natgillin/translations-raw huggingface dataset:
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) i manje od 1 mmol kalija (39 mg) po dozi, tj. gotovo je bez natrija i kalija.
What Pandemrix is and what it is used for What you need to know before you receive Pandemrix How Pandemrix is given
Što je Pandemrix i za što se koristi Što morate znati prije nego primite Pandemrix Kako primjenjivati Pandemrix
The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Nositelj odobrenja će se dogovoriti sa državama članicama o odredbi ciljane komunikacije sa zdravstvenim djelatnicima koja treba uključivati sljedeće:
See sections 4.4, 4.8 and 5.1 for details.
Za više informacija vidjeti dijelove 4.4, 4.8 i 5.1.
However, in the case this needle size would not be available, a 21-G needle might be used.
Međutim, ako ta veličina igle nije na raspolaganju, može se upotrijebiti igla promjera21-G.
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Od životinja koje su primile adjuvantirano cjepivo, njih 87% bilo je zaštićeno od letalnog homolognog a njih 96% od letalnog heterolognog opterećenja.
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Neklinički podaci s modelnim cjepivom koje sadrži soj iz H5N1 cjepiva ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, akutne toksičnosti te toksičnosti ponovljenih doza, lokalne podnošljivosti, plodnosti ženki, embrio-fetalne i postnatalne toksičnosti (do kraja razdoblja laktacije).
The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.
Niže navedene nuspojave pojavile su se u kliničkim ispitivanjima Pandemrixa u odraslih, uključujući i starije osobe.
Additional information is available from the studies conducted with a vaccine similar in composition to Pandemrix but containing antigen derived from H5N1 viruses.
Dostupne su dodatne informacije iz ispitivanja provedenih s cjepivima koja su sastavom slična cjepivu Pandemrix, ali sadrže antigene dobivene iz H5N1 virusa.
Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Farmakoterapijska skupina: Cjepiva protiv gripe, ATK oznaka J07BB02.
One pack of Pandemrix consists of:
Jedno pakiranje Pandemrixa sadrži:
Epidemiological studies relating to Pandemrix in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Epidemiološka ispitivanja povezana s cjepivom Pandemrix provedena u nekoliko europskih zemalja pokazala su povećan rizik od narkolepsije, praćene katapleksijom ili bez nje, u cijepljenih u usporedbi s necijepljenim osobama.
The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects
Preporuke o dozama vode računa o podacima o sigurnosti i imunogenosti dobivenim u kliničkim ispitivanjima na zdravim ispitanicima.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Ovaj lijek sadrži tiomersal (organski spoj žive) kao konzervans te stoga može doći do reakcija senzibilizacije (vidjeti dio 4.4).
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Niže navedene nuspojave zabilježene su nakon nekoliko dana ili tjedana od cijepljenja uobičajenim cjepivima protiv gripe koja se za sprječavanje gripe koriste svake godine.
Drowsiness Irritability Loss of appetite
mjereno aksilarno Omamljenost Razdražljivost Gubitak apetita
Based on the evaluation of the data submitted, the CHMP considers that the above post-authorisation measures as reflected above have been fulfilled.
Na temelju ocjene dostavljenih podataka, CHMP smatra da su gore tražene mjere nakon dobivanja odobrenja za stavljanje lijeka u promet ispunjene.
In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
U kontrolnoj skupini bez adjuvansa, kao i u kontrolnoj skupini s adjuvansom, tri do četiri dana nakon opterećenja sve su životinje uginule ili morale biti eutanazirane jer su bile na umoru.
The side effects listed below have happened after Pandemrix (H1N1)v came on the market:
Niže navedene nuspojave zabilježene su nakon stavljanja Pandemrixa (H1N1)v u promet:
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Vaskulitis (upala krvnih žila što može uzrokovati kožne osipe, bol u zglobovima i probleme s bubrezima)
This leaflet was last revised in {MM/YYYY}.
Ova uputa je zadnji puta revidirana u Drugi izvori informacija
The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Nositelj odobrenja će dogovoriti sa državama članicama mjere koje će pomoći u identifikaciji i slijedljivosti A/H1N1 cjepiva koje je dano svakom bolesniku, kako bi se minimizirale pogreške u liječenju te pomoglo bolesniku i zdravstvenom djelatniku prijaviti nuspojavu.
Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).
Narkolepsija može ili ne mora biti praćena iznenadnom mišićnom slabošću koja može prouzročiti padove (stanje koje se naziva katapleksijom).
Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.
Pandemrix je cjepivo kojim se sprječava influenca (gripa) uzrokovana virusom A(H1N1)v 2009.
In study D-Pan-H1N1-008, the neutralising antibody responses were as follows:
U ispitivanju D-Pan-H1N1-008, odgovor neutralizirajućih protutijela bio je sljedeći: Neutralizirajuća protutijela u serumu
71-80 years 21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose
71-80 godina 21 dan nakon 1. Doze 21 dan nakon 2. doze 21 dan nakon 1. doze 21 dan nakon 2. doze
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Kontrolnu skupinu sačinjavali su tvorovi imunizirani samo s adjuvansom, neadjuvantiranim cjepivom bez (15 mikrograma HA) ili s fiziološkom otopinom s fosfatnim puferom.
Clinical studies have evaluated the incidence of adverse reactions in more than 1,000 subjects 18 years old and above who received Pandemrix (H1N1).
Klinička ispitivanja procjenjivala su incidenciju nuspojava kod više od 1000 ispitanika starijih od 18 godina koji su primili Pandemrix (H1N1).
Some side effects (including local redness and fever) occurred more frequently after the second dose compared to the first dose.
Neke nuspojave (uključujući lokalno crvenilo i vrućicu) bile su učestalije nakon druge doze nego nakon prve doze.
The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.
Gore navedene nuspojave su sa sličnim učestalostima zabilježene i u kliničkim ispitivanjima djece u dobi od 10-17 godina, osim crvenila na mjestu injiciranja koje je bilo vrlo često i znojenja koje je bilo često.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
U nekih cijepljenika možda neće biti postignut zaštitni imunološki odgovor (vidjeti dio 5.1).
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Neki od učinaka koji su navedeni u dijelu 4.8 "Nuspojave", mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
50 vials: emulsion (adjuvant)
50 bočica: emulzija (adjuvans)
No data are available in children aged less than 6 months.
Nema podataka o primjeni u djece u dobi mlađoj od 6 mjeseci.
10-17 years
10-17 godina
What Pandemrix looks like and contents of the pack
Kako Pandemrix izgleda i sadržaj pakiranja
The volume of the Pandemrix vial after mixing is at least 5 ml.
Nakon miješanja volumen cjepiva Pandemrix u bočici iznosi najmanje 5 ml.
In such cases, you should be aware that the side effects may be more intense.
Trebate znati da u takvim slučajevima nuspojave mogu biti izraženije.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/452/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/452/001
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Vrlo rijetko Neurološki poremećaji poput encefalomijelitisa, neuritisa i Guillain Barréovog sindroma
This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
To može uključivati odredbu nositelju odobrenja za naljepnice sa zaštićenim nazivom lijeka i serijskim brojem na svako pakiranje cjepiva.
It is recommended that subjects who receive a first dose of Pandemrix should complete the vaccination course with Pandemrix (see section 4.4).
Preporučuje se da osobe koje prime prvu dozu cjepiva Pandemrix i završe cijeli postupak imunizacije s cjepivom Pandemrix (vidjeti dio 4.4).
Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single dose may be sufficient.
Podaci o imunogenosti dobiveni tri tjedna nakon primjene jedne doze cjepiva Pandemrix (H1N1)v upućuju da bi uporaba jedne doze mogla biti dovoljna.
All subjects received two doses of 0.5 ml 21 days apart, except in study D-Pan H1N1-008, in which half of the subjects received only one dose of 0.5 ml.
Svi ispitanici primili su dvije doze cjepiva od 0,5 ml, u razmaku od 21 dan, osim u ispitivanju D-Pan H1N1-008, u kojem je pola ispitanika primilo samo jednu dozu od 0,5 ml.
If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before each withdrawal.
Ako se pripremljeno cjepivo čuva u hladnjaku, prije svake primjene treba pričekati da se zagrije na sobnu temperaturu (najmanje 15 minuta).
The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).
Cjepivo treba primijeniti sukladno preporučenom doziranju (vidjeti dio 3 "Kako se primjenjuje Pandemrix").
tection rate1 55.0%
stopa seroprotekcije1 55,0%
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake grupe učestalosti nuspojave su navedene u silaznom nizu prema ozbiljnosti.
Split influenza virus, inactivated, containing antigen* equivalent to:
• Djelatna tvar: fragmentirani virus influence, inaktiviran, sadrži antigen* koji odgovara:
Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Suspenziju i emulziju se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
D-Pan H1N1-008 21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose
D-Pan H1N1-008 21 dan nakon 1. doze 21 dan nakon 2. doze 21 dan nakon 1. doze 21 dan nakon 2. doze
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
U svakom pokusu, četiri skupine po šest tvorova imunizirano je AS03-adjuvantiranim cjepivom koje sadrži hemaglutinin dobiven iz soja H5N1/A/Vietnam/1194/04 (NIBRG-14).
Conduct non-clinical (including mechanistic) studies in order to elucidate the role of the vaccine and its adjuvant on the association between Pandemrix and narcolepsy: - Identify T cell signature from narcoleptic patients by deep sequencing of total CD4 T cells obtained from narcolepsy patients and DQ0602-matched non-vaccinated healthy subjects and, if identified, verify if signature is found in CD4 T cells from healthy subjects after vaccination with Pandemrix or non-adjuvanted H1N1v vaccine.
Provesti neklinička ispitivanja (uključujući ispitivanja mehanizma) kako bi se objasnila uloga cjepiva i njegova adjuvansa na vezu između cjepiva Pandemrix i narkolepsije: - Identificirati T-stanični genski profil u bolesnika s narkolepsijom dubokim sekvencioniranjem sveukupnih CD4 T stanica dobivenih od bolesnika s narkolepsijom i DQ0602 podudarnih necijepljenih zdravih ispitanika i, ako je identificiran, utvrditi je li genski profil nađen i u CD4 T stanicama zdravih ispitanika nakon cijepljenja s cjepivom Pandemrix ili s neadjuvantiranim cjepivom H1N1v.
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Kako primjenjivati Pandemrix Vaš liječnik ili medicinska sestra će primijeniti cjepivo u skladu sa službenim preporukama.
Adult dose
Doza za odrasle
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Ako se bilo što od navedenog odnosi na Vas, o tome OBAVIJESTITE LIJEČNIKA ILI MEDICINSKU SESTRU jer se u tom slučaju možda cijepljenje ne preporučuje ili se treba odgoditi.
There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Daljnji imunološki odgovor javlja se na drugu dozu cjepiva od 0,25 ml koja se primjenjuje nakon razdoblja od tri tjedna.
What Pandemrix is and what it is used for
Što je Pandemrix i za što se koristi Što je Pandemrix i za što se koristi
Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Pandemrix se može primiti istovremeno s cjepivom protiv sezonske gripe koje ne sadrži adjuvans.
• Tingling or numbness of the hands or feet
• Trnci ili utrnulost šaka ili stopala
Information from non-clinical studies:
Podaci iz nekliničkih ispitivanja
Narcolepsywith or without cataplexy (see section 4.4)
Narkolepsija s katapleksijom ili bez katapleksije (vidjeti dio 4.4) Somnolencija2
All these side effects were reported very commonly after each dose.
Nakon svake doze ove su nuspojave prijavljivane vrlo često.
What Pandemrix contains
Što Pandemrix sadrži
• Generalised skin reactions including facial swelling and urticaria (hives)
• Generalizirane kožne reakcije uključujući oticanje lica i urtikariju (koprivnjaču)
Children aged 6-35 months
Djeca u dobi od 6-35 mjeseci
Prophylaxis of influenza caused by A (H1N1)v 2009 virus.
Profilaksa influence koju uzrokuje virus A (H1N1)v 2009.
The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses of 0.5 ml 21 days apart were as follows:
Odgovor anti-HA antitijela u zdravih ispitanika u dobi >60 godina koji su primili ili jednu ili dvije doze od 0,5 ml, u razmaku od 21 dan, bio je sljedeći:
• Feeling sick, diarrhoea, vomiting, stomach pain
• Vrućica • Mučnina, proljev, povraćanje, bol u trbuhu
There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.
Nema podataka o sigurnosti, imunogenosti ili djelotvornosti koji bi ukazivali na mogućnost zamjene cjepiva Pandemrix drugim (H1N1)v cjepivima.
Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission.
U usporedbi s kontrolnom skupinom širenje virusa u gornje dišne putove također je bilo smanjeno, ukazujući na smanjen rizik od prijenosa virusa.
The neutralising antibody responses in subjects >60 years were as follows: Serum neutralising antibody
Odgovor neutralizirajućih protutijela u ispitanika dobne skupine >60 godina bio je sljedeći: Neutralizirajuća protutijela u serumu
• A hard lump and warmth at the injection site
• Tvrda oteklina i toplina na mjestu injiciranja
• Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
• Reakcije na mjestu injiciranja poput boli, crvenila, modrica, oticanja i topline (upala), tvrda kvržica (masa)
Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders
vrućica Manje često Otvrdnuće i osjećaj topline na mjestu injiciranja, bolest nalik gripi, malaksalost Postmarketinško iskustvo s cjepivom Pandemrix (H1N1)v
It is not known whether the observed effects would apply to administration of nonadjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals have elapsed since administration of Pandemrix.
Nije poznato da li bi se zamijećeni učinak mogao javiti i u slučaju primjene neadjuvantiranog sezonskog cjepiva protiv influence nakon jedne doze cjepiva Pandemrix ili u slučaju da je od primjene cjepiva Pandemrix prošao dulji vremenski period.
Angioedema, generalised skin reactions, urticaria
Angioedem, generalizirane kožne reakcije, urtikarija
In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%).
U odraslih osoba u dobi od 18 do 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (87,8%), umor (32,9%), glavobolja (28,1%), artralgija (17,9%), mijalgija (30,0%), drhtanje (19,4%), oticanje na mjestu injiciranja (11,5%) i znojenje (11,3%).
In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years.
U djece koja su primila dvije doze za odrasle (0,5 ml), stopa seroprotekcije je 12 mjeseci nakon prve doze bila 100% kod djece u dobi od 3-5 godina te 98,0% kod djece u dobi od 6-9 godina.
4according to protocol anti-HA antibody
4prema planu ispitivanja anti-HA protutijelo
Children aged less than 6 months
Djeca mlađa od 6 mjeseci
Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Dvanaest mjeseci nakon prve doze zabilježena je stopa seroprotekcije od 85% u obje dobne skupine.
Very common Arthralgia, myalgia
Artralgija, mijalgija
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months.
Iz kliničkih ispitivanja cjepiva Pandemrix (H1N1)v nema podataka o sigurnosti i imunogenosti u djece koja su mlađa od 6 mjeseci.
In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
U osoba starijih od 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (59,0%), mijalgija (20,6%), umor (17,9%), glavobolja (17,6%) i artralgija (14,3%).
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Cjepivo se miješa tako da se pomoću štrcaljke od 5 ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
5.0% 5.4% 1.9% 5.8% NA NA NA NA
5,0% 5,4% 1,9% 5,8% ND ND ND ND
Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Podaci stoga ukazuju da se Pandemrix može istovremeno primjenjivati s neadjuvantiranim sezonskim cjepivima protiv influence (uz davanje injekcija cjepiva u različite udove).
Neuralgia
Neuralgija
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
• Neurološki poremećaji poput encefalomijelitisa (upala središnjeg živčanog sustava), neuritisa
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.
Istovremena primjena dva cjepiva nije bila povezana s većim stopama lokalnih ili sistemskih reakcija od onih pri samostalnoj primjeni Pandemrix cjepiva.
In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
U kliničkom ispitivanju u kojem je neadjuvantirano sezonsko cjepivo protiv influence (Fluarix, kao ranije navedeno) primijenjeno 3 tjedna nakon druge doze cjepiva Pandemrix (razdoblje između primijenjenih doza bilo je 21 dan), zamijećen je smanjen imunološki odgovor na cjepivo Fluarix u usporedbi s ispitanicima koji ranije nisu primili Pandemrix.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Nakon miješanja cjepiva: Nakon miješanja, cjepivo upotrijebiti unutar 24 sata i ne čuvati na temperaturi iznad 25°C.
Clinical trials Blood and lymphatic system disorders
Klinička ispitivanja Poremećaji krvi i limfnog sustava
The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Cjepivo treba primijeniti sukladno preporučenom doziranju (vidjeti dio 4.2).
It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix.
Poželjno je da se neadjuvantirana sezonska cjepiva protiv influence primjene prije prve doze ili s prvom dozom cjepiva Pandemrix.
INFORMATION IN BRAILLE
16. PODACI NA BRAILLOVOM PISMU
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
NAZIV LIJEKA Emulzija za emulziju za injekciju za Pandemrix
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Ako je potrebna istovremena primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
mikrograma hemaglutinina ispitivane su u pokusu homolognog opterećenja a doze od 15, 7,5, 3,8 ili 1,75 mikrograma hemaglutinina u pokusu heterolognog opterećenja.
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili medicinskoj sestri.
It is recommended to equip the syringe with a 23-G needle.
Preporučuje se koristiti štrcaljku s iglom promjera 23-G.
Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Dvanaest mjeseci nakon prve doze stopa seroprotekcije bila je 100% u svim dobnim i doznim skupinama.
Total enrolled subjects2
Ukupan broj uključenih ispitanika2
Pandemrix contains thiomersal
Pandemrix sadrži tiomersal
Anaphylaxis, allergic reactions
Anafilaksa, alergijske reakcije
One dose of 0.25 ml at an elected date.
Jedna doza cjepiva od 0,25 ml na odabrani datum.
“Possible side effects” may affect the ability to drive or use machines.
Neki učinci navedeni u dijelu 4. “Moguće nuspojave” mogu utjecati na Vašu sposobnost upravljanja vozilom ili strojevima.
Suspension vial:
Bočica sa suspenzijom:
Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Tvorovi su cijepljeni na nulti i 21. dan, a 49. dana intratrahealnim putem opterećeni su letalnom dozom H5N1/A/Vietnam/1194/04 ili heterolognim
What you need to know before you receive Pandemrix
Što morate znati prije nego primite Pandemrix Nemojte primiti Pandemrix: