natgillin/translations-raw huggingface dataset:
M-M-RVAXPRO can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated persons older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.
M-M-RVAXPRO se također može primijeniti i tijekom epidemija morbila ili nakon izlaganja virusu ili za primjenu u osoba starijih od 9 mjeseci koje do sada nisu bile cijepljene a koje su u kontaktu sa ženama u kojih postoji vjerojatnost da su trudne, te u osoba podložnih zarazi parotitisom i rubelom.
Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Stoga je tuberkulinski test, ako ga se mora raditi, potrebno napraviti prije cijepljenja, istodobno s cijepljenjem ili 4 do 6 tjedana nakon cijepljenja cjepivom M-M-RVAXPRO.
On the basis of the scientific conclusions for measles / mumps / rubella vaccines (live, attenuated) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing measles / mumps / rubella vaccines (live, attenuated) is unchanged subject to the proposed changes to the product information
Na temelju znanstvenih zaključaka za cjepivo protiv morbila, parotitisa i rubele (živo, atenuirano), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) cjepivo protiv morbila, parotitisa i rubele (živo, atenuirano) nepromijenjen, uz predložene izmjene informacija o lijeku.
Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Nisu provedena ispitivanja primjene cjepiva M-M-RVAXPRO u trudnica.
For storage conditions after the reconstitution of the medicinal product, see section 6.3
Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Pri razmatranju cijepljenja u takvim slučajevima, mora se pažljivo procijeniti omjer mogućeg rizika i koristi (vidjeti dio 4.8).
The MAH concluded that the review of both clinical trial and post-marketing data (including the EudraVigilance Data Analysis System (EVDAS)) for MMR, as well as a review of the literature, has not provided evidence to suggest a causal relationship for MMR and crying and therefore, a label update is not warranted at this time.
EudraVigilance Data Analysis System)), kao i pregled literature, nije rezultirao dokazima koji bi ukazali na povezanost MMR cjepiva i nuspojave plača, te je bio pri stavu da ažuriranje informacija o lijeku trenutno nije potrebno.
Pregnant women should not be vaccinated with M-M-RVAXPRO.
Trudnice se ne smiju cijepiti cjepivom M-M-RVAXPRO.
For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines.
Ukoliko se cjepiva ne smiju primijeniti istodobno, M-M-RVAXPRO se mora primijeniti mjesec dana prije ili nakon primjene drugih cjepiva.
Post-exposure vaccination
Postekspozicijsko cijepljenje
The MAH presented an analysis of reports with PT (preferred term) “Crying” From the data provided by the MAH “crying” was reported during clinical trials, post marketing source and literature report in paediatric population as an ADR.
Prema podacima dostavljenima od strane nositelja odobrenja, „plač“ je u pedijatrijskoj populaciji prijavljen kao nuspojava tijekom kliničkih ispitivanja, u razdoblju nakon stavljanja cjepiva u promet te u literaturnim izvješćima.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Pri razmatranju cijepljenja u takvim slučajevima mora se pažljivo procijeniti omjer mogućeg rizika i koristi.
Based on clinical studies with the quadrivalent measles, mumps, rubella and varicella vaccine and with the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., M-M-RVAXPRO can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine.
Na temelju kliničkih ispitivanja s kvadrivalentnim cjepivom protiv morbila, parotitisa, rubele i vodenih kozica i prethodnim kombiniranim cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc., M-M-RVAXPRO se može davati istodobno (ali u različita mjesta primjene) s cjepivom Prevenar i/ili cjepivom protiv hepatitisa A.
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
Za primjenu tijekom epidemije morbila, ili postekspozicijsko cijepljenje ili za primjenu u osoba starijih od 9 mjeseci koje prethodno nisu bile cijepljene, a koje su u kontaktu sa ženama u kojih postoji vjerojatnost da su trudne, te u osoba podložnih zarazi parotitisom i rubelom, vidjeti dio 5.1.
• Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
• začepljenost nosa; upala grla; infekcija gornjih dišnih puteva ili virusna infekcija; curenje nosa
Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Procjena imunogenosti i kliničke djelotvornosti Usporedno kliničko ispitivanje u koje je bilo uključeno 1279 osoba cijepljenih s M-M-RVAXPRO ili prethodnim kombiniranim (proizvedenim s humanim serumskim albuminom) cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. pokazalo je da ta dva cjepiva imaju sličnu imunogenost i sigurnost primjene.
