natgillin/translations-raw huggingface dataset:
It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) - works to ensure that patients in the
Opisano je kako se lijekovi1 odobravaju i nadziru u Europskoj uniji (EU) i kako Europski regulatorni sustav za lijekove, kao partnerstvo među Europskom komisijom, nadležnim tijelima za lijekove u državama članicama EU-a te Europskim gospodarskim prostorom (EGP) i Europskom agencijom za lijekove (EMA), radi na tome da se bolesnicima u EU-u osigura pristup visokokvalitetnim, djelotvornim i sigurnim lijekovima.
All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.
Sve moguće nuspojave o kojima izvijeste bolesnici i zdravstveni radnici moraju se unijeti u sustav EudraVigilance, europski mrežni informacijski sustav kojim upravlja EMA, a koji prikuplja i analizira izvješća o mogućim nuspojavama lijekova te upravlja njima.
It can also take EU-wide action when a safety issue has been identified for a nationally authorised product and when harmonised regulatory measures in all MSs are considered necessary following assessment by EMA's PRAC.
Može i poduzeti radnje na razini cijele Unije kada se utvrdi pitanje sigurnosti za proizvod odobren na nacionalnoj razini i kada se usklađene regulatorne mjere u svim državama članicama smatraju potrebnima nakon procjene EMA-ina Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC).
This booklet explains how the European regulatory system for medicines operates.
U ovoj brošuri objašnjen je način rada Europskog regulatornog sustava za lijekove.
EMA provides public access to reports of suspected side effects for centrally-authorised medicines in the European database of suspected drug-reaction reports.
EMA pruža javni pristup izvješćima o mogućim nuspojavama za lijekove koji su odobreni centraliziranim postupkom u europ skoj bazi podataka izvješća o mogućim reakcijama na lijekove.
The Agency's Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP) then carries out a scientific assessment of the application and gives a recommendation to the European Commission on whether or not to grant a marketing authorisation.
Povjerenstvo za veterinarsko-medicinske proizvode (CVMP) Agencije zatim provodi znanstvenu procjenu zahtjeva i daje preporuku Europskoj komisiji o tome treba li se dodijeliti odobrenje za stavljanje u promet ili ne.
This website allows users to view all suspected side effect reports submitted to EudraVigilance
Taj portal omogućuje korisnicima da vide sva izvješća o mogućim nuspojavama učitana u sustav EudraVigilance.
• Paediatric Committee (PDCO)
• Pedijatrijsko povjerenstvo (PDCO)
Every batch of medicines must be certified as having been manufactured and tested in accordance with GMP and in conformance with the marketing authorisation before it can be released onto the market in the EU.
Svaka serija lijekova mora imati potvrdu o proizvodnji i ispitivanju prema dobroj proizvođačkoj praksi i u skladu s odobrenjem za stavljanje u promet prije nego što može biti stavljena u promet u EU-u.
A subset of this information is made publicly available by EMA via the EU clinical trials register.
EMA pruža javni pristup dijelu tih informacija putem europskog registra za klinička ispitivanja.
A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU.
Izuzeće od obveze primjenjuje se na neke zemlje koje su podnijele zahtjev za EU-ovu procjenu svojih regulatornih sustava za nadzor proizvođača aktivnih farmaceutskih sastojaka i koje su se pokazale jednakima onima u EU-u.
• the mutual-recognition procedure where companies that have a medicine authorised in one EU Member States can apply for this authorisation to be recognised in other EU countries.
• postupak međusobnog priznavanja u kojem tvrtke čiji je lijek odobren u jednoj članici EU-a mogu lijek prijaviti za isto odobrenje u drugim članicama EU-a.
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC)
Scientific advice can also be given by NCAs.
Znanstvene savjete mogu pružati i nacionalna nadležna tijela.
The EU regulatory system for medicines
Regulatorni sustav za lijekove EU-a
The heads of the NCAs work closely with EMA and the European Commission to maximise cooperation and ensure the European medicines regulatory network functions efficiently.
Rav natelji nacionalnih nadležnih tijela blisko surađuju s EMA-om i Europskom komisijom s ciljem osiguravanja učinkovite i djelotvorne suradnje unutar Europske regulatorne mreže za lijekove te njezin rad.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
EGP-a (28 država članica EU-a te Island, Lihtenštajn i Norveška), Europske komisije i EMA-e.
