FrancophonIA/ELRC3.0 huggingface dataset:
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Croatian: Kako bi se dobila konačna koncentracija topotekana između 25 i 50 mikrograma/ml, potrebno je dodatno razrijediti odgovarajući volumen rekonstituirane otopine ili pomoću otopine natrijevog klorida 9 mg/ml (0,9%) ili pomoću 5% w/v otopine glukoze.
English: Reconstitution and dilution prior to administration
Croatian: Potactasol UPUTE ZA UPORABU Rekonstitucija i razrjeđivanje prije primjene
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Croatian: 2 Kao komplikacija neutropenije izazvane topotekanom prijavljen je neutropenijski kolitis, ponekad sa smrtnim ishodom (vidjeti dio 4.4).
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često:
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Croatian: (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥ 10 mg/dl).
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Potactasol 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: pyrexia asthenia fatigue
Croatian: pireksija astenija umor
English: The volume of reconstituted concentrate corresponding to the calculated individual dose should be further diluted with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose, to give a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Croatian: Kako bi se dobila konačna koncentracija topotekana između 25 i 50 mikrograma po ml u otopini za infuziju, potrebno je volumen rekonstituiranog koncentrata koji odgovara izračunatoj individualnoj dozi, dodatno razrijediti ili pomoću otopine natrijevog klorida 9 mg/ml (0,9%) ili pomoću 5% w/v glukoze, npr.:
English: Patients with renal impairment
Croatian: Bolesnici s oštećenom funkcijom bubrega
English: mucosal inflammation
Croatian: Hematološke nuspojave
English: Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Croatian: Potactasol 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leucopenia
Croatian: febrilna neutropenija neutropenija (vidjeti dolje pod Poremećaji probavnog sustava)
English: In those patients (n = 102) with recurrence after 180 days, median survival in the topotecan plus cisplatin arm was 9.9 months (95 % CI: 7, 12.6) versus 6.3 months (95 % CI: 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16).
Croatian: U bolesnica (n = 102) s recidivom nakon 180 dana, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 9,9 mjeseci (95% CI: 7; 12,6), naspram 6,3
English: Potactasol 1 mg powder for concentrate for solution for infusion topotecan
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju topotekan
English: After reconstitution 1 ml concentrate contains 1 mg topotecan.
Croatian: Nakon rekonstitucije, dobiveni koncentrat sadrži 1 mg topotekana po ml.
English: anaphylactic reaction angioedema urticaria
Croatian: trombocitopenija anemija leukopenija
English: How Potactasol is prepared
Croatian: Kako se priprema Potactasol
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Croatian: 1 Smrtni ishodi zbog sepse prijavljeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
English: Ovarian and small cell lung carcinoma
Croatian: Karcinom jajnika i karcinom pluća malih stanica Početna doza
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan, as Potactasol 1 mg contains a 10 % overage of fill.
Croatian: Kako Potactasol 1 mg sadrži 10% suviška u punjenju, prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
English: How Potactasol is given
Croatian: Kako se primjenjuje Potactasol
English: Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - jaka bol u trbuhu, mučnina, povraćanje krvi, crne ili krvave stolice (mogući simptomi puknuća stijenke u probavnom traktu)
English: Haematological
Croatian: Citotoksično
English: - Itching (pruritus).
Croatian: ciklusa).
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Croatian: glukuronidacije topotekana i N-desmetiltopotekan.
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1.5 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Croatian: Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije ≥ 1,5 x 109/l, broj trombocita
English: anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Croatian: anoreksija (koja može biti teška)
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Croatian: pod normalnim svjetlosnim uvjetima te tijekom 24 sata na temperaturi od 2°C do 8°C, zaštićeno od svjetlosti.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Croatian: Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila ≥ 1,5 x 109/l,
English: If, during topotecan/cisplatin combination therapy serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Croatian: mg/dl, preporučuje se proučiti detaljne upute za propisivanje cisplatina radi informacije o smanjenju doze ili nastavku liječenja cisplatinom.
English: - Itchy rash (or hives).
Croatian: - osip praćen svrbežom (ili koprivnjača).
English: Each vial contains 1 mg topotecan (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
English: The second study included a dose range of 2.0 to 5.2 mg/m2 in children
Croatian: U drugom ispitivanju raspon doza bio je 2,0 do
English: MedDRA version 21.0.
Croatian: MedDRA verzija 21.0.
English: At the end of this period the product can be put back in the refrigerator.
Croatian: Na kraju tog razdoblja lijek se može vratiti u hladnjak.
English: Practical advice should be included to mitigate the risk.
Croatian: Potrebno je dati praktičan savjet kako bi se umanjio taj rizik.
English: 5 Wald confidence interval.
Croatian: 5 Waldov interval pouzdanosti.
English: No substantial differences were seen in safety and efficacy related to age.
