Hizentra

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
13-01-2022

Active ingredient:

cilvēka normālais imūnglobulīns (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Un imūnglobulīni,

Therapeutic area:

Imūndeficīta sindromi

Therapeutic indications:

Replacement therapy in adults, children and adolescents (0-18 years) in:- Primary immunodeficiency syndromes with impaired antibody production (see section 4. - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of.

Product summary:

Revision: 21

Authorization status:

Autorizēts

Authorization date:

2011-04-14

Patient Information leaflet

                                28
B. LIETOŠANAS INSTRUKCIJA
29
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
HIZENTRA 200 MG/ML ŠĶĪDUMS SUBKUTĀNĀM INJEKCIJĀM
Human normal immunoglobulin (imūnglobulīns subkutānai
ievadīšanai)
PIRMS ZĀĻU LIETOŠANAS 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 farmaceitam.
-
Šīs zāles ir parakstītas tikai Jums. Nedodiet tās citiem. Tās
var nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.
-
Ja Jums ir jebkādas blakusparādības, konsultējieties ar veselības
aprūpes speciālistu. Tas
attiecas arī uz iespējamām blakusparādībām, kas šajā
instrukcijā nav minētas. Skatīt 4. punktu.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT
1.
Kas ir Hizentra un kādam nolūkam tās lieto
2.
Kas jāzina pirms Hizentra lietošanas
3.
Kā lietot Hizentra
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Hizentra
6.
Iepakojuma saturs un cita informācija
1.
KAS IR HIZENTRA UN KĀDAM NOLŪKAM TĀS LIETO
KAS IR HIZENTRA
Hizentra pieder pie zāļu klases, kuru sauc par cilvēka normālajiem
imūnglobulīniem.
Imūnglobulīnus sauc arī par antivielām, un tās ir asins
olbaltumvielas, kas palīdz ķermenim cīnīties
pret infekcijām.
KĀ HIZENTRA DARBOJAS
Hizentra satur imūnglobulīnus, kas iegūti no veselu cilvēku
asinīm. Imūnglobulīnus izstrādā cilvēka
organisma imūnsistēma. Tie palīdz organismam cīnīties pret
infekcijām, ko izraisa baktērijas un vīrusi,
vai uzturēt imūnsistēmas līdzsvaru (to sauc par imūnmodulāciju).
Šīs zāles darbojas tieši tāpat kā tie
imūnglobulīni, kas ir dabīga Jūsu asins sastāvdaļa.
KĀDAM NOLŪKAM LIETO HIZENTRA
_Aizstājterapija _
Hizentra lieto, lai paaugstinātu nenormāli zemu imūnglobulīnu
līmeni Jūsu asinīs līdz normālam
līmenim (aizvietotājterapija). Šīs zāles lieto pieaugušajiem un
bērniem (0–18 gadi) šādos gadījumos:
1
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Hizentra 200 mg/ml šķīdums subkutānām injekcijām
Hizentra 200 mg/ml šķīdums subkutānām injekcijām pilnšļircē
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Cilvēka normālais imūnglobulīns (SCIg)
Human normal immunoglobulin (SCIg)
Viens ml satur:
cilvēka normālo imūnglobulīnu
.....................................................................................................
200 mg
(tīrība: vismaz 98% ir G tipa imūnglobulīns (IgG))
Flakoni
Katrs 5 ml šķīduma flakons satur: 1 g cilvēka normālā
imūnglobulīna
Katrs 10 ml šķīduma flakons satur: 2 g cilvēka normālā
imūnglobulīna
Katrs 20 ml šķīduma flakons satur: 4 g cilvēka normālā
imūnglobulīna
Katrs 50 ml šķīduma flakons satur: 10 g cilvēka normālā
imūnglobulīna
Pilnšļirces
Katra 5 ml šķīduma pilnšļirce satur: 1 g cilvēka normālā
imūnglobulīna
Katra 10 ml šķīduma pilnšļirce satur: 2 g cilvēka normālā
imūnglobulīna
Katra 20 ml šķīduma pilnšļirce satur: 4 g cilvēka normālā
imūnglobulīna
IgG apakšklašu sadalījums (aptuvenās vērtības):
IgG1 ............ 69%
IgG2 ............ 26%
IgG3 ............ 3%
IgG4 ............ 2%
Maksimālais IgA daudzums ir 50 mikrogrami/ml.
Izgatavots no cilvēku donoru plazmas.
Palīgvielas ar zināmu iedarbību
Hizentra satur aptuveni 250 mmol/l (diapazons: 210–290) L-prolīna.
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3.
ZĀĻU FORMA
Šķīdums subkutānai injekcijai
Tas ir dzidrs šķīdums blāvi dzeltenā vai gaiši brūnā krāsā.
Hizentra osmolalitāte ir aptuveni 380 mOsmol/kg.
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
TERAPEITISKĀS INDIKĀCIJAS
Aizstājterapija pieaugušajiem, bērniem un pusaudžiem (0–18 gadi)
ar:
3
−
primāriem imūndeficīta sindromiem ar antivielu veidošanās
traucējumiem (skatīt
4.4. apakšpunktu);
−
sekundārais imūndeficīts (SID) pacientiem, kuri cieš no smagām
vai atkārtotām infekcijām,
neefektīvas pretmikrobu terapijas un vai nu pierādī
                                
                                Read the complete document

Similar products

Active ingredient cilvēka normālais imūnglobulīns (SCIg)

cilvēka normālais imūnglobulīns (SCIg)

ATC code J06BA01

J06BA01

Marketed by CSL Behring GmbH

CSL Behring GmbH

INN (International Name) human normal immunoglobulin (SCIg)

human normal immunoglobulin (SCIg)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2022
Public Assessment Report Public Assessment Report Bulgarian 13-01-2022
Patient Information leaflet Patient Information leaflet Spanish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2022
Public Assessment Report Public Assessment Report Spanish 13-01-2022
Patient Information leaflet Patient Information leaflet Czech 13-01-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-01-2022
Public Assessment Report Public Assessment Report Czech 13-01-2022
Patient Information leaflet Patient Information leaflet Danish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-01-2022
Public Assessment Report Public Assessment Report Danish 13-01-2022
Patient Information leaflet Patient Information leaflet German 13-01-2022
Summary of Product characteristics Summary of Product characteristics German 13-01-2022
Public Assessment Report Public Assessment Report German 13-01-2022
Patient Information leaflet Patient Information leaflet Estonian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Estonian 13-01-2022
Public Assessment Report Public Assessment Report Estonian 13-01-2022
Patient Information leaflet Patient Information leaflet Greek 13-01-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-01-2022
Public Assessment Report Public Assessment Report Greek 13-01-2022
Patient Information leaflet Patient Information leaflet English 13-01-2022
Summary of Product characteristics Summary of Product characteristics English 13-01-2022
Public Assessment Report Public Assessment Report English 13-01-2022
Patient Information leaflet Patient Information leaflet French 13-01-2022
Summary of Product characteristics Summary of Product characteristics French 13-01-2022
Public Assessment Report Public Assessment Report French 13-01-2022
Patient Information leaflet Patient Information leaflet Italian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Italian 13-01-2022
Public Assessment Report Public Assessment Report Italian 13-01-2022
Patient Information leaflet Patient Information leaflet Lithuanian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-01-2022
Public Assessment Report Public Assessment Report Lithuanian 13-01-2022
Patient Information leaflet Patient Information leaflet Hungarian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 13-01-2022
Public Assessment Report Public Assessment Report Hungarian 13-01-2022
Patient Information leaflet Patient Information leaflet Maltese 13-01-2022
Summary of Product characteristics Summary of Product characteristics Maltese 13-01-2022
Public Assessment Report Public Assessment Report Maltese 13-01-2022
Patient Information leaflet Patient Information leaflet Dutch 13-01-2022
Summary of Product characteristics Summary of Product characteristics Dutch 13-01-2022
Public Assessment Report Public Assessment Report Dutch 13-01-2022
Patient Information leaflet Patient Information leaflet Polish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Polish 13-01-2022
Public Assessment Report Public Assessment Report Polish 13-01-2022
Patient Information leaflet Patient Information leaflet Portuguese 13-01-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 13-01-2022
Public Assessment Report Public Assessment Report Portuguese 13-01-2022
Patient Information leaflet Patient Information leaflet Romanian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Romanian 13-01-2022
Public Assessment Report Public Assessment Report Romanian 13-01-2022
Patient Information leaflet Patient Information leaflet Slovak 13-01-2022
Summary of Product characteristics Summary of Product characteristics Slovak 13-01-2022
Public Assessment Report Public Assessment Report Slovak 13-01-2022
Patient Information leaflet Patient Information leaflet Slovenian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 13-01-2022
Public Assessment Report Public Assessment Report Slovenian 13-01-2022
Patient Information leaflet Patient Information leaflet Finnish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Finnish 13-01-2022
Public Assessment Report Public Assessment Report Finnish 13-01-2022
Patient Information leaflet Patient Information leaflet Swedish 13-01-2022
Summary of Product characteristics Summary of Product characteristics Swedish 13-01-2022
Public Assessment Report Public Assessment Report Swedish 13-01-2022
Patient Information leaflet Patient Information leaflet Norwegian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 13-01-2022
Patient Information leaflet Patient Information leaflet Icelandic 13-01-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 13-01-2022
Patient Information leaflet Patient Information leaflet Croatian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Croatian 13-01-2022
Public Assessment Report Public Assessment Report Croatian 13-01-2022

Search alerts related to this product

Alerts Hizentra cilvēka normālais imūnglobulīns human normal immunoglobulin

Hizentra cilvēka normālais imūnglobulīns human normal immunoglobulin

View documents history

Documents history Documents history

Hizentra