natgillin/translations-raw huggingface dataset:
− Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
- U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila < 0,5 x 109/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20%, na 0,60 mg/m2/dan (ili ukoliko je potrebno nadalje smanjiti dozu na 0,45 mg/m2/dan).
In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m2 given as a
U otvorenom ispitivanju u koje su bila uključena djeca (n=108, raspon dobi: od dojenačke dobi do 16 godina) s recidivirajućim ili progresivnim solidnim tumorima, topotekan se primjenjivao u početnoj dozi od 2,0 mg/m2 u obliku 30-minutne infuzije tijekom 5 dana ponavljano svaka 3 tjedna, u trajanju do godine dana, ovisno o terapijskom odgovoru.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Rijetko su prijavljene značajne posljedice povezane s trombocitopenijom, uključujući smrtne ishode zbog krvarenja povezanog s tumorom.
Median (95 % CI) Hazard ratio (95 % CI)
Medijan (95% CI) Omjer hazarda (95% CI)
The physico-chemical stability of the medicinal product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25oC ± 2oC and then diluted.
Kemijska i fizikalna stabilnost otopine lijeka dobivene nakon razrjeđivanja u otopinama za infuziju (natrijev klorid 0,9% i glukoza 5%) je dokazana za 4 sata na sobnoj temperaturi, pod normalnim svjetlosnim uvjetima na uzorcima koji su pripremljeni i pohranjeni tijekom 12 sati, odnosno 24 sata na temperaturi od 25°C ± 2°C, a potom razrijeđeni.
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Bočice lijeka Potactasol 1 mg moraju se rekonstituirati sa 1,1 ml vode za injekcije.
Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Bezbojna bočica (8 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 4 mg topotekana.
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Ukupni nalaz materijala povezanog s topotekanom nakon pet dnevnih doza topotekana iznosio je 71
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
U urinu, plazmi i fecesu pronađen je jedan N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od roditeljskog spoja u testu koji koristi stanice (engl. cell-based assay).
Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije ≥ 1 x 109/l, broj trombocita ≥ 100 x 109/l i razina hemoglobina ≥ 9 g/dl (nakon transfuzije, ukoliko je potrebna).
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
povraćanja (32%) i proljeva (18%), konstipacije (9%) i mukozitisa (14%).
In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
U bolesnica (n = 39) s recidivom unutar 180 dana nakon kemoradioterapije cisplatinom, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 4,6 mjeseci (95% CI: 2,6; 6,1), naspram 4,5 mjeseca (95% CI: 2,9; 9,6) u skupini liječenoj cisplatinom, uz omjer hazarda od
If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.
Ukoliko se topotekan primjenjuje tijekom trudnoće ili ukoliko bolesnica zatrudni tijekom liječenja,
Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Bezbojna bočica (5 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 1 mg topotekana.
Cisplatin 50 mg/m2 on day 1, + Topotecan 0,75 mg/m2 on days 1-3, every 21 days
topotekan 0,75 mg/m2 1.-3.dana svakih 21 dan
ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
cisplatin 50 mg/m2 1. dana, svakih 21 dan cisplatin 50 mg/m2 1. dana
- Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
- Teška depresija koštane srži prije započinjanja prvog ciklusa, na što ukazuje početni broj neutrofila < 1,5 x 109/l i/ili broj trombocita < 100 x 109/l.
− Pregnant staff should be excluded from working with this medicinal product.
- Trudne djelatnice ne smiju rukovati ovim lijekom.
When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5.
Prilikom primjene topotekana (0,75 mg/m2/dan tijekom 5 uzastopnih dana) i cisplatina (60 mg/m2/dan 1. dana) u 13 bolesnica s rakom jajnika, 5. dan je zabilježen blagi porast vrijednosti AUC-a (12%,
mucositis
mukozitis
- Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.
Rizik da se u Vas razvije ovo teško stanje (intersticijska plućna bolest) je povećan ako već imate probleme s plućima ili ste liječeni zračenjem ili ako ste prije uzimali lijekove koji mogu oštetiti pluća;
Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Neutropenija: Teška neutropenija (broj neutrofila < 0,5 x 109/l) tijekom prvog ciklusa u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju od sedam dana ili dulje.
- Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
vrućice ozbiljnog pogoršanja Vašeg općeg stanja lokalnih simptoma kao što su grlobolja ili osjećaj pečenja pri mokrenju teške boli u trbuhu, vrućice i mogućeg proljeva (rijetko uz krv) što mogu biti znakovi upale crijeva (neutropenijski kolitis)
Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
- bolesnica s metastatskim karcinomom jajnika nakon neuspjeha prve i naknadnih linija liječenja - bolesnika s recidivom karcinoma pluća malih stanica (SCLC, od engl. small cell lung cancer)
Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Bočice lijeka Potactasol 4 mg moraju se rekonstituirati sa 4 ml vode za injekcije.
In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of packed red blood cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %), respectively.
ciklusa primilo G-CSF; 65 bolesnika (60%) je tijekom 139 (30,5%) ciklusa primilo transfuziju eritrocita, a 50 njih (46%) tijekom 159 (34,9%) ciklusa transfuziju trombocita.
In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
U skupini koja je primala oralni topotekan uz BSC bilo je statistički značajno poboljšanje u ukupnom preživljenju u odnosu na skupinu koja je liječena samo BSC-om
gastrointestinal perforation Hepatobiliary disorders Common:
Nepoznato gastrointestinalna perforacija
- Weight loss and loss of appetite (anorexia); tiredness; weakness.
- gubitak na težini i gubitak teka (anoreksija), umor, slabost. - mučnina, povraćanje, proljev, bolovi u trbuhu, zatvor.
A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
[TTP; engl. time to progression] od prve linije liječenja iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za sam BSC) i u bolesnika koji nisu bili pogodni za ponovno liječenje intravenski primijenjenom kemoterapijom.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
U farmakokinetičkom ispitivanju kod pedijatrijskih bolesnika s refraktornim solidnim tumorima, ustanovljena maksimalna podnošljiva doza od 2,0 mg/m2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF
severe bleeding (associated with thrombocytopenia) Immune system disorders
teško krvarenje (povezano s trombocitopenijom)
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Incidencija teških oblika (stupanj 3 ili 4) mučnine bila je 4%, povraćanja 3%, proljeva 2% i mukozitisa 1% bolesnika.
How to store Potactasol
Kako primjenjivati Potactasol
The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Pripremljeni prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows: - Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Potactasol 4 mg with 4 ml water for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
- Potactasol 1 mg sa 1,1 ml vode za injekcije (jer sadrži 10% suviška u punjenju) - Potactasol 4 mg sa 4 ml vode za injekcije
Infections and infestations Very common:
Infekcije i infestacije
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Potactasol 4 mg prašak za koncentrat za otopinu za infuziju
Each vial contains 4 mg topotecan (as hydrochloride).
Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).
Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).
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.
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.
Reconstitution and dilution prior to administration
Potactasol UPUTE ZA UPORABU Rekonstitucija i razrjeđivanje prije primjene
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).
2 Kao komplikacija neutropenije izazvane topotekanom prijavljen je neutropenijski kolitis, ponekad sa smrtnim ishodom (vidjeti dio 4.4).
hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common:
Poremećaji kože i potkožnog tkiva Vrlo često:
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.
(klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥ 10 mg/dl).
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Potactasol 4 mg prašak za koncentrat za otopinu za infuziju topotekan
pyrexia asthenia fatigue
pireksija astenija umor
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:
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.:
Patients with renal impairment
Bolesnici s oštećenom funkcijom bubrega
mucosal inflammation
Hematološke nuspojave
Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Potactasol 4 mg prašak za koncentrat za otopinu za infuziju topotekan
febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leucopenia
febrilna neutropenija neutropenija (vidjeti dolje pod Poremećaji probavnog sustava)
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).
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
Potactasol 1 mg powder for concentrate for solution for infusion topotecan
Potactasol 1 mg prašak za koncentrat za otopinu za infuziju topotekan
After reconstitution 1 ml concentrate contains 1 mg topotecan.
Nakon rekonstitucije, dobiveni koncentrat sadrži 1 mg topotekana po ml.
anaphylactic reaction angioedema urticaria
trombocitopenija anemija leukopenija
How Potactasol is prepared
Kako se priprema Potactasol
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
1 Smrtni ishodi zbog sepse prijavljeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
Ovarian and small cell lung carcinoma
Karcinom jajnika i karcinom pluća malih stanica Početna doza
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.
Kako Potactasol 1 mg sadrži 10% suviška u punjenju, prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
How Potactasol is given
Kako se primjenjuje Potactasol
Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
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)
Haematological
Citotoksično
- Itching (pruritus).
ciklusa).
An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
glukuronidacije topotekana i N-desmetiltopotekan.
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).
Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije ≥ 1,5 x 109/l, broj trombocita
anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
anoreksija (koja može biti teška)
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.
pod normalnim svjetlosnim uvjetima te tijekom 24 sata na temperaturi od 2°C do 8°C, zaštićeno od svjetlosti.
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).
Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila ≥ 1,5 x 109/l,
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.
mg/dl, preporučuje se proučiti detaljne upute za propisivanje cisplatina radi informacije o smanjenju doze ili nastavku liječenja cisplatinom.
- Itchy rash (or hives).
- osip praćen svrbežom (ili koprivnjača).
Each vial contains 1 mg topotecan (as hydrochloride).
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
The second study included a dose range of 2.0 to 5.2 mg/m2 in children
U drugom ispitivanju raspon doza bio je 2,0 do
MedDRA version 21.0.
MedDRA verzija 21.0.
At the end of this period the product can be put back in the refrigerator.
Na kraju tog razdoblja lijek se može vratiti u hladnjak.
Practical advice should be included to mitigate the risk.
Potrebno je dati praktičan savjet kako bi se umanjio taj rizik.
5 Wald confidence interval.
5 Waldov interval pouzdanosti.
No substantial differences were seen in safety and efficacy related to age.
Nisu opažene znatne razlike u pogledu sigurnosti i djelotvornosti povezane s dobi.
The majority (90.9%) of patients were female.
Većina (90,9%) bolesnika bile su žene.
Pontevedra 36400
Pontevedra 36400 Španjolska
For adults:
Za odrasle:
As with all proteins there is a potential for immunogenicity.
Kao i kod drugih proteina, postoji mogućnost imunogenosti.
Following each infusion, you will be monitored for about one hour.
Nakon svake infuzije, bit ćete pod nadzorom otprilike jedan sat.
Your doctor will want to monitor you closely for at least 8 weeks.
Liječnik će Vas htjeti pomno nadzirati najmanje 8 tjedana.
p-value (using repeated measures analysis)
p-vrijednost (na temelju analize ponavljanih mjerenja)
Patients with other diseases
Bolesnici s drugim bolestima
You should also be aware that vaccination may not prevent this type of infection.
Također trebate znati da cijepljenje ne mora spriječiti ovu vrstu infekcije.
1 month to <12 years
1 mjesec do <12 godina
Treatment effect a
Terapijski učinak a
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.
Obavezno morate što prije posjetiti liječnika, čak i ako se počnete bolje osjećati nakon što ste uzeli antibiotik.
Approximately half were White (49.0%).
Približno polovica bolesnika bili su bijelci (49,0%).
DATE OF REVISION OF THE TEXT
DATUM REVIZIJE TEKSTA Datum:
Date of latest renewal : 18 June 2012
Datum posljednje obnove odobrenja: 18. lipnja 2012.
Soliris No transfusion
Soliris Bez transfuzije
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.
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.
Other Systemic Infections
Druge sistemske infekcije
Adult Patients:
Odrasli bolesnici:
Fatigue and health-related quality of life were relevant secondary endpoints.
Umor i kvaliteta života vezana uz zdravlje bili su važni sekundarni ishodi.
Paired t-test
Parni t-test
Discontinuation of treatment should only be considered if medically justified.
O prekidu liječenja treba razmisliti samo ako je to medicinski opravdano.
• Signs and symptoms of severe infection and the need to obtain urgent medical care.
• Znakovi i simptomi teške infekcije i potreba da se dobije hitna liječnička pomoć.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Potrebno je razmotriti službene smjernice za odgovarajuću primjenu antibakterijskih lijekova.
2 Based on the complementary log-log transformation.
Na temelju komplementarne log-log transformacije.
If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed.
Ako osjetite neki od gore navedenih simptoma, morate uzeti antibiotik kako je propisano.
Supplemental Soliris Dose With Each PE/PI Intervention
Dopunska doza lijeka Soliris kod svake PE/PI intervencije
*See paragraph Description of selected adverse reactions.
*Vidjeti odlomak Opis odabranih nuspojava.
In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
U skladu s nacionalnim preporukama, liječnik može razmotriti i dopunske mjere sprječavanja infekcije.
Your doctor's instructions should be carefully observed.
Morate se pažljivo pridržavati uputa liječnika.
If you have any of these symptoms, contact your doctor.
Ako imate neki od ovih simptoma, obratite se liječniku.
Safety Data from Other Clinical Studies
Podaci o sigurnosti primjene iz drugih kliničkih ispitivanja
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Ako niste sigurni što znače nuspojave navedene ispod, zamolite liječnika da Vam objasni.