Focetria

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-02-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-02-2015
Public Assessment Report Public Assessment Report (PAR)
05-10-2010

Active ingredient:

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

Available from:

Novartis Vaccines and Diagnostics S.r.l.

ATC code:

J07BB02

INN (International Name):

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

Therapeutic group:

Influenza vaccines

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

A (H1N1v) 2009 vīrusa izraisīta gripas profilakse. Focetria būtu jāizmanto saskaņā ar oficiālās vadlīnijas.

Product summary:

Revision: 9

Authorization status:

Atsaukts

Authorization date:

2007-05-02

Patient Information leaflet

                                35
B. LIETOŠANAS INSTRUKCIJA
Zāles vairs nav reğistrētas
36
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
FOCETRIA SUSPENSIJA INJEKCIJAI
Gripas vakcīna H1N1v (virsmas antigēni, inaktivēti, pievienots
adjuvants)
Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
PIRMS VAKCINĒŠANĀS AR ŠO VAKCĪNU UZMANĪGI IZLASIET VISU
INSTRUKCIJU, JO TĀ SATUR JUMS SVARĪGU
INFORMĀCIJU.
-
Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.
-
Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam vai medmāsai.
-
Ja Jums ir jebkādas blakusparādības, konsultējieties ar ārstu.
Tas attiecas arī uz iespējamām
blakusparādībām, kas šajā instrukcijā nav minētas.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Focetria un kādam nolūkam to lieto
2.
Kas jāzina pirms vakcinēšanās ar Focetria
3.
Kā lietot Focetria
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Focetria
6.
Iepakojuma saturs un cita informācija
1.
KAS IR FOCETRIA UN KĀDAM NOLŪKAM TO LIETO
Focetria ir vakcīna, lai novērstu gripu, kuru izraisa A (H1N1v) 2009
vīruss.
Pēc tam, kad cilvēks saņēmis vakcīnu, viņa imūnsistēma
(organisma dabiskā aizsargsistēma) rada
aizsardzību (antivielas) pret šo slimību. Neviena no vakcīnas
sastāvdaļām nevar izraisīt gripu.
2.
KAS JĀZINA PIRMS VAKCINĒŠANĀS AR FOCETRIA
NELIETOJIET FOCETRIA ŠĀDOS GADĪJUMOS:

ja Jums kādreiz ir bijusi pēkšņa dzīvībai bīstam
a alerģiska reakcija pret jebkuru Focetria sastāvdaļu
(t
ās ir uzskaitītas šīs instrukcijas beigās) vai jebkuru vielu, kas
var būt šādos piemaisījumos: olu un
vistas proteīnā, ovalbumīnā, formaldehīdā, kanamicīna un
neomicīna sulfātā (antibiotikās) vai
cetiltrimetilamonija bromīdā (CTAB) Alerģiskas reakcijas pazīmes
var būt niezoši ādas izsitumi,
elpas trūkums un sejas vai mēles uztūkums.
BRĪDINĀJUMI UN PIESARDZĪBA LIETOŠANĀ
PIRMS VAKCINĒŠANĀS AR FOCETRIA KONSULTĒJIETIES AR ĀRSTU VAI
MEDMĀSU
ĪPAŠA PIESARDZĪBA, LIETOJOT FOCETRIA, NEPIE
                                
                                Read the complete document

Summary of Product characteristics

                                1
PIELIKUMS I
ZĀĻU APRAKSTS
Zāles vairs nav reğistrētas
2
1.
ZĀĻU NOSAUKUMS
_ _
Focetria suspensija injekcijai pilnšļircē
Gripas vakcīna H1N1v (virsmas antigēni, inaktivēti, pievienots
adjuvants)
Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Gripas vīrusa virsmas antigēni (hemaglutinīns un neiraminidāze)*
celmam:
no A/California/07/2009 (H1N1) atvasināts celms,
izmantots NYMC X-181
7,5 mikrogrami** 0,5 ml devā
* kultivēts olās
** izteikts hemaglutinīna mikrogramos.
Adjuvants MF59C.1 satur:
skvalēnu
9,75 miligramus
polisorbātu 80
1,175 miligramus
sorbitāna trioleātu
1,175 miligramus
Pilnu palīgvielu sarakstu skatīt apakšpunktā 6.1.
3.
ZĀĻU FORMA
Suspensija injekcijai pilnšļircē.
Pienaini balts šķidrums.
4.
KLĪNISKĀ INFORMĀCIJA
4.1
TERAPEITISKĀS INDIKĀCIJAS
Gripas profilaksei, kuru izraisa A (H1N1v) 2009 vīruss (skatīt
apakšpunktu 4.4).
Focetria jālieto atbilstoši oficiālajām
vadlīnijām.
4.2
DEVAS UN LIETOŠANAS VEIDS
Ieteicamās devas balstās uz drošības un imunogenitātes datiem,
kas iegūti klīniskajos pētījumos ar
veseliem pacientiem.
Devas
Pieaugušie (18-60 gadus veci):
Viena 0,5 ml deva izraudzītajā datumā.
Imunogenitātes dati, kas iegūti trīs nedēļas pēc vienas Focetria
H1N1v devas, uzvedina uz domām,
ka viena deva var būt pietiekoša.
Ja tiek ievadīta otra deva, starp pirmo un otro devu jābūt vismaz
trīs nedēļu pārtraukumam.
Gados vecāki cilvēki (>60 gadiem):
Viena 0,5 ml deva izraudzītā datumā.
Otra vakcīnas deva jāievada pēc vismaz trīs nedēļu pārtraukuma.
Zāles vairs nav reğistrētas
3
_Pediatriskā populācija _
Bērni un pusaudži vecumā no 3 līdz 17 gadiem:
Viena 0,5 ml deva izraudzītajā datumā.
Imunogenitātes dati, kas iegūti trīs nedēļas pēc vienas Focetria
H1N1v devas, uzvedina uz domām,
ka viena deva var būt pietiekoša.
Ja tiek ievadīta otra deva, starp pirmo un otro devu jābūt vismaz
trīs nedēļu pārtraukumam.
Bērni vecum
                                
                                Read the complete document

Similar products

Active ingredient Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

ATC code J07BB02

J07BB02

Marketed by Novartis Vaccines and Diagnostics S.r.l.

Novartis Vaccines and Diagnostics S.r.l.

INN (International Name) influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

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