FrancophonIA/ELRC3.0 huggingface dataset:
English: CLOBUTINOL CONTAINING MEDICINAL PRODUCTS WITH MARKETING AUTHORISATION IN THE EUROPEAN UNION Member State
Maltese: PRODOTTI MEDIĊINALI LI FIHOM CLOBUTINOL B'AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-UNJONI EWROPEA Stat Membru
English: Belgium
Maltese: FRANCE
English: Hustenstillerratiopharm Clobutinol ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Hustenstillerratiopharm Clobutinol ratiopharm GmbH Graf-Arco-Str.
English: Rofatuss N 40 mg Capsule, hard
Maltese: Rofatuss N 40 mg Kapsula, iebsa
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA' ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TALPRODOTTI MEDIĊINALI, MNEJN JINGĦATAW U D-DETENTURI TA' LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: 80 mg Capsule, hard ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: 80 mg Kapsula, iebsa ratiopharm GmbH Graf-Arco-Str.
English: 60 mg/ml Oral Solution, Drops
Maltese: 60 mg/ml Qtar orali, soluzzjoni
English: 80 mg Capsule, hard
Maltese: 80 mg Kapsula, iebsa
English: 40 mg Capsule, hard
Maltese: 40 mg Kapsula, iebsa
English: Syrup
Maltese: Soluzzjoni
English: Reizhusten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: 3 D-89079 Ulm
English: Difference [95% CI]
Maltese: Differenza (95% CI)
English: Safety - immunogenicity
Maltese: Sigurtà - immunoġeniċità
English: 0.66 (priming dose)
Maltese: 0.66 (doża Priming)
English: (Dial to 11)
Maltese: (Iddajalja sa 11)
English: The absolute bioavailability is about 64%.
Maltese: Il-bijodisponibilità assoluta hi ta' madwar 64%.
English: 20 (Dial to 20)
Maltese: 20 (Iddajalja sa 20)
English: Manufacturer Ferring GmbH Wittland 11
Maltese: Manifattur Ferring GmbH Wittland 11
English: Gonadotropins are involved in reproduction and fertility.
Maltese: Gonadotropins huma involuti fir riproduzzjoni u l-fertilità.
English: - The active substance is follitropin delta.
Maltese: Is-sustanza attiva hi follitropin delta.
English: The maximum daily dose is 24 micrograms.
Maltese: Id-doża massima ta' kuljum hi ta' 24 mikrogramma.
English: OHSS is an intrinsic risk of the ovarian stimulation.
Maltese: OHSS hu riskju intrinsiku tal-istimulazzjoni tal-ovarji.
English: • Read Step 11 and 12 at Page 14 to 151 before giving your injection.
Maltese: • Aqra Pass 11 u 12 fuq Paġna 14 u 151 qabel ma tagħti l-injezzjoni tiegħek.
English: Clear and colourless solution with a pH of 6.0-7.0.
Maltese: Soluzzjoni ċara u bla kulur b'pH ta' 6.0-7.0.
English: mcg: micrograms
Maltese: (f'mikrogrammi)
English: 18 and 2 lines (Dial to 18 plus 2 clicks)
Maltese: 18 u 2 linji (Iddajalja sa 18 u 2 klikks)
English: The pen is available in 3 different strengths:
Maltese: Il-pinna hi disponibbli fi 3 qawwiet differenti:
English: • 72 micrograms/2.16 mL
Maltese: • 72 mikrogramma/2.16 mL
English: Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes.
Maltese: Tqala multipla ġġorr riskju miżjud ta' riżultati avversi materni u perinatali.
English: Store at or below 25 °C.
Maltese: Aħżen f'temperatura ta' 25°C jew inqas.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA10
Maltese: Ormoni tas-sess u modulatori tas-sistemi ġenitali, gonadotropins, Kodiċi ATC:
English: The incidence of anti-FSH antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
Maltese: FSH wara l-kura b'REKOVELLE kienet ta' 1.1% f'ċiklu 1, 0.8% f'ċiklu 2 u 1.1% f'ċiklu 3.
