natgillin/translations-raw huggingface dataset:
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Tijekom randomizirane komparativne studije faze III, 398 ispitanika starijih od 65 godina primilo je 0,1 ml cjepiva INTANZA intradermalnim putem, a 397 ispitanika iste dobi primilo je 0,5 ml trovalentnog inaktiviranog adjuvantiranog (sadrži MF-59) cjepiva protiv influence u istoj dozi intramuskularnim putem.
- Other vaccines: INTANZA can be given at the same time as other vaccines by using separate limbs.
- Druga cjepiva: INTANZA se može primijeniti istovremeno s drugim cjepivima koja treba primijeniti na različitim udovima.
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France For any information about this medicine, please contact the local representative of the Marketing
Sanofi Pasteur, Parc Industriel d'Incarville, 27 100 Val-de-Reuil, Francuska Sanofi Pasteur, Campus Mérieux, 1541 avenue Marcel Mérieux, 69280 Marcy L`Etoile, Francuska
Marketing Authorisation Holder: Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon,
NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, Francuska.
HOW TO USE INTANZA
Kako čuvati cjepivo INTANZA
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Preosjetljivost na djelatne tvari, neku od pomoćnih tvari navedenih u dijelu 6.1. ili ostatne tvari kao što su jaja (ovalbumin i bjelančevine pilećeg porijekla) neomicin, formaldehid i oktoksinol 9.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Ukoliko nakon primjene cjepiva ostane tekućine na mjestu injiciranja, nije potrebno ponoviti
The active substances are Influenza virus (inactivated split) of the following strains*:
Djelatna tvar je virus influence (inaktiviran, fragmentiran) sljedećih sojeva*:
• Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Bilo koji sastojak ovog cjepiva (naveden u dijelu 6.), Bilo koji sastojak koji može biti prisutan u vrlo maloj količini, kao što su jaja (ovalbumin, pileći proteini), neomicin, formaldehid i oktoksinol 9.
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of INTANZA by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Tijekom randomizirane komparativne pivotalne studije faze III 2606 osoba starijih od 60 godina primilo je 0,1 ml cjepiva INTANZA intradermalnim putem, a 1089 ispitanika iste dobi primilo je 0,5 ml trovalentnog inaktiviranog cjepiva protiv influence intramuskularno.
INTANZA has no or negligible influence on the ability to drive and use machines.
Utjecaj na sposobnost upravljanja vozilima i rada na strojevima INTANZA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Istom rukom u kojoj ju držite, snažno pritisnite klip palcem kako bi aktivirali
Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain.
Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba) - Na mjestu primjene: crvenilo, oteklina, otvrdnuće, svrbež i bolnost.
Ελλάδα
Nuspojave a.
INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection
INTANZA je suspenzija za injekciju u napunjenoj štrcaljki od 0,1 ml s mikroinjekcijskim sustavom u pakovanjima od 1, 10 ili 20.
After repetitive yearly injections the safety profile of INTANZA is similar to the previous injections.
Nakon ponavljane sezonske primjene, sigurnosni profil cjepiva INTANZA sličan je onom dobivenom b. tabelarni sažeti prikaz nuspojava
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vrsta i sadržaj spremnika
INTANZA 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated)
NAZIV GOTOVOG LIJEKA INTANZA 15 mikrograma/soj, suspenzija za injekciju Cjepivo protiv influence (fragmentirani virion, inaktivirano)
- If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor.
- Ako ćete, iz bilo kojeg razloga raditi krvne pretrage unutar nekoliko dana nakon cijepljenja protiv gripe, obavijestite svog liječnika jer to može utjecati na rezultate testova za HIV-1, hepatitis C i HTLV-1.
INTANZA 15 µg/strain 2017/2018 Influenza vaccine
NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA INTANZA 15 µg/soj 2017/2018
Justification for not including Braille is accepted.
16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of INTANZA.
Kod primjene cjepiva INTANZA u kliničkim ispitivanjima i praćenjem nakon stavljanja cjepiva na tržište zabilježene su dolje navedene nuspojave.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not
Ukoliko nakon primjene cjepiva ostane tekućine na mjestu injiciranja, nije
Influenza virus (inactivated, split) of the following strains:
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Virus influence (inaktiviran, fragmentiran) sljedećih sojeva:
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
uključujući upalu mozga ili kralježničke moždine ili Guillain-Barréov sindrom koji uzrokuje ekstremnu slabost i paralizu.
INTANZA is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of age and over.
