natgillin/translations-raw huggingface dataset:
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Table 2: Adverse reactions reported with the use of irbesartan alone Blood and lymphatic system disorders
Tablica 2: Nuspojave prijavljene samo za irbesartan
Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Jedna filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Ifirmacombi 300 mg/25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively.
Učinci najniže i najviše koncentracije na sniženje krvnog tlaka nakon primjene lijeka Ifirmacombi u dozama od 150 mg/12,5 mg, odnosno 300 mg/12,5 mg, prema mjerenjima manžetom za vrijeme kontrolnog pregleda, iznosili su 68%, odnosno 76%.
Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Jedna Ifirmacombi 150 mg/12,5 mg filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi.
Nuspojave prijavljene nakon stavljanja kombinacije irbesartana i hidroklorotiazida na tržište
Common: fatigue
Često: umor
Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Jedna Ifirmacombi 300 mg/25 mg filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets Film coating:
Ifirmacombi 150 mg/12,5 mg i 300 mg/25 mg filmom obložene tablete Film ovojnica: poli(vinilni alkohol)
Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ifirmacombi 300 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Jedna Ifirmacombi 300 mg/12,5 mg filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
Dosage of Ifirmacombi 300 mg/25 mg
Doziranje lijeka Ifirmacombi 300 mg/25 mg
Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
Hepatic impairment:
Nemelanomski rak kože:
Hepatobiliary disorders
Nepoznato: trombocitopenija
It is available as tablets (20 mg; 40 and 80 mg).
Dostupan je u tabletama (20 mg; 40 mg i 80 mg).
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 Telmisartan Actavis.
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 i svoje preporuke o uvjetima za primjenu lijeka Telmisartan Actavis.
This means that Telmisartan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
To znači da je Telmisartan Actavis sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Micardis.
The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavis on 30 September 2010.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Telmisartan Actavis na snazi u Europskoj uniji od 30. rujna 2010.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
To omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, poput moždanog udara.
Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Telmisartan Actavis se također koristi za sprječavanje kardiovaskularnih problema (problema sa srcem i krvnim žilama) poput srčanog zastoja ili moždanog udara).
This is a summary of the European public assessment report (EPAR) for Telmisartan Actavis.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Telmisartan Actavis.
For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Za terapiju esencijalne hipertenzije, uobičajena preporučena doza lijeka Telmisartan Actavis iznosi 40 mg jednom na dan, no pojedini bolesnici mogu imati koristi od doze od 20 mg.
pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
može dostatno kontrolirati, doza se može povećati na 80 mg jedanput na dan ili se mogu dodati drugi antihipertenzivi, poput hidroklorotiazida.
The active substance in Telmisartan Actavis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Telmisartan, djelatna tvar u lijeku Telmisartan Actavis je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
If the target blood
Ako se krvni tlak ne
Telmisartan Actavis is a ‘generic medicine'.
Telmisartan Actavis je „generički lijek”.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Blokiranjem receptora na koja se angiotenzin II inače veže telmisartan sprječava učinak hormona i omogućuje širenje krvnih žila.
The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavis has been shown to have comparable quality and to be bioequivalent to Micardis.
CHMP je zaključio da je, u skladu sa zahtjevima EU-a, potvrđeno kako Telmisartan Actavis posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Micardis.
Because Telmisartan Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je lijek Telmisartan Actavis generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
Telmisartan Actavis is a medicine that contains the active substance telmisartan.
Telmisartan Actavis je lijek koji sadrži djelatnu tvar telmisartan.
The doctor should monitor the patient's blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient's blood pressure-lowering medication.
Prilikom počinjanja terapije lijekom Telmisartan Actavis, liječnik treba pratiti pažljivo krvni tlak bolesnika, te može donijeti odluku o prilagođavanju terapije koja služi za snižavanje krvnoga tlaka bolesnika.
Because Telmisartan Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Budući da je Telmisartan Actavis generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Micardis.
The Committee recommended that Telmisartan Actavis be given marketing authorisation.
Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Telmisartan Actavis.
What are the benefits and risks of Telmisartan Actavis?
Koje su koristi i rizici od lijeka Telmisartan Actavis?
Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults.