English: The REKOVELLE dose is stated in micrograms.
Maltese: Id-doża ta' REKOVELLE hi f'mikrogrammi.
English: Suomi/Finland Ferring Lääkkeet Oy
Maltese: Suomi/Finland Ferring Lääkkeet Oy Puh/Tel:
English: Store in refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2° C - 8 °C).
English: REKOVELLE is dosed in micrograms (see section 5.1).
Maltese: REKOVELLE jingħata f'doża ta' mikrogrammi (ara sezzjoni 5.1).
English: Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).
Maltese: Immunoġeniċità skont l-iżvilupp ta' antikorpi kontra FSH hu riskju potenzjali ta' terapija b'gonadotropin (ara sezzjoni 5.1).
English: • 36 micrograms/1.08 mL
Maltese: • 36 mikrogramma/1.08 mL
English: • 12 micrograms/0.36 mL
Maltese: • 12-il mikrogramma/0.36 mL
English: Blood clotting problems (thromboembolic events)
Maltese: Problemi bl-emboli tad-demm (avvenimenti tromboemboliċi)
English: Among patients with AMH ≥15 pmol/L, the ovarian response with REKOVELLE (N=355) and follitropin alfa (N=353), respectively, was as follows: mean number of oocytes retrieved 11.6 ± 5.9 and 13.3 ± 6.9, and proportion of patients with ≥20 oocytes 10.1% (36/355) and 15.6% (55/353).
Maltese: ≥15 pmol/L, ir-rispons tal-ovarji b'REKOVELLE (N=355) u follitropin alfa (N=353), rispettivament, kien kif ġej: medja tan-numru ta' ooċiti miksuba 11.6 ± 5.9 u 13.3 ± 6.9, u lproporzjon ta' pazjenti b'≥20 ooċita kien ta' 10.
English: Step 11 and 12:
Maltese: Pass 11 u 12:
English: • The number ‘0' is lined up with the dose indicator.
Maltese: • In-numru ‘0' ikun bi dritt mal-indikatur tad-doża.
English: The ESTHER-1 trial was a randomised, assessor-blinded, controlled trial in 1,326 IVF/ICSI patients.
Maltese: Il-prova ESTHER-1 kienet prova kkontrollata li fiha l-parteċipanti ntgħażlu b'mod każwali, assessorblinded, li saret fuq 1,326 pazjenta b'IVF/ICSI.
English: (See Steps 3 to 6), and repeat priming (See Steps 7 to 9).
Maltese: Passi 3 sa 6), u irrepeti l-Priming (Ara Passi 7 sa 9).
English: Ovulatory patients with polycystic ovaries have been included in clinical trials (see section 5.1).
Maltese: Pazjenti ovulatorji b'ovarji poliċistiċi ġew inklużi fil-provi kliniċi (ara sezzjoni 5.1).
English: In ovulatory patients with polycystic ovaries, the incidence of early moderate/severe OHSS and/or preventive interventions for early OHSS was 7.7% with REKOVELLE and 26.7% with follitropin alfa.
Maltese: F'pazjenti ovulatorji b'ovarji poliċistiċi, l-inċidenza ta' OHSS bikri moderat/sever u/jew interventi ta' prevenzjoni għal OHSS bikri, kienet ta' 7.7% b'REKOVELLE u 26.7% b'follitropin alfa.
English: Ovarian and other reproductive system tumours
Maltese: Tumuri tal-ovarji u tumuri oħrajn tas-sistema riproduttiva
English: Ovarian hyperstimulation syndrome
Maltese: Sindrome tal-iperstimulazzjoni tal-ovarji
English: INFORMATION IN BRAILLE REKOVELLE 72 micrograms/2.16 mL
Maltese: INFORMAZZJONI BIL-BRAILLE REKOVELLE 72 mikrogramma/2.16 ml
English: 12 and 1 line (Dial to 12 plus 1 click)
Maltese: 12 u 1 linja (Iddajalja sa 12 u 1 klikk)
English: Constipation Abdominal discomfort
Maltese: Skonfort addominali
English: 0 and 2 lines (Dial to 0 plus 2 clicks)
Maltese: 0 u 2 linji (Iddajalja sa 0 u 2 klikks)
English: Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial REKOVELLE in an individualised dosing regimen (N=665)
Maltese: Rata ta' tqala kurrenti u rata ta' impjantazzjoni kurrenti fil-prova ESTHER-1 REKOVELLE f'kors ta' dożaġġ individwalizzat (N=665)
English: Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections
Maltese: Eċċipjenti: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, phosphoric acid konċentrat, sodium hydroxide, ilma għall-injezzjonijiet
English: REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins.
