FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Latvian: Zoonozes gripas vakcīna (H5N1) (virsmas antigēns, inaktivēts, ar adjuvantu)
English: In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Latvian: Pētījumā V87P11 MN rezultāti pret homologo A/turkey/Turkey/1/2005 uzrāda seroprotekcijas un serokonversijas līmeņus, attiecīgi, 85% (79-90) un 93% (89-96).
English: In this trial no vaccine related SAEs were observed.
Latvian: Šajā pētījumā netika novērota neviena ar vakcīnu saistīta nopietna nevēlama blakusparādība.
English: Immunogenicity was assessed in 182 subjects.
Latvian: Imūngenitāte tika novērtēta 149 personām.
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 listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide).
Latvian: Jāievēro piesardzība, ievadot šo vakcīnu personām ar zināmu paaugstinātu jutību (atšķirīgu no anafilaktiskās reakcijas) pret aktīvo vielu, kādu no 6.1. apakšpunktā uzskaitītajām palīgvielām un to paliekām (olas un cāļa olbaltumvielām, ovalbumīnu, kanamicīna, neomicīna sulfātu, formaldehīdu un cetiltrimetilamonija bromīdu).
English: In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.
Latvian: Turklāt, gan personām ar imūnās sistēmas traucējumiem, gan personām ar jau esošiem medicīniskiem stāvokļiem ziņots par lielākiem artralģijas rādītājiem (līdz 23,3%).
English: Information from non-clinical studies
Latvian: KLĪNISKĀ INFORMĀCIJA
English: Adults (19- 60 years)a
Latvian: Pieaugušie (19-60 gadi)a
English: Side effects from clinical study in children (6 months to 17 years of age) General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying.
Latvian: Parastās blakusparādības, kuras ļoti bieži novēroja vecuma grupā no 6 līdz 35 mēnešiem, bija apsārtums injekcijas vietā, muskuļu sāpes, aizkaitināmība un pastiprināta raudāšana.
English: Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions.
Latvian: Serokonversijas līmenis pret homologu A/turkey/Turkey/1/2005 bija robežās no 37,50% līdz 43,10% veseliem pieaugušajiem un no 19,18% līdz 26,47% pieaugušajiem ar imūnsupresīviem vai esošiem medicīniskiem stāvokļiem; attiecīgi serokonversijas līmenis bija robežās no 21,43% līdz 30,65% veselām pieaugušajām personām un no 24,49% līdz 27,86% gados vecākām personām ar
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
Latvian: A/turkey/Turkey/1/2005 (H5N1) līdzīgs celms (NIBRG-23) (grupa 2.2.1) 7,5 mikrogrami**
English: Elderly years)*
Latvian: 91 gadi)*
English: In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
Latvian: III fāzes klīniskā pētījumā (V87P13) tika iesaistītas 2693 pieaugušas personas un 2566 personas ar triju nedēļu intervālu saņēma divas devas AFLUNOV (A/Vietnam/1194/2004).
English: Common (affects 1 to 10 users in 100):
Latvian: Bieži (novēro 1 līdz 10 lietotājiem no 100)
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Latvian: Reģistrācijas apliecības īpašnieks un ražotājs:
English: • Rash or swelling of the skin and mucous membranes
Latvian: • izsitumus vai ādas un gļotādu pietūkumu
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Latvian: CITI REĢISTRĀCIJAS NOSACĪJUMI UN PRASĪBAS D. NOSACĪJUMI VAI IEROBEŽOJUMI ATTIECĪBĀ UZ DROŠU UN
English: • Headache, dizziness, drowsiness, fainting.
Latvian: • Galvassāpes, reibonis, miegainība, ģībonis
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of AFLUNOV (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Latvian: • ja Jums agrāk ir bijusi dzīvību apdraudoša alerģiska reakcija uz kādu no AFLUNOV sastāvdaļām (minētas 6. punktā) vai uz kādu no vielām, kas vakcīnas sastāvā var būt nelielā daudzumā, proti: olas un cāļa olbaltumvielas, ovalbumīns, formaldehīds, kanamicīna un neomicīna sulfāts (antibiotikas) vai cetiltrimetilamonija bromīds (CTAB).
English: Toddlers (6-<36 months)
Latvian: Bērni (6-< 36 mēnešus veci)
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, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
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 bromīdu (CTAB) (papildu informāciju skatīt 6. punktā);
English: Adults years)*
Latvian: Pieaugušie 60 gadi)*
English: Rare (affects 1 to 10 users in 10.000):
Latvian: Reti (novēro 1 līdz 10 lietotājiem no 10 000)
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows:
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis** un serokonversijas faktors*** anti-HA antivielai pret H5N1 (A/Vietnam/1194/2004 un pret A/turkey/Turkey/1/2005) 61 gadu vecām un vecākam personām (ierobežots personu skaits bija vecākas par 70 gadiem; N=123), mērot ar SRH analīzi trīs klīniskos pētījumos, bija šāds:
English: Adults (20- 60 years)a
Latvian: Pieaugušie (20-60 gadi)a
English: MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively.
Latvian: MN analīzes rezultāti pret homologu 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: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Latvian: Kuņģa-zarnu trakta traucējumi Kuņģa-zarnu trakta traucējumi, piemēram, slikta dūša, vemšana, sāpes vēderā un caureja
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below.
Latvian: Pēc 3 nedēļām no 2. vakcinācijas (43. dienā) visās vecuma grupās (t.i., 6-35 mēneši, 3-8 gadi un 9-17 gadi) tika sasniegts augsts antivielu līmenis pret
English: BATCH NUMBER
Latvian: Personu skaits
English: Elderly (>61 years)
Latvian: Gados vecākas personas (≥ 61 gadi)
English: % SP (95% CI) Day 43 GMR Day 43 to Day 1 % SC (95% CI)Day 43
Latvian: VĢL (95% TI) 43. diena:1. dienu % SK (95% TI) 43. diena
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) of this vaccine.
Latvian: Anafilaktiska (t.i., dzīvību apdraudoša) reakcija anamnēzē uz kādu no sastāvdaļām vai niecīgām paliekām (olas un cāļa olbaltumvielām, ovalbumīnu, kanamicīna, neomicīna sulfātu, formaldehīdu un cetiltrimetilamonija bromīdu) šajā vakcīnā.
English: ** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** GMRs of SRH
Latvian: Serokonversija tika definēta kā SRH laukums ≥ 25 mm2 personām, kuras sākotnēji (1. dienā SRH laukums ≤ 4 mm2) bija seronegatīvas, vai nozīmīga (vismaz 50%) SHR laukuma palielināšanās personām, kuras sākotnēji (1. dienā SRH laukums > 4 mm2) bija seropozitīvas.
English: One dose of 0.5 ml will be given.
Latvian: Ievada vienu 0,5 ml devu.
English: In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
Latvian: Pētījumā V87P11 MN rezultāti pret homologo A/turkey/Turkey/1/2005 uzrāda seroprotekcijas un serokonversijas līmeņus, attiecīgi, 68% (59-75) un 81% (74-87).
English: Up to 50% (n=33) of the elderly subjects aged 62 to 88 years immunised with AFLUNOV in trial V87P1 were seroprotected at six months.
Latvian: 88 gadiem, kas bija imunizētas ar AFLUNOV pētījumā V87P1, pēc sešiem mēnešiem bija seroprotekcija.
English: Fainting can occur following, or even before, any needle injection.
Latvian: Pēc vai pat pirms injekcijas ar adatu var rasties ģībonis.
English: MicroNeutralisation (MN) results against homologous 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: Mikroneitralizācijas (MN) analīzes rezultāti pret homologu 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: Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator).
Latvian: AFLUNOV (A/turkey/Turkey/1/2005) imūngenitāte pieaugušām (18-60 gadi) un gados vecākām personām (>61gadiem) ar esošiem medicīniskiem (pētījums V87_25) vai imūsupresīviem stāvokļiem (galvenokārt ar HIV inficētām personām) (pētījums V87_26) salīdzinājumā ar veseliem pieaugušajiem
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182
Latvian: A/turkey/Turkey/1/2005 21 dienu pēc 2. devas N=182
English: Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
Latvian: Ar triju nedēļu intervālu 156 veseliem pieaugušajiem tika ievadītas divas devas AFLUNOV.
English: To be administered intramuscularly into the deltoid muscle.
Latvian: Ievadīšanai intramuskulāri deltveida muskulī.
English: MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly.
Latvian: MN rezultāti A/Indonesia/5/2005 gadījumā uzrādīja seroprotekcijas līmeni 38% (31-45) pieaugušajiem vecumā no 18 līdz 60 gadiem un 14% (8-20) gados vecākām personām (≥ 61 gads); serokonversijas līmeni 58% (50-65) pieaugušajiem un 30% (23-38) gados vecākām personām un, beidzot,
English: • Pain at the site of injection
Latvian: • Sāpes injekcijas vietā
English: There are no data with AFLUNOV using the subcutaneous route of administration.
Latvian: Nav datu par AFLUNOV ievadīšanu, izmantojot subkutānu ievadīšanas veidu.
English: Keep this vaccine out of the sight and reach of children.
Latvian: Uzglabāt vakcīnu bērniem neredzamā un nepieejamā vietā.
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: MN 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
English: • Vomiting
Latvian: • tirpšana
English: Seroconversion rate (95%CI)°
Latvian: Serokonversijas līmenis (95% TI)°
English: • Fever and nausea
Latvian: • Drudzis un slikta dūša
English: assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4).
Latvian: Abos pētījumos, V87_25 un V87_26, zemāks antivielu līmenis (mērot ar HI, SRH un MN analīzi) un samazināts seroprotekcijas līmenis pieaugušām un gados vecākām personām (≥ 61 gadu vecumā) ar esošiem medicīniskiem stāvokļiem vai imūnsupresīviem stāvokļiem liecina, ka AFLUNOV var neuzrādīt tādu pašu aizsardzības līmeni pret A/H5N1 celmu, salīdzinot ar veseliem pieaugušajiem (skatīt 4.4. apakšpunktu).
English: Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Latvian: Vidējais ģeometriskais laukums*, seroprotekcijas līmenis*, serokonversijas līmenis* un serokonversijas faktors** anti-HA antivielām pret H5N1 A/turkey/Turkey/1/2005, mērot ar SRH analīzēm, 21 dienu pēc 2. devas bija šāds:
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
Latvian: A/turkey/Turkey/1/2005 (H5N1) līdzīgs celms (NIBRG-23) (2.2.1 grupa) 7,5 mikrogrami hemaglutinīna
English: OTHER
Latvian: Visas
English: Elderly (61-84 years)a
Latvian: Gados vecākas personas (61-84 gadi)a
English: The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly:
Latvian: Focetria (AFLUNOV līdzīga H1N1 pandēmijas vakcīna), kas satur tādu pašu daudzumu MF59C.1 adjuvantu kā AFLUNOV un ir atļauta lietošanai bērniem no 6 mēnešu vecuma, pieaugušajiem un gados vecākiem cilvēkiem pēcreģistracijas uzraudzības laikā ziņots par šādām nevēlamajām blakusparādībām.
English: MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
Latvian: MN rezultāti A/Vietnam/1194/2004 gadījumā uzrādīja seroprotekcijas līmeni 10% (6-16) pieaugušajiem vecumā no 18 līdz 60 gadiem un 6% (3-11) gados vecākām personām (≥ 61 gads); serokonversijas līmeni 19% (13-25) pieaugušajiem un 7% (4-13) gados vecākām personām un,
English: Elderly (61-79 years)a
Latvian: Gados vecākas personas (61-79 gadi)a
English: Urticaria
Latvian: skvalēnu
English: Baseline Serostatus
Latvian: • Sāpošas locītavas
English: Study V87P13 21 days after 2nd dose N=197
Latvian: V87P13 pētījums 21 dienu pēc 2.
English: AFLUNOV suspension for injection in pre-filled syringe.
Latvian: AFLUNOV ir suspensija injekcijām pilnšļircē.
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis** un serokonversijas faktors*** anti-HA antivielām pret H5N1 A/Indonesia/5/2005 un A/Vietnam/1194/2004 pēc 2. devas pieaugušajiem (18-60 gadi) un gados vecākām personām (≥ 61 gadi), mērot ar SRH un HI analīzēm, bija šāds.
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Latvian: A/turkey/Turkey/1/2005 21 dienu pēc2. devas N=132c
English: • Disorders of the gut such as
Latvian: • Vēdera darbības traucējumi, piemēram, • slikta dūša
English: Study V87P1 Elderly booster after 2nd dose
Latvian: V87P1. pētījums, gados vecākas personas,
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Latvian: Seroprotekcijas līmenis*, serokonversijas līmenis** un serokonversijas faktors*** anti-HA antivielām pret H5N1 A/turkey/Turkey/1/2005 pēc 2. devas pieaugušajiem vecumā no 18 līdz 60 gadiem, mērot ar SRH un HI analīzēm, bija šāds.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Latvian: KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS Gripas vīrusa virsmas antigēni (hemaglutinīns un neiraminidāze)*, celms:
English: Skin and subcutaneous tissue disorders Erythema multiforme.
Latvian: Ādas un zemādas audu bojājumi Daudzformu eritēma
English: ** geometric mean ratios of SRH
Latvian: *** vidējais ģeometriskais SRH līmenis.
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 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 un pret H5N1 A/turkey/Turkey/1/2005 pieaugušajiem, mērot ar
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Latvian: AFLUNOV ārējais izskats un iepakojums
English: Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
Latvian: A gripai (H5N1) nav pierādīta aizsardzības imūnā korelācija.
English: Common (≥1/100 to <1/10)
Latvian: (≥ 1/100 līdz
English: Elderly (61-91 years)a
Latvian: Gados vecākas personas (61-91 gadi)a
English: Immunocompromised
Latvian: Imūngenitāte tika novērtēta
English: Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=84a
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Latvian: • Neiroloģiski traucējumi, piemēram, encefalomielīts (centrālās nervu sistēmas iekaisums) un paralīzes veids, kas pazīstama kā Gijēna-Barē sindroms.
English: Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Latvian: A/turkey/Turkey/1/2005 un A/Indonesia/5/2005
English: Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd
Latvian: Bioloģiski aktīvās vielas ražotāju nosaukums un adrese
English: AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Latvian: līdzīga H5N1 vakcīna (līdzīga A/turkey/Turkey/1/2005).
English: HI Seroprotection rate (95%CI)°
Latvian: Seroprotekcijas līmenis (95% TI)°
English: AFLUNOV is a suspension for injection in a pre-filled syringe.
Latvian: AFLUNOV suspensija injekcijām pilnšļircē.
English: Talk to your doctor or nurse before having this vaccine
Latvian: Pirms šīs vakcīnas saņemšanas konsultējieties ar savu ārstu vai medmāsu:
English: Study V87P3 21 days after 2nd dose N=30
Latvian: 21 dienu pēc 2. devas N=30
English: Injection site ecchymosis, Fever, Malaise, Shivering
Latvian: Injekcijas vietas ekhimoze, drudzis,
English: • Convulsions
Latvian: • lēkmes
English: • Fits
Latvian: • Drebuļi
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: V87P1. pētījums,
English: • Shivering
Latvian: • vemšana
English: Seroprotection rate (95%CI) ° Seroconversion rate (95%CI) ° Seroconversion factor (95%CI) °°
Latvian: Serokonversijas faktors (95% TI)°°
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=210b
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=128
English: Reactogenicity after the third dose,
Latvian: revakcinācija pēc 2. d evas
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=66
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=69
English: Seroconversion factor (95%CI)°° * Seroprotection: SRH area ≥ 25 mm2
Latvian: Seroprotekcija: SRH laukums ≥ 25 mm2.
English: Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=149
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=149
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)***
Latvian: Serokonversijas faktors (95% TI)***
English: Immunogenicity was assessed in a subset (n=197) of subjects .
Latvian: Imūngenitāte tika novērtēta personu apakšgrupā
English: • Aching joints
Latvian: • Krampji • Acu pietūkums
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=197
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=197
English: Suspension for injection in pre-filled syringe.
Latvian: ZĀĻU FORMA Suspensija injekcijām pilnšļircē.
English: • Brusing of the skin at the injection site
Latvian: • Ādas sacietējums injekcijas vietā
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Latvian: A/Vietnam/1194/2004 21 dienu pēc 2. devas N=143
English: SRH Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor(95%CI)***
Latvian: Serokonversijas faktors (95% TI)**
English: Adults and elderly (18 years of age and above):
Latvian: Pieaugušie un gados vecākas personas (sākot no 18 gadiem): viena 0,5 ml deva izvēlētā datumā.
English: Cross-reactive immune response elicited by A/Vietnam/1194/2004 against A/turkey/Turkey/1/2005 and A/Indonesia/5/2005
Latvian: Krusteniskās reaktivitātes dati pieaugušajiem A/Vietnam/1194/2004 izraisītās imūnās atbildes krusteniskā reaktivitāte pret
English: • Nausea
Latvian: • nātreni
English: Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue
Latvian: Injekcijas vietas pietūkums, sāpes injekcijas vietā,
English: Nausea
Latvian: VĢL
English: Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
Latvian: un V87_26, kuros bija iesaistīti pieaugušie (18-60 gadi) un gados vecākas personas (≥ 61 gads),
English: A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Latvian: Pieaugušie (18-60 gadus veci) Tika veikts II fāzes klīniskais pētījums (V87P1) ar AFLUNOV (A/Vietnam/1194/2004),