qanastek/EMEA-V3 huggingface dataset:
The safety profile of Luveris is expected to be very similar to that of urine derived hLH, with the exception of hypersensitivity reactions and application site disorders.
Is- sigurta 'ta' Luveris għandha tkun simili ħafna għal dik tal- hLH li ġej mill- urina, bl- eċċezzjoni ta ’ reazzjonijiet ta ’ ipersensittività u problemi fis- sit ta ’ l- applikazzjoni.
In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4% and 0.9% of the injections, respectively.
Fi studju kliniku, reazzjonijiet ħfief u moderati fis- sit ta ’ l- injezzjoni (tbenġil, uġigħ, ħmura, tekil jew nefħa) ġew irrappurtati f’ 7. 4% u 0. 9% ta ’ l- injezzjonijiet, rispettivament.
No severe injection site reactions were reported.
Ma ġewx irrappurtati reazzjonijiet serji fis- sit ta 'l- injezzjoni.
To date no systemic allergic reactions have been reported following Luveris administration.
Sal- lum ma ġiet irrappurtata l- ebda reazzjoni allerġika sistematika meta ittieħed Luveris.
Ovarian hyperstimulation syndrome was observed in less than 6% of patients treated with Luveris.
Inqas minn 6% tal- pazjenti trattati b’ Luveris qabadhom is- sindromu ta 'iperstimulazzjoni ta' l- ovarji.
No severe ovarian hyperstimulation syndrome was reported (section 4.4).
Ma ġewx irrappurtati każi serji tas- sindromu ta 'iperstimulazzjoni tal- ovarji (sezzjoni 4. 4).
In rare instances, thromboembolisms, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotrophin therapy.
F’ każijiet rari, tromboemboliżmi, torsjoni adnessali (kumplikazzjoni ta ’ meta jikbru l- ovarji), u emoperitoneum kienu assoċjati mat- terapija ta 'gonadotrofina tal- menopawża.
Although these adverse events were not observed, there is the possibility that they may also occur with Luveris.
Għalkemm ma dehrux, hemm il- possibilità li jiġru wkoll bil- Luveris.
Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease.
Tista ’ tirriżulta wkoll tqala barra mill- utru, speċjalment f’ nisa bi storja preċedenti ta ’ mard fit- tubi.
b) Undesirable effects
b) Effetti mhux mixtieqa
The following convention was used for the frequency (events/ no. of patients): very rare :< 1/10,000, rare :> 1/ 10,000 ,< 1/1 ,000, uncommon: > 1/ 1,000 ,< 1/100, common: > 1/ 100 ,< 1/10, very common: > 1/ 10
(avvenimenti/ nru. ta ’ pazjenti): rari ħafna: < 1/ 10000, rari: > 1/ 10000, < 1/ 1000, mhux komuni: > 1/ 1000, < 1/ 100, komuni: > 1/ 100, < 1/ 10, komuni ħafna: > 1/ 10
After best evidence assessment, the following undesirable effects may be observed after administration of Luveris.
4 Hemm evidenza li l- effetti mhux mixtieqa segwenti jistgħu jidhru meta jingħata Luveris.
4 Common Gastro-intestinal disorders: nausea, abdominal pain, pelvic pain Reproductive system and breast disorders: ovarian hyperstimulation syndrome, ovarian cyst, breast pain General disorders and administration site conditions: headache, somnolence, injection site reaction
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: reazzjoni fis- sit ta ’ l- injezzjoni
The reported undesirable effects are in agreement with those reported for other hLH-containing medicinal products, except for injection site reactions where the incidence was significantly lower with Luveris treatment.
L- effetti mhux mixtieqa rrapurtati huma l- istess bħal dawk li dehru meta ittieħdu medicini oħra li fihom hLH, ħlief għar- reazzjonijiet fis- sit ta ’ l- injezzjoni li kienu inqas b’ mod sinjifikanti meta ittieħed Luveris.
The effects of an overdose of lutropin alfa are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described in section 4.4.
L- effetti ta ’ doża eċċessiva ta ’ lutropin alfa mhumiex magħrufa, madankollu hemm il- possibilità li jirriżulta s- sindromu ta ’ l- iperstimulazzjoni.
Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers without serious adverse events and were well tolerated.
Din id- doża setgħu jittollerawha tajjeb u ma kienx hemm effetti ħziena serji.
Pharmacotherapeutic group: gonadotrophins.
Katergorija farmakoterapewtika: gonadotrofini.
Lutropin alfa is a recombinant human luteinising hormone, a glycoprotein composed of non- covalently bound α - and β -subunits.
Lutropin alfa hu ormon uman lutejniku rikombinanti, glikoproteina magħmula minn partiċelli sekondarji α - u β - marbuta b’ mod kovalenti.
Luteinising hormone binds on the ovarian theca (and granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotrophin hormone (hCG).
Dan ir- riċettur jaqbad miegħu ukoll l- ormon korjoniku gonadotrofiku uman.
This LH/ CG transmembrane receptor is a member of the super-family of G protein-coupled receptors; specifically, it has a large extra-cellular domain.
Dan ir- riċettur transmembraniku LH/ CG jagħmel parti mir- razza ta ’ riċetturi tal- proteina G doppja; speċifikament, għandu dominju extra- ċellulari.
In vitro the affinity binding of recombinant hLH to the LH/ CG receptor on Leydig tumour cells (MA-10) is between that for hCG and that of pituitary hLH, but within the same order of magnitude.
In vitro, l - affinità li għandu hLH rikombinanti biex jaqbad mar- riċettur tal- LH/ CG li qiegħed fuq iċ- ċelloli tat - tumur tal - 'Leydig' (MA- 10) hi bejn dik tal- hCG u dik tal- pitwitarjah LH iżda f' din l- istess ordni.
In the ovaries, during the follicular phase, LH stimulates theca cells to secrete androgens, which will be used as the substrate by granulosa cell aromatase enzyme to produce oestradiol, supporting FSH-induced follicular development.