Telmisartan Actavis koristi se za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
The full EPAR for Telmisartan Actavis can be found on the Agency's website EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Telmisartan Actavis nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Telmisartan Actavis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Other information about Telmisartan Actavis:
Ostale informacije o lijeku Telmisartan Actavis
Why has Telmisartan Actavis been approved?
Zašto je Telmisartan Actavis odobren?
What is Telmisartan Actavis?
Što je Telmisartan Actavis?
What is Telmisartan Actavis used for?
Za što se Telmisartan Actavis koristi?
How is Telmisartan Actavis used?
Kako se koristi Telmisartan Actavis?
How has Telmisartan Actavis been studied?
Kako je Telmisartan Actavis ispitivan?
How does Telmisartan Actavis work?
Kako djeluje Telmisartan Actavis?
MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Broj (EU) odobrenja
0.6 ml (10 mg/ml) 1 pre-filled syringe
0,6 ml (10 mg/ml) 1 napunjena štrcaljka
6 mg
6 mg Otopina za injekciju Potkožno
Strength Pharmaceutical Form
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakiranje
In the future if the animals are exposed to similar proteins the immune system will be able to respond more quickly.
Ako životinje u budućnosti budu izložene sličnim bjelančevinama, imunosni sustav moći će brže reagirati.
Vaccinated birds had a protection level of between 81% and 95% against disease signs.
Cijepljena perad imala je razinu zaštite od znakova bolesti između 81 % i 95 %.
Safety studies have shown that the strain is safe for turkeys, however, precautionary measures must be followed to avoid direct or indirect contact between vaccinated chickens and turkeys.
Sigurnosna ispitivanja pokazala su da je soj siguran za purane, međutim potrebno je poduzimati mjere opreza kako bi se izbjegao izravan ili neizravan kontakt cijepljenih pilića i purana.
This overview was last updated in March 2019.
Pregled je posljednji put ažuriran u 3. 2019.
The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck or directly into 18 - 19-day-old chicken eggs containing embryos (unhatched developing chicks).
Cjepivo se može dati pilićima starima jedan dan kao jednokratna injekcija pod kožu vrata ili izravno u jaja stara 18 - 19 dana koja sadržavaju zametke (neizlegnute piliće u razvoju).
The full EPAR for Innovax-ND-IBD can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Cjeloviti EPAR za VMP Innovax-ND-IBD nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Vaccinated chickens were taken from a field study and challenged (brought in contact with the viruses) in the laboratory to show protection after vaccination.
Cijepljeni pilići preuzeti su iz terenskog ispitivanja i izloženi (dovedeni u kontakt s virusima) u laboratoriju kako bi se utvrdila zaštita nakon cijepljenja.
ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.
ND je virusna infekcija pilića koja uzrokuje dahtanje i kašalj, znakove nervoze (padanje krila, zaokretanje glave i vrata, kruženje i paralizu), oticanje tkiva oko očiju i vrata, zelenkasti vodenasti proljev i smanjenu nesivost.
It can make birds more prone to other diseases and can interfere with effective vaccination.
Zbog nje perad može biti sklonija drugim bolestima, a može utjecati i na učinkovito cijepljenje.
IBD, also known as Gumboro disease, is a viral infection of chickens associated with death at 3-6 weeks of age.
IBD, poznat i kao gumborska bolest, virusna je infekcija pilića povezana sa smrtnim ishodom u dobi od tri do šest tjedana.
Innovax-ND-IBD received a marketing authorisation valid throughout the EU on 22 August 2017.
VMP Innovax-ND-IBD dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 22. kolovoza 2017.
The withdrawal period for meat and eggs from chickens treated with Innovax-ND-IBD is ‘zero' days, which means there is no mandatory waiting time.
Razdoblje karencije za meso i jaja pilića liječenih VMP-om Innovax-ND-IBD iznosi „nula” dana, odnosno nema obaveznog razdoblja čekanja.
Similar challenges were carried out after hatching to show the effects of vaccination of chicken eggs.
Slična su izlaganja provedena nakon izlijeganja za utvrđivanje učinaka cjepiva na jaja s pilićima.
As the vaccine is stored in liquid nitrogen, it is important that any handling is done in a well-ventilated area and that precautions are taken when preparing the vaccine.
Budući da se cjepivo drži u tekućem dušiku, važno je da se njime uvijek rukuje u dobro prozračenom prostoru te da se pri pripremi cjepiva provode mjere opreza.
