Luveris

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
06-09-2022
Public Assessment Report Public Assessment Report (PAR)
03-08-2011

Active ingredient:

lutropin alfa

Available from:

Merck Europe B.V. 

ATC code:

G03GA07

INN (International Name):

lutropin alfa

Therapeutic group:

Spolni hormoni in zdravila genitalni sistem,

Therapeutic area:

Ovulation Induction; Infertility, Female

Therapeutic indications:

Luveris v povezavi z folikle stimulirajočega hormona (FSH) pripravo se priporoča za stimulacijo razvoja foliklov pri ženskah s hudo luteinising-hormon (LH) in pomanjkanje FSH. V kliničnih preskušanjih, ti bolniki so bili opredeljeni z endogeno serum LH ravni.

Product summary:

Revision: 21

Authorization status:

Pooblaščeni

Authorization date:

2000-11-29

Patient Information leaflet

                                17
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25 °C. Shranjujte v originalni ovojnini
za zagotovitev zaščite
pred svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z
lokalnimi predpisi.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/00/155/001 (1 viala/ 1 ampula)
EU/1/00/155/002 (3 viale/ 3 ampule)
EU/1/00/155/003 (10 vial/ 10 ampul)
EU/1/00/155/004 (1 viala/ 1 viala)
EU/1/00/155/005 (3 viale/ 3 viale)
EU/1/00/155/006 (10 vial/ 10 vial)
13.
ŠTEVILKA SERIJE
Lot
Lot vehikla
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
luveris 75 i.e.
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
_ _
PC
SN
19
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
LUVERIS 75 I.E., VIALE
1.
IME ZDRAVILA IN POT(I ) UPORABE
Luveris 75 i.e. prašek za injekcijo
lutropin alfa
subkutana uporaba
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
75 i.e.
6.
DRUGI PODATKI
20
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
LUVERIS 75 I.E., AMPULE Z VEHIKLOM
1.
IME ZDRAVILA IN POT(I ) UPORABE
vehikel za zdravilo Luveris
voda za injekcije
s.c.
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
1 ml
6.
DRUGI PODATKI
21
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
LUVERIS 75 I.E., VIALE Z VEHIKLOM
1.
IME ZDRAVILA IN POT(I ) UPORABE
vehikel za zdravilo Luveris
voda za injekcije
s.c.
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA U
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Luveris 75 i.e. prašek in vehikel za raztopino za injiciranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena viala vsebuje 75 i.e. lutropina alfa*.
* rekombinantni humani luteinizirajoči hormon (r-hLH), pridobljen z
gensko rekombinantno
tehnologijo DNA na ovarijskih celicah kitajskega hrčka (CHO)
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
prašek in vehikel za raztopino za injiciranje (prašek za injekcijo)
Videz praška: bele liofilizirane pelete.
Videz vehikla: bistra brezbarvna raztopina.
pH rekonstituirane raztopine je 7,5 do 8,5.
Poleg ampul je treba razmisliti tudi o drugih oblikah zdravila, ki
omogočajo bolnicam, da si lahko
dajejo zdravilo same.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Luveris je skupaj s preparatom, ki vsebuje folikle
stimulirajoči hormon (FSH), indicirano za
spodbujanje folikularnega razvoja pri odraslih ženskah s hudim
pomanjkanjem luteinizirajočega
hormona (LH) in FSH.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje z zdravilom Luveris se mora začeti pod nadzorom
zdravnika, ki ima izkušnje z
zdravljenjem motenj plodnosti.
Odmerjanje
Pri ženskah s pomanjkanjem LH in FSH je cilj terapije z zdravilom
Luveris v kombinaciji s FSH
spodbujanje razvoja foliklov, ki mu sledi končno dozorevanje le-teh
po dajanju humanega horionskega
gonadotropina (hCG). Zdravilo Luveris se mora dajati kot serijo
dnevnih injekcij sočasno s FSH. Če je
bolnica amenoreična in ima nizko izločanje endogenega estrogena, se
zdravljenje lahko začne
kadarkoli.
Zdravilo Luveris se daje sočasno s folitropinom alfa.
Priporočeni režim se začne s 75 i.e. lutropina alfa (tj. ena viala
zdravila Luveris) na dan in s
75 do 150 i.e. FSH. Zdravljenje mora biti prilagojeno individualnemu
odzivu bolnice, ki se ga
ovrednoti z merjenjem velikosti foliklov z ultrazvokom in estrogenskim
odzivom.
3
V kliničnih preskušanjih se je pokazalo, da zdravilo Luveris poveča
občutljivost jajčnikov na
folitropin alf
                                
                                Read the complete document

Similar products

Active ingredient lutropin alfa

lutropin alfa

ATC code G03GA07

G03GA07

Marketed by Merck Europe B.V. 

Merck Europe B.V. 

INN (International Name) lutropin alfa

lutropin alfa

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Luveris