qanastek/EMEA-V3 huggingface dataset:
A strict dose/ response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
5 Relazzjoni preċiża bejn id- doża u r- reazzjoni ma tistax tkun definita, għalkemm instab li dożi aktar qawwija jipproduċi effett ta ’ kuntrast li jdum aktar.
The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 50 µl/ kg dose of the product.
It- tagħrif farmakokinetiku ta ’ Luminity ġie evalwat f’ suġġetti normali b’ saħħithom u f’ suġġetti b’ mard kroniku ta ’ imblokk tal- pulmun (COPD – chronic obstructive pulmonary disease) wara li ngħatat doża ta ’ 50 µl/ kg tal- prodott ġol- vina.
The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs.
Il- komponent ta ’ perflutren ta ’ Luminity tneħħa malajr miċ- ċirkolazzjoni sistemika permezz tal - pulmuni.
The percentage of the perflutren dose excreted in expired air was approximately 50% of the administered dose due to the small quantities of perflutren given and the inability to quantify low levels of perflutren by gas chromatography.
Il- perċentwal tad- doża ta ’ perflutren imneħħija fl- arja mixħuta ’ l barra kien madwar 50% tad- doża mogħtija minħabba l- kwantitajiet żgħar ta ’ perflutren mogħtija u l- inkapaċità li jiġu kkwantifikati l- livelli baxxi ta ’ perflutren permezz ta ’ kromotografija tal- gass.
In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air.
Fil- biċċa l- kbira tas - suġġetti wara 4- 5 minuti, perflutren ma setax jiġi rilevat fid- demm u fl- arja mormija ’ l barra.
Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in COPD subjects.
Intwera li l- konċentrazzjonijiet ta ’ perflutren fid- demm jonqsu b’ mod mono- esponenzjali b’ half- life medja ta ’ 1. 3 minuti f’ suġġetti b’ saħħithom u ta ’ 1. 9 minuti f’ suġġetti b’ COPD.
The systemic clearance of perflutren was similar in healthy and COPD subjects.
It- tneħħija sistemika ta ’ perflutren kienet simili f’ suġġetti b’ saħħithom u f’ suġġetti b’ COPD.
Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
Instab li t- tneħħija totali ta ’ perflutren mill- pulmun (CLpulmun) ma kinetx differenti f’ suġġetti b’ saħħithom meta mqabbel ma ’ suġġetti b’ COPD.
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Instab li CLpulmun kienet notevolment inqas (51%) fin- nisa meta mqabbel ma ’ l- irġiel (is- suġġetti kollha).
These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Dawn ir- riżultati jissuġġerixxu li globalment, it- tneħħija sistemika ta ’ perflutren hija veloċi u mhijiex konsiderevolment inqas f’ pazjenti b’ COPD meta mqabbel ma ’ suġġetti b’ saħħithom.
Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of
Twettaq kejl b’ ultrasound Doppler b’ Luminity flimkien mal- valutazzjoni farmakokinetika ta ’ perflutren.
Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
L- intensità tas- sinjal Doppler ikkorrispondiet sewwa mal - konċentrazzjonijiet imkejla u estrapolati ta ’ perflutren fid- demm.
The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Il- ħin sa l- intensità massima tas - sinjal Doppler tmas instab li kien simili għat - tmas tad- demm għal perflutren (1. 13 kontra 1. 77 minuti).
The observed 99% drop in Doppler signal intensity within 10 minutes (t1/ 2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
It - tnaqqis osservat ta ’ 99% fl- intensità tas- sinjal Doppler f’ għaxar minuti (t1/ 2 madwar 2 minuti) kien jaqbel mat- tnaqqis fil- livelli mkejla ta ’ perflutren fid- demm.
Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/ or amplitude modulation) using both continuous and triggered acquisition were utilised in clinical studies with Luminity.
Intużaw tekniki ta ’ immaġni fundamentali u mhux lineari (second harmonic, multipulse phase u/ jew amplitude modulation) bl- użu ta ’ ksib kontinwu jew imqabbad fi studji kliniċi b’ Luminity.
The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been shown to be excreted in the urine in preclinical studies.
Il- fosfolipidi li jseħħu b’ mod naturali f’ Luminity (ara sezzjoni 6. 1) huma mqassma fil- postijiet endoġeniċi tal- lipidi fil- ġisem (pereżempju, il- fwied) filwaqt li l- komponent sintetiku (MPEG5000) ġie muri li jitneħħa fl- awrina fi studji ta ’ qabel l- użu kliniku.
All lipids are metabolised to free fatty acids.
Il- lipidi kollha jiġu metabolizzati f’ aċidi grassi liberi.
The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans.
Il- farmakokinetika u l- metaboliżmu ta ’ MPEG5000 DPPE ma ġewx evalwati fil - bnedmin.
Pharmacokinetics in special population groups
Farmakokinetiċi fi gruppi ta ’ popolazzjonijiet speċjali
Pharmacokinetics has not been specifically studied in the elderly.
Il- farmakokinetiċi ma ġewx studjati speċifikament fl- anzjani.
Renal Disease:
Mard Renali:
Pharmacokinetics has not been specifically studied in the renal disease patients.
Il- farmakokinetiċi ma ġewx studjati speċifikament f’ pazjenti b’ mard tal- kliewi.