Innovax-ND-IBD is a veterinary vaccine used to protect chickens against Newcastle disease (ND), infectious bursal disease (IBD) and Marek's disease (MD).
Innovax-ND-IBD je veterinarsko cjepivo koje se koristi za zaštitu pilića od njukastelske bolesti (ND), zarazne bolesti burze (IBD) i Marekove bolesti (MD).
MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
MD je herpesvirusna infekcija pilića koja može uzrokovati paralizu krila i nogu te uzrokuje tumore raznih organa.
Innovax-ND-IBD is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which does not cause disease in chickens but which is similar to the virus that causes MD.
Innovax-ND-IBD cjepivo je koje sadrži serotip 3 herpesvirusa purana, vrstu herpesvirusa koja ne izaziva bolest u pilića, ali je slična virusu koji uzrokuje MD.
Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Pilići dobivaju infekciju u ranoj dobi udisanjem peruti (ljuskica kože) koja sadržava virus i može biti zarazna i do nekoliko mjeseci nakon što se oljušti s kože.
Birds infected with MD virus can be carriers and shedders of the virus for life.
Perad zaražena virusom MD-a može biti prijenosnik i nositelj virusa cijeli život.
When Innovax-ND-IBD is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against its proteins.
Kada se cjepivo Innovax-ND-IBD primijeni na pilićima, imunosni sustav životinje prepoznaje virus kao „strano tijelo” te protiv njega proizvodi protutijela.
An overview of Innovax-ND-IBD and why it is authorised in the EU
Pregled informacija o VMP-u Innovax-ND-IBD i zašto je odobren u EU-u
Other information about Innovax-ND-IBD
Ostale informacije o VMP-u Innovax-ND-IBD
Innovax-ND-IBD contains a live modified strain of turkey herpesvirus called strain HVP360.
Innovax-ND-IBD sadrži živi modificirani soj herpesvirusa purana naziva soj HVP360.
Since Innovax-ND-IBD is a live vaccine, the vaccine strain can be passed into the environment from vaccinated chickens and may spread to turkeys.
Budući da je Innovax-ND-IBD živo cjepivo, soj cjepiva može se s cijepljenih pilića prenijeti u okoliš i proširiti na purane.
For ND, 60% of vaccinated chickens did not develop ND when challenged at 4 weeks after vaccination and 95% of vaccinated chickens were protected 6 weeks after vaccination.
Među cijepljenim pilićima, 60 % ih nije razvilo ND prilikom izlaganja virusu četiri tjedna nakon cijepljenja, a 95 % cijepljenih pilića bilo je zaštićeno šest tjedana nakon cijepljenja.
For IBD, vaccinated birds were challenged at 3, 4, 6 and 8 weeks after vaccination.
Kod IBD-a cijepljena i necijepljena perad bila je izložena virusu tri, četiri, šest i osam tjedana nakon cijepljenja.
Innovax-ND-IBD is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Innovax-ND-IBD dostupan je kao suspenzija i otapalo za pripremu suspenzije za injekciju te se izdaje samo na veterinarski recept.
Protection against IBD starts 3 weeks after vaccination and lasts 8 weeks.
Zaštita od IBD-a započinje tri tjedna nakon cijepljenja i traje osam tjedana.
The European Medicines Agency decided that Innovax-ND-IBD's benefits are greater than its risks and recommended it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od veterinarskog cjepiva Innovax-ND-IBD nadmašuju s njim povezane rizike te da VMP može biti odobren za primjenu u Europskoj uniji.
Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ND-IBD, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Innovax-ND-IBD nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici te vlasnici životinja ili uzgajivači trebaju pridržavati.
Protection against ND starts 4 weeks after vaccination and lasts 8 weeks.
Zaštita od ND-a započinje četiri tjedna nakon cijepljenja i traje osam tjedana.
For MD, 87% of the vaccinated chickens were protected against challenge at 9 days after vaccination.
Kod MD-a je 87 % cijepljenih pilića bilo zaštićeno prilikom izlaganja virusu devet dana nakon cijepljenja.
What is Innovax-ND-IBD and what is it used for?
Što je Innovax-ND-IBD i za što se koristi?