Croatian: Nisu opažene znatne razlike u pogledu sigurnosti i djelotvornosti povezane s dobi.
English: The majority (90.9%) of patients were female.
Croatian: Većina (90,9%) bolesnika bile su žene.
English: Pontevedra 36400
Croatian: Pontevedra 36400 Španjolska
English: For adults:
Croatian: Za odrasle:
English: As with all proteins there is a potential for immunogenicity.
Croatian: Kao i kod drugih proteina, postoji mogućnost imunogenosti.
English: Following each infusion, you will be monitored for about one hour.
Croatian: Nakon svake infuzije, bit ćete pod nadzorom otprilike jedan sat.
English: Your doctor will want to monitor you closely for at least 8 weeks.
Croatian: Liječnik će Vas htjeti pomno nadzirati najmanje 8 tjedana.
English: p-value (using repeated measures analysis)
Croatian: p-vrijednost (na temelju analize ponavljanih mjerenja)
English: Patients with other diseases
Croatian: Bolesnici s drugim bolestima
English: You should also be aware that vaccination may not prevent this type of infection.
Croatian: Također trebate znati da cijepljenje ne mora spriječiti ovu vrstu infekcije.
English: 1 month to <12 years
Croatian: 1 mjesec do <12 godina
English: Treatment effect a
Croatian: Terapijski učinak a
English: You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Croatian: Obavezno morate što prije posjetiti liječnika, čak i ako se počnete bolje osjećati nakon što ste uzeli antibiotik.
English: Approximately half were White (49.0%).
Croatian: Približno polovica bolesnika bili su bijelci (49,0%).
English: DATE OF REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKSTA Datum:
English: Instructions:
Croatian: Upute:
English: Statistic
Croatian: Statistika
English: Date of latest renewal : 18 June 2012
Croatian: Datum posljednje obnove odobrenja: 18. lipnja 2012.
English: Soliris No transfusion
Croatian: Soliris Bez transfuzije
English: There is no evidence to suggest that any special precautions are needed when older people are treated - although experience with Soliris in this patient population is still limited.
Croatian: Nema dokaza koji pokazuju da su potrebne ikakve posebne mjere opreza kad se liječe starije osobe, iako je iskustvo s lijekom Soliris u ove populacije bolesnika i dalje ograničeno.
English: Other Systemic Infections
Croatian: Druge sistemske infekcije
English: Adult Patients:
Croatian: Odrasli bolesnici:
English: Fatigue and health-related quality of life were relevant secondary endpoints.
Croatian: Umor i kvaliteta života vezana uz zdravlje bili su važni sekundarni ishodi.
English: Paired t-test
Croatian: Parni t-test
English: Discontinuation of treatment should only be considered if medically justified.
Croatian: O prekidu liječenja treba razmisliti samo ako je to medicinski opravdano.
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care.
Croatian: • Znakovi i simptomi teške infekcije i potreba da se dobije hitna liječnička pomoć.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je razmotriti službene smjernice za odgovarajuću primjenu antibakterijskih lijekova.
English: 2 Based on the complementary log-log transformation.
Croatian: Na temelju komplementarne log-log transformacije.
English: If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed.
Croatian: Ako osjetite neki od gore navedenih simptoma, morate uzeti antibiotik kako je propisano.
English: Supplemental Soliris Dose With Each PE/PI Intervention
Croatian: Dopunska doza lijeka Soliris kod svake PE/PI intervencije
English: *See paragraph Description of selected adverse reactions.
Croatian: *Vidjeti odlomak Opis odabranih nuspojava.
English: In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Croatian: U skladu s nacionalnim preporukama, liječnik može razmotriti i dopunske mjere sprječavanja infekcije.
English: Your doctor's instructions should be carefully observed.
Croatian: Morate se pažljivo pridržavati uputa liječnika.
English: If you have any of these symptoms, contact your doctor.
Croatian: Ako imate neki od ovih simptoma, obratite se liječniku.
English: Safety Data from Other Clinical Studies
Croatian: Podaci o sigurnosti primjene iz drugih kliničkih ispitivanja
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Croatian: Ako niste sigurni što znače nuspojave navedene ispod, zamolite liječnika da Vam objasni.
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab.
Croatian: Nisu provedena ispitivanja na životinjama kako bi se procijenio genotoksični i kancerogeni potencijal ekulizumaba.
English: Both patients were negative for neutralizing antibodies.
Croatian: Oba bolesnika bila su negativna na neutralizirajuća protutijela.
English: Responses were similar across all ages from 5 months to 17 years of age.
Croatian: Odgovori su bili slični za sve dobne skupine od 5 mjeseci do 17 godina.