Hepatic Disease:
Mard tal- Fwied:
Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Il- farmakokinetiċi ma ġewx studjati speċifikament f’ pazjenti b’ mard tal- fwied.
Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, fertility, embryo/ foetal development, parturition or post-natal development, and local tolerance.
Informazzjoni ta ’ qabel l- użu kliniku, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku fuq il- ġeni, il- fertilità, l- iżvilupp embrijoniku/ tal- fetu, it- twelid jew l- iżvilupp ta ’ wara t - twelid, u t- tolleranza lokali ma turi l- ebda periklu speċjali għall- bnedmin.
Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous injection of Luminity at doses ≥ 0.3 ml/ kg in single and repeat-dose toxicity studies in rats and monkeys.
Ftit wara l- injezzjoni ġol- vina ta ’ Luminity f’ dożi ta ’ ≥ 0. 3 ml/ kg fi studji dwar it- tossiċità b’ doża waħda jew dożi ripetuti fuq il- firien u x- xadini, ġew osservati respirazzjoni anormali, bidliet fit- taħbit tal- qalb u attività mnaqqsa.
Higher doses of the product, typically ≥ 1 ml/ kg, resulted in more severe signs including unresponsiveness and occasionally death.
Dożi akbar tal- prodott, ġeneralment ≥ 1 ml/ kg, irriżultaw f’ sinjali aktar severi, fosthom nuqqas ta ’ reazzjoni u kultant mewt.
These levels are substantially above the recommended maximal clinical dose.
Dawn il- livelli huma konsiderevolment ogħla mid- doża klinika massima rakkomandata.
PHARMACEUTICAL PARTICULARS
Il- firien ikkurati b’ Luminity għal xahar urew infiltrazzjoni
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride Propylene glycol Glycerol Water for injections
6 eosinofilika perivaskulari u peribronkjali riversibbli, relatata mad- doża, akkumulazzjoni ta ’ makrofagi alveolari u daqs u numru akbar ta ’ ċelloli goblet fil- pulmun.
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products except those mentioned in section 6.6.
Dawn l- effetti ġew osservati f’ livelli ta ’ espożizzjoni ogħla mill- espożizzjoni massima umana, u dan jindika ftit li xejn rilevanza għall- użu kliniku.
6 6.3 Shelf life
TAGĦRIF FARMAĊEWTIKU
Before activation:
6. 1 Lista ta ’ sustanzi mhux attivi
After activation:
Wara l- attivazzjoni:
12 hours.
12- il siegħa.
The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Il- prodott jista ’ jerġa ’ jiġi attivat sa 48 siegħa wara l- attivazzjoni inizjali u jintuża sa 12- il siegħa wara t- tieni attivazzjoni.
Before activation:
Qabel l- attivazzjoni:
Store in a refrigerator (2°C - 8°C) After activation:
Wara l- attivazzjoni:
Clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
Kunjett ċar tal- ħġieġ tal- borosilikat tat- tip I, magħluq b’ tapp tal- chlorobutyl elastomeric lyophilisation, u ssiġillat b’ siġill irbattut ta ’ l- aluminju li jkollu buttuna tal- plastik tat- tip flip- off.
The product is supplied as 1 x 1.5 ml or 4 x 1.5 ml single-dose vials.
Il- prodott huwa fornut bħala kunjett wieħed ta ’ doża waħda ta ’ 1. 5 ml jew bħala 4 kunjetti ta ’ doża waħda ta ’ 1. 5 ml.
It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Huwa importanti li jiġu segwiti l- istruzzjonijiet għall- użu u l- immaniġġjar ta ’ Luminity u li jiġu osservati proċeduri stretti asettiċi waqt il- preparazzjoni.
Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Bħal kull prodott ieħor li ma jitteħidx mill - kanal ta ’ l- ikel, il- kunjetti jridu jiġu spezzjonati viżwalment għall- partiċelli separati u għall- integrità tal- kunjett.
Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device.
Qabel ma l- prodott jingħata, dan irid jiġi attivat billi jintuża l- Vialmix, apparat mekkaniku li jħawwad.
The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Il- Vialmix mhuwiex inkluż fil- pakkett ta ’ Luminity iżda se jkun ipprovdut lill - professjonisti tal- kura tas- saħħa malli jordnaw il- pakkett.
Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds.
7 Luminity huwa attivat billi jintuża l- Vialmix li għandu ħin ipprogrammat ta ’ taħwid ta ’ 45 sekonda.
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Il - Vialmix jinforma lill- operatur jekk il- frekwenza tat- taħwid tvarja b’ 5% jew aktar taħt il- frekwenza fil - mira.
It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Huwa ġie pprogrammat ukoll biex jintefa u għandu jagħti twissijiet viżwali u bil- ħoss jekk il - frekwenza tat- taħwid taqbeż il- frekwenza fil- mira b’ 5%, jew jekk din tinżel taħt il- frekwenza fil- mira b’ 10%.
Activation process and administration
Proċess ta ’ l- attivazzjoni u kif jingħata
- The vial should be activated using the Vialmix.
- Il- kunjett għandu jiġi attivat bl- użu tal- Vialmix.
Immediately after activation, Luminity appears as a
Immedjatament wara l- attivazzjoni, Luminity
milky white dispersion.
jidher bħala taħlita bajda lewn il- ħalib.
Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial.
