qanastek/EMEA-V3 huggingface dataset:
The potential risk for humans is unknown.
Ir- riskju potenzjali fuq il- persuni mhux magħruf.
There are no data on the excretion of choriogonadotropin alfa in milk.
Ma teżisti l- ebda data dwar il- ħruġ ta ’ choriogonadotropin alfa fil- ħalib.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddim ta ’ magni
In comparative trials with different doses of Ovitrelle, the following undesirable effects were found to be associated with Ovitrelle in a dose-related fashion: ovarian hyperstimulation syndrome, and vomiting and nausea.
F’ testijiet komparattivi b’ dożi differenti ta ’ Ovitrelle, instab li dawn l- effetti mhux mixtieqa segwenti huma marbuta mad- doża ta ’ Ovitrelle li tkun ittieħdet: sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji OHSS, vomtu u nawżea.
Ovarian hyperstimulation syndrome was observed in approximately 4% of patients treated with Ovitrelle.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji OHSS kien osservat
Severe ovarian hyperstimulation syndrome was reported in less than 0.5% patients (see section 4.4).
Sindromu sever ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji kien irrapurtat f’ inqas minn 0. 5% tal- pazjenti (sezzjoni 4. 4).
In rare instances, thromboembolisms have been associated with menotrophin/ hCG therapy.
F’ każi rari, tromboemboliżmi kienu marbuta ma ’ terapija permezz tal- menotrofin/ hCG.
Although this adverse event was not observed, there is the possibility that this may also occur with Ovitrelle.
Għalkemm dan l- avveniment mhux mixtieq ma kienx osservat, hemm il- possibilità li dan jista ’ jseħħ ukoll ma ’ l - Ovitrelle.
Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration.
Tqala barra mill- utru, torsjoni ta ’ l- ovarji u kumplikazzjonijiet oħra kienu rrappurtati fil- pazjenti wara li jingħata tal- hCG.
These are considered concomitant effects related to Assisted Reproductive Technologies (ART).
Dawn huma meqjusa bħala effetti konkomitanti marbuta mat- Teknoloġiji ta ’ Riproduzzjoni Assistita (ART).
After best evidence assessment, the following undesirable effects may be observed after administration of Ovitrelle.
Wara analiżi ta ’ l- aqwa evidenza, l- effetti mhux mixtieqa segwenti jistgħu jkunu osservati wara li jingħata Ovitrelle.
4 Common (> 1/ 100, < 1/ 10) Gastrointestinal disorders:
Komuni (> 1/ 100, < 1/ 10) Disturbi gastrointestinali:
Vomiting/ nausea, abdominal pain Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Mild or moderate ovarian hyperstimulation syndrome General disorders and administration site conditions:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata:
Headache, tiredness, local reaction/ pain at injection site.
Uġigħ ta ’ ras, għeja, reazzjoni/ uġigħ fis- sit ta ’ l - injezzjoni,
Uncommon (> 1/ 1,000, < 1/ 100) Psychiatric disorders:
Mhux komuni (> 1/ 1000, < 1/ 100) Disturbi psikjatriċi:
Depression, irritability, restlessness Gastrointestinal disorders:
Disturbi gastrointestinali:
Diarrhoea Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Severe ovarian hyperstimulation syndrome, Breast pain
Sindromu sever ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji, uġigħ fis- sider.
Mild reversible skin reactions manifesting as rash,
Rari ħafna (< 1/ 10, 000) Disturbi fis- sistema immuni: reazzjonijiet allerġiċi Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: reazzjonijiet tal- ġilda li jfiequ, li huma manifestati bħala raxx.
Nevertheless, there is a possibility that ovarian hyperstimulation syndrome (OHSS) may result from an overdosage of Ovitrelle (see section 4.4).
Madankollu, teżisti l- possibilità li sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) jista ’ jirriżulta minn doża eċċessiva ta ’ Ovitrelle (ara sezzjoni 4. 4).
Pharmacotherapeutic group: gonadotropins, ATC code:
Kategorija farmakoterapewtika: gonadotropins, kodiċi ATC:
Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Ovitrelle hu prodott mediċinali ta ’ choriogonadotropin alfa magħmul minn teknika ta ’ DNA rikombinat.
It shares the amino acid sequence with urinary hCG.
Għandhu l- istess sekwenza ta ’ amino aċidi ta ’ l- hCG urinarji.
Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/ CG receptor.
Chorionic gonadotropin jingħaqqad fuq iċ- ċelloli theca (u granulosa) ta ’ l- ovarji ma ’ riċettur transmembraniku li hu wżat ukoll mill- ormon ta ’ lutejniżżazzjoni, ir- riċettur LH/ CG.
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
L- attività farmakodinamika prinċipali fin- nisa hu l- bidu mill- ġdid ta ’ mejosi ta ’ l- ooċit, ftuħ follikulari (ovulazzjoni), formazzjoni ta ’ korpus lutejum u produzzjoni ta ’ progesterone u estradajol mill- korpus lutejum.
In women, Chorionic gonadotropin acts as a surrogate LH- surge that triggers ovulation.
Fin- nisa, Chorionic gonadotropin taġixxi bħala sostitut għaż- żieda fl- LH li jwassal għal l- ovulazzjoni.
Ovitrelle is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth.
5 Ovitrelle jintuża biex iwassal għal- maturazzjoni follikulari finali u lutejniżżazzjoni bikrija wara l- użu ta ’ prodotti mediċinali li jistimulaw it- tkabbir follikulari.
In comparative clinical trials, administration of a dose of 250 micrograms of Ovitrelle was as effective as 5000 IU and 10000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive techniques, and as effective as 5000 IU of urinary hCG in ovulation induction.
F’ testijiet kliniċi komparattivi, it- teħid ta ’ doża ta ’ 250 mikrogrammi ta ’ Ovitrelle kienet effettiva daqs 5000 IU u 10000 IU ta ’ hCG urinarja biex iġġiegħel il- maturazzjoni follikulari finali u lutejniżżazzjoni bikrija fit- teknika ta ’ riproduzzjoni assistita, u effettiva daqs 5000 IU ta ’ hCG urinarja biex iġġiegħel l - ovulazzjoni.