• Committee for Orphan Medicinal Products (COMP)
• Povjerenstvo za „lijekove siročad” (COMP)
They are available to guide the development programmes of all medicine developers who wish to submit an application for a marketing authorisation in the EU, and to ensure that medicines are developed consistently and to the highest quality.
Dostupne su svim proizvođačima lijekova u svijetu koji žele podnijeti zahtjev za odobrenje za stavljanje u promet u EU-u za usmjeravanje u njihovim programima razvoja te osiguravanje dosljednog i visokokvalitetnog razvoja lijekova u EU-u.
• Committee for Medicinal Products for Veterinary Use (CMVP)
• Povjerenstvo za veterinarsko-medicinske proizvode (CVMP)
This includes manufacturers located outside the EU unless a mutual recognition agreement (MRA) is in place between the European Union and the country of manufacture.
Proizvođače navedene u dokumentaciji u vezi sa zahtjevom za stavljanje lijeka u promet u EU-u pregledava nadležno tijelo EU-a, uključujući one koji se nalaze izvan EU-a, osim ako postoji sporazum o međusobnom priznavanju (MRA) između Europske unije i zemlje proizvodnje.
• Committee on Herbal Medicinal Products (HMPC)
• Povjerenstvo za biljne lijekove (HMPC)
• Committee for Medicinal Products for Human Use (CHMP)
• Povjerenstvo za humane lijekove (CHMP)
Medicines regulatory authorities:
Regulatorna tijela za lijekove:
encourages the exchange of knowledge, ideas and best practice between scientists striving for the highest standards for medicines'
Raznolikost stručnjaka uključenih u regulaciju lijekova u EU-u potiče razmjenu znanja, ideja i najboljih praksi među znanstvenicima koji teže najvišim standardima regulacije lijekova.
States.
Kraljevstvo
This helps to protect against the disease.
To pomaže pri zaštiti od bolesti.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Imunosni sustav potom će moći brže proizvoditi protutijela kada bude ponovno izložen virusu.
One study involved 408 healthy adults, half of whom were over 60 years of age (202 received a full dose of Celvapan, the others a half dose) and the second involved 167 healthy children aged between six months and 17 years (101 received a full dose of Celvapan, the others a half dose).
Jedno je ispitivanje obuhvatilo 408 zdravih odraslih osoba, od kojih je pola bilo starijih od 60 godina (202 je primilo punu dozu lijeka Celvapan, dok su drugi primili pola doze), a drugo je ispitivanje obuhvatilo 167 zdrave djece u dobi između šest mjeseci i 17 godina (101 dijete primilo je punu dozu lijeka Celvapan, dok su drugi primili pola doze).
The virus has been inactivated (killed) so that it does not cause any disease.
Virus je prvo inaktiviran (ubijen) kako ne bi uzrokovao bolesti.
This summary was last updated in 03-2015.
Sažetak je posljednji put ažuriran: 03.2015.
Two main studies have been carried out that looked at the ability of two doses of Celvapan H1N1 given three weeks apart to trigger an immune response.
Provedena su dva glavna ispitivanja kako bi se istražila sposobnost dviju doza lijeka Celvapan H1N1 danih u razmaku od tri tjedna da potaknu imunosni odgovor.
Celvapan must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Celvapan se ne smije primjenjivati u osoba koje su imale anafilaktičku reakciju (tešku alergijsku reakciju) na bilo koju komponentu cjepiva ili na bilo koju tvar prisutnu u tragovima (u vrlo malim količinama) u cjepivu, kao što su formaldehid, benzonaza ili sukroza.
It contains influenza (flu) viruses that have been inactivated.
Sadrži određene dijelove virusa influence (gripe) koji su inaktivirani.
The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan on 4 March 2009.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Celvapan na snazi u Europskoj uniji od 4. ožujka 2009.
Celvapan is given by injection into the muscle of the shoulder or thigh, as two doses at least three
Celvapan se primjenjuje injekcijom u mišić ramena ili bedra, kao dvije doze u razmaku od najmanje tri tjedna.
This is a summary of the European Public Assessment Report (EPAR) for Celvapan.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Celvapan.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Celvapan.
A risk management plan has been developed to ensure that Celvapan is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Celvapan.
Celvapan is a vaccine that is given by injection.
Celvapan je cjepivo koje se primjenjuje injekcijom.
influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Celvapan cjepivo protiv influence (H1N1)v (cijeli virion, iz Vero stanica, inaktivirano)
What measures are being taken to ensure the safe and effective use of
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Celvapan?
What is the risk associated with Celvapan?
Koji su rizici povezani s lijekom Celvapan?
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Kada osoba primi cjepivo, imunosni sustav prepoznaje virus kao „strano tijelo” i proizvodi protutijela na virus.
The viruses used in Celvapan are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Virusi korišteni u lijeku Celvapan uzgojeni su u stanicama sisavaca („vero stanicama”) umjesto u jajima kokoši.
Celvapan is a vaccine.
Celvapan je cjepivo.
The most common side effects with Celvapan (seen in more than 1 people vaccinated in 10) are headache and fatigue (tiredness).
Najčešće nuspojave lijeka Celvapan (koje se mogu javiti u više od 1 na 10 cijepljenih osoba) su glavobolja i iscrpljenost (umor).
In both studies, the full dose of the vaccine was shown to bring about protective levels of antibodies to a satisfactory level in line with the criteria laid down by the CHMP.
U oba ispitivanja utvrđeno je da cjepivo proizvodi zaštitne razine protutijela u zadovoljavajućoj koncentraciji, u skladu s kriterijima koje je utvrdio CHMP.
Celvapan was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Celvapan je prvobitno razvijen kao pandemijsko cjepivo, a korišten je tijekom pandemije influence A (H1N1) proglašene u lipnju 2009.
Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.
Sadrži soj gripe zvan A/California/07/2009 (H1N1)v.
The full EPAR for Celvapan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Celvapan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Celvapan pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite se svom liječniku ili ljekarniku.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Celvapan, including the appropriate precautions to be followed by healthcare
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Celvapan nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Celvapan contains a virus called A(H1N1)v 2009.
Celvapan sadrži virus naziva A(H1N1)v 2009.
Celvapan is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Celvapan je cjepivo za zaštitu od gripe uzrokovane virusom A (H1N1)v 2009.
How has Celvapan been studied?
Kako je Celvapan ispitivan?
The CHMP decided that Celvapan's benefits of are greater than its risks and recommended that it be
CHMP je odlučio da koristi lijeka Celvapan nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
What benefit has Celvapan shown during the studies?
Koje su koristi lijeka Celvapan dokazane u ispitivanjima?
For the full list of all side effects reported with Celvapan, see the
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Celvapan potražite u uputi o lijeku.
Meda Pharma 25 boulevard de l'Amiral Bruix
Francuska Meda Pharma 25 boulevard de l'Amiral Bruix
s r. o. Trnavská cesta 50
Trnavská cesta 50
Dr. Franje Tuđmana 3 Sveta Nedjelja
Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 Sveta Nedelja
Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland
Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co.
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, podnositelja zahtjeva, nositelja odobrenja u državama članicama
Pipers väg 2A, Box 906 SE-170 09, Solna Sweden
Pipers väg 2A, Box 906 SE-170 09, Solna Sweden adrenalin (epinefrin)
mg/dose
mg/doza
Kodaňská 1441/46 110 00 Prague 10
MEDA Pharma s.r.o. Kodaňská 1441/46 110 00 Prague 10
1 + Bad Homburg
Benzstr. 1 + Bad Homburg
Anapen Junior mg/dose
Anapen Junior mg/doza paranteralno
Jankovcova 1569/2c 170 00 Prague Czech Republic
Jankovcova 1569/2c 170 00 Prague Czech Republic adrenalintartarat
Adrenalin
adrenalintartarat
Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul.
Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul. Karolkowa 22/24
BIOPROJET PHARMA 9 Rue Rameau 75002 Paris France
Francuska BIOPROJET PHARMA 9 Rue Rameau
Anapen, oplossing voor injectie microgram/ dosis
Anapen, oplossing voor injectie mikrograma /doza
Germany PharmaSwiss Ceska republika s.r.o.
Njemačka PharmaSwiss Ceska republika s.r.o.
Nepipe Junior mikrogram
Nepipe Junior paranteralno
Epipen 300 mikrogramů 0,3 mg per dose (0,3 mg/0,3 ml)
Epipen 300 mikrogramů 0,3 mg po dozi (0,3 mg/0,3 ml)
Meda Pharma Hungary Kft. Váci út 91.
Mađarska Meda Pharma Hungary Kft.
EpiPen 300 microgram/dosis microgram/ dosis
EpiPen 300 microgram/dosis mikrograma doza
Adrenalină (epinefrină)
adrenalin (epinefrin)
MEDA Pharma s.r.o.
Meda Pharma spol. s r. o.
EpiPen Junior 150 microgram/dosis microgram/ dosis
EpiPen Junior 150 microgram/dosis mikrograma doza
Anapen junior, oplossing voor injectie microgram/ dosis
Anapen junior, oplossing voor injectie mikrograma doza
Jext 150 microgram, oplossing voor injectie microgram/ dosis
Jext 150 microgram, oplossing voor injectie mikrograma doza
Jext 300 microgram, oplossing voor injectie microgram/ dosis
Jext 300 microgram, oplossing voor injectie mikrograma doza
Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
Norveška Meda AS Askerveien 61
Adrenalin (hydrochloride)
Germany adrenalin (klorid)
ALK-Abelló AS Bøge Alle 6-8
Norveška ALK-Abelló AS Bøge Alle 6-8
EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban mikrograma/ 0,3 ml
0,15 mg per dose (0,15 mg/0,3 ml)
0,15 mg po dozi (0,15 mg/0,3 ml)
300 mcg / dose
300 µg / dose
EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban mikrograma/ 0,3 ml
ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben mikrograma/ 0,3 ml
Epipen microgram/ 0,3 ml
Epipen mikrograma / 0,3 ml
ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben mikrograma/ 0,3 ml
ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Denmark
ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Denmark adrenalintartarat
0,3 mg per dose (0,3 mg/0,3 ml)
0,3 mg po dozi (0,3 mg/0,3 ml)
Epipen 300 micrograms solution for injection in pre-filled pen micrograms in 0.3ml solution
Epipen 300 micrograms solution for injection in pre-filled pen mikrograma in 0,3 ml otopine
ALK-Abelló A/S Boge Allé 6-8.
Francuska ALK-Abelló A/S Boge Allé 6-8.
Anapen Junior microg/0,3 ml
Anapen Junior mikrograma/ 0,3 ml
Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Denmark
Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Denmark adrenalintartarat
Adrenaline Ph. Eur.
Meath Ireland adrenalin Ph. Eur.
Salisbury SP2 0AH Great Britain
Salisbury SP2 0AH
Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms/ 0.3ml
Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe mikrograma /0,3 ml
Mikrogramm /0,3ml
mikrograma/ 0,3ml
Germany MEDA Pharma GmbH & Co. KG
Njemačka MEDA Pharma GmbH & Co.
Nepipe mikrogram
Nepipe paranteralno
Mikrogramm/0,3 ml Injektionslösung in einer Fertigspritze
Mikrogramm/0,3 ml Injektionslösung in einer Fertigspritze mikrograma /0,3ml
EpiPen 300 micrograme 300 micrograms/ dose
Germany adrenalin (epinefrin) EpiPen 300 micrograme 300 mikrograma /dose
MEDA PHARMA, SAU Avda.