Kod ispitanika u dobi od 60 godina i starijih u slučaju sva tri soja cjepivo INTANZA je u komparaciji s trovalentnim inaktiviranim cjepivom protiv influence koje se primjenjuje intramuskularnim putem pokazalo najmanje istu imunogenost.
INTANZA is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Kada govorimo o GMT-u određenom SRH metodom za sva tri soja, te HI metodom za dva soja, INTANZA je imunogena kao i komparativno trovalentno adjuvantirano (sadrži MF-59) cjepivo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE Tekst na naljepnici za napunjenu štrcaljku
Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Pakovanje od 1,10 ili 20 napunjenih štrcaljki s mikroinjekcijskim sustavom
MARKETING AUTHORISATION HOLDER
Sažetak sigurnosnog profila
Pre-filled syringe label text
Gornji rub cilindra štrcaljke
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) ............................................................................................................................. 15 micrograms HA**
A/Hong Kong/4801/2014 (H3N2) - sličan soj B/Brisbane/60/2008 - sličan soj 15 µg hemaglutinina po soju po dozi od 0,1 ml
Transient thrombocytopenia, transient lymphadenopathy
natrijev hidrogenfosfat dihidrat
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) .................... 15 micrograms HA**
B A/New Caledonia/20/99 A/Winconsin/67/2005 B/Malaysia/2506/ 2004 N=2586
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 June 2017
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26. lipnja 2017.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/118)
Ishod arbitražnog postupka u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/118)
What is zinc oxide?
Što je cinkov oksid?
Zinc oxide is an inorganic compound and is known to be relatively poorly absorbed.
Cinkov oksid je anorganski spoj i poznato je da se relativno loše apsorbira.
Different indications and dosages are currently recommended, but zinc oxide is mainly used in the feed at a dosage of 100 mg per kg body weight per day for 14 consecutive days, which equates to 2500 ppm zinc in feed.
Trenutačno se preporučuju različite indikacije i doze, ali cinkov oksid uglavnom se koristi u hrani u dozi od 100 mg po kg tjelesne težine na dan tijekom 14 uzastopnih dana, što odgovara količini od 2500 ppm cinka u hrani.
The European Commission issued a decision on 26 June 2017 and Member States may defer the withdrawal of the marketing authorisations for up to five years from this date, if they consider that immediate action may have adverse impact in their territory given the lack of availability of alternatives and the change required in pig farming practices.
Prema odluci Europske komisije od 26. lipnja 2017., države članice mogu odgoditi povlačenje odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet do pet godina od navedenog datuma ako smatraju da bi povlačenje bez odgode moglo imati štetan učinak na njihovu području uzimajući u obzir nepostojanje alternativa i promjene potrebne u dosadašnjoj praksi uzgoja svinja.
1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link
1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no.
In May 2015, following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets1, the CVMP identified a risk to the environment due to accumulation of zinc.
U svibnju 2015., nakon arbitražnog postupka (EMEA/V/A/108) prema članku 33. stavku 4. Direktive 2001/82/EZ za Gutal 1000 g/kg premiks za ljekovitu hranu za praščiće1, CVMP je utvrdio rizik za okoliš zbog akumulacije cinka.
The CVMP considered that there is some uncertainty associated with the calculated risks for some environmental compartments and recommended various risk mitigation measures, which were anticipated to reduce the accumulation of zinc in the environment.
CVMP smatra da postoji određena nesigurnost povezana s izračunatim rizicima za neke dijelove okoliša i preporučene različite mjere za ublažavanje rizika za koje se predviđalo da će smanjiti akumulacija cinka u okolišu.
The CVMP acknowledged that there is a risk of co-selection for resistance (the selection of multiple antimicrobial resistance genes by an antimicrobial) associated with the use of zinc oxide but that, at the present time, such risk is not quantifiable.
CVMP prihvaća da postoji rizik od koselekcije s obzirom na rezistenciju (selekcija gena s višestrukom antimikrobnom rezistencijom) povezan s primjenom cinkova oksida, ali u ovom trenutku taj se rizik ne može kvantificirati.
Veterinary medicinal products containing zinc oxide are used for the treatment and/or prevention and control of post-weaning diarrhoea in piglets.
Veterinarsko-medicinski proizvodi koji sadrže cinkov oksid namijenjeni su za liječenje i/ili sprječavanje i kontrolu proljeva u praščića nakon odbijanja.
On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicinal products containing zinc oxide to be administered orally to food-producing species.
Europska agencija za lijekove (Agencija) završila je 16. ožujka 2017. ocjenu sigurnosti i učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane.
Questions and answers on veterinary medicinal products containing zinc oxide to be administered orally to food-producing species EMA/394961/2017
Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane EMA/478878/2017
The applicants and marketing authorisation holders concerned by the referral procedure submitted proprietary data and scientific references on efficacy, antimicrobial resistance and environmental risk.
Podnositelj zahtjeva i nositelji odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet na koje se ovaj arbitražni postupak odnosi dostavili su vlasničke podatke i znanstvene referencije o djelotvornosti, antimikrobnoj rezistenciji i riziku za okoliš.
Effective measures to manage the accumulation of zinc in the environment were not identified and, as a result, the CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Učinkovite mjere kojima bi se riješilo pitanje akumulacije cinka u okolišu nisu utvrđene te je, posljedično tomu, CVMP preporučio odbijanje odobrenja za stavljanje u promet i povlačenje postojećih odobrenja za veterinarsko-medicinske proizvode koji sadrže cinkov oksid.
Why were orally-administered veterinary medicinal products containing zinc oxide reviewed?
Zašto su ocjenjivani veterinarsko-medicinski proizvodi za peroralnu primjenu koji sadrže cinkov oksid?
Questions and answers on veterinary medicinal products containing zinc oxide to be administered orally to food-producing species
Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja koje se uzgajaju za proizvodnju hrane
The CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
CVMP je preporučio da se odbije izdavanje odobrenja za stavljanje u promet te da se povuku sadašnja odobrenja za stavljanje u promet veterinarskomedicinskih proizvoda koji sadrže cinkov oksid.
Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Na temelju procjene trenutačno dostupnih podataka, CVMP je zaključio da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u svinja negativan jer koristi cinkova oksida za sprječavanje proljeva u svinja ne premašuju rizike za okoliš.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u svinja negativan jer koristi cinkova oksida za sprječavanje proljeva u svinja ne premašuju rizike za okoliš.
Nevertheless, in February 2016, due to remaining concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide, the Netherlands and France initiated a referral procedure under Article 35 of Directive 2001/82/EC for all orally-administered veterinary medicinal products containing zinc oxide and requested the CVMP to review all available data and to evaluate the overall benefit-risk balance of the products concerned.
Štoviše u veljači 2016. zbog preostalih zabrinutosti povezanih s rizikom za okoliš i mogućom povećanom prevalencijom bakterija otpornih na antibiotike zbog primjene proizvoda koji sadrže cinkov oksid, Nizozemska i Francuska pokrenule su arbitražni postupak prema članku 35.
Oral use bottle (HDPE)
Peroralna primjena Boca (HDPE)
MA (EU) Number
Broj EU odobrenja (Novoizumljen o) ime
This overview was last updated in September 2018.
Ovaj pregled informacija posljednji je put ažuriran u 9. 2018.
Afoxolaner kills parasites by causing an over-stimulation of their nervous system.
Afoksolaner ubija parazite uzrokujući prekomjernu stimulaciju njihova živčanog sustava.
Further information on NexGard can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
Više informacija o VMP-u NexGard nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
NexGard kills fleas within 8 hours and ticks within 48 hours.
NexGard ubija buhe unutar 8 sati, a krpelje unutar 48 sati.
This results in uncontrolled activity of the nervous system and the paralysis and
To rezultira nekontroliranim djelovanjem živčanog sustava i paralizom te smrću
NexGard (afoxolaner) EMA/783550/2013
NexGard (afoksolaner) EMA/783550/2013
It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter).
Blokira normalno kretanje nabijenih čestica klorida (iona) u živčanim stanicama i iz njih, posebno onih povezanih s gama-aminobutričnom kiselinom (GABA), tvari koja prenosi poruke između živaca (neurotransmiteri).
NexGard received a marketing authorisation valid throughout the EU on 11 February 2014.
VMP NexGard dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 11. veljače 2014.
This means that it kills parasites that live on or in the skin or in the fur of animals, such as fleas, ticks and mites.
To znači da ubija parazite koji žive na koži ili u krznu životinja, poput buha, krpelja i grinja.
The effectiveness of NexGard was investigated in both laboratory and field studies.
Djelotvornost VMP-a NexGard ispitana je i u laboratorijskim i u terenskim ispitivanjima.
In order for the active substance to have an effect, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Kako bi ih se izložilo djelatnoj tvari, buhe i krpelji moraju biti pričvršćeni na kožu i početi se hraniti krvlju životinje.