Dawn jintużaw bħala sottostrata mill- enżima aromatejs taċ- ċellola granulosa biex tipproduċi l - estradajol, li jgħin għall- iżvilupp tal- follikulu li jseħħ permezz tal- FSH.
At mid-cycle, high levels of LH trigger corpus luteum formation and ovulation.
F’ nofs iċ- ċiklu, livelli għolja ta ’ LH iwasslu għall- formazzjoni tal- korpus lutejum u ovulazzjoni.
After ovulation, LH stimulates progesterone production in the corpus luteum by increasing the conversion of cholesterol to pregnenolone.
Wara l- ovulazzjoni, l- LH jistimula produzzjoni ta ’ proġesterone fil- korpus lutejum billi jżid il- bidla tal- kolesterol fi pregnenolon.
In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
Meta n- nisa, li ma jistax ikollhom ovulazzjoni minħabba nuqqas ta 'LH u FSH, jingħataw Lutropin alfa biex jistimula l- iżvilupp tal- follikulu, l- ewwel effetti ikunu żieda tal- estroġenu prodott mill - follikuli li jkunu qed jikbru għax stimulati mill- FSH.
In clinical trials, patients were defined by an endogenous serum LH level < 1.2 IU/ l as measured in a central laboratory.
Fl- istudji kliniċi il- pażjenti kellhom < 1. 2 IU/ l LH endoġenu fis- serum meta mkejjel f' laboratorju ċentrali.
However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Madankollu, wieħed irid jikkunsidra li jkun hemm differenza fil- kejl tal- LH meta mkejjel f' laboratorji differenti.
In these trials the ovulation rate per cycle was 70-75%.
F’ dawn l - istudji ir- rata ta ’ ovulazzjoni f' kull ċiklu kienet ta ’ 70- 75%.
The combination of r-hLH and r-hFSH has not been directly compared with treatment with hMG.
It- taħlita ta ’ r- hLH u r- hFSH ma kienetx imqabbla direttament mal- kura bl- hMG.
The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU.
It- tagħrif farmakokinetiku tal- lutropin alfa ġie miksub minn studji li saru fuq voluntiera femminili li
Following
5 kellhom il- pitwitarja desensitizzata - minn 75 IU sa 40, 000 IU.
5 intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours.
Meta lutropin alfa jingħata mill- vini, jinfirex malajr mal- ġisem u fil- bidu jonqos bin- nofs bejn wieħed u ieħor f ’ siegħa u jitneħħa mill- ġisem billi kull bejn 10 u tnax - il siegħa jkompli jonqos bin- nofs.
The steady state volume of distribution is around 10-14 l.
L- istat fiss tal - volum ta ’ distribuzzjoni hu ta ’ madwar 10- 14 l.
Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Il- Lutropin alfa juri farmakokinetika lineari, kif osservata mill- AUC li tvarja proporzjonalment skond d- doża meħudha.
The mean residence time is approximately 5 hours.
Idum medja ta 'bejn wieħed u ieħor ħames siegħat.
Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Meta jittieħed minn taħt il- ġilda, il- biodisponibilità assoluta hi ta ’ madwar 60%; Il- ħin li jieħu biex l - ammont fid- demm jonqos bin- nofs jitwal bi ftit. - Meta doża waħda jew dożi repetuti ta 'lutropin alfa jittieħdu, wieħed jista' jikkompara tajjeb ir- riżultati farmakokinetiċi tiegħu.
The lutropin alfa pharmacokinetics following single and repeated administration of Luveris are comparable and the accumulation ratio of lutropin alfa is minimal.
L- ammont ta 'lutropin alfa li jakkumula huwa minimu.
There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Ma hemm l- ebda interazzjoni farmakokinetika mal- follitropin alfa meta dawn jittieħdu fl- istess ħin.
Non clinical data reveal no special harzard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
As expected from the heterologous protein nature of the hormone, lutropin alfa raised an antibody response in experimental animals after a period that reduced the measurable serum LH levels but did not fully prevent its biological action.
Meta lutropin alfa ingħata lill- annimali li fuqhom kien qed isir l- esperiment, kif kien mistenni minn proteina eteroloġika, kien hemm effett tal - anti- korpi u dawn naqqsu l- ammont tal - LH imkejjel iżda ma waqqfux kompletament l- effetti bioloġiċi tal- prodott.
No signs of toxicity due to the development of antibodies to lutropin alfa were observed.
Ma deherx li saret ħsara minħabba l- anti- korpi għal lutropin alfa.
At doses of 10 IU/ kg/ day and greater, repeated administration of lutropin alfa to pregnant rats and rabbits caused impairment of reproductive function including resorption of foetuses and reduced body weight gain of the dams.
Saħansitra tilfu il- fetu u kien hemm tnaqqis fiż- żieda tal- piż ta ’ l- annimal femminili.
However, drug-related teratogenesis was not observed in either animal model.
Madankollu, ma dehrux effetti teratoġeniki fuq l- ebda tip ta ’ animal.
Other studies have shown that lutropin alfa is not mutagenic.
Studji oħra wrew li l - lutropin alfa mhux mutaġeniku.
Sucrose Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide Methionine Nitrogen
Sukrożju Fosfat tad- dissodju bi- idrat Fosfat mono- idrat tas- sodju di- idroġinat Polisorbat 20 Aċidu fosforiku, konċentrat Sodju idrossidu Metjonina Nitroġenu
Water for injection
Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra ħlief dawk imsemmija f’ 6. 6.
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġnali sabiex tilqa ’ mid- dawl.
6 6.5 Nature and contents of container
6 6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
The powder is packaged in 3 ml neutral colourless glass (type I) vials.
It- trab hu ppakjat f’ kunjett tal- ħġieġ (tip I) bla kulur ta ’ 3ml.
The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps.
Il- kunjetti huma magħluqa b’ tappijiet tal - bromobutil ipproteġuti b' siġill ta ’ l- aluminju u tappijiet li jfaqqaw f' posthom.