Maltese: REKOVELLE fih follitropin delta, ormon li jistimula l-follikuli (follicle stimulating hormone) li jappartjeni għall-familja ta' ormoni msejħa gonadotropins.
English: INFORMATION IN BRAILLE REKOVELLE 36 micrograms/1.08 mL
Maltese: INFORMAZZJONI BIL-BRAILLE REKOVELLE 36 mikrogramma/1.08 ml
English: One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology.
Maltese: 1 mL ta' soluzzjoni fih 33.3 mikrogramma ta' follitropin delta* *ormon uman rikombinanti li jistimula l-follikuli (FSH, follicle-stimulating hormone) prodott f'razez ta' ċelluli tal-bniedem (PER.C6) minn teknoloġija ta' DNA rikombinanti.
English: INFORMATION IN BRAILLE REKOVELLE 12 micrograms/0.36 mL
Maltese: INFORMAZZJONI BIL-BRAILLE REKOVELLE 12-il mikrogramma/0.36 ml
English: • See “Disposal” at Page 181.
Maltese: • Ara “Rimi” fuq Paġna 181.
English: • Prepare and prime a new pen (Step 1 to 9).
Maltese: • Ipprepara u pprajmja pinna ġdida (Pass 1 sa 9).
English: Table 1 Dosing regimen
Maltese: Tabella 1 Kors ta' dożaġġ
English: Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment (see section 4.4).
Maltese: Torsjoni tal-ovarji u avvenimenti tromboemboliċi huma magħrufa bħala kumplikazzjonijiet rari tal-kura tal istimulazzjoni tal-ovarji (ara sezzjoni 4.4).
English: 0 and 1 line (Dial to 0 plus 1 click)
Maltese: 0 u 1 linja (Iddajalja sa 0 u 1 klikk)
English: Fertility REKOVELLE is indicated for use in infertility (see section 4.1).
Maltese: REKOVELLE hu indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: • Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms.
Maltese: • Id-dożi għandhom jitqarrbu (rounded) lejn l-eqreb inkrement, X.00, X.33 jew X.66 mikrogrammi.
English: Follitropin delta is a recombinant human FSH.
Maltese: Follitropin delta hu FSH uman rikombinanti.
English: REKOVELLE contains sodium
Maltese: Kontenut tas-sodium
English: Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Maltese: Fil-medda tad-doża terapewtika, l esponiment għal follitropin delta jiżdied proporzjonalment mad-doża.
English: • The dose scale of the pen is numbered from 0 to 20 micrograms.
Maltese: • L-iskala tad-doża tal-pinna hi enumerata minn 0 sa 20 mikrogramma.
English: Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta.
Maltese: Minħabba li follitropin delta hu prodott fir-razza ta' ċelluli umani PER.C6, il-profil ta' glikosilazzjoni hu differenti minn follitropin alfa u follitropin beta.
English: Women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (body mass index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins.
Maltese: Nisa b'mard tromboemboliku riċenti jew li għadu għaddej, jew nisa b'fatturi ta' riskju ġeneralment rikonoxxuti għal avvenimenti tromboemboliċi, bħal storja medika personali jew familjari, obeżità severa (indiċi tal-massa tal-ġisem ta' >30 kg/m2) jew trombofilija, jista' jkollhom riskju miżjud ta' avvenimenti tromboemboliċi venużi jew arterjali, matul jew wara l-kura b'gonadotropins.