Nota: jekk il- prodott jitħalla joqgħod għal aktar minn 5 minuti wara l- attivazzjoni, huwa għandu jiġi sospiż mill- ġdid b’ 10 sekondi ta ’ aġitazzjoni bl- idejn qabel ma jinġibed bis- siringa mill- kunjett.
Luminity should be used within 12 hours following activation.
Luminity għandu jintuża fi żmien 12- il siegħa wara l- attivazzjoni.
The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature.
Il- prodott jista ’ jerġa ’ jiġi attivat sa 48 siegħa wara l- attivazzjoni inizjali u jintuża sa 12- il siegħa wara t- tieni attivazzjoni, kemm jekk maħżun fi friġġ kif ukoll jekk fit- temperatura tal- kamra.
Do not store the vial above 30°C following activation.
Taħżinx il- kunjett f’ temperatura ogħla minn 30°C wara l- attivazzjoni.
- The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before
- Il- kunjett għandu jittaqqab b’ labra ta ’ siringa sterilizzata jew b’ mini- spike sterilizzat mhux
withdrawing the dispersion.
silikonizzat qabel ma tinġibed it- taħlita.
- The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile
- It- taħlita għandha tinġibed mill- kunjett billi tintuża siringa b’ labra sterilizzata b’ gauge ta ’ 18 sa
needle or attached to a sterile non-siliconised mini-spike.
20 jew imqabbda ma ’ mini- spike sterilizzat mhux silikonizzat.
When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial.
Meta tintuża labra, din għandha tiġi ppożizzjonata biex tiġbed il- materjal minn nofs il- likwidu fil- kunjett rasu l- isfel.
No air should be injected into the vial.
M’ għandha tiġi injettata l- ebda arja ġol- kunjett.
The product should be used immediately after its withdrawal from the vial.
Il- prodott għandu jintuża minnufih wara li jinġibed mill - kunjett.
- Luminity may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose
- Luminity jista ’ jiġi dilwit b’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride għal injezzjoni
50 mg/ ml (5%) solution for injection.
jew soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni.
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / Brussel Belgium
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Il- Belġju
20 September 2006
20 ta ’ Settembru 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
2.800 I-04010 Sermoneta (Latina) Italy
2. 800 I- 04010 Sermoneta (Latina) L- Italja
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren
Luminity 150 mikrolitri/ ml soluzzjoni għal taħlita għal injezzjoni jew infużjoni Perflutren
Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μ m (approximately 150 μ l perflutren gas per ml).
Kull ml fih massimu ta ’ 6. 4 x 109 mikrosferi lipidi li fihom perflutren li d- dijametru medju tagħhom huwa 1. 1- 2. 5 μm (bejn wieħed u ieħor 150 μl ta ’ gass ta ’ perflutren għal kull ml).
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylcholine (DPPC), 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidic acid, monosodium salt (DPPA), N - (methoxypolyethylene glycol 5000 carbamoyl) - 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, ilma għall- injezzjonijiet
1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
1 x kunjett ta ’ doża waħda ta ’ 1. 5 ml 4 x kunjetti ta ’ doża waħda ta ’ 1. 5 ml
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EXP After activation: use within 12 hours
JIS Wara l- attivazzjoni: uża fi żmien 12- il siegħa
Store in a refrigerator After activation:
Aħżen fi friġġ Wara l- attivazzjoni:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDICINALI, JEKK HEMM BŻONN
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / BrusselBelgium
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Il- Belġju
EU/ 1/ 06/ 361/ 001 4 single-dose vials EU/ 1/ 06/ 361/ 002 1 single-dose vial
EU/ 1/ 06/ 361/ 001 4 kunjetti ta ’ doża waħda EU/ 1/ 06/ 361/ XXX kunjett wieħed ta ’ doża waħda
As Luminity is only intended for administration by healthcare professionals no information will be included in Braille.
Minħabba li Luminity huwa maħsub biss sabiex jingħata minn professjonisti fil- qasam tal- kura tas - saħħa, ebda informazzjoni m’ hija se tiġi inkluża bil- Braille.
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren Intravenous use
Luminity 150 mikrolitri/ ml soluzzjoni għal taħlita għal injezzjoni jew infużjoni Perflutren Użu għal ġol- vini
16 PACKAGE LEAFLET:
16 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you are given this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
What Luminity is and what it is used for 2.
X’ inhu Luminity u għalxiex jintuża 2.
Before you are given Luminity 3.
Qabel ma tieħu Luminity 3.
How Luminity is given 4.
Kif għandek tieħu Luminity 4.
How to store Luminity 6.
Kif taħżen Luminity 6.
WHAT LUMINITY IS AND WHAT IT IS USED FOR
X’ INHU LUMINITY U GĦALXIEX JINTUŻA
Luminity is an ultrasound contrast agent that contains tiny gas bubbles.
Luminity huwa sustanza ta ’ kuntrast użat f’ ultrasound li fiha bżieżaq żgħar tal- gass.
It enhances the images seen with ultrasound and helps your doctor to get a clearer picture (scan) of your heart.
Itejjeb l- immaġnijiet li jidhru permezz ta ’ ultrasound and jgħin lit- tabib tiegħek jikseb stampa (scan) aktar ċara ta ’ qalbek.
This medicine is for diagnostic use only.
Din il- mediċina hija biss għal użu dijanjostiku.
BEFORE YOU ARE GIVEN LUMINITY
QABEL MA TIEĦU LUMINITY
Do not use Luminity
Tużax Luminity
- if you are allergic (hypersensitive) to perflutren or any of the other ingredients of Luminity.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal perflutren jew sustanzi oħra ta ’ Luminity.
Luminity should not be used in children and adolescents as it has not been studied in these groups.
Luminity ma għandux jintuża fi tfal u adoloxxenti minħabba li għadu ma ġiex studjat f’ dawn il- gruppi.
If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
Jekk fil- passat esperjenzajt reazzjoni allerġika b’ Luminity jew b’ xi sustanza oħra ta ’ kuntrast ta ’ l - ultrasound, għid lit- tabib tiegħek.
Take special care with Luminity
Oqgħod attent ħafna b’ Luminity
- if you have been told you have a heart shunt
- jekk qalulek li għandek mogħdija alternattiva għaċ- ċirkolazzjoni tad- demm (heart shunt)
- if you have severe heart or lung diseases
- jekk għandek mard serju tal- qalb jew tal- pulmun
- if you have an artificial valve in your heart
- ekk għandek valv artifiċjali f’ qalbek
- if you have acute severe inflammation/ sepsis
- jekk għandek infjammazzjoni/ sepsis severa akuta
- if you have known hyperactive coagulation system/ or recurrent thromboembolism
- jekk taf li għandek sistema ta ’ koagulazzjoni attiva żżejjed/ jew tromboemboliżmu rikorrenti
- if you have liver disease
- jekk għandek mard tal- fwied
- if you have kidney disease
- jekk għandek mard tal- kliewi
17 Pregnancy and breast-feeding Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
17 Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila jew jekk qegħda tredda ’ u itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu Luminity.
Driving and using machines The ability to drive and use machines is not affected.
Sewqan u tħaddim ta ’ magni Il- ħila biex issuq u tħaddem magni mhijiex affettwata.
Important information about some of the ingredients of Luminity This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Luminity Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodium (23 mg) għal kull doża, jiġifieri, essenzjalment huwa ‘ bla sodju ’.
HOW LUMINITY IS GIVEN
KIF GĦANDEK TIEĦU LUMINITY
Luminity is given to you before or during your ultrasound examination by healthcare professionals such as doctors who are experienced in this type of examination.
Luminity jingħatalek qabel jew matul l- eżaminazzjoni tiegħek b’ ultrasound minn professjonisti tal - kura tas- saħħa bħal tobba li għandhom esperjenza f’ din it- tip ta ’ eżaminazzjoni.
They will calculate the right dose for you.
Huma jikkalkolaw id - doża li jkollok bżonn.
Luminity is for intravenous use and the prepared dispersion is either diluted with sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection and given by infusion over a period of time (drip solution), or given undiluted as an intravenous injection (direct injection into the vein).
Luminity jingħata ġol- vina u t- taħlita mħejjija tiġi dilwita jew b’ soluzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew b’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glukosju sabiex tiġi injettata u mogħtija permezz ta ’ infużjoni fuq perjodu ta ’ żmien (soluzzjoni bi drip), jew mogħtija mhux dilwita bħala injezzjoni ġol- vina (injezzjoni direttament ġol- vina).
For heart ultrasound examination, the recommended dose is multiple intravenous injections of 0.1 to 0.4 ml of Luminity, followed by an intravenous injection of 3 to 5 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Għal eżaminazzjoni tal- qalb b’ ultrasound, id- doża rakkomandata hija injezzjonijiet multipli ġol- vina ta ’ 0. 1 sa 0. 4 ml ta ’ Luminity, segwiti b’ injezzjoni ġol- vina ta ’ 3 sa 5 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni.
The maximum total dose is 1.6 ml.
Id- doża massima totali hija 1. 6 ml.
The product can also be given at a dose of 10 microlitre/ kg by intravenous injection followed by an intravenous injection of 10 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection, depending on which ultrasound technique your doctor has chosen to use.
Il- prodott jista ’ jingħata wkoll b’ doża ta ’ 10 mikrolitri/ kg b’ injezzjoni ġol- vina segwita b’ injezzjoni ġol- vina ta ’ 10 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni, jiddependi fuq liema teknika ta ’ ultrasound ikun għażel it- tabib tiegħek.
In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
F’ xi każijiet, it- tabib tiegħek jista ’ jagħżel li juża żewġ injezzjonijiet sabiex iwettaq l - eżaminazzjoni b’ ultrasound.
Your doctor may also choose to give Luminity via an intravenous infusion of 1.3 ml added to 50 ml of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
It- tabib tiegħek jista ’ jagħżel li jagħti Luminity permezz ta ’ infużjoni ġol - vina ta ’ 1. 3 ml miżjuda ma ’ 50 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride jew 50 mg/ ml (5%) ta ’ glukosju għall- injezzjoni.
Your doctor will decide on the speed at which the infusion should be given.
It- tabib tiegħek jiddeċiedi fuq il- veloċità li biha għandha tingħata l - infużjoni.
If you are given more Luminity than you should It is not known what the effect of an overdose is.
Jekk tieħu Luminity aktar milli suppost L- effett ta ’ doża eċċessiva għadu mhuwiex magħruf.
Like all medicines, Luminity can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Luminity jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (greater than 1 patient out of 100, less than 1 patient out of 10) Headache, flushing.