Intramuscular or subcutaneous use.
Za primjenu u mišić ili potkožno.
Uncommon (may affect 1 to 10 in 1000 vaccinees)
Manje često (može se javiti u 1 do 10 na 1000 cijepljenih osoba)
M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
M-M-RVAXPRO prašak za suspenziju za injekciju u napunjenoj štrcaljki
M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened.
M-M-RVAXPRO je cjepivo koje sadrži oslabljene viruse morbila (ospica), parotitisa (zaušnjaka) i rubele (crljenca).
The solvent is a clear and colourless liquid.
Otapalo je bistra i bezbojna tekućina.
IM or SC use
Za i.m. ili s.c. primjenu
Rubella virus Wistar RA 27/3 strain (live attenuated)
živi, atenuirani virus rubele, soj Wistar RA 27/3
Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Viral infection
Infekcije i infestacije nazofaringitis, infekcije gornjih dišnih puteva ili virusne infekcije manje često aseptički meningitis
Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.
Sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, podloga 199 s Hanksovim solima, MEM, natrijev L-glutamat, neomicin, fenolno crvenilo, natrijev hidrogenkarbonat, kloridna kiselina, natrijev hidroksid i voda za injekcije.
Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Poremećaji imunološkog sustava anafilaktoidna reakcija, anafilaksija i slične pojave poput angioneurotskog edema, edema lica i perifernih edema nepoznato
The solvent is a clear colourless liquid.
Otapalo je bistra bezbojna tekućina.
*These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies.
*Ove su nuspojave bile zabilježene nakon stavljanja lijeka u promet i/ili u vrijeme trajanja kliničkih ispitivanja primjene cjepiva M-M-RVAXPRO ili cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc ili s njihovim monovalentnim (pojedinačnim) komponentama.
Powder and solvent for suspension for injection in pre-filled syringe.
Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki.
Pregnancy.
Trudnoća.
M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site.
Kod primjene u mišić, u mlađe se djece injekcija obično daje u natkoljenicu, dok se u starijih osoba prednost daje nadlaktici kao mjestu za davanje injekcije.
Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Prašak: sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, podloga 199 s Hanksovim solima, MEM, natrijev L-glutamat, neomicin, fenolno crvenilo, natrijev hidrogenkarbonat, kloridna kiselina (za podešavanje pH) i natrijev hidroksid (za podešavanje pH)
Solvent for M-M-RVAXPRO
Otapalo za M-M-RVAXPRO
Ear and labyrinth disorders Nerve deafness
Poremećaji uha i labirinta senzorička gluhoća nepoznato
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
M-M-RVAXPRO - Prašak u bočici i otapalo u bočici-Pakiranje od 1, 10
Additionally, other adverse reactions reported with post-marketing use of M-M-RVAXPRO and/or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc. without regard to causality or frequency are available and are summarised in section b. The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Osim toga, druge nuspojave prijavljene nakon stavljanja cjepiva M-M-RVAXPRO u promet i/ili tijekom kliničkih ispitivanja i nakon stavljanja u promet prethodnih monovalentnih i kombiniranih cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc., bez obzira na njihovu uzročno-posljedičnu povezanost ili učestalost navedene su u dijelu b.
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Međutim, zabilježen je prijenos virusa rubele iz cjepiva putem majčinog mlijeka na dojenčad, ali bez znakova kliničke bolesti (vidjeti dio 4.6).
What you need to know before you receive M-M-RVAXPRO 3.