The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Is- solvent jinsab f’ kunjetti tal- ħġieġ (tip I) bla kulur ta '2 jew 3 ml b’ tapp tal- gomma miksi bit- Teflon jew f’ ampulla tal - ħġieġ (tip I) bla kulur ta ’ 2ml.
The product is supplied in packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 3 jew 10 kunjetti bl- istess ammont ta ’ kunjetti jew ampulli bis- solvent.
The powder must be reconstituted with the solvent before use by gentle swirling.
It- trab irid jinħall fis- solvent qabel l- użu permezz ta ’ taħlit bil- mod.
The reconstituted solution should not be administered if it contains particles or is not clear.
It- taħlita likwida m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
Luveris may be mixed with follitropin alfa and co-administered as a single injection.
Luveris jista ’ jitħallat mal- follitropin alfa u jittieħdu f’ daqqa f' injezzjoni waħda.
In this case Luveris should be reconstituted first and then used to reconstitute the follitropin alfa powder.
F’ dan il- każ il- Luveris irid jinħall fis- solvent l- ewwel u mbagħad it- taħlita tintuża biex idub fiha t- trab tal- follitropin alfa.
In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with one or two ampoule(s)/ vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.
Biex jiġi evitat li jingħataw injezzjonijiet ta ’ volumi kbar, kunjett ta ’ Luveris u ampulla/ kunjett jew tnejn ta ’ follitropin alfa, 37. 5 IU, 75 IU jew 150 IU jistgħu jinħallu f’ 1 ml ta ’ solvent.
SERONO EUROPE LIMITED, 56 Marsh Wall, London E14 9TP United Kingdom
SERONO EUROPE LIMITED, 56 Marsh Wall, London E14 9TP United Kingdom
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L- AWTORIZZAZZJONI
Date of first authorisation:
2000.
29th November 2000.
Data ta ’ l- aħħar irrinnovament:
Date of last renewal:
11.
30th November 2005.
2005.
7 ANNEX II
7 ANNEX II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U D- DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U > DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
1170 Aubonne Switzerland
1170 Aubonne Switzerland
Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Via delle Magnolie 15 I- 70026 Modugno (Bari) Italy
9 ANNEX III
9 ANNESS III
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING LUVERIS 75 IU, VIALS
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA TAL- PAKKETT LUVERIS 75 IU, KUNJETTI
Luveris 75 IU, powder and solvent for solution for injection.
Luveris 75 IU, trab u solvent għat- taħlita likwida għall- injezzjoni.
Composition: one vial of powder contains: lutropin alfa 75 IU.
Kompożizzjoni: kunjett ta ’ trab fih: lutropin alfa 75 IU.
Other ingredients: polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid, concentrated, sodium hydroxide, methionine and nitrogen.
Sustanzi oħra: polisorbat 20, sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di - sodju, aċidu fosforiku, konċentrat, idrossidu tas- sodju, metjonina u nitroġenu.
One ampoule of solvent contains:
Ampulla ta ’ solvent fiha:
One vial of solvent contains:
1 ml ilma għall- injezzjonijiet Kunjettta ’ solvent fiha:
1 ml water for injection.
1 ml ilma għall- injezzjonijiet
(EU/ 1/ 00/ 155/ 001-003) (EU/ 1/ 00/ 155/ 004-006)
EU/ 1/ 00/ 155/ 001- 003 EU/ 1/ 00/ 155/ 004- 006
10 vials of powder for solution for injection / 10 ampoules of solvent.
Kunjett bi trab għal taħlita likwida għall- injezzjoni / ampulla bis- solvent 3 kunjetti bi trab għal taħlita likwida għall- injezzjoni / 3 ampulli bis- solvent 10 kunjetti bi trab għal taħlita likwida għall- injezzjoni / 10 ampulli bis- solvent
10 vials of powder for solution for injection / 10 vials of solvent.
Kunjett bi trab għal taħlita likwida għall- injezzjoni / kunjett bis- solvent 3 kunjetti bi trab għal taħlita likwida għall- injezzjoni / 3 kunjetti bis- solvent 10 kunjetti bi trab għal taħlita likwida għall- injezzjoni / 10 kunjetti bis- solvent
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF, U MNEJN JINGĦATA
Subcutaneous use.
Minn taħt il- ġilda.
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma 'jidhirx mit- tfal.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
SPECIAL STORAGE CONDITIONS
TAGĦRIF DWAR ĦAŻNA SPEĊJALI
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġnali sabiex tilqa 'mid- dawl.
Discard any unused solution.
Armi l- fdal tat- taħlita likwida li ma ntużax.
Marketing authorisation holder:
Detentur ta ’ l- Awtorizzazzjoni għall- Kummerċ:
EU/ 1/ 00/ 155/ 001 (1vial/ 1 ampoule) EU/ 1/ 00/ 155/ 002 (3 vials/ 3 ampoules) EU/ 1/ 00/ 155/ 003 (10 vials/ 10 ampoules) EU/ 1/ 00/ 155/ 004 (1 vial/ 1 vial) EU/ 1/ 00/ 155/ 005 (3 vial/ 3 vials) EU/ 1/ 00/ 155/ 006 (10 vials/ 10 vials)
EU/ 1/ 00/ 155/ 001 (kunjett / ampulla) EU/ 1/ 00/ 155/ 002 (3 kunjetti / 3 ampulli) EU/ 1/ 00/ 155/ 003 (10 kunjetti / 10 ampulli) EU/ 1/ 00/ 155/ 004 (1 kunjett / 1 kunjett) EU/ 1/ 00/ 155/ 005 (3 kunjetti / 3 kunjetti) EU/ 1/ 00/ 155/ 006 (10 kunjetti / 10 kunjetti)
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, VIALS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN LUVERIS 75 IU, KUNJETTI
Luveris 75 IU
Luveris 75 IU,
Powder for injection.
Trab u solvent għat- taħlita likwida għall- injezzjoni.
Lutropin alfa Subcutaneous use.
