natgillin/translations-raw huggingface dataset:
The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Liječenje je prosječno trajalo 33,7 dana, u rasponu od 1 do 162 dana.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika te ne bi trebali biti dulji od 24 sata pri temperaturi od 2°C do 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
This infection is caused by a mould called Aspergillus.
Ovu infekciju uzrokuje plijesan pod nazivom Aspergilus.
• some HIV medicines such as efavirenz or nevirapine
• neki lijekovi za liječenje HIV infekcije kao što su efavirenz ili nevirapin
Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Koncentracija kaspofungina u plazmi opada na polifazni način nakon primjene jedne intravenske infuzije u trajanju od 1 sat.
Patients who met the entry criteria and received one or more doses of caspofungin study therapy were included in the efficacy analysis.
Bolesnici koji su zadovoljili kriterije uključenja i primili jednu ili više doza ispitivane terapije kaspofunginom bili su uključeni u analizu djelotvornosti.
Instructions of how to reconstitute and dilute Caspofungin Accord:
Upute kako rekonstituirati i razrijediti Caspofungin Accord:
It is likely that only a small fraction of the caspofungin taken up into tissues later returns to plasma as parent compound.
Vjerojatno se samo mali dio kaspofungina koji su preuzela tkiva kasnije vraća u plazmu u izvornom obliku.
• difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.
• otežano disanje uz piskanje pri disanju ili osip koji se pogoršava - možda imate alergijsku reakciju na ovaj lijek.
The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Nevezana frakcija kaspofungina u plazmi varira od 3,5% u zdravih ispitanika do 7,6% u bolesnika s invazivnom kandidijazom.
If you weigh more than 80 kg, you may need a different dose.
Ako je Vaša tjelesna težina veća od 80 kg, doza će se morati prilagoditi.
In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
In vitro ispitivanja pokazuju da kaspofungin ne inhibira enzime citokroma P450 1A2, 2A6, 2C9, 2C19, 2D6 ili 3A4.
Caspofungin Accord contains a medicine called caspofungin.
Caspofungin Accord sadrži lijek koji se zove kaspofungin.
• Loss of kidney function, sudden loss of kidney function
• Gubitak funkcije bubrega, iznenadni gubitak funkcije bubrega
Approximately 75 % of a radioactive dose was recovered during 27 days: 41 % in urine and 34 % in faeces.
Oko 75% radioaktivne doze otkriveno je u razdoblju od 27 dana, i to 41% u mokraći, a 34% u stolici.
• fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis') if other anti-fungal treatments have not worked or have caused side effects.
• gljivične infekcije nosa, nosnih sinusa ili pluća (nazvane „invazivna aspergiloza“) ukoliko drugi antimikotici nisu pomogli ili su uzrokovali pojavu nuspojava.
DOSE*
DOZA*
The following adverse reactions were reported:
Prijavljene su sljedeće nuspojave:
Caspofungin should be given as a single daily infusion.
Kaspofungin treba primjenjivati kao infuziju jedanput na dan.
The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Intravenska terapija prosječno je trajala 11,9 dana u rasponu od 1 do 28 dana.
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
Nervous system disorders headache
Poremećaji živčanog sustava glavobolja
For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Od bolesnika koji su primali terapiju kaspofunginom dulje od 7 dana, 50% (26/52) imalo je povoljan odgovor.
How to store Caspofungin Accord Contents of the pack and other information
Kako čuvati Caspofungin Accord Sadržaj pakiranja i druge informacije
The efficacy of caspofungin against these fungal pathogens has not been established.
Nije bila utvrđena djelotvornost kaspofungina na te gljivične patogene.
All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Svi su adolescenti primali doze >50 mg na dan, a njih 6 od 8 je, u načelu, primalo maksimalnu dozu od 70 mg/dan.
There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Nema podataka koji ukazuju na to da Caspofungin Accord utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Od njih je 37 bolesnika imalo invazivnu kandidijazu, 10 je imalo invazivnu aspergilozu, a 1 je bolesnik imao kandidijazu jednjaka.
After two weeks' administration rifampicin had limited effect on AUC, but trough levels were 30 % lower than in adult subjects who received caspofungin alone.
Nakon dvotjedne primjene rifampicin je imao ograničeni utjecaj na AUC, ali vrijednosti najniže koncentracije bile su 30% niže nego u odraslih ispitanika koji su primali samo kaspofungin.
The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Eliminacija kaspofungina iz plazme je spora, klirens iznosi 10-12 ml/min.
• suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
• stanja u kojima postoji sumnja na gljivičnu infekciju, ako imate vrućicu i smanjeni broj bijelih krvnih stanica, koja nisu poboljšana nakon terapije antibioticima.