English: Berkshire SL1 4DX United Kingdom
Croatian: Berkshire SL1 4DX Ujedinjeno Kraljevstvo
English: Patients with eGFR improvement
Croatian: Bolesnici s poboljšanjem eGFR
English: The corresponding elimination half-life remained almost unchanged within a range of 349 to 378 h (approximately 14.5 to 15.8 days).
Croatian: Poluvijek eliminacije ostao je gotovo nepromijenjen unutar raspona od 349 do 378 sati (približno 14,5 do 15,8 dana).
English: Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours.
Croatian: Izmjena plazme rezultirala je sniženjem koncentracije ekulizumaba za približno 50% nakon 1 sata intervencije, a poluvijek eliminacije ekulizumaba bio je smanjen na 1,3 sata.
English: However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost lijeka je 24 sata na temperaturi od 2 °C - 8 °C.
English: Patients reported improved health-related quality of life (QoL).
Croatian: Bolesnici su primijetili i poboljšanje kvalitete života (QoL) povezane sa zdravljem.
English: weeks to 86 weeks).
Croatian: 13 tjedana do 86 tjedana).
English: Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Croatian: Soliris sadrži proteine, a proteini u nekih ljudi mogu uzrokovati alergijske reakcije.
English: Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Croatian: Stoga se Soliris smije davati trudnicama samo ako je to neophodno.
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Croatian: Edukacijski materijal treba dogovoriti s nacionalnim nadležnim tijelom a mora sadržavati sljedeće:
English: No unexpected tissue cross-reactivity was observed.
Croatian: Nije primijećena neočekivana križna reaktivnost tkiva.
English: The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
Croatian: Proces proizvodnje djelatne tvari u lijeku također uključuje specifične korake inaktivacije i uklanjanja virusa.
English: 30 months.
Croatian: 30 mjeseci
English: Haemolytic activity during the course of the study was effectively blocked in both female and male mice.
Croatian: Hemolitička aktivnost tijekom trajanja ispitivanja bila je učinkovito blokirana i u mužjaka i u ženki miša.
English: If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
Croatian: Ako sumnjate da ste slučajno primili veću dozu lijeka Soliris nego što je propisana, obratite se liječniku za savjet.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA25
Croatian: Farmakoterapijska skupina: selektivni imunosupresivi, ATK oznaka: L04AA25
English: See Table 3.
Croatian: Vidjeti tablicu 3.
English: 4 Based on a stratified Cox proportional hazards model.
Croatian: Na temelju stratificiranog Coxovog modela proporcionalnih hazarda.
English: At 26-weeks
Croatian: U 26. tjednu
English: It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.
Croatian: Preporučuje se da početak liječenja, koji se zove početna faza, traje 4 tjedna, nakon čega slijedi faza održavanja.
English: The safety profiles in the different paediatric subsets of age appear similar.
Croatian: Sigurnosni profili različitih dobnih podskupina pedijatrijskih bolesnika izgledaju slično.
English: Your doctor will want to monitor you closely.
Croatian: Liječnik će Vas htjeti pomno nadzirati.
English: This card is named: “Patient Safety Card”.
Croatian: Kartica se zove „kartica za bolesnika sa sigurnosnim podacima“.
English: Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Croatian: Istovremeno primjenjivani lijekovi uključivali su antitrombotične lijekove u 63% bolesnika i sistemske kortikosteroide u 40% bolesnika.
English: These studies included assessment of fertility and early embryonic development, developmental toxicity, and pre and post-natal development.
Croatian: Ta su ispitivanja uključila procjenu plodnosti i ranog embrionalnog razvoja, razvojne toksičnosti i prenatalnog i postnatalnog razvoja.
English: Subjects who undergo plasma exchange may receive additional doses of Soliris.
Croatian: Osobe koje se liječe izmjenom plazme mogu primiti dodatne doze lijeka Soliris.
English: It also resulted in a marked decrease or elimination of blood transfusions, and a trend towards an overall improvement in general function.
Croatian: Liječenje je kao rezultat imalo i izrazito smanjenje ili eliminaciju transfuzija krvi i pokazivalo je trend prema sveukupnom poboljšanju opće funkcije.
English: Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended.
Croatian: Ako se ustanovi da je takvo liječenje potrebno tijekom trudnoće, preporučuje se pažljivo praćenje majke i fetusa prema nacionalnim smjernicama.
English: Maintenance Phase
Croatian: Faza održavanja
English: However, this finding was shown in non-controlled clinical trials.
Croatian: Međutim, ovaj su nalaz pokazala nekontrolirana klinička ispitivanja.
English: • Contact details where a health care practitioner can receive further information.
Croatian: • Podaci kome se zdravstveni radnik može obratiti za dodatne informacije.
English: 3 Based on a stratified log-rank test.
Croatian: 3 Na temelju stratificiranog log-rang testa.
English: In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
Croatian: U ispitivanju SHEPHERD, 96 od 97 uključenih bolesnika završilo je ispitivanje (jedan je bolesnik umro nakon trombotičnog incidenta).