Što morate znati prije nego što primite M-M-RVAXPRO 3. Kako primjenjivati M-M-RVAXPRO 4. Moguće nuspojave
Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
Poremećaji dišnog sustava, prsišta i sredoprsja rinoreja manje često bronhospazam, kašalj, upala pluća, pneumonitis (vidjeti dio 4.3), grlobolja nepoznato
INSTRUCTIONS IN USE
15. UPUTE ZA UPORABU
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe without needle - Pack of 1, 10,
M-M-RVAXPRO - Prašak u bočici i otapalo u napunjenoj štrcaljki bez igle -Pakiranje od 1, 10,
PostDose 1 PostDose 2
Nakon 2. doze
EU/1/06/337/011 - pack of 1 EU/1/06/337/012 - pack of 10 EU/1/06/337/013 - pack of 20
EU/1/06/337/011 - pakiranje od 1 EU/1/06/337/012 - pakiranje od 10 EU/1/06/337/013 - pakiranje od 20
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Prašak u bočici (staklo) s čepom (butil guma) i otapalo u napunjenoj štrcaljki (staklo) s pričvršćenom iglom i čepom klipa (klorobutil guma) i zaštitom za iglu (prirodna guma) u pakiranju od 1 ili 10.
How to use M-M-RVAXPRO
Kako primjenjivati M-M-RVAXPRO
However, foetal damage has not been documented when measles or mumps vaccines have been given to pregnant women.
Međutim, kad se trudnicama davalo cjepivo protiv ospica ili zaušnjaka nije bilo zabilježeno oštećenje fetusa.
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in pack size 1, 10 and 20.
Prašak u bočici (staklo) s čepom (butil guma) i otapalo u napunjenoj štrcaljki (staklo) i čepom klipa (klorobutil guma) i zatvaračem vrha (stiren-butadien guma), s jednom ili dvije nepričvršćene igle u pakiranju od 1, 10 ili 20.
Mumps (titre ≥10 ELISA Ab units/mL)
Parotitis (titar ≥10 ELISA
3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10
živi, atenuirani virus parotitisa 1, soj Jeryl Lynn™ [Razina B]...........ne manje od 12,5x10
Dose 1 at 9 months / Dose 2 at 12 months
1. doza u dobi od 9 mjeseci / 2. doza u dobi od 12 mjeseci N = 527
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack of 1, 10, 20
M-M-RVAXPRO - Prašak u bočici i otapalo u napunjenoj štrcaljki s dvije igle koje nisu pričvršćene na štrcaljku -Pakiranje od 1, 10, 20
20 single dose vials (powder) + 20 prefilled syringes (solvent) without needle.
20 jednodoznih bočica (prašak) + 20 napunjenih štrcaljki (otapalo) bez igle.
How to store M-M-RVAXPRO
Kako čuvati M-M-RVAXPRO
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20.
Prašak u bočici (staklo) s čepom (butil guma) i otapalo u napunjenoj štrcaljki (staklo) i čepom klipa (klorobutil guma) i zatvaračem vrha (stiren-butadien guma), bez igle u pakiranju od 1, 10 ili 20.
Withdraw the entire volume of solvent into a syringe.
Izvucite cijeli sadržaj bočice s otapalom u štrcaljku.
2 Wistar RA 27/3 strain (live, attenuated) ……………….….not less than 1x10 3 CCID50*
živi, atenuirani virus rubele 2, soj Wistar RA 27/3 …………...……..ne manje od 1x10 3 CCID50*
1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
živi, atenuirani virus parotitisa 1, soj Jeryl Lynn™ [Razina B]...........ne manje od 12,5x10 3 CCID50*
EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10
EU/1/06/337/003 - pakiranje od 1 EU/1/06/337/004 - pakiranje od 10
EU/1/06/337/008 - pack of 1 EU/1/06/337/009 - pack of 10 EU/1/06/337/010 - pack of 20
EU/1/06/337/008 - pakiranje od 1 EU/1/06/337/009 - pakiranje od 10 EU/1/06/337/010 - pakiranje od 20
EU/1/06/337/005 - pack of 1 EU/1/06/337/006 - pack of 10 EU/1/06/337/007 - pack of 20
EU/1/06/337/005 - pakiranje od 1 EU/1/06/337/006 - pakiranje od 10 EU/1/06/337/007 - pakiranje od 20
Injection site pain, and Injection site swelling Injection site bruising
• crvenilo na mjestu injekcije; bol na mjestu injekcije; oticanje na mjestu injekcije
b. Tabulated list of adverse reactions
Tablični prikaz nuspojava
10 single dose vials (powder) + 10 prefilled syringes (solvent) without needle.