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
U pedijatrijskih bolesnika (u dobi od 12 mjeseci do 17 godina) doza se određuje na temelju površine tijela bolesnika (vidjeti Upute za primjenu u pedijatrijskih bolesnika, Mostellerova1 formula).
• phenytoin or carbamazepine (used for the treatment of seizures)
• fenitoin ili karbamazepin (koriste se za liječenje epileptičkih napadaja)
AUC0-24 hr measurements were not performed in this study due to the sparse plasma sampling.
AUC0-24 h u ovom ispitivanju nije mjerena zbog nedovoljnog uzorkovanja plazme.
In general, treatment should continue for at least 7 days after resolution of symptoms.
Liječenje općenito mora trajati još najmanje 7 dana nakon nestanka simptoma.
Your doctor will determine the duration of your treatment and how much Caspofungin Accord you will be given each day.
Liječnik će odrediti trajanje liječenja i koliko ćete lijeka Caspofungin Accord primiti svakog dana.
The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Djelotvornost i sigurnost primjene kaspofungina procjenjivala se u pedijatrijskih bolesnika u dobi od 3 mjeseca do 17 godina u dva prospektivna, multicentrična klinička ispitivanja.
Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Bolesnici su trebali biti liječeni do 72 sata nakon prestanka neutropenije, uz maksimalno trajanje terapije od 28 dana.
A higher exposure than in moderate hepatic impairment is expected and caspofungin should be used with caution in these patients (see sections 4.2 and 5.2).
Očekuje se veća izloženost nego u slučaju umjerenog oštećenja jetre pa se kaspofungin u takvih bolesnika mora primjenjivati s oprezom (vidjeti dijelove 4.2 i 5.2).
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.
Liječenje kaspofunginom mora započeti liječnik s iskustvom u liječenju invazivnih gljivičnih infekcija.
For caspofungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Kaspofungin, nije imao utjecaja na plodnost u ispitivanjima provedenim na mužjacima i ženkama štakora (vidjeti dio 5.3).
Supplied in packs of 1 vial.
Dostupno u pakiranju s 1 bočicom.
Preparation notes:
Napomene za pripremu:
No dosage adjustment is necessary based on gender or race (see section 5.2).
Nije potrebno prilagođavati dozu zbog spola ili rase (vidjeti dio 5.2).
Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/5 versus 17/48, respectively).
Premda su doze prethodno primijenjenih antimikotika u 5 bolesnika s infekcijom otpornom na liječenje bile niže od onih često primjenjivanih za invazivnu aspergilozu, stopa povoljnih odgovora tijekom liječenja kaspofunginom u tih bolesnika bila je slična onoj u preostalih bolesnika s infekcijom otpornom na liječenje (2/5 naspram 17/48).
Caspofungin Accord may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Caspofungin Accord također može uzrokovati ozbiljne kožne nuspojave kao što su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN).
There is limited treatment experience in patients 65 years of age and older (see section 5.2).
Iskustvo s liječenjem bolesnika u dobi od 65 godina i starijih je ograničeno (vidjeti dio 5.2).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
Data in patients with non-blood sites of infection were more limited.
Podaci prikupljeni u bolesnika s infekcijama koje nisu zahvaćale krv su ograničeni.
Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response.
Među bolesnicima s ekstrapulmonarnom bolesti, 2 od 8 bolesnika u kojih je postojala sigurna, vjerojatna ili moguća zahvaćenost središnjeg živčanog sustava imalo je povoljan odgovor.
Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Klinički i laboratorijski poremećaji prijavljeni u svih odraslih bolesnika liječenih kaspofunginom (ukupno 1780) bili su tipično blagi i rijetko su dovodili do prekida terapije.
However, patients found to have a documented fungal infection could be treated longer.
Međutim, bolesnici s utvrđenom gljivičnom infekcijom mogli su biti liječeni i dulje.
Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Bolesnici u kojih je pronađena gljivična infekcija moraju se liječiti najmanje 14 dana, a liječenje se mora nastaviti najmanje 7 dana nakon prestanka i neutropenije i kliničkih simptoma.
• Itching, rash, skin redness or sweating more than usual
• Svrbež, osip, crvenilo kože ili znojenje više nego uobičajeno
Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se kaspofungin izlučuje u mlijeko.
Caspofungin did not increase the plasma levels of cyclosporin.
Kaspofungin nije povisio razinu ciklosporina u plazmi.
In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/kg dose or two 3 mg/kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35 %.
U dva klinička ispitivanja provedena u zdravih odraslih ispitanika ciklosporin A (jedna doza od 4 mg/kg ili dvije od 3 mg/kg u razmaku od 12 sati) povećao je AUC kaspofungina za otprilike 35%.