English: • All patients must be monitored for signs of meningococcal infection.
Croatian: • Svi bolesnici moraju biti pod nadzorom zbog znakova meningokokne infekcije.
English: The clearance and half-life of eculizumab were also evaluated during plasma exchange interventions.
Croatian: Klirens i poluvijek ekulizumaba također su se ocjenjivali tijekom intervencija izmjene plazme.
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Croatian: Rekonstituciju i razrjeđivanje treba provesti u skladu s pravilima dobre prakse, osobito s obzirom na asepsu.
English: There are no well-controlled studies in pregnant women treated with eculizumab.
Croatian: Trudnoća Nema dobro kontroliranih ispitivanja provedenih u trudnica liječenih ekulizumabom.
English: However, due to the lack of wellcontrolled studies, uncertainties remain.
Croatian: Međutim, zbog nepostojanja dobro kontroliranih ispitivanja, to još nije sa sigurnošću potvrđeno.
English: Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment.
Croatian: Dostupni podaci pokazuju da se klinički odgovor obično postiže za 12 tjedana liječenja Solirisom.
English: • Maintenance Phase:
Croatian: • Faza održavanja:
English: 1 Based on the Kaplan-Meier product limit method.
Croatian: 1 Na temelju Kaplan-Meierove metode za procjenu.
English: There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Croatian: Bilo je manje trombotičnih incidenata uz liječenje lijekom Soliris nego tijekom istog vremenskog razdoblja prije liječenja.
English: • Initial Phase:
Croatian: • Početna faza:
English: What Soliris is and what it is used for
Croatian: Što je Soliris i za što se koristi
English: The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.
Croatian: Križna reaktivnost tkiva na ekulizumab ocijenjena je procjenom vezanja za panel s 38 humanih tkiva.
English: However, renal function was not changed due to prior irreversible kidney damage (Table 16).
Croatian: Međutim, funkcija bubrega nije se mijenjala zbog ireverzibilnog oštećenja bubrega (tablica 16).
English: Rare: may affect up to 1 in 1,000 people:
Croatian: Rijetko: mogu se javiti u do 1 na 1000 osoba:
English: Clear, colorless, pH 7.0 solution.
Croatian: Bistra, bezbojna otopina s pH 7,0.
English: After dilution, the medicinal product should be used immediately.
Croatian: Nakon razrjeđivanja, lijek se mora odmah primijeniti.
English: TMA interventions were defined as PE/PI or new dialysis.
Croatian: Intervencije zbog TMA definirane su kao PE/PI terapija ili nova dijaliza.
English: • Warning to seek immediate medical care if above are present.
Croatian: • Upozorenje da se odmah potraži liječnička pomoć ako su prisutni gore navedeni znakovi i simptomi.
English: Total number of relapses
Croatian: Ukupni broj recidiva
English: Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids.
Croatian: Humana protutijela pretežno kataboliziraju lizosomni enzimi do malih peptida i aminokiselina.
English: The most serious side effect was meningococcal sepsis.
Croatian: Najozbiljnija nuspojava bila je meningokokna sepsa.
English: The median age at first dose of study drug was 45 years.
Croatian: Medijan dobi u vrijeme prve primljene doze ispitivanog lijeka bio je 45 godina.
English: Basedow's disease
Croatian: Basedowljeva bolest
English: The most common reason for change in immunosuppressant therapy was improvement in MG symptoms while on eculizumab treatment.
Croatian: Najčešći razlog promjene terapije imunosupresivima bilo je poboljšanje simptoma MG-a za vrijeme liječenja ekulizumabom.
English: Infections Before starting Soliris, inform your doctor if you have any infections.
Croatian: Prije nego što počnete liječenje Solirisom obavijestite liječnika ako imate ikakvu infekciju.
English: These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Croatian: Ovi su se učinci vidjeli u bolesnika u svakom od tri razreda transfuzije crvenih krvnih stanica prije ispitivanja (4 - 14 jedinica; 15 - 25 jedinica; >25 jedinica).
English: Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Croatian: Ekulizumab sadrži samo prirodne aminokiseline i nema poznatih djelatnih metabolita.
English: Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days.
Croatian: Bočice lijeka Soliris u originalnom pakiranju mogu se izvaditi iz hladnjaka samo jednokratno na najviše 3 dana.
English: If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents and four hours in children aged less than 12.
Croatian: Ako se infuzija uspori, ukupno trajanje infuzije ne smije biti dulje od dva sata u odraslih i adolescenata i četiri sata u djece mlađe od 12 godina.
English: • The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Croatian: • Razrijeđena otopina ne smije se zagrijavati u mikrovalnoj pećnici niti pomoću ikakvog drugog izvora topline osim sobne temperature.
English: • spasm of mouth muscle
Croatian: • grč mišića usta