10 jednodoznih bočica (prašak) + 10 napunjenih štrcaljki (otapalo) bez igle.
2 Wistar RA 27/3 strain (live, attenuated) ………………..….not less than 1x10 3 CCID50*
živi, atenuirani virus rubele 2, soj Wistar RA 27/3 ….. ……...…….. ne manje od 1x10 3 CCID50*
How to use M-M-RVAXPRO 4.
Kako primjenjivati M-M-RVAXPRO.
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack of 1, 10, 20
M-M-RVAXPRO - Prašak u bočici i otapalo u napunjenoj štrcaljki s jednom iglom koja nije pričvršćena na štrcaljku -Pakiranje od 1, 10, 20
Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
Nakon pripreme, cjepivo se mora primijeniti odmah ili unutar 8 sati ukoliko se čuva u hladnjaku.
20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 needles.
20 jednodoznih bočica (prašak) + 20 napunjenih štrcaljki (otapalo) + 40 igala.
10 single dose vials (powder) + 10 vials (solvent).
10 jednodoznih bočica (prašak) + 10 bočica (otapalo).
- If you get any of the side effects, talk to your doctor of pharmacist.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Prašak u bočici (staklo) s čepom (butil guma) i otapalo u bočici (staklo) s čepom (klorobutil guma) u pakiranju od 1 ili 10.
10 single dose vials (powder) + 10 prefilled syringes (solvent) + 10 needles.
10 jednodoznih bočica (prašak) + 10 napunjenih štrcaljki (otapalo) + 10 igala.
10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 needles.
10 jednodoznih bočica (prašak) + 10 napunjenih štrcaljki (otapalo) + 20 igala.
1 Enders' Edmonston strain (live, attenuated) ………...…….not less than 1x10 3 CCID50*
živi, atenuirani virus morbila 1, soj Enders Edmonston …………….ne manje od 1x10 3 CCID50*
EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10
EU/1/06/337/001 - pakiranje od 1 EU/1/06/337/002 - pakiranje od 10
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles.
Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki 1 jednodozna bočica (prašak) + 1 napunjena štrcaljka (otapalo) + 2 igle.
Burning and/or Stinging of short duration at the injection site, Malaise, Papillitis, Peripheral oedema, Swelling, Tenderness, Vesicles at the injection site, Wheal and Flare at the injection site
Opći poremećaji i reakcije na mjestu primjene vrućica (38,5°C ili viša), eritem na mjestu injekcije, bol na mjestu injekcije i oticanje na mjestu injekcije vrlo često podljev na mjestu injekcije često osip na mjestu injekcije manje često kratkotrajno pečenje i/ili bockanje na mjestu injekcije, opća slabost, papilitis, periferni edemi, oticanje, osjetljivost na dodir, vezikule na mjestu injekcije, oticanje i žarenje na mjestu injekcije nepoznato
20 single dose vials (powder) + 20 prefilled syringes (solvent) + 20 needles.
20 jednodoznih bočica (prašak) + 20 napunjenih štrcaljki (otapalo) + 20 igala.
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) without needle.
Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki 1 jednodozna bočica (prašak) + 1 napunjena štrcaljka (otapalo) bez igle.
Powder and solvent for suspension for injection 1 single dose vial (powder) + 1 vial (solvent).
Prašak i otapalo za suspenziju za injekciju 1 jednodozna bočica (prašak) + 1 bočica (otapalo).
10 single dose vials (powder) + 10 prefilled syringes (solvent) with needle.
10 jednodoznih bočica (prašak) + 10 napunjenih štrcaljki (otapalo) s iglom.
Musculoskeletal, connective tissue and bone disorders Arthritis † and/or Arthralgia † (usually transient and rarely chronic), Myalgia
Poremećaji kože i potkožnog tkiva morbiliformni osip ili drugi oblici osipa često urtikarija manje često panikulitis, pruritus, purpura, induracije kože, Stevens-Johnsonov sindrom nepoznato Poremećaji mišićno-koštanog sustava i vezivnog tkiva artritis † i/ili artralgija † (obično prolazna i rijetko kronična), mialgija nepoznato
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 1 needle.
Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki 1 jednodozna bočica (prašak) + 1 napunjena štrcaljka (otapalo) + 1 igla.
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
M-M-RVAXPRO Prašak i otapalo za suspenziju za injekciju Cjepivo protiv morbila, parotitisa i rubele (živo)
M-M-RVAXPRO powder and solvent for suspension for injection Measles, mumps, and rubella vaccine (live)
M-M-RVAXPRO prašak i otapalo za suspenziju za injekciju Cjepivo protiv morbila, parotitisa i rubele (živo)
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
M-M-RVAXPRO Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki Cjepivo protiv morbila, parotitisa i rubele (živo)
Not known see section c c. Description of selected adverse reactions
Krvožilni poremećaji vaskulitis nepoznato vidjeti dio c c.
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) with needle.
Prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki 1 jednodozna bočica (prašak) + 1 napunjena štrcaljka (otapalo) s iglom.
Hydrolysed gelatin
• otečeni limfni čvorovi
This is expected and may last for a few months.
To je očekivano i može trajati nekoliko mjeseci.
This generally does not mean that your blood cancer is getting worse.
To obično ne znači da Vam se rak krvi pogoršava.
N at risk (Events)
N pod rizikom (događaji)
This list is not exhaustive and is intended to serve as guidance only.
Taj popis nije konačan i svrha mu je da služi samo kao smjernica.
Do not give this medicine to children and adolescents under 18 years of age because it has not been studied in this age group.
Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina jer nije ispitan na ovoj dobnoj skupini.
• if you have any other medical conditions or illness (especially an infection or fever)
• ako imate bilo kakva druga medicinska stanja ili bolesti (osobito infekciju ili vrućicu)
This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect.
To je jako važno jer uzimanje više lijekova u isto vrijeme može pojačati ili oslabiti njihov učinak.
Each carton contains 1 bottle.
Jedna kutija sadrži 1 bocu.
The safety and efficacy of Zydelig in children under the age of 18 years have not been established.
Sigurnost i djelotvornost Zydeliga u djece mlađe od 18 godina nisu ustanovljene.
Keep the bottle and this leaflet with you so that you can easily describe what you have taken.
Ponesite bocu i ovu uputu o lijeku sa sobom kako biste mogli lakše opisati što ste uzeli.
This is to check that you do not have an infection, that your liver is working properly, and that your blood counts are normal.
To je zato da bi se provjerilo da nemate infekciju, da Vam jetra radi pravilno i da Vam je krvna slika normalna.
Contact your doctor or nearest emergency department immediately for advice.
Odmah se javite svom liječniku ili u najbližu hitnu ambulantu za savjet.
• Tell your doctor immediately if you become pregnant.
• Odmah obavijestite svog liječnika ako zatrudnite.
What Zydelig is and what it is used for
Što je Zydelig i za što se koristi
If you take more Zydelig than you should
Ako uzmete više Zydeliga nego što ste trebali
Age ≥ 65 years
Dob ≥ 65 godina
The median number of prior therapies was 3.0.
Medijan broja prethodnih terapija bio je 3,0.
Your doctor will monitor you for evidence of infection.
Liječnik će Vas nadzirati zbog znakova infekcije.
Infections (see section 4.4)
Infekcije (vidjeti dio 4.4)
STOP taking Zydelig and seek medical help immediately if you experience any of the following:
PRESTANITE uzimati Zydelig i odmah potražite liječničku pomoć ako osjetite nešto od sljedećeg:
The median duration of response (DOR) has not been reached.
Medijan trajanja odgovora (DOR, duration of response) nije dosegnut.
• Zydelig should not be used during pregnancy.
• Zydelig se ne smije uzimati u trudnoći.
→ Talk to your doctor if this applies to you.
→ Obratite se svom liječniku ako se to odnosi na Vas.
Zydelig can be taken with or without food.
Zydelig se može uzimati s hranom ili bez hrane.
The median time since diagnosis was 7.7 years.
Medijan vremena od postavljanja dijagnoze iznosio je 7,7 godina.
Most frequently observed were infections in the respiratory system and septic events.
Najčešće su bile uočene infekcije dišnog sustava i septički događaji.