So far, there are no signs of antibody development in humans to Ovitrelle.
S’ issa ma kienx hemm sinjali ta ’ żvilupp ta ’ antikorpi għall- Ovitrelle fl- umani.
Repeated exposure to Ovitrelle was investigated in male patients only.
Espożizzjoni ripetuta għall- Ovitrelle kienet investigata fuq pazjenti rġiel biss.
Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.
Investigazzjoni klinika fuq in- nisa għall - indikazzjoni ta ’ ART u għan- nuqqas ta ’ ovulazzjoni kienet limitata għal trattament ta ’ ċiklu wieħed.
Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours.
Wara teħid minn ġol- vini, choriogonadotropin alfa jitqassam fl- ispazju fluwidu extra- ċellulari b’ nofs - ħajja ta ’ distribuzzjoni ta ’ madwar 4. 5 siegħa.
The steady-state volume of distribution and the total clearance are 6 l and 0.2 l/ h, respectively.
Il- volum stabbli tad- distribuzzjoni u t- tneħħija kompluta tiegħu huma ta ’ 6 litri u 0. 2 litru / siegħa, rispettivament.
There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
M’ hemmx indikazzjoniet li choriogonadotropin alfa jiġi metaboliżżat u maħruġ b’ mod differenti mill- hCG endoġeniku.
5 Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Wara teħid minn taħt il- ġilda, choriogonadotropin alfa jitneħħa mill- ġisem b’ nofs ħajja terminali ta ’ madwar 30 siegħa, u l- biodisponibilita assoluta hi ta ’ madwar 40%.
A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Studju komparattiv bejn il- formulazzjoni friżata- niexfa li hi reġistrata preżentement u l- formulazzjoni likwida juri bio- ekwivalenza bejn iż- żewġ formulazzjonijiet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Tagħrif ta ’ qabel l- użu kliniku ma sabu l- ebda tossiċità intrinsika ta ’ choriogonadotropin alfa.
Studies on carcinogenic potential were not performed.
Ma sarux studji dwar il- potenzjal karċinoġeniku tiegħu.
This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
Dan hu ġustifikat minħabba li s- sustanza attiva hi magħmula mill- proteini u minħabba t- tossiċita fil- ġeni rriżulta fin- negattiv.
Studies on reproduction were not performed in animals.
Ma sarux studi dwar ir- riproduzzjoni fuq l- annimali.
Powder for solution for injection:
Trab għal soluzzjoni għall- injezzjoni:
Sucrose Phosphoric acid, concentrated Sodium hydroxide
sukrożju Phosphoric acid, concentrated Sodium hydroxide
6.2 Incompatibilities
Ilma għall- injezzjonijiet
For immediate and single use following first opening and reconstitution.
Għall- użu immedjat u ta ’ darba wara li jkun infetaħ u ssir it- taħlita likwida.
The powder container is a neutral colourless (type 1, Ph.
Il- kontenitur tat- trab huwa fjala tal- ħġieġ newtrali u mingħajr kulur (tip 1, Ph.
Eur.) glass vial with a bromobutyl rubber stopper.
Eur.) b’ tapp tal- lasktu tal- bromobutajl.
The solvent container is a neutral, colourless glass type 1 vial with a bromobutyl rubber stopper or a neutral, colourless glass type 1 ampoule.
Il- kontenitur għas- solvent huwa fjala tal- ħġieġ newtrali u mingħajr kulur tip 1 b’ tapp tal- lastku tal bromobutyl jew ampulla tal- ħġieġ newtrali u mingħajr kulur tip 1.
The product is supplied in packs of 1, 2, 10 vials with the corresponding number of solvent containers.
Il- prodott jiġi provdut f’ pakketti ta ’ 1, 2 jew 10 fjali bin- numru korrispondenti ta ’ kontenituri għas - solvent.
6 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Ovitrelle is for single use only.
Ovitrelle għandu jintuża darba biss.
One vial of Ovitrelle can be reconstituted with 1 ml of the solvent before use.
Fjala waħda ta ’ Ovitrelle tista ’ titħallat ma ’ 1 millilitru ta ’ solvent qabel l- użu.
The reconstituted solution should not be administered if it contains particles or is not clear.
It- taħlita likwida m’ għandiex tittieħed jekk fiha xi trab jew mhix ċara.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal - prodott li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
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 authorization:
Data ta l- ewwel awtoriazzazzjoni:
2 February 2001 Date of last renewal:
2 Frar 2001 Data ta ’ l- aħħar tiġdid:
6 February 2006
6 Frar 2006
Ovitrelle 250 micrograms/ 0.5 ml, solution for injection in a pre-filled syringe
Ovitrelle 250 mikrogrammi/ 0. 5 millitru, taħlita likwida għall- injezzjoni f’ siringa mimlija lesta.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA U KWANTITTATIVA
Choriogonadotropin alfa* 250 micrograms in 0.5 ml.
Choriogonadotropin alfa * 250 mikrogrammi f’ 0. 5 millilitru.
(equivalent to approximately 6500 IU)
(ekwivalenti għal madwar 6500 IU)
27.3 mg mannitol, 0.05 mg poloxamer 188, 0.1 mg L-methionine
27. 3 mg mannitol, 0. 05 mg poloxamer 188, 0. 1 mg L- methionine
Produced by recombinant DNA technology in CHO
* Prodott permezz ta ’ teknoloġija rikombinat ta ’ DNA f’ CHO
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara 6. 1.
Solution for injection
Soluzzjoni għall- injezzjoni.
The pH of the solution is 7.0 ± 0.3, its osmolarity 250-400 mOsm/ L
Il - pH tas- soluzzjoni hija 7. 0 ± 0. 3, b’ osmolarita ta ’ 250- 400 mOsm/ L
Ovitrelle is indicated in the treatment of
Ovitrelle hu indikat fil- kura ta ’
Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Nisa li għaddejjin minn ovulazzjoni mgħaġġla qabel l- użu ta ’ teknika ta ’ riproduzzjoni assistita bħall - fertiliżżazzjoni in vitro (IVF):
Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,
Ovitrelle jittieħed biex iħeġġeġ maturazzjoni follikulari finali u lutejniżżazzjoni wara l- istimulazzjoni tat- tkabbir follikulari.
Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
Ovitrelle jittieħed biex iħeġġeġ l- ovulazzjoni u lutejniżżazzjoni f’ nisa li ma jovulawx jew li għandhom l- ovarji li jagħmlu inqas bajd min- normal wara l- istimulazzjoni tat- tkabbir follikulari.
Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura b’ Ovitrelle għandha ssir taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi tal - fertilità.
One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of an FSH- or hMG preparation, i. e. when optimal stimulation of follicular growth is achieved.
Siringa waħda mimlija lesta ta ’ Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara l- aħħar somministrazjoni ta ’ preparazzjoni ta ’ FSH - jew hMG, i. e. meta l- istimulazzjoni ottimali tat- tkabbir follikulari tkun inkisbet.
Anovulatory or oligo-ovulatory women:
Nisa li ma jovulawx jew li għandhom l- ovarji jagħmlu anqas bajd min- normal:
One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
8 Siringa waħda mimlija lesta ta ’ Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara li tinkiseb stimulazzjoni ottimali tat- tkabbir follikulari.
The patient is recommended to have coitus on the day of, and the day after, Ovitrelle injection.
Hu rakkomandat li l- pazjent ikollu kopulazzjoni fil - ġurnata ta ’, jew fil- ġurnata ta ’ wara, l- injezzjoni ta ’ Ovitrelle.
Ovitrelle is contraindicated for safety reasons in case of: • Tumours of the hypothalamus and pituitary gland • Hypersensitivity to the active substance or to any of the excipients • Ovarian enlargement or cyst due to reasons other than polycystic ovarian disease • Gynaecological haemorrhages of unknown aetiology • Ovarian, uterine or mammary carcinoma • Extrauterine pregnancy in the previous 3 months • Active thrombo-embolic disorders
• Tumuri fl- ipotalamu u l- glandola pitwitarja • Sensittività eċċessiva għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi • Tkabbir ta ’ l- ovarji jew ċista minħabba raġunijiet oħra ħlief mard poliċistiku fl- ovarji • Emorraġija ginekoloġika ta ’ etjoloġija mhux magħrufa • Karċinoma fl- ovarji, fl- utru jew mammarja • Tqala barra mill- utru matul l- aħħar 3 xhur • Problemi trombo- emboliċi attivi
To date, there is no clinical experience with Ovitrelle in other indications commonly treated with urine derived human chorionic gonadotropin.
Sal- lum, ma hemm l- ebda esperjenza klinika dwar l- użu ta ’ Ovitrelle f’ indikazzjonijiet oħra li normalment jingħataw kura permezz ta ’ human chorionic gonadotropin derivat mill- urina.
Special precautions should be taken before administering Ovitrelle to patients with clinically significant systemic disease where pregnancy could lead to a worsening of the condition.
Għandhom jittieħdu prekawzjonijiet speċjali qabel ma jingħata Ovitrelle lill- pazjenti b’ xi marda sistemika li hi klinikament sinifikanti u fejn it- tqala tista ’ twassal biex il- kundizzjoni tagħhom tmur għall- agħar.
Patients undergoing ovarian stimulation are at an increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to multiple follicular development.
Pazjenti li fuqhom qed titwettaq l- istimulazzjoni ta ’ l- ovarji jiltaqgħu ma ’ riskju akbar li jiżviluppaw is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) minħabba żvilupp follikulari multiplu.
Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts, which are prone to rupture and the presence of ascites within a clinical picture of circulatory dysfunction.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji jista ’ jsir avveniment mediku serju karatteriżżat minn ċisti kbar fl- ovarji, li jistgħu jinfaqgħu u il- preżenza ta ’ axxite fi ħdan sitwazzjoni klinika ta ’ funzjonament ċirkolatorju ħażin.
Ovarian hyperstimulation syndrome due to excessive ovarian response can be avoided by withholding hCG administration.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji minħabba reazzjoni eċċessiva mill- ovarji jista ’ jiġi evitat billi jitwaqqaf it- teħid ta ’ hCG.
Careful monitoring of estradiol levels and ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, for all patients.
Osservazzjoni attenta tal- livelli ta ’ estradiol u r- reazzjoni ta ’ l- ovarji, permezz ta ’ l- ultrasawnd, hu rakkomandat qabel u matul it- terapija ta ’ stimulazzjoni, għall- pazjenti kollha.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of embryos replaced.
Ir- riskju ta ’ tqala multipla wara l- użu ta ’ teknoloġiji ta ’ riproduzzjoni assistita hu marbut man- numru ta ’ embrijoni mibdula.
To minimise the risk of OHSS and of multiple pregnancy, ultrasound scans as well as estradiol measurements are recommended.
Biex jitnaqqas ir- riskju ta’ OHSS u ta ’ tqala multipla, hu rakkomandat li jsiru scans permezz ta ’ l - ultrasawnd kif ukoll għandu jitkejjel il- livell ta ’ estradiol.
In anovulation, the risk of OHSS is increased by a serum estradiol level > 1500 pg/ ml (5400 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
Waqt ovulazzjoni, ir- riskju ta ’ OHSS jiżdied b’ livell ta ’ estradiol fis- serum ta ’ > 1500 pikogramma/ millitru (5400 pikomol/ litru) u aktar minn 3 follikuli ta ’ dijametru ta ’ 14 millimetru jew aktar.
In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol > 3000 pg/ ml (11000 pmol/ l) and 20 or more follicles of 12 mm or more in diameter.
9 ta ’ OHSS meta l’ estradiol fis- serum > 3000 pikogramma/ millitru (11000 pikomol/ litru) u 20 jew aktar follikuli ta ’ dijametru ta ’ 12 millimetru jew aktar.
When the estradiol level is > 5500 pg/ ml (20000 pmol/ l) and when there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Meta l- livell ta ’ estradiol hu ta ’ > 5500 pikogramma/ millitru (20000 pikomol/ litru) u fejn hemm 40 follikulu jew aktar b’ kollox, jista ’ jkun meħtieġ li jitwaqqaf it- teħid tal- hCG.
9 Adherence to recommended Ovitrelle dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy.
Ir- rispett tad- doża rakkomandata ta ’ Ovitrelle, ir- reġim ta ’ teħid tagħha u osservazzjoni attenta tat - terapija jnaqqsu l- possibilità li sseħħ l- istimulazzjoni eċċessiva ta ’ l- ovarji u tqala multipla.
During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Matul it- terapija permezz ta ’ Ovitrelle, hemm il- possibilità ta ’ stimulazzjoni żghira ta ’ tirojde, li tagħha r- relevanza klinika mhix magħrufa.
Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Il- pazjenti jistgħu jieħdu Ovitrelle waħedhom meta huma mħarrġa b’ mod adegwat u għandhom aċċess għal konsulenza esperta.
No specific interaction studies with Ovitrelle and other medicines have been performed however no clinically significant drug interactions have been reported during hCG therapy.
Ma saru l- ebda studji speċifiċi dwar l- interazzjoni ta ’ Ovitrelle ma ’ mediċini oħra iżda ebda interazzjonijiet klinikament sinifikanti ma ’ drogi oħra ma kienu rrapurtati matul it- terapija bl- hCG.
No clinical data on exposed pregnancies are available.
Għal Ovitrelle ma teżistix informazzjoni klinika dwar tqala esposta għaliha.
No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Ma saru l- ebda studji dwar ir - riproduzzjoni permezz choriogonadotropin alfa fuq annimali (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali fuq il- persuni mhix magħrufa.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddim ta ’ magni.
In comparative trials with different doses of Ovitrelle, the following undesirable effects were found to be associated with Ovitrelle in a dose-related fashion: ovarian hyperstimulation syndrome, and vomiting and nausea.
F’ testijiet komparattivi b’ dożi differenti ta ’ Ovitrelle, instab li dawn l- effetti mhux mixtieqa segwenti huma marbuta mad- doża ta ’ Ovitrelle li tkun ingħatat: sindromu ta ’ stimulazzjoni eċċessiva ta ’ l - ovarji, vomtu u nawżea.
Ovarian hyperstimulation syndrome was observed in approximately 4% of patients treated with Ovitrelle.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji kien osservat f’ madwar 4% tal- pazjenti li ngħataw il- kura permezz ta ’ Ovitrelle.
Severe ovarian hyperstimulation syndrome was reported in less than 0.5% patients (see section 4.4).
Sindromu ta ’ stimulazzjoni eċċessiva ta ’ l - ovarji sever kien irrapurtat f’ inqas minn 0. 5% tal- pazjenti (sezzjoni 4. 4).
In rare instances, thromboembolisms have been associated with menotropin/ hCG therapy.
F’ każi rari, tromboemboliżmi kienu marbuta ma ’ terapija permezz tal- menotropin/ hCG.
Although this adverse event was not observed, there is the possibility that this may also occur with Ovitrelle.
Għalkemm dan l- avveniment mhux mixtieq ma kienx osservat, hemm il- possibilità li dan jista ’ jseħħ ukoll ma ’ Ovitrelle.
After best evidence assessment, the following undesirable effects may be observed after administration of Ovitrelle.
10 Wara analiżi ta ’ l- aqwa evidenza, l- effetti mhux mixtieqa segwenti jistgħu jkunu osservati wara t- teħid ta ’ Ovitrelle.
Common (> 1/ 100, < 1/ 10) Gastrointestinal disorders:
Komuni (> 1/ 100, < 1/ 10) Disturbi gastrointestinali:
10 Uncommon (> 1/ 1,000, < 1/ 100) Psychiatric disorders:
Mhux komuni (> 1/ 1000, < 1/ 100) Disturbi psikjatriċi:
Depression, irritability, restlessness, Gastrointestinal disorders:
Disturbi gastrointestinali:
Diarrhoea, Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Severe ovarian hyperstimulation syndrome, breast pain.
Sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji sever, uġigħ fis- sider.
No case of overdose has been reported.
L- ebda kas ta ’ doża eċċessiva ma ġie rrapurtat.
Nevertheless, there is a possibility that ovarian hyperstimulation syndrome (OHSS) may result from an overdosage of Ovitrelle (see section 4.4).
Madankollu, teżisti l- possibilità li is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) jista ’ jirriżulta minn doża eċċessiva ta ’ Ovitrelle (ara sezzjoni 4. 4).
Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Ovitrelle hu prodott mediċinali ta ’ choriogonadotropin alfa prodott minn teknika ta ’ DNA rikombinat.
Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/ CG receptor.
Il - chorionic gonadotropin tingħaqqad fuq iċ- ċelloli theca (u granulosa) ta ’ l- ovarji ma ’ riċettur transmembraniku li hu wżat ukoll mill- ormon ta ’ lutejniżżazzjoni, ir- riċettur LH/ CG.
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
L- attività farmakodinamika prinċipali fin- nisa hu l- bidu mill- ġdid ta ’ mejosi ta ’ l- ooċit, ftuħ follikulari (ovulazzjoni), formazzjoni ta ’ korpus lutejum u produzzjoni ta ’ progesterone u estradiol mill- korpus lutejum.
In women, chorionic gonadotropin acts as a surrogate LH- surge that triggers ovulation.
Fin- nisa, chorionic gonadotropin jaġixxi bħala sostitut għaż- żieda fl- LH li jwassal għal l- ovulazzjoni.
Ovitrelle is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth.
Ovitrelle jintuża biex iwassal għal- maturazzjoni follikulari finali u lutejniżżazzjoni bikrija wara l- użu ta ’ prodotti mediċinali li jistimulaw it- tkabbir follikulari.
So far, there are no signs of antibody development in humans to Ovitrelle.
11 S’ issa ma kienx hemm sinjali ta ’ żvilupp ta ’ antikorpi għal Ovitrelle fil- persuni.
Repeated exposure to Ovitrelle was investigated in male patients only.
Espożizzjoni ripetuta għal Ovitrelle kienet investigata fuq pazjenti rġiel biss.