Effetti sekondarji komuni (aktar minn pazjent wieħed minn kull 100, inqas minn pazjent wieħed minn kull 10) Uġigħ ta ’ ras, fwawar.
Uncommon side effects (greater than 1 patient out of 1,000, less than 1 patient out of 100) Dizziness, altered taste, reduced blood pressure, difficulty in breathing, throat irritation, abdominal pain, diarrhoea, nausea (feeling sick), vomiting, itching, increased sweating, back pain, chest pain, fatigue, feeling hot and pain at the site of injection.
Effetti sekondarji mhux komuni (aktar minn pazjent wieħed minn kull 1, 000, inqas minn pazjent wieħed minn kull 100) Sturdament, togħma mibdula, pressjoni tad- demm baxxa, diffikultà fit- teħid tan- nifs, irritazzjoni tal - gerżuma, uġigħ addominali, dijarea, nawsja (tħossok marid/ a), rimettar, ħakk, żjieda fl- ammont ta ’ għaraq, uġigħ fid- dahar, uġigħ fis- sider, għeja, sensazzjoni ta ’ sħana u wġigħ fil- post fejn tingħata l - injezzjoni.
Rare side effects (greater than 1 patient out of 10,000, less than 1 patient out of 1,000) Numbness, tingling and or burning sensation, altered heart rate, palpitations (you feel your heart beats harder or in an irregular way), feeling faint, increased blood pressure, peripheral coldness, breathing problems, cough, dry throat, difficulty in swallowing, rash, redness of the skin, joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness and abnormal electrocardiogram.
18 Effetti sekondarji rari (aktar minn pazjent wieħed minn kull 10, 000, inqas minn pazjent wieħed minn kull 1, 000) Ħedla, tingiż jew sensazzjoni ta ’ ħruq, rata ta ’ taħbit tal- qalb mibdula, palpitazzjonijiet (tħoss it - tħabbit ta ’ qalbek iktar b’ saħħithom jew b’ mod irregolari), ħass ħażin, żjieda fil- pressjoni tad- demm, kesħa fl- estremitajiet tal- ġisem, problemi bit- teħid tan- nifs, sogħla, gerżuma xotta, diffikultà biex tibla ’, raxx, ħmurija tal- ġilda, uġigħ fil- ġogi, uġigħ fil- ġenb, uġigħ fl- għonq, bugħawwieġ, deni, għebusija tal- muskoli u elettrokardjogramma anormali.
These side effects usually go away quickly without any treatment.
Dawn l- effetti sekondarji jmorru malajr mingħajr trattament ieħor.
18 Some patients may experience allergic type reactions such as swelling of the face.
Xi pazjenti jistgħu jesperjenzaw reazzjonijiet ta ’ tip allerġiku bħal nefħa fil- wiċċ.
There is however a risk that these allergic type reactions become severe and may include anaphylactic shock.
Madankollu, hemm ir- riskju li dawn ir- reazzjonijiet ta ’ tip allerġiku jsiru severi u jistgħu jinkludu xokk anafilattiku.
In addition, some patients may experience convulsions, which may be associated with these allergic reactions.
Barra minn hekk, xi pazjenti jistgħu jesperjenzaw konvulżjonijiet, li jistgħu jkunu assoċjati ma ’ dawn ir - reazzjonijiet allerġiċi.
HOW TO STORE LUMINITY
KIF TAĦŻEN LUMINITY
Do not use Luminity after the expiry date which is stated on the carton and label.
Tużax Luminity wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq it- tikketta.
Before activation, store in a refrigerator (2°C - 8°C).
Qabel attivazzjoni, aħżen fi friġġ (2°C - 8°C).
After activation, do not store above 30°C.
Wara attivazzjoni, taħżinx f’ temperatura ’ l fuq minn 30°C.
The dispersion should be given to you within 12 hours of activation.
It- taħlita għandha tingħatalek fi żmien 12- il siegħa mill- attivazzjoni.
What Luminity contains
X’ fih Luminity
The active substance is perflutren.
Is- sustanza attiva hi perflutren.
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Kull ml fih massimu ta ’ 6. 4 x 109 bżieżaq lipidi li fihom perflutren, b’ dijametru li jvarja bejn 1. 1 u 2. 5 mikrometri.
The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
L- ammont approssimattiv ta ’ gass ta ’ perflutren f’ kull ml ta ’ Luminity huwa 150 mikrolitri.
The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl- sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
L- ingredjenti l- oħra huma 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylcholine (DPPC), 1, 2- dipalmitoyl - sn- glycero- 3- phosphatidic acid, monosodium salt (DPPA), N - (methoxypolyethylene glycol 5000 carbamoyl) - 1, 2- dipalmitoyl- sn- glycero- 3- phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol u ilma għall- injezzjonijiet.
What Luminity looks like and contents of the pack
Id- Dehra ta ’ Luminity u l- kontenuti tal- pakkett
Luminity is a solution for dispersion for injection or infusion and is available in a pack containing one or four single-use 1.5 ml vials.
Luminity huwa soluzzjoni għal taħlita għal injezzjoni jew infużjoni u huwa disponibbli f’ pakkett li jkun fih jew kunjett wieħed ta ’ 1. 5 ml li jintuża darba, jew erba ’ kunjetti ta ’ 1. 5 ml kull wieħed li jintużaw darba.