Španjolska MEDA PHARMA, SAU Avda. de Castilla, 2
Hersholm 2970 Denmark
Hersholm 2970 Denmark adrenalintartarat
Adrenaline acid tartrate
Denmark adrenalintartarat
Jext 300 micrograms solution for injection in pre-filled pen micrograms
Jext 300 micrograms solution for injection in pre-filled pen
150 mcg / dose
150 µg / dose
Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe mikrograma /0,3 ml
Epipen Junior 150 micrograms solution for injection in pre-filled pen micrograms
Epipen Junior 150 micrograms solution for injection in pre-filled pen
Epipen 300 micrograms solution for injection in pre-filled pen micrograms
Epipen 300 micrograms solution for injection in pre-filled pen
Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe mikrograma /0,3 ml
Jext 150 micrograms solution for injection in pre-filled pen micrograms
Jext 150 micrograms solution for injection in pre-filled pen
Sweden ALK-Abelló A/S Boge Allé 6-8
Nizozemska ALK-Abelló A/S Boge Allé 6-8
Epinephrine Bitartrate
EpiPen paranteralno
EpiPen 150 micrograme 150 micrograms/ dose
Germany adrenalin (epinefrin) EpiPen 150 micrograme 150 mikrograma /dose
Adrenaline tartrate Jext 150 microgramos solución inyectable en pluma precargada
Jext 150 microgramos solución inyectable en pluma precargada
Anapen microgram/ 0,3 ml
Anapen mikrograma /0,3 ml
Adrenaline tartrate Jext mikrogram
Denmark adrenalinhidrogentar tarat (epinefrinhidrogenta rtarat)
Adrenaline tartrate Jext 300 microgramos solución inyectable en pluma precargada
Jext 300 microgramos solución inyectable en pluma precargada
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms/ 0.3ml
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe mikrograma /0,3 ml
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe mikrograma in 0,3 ml otopine
Epipen 150 micrograms solution for injection in pre-filled pen micrograms
Epipen 150 micrograms solution for injection in pre-filled pen
Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark
Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark epinefrin hidrogentartarat
Anapen microg/0,3 ml
Anapen mikrograma/ 0,3 ml
1 in 1000 Solution for injection Intramuscular/subcu taneous use
1 in 1000 otopina za injekciju u mišić/ potkožno
Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
Norveška Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
Lincoln Medical Ltd Unit 8 Wilton Business Centre
0,3 mg/dose Solution for injection Intramuscular use
0,3 mg/doza otopina za injekciju u mišić
Adrenaline tartrate Emerade 500 micrograms solution for injection in pre-filled pen micrograms
Emerade 500 micrograms solution for injection in pre-filled pen
0,15 mg Solution for injection Intramuscular use
0,15 mg otopina za injekciju u mišić
EpiPen jr mikrogram
EpiPen jr paranteralno
150 mikrog Solution for injection in pre-filled pen
Emerade 150 micrograms solution for injection in pre-filled pen
0,15 mg/3ml Solution for injection Intramuscular use
0,15 mg/3ml otopina za injekciju u mišić
Adrenaline tartrate Emerade 300 micrograms solution for injection in pre-filled pen micrograms
Emerade 300 micrograms solution for injection in pre-filled pen
Adults, including the elderly
Odrasli, uključujući starije osobe
Talk to your doctor immediately if these symptoms become severe.
Odmah obavijestite svog liječnika ako ti simptomi postanu teški.
Date of first authorisation: 22 March 2018
Datum prvog odobrenja: 22. ožujka 2018.
NS: not significant
NZ: nije značajno
Treatment was discontinued on study exit (Day 365).
Liječenje je prekinuto na dan izlaska iz ispitivanja (365. dan).
Not known (frequency cannot be estimated from the available data).
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
• Do not take this starting dose for more than three days.
• Nemojte uzimati tu početnu dozu dulje od tri dana.
• Try to take Lokelma at the same time each day.
• Pokušajte uzimati lijek Lokelma svaki dan u isto vrijeme.
The suspension can be taken with or without food.
Suspenzija se može uzeti s hranom ili bez nje.
Do not give this medicine to children and adolescents under 18 years of age.
Ovaj lijek se ne smije davati djeci i adolescentima mlađima od 18 godina.
• Then take the next dose as usual at your normal time.
• Zatim uzmite sljedeću dozu u uobičajeno vrijeme.
The risk of interaction with X-rays
Rizik od interakcije s rendgenskim zrakama
• The medicine takes one to two days to work.
• Lijeku je potreban jedan ili dva dana da ostvari svoj učinak.
Therefore, the subject was eligible for the Correction Phase ITT Population; however, the time point was excluded from the analysis.
Stoga je taj ispitanik mogao biti uključen u ITT populaciju korekcijske faze; međutim, ta je vremenska točka isključena iz analize.
If you take more Lokelma than you should:
Ako uzmete više lijeka Lokelma nego što ste trebali: