FrancophonIA/ELRC3.0 huggingface dataset:
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Latvian: Novartis Vaccines and Diagnostics tika novērtēta, ievadot to veseliem pieaugušajiem (18-60 gadus veciem) un veselām gados vecākām personām (vecākām par 60 gadiem), izmantojot primārās vakcinācijas grafiku, pēc kura vakcinēja 1. un 22. dienā, un revakcināciju (skatīt apakšpunktus 4.8 un 5.1).
English: Data obtained in adults showed that co-administration of adjuvanted H5N1 vaccine and seasonal (inactivated surface, non-adjuvanted) antigens did not lead to any interference neither for seasonal strains nor for H5N1 strains.
Latvian: Ar pieaugušajiem iegūtie dati parādīja, ka vienlaicīga adjuvantus saturošas vakcīnas H5N1 un sezonālo (inaktivētu virsmas) antigēnu bez adjuvanta ievadīšana neizraisīja nekādus traucējumus nedz sezonāliem celmiem, nedz arī H5N1 celmiem.
English: (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dose, SRH CHMP criteria were achieved in all the vaccine schedule groups after 3 weeks from the 2nd vaccination.
Latvian: Novartis Vaccines and Diagnostics devas, SRH CHMP kritēriji tika sasniegti visās vakcinācijas grafika grupās pēc trim nedēļām no 2. vakcinācijas.
English: Very limited data in subjects with co-morbidities, including immunocompromised subjects are available for this H5N1 vaccine.
Latvian: Šai H5N1 vakcīnai ir pieejami ļoti ierobežoti dati par slimniekiem ar pavadošām slimībām, ieskaitot personas ar vājinātu imunitāti.
English: In another clinical trial (Study V87P13) 2693 adult subjects were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Latvian: Citā klīniskā pētījumā (V87P13. pētījums) tika iesaistītas 2693 pieaugušas personas, kas saņēma divas devas H5N1 vakcīnas (A/Vietnam/1194/2004; 7,5 µg HA/devā, ar adjuvantu).
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Latvian: MK analīzes rezultāti pret A/Vietnam/1194/2004 liecina par seroprotekcijas līmeni 99% (95% TI: 94-100); serokonversijas līmenis robežās no 97% (95% TI: 91-99) līdz 99% (95% TI: 96-100) un VĢL robežās no 29 (95% TI: 25-35) līdz 50% (95% TI: 44-58).
English: adjuvanted) Novartis Vaccines and Diagnostics;
Latvian: Novartis Vaccines and Diagnostics;
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
Latvian: Vispārēji traucējumi un reakcijas ievadīšanas vietā Ļoti bieži: injekcijas vietas satūkums, sāpes injekcijas vietā, injekcijas vietas sacietējums, injekcijas vietas sasārtums, nogurums
English: In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose was after either 1, 2, 3 or 6 weeks after the first Prepandemic Influenza vaccine
Latvian: Klīniskajā pētījumā, kurā novērtēja 4 dažādus vakcinācijas grafikus, iesaistot 240 personas vecumā no 18 līdz 60 gadiem, otro devu ievadot 1, 2, 3 vai 6 nedēļas pēc pirmās Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Latvian: Satūkuši limfmezgli, palpitācijas, vājums, sāpes locekļos un klepus.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2
Latvian: Serokonversijas faktors (95% TI)** * mērot ar SRH analīzi ≥ 25 mm ** vidējais ģeometriskais SRH līmenis
English: Data on safety of a booster dose of the current Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics formulation are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults and 56 elderly.
Latvian: Novartis Vaccines and Diagnostics zāļu formai aprobežojas ar trim pētījumiem, V87P1, V87P2 un V87P1E1, kuros bija iekļauti 116 pieaugušie un 56 gados vecākas personas.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Sodium citrate
Latvian: Kālija dihidrogēnfosfāts Nātrija hidrogēnfosfāta dihidrāts Magnija hlorīda heksahidrāts Kalcija hlorīda dihidrāts Nātrija citrāts
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Latvian: Jāievēro piesardzība, ievadot šo vakcīnu personām ar zināmu paaugstinātu jutību (atšķirīgu no anafilaktiskās reakcijas) pret aktīvo vielu, kādu no palīgvielām un to paliekām (olas un cāļa olbaltumvielām, ovalbumīnu, kanamicīna un neomicīna sulfātu, formaldehīdu un cetiltrimetilamonija bromīdu (CTAB)).
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis* un serokonversijas faktors** anti-HA antivielai pret H5N1 A/Vietnam/1194/2004 personām, kas vecākas par 60 gadiem (ierobežots personu skaits bija vecākas par 70 gadiem), mērot ar SRH analīzi divos klīniskos pētījumos, bija šāds:
English: Vaccines and Diagnostics (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin,
Latvian: Novartis Vaccines and Diagnostics sastāvdaļām (tās ir uzskaitītas instrukcijas beigās) vai uz kādu no vielām, kas var būt zīmju daudzumā, proti: olas un cāļa olbaltumvielas, ovalbumīns, formaldehīds, kanamicīna un neomicīna sulfāts (antibiotikas) vai cetiltrimetilamonija bromīds (CTAB).
English: week later and higher in the groups with longer interval schedules.
Latvian: Imūnreakcija bija mazāka tajā grupā, kas saņēma 2. devu pēc 1 nedēļas, un lielāka grupās, kuru grafikā bija garāki intervāli.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Latvian: Gripas vīrusa virsmas antigēni (hemaglutinīns un neiraminidāze)*, celms: A/Vietnam/1194/2004 (H5N1) līdzīgs celms (NIBRG-14)
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Latvian: Anafilaktiska (t.i., dzīvību apdraudoša) reakcija anamnēzē uz kādu no sastāvdaļām vai niecīgām paliekām (olas un cāļa olbaltumvielām, ovalbumīnu, kanamicīna un neomicīna sulfātu, formaldehīdu un cetiltrimetilamonija bromīdu (CTAB)) šajā vakcīnā.
English: It is estimated that more than 90,000 women have been vaccinated during pregnancy with H1N1v vaccine Focetria which contains the same amount of adjuvant MF59C.1 as. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics However information on outcomes is currently limited.
Latvian: Tiek vērtēts, ka vairāk nekā 90000 sieviešu grūtniecības laikā saņēma H1N1v vakcīnu Focetria, kas satur tādu pašu daudzumu adjuvanta MF59C.1 kā Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: GMR (95% CI) Day 43 to Day 1 % SC (95% CI) Day 43
Latvian: % SP (95 % TI) 43. diena VĢL (5% TI) 43. diena:1. dienu % SK (95% TI)
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis
Latvian: • ja Jums agrāk ir bijusi dzīvību apdraudoša alerģiska reakcija uz kādu no Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: very rare (affects less than 1 user in 10,000)
Latvian: reti (novēro 1 līdz 10 lietotājiem no 10000) ļoti reti (novēro mazāk nekā 1 lietotājam no 10000)
English: Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Latvian: Nervu sistēmas traucējumi Neiroloģiski traucējumi, piemēram, encefalomielīts un Gijēna-Barē sindroms.
English: Rare: Convulsions, eye swelling and anaphylaxis.
Latvian: Reti: Krampji, acu satūkums un anafilakse.
English: ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND
Latvian: (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
English: Common: Brusing of the skin at the injection site, fever and nausea, generally feeling unwell and shivering.
Latvian: Bieži: Zilums injekcijas vietā, drudzis un nelabums, slikta vispārēja pašsajūta un drebuļi.
English: A single vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics but using the strain H5N3.
Latvian: Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) ierosināja augstu un ātru seroloģisko atbildi personām, kuras bija pirms 6-8 gadiem vakcinētas ar divām devām citas H5N surogātvakcīnas, kurai ir tāda pati zāļu forma, bet tiek izmantots celms H5N3.
English: Day 43 to Day 1 % SC (95% CI)
Latvian: 43. diena:1. dienu % SK (95% TI) 43. diena
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Latvian: MK analīzes rezultāti pret A/Vietnam/1194/2004 uzrāda seroprotekcijas un serokonversijas līmeni, attiecīgi, robežās no 67% (60-74) līdz 85% (78-90) un no 65% (58-72) līdz 83% (77-89).
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Latvian: MK analīzes rezultāti pret A/Vietnam/1194/2004 uzrāda seroprotekcijas un serokonversijas līmeni, attiecīgi, robežās no 57% (50-64) līdz 79% (68-87) un no 55% (48-62) līdz 58% (47-69).
English: Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other H5N1 monovalent vaccines.
Latvian: Tā kā ir ieteicama otra deva, ir jāatzīmē, ka nav nekādu drošības, imunogenitātes vai efektivitātes datu, kas atbalstītu Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Latvian: * mērot ar SRH analīzi ≥ 25 mm ** vidējais ģeometriskais SRH līmenis
English: Baseline Serostatus
Latvian: Seroloģiskais stāvoklis bāzlīnijā
English: Do not use Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics after the expiry date which is stated on the carton and the label.
Latvian: Nelietojiet Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics pēc derīguma termiņa beigām, kas norādīts uz ārējās kartona kārbas un etiķetes.
English: DIAGNOSTICS
Latvian: pētījums)
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Latvian: Serokonversijas faktors (95% TI)**
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics alone.
Latvian: Vienlaicīga ievadīšana nebija saistāma ar augstāku vietēju vai sistēmisku reakciju līmeni, salīdzinot ar Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Latvian: Bieži: svīšana Retāk: nātrene Reti: acu pietūkums
English: Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate,
Latvian: Kālija dihidrogēnfosfāts, Nātrija hidrogēnfosfāta dihidrāts, Magnija hlorīda heksahidrāts, Kalcija hlorīda dihidrāts, Nātrija citrāts.
English: Non-clinical data obtained with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Latvian: Novartis Vaccines and Diagnostics un ar sezonālo gripas vakcīnu, kas satur adjuvantu MF59C.1, pamatojoties uz parastajiem atkārtotu devu toksicitātes pētījumiem, lokālo panesību, mātīšu fertilitāti un reproduktīvo un attīstības toksicitāti (līdz laktācijas perioda beigām), neliecina par īpašiem draudiem cilvēkiem.
English: HOW TO STORE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE
Latvian: KĀ UZGLABĀT PREPANDEMIC INFLUENZA VACCINE (H5N1)
English: Local
Latvian: Visas
English: The side effects listed below have occurred with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in clinical studies in adults, including the elderly:
Latvian: Zemāk uzskaitītās blakusparādības tika novērotas Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics klīniskajos pētījumos ar pieaugušajiem, ieskaitot gados vecākas personas.
English: The incidence of adverse reactions has been evaluated in six clinical trials involving approximately 4,000 adults and elderly receiving (Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics at least 7.5 µg HA, adjuvanted).
Latvian: Nevēlamo blakusparādību biežums tika novērtēts sešos klīniskajos pētījumos, kuros bija iesaistīti aptuveni 4000 pieaugušo un gados vecāku personu, kas saņēma Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: Adverse reactions from clinical trials in adults (18 years old and above).
Latvian: Ziņas par nevēlamām blakusparādībām no klīniskajiem pētījumiem ar pieaugušajiem no18 gadu vecuma.
English: 4.9 Overdose No case of overdose has been reported.
Latvian: Nav ziņu par pārdozēšanas gadījumu.
English: Palpitation, tachycardia.
Latvian: Sirdsdarbības traucējumi Palpitācija, tahikardija.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis* un serokonversijas faktors** anti-HA antivielai pret H5N1 A/Vietnam/1194/2004, mērot ar SRH analīzi, bija šāds:
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Latvian: Vēdera darbības traucējumi, piemēram, nelabums, vemšana, sāpes vēderā un caureja.
English: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms haemagglutinin Adjuvant: MF59C.1 oil composed of squalene, polysorbate 80 and sorbitan trioleate.
Latvian: A/Vietnam/1194/2004 (H5N1) līdzīgs celms (NIBRG-14) 7,5 mikrogrami hemaglutinīna
English: This section describes the clinical experience with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics following a two-dose administration and booster.
Latvian: Šajā apakšpunktā ir aprakstīta klīniskā pieredze ar Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics pēc divu devu un pastiprinošās devas ievadīšanas.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by SRH assay was as follows:
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis* un serokonversijas faktors** anti-HA antivielai pret H5N1 A/Vietnam/1194/2004 pieaugušajiem, mērot ar SRH analīzi, bija šāds:
English: These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Latvian: Šīs blakusparādības var parādīties arī lietojot Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Latvian: Ādas un zemādas audu bojājumi Vispārējas ādas reakcijas, ieskaitot niezi, nātreni vai nespecifiskus izsitumus; angioedēma.
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) were administered three weeks apart to 156 healthy adults.
Latvian: Ar triju nedēļu intervālu 156 veseliem pieaugušajiem tika ievadītas divas devas vakcīnas H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/devā, ar adjuvantu).
English: ** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
Latvian: TI)°° * mērot ar SRH analīzi ≥ 25 mm ** vidējais ģeometriskais SRH līmenis °° mērot ar SRH analīzi ≥ 40 °° vidējais ģeometriskais HI līmenis
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Latvian: Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) vienā vai vairākās pediatriskās populācijas apakšgrupās par aktīvo imunizāciju pret A tipa gripas vīrusa H5N1 apakštipu.