Before activating the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid.
19 Qabel tattiva l- kontenut tal- kunjett, Luminity jidher bħala likwidu bla kulur, ċar għal trasluċidu b’ mod uniformi.
After activation, the product appears as a milky white liquid.
Wara attivazzjoni, il- prodott jidher bħala likwidu bajdani lewn il- ħalib.
Marketing Authorisation Holder Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / Brussel Belgium
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Il- Belġju
Via del Murillo Km 2,800
Via del Murillo Km 2, 800 04010 Sermoneta (LT) L- Italja
France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
20 France BRISTOL- MYERS SQUIBB SARL Tél: + 33 (0) 810 410 500
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL.
BRISTOL- MYERS SQUIBB PHARMACEUTICALS LTD
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
--------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Huwa importanti li jiġu segwiti l- istruzzjonijiet għall- użu u l- immaniġġjar ta ’ Luminity u li jiġu osservati proċeduri asettiċi stretti waqt il- preparazzjoni.
Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Bħal kull prodott ieħor li ma jitteħidx mill - kanal ta ’ l- ikel, il- kunjetti jridu jiġu spezzjonati viżwalment għall- partikuli separati u għall- integrità tal- kunjett.
The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Il- Vialmix mhux inkluż fil- pakkett ta ’ Luminity iżda se jkun ipprovdut lill- professjonisti tal- kura tas- saħħa malli jordnaw il- pakkett.
Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds.
Luminity huwa attivat billi jintuża l- Vialmix li għandu ħin ipprogrammat ta ’ taħwid ta ’ 45 sekonda.
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Il - Vialmix għandu jinforma lill- operatur jekk il- frekwenza tat- taħwid tvarja b’ 5% jew aktar taħt il - frekwenza fil- mira.
It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Huwa ġie pprogrammat ukoll biex jintefa u għandu jagħti twissijiet viżwali u bil - ħoss jekk il- frekwenza tat- taħwid taqbeż il- frekwenza fil- mira b’ 5%, jew tinżel taħt il- frekwenza fil - mira b’ 10%.
Activation process and administration
21 Proċess ta ’ l- attivazzjoni u kif jingħata
- The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile
- Id- dispersjoni għandha tinġibed mill- kunjett billi tintuża labra sterilizzata b’ kejl ta ’ 18 sa 20 jew
needle or attached to a sterile non-siliconised mini-spike.
imqabbda ma ’ mini- spike sterilizzat mhux silikonizzat.
The product should be used immediately after its withdrawal from the vial.
Il- prodott għandu jintuża immedjatament wara li jinġibed mill - kunjett.
50 mg/ ml (5%) solution for injection.
jew b’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glukosju għal injezzjoni.
The contents of the vial are intended for single use only.
Il- kontenut tal- kunjett huwa maħsub għal użu wieħed biss.
Luveris 75 IU, powder and solvent for solution for injection.
Luveris 75 IU, trab u solvent għal taħlita likwida għall- injezzjoni.
One vial contains 75 IU of lutropin alfa (recombinant human luteinising hormone {LH}).
Kunjett wieħed fih75 IU ta ’ lutropin alfa (ormon uman lutejniku rikombinanti{ LH}).
Lutropin alfa is produced in genetically engineered Chinese hamster ovary (CHO) cells.
Lutropin alfa jsir fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
47.75 mg sucrose, 0.1 mg L-methionine, 0.05 mg polysorbate 20
47. 75 mg sukrożju, 0. 1 mg L- metjonina, 0. 05 mg Polisorbat 20
Powder and solvent for solution for injection.
Trab u solvent li fih jinħall il- likwidu għall- injezzjoni.
Appearance of the powder: white lyophilised pellet Appearance of the solvent: clear colourless solution
Dehra tat- trab: pritkuna bajda lajofilizzat Dehra tas- solvent: taħlita likwida mingħajr kulur
The pH of the reconstituted solution is 7.5 - 8.5.
Il- pH tas- soluzzjoni rrikostitut huwa 7. 5 - 8. 5.
Luveris in association with a follicle stimulating hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Luveris jista 'jingħata ma ’ ormon li jistimula l- follikulu (FSH) biex iqanqal l- iżvilupp tal- follikuli fin - nisa li għandhom nuqqas qawwi ta ’ LH u FSH.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
Fi studji kliniċi dawn kienu dawk il- pazjenti li kellhom < 1. 2 IU/ l ta 'LH fis- serum endoġenu.
Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Kura bil- Luveris għall- ewwel għandha tkun taħt l- osservazzjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi marbuta mal- fertilità.
Self-administration of Luveris should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Luveris jista 'jittieħed mill- pazjenti innifishom biss meta jkunu motivati sew, imħarrġa b’ mod xieraq u jistgħu jirreferu għal pariri professjonali.
In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Luveris u FSH jingħataw flimkien, lin- nisa li għandhom nuqqas ta 'LH u FSH, biex jiżviluppa follikulu Grafjan matur minn fejn jinħeles l- ooċit wara li jingħataw il- gonadotrofina korjonika umana (hCG).
Luveris should be given as a course of daily injections simultaneously with FSH.
Luveris għandu jingħata bħala kors ta ’ injezzjonijiet ta ’ kuljum flimkien mal- FSH.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Billi dawn il- pazjenti jkunu amenorrejiċi u jkollhom livelli baxxi ta 'estroġenu endoġeniku l- kura tista' tibda ikun meta jkun.
