natgillin/translations-raw huggingface dataset:
For the documentation of your injections of Zutectra it is strongly recommended to use the treatment diary.
Preporučuje se da injiciranje lijeka Zutectra redovito bilježite u dnevnik liječenja.
Luxembourg/Luxemburg Biotest AG
Luxembourg/Luxemburg
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Usprkos tome, pri primjeni lijekova proizvedenih od ljudske krvi ili plazme ne može se u potpunosti isključiti mogućnost prijenosa infekcije.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) weekly or fortnightly.
Doza se može odrediti za pojedinog bolesnika i prilagoditi od 500 IU do 1000 IU (u iznimnim slučajevima do 1500 IU) za davanje jednom tjedno ili jednom u dva tjedna.
In total, 42/61 patients (68.9 %) used antiviral medication and 19 patients received monotherapy with Zutectra during this study.
Tijekom ovog ispitivanja antivirusne lijekove koristilo je ukupno 42 od 61 bolesnika (68,9%), a monoterapiju lijekom Zutectra primalo je ukupno 19 bolesnika.
Via Leonardo da Vinci 43 I-20090 Trezzano sul Naviglio Tel: + 39 02 4844 2951
Via Leonardo da Vinci 43 I-20090 Trezzano sul Naviglio
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
The following side effects have been reported with Zutectra:
Prijavljene su sljedeće nuspojave na lijek Zutectra:
Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.
Ljudski imunoglobulin protiv hepatitisa B trebao bi se primijeniti tri do četiri tjedna nakon cijepljenja takvim živim atenuiranim cjepivom; ako je primjena ljudskog imunoglobulina protiv hepatitisa B
PHARMACEUTICAL PARTICULARS
FARMACEUTSKI
How to inject Zutectra by yourself or by caregiver
Kako samostalno injicirati lijek Zutectra ili kako će Vam ga injicirati njegovatelj
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 virus (causative agent of Ringel rubella).
Mjere koje se poduzimaju mogu imati ograničeni učinak na viruse bez ovojnice poput parvovirusa B19 (uzročnik infektivnog eritema (pete bolesti)).
No hepatitis B reinfection was reported and no patient was tested HBsAg positive during the treatment period of 48 weeks.
Tijekom razdoblja liječenja od 48 tjedana nije prijavljena nijedna ponovna infekcija hepatitisom B te nijedan ispitanik nije imao pozitivne rezultate ispitivanja HBsAg-a.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections on a weekly or fortnightly basis, according to the serum antiHBs concentrations and at the discretion of the physician in charge.
Doza lijeka može se odrediti za pojedinog bolesnika i prilagoditi od 500 IU do 1000 IU (u iznimnim slučajevima i do 1500 IU) u supkutanim injekcijama koje se, u skladu s koncentracijama anti-HBs-a u serumu i prema procjeni nadležnog liječnika, daju jednom tjedno ili jednom u dva tjedna.
What Zutectra is used for
Za što se Zutectra koristi
Biotest Austria GmbH Einsiedlergasse 58
Österreich Biotest Austria GmbH
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Local reactions at injection sites Swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Reakcije na mjestu ubrizgavanja: oticanje, bol, crvenilo, otvrdnjavanje kože, lokalna toplina, svrbež, masnice i osip.
6.6 Special precautions for disposal and other handling This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.
Ovaj lijek treba ostaviti da postigne sobnu temperaturu (oko 23 °C - 27 °C) prije uporabe.
With normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
omaglica, vrućica, povraćanje, alergijske reakcije, mučnina, artralgija, nizak krvni tlak i umjerena bol u donjem dijelu leđa.
5.1 Pharmacodynamic properties
FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
U HBsAg i HBV-DNA negativnih bolesnika moraju se održavati razine antitijela > 100 IU/l.
The solution must be brought to room temperature before use.
Otopina prije uporabe mora postići sobnu temperaturu.
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Jedna napunjena štrcaljka od 1 ml sadrži 500 IU ljudskog imunoglobulina protiv hepatitisa B.
How to store Zutectra
Kako čuvati lijek Zutectra
5 pre-filled syringes
Otopina za injekciju 5 napunjenih štrcaljki
Most adverse drug reactions (ADRs) were mild to moderate in nature.
Većina nuspojava na lijek bile su blage do umjerene naravi.
The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events.
vođenju dnevnika liječenja i mjerama koje treba poduzeti u slučaju teških nuspojava.
Precautions to be taken before handling or administering the medicinal product Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment.
Ako lijek injicira sam bolesnik ili njegovatelj kod kuće, te osobe dodatno mora obučiti liječnik koji ima iskustva s bolesnicima u kućnoj njezi.
