.
Croatian: Manje često (mogu se pojaviti u do 1 na 100 osoba) − gubitak spolne želje, bol u testisima, bol u zdjelici, nemogućnost ejakulacije, genitalna nadraženost, bol u dojkama
English: Remove the cap of the pre-filled syringe.
Croatian: Skinite zatvarač s napunjene štrcaljke.
English: FIRMAGON 120 mg powder and solvent for solution for injection degarelix
Croatian: FIRMAGON 120 mg prašak i otapalo za otopinu za injekciju degareliks
English: FIRMAGON 80 mg powder and solvent for solution for injection degarelix
Croatian: FIRMAGON 80 mg prašak i otapalo za otopinu za injekciju degareliks
English: Attainment of serum testosterone (T) ≤0.5 ng/ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Croatian: Postizanje testosterona u serumu (T) ≤0,5 ng/ml
English: If you get any of the side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.
Croatian: Česte nuspojave koje bi mogle utjecati na sposobnost vožnje i upravljanja strojevima su umor i omaglica.
English: After reconstitution each ml of the solution contains 20 mg degarelix.
Croatian: Nakon rekonstitucije jedan ml otopine sadrži 20 mg degareliksa.
English: After reconstitution each ml of the solution contains 40 mg degarelix.
Croatian: Nakon rekonstitucije jedan ml otopine sadrži 40 mg degareliksa.
English: 3 injection needle
Croatian: 3 nastavka za bočicu 3 igle za injekciju
English: Subcutaneous use only.
Croatian: Samo za potkožnu primjenu.
English: Cardiovascular disease
Croatian: zatajenje srca.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost anafilaktičke reakcije
English: Eye disorders
Croatian: Poremećaji oka zamagljen vid
English: Monitoring is advised when possible.
Croatian: Preporučuje se nadzor kad god je to moguće.
English: Annual reports: as part of the annual re-assessment dossier
Croatian: Godišnja izvješća: kao dio godišnje ponovne procjene dosjea
English: • Cold hands and feet
Croatian: • hladne ruke i stopala
English: These measures will help to protect the environment.
Croatian: Ove će mjere pomoći u zaštititi okoliša.
English: Tell your doctor if you have
Croatian: Obavijestite svog liječnika ako imate
English: Your doctor will also monitor your heart at the start of your treatment and also every year thereafter.
Croatian: Vaš liječnik će također kontrolirati Vaše srce na početku liječenja te također svake godine nakon toga.
English: The clinical relevance of these results is unknown.
Croatian: Klinički značaj ovih rezultata nije poznat.
English: The more points = worse symptoms.
Croatian: Više bodova = teži simptomi.
English: What FIRDAPSE is and what is it used for
Croatian: Što je FIRDAPSE i za što se koristi
English: They can present in many locations, therefore the clinical presentation can be varied.
Croatian: Oni se mogu javiti na mnogo mjesta, stoga klinička slika može varirati.
English: Baseline assessments were obtained on day 0.
Croatian: Početne procjene napravljene su na dan 0.
English: Do not drive or operate machines if you experience these side effects.
Croatian: Nemojte voziti niti raditi na strojevima ako osjetite ove nuspojave.
English: Combinations to be taken into consideration
Croatian: Kombinacije koje treba uzeti u obzir
English: Amifampridine 20 mg
Croatian: Amifampridin 20 mg
English: Date of latest renewal: 1 December 2014
Croatian: Datum posljednje obnove odobrenja: 1. prosinca 2014.
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10), često (≥ 1/100 i <1/10), manje često (≥ 1/1000 i <1/100), rijetko (≥ 1/10 000 i <1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following side effects have also been reported (frequencies cannot be estimated from the available data):
Croatian: Zabilježene su također i sljedeće nuspojave (učestalosti se ne mogu procijeniti iz dostupnih podataka):
English: This medicine has been authorised under “Exceptional Circumstances”.
Croatian: Ovaj lijek je odobren u „iznimnim okolnostima”.
English: The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka FIRDAPSE u djece u dobi od 0 do 17 godina nije ustanovljena.
English: Tablets are to be taken with food.
Croatian: Tablete se moraju uzeti s hranom.
English: • Increase sweating, cold sweat
Croatian: • pojačano znojenje, hladan znoj
English: The following medicines must not be combined with FIRDAPSE:
Croatian: Sljedeći lijekovi ne smiju se kombinirati s lijekom FIRDAPSE:
English: The tablets can be divided into equal halves.
Croatian: Tablete se mogu razdijeliti na jednake polovice.
English: Therefore, in exceptional circumstances higher doses up to a maximum of 80 mg/day may be of benefit when given with the appropriate safety monitoring.
Croatian: Stoga u iznimnim okolnostima doze više od maksimalnih 80 mg/dan mogu biti od koristi uz odgovarajuće sigurnosno praćenje.
English: Other side effects are:
Croatian: Druge nuspojave su:
English: The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors.
Croatian: Dozu koju trebate uzimati utvrđuje Vaš liječnik na temelju težine Vaših simptoma i određenih genetskih čimbenika.
English: There is little experience with overdose.