Duration of empirical therapy should be based on the patient's clinical response.
Trajanje empirijskog liječenja mora se temeljiti na kliničkom odgovoru bolesnika.
Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Kaspofungin acetat je polusintetski lipopeptidni (ehinokandin) spoj koji se sintetizira iz fermentacijskog produkta Glarea lozoyensis.
Distribution plays the prominent role in caspofungin plasma pharmacokinetics and is the rate-controlling step in both the alpha- and beta-disposition phases.
Distribucija igra značajnu ulogu u farmakokinetici kaspofungina u plazmi i ona je korak koji regulira brzinu alfa i beta faze raspoloživosti lijeka.
• Changes in some laboratory blood tests.
Promjene nekih krvnih laboratorijskih testova
There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.
Izlučivanje i biotransformacija kaspofungina tijekom prvih 30 sati nakon primjene je izrazito malo.
These data suggest that caspofungin can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Takvi podaci pokazuju da se kaspofungin i ciklosporin istodobno mogu davati bolesnicima u kojih očekivana korist nadmašuje mogući rizik.
Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1).
Kaspofungin je ispitivan i u dozi od 150 mg dnevno (u trajanju do 51 dana) u 100 odraslih bolesnika (vidjeti dio 5.1).
Caution should apply in patients with history of allergic skin reaction (see section 4.8).
Potreban je oprez u bolesnika s alergijskom kožnom reakcijom u anamnezi (vidjeti dio 4.8).
** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials
**Ako bočica od 70 mg nije na raspolaganju, doza od 70 mg može se pripremiti iz dvije bočice od 50 mg
• Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
• Povišene vrijednosti krvnog tlaka i promjene nekih laboratorijskih krvnih testova (uključujući bubrežne elektrolite i testove zgrušavanja), povišene razine lijekova koje uzimate koji slabe imunološki sustav
Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.
Trajanje liječenja invazivne aspergiloze određuje se za svakog bolesnika posebno i mora se temeljiti na težini osnovne bolesti, oporavku od imunosupresije i kliničkom odgovoru.
Do not use this medicine after the expiry date which is stated on the carton and the vial .
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici
• Diarrhoea, nausea or vomiting
• Proljev, mučnina ili povraćanje
Also some other medicines can affect the way Caspofungin Accord works.
Također, drugi lijekovi mogu utjecati na djelovanje lijeka Caspofungin Accord .
The plasma concentrations decrease with increasing weight.
S porastom tjelesne težine smanjuje se njegova koncentracija u plazmi.
Caspofungin is not dialysable, thus supplementary dosing is not required following haemodialysis.
Kaspofungin se ne može ukloniti dijalizom pa stoga nije potrebna primjena dodatne doze nakon hemodijalize.
Two intermediate products, formed during the degradation of caspofungin to this open ring compound, form covalent adducts to plasma proteins resulting in a low-level, irreversible binding to plasma proteins.
Dva intermedijarna spoja, koji nastaju tijekom razgradnje kaspofungina na taj spoj s otvorenim prstenom, spajaju se kovalentnom vezom za proteine plazme, posljedica čega je slabo ireverzibilno vezanje za proteine plazme.
The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle.
Otopina za infuziju priprema se dodavanjem odgovarajuće količine rekonstituiranog koncentrata (kako je prikazano u donjoj tablici) u aseptičkim uvjetima u infuzijsku vrećicu ili bocu od 250 ml.
Talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord if:
Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite Caspofungin Accord :
• The active substance is caspofungin.
• Djelatna tvar je kaspofungin.
Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Istodobna primjena kaspofungina i ciklosporina bila je ispitana u odraslih zdravih dobrovoljaca i u odraslih bolesnika.
• The other ingredients are sucrose, mannitol, succinic acid and sodium hydroxide (please see section 2.
• Drugi sastojci su saharoza, manitol, sukcinatna kiselina i natrijev hidroksid (vidjeti dio 2.
For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
U bolesnika koji primaju oba lijeka obavezno je standardno praćenje koncentracije takrolimusa u krvi i prilagođavanje doze na odgovarajući način.
There are no or limited data from the use of caspofungin in pregnant women.
Nema podataka ili su podaci o primjeni kaspofungina u trudnica ograničeni.
The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Incidencija rezistencije različitih kliničkih izolata roda Aspergillus na kaspofungin je rijetka.
The interaction of higher doses of caspofungin with other medicinal products has not been formally studied.
Interakcije između kaspofungina primijenjenog u većim dozama i drugih lijekova nisu službeno ispitivane.
Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injections.
Podaci o stabilnosti pokazali su da se koncentrat za otopinu za infuziju može čuvati najdulje 24 sata kad se bočica čuva pri temperaturi od 25°C ili nižoj i kad je rekonstituiran s vodom za injekciju.
DO NOT MIX OR CO-INFUSE CASPOFUNGIN ACCORD WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of Caspofungin Accord with other intravenous substances, additives, or medicinal products.
NEMOJTE MIJEŠATI NI DAVATI Caspofungin Accord U INFUZIJI ISTODOBNO S DRUGIM LIJEKOVIMA jer nema podataka o kompatibilnosti lijeka Caspofungin Accord s ostalim intravenskim pripravcima, aditivima ili lijekovima.
• rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.
• osip, svrbež, osjećaj topline, oticanje lica, usana ili grla uz otežano disanje - možda imate histaminsku reakciju na lijek.
What Caspofungin Accord is and what it is used for What you need to know before you are given Caspofungin Accord How to use Caspofungin Accord
Što je Caspofungin Accord i za što se koristi Što morate znati prije nego počnete primati Caspofungin Accord Kako primjenjivati Caspofungin Accord Moguće nuspojave
• Treatment of invasive candidiasis in adult or paediatric patients.
• Liječenje invazivne kandidijaze u odraslih ili pedijatrijskih bolesnika.
The most common drug-related clinical adverse experiences reported in paediatric patients treated with caspofungin were pyrexia (11.7%), rash (4.7%) and headache (2.9%).
Najčešći štetni događaji povezani s primjenom kaspofungina zabilježeni u pedijatrijskih bolesnika bili su pireksija (11,7%), osip (4,7%) i glavobolja (2,9%).
Elderly: A modest increase in AUC (28 %) and C24h (32 %) was observed in elderly male subjects compared with young male subjects.
Stariji bolesnici: u starijih muškaraca uočen je umjereni porast AUC-a (28%) i C24h (32%) u usporedbi s mlađim muškarcima.
• Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
• Liječenje invazivne aspergiloze u odraslih ili pedijatrijskih bolesnika u kojih je izostao odgovor na liječenje ili ne podnose amfotericin B, lipidne pripravke amfotericina B i/ili itrakonazol.
Standard preparation (reconstituted Caspofungin Accord added to 250 mL) final concentration
Standardna priprema (rekonstituirani Caspofungin Accord dodan u 250 ml otopine) završna koncentracija
Other medicines and Caspofungin Accord
Drugi lijekovi i Caspofungin Accord
Women receiving caspofungin should not breast-feed.
Žene koje primaju kaspofungin ne smiju dojiti.
These AUC increases are probably due to reduced uptake of caspofungin by the liver.
To je povećanje AUC-a vjerojatno posljedica smanjenog ulaska kaspofungina u jetru.
Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥500).
Liječenje se mora nastaviti do 72 sata nakon prestanka neutropenije (apsolutni broj neutrofila ≥500).
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
ROK VALJANOSTI Rok valjanosti POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84 % of the enrolled patients) or intolerant of (16 % of enrolled patients) other standard antifungal therapies.
Bolesnici su imali infekciju otpornu na liječenje (napredovanje bolesti ili izostanak poboljšanja pri liječenju drugim antimikoticima koje su prethodno primali 7 dana) (84% uključenih bolesnika) ili nisu podnosili druge standardne antimikotike (16% uključenih bolesnika).
Both 70 mg and 50 mg vials are available.
Dostupne su bočice od 70 mg i 50 mg.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
PRIPREMA OTOPINE ZA INFUZIJU ZA ODRASLE
Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds: Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Bolesnici u skupini koja je primala kaspofungin imali su novonastale infekcije prouzročene sljedećim manje čestim kvascima i plijesnima: rod Trichosporon (1), rod Fusarium (1), rod Mucor (1) i rod Rhizopus (1).
• Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells
• Smanjena razina hemoglobina (smanjena količina tvari koja prenosi kisik u krvi), smanjeni broj bijelih krvnih stanica
Caspofungin is extensively bound to albumin.
Kaspofungin se opsežno veže za albumin.
This is because Caspofungin Accord can affect the way some other medicines work.
Caspofungin Accord može utjecati na djelovanje drugih lijekova.
• Chills, fever
• Zimica, vrućica
Rifampicin caused a 60 % increase in AUC and 170 % increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers.
Rifampicin je povećao AUC kaspofungina za 60% i povisio najnižu koncentraciju kaspofungina za 170% od prvog dana istodobne primjene ta dva lijeka u zdravih odraslih ispitanika.
Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4).
Prijavljene su reakcije preosjetljivosti (anafilaksija i nuspojave koje bi mogle biti posredovane histaminom) (vidjeti dio 4.4).