The steady-state volume of distribution and the total clearance are 6 l and 0.2 l/ h, respectively.
Il- volum stabbli tad- distribuzzjoni u t- tneħħija kompluta tiegħu huma ta ’ 6 litri u 0. 2 litri / siegħa, rispettivament.
Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Wara teħid minn taħt il- ġilda, choriogonadotropin alfa jitneħħa mill- ġisem b’ nofs ħajja terminali ta ’ madwar 30 siegħa, u l- biodisponibilita assoluta hi ta ’ madwar 40%.
11 A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Studju komparattiv bejn il- formulazzjoni friżata- niexfa li hi reġistrata preżentement u l- formulazzjoni likwida juri bio- ekwivalenza bejn iż- żewġ formulazzjonijiet.
This is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing.
Dan hu ġustifikat minħabba li s- sustanza mediċinali hi magħmula mill- proteini u minħabba li l- effett tossiku fuq il- ġeni rriżulta fin- negativ.
Mannitol Methionine Poloxamer 188 Diluted phosphoric acid Sodium hydroxide Water for injections
Mannitol Methionine Poloxamer 188 Diluted phosphoric acid Sodium hydroxide Ilma għall- injezzjonijiet
After opening, the product should be used immediately.
Wara li jinfetaħ, il- prodott għandu jiġi użat immedjatament.
However, the in-use stability has been demonstrated for 24 hours at +2° to 8° C.
Madankollu, instab li dan il- prodott jibqa ’ tajjeb biex jintuża sa 24 siegħa f’ temperatura li tvarja minn +2 ° to 8° C.
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C u 8°C).
Within its shelf-life, the solution may be stored at or below 25°C for up to 30 days without being refrigerated again during this period.
Matul iż- żmien li jdum tajjeb, il- prodott jista ’ jinħażen f’ temperatura ta ’ 25°C jew anqas għal 30 ġurnata mingħajr ma jerġa ’ jiddaħħal fil- friġġ matul dan il- perjodu.
It must be discarded if not used after these 30 days.
Dan għandu jintrema jekk ma jintużax matul dawn it- 30 ġurnata.
6.5 Nature and contents of container
12 6. 5 In- natura tal- materjal tal- kontenitur u ta dak li hemm ġo fiħ
0.5 ml of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) – pack of 1.
0. 5 millitru ta ’ taħlita likwida f’ siringa mimlija lesta (ħġieġ tip I) b’ tapp li jitla ’ u jinżel (lastku tal - halobutajl) u planġer (plastik), b’ labra għall- injezzjoni (azzar li ma jissaddadx) – pakkett ta ’ 1.
6.6 Special precautions for disposal
6. 6 Struzzjonijiet għall- użu w mmaniġġjar u għar- rimi
Only clear solution without particles should be used.
Għandu jintuża biss jekk it- taħlita hi ċara u mingħajr frak.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
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 authorization:
Data ta l- ewwel awtorizzazzjoni:
MANUFACTUREROF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
OVITRELLE 250 MICROGRAMS, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, SOLVENT IN AMPOULES
OVITRELLE 250 MIKROGRAMMI, TRAB U SOLVENT GĦAL SOLUZZJONI GĦALL - INJEZZJONI, SOLVENT F’ AMPULLI
Ovitrelle 250 micrograms powder and solvent for solution for injection.
OVITRELLE 250 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Composition: one vial delivers:
Fjala waħda tagħti:
Choriogonadotropin alfa 250 micrograms (6500 IU).
Choriogonadotropin alfa 250 mikrogrammi (6500 IU).
Other ingredients:
Ingredjenti oħra:
Sucrose, phosphoric acid, sodium hydroxide.
Sucrose, phosphoric acid, sodium hydroxide.
One ampoule of solvent contains:1 ml water for injections.
1 millilitru ilma għall- injezzjonijiet.
1 ampoule of solvent.
1 fjala ta ’ trab għal taħlita likwida għall- injezzjoni.
EU/ 1/ 00/ 165/ 001
EU/ 1/ 00/ 165/ 001 1 ampulla ta ’ solvent.
2 vials of powder for solution for injection 2 ampoules of solvent
2 ampulli ta ’ solvent.
10 vials of powder for solution for injection 10 ampoules of solvent
10 ampulli ta ’ solvent.
Keep out of the reach and sight of children
Żomm fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal żgħar.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Do not store above 25oC.
Taħżinx f’ temperatura ‘ l- fuq minn 25°C.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
TWISSIJA SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Discard any unused solution.
Kull fdal tal- prodott li ma ntużax għandu jintrema skond il- liġijiet lokali
EU/ 1/ 00/ 165/ 001 1 vial of powder/ 1 ampoule of solvent EU/ 1/ 00/ 165/ 002 2 vials of powder/ 2 ampoules of solvent EU/ 1/ 00/ 165/ 003 10 vials of powde/ 10 ampoules of solvent
EU/ 1/ 00/ 165/ 001 1 fjala ta ’ trab / 1 ampulla ta ’ solvent EU/ 1/ 00/ 165/ 002 2 fjali ta ’ trab / 2 ampulli ta ’ solvent EU/ 1/ 00/ 165/ 003 10 fjali ta ’ trab / 10 ampulli ta ’ solvent
Batch Solvent Batch
Lott Lott tas- solvent
OVITRELLE 250 MICROGRAMS, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, SOLVENT IN VIALS
OVITRELLE 250 MIKROGRAMMI, TRAB U SOLVENT GĦAL SOLUZZJONI GĦALL - INJEZZJONI, SOLVENT F’ AMPULLI
Ovitrelle 250 micrograms powder and solvent for solution for injection.
OVITRELLE 250 mikrogrammi trab u solvent għal taħlita likwida għall- injezzjoni.
One vial of solvent contains:1 ml water for injections.
1 millilitru ilma għall- injezzjonijiet.
1 vial of solvent.
1 fjala ta ’ trab għal soluzzjoni għall- injezzjoni 1 fjala ta’ solvent.
2 vials of powder for solution for injection 2 vials of solvent
2 fjali ta ’ solvent.
EU/ 1/ 00/ 165/ 006
10 fjali ta ’ trab għal soluzzjoni għall- injezzjoni EU/ 1/ 00/ 165/ 006 10 fjali ta’ solvent
Discard any unused solution.
Kull fdal tal- prodott li ma ntużax għandu jintrema skond il- liġijiet lokali.
1 vial of powder/ 1 vial of solvent 2 vials of powder/ 2 vials of solvent 10 vials of powder/ 10 vials of solvent
1 fjala ta ’ trab / 1 fjala ta ’ solvent 2 fjali ta ’ trab/ 2 fjali ta’ solvent 10 fjali ta ’ trab/ 10 fjali ta ’ solvent
INSTRUCTIONS ON USE
STRUZZJONIIJET DWAR L- UŻU
OVITRELLE 250 MICROGRAMS, SOLUTION FOR INJECTION
OVITRELLE 250 MIKROGRAMMI, SOLUZZJONI GĦALL- INJEZZJONI,
Ovitrelle 250 micrograms/ 0.5 ml solution for injection in a pre-filled syringe.
OVITRELLE 250 mikrogrammi/ 0. 5ml soluzzjoni għall- injezzjoni f’ siringa mimlija lesta..
One pre-filled syringe contains:
Siringa mimlija lesta fiha:
250 micrograms (6500 IU) of Choriogonadotropin alfa
250 mikrogrammi (6500 IU) ta ’ Choriogonadotropin alfa.
Mannitol, methionine, poloxamer 188, diluted phosphoric acid, sodium hydroxide, water for injections.
Mannitol, methionine, poloxamer 188, phosphoric acid mhux konċentrat, sodium hydroxide, ilma għall- injezzjonijiet.
1 pre-filled syringe with 0.5 ml solution for injection
Siringa mimlija lesta ma ’ o. 5ml sluzzjoni għall- injezzjoniji
May be stored at or below + 25° C for up to 30 days without being refrigerated again during this period and must be discarded if not used during these 30 days.
Jista jinħażen f’ temperatura ta ’ + 25° C jew inqas sa 30- il ġurnata mingħajr ma jerġa jitpoġġa ġol- friġġ tul dan iz- zmien, u għandu jintrem jekk ma jintużax waqt dawn il 30- il ġurnata.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIIJET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Any unused solution or waste material should be disposed of in accordance with local requirements
Kull taħlita mhux użata għandha tintrema.
ovitrelle 250/ 0.5 ml
ovitrelle 250/ 0. 5ml
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL - PAKKETT Ż- ŻGĦAR EWLENIN
OVITRELLE 250 MICROGRAMS s, POWDER
OVITRELLE 250 MIKROGRAMMI, TRAB
Ovitrelle 250 micrograms powder for injection
OVITRELLE 250 mikrogrammi trab għall- injezzjoni.
METHOD OF ADMINISTRATION
METODU TA ’ KIF GHANDU JINGHATA
OVITRELLE 250 MICROGRAMS s, SOLVENT VIALS AND AMPOULES
OVITRELLE 250 MIKROGRAMMI, FJALI U AMPULLI TA ’ SOLVENT
OVITRELLE 250 MICROGRAMS s, PRE-FILLED SYRINGE
OVITRELLE 250 MIKROGRAMMI, SIRINGA MIMLIJA LESTA
Ovitrelle 250 micrograms/ 0.5 ml solution for injection in a pre-filled syringe Choriogonadotropin alfa Subcutaneous use.
Choriogonadotropin alfa Użu għal taħt il- ġilda.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, SKOND IL- VOLUM JEW PARTI INDIVIDWALI
250 micrograms/ 0.5 ml
250 mikrogrammi/ 0. 5 millilitru
INFORMATION FOR THE USER (Solvent container:
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA (Kontenitur tas- solvent:
Ampoule)
Ampulla)
Choriogonadotropin alfa.
Ovitrelle 250 mikrograami trab u solvent għal soluzzjoni għall- injezzjoni Choriogonadotropin alfa.
It may harm them, even
TAGĦTIHIEX lil persuni oħra Tista ’ tagħmlilhom il- ħsara,
if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħall- tiegħek.
Before you use Ovitrelle 3.
Qabel ma tuża Ovitrelle 3.
How to use Ovitrelle 4.
Kif għandek tuża Ovitrelle 4.
How to store Ovitrelle 6.
Kif taħżen Ovitrelle 6.
WHAT OVITRELLE IS AND WHAT IT IS USED FOR
X’ INHU OVITRELLE U GĦALXIEX JINTUŻA
Ovitrelle is a medicinal product containing choriogonadotropin alfa, which is very similar to chorionic gonadotrophin found naturally in humans, but it is made in laboratories by special recombinant DNA techniques.
Ovitrelle hu prodott mediċinali li fih choriogonadotropin alfa, li hi simili ħafna għal chorionic gonadotrophin li tinstab b’ mod naturali fil- persuni, iżda li ssir fil- laboratorji bl- użu ta ’ teknika speċjali ta ’ DNA rikombinat.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Dan jagħmel parti mill- familja ta ’ ormoni magħrufa bħala gonadotrophins, li huma involuti fil- kontroll normali tar- riproduzzjoni.
Ovitrelle is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF).
Ovitrelle jintuża fuq nisa li fuqhom qed tintuża teknika ta ’ riproduzzjoni assistita bħal fertiliżżazzjoni in vitro (IVF).
Other medicines are given first to bring about the growth and development of several follicles, to produce eggs.
Mediċini oħra jittieħdu qabel biex iwasslu għat- tkabbir u żvilupp ta ’ diversi follikuli, biex jipproduċu l- bajd.
Ovitrelle is then used to ripen (mature) these follicles.
Ovitrelle imbagħad jintuża biex jimmatura dawn il- follikuli.
Ovitrelle is also used in women who do not produce eggs (a condition called anovulation) or who produce too few eggs (oligo-ovulation).
Ovitrelle jintuża wkoll f’ nisa li ma jipproduċux bajd (kundizzjoni magħrufa bħala nuqqas ta ’ ovulazzjoni) jew li jipproduċu ftit bajd (l- ovarji jagħmlu anqas bajd min- normal).
It is given to bring about the release of eggs (ovulation), after other medicines have been used to develop the follicles.
Dan jingħata biex iwassal għall- ħelsien tal- bajd (ovulazzjoni), wara li mediċini oħra jkunu ntużaw biex jiġu żviluppati l - follikuli.
BEFORE YOU USE OVITRELLE
QABEL MA TUŻA OVITRELLE
You and your partner's fertility should be evaluated before the treatment is started.
Għandha ssir evalwazzjoni tal- fertilità tiegħek u tas- sieħeb tiegħek qabel ma tibda l- kura.
- If you have ovarian enlargement or one or more large ovarian cysts
Tieħux Ovitrelle jekk twieġeb ‘ IVA ’ għal imqar waħda minn dawn:
- if you are allergic (hypersensitive) to choriogonadotropin, or any of the ingredients of Ovitrelle
• inti tqila jew jekk qed tredda ’? • għandek tkabbir ta ’ l- ovarji jew waħda jew iżjed ta’ ċisti ovarji kbar? • għandek demm vaġinali mingħajr spjegazzjoni? • kien djanjostikat fuqek kanċer fl- ovarji, utru jew fis- sider? • kellek tumur fl- ipotalamu jew fil- glandola pitwitarja? • tbati minn infjamazzjoni severa fil- vini jew għandek ċappep ta ’ demm fil- vini (disturbi trombo - emboliċi attivi)? • għandek xi allerġija magħrufa għal din il- mediċina jew għal xi waħda simili għaliha, jew għal xi ingredjenti minnha?
- if you had an extrauterine pregnancy within the last 3 months
28 • għandek xi kundizzjoni li minħabba fiha tqala normali mhix possibbli (eż. nuqqas ta ’ utru, ovarji li mhumiex żviluppati sew, fibrojdi) jew diġà għaddejt mill- menopawża • kellek tqala barra mill- utru f’ dawn l- aħħar 3 xhur?
28 Take special care with Ovitrelle:
Oqgħod attent ħafna b’ Ovitrelle:
Treatment with Ovitrelle may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also ‘ Possible side effects’).
Dan it- trattament bl- Ovitrelle jista ’ jżidlek ir- riskju li tiżviluppa kundizzjoni magħrufa bħala sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) (ara wkoll ‘ X’ effetti oħra jista ’ jkollu ’).
This is when the ovaries over- react to the treatment and develop too many follicles.
Dan iseħħ meta l- ovarji jkollhom reazzjoni qawwija għat- trattament u jiżviluppaw ħafna follikuli żejda.
The most common symptom is abdominal pain.
L- aktar sintomu komuni hu wġigħ fl- istonku.
If you have significant abdominal pain or discomfort, do not take the injection, and speak to your doctor or nurse as soon as possible.
Jekk għandek uġigħ jew skumdità sinifikanti fl- istonku, tagħtix l- injezzjoni lilek innifsek, u kellem lit- tabib jew lill- infirmiera tiegħek kemm jista ’ jkun malajr.
You should not have intercourse for at least 4 days, or otherwise you should use a barrier method for contraception.
M’ għandux ikollok rapport sesswali għal mill- anqas erbat ijiem, jew inkella għandek tuża metodu protettiv ta ’ kontraċezzjoni.
Compared with natural conception, the frequency of multiple pregnancies and births is increased in patients receiving this treatment.
Meta mqabbla mal- konċepiment naturali, il- frekwenza ta ’ tqala u twelid multiplu tiżdied fil- pazjenti li jirċievu din il- kura.
The majority of these are twins.
Il- maġġoranza ta ’ dawn huma tewmin.
In assisted conception techniques, the number of babies is related to the number of embryos replaced.
Fit- teknika ta ’ konċezzjoni assistita, in - numru ta ’ trabi hu marbut man- numru ta ’ embrijuni mibdula.
Your risk of OHSS or multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and you are monitored closely throughout your treatment cycle (e. g. blood tests for estradiol levels and ultrasound).
Ir- riskju ta ’ OHSS jew tqala multipla jonqos jekk tittieħed id- doża normali ta ’ Ovitrelle, u jekk int kont kontrollat tajjeb matul iċ- ċiklu kollu tat- trattament tiegħek (eż. eżamijiet tad- demm għal- livelli ta ’ estradiol u ultrasawnd).
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 qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
You should not take Ovitrelle if you are pregnant or breast-feeding.
M’ għandekx tieħu l- Ovitrelle jekk int tqila jew qed tredda ’.
HOW TO USE OVITRELLE
KIF JINTUŻA OVITRELLE
Always take Ovitrelle exactly as your doctor has told you.
Dejjem għandek tieħu Ovitrelle skond il- parir tat- tabib.
The usual dose of Ovitrelle is 1 vial (250 micrograms) given as a single injection.
Id- doża ta ’ Ovitrelle hi ta ’ fjala 1 (250 mikrogrammi) mogħtija bħala injezzjoni waħda.
Your doctor will have explained exactly when to give the injection.
It- tabib tiegħek se jkun spjegalek eżattament fejn għandek tieħu l- injezzjoni.
Ovitrelle is intended for subcutaneous use, that means given by injection under the skin.
Ovitrelle tingħata permezz ta ’ injezzjoni minn taħt il- ġilda.
Each vial is for single use only.
Kull fjala tintuża darba waħda biss.
Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.
Xi kultant l- injezzjoni se tingħatalek minn tabib jew infirmiera, jew int jew is- sieħeb tiegħek tkunu tħarriġtu biex tieħu l- injezzjoni d- dar.
If you administer Ovitrelle to yourself, please carefully read the following instructions:
Jekk se tagħti l- Ovitrelle lilek innifsek, jekk jogħġbok aqra b’ attenzjoni l- istruzzjonijiet segwenti:
Assemble everything you need.
Iġbor dak kollu li għandek bżonn.
Please note that alcohol swabs, syringes and needles are not contained in the package.
Jekk jogħġbok innota li ċ- ċraret bl- alkoħol, is- siringi u l- labar mhumiex inklużi fil- pakkett.
two alcohol swabs, one solvent ampoule, one vial containing the medicinal product one syringe, one big needle for reconstitution, a fine-bore needle for subcutaneous injection.
żewġ ċraret bl- alkoħol ampulla waħda bis- solvent fjala waħda li fiha l- prodott mediċinali siringa waħda labra waħda kbira għal taħlita labra fina għat- titqib għall- injezzjoni minn taħt il- ġilda
Opening the ampoule of solvent:
Iftaħ l- ampulla tas- solvent:
On the head of the solvent ampoule, you will see a small coloured dot.
Fuq ir- ras tal- ampulla tas- solvent, se tara tikka żgħira kkulurita.
Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Taħtha eżatt jinsab fejn l- għonq ta ’ l- ampulla kien trattat biex ikun jista ’ jinkiser aktar faċilment.
Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber.
Flikkja bil- mod il- parti ta ’ fuq ta ’ l - ampulla biex jekk hemm xi fluwidu f’ għonqha dan jinżel fil- parti t’ isfel.
Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot.
Issa agħfas l- ampulla b’ fermezza fuq l- għonq, u ikser l - ampulla lejn in- naħa l- oħra ta’ tikka kkulurita.
Carefully place the open ampoule upright on the work-surface.
B’ attenzjoni poġġi l - ampulla miftuħa fil- post fejn se taħdem wiċċha ‘ l fuq.
Drawing up the solvent:
Ġbid tas- solvent:
Attach the needle for reconstitution to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the solvent.
Waħħal il- labra għat- taħlita mas- siringa, u bis- siringa f’ id waħda, aqbad l- ampulla miftuħa, daħħal il- labra u iġbed is- solvent kollu.
Carefully set the syringe down on the work- surface, taking care not to touch the needle.
B’ attenzjoni niżżel is- siringa fuq il- post fejn qed taħdem, u oqgħod attent li ma tmissx il- labra.
Preparation of the injection solution:
Preparazzjoni tat- taħlita likwida għall- injezzjoni:
Remove the protective cap from the Ovitrelle powder vial, pick up your syringe and slowly inject the solvent into the vial of Ovitrelle.
Neħħi l- għatu protettiv mill- fjala tat- trab ta ’ Ovitrelle, aqbad is - siringa tiegħek u bil- mod injetta s- solvent fil- fjala ta ’ l- Ovitrelle.
Swirl gently.
Ċaqlaq bil- mod.
The powder should dissolve into a clear solution immediately.
It- trab għandu jinħall f’ taħlita ċara immedjatament.
Turn the vial upside down, gently draw the solution back into the syringe.
Aqleb il- fjala rasa ‘ l isfel, iġbed bil- mod it- taħlita likwida lura fis - siringa.
Injection:
Injezzjoni:
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Ibdel il- labra u poġġi l- labra fina għat- titqib u neħħilha xi bżieżaq ta ’ l- arja li jista ’ jkun hemm: jekk tara xi bżieżaq ta ’ l- arja fis- siringa, żomm is- siringa bil- labra tipponta ‘ l fuq u bil- mod flikkja s- siringa sakemm l- arja kollha tinġabar fil- parti ta ’ fuq.
Gently push the plunger until the air bubbles are gone.
Bil - mod ibbota l- planġer sakemm il- bżieżaq ta ’ l- arja jitilqu kollha.
30 Immediately inject the solution:
30 Injetta t- taħlita likwida mill- ewwel:
Your doctor or nurse will have already advised you where to inject (e. g. tummy, front of thigh).
It- tabib jew l- infirmiera tiegħek diġà se jkunu infurmawk dwar fejn tinjetta (eż. żaqq, fil- parti ta ’ quddiem tal- koxxa).
Wipe the chosen area with an alcohol swab.
Imsaħ il- post magħżul b’ ċaruta bl- alkoħol.
Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
B’ fermezza oqros il- ġilda u daħħal il- labra f’ anglu ta ’ bejn 45° to 90° b’ moviment simili għal dak ta ’ dart.
Inject under the skin, as you were taught.
Injetta taħt il- ġilda, kif ġie spjegat lilek qabel.
Inject the solution by pushing gently on the plunger.
Injetta s - soluzzjoni billi tagħfas bil- mod il- planġer.
Take as much time as you need to inject all the solution.
Dum kemm hemm bżonn biex tinjetta t- taħlita likwida kollha.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Oħroġ il- labra mill - ewwel u naddaf il- ġilda b’ ċaruta bl- alkoħol f’ moviment ċirkolari.
Dispose of all used items:
Armi l- oġġetti wżati kollha:
Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi mill- ewwel il- labbar u il- kontenituri tal- ħġieġ kollha f’ kontenitur apposta għar- rimi ta ’ dawn l- oġġetti.
Any unused solution must be discarded.
Kull taħlita likwida li ma tintużax għandha tintrema.
If you take more Ovitrelle than you should:
Jekk tuża Ovitrelle aktar milli suppost għandek
If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described under ‘ Take special care with Ovitrelle’ and ‘ Possible side effects'.
Jekk jittieħed ammont żejjed ta ’ Ovitrelle, hemm il- possibilità li jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji, li hu deskritt f’ aktar dettall fis- sezzjoni ‘ Oqogħod attent ħafna bl- Ovitrelle ’ u ‘ X’ effetti oħra jista ’ jkollu ’.
You should consult your doctor if symptoms of this syndrome occur.
Int għandek tikkonsulta lit- tabib tiegħek jekk sintomi minn dan is - sindromu jseħħu.
If you forget to take Ovitrelle:
Jekk tinsa tieħu Ovitrelle
You should contact your doctor.
Int għandek tagħmel kuntatt mat- tabib tiegħek.
Like all medicines, Ovitrelle can cause side effects, although not everybody gets them..
Bħal kull mediċina oħra, Ovitrelle jista ’ jkollu effetti mhux mixtieqa.
The majority of side effects seen to date have been mild or moderate.
Il- parti kbira ta ’ l- effetti mhux mixtieqa li dehru s’ issa kienu ħfief jew moderati.