NexGard (afoxolaner)
NexGard (afoksolaner)
Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Terapiju treba ponoviti u mjesečnim intervalima tijekom sezone buha ili krpelja, mjesečno kod demodikoze sve dok je se uspješno ne izliječi (što se potvrđuje dvama negativnima strugotinama kože u razmaku od mjesec dana) i jednom mjesečno tijekom dva mjeseca kod sarkoptoze ili duže ako terapija nije uspješna, što se utvrđuje kliničkim znakovima i strugotinama kože.
Other information about NexGard
Ostale informacije o VMP-u NexGard
The European Medicines Agency decided that NexGard's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a NexGard nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
Why is NexGard authorised in the EU?
Zašto je NexGard odobren u EU-u?
What is NexGard and what is it used for?
Što je NexGard i za što se primjenjuje?
NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as a spoton medicine containing pyriprole (another medicine against fleas and ticks).
NexGard je smanjio broj buha i krpelja za najmanje 98 % i bio je barem jednako djelotvoran kao VMP za nakapavanje na kožu koji sadržava piriprol (drugi VMP protiv buha i krpelja).
NexGard reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
NexGard smanjio je broj živih grinja za 97 % 56 dana nakon početka terapije te za 98 % 84 dana nakon početka terapije.
NexGard is given as a tablet of the appropriate strength for the dog's bodyweight.
NexGard se daje kao tableta odgovarajuće jačine prema tjelesnoj težini pasa.
NexGard reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
NexGard smanjio je broj živih grinja za 96% 28 dana nakon početka terapije te za 100% 56 dana nakon početka terapije.
The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide'.
Djelatna tvar u VMP-u NexGard, afoksolaner, djeluje kao „ektoparaziticid”.
An overview of NexGard and why it is authorised in the EU
Pregled informacija o VMP-u NexGard i zašto je odobren u EU-u
In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
U terenskom ispitivanju EU-a koje je obuhvatilo 146 pasa s infestacijama buha ili krpelja, jedan tretman VMP-om NexGard bio je djelotvoran u liječenju infestacija buha i krpelja u pasa do 30 dana nakon terapije.
NexGard is a medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
NexGard je VMP koji se primjenjuje za liječenje infestacija buhama i krpeljima, kao i demodikoze i sarkoptoze (infestacija kože koje uzrokuju dvije različite vrste grinja) u pasa.
What are the risks associated with NexGard?
Koji su rizici povezani s VMP-om NexGard?
death of fleas, ticks and mites.
buha, krpelja i grinja.
How does NexGard work?
Kako djeluje NexGard?
For more information about using NexGard, see the package leaflet or contact your veterinarian or pharmacist.
Više informacija o primjeni VMP-a NexGard pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with NexGard.
Drugo terensko ispitivanje EU-a uključivalo je 31 psa s demodikozom koja je tretirana tri puta u mjesečnim intervalima VMP-om NexGard.
NexGard is available as chewable tablets in four different strengths for use in dogs of different weights.
VMP NexGard dostupan je u obliku tableta za žvakanje u četiri različite jačine za primjenu u pasa različite tjelesne težine.
A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with NexGard.
Treće terensko ispitivanje EU-a obuhvatilo je 38 pasa sa sarkoptozom koja je tretirana VMP-om NexGard jednom mjesečno tijekom dva mjeseca.
What benefits of NexGard have been shown in studies?
Koje su koristi od VMP-a NexGard utvrđene u ispitivanjima?
NexGard contains the active substance afoxolaner.
VMP NexGard sadržava djelatnu tvar afoksolaner.
These patients should be monitored closely.
Te se bolesnike mora pozorno nadzirati.
OTHER SPECIAL WARNINGS, IF NECESSARY
DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
> 3 hours to ≤ 7 days
> 3 sata do ≤ 7 dana
The company will start to include the pre-infusion check list in packs packed at the packaging site as soon as possible but at the latest on 15 November 2012.
Proizvođač će predinfuzijski kontrolni upitnik početi umetati u pakiranja u procesu pakiranja na mjestu pakiranja što je prije moguće, a najkasnije 15. studenog 2012.
(see sections 4.4 Hypotension, Congestive Heart Failure).
(Vidjeti dijelove 4.4 Hipotenzija, Kongestivno zatajenje srca).
• Bradycardia
• bradikardija
In the remaining patients, electrical cardioversion can be recommended.
Za preostale se bolesnike može preporučiti električna kardioverzija.