EXP The solution should be administered immediately after opening the syringe.
Otopinu treba primijeniti odmah nakon otvaranja štrcaljke.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
B19 s imunoglobulinima, a pretpostavlja se i da sadržaj antitijela znatno pridonosi sigurnosti od virusa.
It is much easier for someone else to use this site if you do need help.
Ako Vam je potrebna pomoć, bit će puno lakše da Vam na tom mjestu lijek primjeni druga osoba.
In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs.
Tijekom davanja prve injekcije i u prvom satu nakon prve injekcije posebno se moraju pratiti bolesnici koji prije nisu primali ljudski normalni imunoglobulin, bolesnici koji se prebacuju sa zamjenskog lijeka ili oni u kojih je od prethodne injekcije prošlo dulje razdoblje, radi uočavanja mogućih znakova nuspojava.
* single case reports Adverse reactions observed with other human immunoglobulin preparations
Nuspojave uočene kod drugih pripravaka ljudskog imunoglobulina
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure.
Prevencija ponovne infekcije virusom hepatitisa B (HBV) u HBsAg i HBV-DNA negativnih odraslih bolesnika najranije tjedan dana nakon transplantacije jetre zbog zatajenja jetre uzrokovanog hepatitisom B. Potrebno je potvrditi HBV-DNA negativan status unutar zadnja tri mjeseca prije ortotopne transplantacije jetre.
NAME OF THE MARKETING AUTHORISATION HOLDER Biotest Pharma GmbH
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Biotest Pharma GmbH
The active substance is human hepatitis B immunoglobulin 500 IU/ml.
Djelatna tvar je ljudski imunoglobulin protiv hepatitisa B 500 IU/ml.
Triq ir-Russett MT-Kappara SGN 4432 Tel: + 356 27 386221
Triq ir-Russett MT-Kappara SGN 4432
49 patients received subcutaneous injections of Zutectra of 500 IU (1 mL) or 1,000 IU (2 mL) (dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels.
500 IU (1 ml) ili 1000 IU (2 ml) (u iznimnim slučajevima doza se može prilagoditi na do 1500 IU) tjedno ili svaka dva tjedna u skladu s najnižim razinama anti-HBs-a u serumu.
If you get any side effects, talk to your doctor, healthcare professional or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, zdravstvenog djelatnika ili ljekarnika.
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe
Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki
Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany
Biotest AG Landsteinerstrasse 5 D-63303 Dreieich
Furthermore the following reactions have been reported once only: tiredness (fatigue) high blood pressure (hypertension) inflammation of the nose and throat (nasopharyngitis) muscle spasm allergic reactions (hypersensitivity) abnormal heartbeat (palpitations), cardiac discomfort itching (pruritus), rash pain in the mouth and throat
mišićni grčevi alergijske reakcije (preosjetljivost) neuobičajeni otkucaji srca (palpitacije), nelagoda u prsnom košu svrbež (pruritus), osip bol u ustima i grlu
Zutectra is for subcutaneous (under the skin) injection only.
Zutectra se primjenjuje samo potkožnom injekcijom.
Reporting of side effects
* prijave pojedinačnih slučajeva
D-63303 Dreieich Tél/Tel: + 49 6103 801-0
Tél/Tel: + 49 6103 801-0
The solution should be administered immediately after opening the syringe.
Otopinu je potrebno primijeniti odmah nakon otvaranja štrcaljke.
Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit.
Prema razini anti-HBs-a u serumu suradljivost se može dokazati za 57 (od 61) bolesnika (93%) koji nisu imali vrijednosti ispod
Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki ljudski imunoglobulin protiv hepatitisa B
The colour of the solution can vary from clear to pale yellow up to light brown.
Boja otopine može biti od bezbojne preko svijetložute do svijetlosmeđe.
SE-102 34 Stockholm Puh/Tel: + 46 10 130 99 80
Puh/Tel: + 46 10 130 99 80
ES-08960 Sant Just Desvern Barcelona Tel: + 34 935 952 661
ES-08960 Sant Just Desvern
How to use Zutectra
Kako primjenjivati lijek Zutectra
What Zutectra is and what it is used for What you need to know before you use Zutectra How to use Zutectra
Što je Zutectra i za što se koristi Što je Zutectra
Wipe the intended area with an alcohol swab.
Obrišite mjesto davanja lijeka gazom natopljenom alkoholom.
SE-102 34 Stockholm Tlf:+ 46 10 130 99 80
Tlf:+ 46 10 130 99 80
Musculosceletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni spazmi rijetko*
The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra.
primatelja transplantirane jetre koji su profilaktički dobivali intravenski imunoglobulin protiv hepatitisa B i nakon toga su prebačeni na supkutanu primjenu lijeka Zutectra.
Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
A ili parvovirusom B19 zbog zaštite antitijelima protiv tih infekcija koje sadrži lijek.
61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO Tel: + 40 743 207 205
013982 Bucharest, District 1 - RO
You will be carefully observed during and shortly after the 1st injection with Zutectra to make sure that you do not suffer from a reaction.
Tijekom primanja prve injekcije lijeka Zutectra i odmah nakon toga bit ćete pod pažljivim nadzorom zbog moguće reakcije.
Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: mail@biotest.com
Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150
Headache
Nuspojave
It may be helpful to keep a record of where you had the last injection to avoid problems.
Kako biste izbjegli probleme, korisno je bilježiti mjesta injiciranja.
If you use more Zutectra than you should
Ako primijenite više lijeka Zutectra nego što ste trebali Posljedice predoziranja nisu poznate.
Muscle spams
A ili parvovirusa
Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150 Email: mail@biotest.com
Tel.: +49 6103 801-0 Faks: +49 6103 801-150
The solution can vary from colourless to pale yellow up to light brown.
Otopina može varirati od bezbojne preko blijedožute do svijetlosmeđe.
If you notice any of the following effects stop the injection and tell your doctor immediately: rash, itching, wheezing, difficulty in breathing, swelling of the eyelids, face, lips, throat or tongue, low blood pressure, fast pulse
oticanje kapaka, lica, usnica, grla ili jezika, nizak krvni tlak, brz puls
Please tell your doctor about your treatment with Zutectra prior to any vaccination.
Prije bilo kakvog cijepljenja obavijestite liječnika o tome da uzimate lijek Zutectra.
Glycine
Hrvatska
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja orofaringealna bol rijetko*
Live attenuated virus vaccines
NAČIN PRIMJENE LIJEKA Potkožno
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Uputa o lijeku: Informacije za korisnika Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki ljudski imunoglobulin protiv hepatitisa B
Please tell your doctor about your treatment with Zutectra prior to any blood test.
Prije bilo kakvih krvnih pretraga obavijestite liječnika o tome da uzimate lijek Zutectra.
The non-interventional post authorization safety study (PASS 978) enrolled 61 adult patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure.
Neintervencijsko ispitivanje sigurnosti primjene nakon dobivanja odobrenja lijeka (PASS 978, eng.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Lijek se izdaje na recept.
PL-01-793 Warszawa Tel.: + 48 22 8322638
Tel.: + 48 22 8322638
Injection site reactions like pain, urticaria at injection site, haematoma and erythema
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injiciranja, poput boli, urtikarija na mjestu injiciranja, hematom i eritem često umor, zamaranje rijetko*
België/Belgique/Belgien Infarama BVBA Stationsstraat 27
België/Belgique/Belgien
Hypertension
Cijepljenja
PHARMACEUTICAL FORM AND CONTENTS Solution for injection
NAZIV LIJEKA I PUTEVI PRIMJENE LIJEKA
Oropharyngeal pain
cm oko pupka.
Nervous system disorders
Poremećaji živčanog sustava glavobolja manje često
EXP
osip,
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU injection Human hepatitis B immunoglobulin Subcutaneous use
Zutectra 500 IU injekcija ljudski imunoglobulin protiv hepatitisa B
INFORMATION IN BRAILLE Zutectra 500 IU
Zutectra 500 IU
Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack.
Zutectra se isporučuje u pakiranju od 5
Contents of the pack and other information How to inject Zutectra by yourself or by caregiver
Sadržaj pakiranja i druge informacije Što Zutectra sadrži
SE-102 34 Stockholm Tel: + 46 10 130 99 80
Tel: + 46 10 130 99 80
Posology
Serija
Immune system disorders
Poremećaji imunološkog sustava preosjetljivost rijetko*
Official batch release
Službeno puštanje serije lijeka u promet
The withdrawal letter is available here.
Dopis o povlačenju dostupan je ovdje.
What is Arikayce?
Što je Arikayce?
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24. lipnja 2016.
It was to be available as a suspension for inhalation.
Trebao je biti dostupan kao suspenzija za inhalaciju.
What was the recommendation of the CHMP at that time?
Koja je bila preporuka CHMP-a u tom trenutku?
If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you.
Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o svom liječenju, obratite se liječniku koji vas liječi.
What consequences does this withdrawal have for patients in clinical trials?
Koje su posljedice ovog povlačenja za bolesnike u kliničkim ispitivanjima?
It was to be used in patients whose infection has persisted despite previous treatment.