Lutropin alfa Minn taħt il- ġilda
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT AMPOULES
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN LUVERIS 75 IU, AMPULLI TAS- SOLVENT
Water for injection Solvent for use with Luveris Injection.
Ilma għall- injezzjonijiet Solvent għall- użu mal- Luveris Injezzjoni
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT VIALS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN LUVERIS 75 IU, KUNJETTI TAS- SOLVENT
Water for injection Solvent for use with Luveris Injection.
Solvent għall- użu mal- Luveris Injezzjoni
INFORMATION FOR THE USER Solvent in ampoules
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Solvent fl- ampulli
Luveris 75 IU, powder and solvent for solution for injection Lutropin alfa
Luveris 75 IU, trab u solvent għal taħlita likwida għall- injezzjoni Lutropin alfa
- If you have any further questions, ask your doctor or pharmacist.
- Jekk għandek aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lis- spiżjar tiegħek.
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħall tiegħek.
Before you use Luveris 3.
Qabel ma tuża Luveris 3.
How to use Luveris 4.
Kif tuża l- Luveris 4.
How to store Luveris 6.
Kif taħżen il- Luveris 6.
WHAT LUVERIS IS AND WHAT IT IS USED FOR
X’ INHU LUVERIS U GĦALXIEX JINTUŻA
Luveris is a medicine containing lutropin alfa, a recombinant luteinising hormone (LH) which is essentially similar to the hormone found naturally in humans, but is made by means of biotechnology.
Luveris hu prodott mediċinali li fih lutropin alfa, ormon lutejniku rikombinanti (LH).
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Dan hu simili għall- ormon naturali li jinsab fil- bnedmin iżda li ġie magħmul permezz tal- bioteknoloġija.
Luveris is recommended for the treatment of women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle.
Luveris hu rakkomandat għall- kura tan- nisa li jipproduċu livelli baxxi ħafna ta ’ wħud mill- ormoni involuti fiċ- ċiklu naturali riproduttiv.
The medicine is used together with another hormone called FSH (follicle stimulating hormone), to bring about the development of follicles, which are in the ovary, the structures maturing the eggs (ova).
Il- mediċina tintuża flimkien ma ’ ormon ieħor magħruf bħala FSH (ormon li jistimula l- follikolu), biex jwass u għall- iżvilupp ta ’ follikuli li jinsabu fl- ovarju, l - istrutturi li jimmaturaw il- bajd (ova).
It is followed by treatment with a single dose of human chorionic gonadotrophin (hCG), which leads to the release of an egg from the follicle (ovulation).
Dan hu segwit minn trattament b’ doża waħda ta ’ gonadotrofina korjonika umana (hCG), li twassal biex il- bajda tinħeles mill- follikulu (ovulazzjoni).
BEFORE YOU USE LUVERIS
QABEL MA TUŻA L- LUVERIS
You and your partner's fertility should be evaluated before the treatment is started.
Qabel ma tibda il- kura għandha tiġi eżaminata il- fertilità tiegħek u tas- sieħeb tiegħek
Do not take Luveris
Tieħux Luvris:
• If you are allergic (hypersensitive) to lutropin alfa or any of the other ingredients of Luveris. • If you have been diagnosed as having ovarian, uterine or breast cancer. • If you have had a brain tumour diagnosed. • If you have ovarian enlargement or cyst not due to polycystic ovarian disease. • If you have unexplained vaginal bleeding.
• Jekk inti allerġika għal din il- mediċina, għal xi mediċina simili, jew għal xi wieħed mis- sustanzi li fih il- prodott. • Jekk it- testijiet urew li inti tbati minn kanċer fl- ovarji, fl- utru jew fis- sider. • Jekk it- testijiet urew li kellek tumur fil- moħħ. • Jekk għandek l- ovarji akbar milli suppost jew għandek xi ċista mhux ikkawżata minn mard poliċistiku fl- ovarji. • Jekk ikollok demm mill- vaġina li ma tafx x' qed jikkawżah.
Take special care with Luveris
Oqgħod attent ħafna b’ Luveris
This treatment increases your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘ Possible side effects’).
Din il- kura iżidlek ir- riskju li taqbdek kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni fl - ovarji (OHSS) (ara wkoll is- sezzjoni bit- titlu 'Effetti oħra li jistgħu jinħassu).
However, if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is uncommon.
Madankollu OHSS hi rari jekk tittieħed id- doża rakkomandata u jittieħed kif suppost.
Luveris treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation
Huwa rari li kura bil- Luveris tati lok
18 (containing hCG) is administered.
18 għal OHSS sinifikanti jekk ma tkunx qed tittieħed mediċina (li fiha hCG) li twassal għal maturazzjoni finali tal- follikuli.
It is therefore prudent not to give hCG in cases where OHSS is developing and not to have sexual intercourse or use barrier methods for at least four days.
Għalhekk ikun aħjar jekk ma ttieħidtx l- hCG f’ każijiet fejn hemm l- OHSS u ma jkollokx x' taqsam mas- sieħeb tiegħek jew tuża metodi kontraċettivi ta ’ barriera għal ta ’ l- anqas erbat ijiem.
Your doctor is well aware of this condition and will inform you if necessary.
It- tabib tiegħek jaf b' din il- kundizzjoni u jinfurmak jekk ikun meħtieġ.
This is the reason why he will organise careful monitoring of ovarian response, based on ultrasound and blood sampling before and during the course of treatment.
Din hi r- raġuni għalfejn hu ser jeżamina bir- reqqa l- effett fuq l- ovarji, bl- ultrasawnd u kampjuni tad- demm qabel u matul il- kura.
The medicine should not be used when a condition exists which would make a normal pregnancy impossible, such as malformation of sexual organs or benign tumours of the womb.
Il- mediċina m’ għandiex tintuża jekk hemm kundizzjoni li tagħmel tqala normali impossibbli, bħall - malformazzjoni ta ’ organi sesswali jew tumur mhux perikoluż fil- ġuf.
Compared with natural conception, the incidence of multiple pregnancies (mainly twins) and births is increased in patients undergoing this type of treatment.