Croatian: Nema puno iskustva s predoziranjem.
English: • Together with medicines with a therapeutic dose close to the maximum safe dose
Croatian: • zajedno s lijekovima čija je terapijska doza blizu maksimalno sigurne doze,
English: Cold extremities1
Croatian: Hladni ekstremiteti1
English: It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines:
Croatian: Posebice je važno obavijestiti svog liječnika ako uzimate ili planirate početi uzimati jedan od sljedećih lijekova:
English: Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Croatian: Švanomi obično sporo rastu i mogu postojati mjesecima ili godinama bez pojave simptoma.
English: If you have LEMS but do not have cancer, your doctor will make a thorough assessment of the potential risk of cancer with FIRDAPSE before commencing treatment.
Croatian: Ukoliko imate LEMS, ali nemate karcinom, Vaš liječnik će napraviti temeljitu procjenu mogućeg rizika od nastanka karcinoma s lijekom FIRDAPSE prije početka liječenja.
English: FIRDAPSE should be given in divided doses, three or four times a day.
Croatian: FIRDAPSE se mora davati u podijeljenim dozama, tri ili četiri puta dnevno.
English: If you forget to take FIRDAPSE, do not take a double dose to make up for the dose you have forgotten but continue to take your treatment as prescribed by your doctor.
Croatian: Ako ste zaboravili uzeti FIRDAPSE, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, ali nastavite s liječenjem kao što je propisao liječnik.
English: • Reduced sense of touch or sensation
Croatian: • smanjen osjećaj dodira ili osjeta
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Croatian: Nisu postignute sigurnosne granice kod izloženosti ljudi u ispitivanjima na životinjama zbog osjetljivosti korištenih životinjskih modela.
English: Do not stop treatment without consulting your doctor.
Croatian: Nemojte prekinuti liječenje bez dogovora s liječnikom.
English: The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time.
Croatian: Korelacija između uporabe amifampridina i razvoja tumora kod ljudi u ovom trenutku nije poznata.
English: The dose of the concomitantly given medicinal product should be adjusted if necessary.
Croatian: Dozu istodobno primijenjenog lijeka treba prilagoditi ako je potrebno.
English: If you discover that you are pregnant during the treatment, inform your doctor immediately.
Croatian: Ako tijekom liječenja otkrijete da ste trudni, odmah obavijestite svog liječnika.
English: Do not take FIRDAPSE
Croatian: Nemojte uzimati FIRDAPSE
English: What FIRDAPSE is and what it is used for What you need to know before you take FIRDAPSE How to take FIRDAPSE
Croatian: Što je FIRDAPSE i za što se koristi Što morate znati prije nego počnete uzimati FIRDAPSE Kako uzimati FIRDAPSE
English: What FIRDAPSE contains
Croatian: Što FIRDAPSE sadrži
English: FIRDAPSE should not be used if you are pregnant.
Croatian: FIRDAPSE se ne smije uzimati ako ste trudni.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Croatian: OBLIK I SADRŽAJ 100 tableta
English: Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take.
Croatian: Liječnik će pomno pratiti kako FIRDAPSE djeluje na Vas te će možda biti potrebno promijeniti dozu lijekova koje uzimate.
English: What you need to know before you take FIRDAPSE
Croatian: Što morate znati prije nego počnete uzimati FIRDAPSE
English: • If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na amifampridin ili neki drugi sastojak ovog lijeka (navedenog u dijelu 6.),
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Croatian: Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju ove bolesti.
English: This dose suits you only.
Croatian: Ova doza odgovara samo Vama.
English: Combinations requiring precautions for use
Croatian: Kombinacije koje zahtijevaju mjere opreza pri uporabi
English: Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i FIRDAPSE Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
Croatian: e p-vrijednost na temelju Wilcoxonovog testa sume rangova za razlike u liječenju.
English: Total daily doses above 20 mg should be divided into two to four separate doses.
Croatian: Ukupne dnevne doze iznad 20 mg treba podijeliti u dvije do četiri zasebne doze.
English: • If you have uncontrolled asthma
Croatian: • ako imate nekontroliranu astmu,
English: Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter.
Croatian: Kliničko i elektrokardiogramsko (EKG) praćenje indicirano je na početku liječenja te nakon toga jednom godišnje.
English: Most Schwannomas are benign and asymptomatic.
Croatian: Većina švanoma je benigna i asimptomatska.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom FIRDAPSE uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
Croatian: U slučaju znakova i simptoma koji upućuju na srčane aritmije, EKG treba odmah provesti.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Croatian: Farmakoterapijska skupina: drugi lijekovi za živčani sustav, ATK oznaka: N07XX05.
English: Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Croatian: Raspon rezultata ukupnog QMG-a bio je 0 - 39, 13 stavki i 0 - 3 boda za svaki od testova.
English: Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Croatian: Izloženost amifampridinu povezana je s povećanim rizikom od epileptičkih napadaja.
English: Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Croatian: Medijan dobi bolesnika bio je 55,5 godina (raspon: od 31 do 75 godina), pri čemu je 62% bolesnika bilo ženskog spola a 38% bolesnika muškog spola.