All clinical experience to date with Luveris in this indication has been gained with concomitant administration of follitropin alfa.
It- tagħrif kliniku li hemm s’ issa fuq l- effetti ta 'Luveris f' dan il- qasam dejjem inkiseb meta ngħata ma' follitropin alfa.
Luveris is intended for subcutaneous administration.
Luveris għandu jittieħed minn taħt il- ġilda.
The powder should be reconstituted, immediately prior to use, with the solvent provided.
It- trab irid jitħallat mas- solvent provdut eżatt qabel ma 'jittieħed.
Treatment should be tailored to the individual patient’ s response as assessed by measuring (i) follicle size by ultrasound and (ii) oestrogen response.
Dan jista 'jitqies billi jitkejjel (i) id- daqs tal- follikulu permezz ta ’ l - ultrasawnd u (ii) l- ammont ta ’ estroġenu.
A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
Hu rakkomandat li l- kura tibda b 'doża ta' 75 IU ta ’ lutropin alfa (ie. kunjett wieħed ta ’ Luveris) kuljum flimkien ma ’ 75- 150 IU FSH.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Jekk ikun hemm bżonn li tiżdied id- doża tal- FSH, ikun aħjar jekk tibdil fid- doża jsir wara intervalli ta ’ 7- 14- il ġurnata u b’ żidiet ta’ 37. 5 IU- 75 IU.
It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Jista ’ jkun aċċettabbli li jkun estiż it- tul ta ’ żmien ta ’ l - istimulazzjoni fi kwalunkwe ċiklu sa 5 ġimgħat.
2 When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections.
2 Meta l- effett mixtieq jintlaħaq, injezzjoni waħda ta ’ bejn 5, 000 IU u 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjonijiet ta ’ Luveris u FSH.
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Il- pazjenta hi rakkomandata li jkollha x' taqsam mas- sieħeb tagħha dak in- nhar u l- għada li tieħu l- hCG.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/ hCG) after ovulation may lead to premature failure of the corpus luteum.
Meta l- mara tkun fil- fażi lutejali taċ- ċiklu, in- nuqqas ta 'sustanzi b' attivita' lutejatrofika wara l - ovulazzjoni tista 'tikkawża nuqqas ta' żvilupp fil- korpus lutejum.
If an excessive response is obtained, treatment should be stopped and hCG withheld.
Jekk l- effett ikun aktar milli mixtieq, kemm il- kura kif ukoll l- hCG għandhom jitwaqfu.
Luveris is contraindicated in patients with:
Luveris m’ għandux jintuża minn pazjenti li:
• hypersensitivity to gonadotrophins or to any of the excipients. • ovarian, uterine, or mammary carcinoma; • active, untreated tumours of the hypothalamus and pituitary gland; • ovarian enlargement or cyst not due to polycystic ovarian disease; • gynaecological haemorrhages of unknown origin
• għandhom sensittivita ’ eċċessiva għal gonadotrofini jew għal xi wieħed mis- sustanzi mhux attivi • qed ibatu minn karċinoma fl- ovarji, fl- utru jew mammarja. • għandhom tumuri attivi, mhux trattati fil- glandola ipotalamika u pitwitarja; • għandhom l- ovarji akbar milli suppost jew għadhom xi ċista li mhux ikkaġunata minn mard poliċistiku tal- ovarji; • qed ibatu minn emorraġija ġinekoloġika li ma jafux x' qed jikkawżha
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Qabel ma 'tibda l- kura għandha tiġi eżaminata l- infertilita' tal- koppja u għandha issir evalwazzjoni biex tistabbilixxi x' qed jimpedixxi t- tqala.
This medicinal product should not be used when an effective response cannot be obtained, such as ovarian failure, malformation of the sexual organs incompatible with pregnancy or fibroid tumours of the uterus incompatible with pregnancy.
Dan il- prodott mediċinali m’ għandux jintuża f' każijiet fejn ma jistax jagħati riżultati tajbin bħal per eżempju meta l- ovarji ma jkunux qed jiffunzjonaw, meta jkun hemm difett fiżiku ta ’ l- organi sesswali li jaġħtu problemi għat- tqala jew tumuri fibrużi ta ’ l- utru li minħabba fihom il- mara ma tkunx tista 'toħroġ tqila.
In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Barra minn hekk, il- pazjenti għandhom ikunu eżaminati biex jiġi stabbilit jekk ibatux minn ipotirojdiżmu, defiċjenza adrenokortikali, iperprolaktinimja jew tumuri pitwitarji jew ipotalamiċi, u jingħataw il- kura meħtieġa.
Patients undergoing stimulation of follicular growth are at an increased risk of developing hyperstimulation in view of possible excessive oestrogen response and multiple follicular development.
Meta l- follikuli tal- pazjenti jkunu qed jiġu stimulati biex jikbru, ikun hemm riskju li jiġu stimulati izzejjed għax jista 'jkun hemm effett eċċessiv tal- estroġenu u żvilupp ta' aktar minn follikulu wieħed.
Ovarian hyperstimulation syndrome (OHSS) can become a serious medical event characterised by large ovarian cysts which are prone to rupture.
Il- pazjenti tista 'taqbadhom is- sindromu ta ’ iperstimulazzjioni ta ’ l- ovarji (OHSS) karaterizzata minn ċisti kbar fl- ovarji li faċilment jistgħu jinfaqgħu.
Excessive ovarian response seldom gives rise to significant hyperstimulation unless hCG is administered to induce ovulation.
Meta l- effett fuq l- ovarji jkun eċċessiv, rarament jagħti lok għal iperstimulazzjoni sinifikanti sakemm ma jingħatax l- hCG biex jinduċi l- ovulazzjoni.
It is therefore prudent to withhold hCG in such cases and advise the patient to refrain from coitus or use barrier methods for at least 4 days.
Għalhekk ikun aħjar jekk jinżamm l- hCG f’ dawn il- każi u l- pazjenti jingħataw l- parir biex ma jkollhomx x' jaqsmu mas- sieħeb tagħhom jew jużaw kontraċettivi ta 'barriera għal ta ’ l- anqas erbat ijiem.
Careful monitoring of ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, especially in patients with polycystic ovaries.
Hu rrakkomandat li wieħed josserva tajjeb l- effett fuq l- ovarji permezz tal- ultrasawnd kemm qabel kif ukoll matul il- kura, speċjalment f’ pazjenti li għandhom ovarji poliċistiċi.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Il- pazjenti li jkollhom l- ovulazjoni tagħhom stimulate, għandhom aktar ċans għal tqala u twelied ta 'aktar minn tarbija waħda, meta imqabbla ma konċepiment naturali.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Biex tnaqqas ir- riskju li l- mara taqbadha OHSS jew li jkollha aktar minn tarbija waħda fl- istess tqala, ikun aħjar jekk isiru testijiet bl- ultrasawnd u jitqies l- ammont ta 'estradajol.
In anovulation the risk of OHSS is increased by a serum oestradiol level > 900 pg/ ml (3300 pmol/ l) and by the presence of more than 3 follicles of 14 mm or more in diameter.
Waqt l- ovulazzjoni r- riskju ta ’ OHSS jiżdied meta l- ammont ta 'estradajol fis- serum ikun > 900 pg/ ml (3300 pmol/ l) u meta jkun hemm aktar minn 3 follikuli ta ’ dijametru ta ’ 14 mm jew akbar.
In clinical trials, the medicinal product has been shown to increase the ovarian sensitivity to follitropin
Il - pazjenti għandhom jieħdu d- doża ta 'Luveris u FSH kif inhi rrakkomandata u jeħduhom kif suppost
3 alfa.
3 filwaqt li jibqgħu jiġu osservati tajjeb waqt il- kura biex inaqqsu l- possibiltà ta 'iperstimulazzjoni ta’ l - ovarji u tqala b' aktar minn tarbija waħda.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Jekk ikun hemm bżonn li tiżdid id- doża tal - FSH, jekk jista 'jkun, tibdil fid- doża għandu jsir f’ intervalli ta ’ 7- 14- il ġurnata u preferibilment b’ żidiet ta’ 37. 5- 75IU.
In clinical trials, there have been no reports of hypersensitivity to lutropin alfa.
Fl- istudji kliniċi, ma kien hemm l- ebda rapport ta ’ ipersensittività għal- lutropin alfa.
No direct comparison of Luveris/ FSH versus human menopausal gonadotrophin (hMG) has been performed.
Ma sarx studji biex jitqabbel l- effett ta 'Luveris/ FSH ma ’ l- effett tal- gonadotrofina tal- menopawża (hMG) fin- nies.
Comparison with historical data suggests that the ovulation rate obtained with Luveris/ FSH is similar to what can be obtained with hMG.
It - tqabbil li sar kien ma 'l- informazzjoni li kien hemm miġbura u dan wera li r- rata ta ’ ovulazzjoni miksuba mill- Luveris/ FSH hi simili għal dik li tista ’ tinkiseb mill- hMG.
Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Luveris m’ għandux jitħallat ma ’ prodotti mediċinali oħra u jingħata fl- istess injezzjoni, ħlief mal - follitropin alfa għax l- istudji wrew li meta dawn jittieħdu flimkien ma jkunx hemm tibdil sinifikanti fl - attività, stabbiltà u l- karatteristiċi farmakokinetiċi jew farmakodinamiċi tas- sustanzi attivi.
Luveris should not be administered during pregnancy or lactation.
Luveris m’ għandux jittieħed matul it- tqala jew jekk qed tredda ’.
Luveris has no influence on the ability to drive and use machines.
Luveris m' għandu l- ebda effett fuq il- ħila ta 'sewqan u l- użu ta' magni.
a) General description
a) Deskrizzjoni ġenerali
Lutropin alfa is used for the stimulation of follicular development in association with follitropin alfa.
Lutropin alfa jintuża biex jistimula l- iżvilupp tal- follikulu meta jingħata ma 'follitropin alfa.
In this context, it is difficult to attribute undesirable effects to any one of the substances used.
F’ dan il - kuntest, hu diffiċli li tattribwixxi l- effetti mhux mixtieqa ma 'wieħed minn dawn is- sustanzi.
There is considerable post-marketing safety experience with human luteinising hormone (hLH)- containing medicinal products of urinary origin.
Hemm esperjenza konsiderevoli fuq is- sigurta 'tal- użu ta' prodotti medicinali li fihom l- ormon lutejniku ta ’ oriġini urinarja.