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Children (3-<9 years)
Latvian: Citas blakusparādības Bērni (3-<9 gadus veci)
English: c)
Latvian: oC)
English: The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and an MF59 seasonal adjuvanted trivalent vaccine with a composition similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (surface antigen, inactivated, adjuvanted with MF59C.1) that is licensed for use in elderly subjects 65 years of age and older: Blood and lymphatic system disorders
Latvian: Papildus no pēcreģistrācijas uzraudzības zināmas šādas nevēlamās blakusparādības visām vecuma grupām saistībā ar sezonālām trivalentām vakcīnām bez adjuvanta un sezonālu trivalentu vakcīnu ar adjuvantu MF59, kuras sastāvs ir līdzīgs Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: Marketing Authorisation Holder Novartis Vaccines and Diagnostics S.r.l.
Latvian: Reģistrācijas apliecības īpašnieks Novartis Vaccines and Diagnostics S.r.l.
English: Study V87P13 21 days after 2nd dose N=66
Latvian: V87P13. pētījums 21 dienu pēc 2. devas N=66
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and, chicken protein, ovalbumin, formaldehyde,
Latvian: • ja Jums ir bijusi alerģiska reakcija, kas nav pēkšņa dzīvību apdraudoša reakcija, uz kādu no šajā vakcīnā esošajām sastāvdaļām, uz olas un cāļa olbaltumvielu, ovalbumīnu, formaldehīdu, kanamicīna un neomicīna sulfātu (antibiotikām) vai cetiltrimetilamonija bromīdi (CTAB) (papildu informāciju skatīt apakšpunktā 6).
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics looks like and contents of the pack Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a suspension for injection in a pre-filled syringe.
Latvian: Novartis Vaccines and Diagnostics ārējais izskats un iepakojums Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ir suspensija injekcijām pilnšļircē.
English: Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Latvian: Kuņģa-zarnu trakta traucējumi Kuņģa-zarnu trakta traucējumi, piemēram, nelabums, vemšana, sāpes vēderā un caureja.
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Latvian: Suspensija injekcijām pilnšļircē.
English: Study V87P13 21 days after 2nd dose N=143
Latvian: V87P13. pētījums 21 dienu pēc 2. devas N=143
English: Study V87P2 Adults booster after 2rd dose
Latvian: V87P12. pētījums, pieaugušie, pastiprināšana pēc 2. devas
English: st nd or booster) were similar and are listed according to the following frequency:
Latvian: Blakusparādību līmenis, par kurām ziņots pēc jebkuras vakcinācijas devas (t.i., 1., 2. vai revakcinācijas), bija līdzīgs un tiek uzskaitīts atbilstoši turpmāk norādītajam biežumam:
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics containing HA from A/Vietnam/1194/2004 (homologous to the challenge strain) and an Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics -like H5N1 vaccine, containing hemagglutinin from the A/turkey/Turkey/1/2005-like (heterologous to the challenge strain) were tested.
Latvian: Novartis Vaccines and Diagnostics līdzīga H5N1 vakcīna, kas satur hemaglutinīnu no A/turkey/Turkey/1/2005 līdzīga celma (heterologa pārbaudāmajam vīrusam.
English: How to store Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Latvian: Kā uzglabāt Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
English: In a phase 2 clinical trial (Study V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine /A/Duck/Singapore/97 were administered 2 booster doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, met all CHMP criteria.
Latvian: 2. fāzes kīniskajā pētījumā (V87P3. pētījums) pieaugušas personas vecumā no 18 līdz 65 gadiem, kas bija saņēmušas sākumdevu pirms 6-8 gadiem ar 2 devām adjuvantu MF59-saturošas H5N3 vakcīnas
English: Study V87P1 Elderly booster after 2nd dose
Latvian: V87P1. pētījums, gados vecākas personas, revakcinācija pēc 2. devas
English: Study V87P1 Adults booster after 2nd dose
Latvian: V87P1. pētījums, pieaugušie, pastiprināšana pēc 2. devas
English: Lymphadenopathy.
Latvian: Kālija hlorīds
English: In the first few weeks after vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen,
Latvian: Pirmajās nedēļās pēc vakcinācijas ar Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Latvian: Citas blakusparādības Pusaudţi (9-<18 gadus veci)
English: Toddlers (6-<36 months) Children (3-<9 years) Adolescents (9-<18 years) N=91
Latvian: Bērni (3-<9 gadus veci)