Il- pazjenti li jieħdu din il- kura għandhom aktar ċans li jkollhom tqala u twelid ta 'aktar minn tarbija waħda (l- aktar komuni tewmin) meta mqabbla ma ’ konċepiment naturali.
However, this can be minimised by using the recommended dose and schedule of administration.
Madankollu dan ir- riskju jista 'jitnaqqas jekk tittieħed d- doża rakkomandata u jittieħed kif suppost.
If you have had allergic reactions to similar medicines, please inform your doctor.
Jekk ġieli kellek reazzjoni allerġika għall- mediċina simili, jekk jogħġbok informa lit- tabib tiegħek.
Using other medicines
L- użu ta ’ mediċini oħra:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
Luveris should not be mixed with other medicinal products in the same injection, except for follitropin alfa.
Luveris m’ għandux jitħallat ma ’ prodotti oħra u jingħata fl- istess injezzjoni ħlief għall- follitropin alfa.
Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Studji wrew li dawn iż- żewġ mediċini jistgħu jitħalltu u jiġu injettati flimkien, mingħajr ma jkun hemm effetti ħżiena fuq xi wieħed mill- prodotti.
Pregnancy and breast-feeding
Tqala u treddiegħ
You should not take Luveris if you are pregnant or breast-feeding.
M’ għandekx tieħu l- Luveris jekk int tqila jew qed tredda ’.
HOW TO USE LUVERIS
KIF JINTUŻA LUVERIS
Always take Luveris exactly as your doctor has told you.
Dejjem għandek tieħu Luveris skond il- parir tat- tabib.
Your doctor will decide on the dose and schedule of administration, which are most appropriate for you during this course of treatment.
It- tabib tiegħek se jiddeċiedi d- doża li għandek tieħu u kif għandek tieħu dan il- prodott, skond kif inhu l- aktar addattat għalik matul din il- kura.
Luveris is usually taken every day for up to three weeks simultaneously with injections of FSH.
Ġeneralment Luveris jittieħed kuljum flimkien ma ’ injezzjonijiet ta 'FSH għal massimu ta' tliet ġimgħat.
The usual dose starts with 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
Doża komuni li tintuża tibda b' 75 IU (kunjett) ta ’ Luveris flimkien ma ’ 75 IU jew 150 IU ta ’ FSH.
According to your response, your doctor may increase your dose of FSH by preferably 37.5-75 IU at 7-14-day intervals.
Skond l- effett li jkollok, it- tabib jista ’ jżidlek id- doża ta ’ FSH preferibilment bi 37. 5- 75 IU f’ intervalli ta ’ 7- 14- il ġurnata.
Your physician may decide to extend your treatment up to 5 weeks.
It- tabib tiegħek jista ’ jiddeċiedi li jestendilek il- kura sa 5 ġimgħat.
When the desired response has been obtained, a single injection of hCG is given 24-48 hours after the last injections of Luveris and FSH.
Meta l- effett mixtieq jintlaħaq, injezzjoni waħda ta ’ hCG tingħata 24- 48 siegħat wara l- aħħar injezzjonijiet ta ’ Luveris u FSH.
You are recommended to have sexual intercourse on the day of, and the day following, administration of the hCG.
Hu rakkomandat li jkollok x' taqsam mas- sieħeb tiegħek dak in- nhar u l- għada li tkun ħadt l- hCG.
Alternatively, intrauterine insemination (IUI) may be performed.
Jew inkella, tista ’ ssir inseminazzjoni fl- utru (IUI).
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section headed ‘ Possible Side Effects’).
Jekk l- effett ikun aktar milli mixtieq kemm il- kura kif ukoll l- hCG għandhom jitwaqqfu (ara ‘ Effetti oħra li jistgħu jinħassu).
For the following cycle, your doctor will prescribe FSH at a lower dose than that of the previous cycle.
Għaċ- ċiklu segwenti, it- tabib tiegħek jagħtik doża ta ’ FSH aktar baxxa minn dik taċ- ċiklu preċedenti.
Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Luveris hu intenzjonat għall- użu minn taħt il- ġilda jiġifieri jittieħed permezz ta ’ injezzjoni minn taħt il - ġilda.
Each vial is for single use only.
Kull kunjett għandu jintuża darba waħda biss.
19 If you administer Luveris to yourself, please carefully read the following instructions:
Jekk tieħu Luveris waħdek, jekk jogħġbok aqra sew l- istruzzjonijiet segwenti:
It is important that your hands and the items you use be as clean as possible.
Hu importanti li idejk u l- oġġetti li tuża jkunu nodfa kemm jista ’ jkun.
• Assemble everything you need.
19 • Iġbor dak kollu li għandek bżonn.
Find a clean area and lay out everything:
Sib post nadif u ifrex kollox:
one vial of Luveris, one ampoule of solvent, two alcohol swabs, one syringe, one reconstitution needle for dissolving the powder in the solvent, a fine-bore needle for subcutaneous injection, a sharps container for safe disposal of glass and needles.
kunjett ta ’ Luveris, ampulla ta ’ solvent, żewġ ċraret imxarrba bl- alkoħol, siringa labra li ser tintuża biex tħallat u tħoll t- trab fis- solvent labra fina għall- injezzjoni taħt il- ġilda kontenitur għar- rimi b’ sigurtà tal- ħġieġ u s- siringi.
Open
Iftaħ Eżatt
On the head of the solvent ampoule, you will see a small
l- ampulla tas- solvent:
Directly below it is where the neck of the ampoule has been treated to make it
Fuq ir- ras ta’ l- ampulla tas- solvent se tara tikka żgħira kkulurita. taħtha hemm l- għonq ta 'l- ampulla li jinkiser faċilment.
Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber.
Taptap bil- mod fuq il- parti ta ’ fuq tal- ampulla biex kull likwidu li jinsab fl- għonq tal- ampulla jinżel fil- parti t’ isfel.
Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot.
Issa agħfas sew l- għonq tal- ampulla u ikser l- ampulla ‘ l bogħod mit- tikka kkulurita.
Carefully place the open ampoule upright on the work- surface.
B’ attenzjoni poġġi l– ampulla bil- wieqfa fuq il- bank fejn qed taħdem.
Attach the reconstitution needle to the syringe, with the syringe in
Waħħal il- labra li ser tuża biex tħallat mas- siringa. Bis- siringa f’ id waħda, aqbad l- ampulla miftuħa, daħħal il- labra u iġbed 'l fuq is- solvent kollu.
Carefully set the syringe down on the work-surface, taking care not to touch the needle.
B’ attenzjoni niżżel is- siringa mal - wiċċ fejn qed taħdem, u oqgħod attent li ma tolqotx il- labra.
Remove the protective cap from the Luveris powder vial, pick
• Ipprepara t- taħlita likwida għall- injezzjoni:
up your syringe and slowly inject the solvent into the vial of Luveris.
Neħħi l- għatu protettiv tal- kunjett tat- trab tal - Luveris, aqbad is- siringa u injetta bil- mod is- solvent fil - kunjett tal- Luveris.
Swirl gently without removing the syringe.
Dawwar il- kunjett bil- mod mingħajr ma tneħħi is- siringa.
Do not shake.
Tħawwadx bis- saħħa.
Turn the vial upside down and
• Meta jinħall it- trab (li normalment tiġri immedjatament), ivverifika li t- taħlita likwida hi ċara u ma fihiex frak.
20 gently draw the solution back into the syringe.
Aqleb il- kunjett rasu l- isfel u iġbed it- taħlita bil- mod lura fis- siringa.
You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Tista ’ ukoll tħallat il- Luveris mal- follitropin alfa minflok ma tinjetta ż- żewġ prodotti seperatament.
After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the container with the follitropin alfa powder.
Meta t- trab tal- Luveris jinħall, iġbed it- taħlita lura fis- siringa u erġa ’ injettaha fil - kontenitur bit- trab tal- follitropin alfa.
Once the powder has dissolved, draw the solution back into the syringe.
Meta jinħall it- trab, erġa ’ iġbed lura t- taħlita likwida fis - siringa.
Inspect for particles as before, and do not use if the solution is not clear.
Bħal qabel, erġa ’ ara hemmx xi frak, u tużax it- taħlita likwida jekk din mhix ċara.
Up to 3 containers of powder may be dissolved in 1 ml of solvent.
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ 1 ml ta ’ solvent.
If you see air bubbles
20 • Ibdel il- labra għal- labra fina għat- titqib u neħħi xi bżieżaq ta ’ l- arja:
in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Jekk tara xi bżieżaq ta ’ l - arja fis- siringa, żomm is- siringa bil- labra tipponta ‘ l fuq u bil- mod taptap fuq s- siringa sakemm l- arja kollha tinġabar fuq.
Gently push the plunger until the air bubbles are gone.
Bil- mod ibbotta il- parti ta 'isfel tas- siringa sakemm il - bżieżaq ta ’ l- arja jitilqu.
• Immediately inject the solution:
• Injetta t- taħlita likwida immedjatament:
Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
It- tabib jew l- infirmiera tiegħek ikunu diġà issuġġerewlek fejn għandek tinjetta (eż żaqq, naħa ta ’ quddiem tal- koxxa).
skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Oqros il- ġilda u daħħal il- labra f’ anglu ta ’ 45° sa 90° qisek qed twaddab dart.
Inject the solution by pushing gently on the plunger.
Injetta t- taħlita likwida billi tibbota bil- mod il- planġer.
Take as much time as you need to inject all the solution.
Dum kemm hemm bżonn sakemm tinjetta t- taħlita likwida kollha.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharps container provided.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi l- labar u l - kontenituri tal- ħġieġ vojta fil- kontenitur provdut.
Any unused solution must be discarded.
Kull fdal tat- taħlita likwida mhux użat għandu jintrema.
If you use more Luveris than you should
Jekk tieħu Luveris aktar milli suppost:
The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described in ‘Possible side effects'.
L- effetti ta ’ doża eċċessiva ta ’ Luveris mhumiex magħrufa, madankollu hemm il- possibilità li jirriżulta s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu spjegat f’ aktar dettall f ’’ Effetti oħra li jistgħu jinħassu ’.
However this will only occur if hCG is administered (see section headed ‘Take special care with Luveris’).
(ara s- sezzjoni bit- titlu ‘ Oqgħod attent ħafna bil- Luveris ’).
If you forget to take Luveris
Jekk tinsa ’ tieħu Luveris:
Please contact your doctor.
M’ għandekx tieħu doża doppja, jekk jogħġbok kellem lit- tabib tiegħek.
Like all medicines, Luveris can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Luveris jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most frequent adverse events reported have been headache, abdominal pain, breast pain, nausea, somnolence (sleepiness) and ovarian cysts.
L- effetti mhux mixtieqa l- aktar komuni li ġew irrappurtati kienu l- uġigħ ta ’ ras, uġigħ addominali, uġigħ fis- sider, nawżea, sonnolenza (nuqqas ta ’ irqad) u ċisti fl- ovarji.
Local reactions at the injection site (pain, redness, itching, swelling and bruising) have been observed in some cases.
Reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tekil, nefħa u tbenġil) kienu rrappurtati f' ċerti każijiet.
Treatment with FSH and LH followed by hCG can lead to a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘Take Special Care with Luveris’).
Kura bl- FSH u l- LH mal- hCG tista ’ twassal għall- kundizzjoni magħrufa bħala sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji.
This is when the ovaries over-react to the treatment, and large ovarian cysts develop.
(ara wkoll is- sezzjoni bit- titlu ta ’ ‘ Oqgħod attent ħafna bil- Luveris ’).
First symptoms of OHSS are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
L- ewwel sintomi ta ’ l- OHSS huma uġigħ fil- parti t' isfel tal- addome, possibilment flimkien ma nawżea, vomtu u żieda fil- piż.
If you experience serious abdominal pain together with these symptoms, do not give any more injections, and speak to your doctor as soon as possible.
Jekk tħoss uġigħ kbir addominali flimkien ma ’ dawn is- sintomi, tieħux aktar injezzjonijiet, u kellem lit- tabib tiegħek kemm jista ’ jkun malajr.
A careful examination will establish whether your ovaries have responded excessively to the treatment.
Eżaminazzjoni bir- reqqa tistabbilixxi jekk l- ovarji tiegħek irreaġġixxewx b’ mod eċċessiv għall- kura.
If so, your doctor may discontinue the FSH and LH, and abandon the treatment with hCG, to prevent the development of more severe OHSS.
21 Jekk jiġri hekk, it- tabib jista ’ jwaqqaflek l- FSH u l- LH, u iwaqqaflek il- kura bl- hCG, biex jevita l - iżvilupp ta ’ OHSS aktar gravi.
Rarely abnormal blood clots in veins have been seen to occur with similar medicines, so this could possibly occur with Luveris / FSH / hCG therapy.
F' każijiet rari, dehru ċappep ta demm magħqud fil - vini tal- pazjenti li kienu qed jieħdu medicini simili, għalhekk dan jista ’ jseħħ ukoll bil- kura tal- Luveris / FSH / hCG.
Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, there have been rare cases reported following treatment with human menopausal gonadotrophin (hMG), a urine-derived medication also containing LH.
Tidwir ta ’ l- ovarju u d- demm fl- addome ma kienux irrapurtat meta ttieħed il- Luveris iżda dawn dehru f' każijiet meta ngħatat kura bil- gonadotrofina umana tal- menopawża (hMG), mediċina derivata mill - urina li fiha LH.
Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Tqala ektopika (embriju impjantat barra il- ġuf) tista ’ tirriżulta speċjalment f’ nisa bi storja preċedenti ta ’ mard fit- tubi.
HOW TO STORE LUVERIS
KIF TAĦŻEN LUVERIS
Keep out of the reach and sight of children.
Żomm fejn ma’ jintlaħaqx u ma jidhirx mit- tfal.
Do not store above 25°C.
Taħżinx f’ temperatura ‘ l- fuq minn 25°C.
Store in the original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa mid- dawl.
Do not use Luveris after the expiry date, which is stated on the vials after EXP.
M’ ghandekx tuża wara id- data li jiskadi li tidher fuq il- kunjetti wara JISS.
Do not use Luveris if you notice any visible signs of deterioration, such as discolouration of the powder or damage to the container.
Id- Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar Tużaħx jekk tara xi sinjali viżibbli ta ’ deterjorazzjoni, bħal meta t- trab jitlef il- kulur jew hemm ħsara lil- kontenitur.
The medicine should be administered immediately after dissolving the powder.
Il- mediċina għandha tittieħed immedjatament wara li jinħall it- trab.
The solution should not be administered if it contains particles or is not clear.
It- taħlita likwida m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
What Luveris contains
X’ fih Luveris
- The active substance is lutropin alfa 75 IU (International Units).
- Is- sustanza attiva hi lutropin alfa 75 IU
- The other ingredients are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate,
- Is- sustanzi l- oħra huma polisorbat 20, sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di -
disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, methionine and nitrogen.
idrat tad- di- sodju, aċidu fosforiku konċentrat, idrossidu tas- sodju, metjonina u nitroġenu
- The solvent is water for injection.
- Is- solvent hija ilma g ħall- injezzjoni.
22 What Luveris looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Luveris is provided as a powder and solvent for solution for injection.
Luveris huwa trab u solvent għal taħlita likwida għall- injezzjoni.
It is supplied in packs containing 1, 3 or 10 vials of powder, together with the same number of solvent ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 3 jew 10 kunjetti bl- istess ammont ta ’ ampulli bis- solvent
Each vial of powder contains 75 IU of lutropin alfa and each ampoule of solvent contains 1 ml of water for injection.
Kull kunjett ta ’ trab fiha 75 IU ta ’ lutropin alfa u kull ampulla ta ’ solvent fiha 1ml ta ’ ilma għall - injezzjoni
Merck Serono S.p.A.
22 Il- Manifattur Merck Serono S. p. A.
23 Deutschland Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel: +49-6151-6285-0
Norge Deutschland Serono GmbH Alsfelder Straße 17 D- 64289 Darmstadt Tel: +49- 6151- 6285- 0
Eesti Merck Serono Esindaja C/o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
Eesti Merck Serono Esindaja
Κηφισίας 41-45, Κτίριο Β GR-151 23 Μαρούσι Αθήνα T: +30-210-61 65 100
C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
25 PACKAGE LEAFLET:
24 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Solvent in vials
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Solvent fil- kunjetti
- If you have any further questions, ask your doctor or pharmacist.
- Jekk għandek aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek.
How to use Luveris 4.
Kif għandek tuża Luveris 4.
Possible side effects 5.
X’ efetti oħra jista ’ jkollu 5.
How to store Luveris 6.
Kif taħżen Luveris 6.
WHAT LUVERIS IS AND WHAT IT IS USED FOR
X’ INHU L- LUVERIS U GĦALXIEX JINTUŻA
The medicine is used together with another hormone called FSH (follicle stimulating hormone), to bring about the development of follicles which are in the ovary, the structures maturing the eggs (ova).
Il- mediċina tintuża flimkien ma ’ ormon ieħor magħruf bħala FSH (ormon ta ’ stimulazzjoni follikola), biex iwassal għall- iżvilupp ta ’ follikuli li jinsabu fl- ovarju, l - istrutturi li jimmaturaw il- bajd (ova).
BEFORE YOU USE LUVERIS
QABEL MA TUŻA LUVERIS
You and your partner's fertility should be evaluated before the treatment is started.
Għandha ssir evalwazzjoni tal- fertilità tiegħek u ta ’ sieħbek qabel ma tibda l- kura.
• If you are allergic (hypersensitive) to lutropin alfa or any of the other ingredients of Luveris. • If you have been diagnosed as having ovarian, uterine or breast cancer. • If you have had a brain tumour diagnosed. • If you have ovarian enlargement or cyst not due to polycystic ovarian disease. • If you have unexplained vaginal bleeding.
• Jekk inti allerġika għal din il- mediċina, għal xi mediċina simili, jew għal xi wieħed mis- sustanzi li fih il- prodott • Jekk it- testijiet urew li inti tbati minn kanċer fl- ovarji, fl- utru jew fis- sider • Jekk it- testijiet urew li kellek tumur fil- moħħ? • Jekk għandek l- ovarji akbar milli suppost jew għandek xi ċista mhux ikkawżata minn mard poliċistiku fl- ovarji? • Jekk ikollok demm mill- vaġina li ma tafx x' qed jikkawżah?
Take special care with Luveris
Oqgħod attent ħafna bil- Luveris
This treatment increases your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘Possible side effects’).
Din il- kura iżidlek ir- riskju li taqbdek kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni fl - ovarji (OHSS) (ara wkoll is- sezzjoni bit- titlu 'Effetti oħra li jistgħu jinħassu).
Luveris treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation
Huwa rari li kura bil- Luveris tati lok għal OHSS sinifikanti jekk ma tkunx qed tittieħed mediċina (li fiha hCG) li twassal għal maturazzjoni
26 (containing hCG) is administered.
25 finali tal- follikuli.
The medicine should not be used when a condition exists which would make a normal pregnancy impossible, such as malformation of sexual organs or benign tumours of the womb.
Il- mediċina m’ għandiex tintuża fejn teżisti kundizzjoni li tagħmel tqala normali impossibbli, bħall - malformazzjoni ta ’ organi sesswali jew tumur mhux perikoluż fil- ġuf.
Compared with natural conception, the incidence of multiple pregnancies (mainly twins) and births is increased in patients undergoing this type of treatment.
Meta mqabbel mal- konċepiment naturali, l- okkorenza ta ’ tqala u twelid multiplu (l- aktar tewmin) hi akbar fost pazjenti li jieħdu din il- kura.
However, this can be minimised by using the recommended dose and schedule of administration.
Madankollu, dan jista ’ jitnaqqas bl- użu dad- doża u skeda ta ’ teħid rakkomandati.
You should not take Luveris if you are pregnant or breast-feeding.
Tqala u Treddigħ M’ għandekx tieħu l- Luveris jekk int tqila jew qed tredda ’.
Luveris is usually taken every day for up to three weeks simultaneously with injections of FSH.
Il- Luveris ġeneralment jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet tal- FSH.
The usual dose starts with 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
Doża li tintuża komunement tibda minn 75 IU (1 kunjett) ta ’ Luveris flimkien ma ’ 75 IU jew 150 IU ta ’ FSH.
According to your response, your doctor may increase your dose of FSH by preferably 37.5-75 IU at 7-14-day intervals.
Skond ir- risposta tiegħek, it- tabib jista ’ jżid id- doża tiegħek ta ’ FSH preferibilment bi 37. 5- 75 IU f’ intervalli ta ’ 7- 14- il ġurnata.
Your physician may decide to extend your treatment up to 5 weeks.
It- tabib tiegħek jista ’ jiddeċiedi li jestendi l- kura tiegħek sa 5 ġimgħat.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section headed ‘Possible Side Effects’).
Jekk tinkiseb risposta eċċessiva, il- kura għandha tieqaf u l- hCG miżmum (ara ‘ Effetti oħra li jistgħu jinħassu ’).
For the following cycle, your doctor will prescribe FSH at a lower dose than that of the previous cycle.
Għaċ- ċiklu segwenti, it- tabib tiegħek jagħtik doża aktar baxxa ta ’ FSH minn dik taċ- ċiklu preċedenti.
Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Luveris hu intiż għall- użu minn taħt il- ġilda li jfisser li dan jittieħed permezz ta ’ injezzjoni taħt il- ġilda.
27 If you administer Luveris to yourself, please carefully read the following instructions:
Jekk tieħu Luveris waħdek, jekk jogħġbok aqra sew dawn l- istruzzjonijiet segwenti:
• Assemble everything you need.
26 • Iġbor dak kollu li għandek bżonn.
Find a clean area and lay out everything:
kunjett ta ’ Luveris, kunjett ta ’ solvent,
- - - - - - -
- - -
one vial of Luveris, one vial of solvent, two alcohol swabs, one syringe, one reconstitution needle for dissolving the powder in the solvent, a fine-bore needle for subcutaneous injection, a sharps container for safe disposal of glass and needles.
labra fina għall- injezzjoni taħt il- ġilda kontenitur għar- rimi b’ sigurtà tal- ħġieġ u s- siringi.
• Remove the protective cap from the solvent vial.
• Neħħi l- għatu protettiv mill- kunjett tas- solvent.
Attach the reconstitution needle to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Waħħal il- labra li ser tintuża biex tħallat mas - siringa u iġbed ftit arja fis- siringa billi tiġbed il- planġer sa madwar il- marka ta ’ 1ml.
Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Imbagħad, daħħal il- labra fil - kunjett, imbotta il- planġer biex tneħħi l- arja, aqleb il- kunjett rasu ‘ l isfel u bil- mod iġbed is- solvent kollu.
Set the syringe down carefully on the work-surface taking care not to touch the needle.
B’ attenzjoni niżżel is- siringa mal- wiċċ fejn qed taħdem, u oqgħod attent li ma tolqotx il- labra.
• Prepare the injection solution:
• Ipprepara t- taħlita likwida għall- injezzjoni:
Remove the protective cap from the Luveris powder vial, pick up your syringe and slowly inject the solvent into the vial of Luveris.
Neħħi l- għatu protettiv mill- kunjett tat- trab tal - Luveris, aqbad is- siringa tiegħek u bil- mod injetta s- solvent fil- kunjett tal- Luveris.
Swirl gently without removing the syringe.
Dawwar bl- mod mingħajr ma tneħħi is- siringa.