Trebao se upotrebljavati u bolesnika čija se infekcija nastavila unatoč prethodnom liječenju.
These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Ti liposomi pomažu pri smanjivanju brzine razgradnje djelatne tvari, zbog čega se ona dulje zadržava u tijelu.
Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Osim toga, s obzirom na to da se lijek udiše, on dolazi do pluća izravnije nego amikacin koji se daje injekcijom.
On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Dana 8. lipnja 2016. tvrtka Insmed Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Arikayce namijenjenog za liječenje bolesti pluća Mycobacterium avium kompleks (MAK).
What was Arikayce expected to be used for?
Za što se Arikayce trebao koristiti?
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su postojale neke nedoumice.
How is Arikayce expected to work?
Kako je Arikayce trebao djelovati?
Arikayce is an antibiotic containing the active substance amikacin.
Arikayce je antibiotik koji sadrži djelatnu tvar amikacin.
In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data.
U dopisu kojim obavještava Agenciju o povlačenju tvrtka je navela da je odluka o povlačenju utemeljena na prihvaćanju činjenice da CHMP neće preporučiti odobrenje lijeka na temelju postojećih podataka.
The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Tvrtka je dostavila rezultate ranog ispitivanja (2. faza) u 89 odraslih bolesnika s infekcijom pluća kojoj je uzročnik bio MAK ili slična bakterija.
Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Arikayce (amikacin)
What were the reasons given by the company for withdrawing the application?
Koje je razloge za povlačenje zahtjeva navela tvrtka?
The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum.
Glavna zabrinutost Odbora bila je da ispitivanje podneseno sa zahtjevom nije pružilo dostatne dokaze da lijek Arikayce može trajno ukloniti bakterije iz sputuma bolesnika.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Arikayce.
How far into the evaluation was the application when it was withdrawn?
U kojoj je fazi bila ocjena zahtjeva kada je povučen?
This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
U tom je ispitivanju lijek Arikayce uspoređen s placebom (prividno liječenje), a uglavnom se istraživala učinkovitost lijeka u uklanjanju bakterija iz sputuma (ispljuvka) bolesnika nakon tri mjeseca liječenja.
Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water.
Lijek Arikayce trebao se koristiti za liječenje odraslih osoba s infekcijom pluća kojoj je uzročnik Mycobacterium avium kompleks (MAK), skupina bakterija koja se najčešće nalazi u okolišu, primjerice u tlu i vodi.
In this medicine, amikacin is contained within microscopic fat capsules known as liposomes.
Amikacin se u ovom lijeku nalazi u mikroskopskim mjehurićima masti koji se nazivaju liposomi.
Further information on the orphan designation can be found here.
Dodatne informacije o odobrenjima za lijekove za rijetke bolesti možete pronaći ovdje.
What did the company present to support its application?
Što je tvrtka dostavila u prilog zahtjevu?
Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria.
Lijek Arikayce bio je označen kao lijek za liječenje rijetkih bolesti dana 8. travnja 2014. za liječenje infekcija uzrokovanih MAK-om i sličnim bakterijama.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks.
U skladu s navedenim, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Arikayce ne nadmašuju s njim povezane rizike.
Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection.
Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja privremeno mišljenje CHMP-a bilo je da nije moguće dati odobrenje za lijek Arikayce za liječenje infekcije pluća kojoj je uzročnik MAK.
The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins.
Djelatna tvar u lijeku Arikayce, amikacin, poznati je antibiotik koji pripada skupini „aminoglikozoida”, a djeluje tako da ometa bakterije u stvaranju vitalnih bjelančevina.
Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016
(amikacin) EMA/430267/2016
It may harm them,
NAVOĐENJE DJELATNE(IH) TVARI
No special requirements.
Nema posebnih zahtjeva.
8501 Novo mesto Slovenia
8501 Novo mesto Slovenija
The clinical relevance of these differences is unknown.
Klinička važnost tih razlika nije poznata.
• Risk management plan (RMP)
• Plan upravljanja rizikom (RMP)
FBAL is a metabolite without antiproliferative activity.
FBAL je metabolit koji nema antiproliferativnu aktivnost.
- Vomiting: if you vomit more than once in a 24-hour time period.
- povraćanje: ako povratite više od jednom u 24 sata.
Median survival was 384 and 373 days.
Medijan preživljenja iznosio je 384 i 373 dana.
Do not store above 30°C.
Ne čuvati na temperaturi iznad 30C.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
To je vrlo važno jer istovremeno uzimanje više lijekova može pojačati ili oslabiti njihov učinak.
The consequences of a reduced dose for efficacy are currently uncertain.
Posljedice smanjene doze na djelotvornost trenutno nisu jasne.