For MD, 91% of chickens from vaccinated eggs did not develop MD when challenged at 8 days of age.
Kod MD-a 91 % pilića iz cijepljenih jaja nije razvilo MD kad su bili izloženi bolesti u dobi od osam dana.
Why is Innovax-ND-IBD authorised in the EU?
Zašto je Innovax-ND-IBD odobren u EU-u?
The virus in the vaccine has been modified so that it also makes proteins from ND and IBD viruses.
Virus u cjepivu modificiran je na način da proizvodi i bjelančevine iz virusa ND-a i IBD-a.
For IBD, 100% of vaccinated chickens did not develop IBD when challenged at 46 days after vaccination.
Kod IBD-a 100 % cijepljenih pilića nije razvilo IBD kad su bili izloženi bolesti 46 dana nakon cijepljenja.
This will help protect the chickens against ND, IBD and herpesvirus infections like MD.
To će pomoći u zaštiti pilića od bolesti ND, IBD i MD.
The turkey herpesvirus strain HVP360 has been modified so that it will produce proteins from ND virus and IBD virus.
Soj herpesvirusa purana HVP360 modificiran je tako da proizvodi bjelančevine ND virusa i IBD virusa.
Protection against MD starts 9 days after vaccination and lasts for life.
Zaštita od MD-a započinje devet tjedana nakon cijepljenja i traje cijeli život.
What are the risks associated with Innovax-ND-IBD?
Koji su rizici povezani s VMP-om Innovax-ND-IBD?
How is Innovax-ND-IBD used?
Kako se Innovax-ND-IBD koristi?
For ND, 92% of chickens from vaccinated eggs did not develop ND when challenged at 46 days after vaccination.
Kod ND-a 92 % pilića iz cijepljenih jaja nije razvilo ND kad su bili izloženi bolesti 46 dana nakon cijepljenja.
What benefits of Innovax-ND-IBD have been shown in studies?
Koje su koristi od VMP-a Innovax-ND-IBD utvrđene u ispitivanjima?
How does Innovax-ND-IBD work?
Kako djeluje Innovax-ND-IBD?
List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States
Popis naziva, farmaceutskih oblika, jačine lijeka, puta primjene i podnositelja zahtjeva u državama članicama
(Invented) Name
(Zaštićen) Naziv
02130 Espoo Finland
02130 Espoo Finska
AT-1020 Vienna Austria
AT-1020 Vienna Austrija
16904 Solna Sweden
16904 Solna Švedska
41470 Neuss Germany
41470 Neuss Njemačka
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene,
5026 RH Tilburg The Netherlands
5026 RH Tilburg Nizozemska
F-92787 Issy Les Moulineaux, Cedex 9 France
F-92787 Issy Les Moulineaux, Cedex 9 Francuska
Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy
Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italija
Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark
Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Danska
High Wycombe Buckinghamshire HP12 4EG United Kingdom
High Wycombe Buckinghamshire HP12 4EG Ujedinjeno Kraljevstvo
56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
56 Eirinis Ave, Pefki Athens GR-151 21 Grčka
Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Janssen-Cilag Limited 50-100 Holmers Farm Way
50-100 Holmers Farm Way
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium
Vorgartenstraße 206B
Janssen-Cilag Pharma GmbH Vorgartenstraße 206B
(cannot be estimated from the available data)
(ne može se procijeniti iz dostupnih podataka)
This results in protection against the disease.
To rezultira zaštitom od bolesti.
The potential risk for pregnant women is unknown.
Potencijalan rizik za trudnice nije poznat.
Date of latest renewal: 18 September 2017
Datum posljednje obnove odobrenja: 18. rujna 2017.
These symptoms have been of mild and transient nature)
Ti su simptomi bili blage i prolazne prirode.)
Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
Kanamicin se koristi u ranom procesu proizvodnje i uklanja se tijekom kasnijih stadija proizvodnje.
Immunogenicity in special populations
Imunogenost u posebnim populacijama
Ask your doctor or nurse how to throw away medicines you no longer use.
Pitajte svog liječnika ili medicinsku sestru kako baciti lijekove koje više ne koristite.
- if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had breathing difficulties.
- ako je Vaše dijete bilo prijevremeno rođeno (u 28 tjednu trudnoće ili ranije), posebice ako je imalo problema s disanjem.