English: 2 and 1 line (Dial to 2 plus 1 click)
Maltese: 2 u 1 linja (Iddajalja sa 2 u 1 klikk)
English: Table 2 Adverse reactions in pivotal clinical trials System Organ Class
Maltese: Tabella 2 Frekwenza ta' reazzjonijiet avversi fil-provi kliniċi importanti ħafna Sistema tal-Klassifika tal
English: • you have malformations of the sexual organs which make a normal pregnancy impossible
Maltese: • jekk int għandek malformazzjonijiet tal-organi sesswali, li jagħmlu tqala normali impossibbli
English: Pelvic pain Adnexa uteri pain Pelvic discomfort
Maltese: Uġigħ pelviku Uġigħ adnexa uteri
English: Single blastocyst transfer on day 5 was compulsory with the exception of patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts were available.
Maltese: Trasferiment wieħed ta' blastocysts f'jum 5 kien obbligatorju, bl-eċċezzjoni ta' pazjenti li kellhom 38-40 sena, li fihom twettaq trasferiment doppju ta' blastocysts, jekk ma kien hemm disponibbli l-ebda blastocysts ta' kwalità tajba.
English: The first injection should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni għandha tingħata taħt superviżjoni medika diretta.
English: One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution.
Maltese: 1 mL ta' soluzzjoni fih 33.3 mikrogramma ta' follitropin delta f'kull millilitru ta' soluzzjoni.
English: Anti-FSH antibodies were measured pre-dosing and post-dosing in patients undergoing up to three repeated treatment cycles with REKOVELLE (665 patients in cycle 1 in the ESTHER-1 trial as well as 252 patients in cycle 2 and 95 patients in cycle 3 in the ESTHER-2 trial).
Maltese: FSH tkejlu qabel id-dożaġġ u wara d-dożaġġ f'pazjenti li kien qed ikollhom sa tliet ċikli ta' kura ripetuti b'REKOVELLE (665 pazjenta f'ċiklu 1 fil-prova ESTHER-1, kif ukoll 252 pazjenta f'ċiklu 2 u 95 pazjenta f'ċiklu 3 fil-prova ESTHER-2).
English: The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred, respectively.
Maltese: Iż-żewġ punti aħħarin koprimarji kienu r-rata ta' tqala kurrenti u r-rata ta' impjantazzjoni kurrenti fiċ-ċiklu l-ġdid, definita bħala mill-inqas fetu vijabbli wieħed ġol-utru, 10-11-il ġimgħa wara t-trasferiment, u n-numru ta' feti vijabbli ġol-utru 10-11-il ġimgħat wara t-trasferiment, diviż bin-numru ta' blastocysts ttrasferiti, rispettivament.
English: Following daily administration of equal IU doses of REKOVELLE and follitropin alfa as determined in the rat in vivo bioassay (Steelman-Pohley assay), higher ovarian response (i.e. estradiol, inhibin B and follicular volume) was observed in patients after administration of REKOVELLE compared to follitropin alfa.
Maltese: Wara l-għoti ta' kuljum ta' dożi indaqs ta' IU ta' REKOVELLE u follitropin alfa kif stabbilit fil bijoassaġġ in vivo tal-firien (assaġġ ta' Steelman-Pohley), rispons ogħla tal-ovarji (i.e., estradiol, inhibin B u volum follikulari) ġie osservat fil-pazjenti wara l-għoti ta' REKOVELLE meta mqabbel ma' follitropin alfa.
English: Step 3: • Pull off the protective foil from the needle.
Maltese: Pass 3: • Iġbed il-fojl protettiv mil-labra.
English: Information about your REKOVELLE pre-filled pen The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in marked increments of 0.33 micrograms.
Maltese: Il-pinna tista' tiġi ddajaljata biex tagħti doża minn 0.33 mikrogramma sa 20 mikrogramma ta' REKOVELLE f'inkrementi mmarkati ta' 0.33 mikrogramma.
English: If the AMH concentration is in ng/mL, the concentration should be converted to pmol/L by multiplying with 7.14 (ng/mL x 7.14 = pmol/L) before use.
Maltese: billi tiġi mmultiplikata b'7.14 (ng/mL x 7.14=pmol/L) qabel l-użu. mcg: mikrogrammi
English: Frequently Asked Questions (FAQ)
Maltese: Mistoqsijiet li Jsiru Sikwit (FAQ, Frequently Asked Questions)
English: There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive technology treatment.
Maltese: Kien hemm rapporti ta' liwi tal-ovarji (torsjoni tal-ovarji) wara kura b'teknoloġija riproduttiva assistita.
English: (listed in section 6)
Maltese: (Tabella 1).
English: cz1-info@ferring.com
Maltese: cz1-info@ferring.com ferring@ferring.hu
English: REKOVELLE 12 micrograms/0.36 mL solution for injection REKOVELLE 36 micrograms/1.08 mL solution for injection REKOVELLE 72 micrograms/2.16 mL solution for injection
Maltese: REKOVELLE 12-il mikrogramma/0.36 ml soluzzjoni għall-injezzjoni REKOVELLE 36 mikrogramma/1.08 ml soluzzjoni għall-injezzjoni REKOVELLE 72 mikrogramma/2.16 ml soluzzjoni għall-injezzjoni
English: (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Maltese: Mhux komuni (≥1/1,000 sa <1/100)
English: In general, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 250 micrograms or 5,000 IU for final development of the follicles.
Maltese: B'mod ġenerali, inti se tingħata injezzjoni waħda ta' mediċina msejħa gonadotrophin korjoniku uman (hCG, human chorionic gonadotrophin) f'doża ta' 250 mikrogramma jew 5,000 IU għall-iżvilupp finali tal follikuli.
English: Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Maltese: Stimulazzjoni kkontrollata tal-ovarji għall-iżvilupp ta' follikuli multipli f'nisa li jkunu qed jirċievu teknoloġiji riproduttivi assistiti (ART, assisted reproductive technologies) bħal fertilizzazzjoni in vitro (IVF, in vitro fertilisation) jew ċiklu ta' injezzjoni ta' sperma intraċitoplażmatika (ICSI,
English: The relevance of these findings for the clinical use of REKOVELLE is limited.
Maltese: Ir rilevanza klinika ta' dawn is-sejbiet għall-użu kliniku ta' REKOVELLE hi limitata.
English: • Throw away (dispose of) the used needle carefully (D).
Maltese: • Armi l-labra użata b'attenzjoni (D).
English: Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome.
Maltese: Gonadotropins bħal din il-mediċina, jistgħu jikkawżaw is-sindrome tal-iperstimulazzjoni tal-ovarji .
English: • malformations of sexual organs incompatible with pregnancy
Maltese: • malformazzjonijiet tal-organi sesswali inkompatibbli mat-tqala • tumuri fibrojdi tal-utru inkompatibbli mat-tqala
English: The terminal elimination half-life after single subcutaneous administration is 40 hours and after multiple subcutaneous administration is 28 hours.
Maltese: L-eliminazzjoni tal-half-life terminali wara għoti wieħed taħt il-ġilda hi ta' 40 siegħa, u wara għoti multiplu taħt il-ġilda hi ta' 28 siegħa.
English: The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH antagonist protocol.
Maltese: REKOVELLE, fejn id-doża ta' kuljum ġiet stabbilita għal kull pazjenta, u ġiet iffissata matul listimulazzjoni mingħajr l-ebda aġġustamenti (ara sezzjoni 4.2) lil follitropin alfa filled-by-mass, b'doża tal-bidu ta' 11-il mikrogramma (150 IU) għall-ewwel ħamest ijiem, segwita minn aġġustamenti fid-doża minn jum 6 ta' stimulazzjoni, ibbażat fuq l-iżvilupp follikulari fi protokoll ta' antagonist ta' GnRH. Il-pazjenti kellhom sa 40 sena u kellhom ċikli mestrwali regolari, li kienu preżunti li kienu ovulatorji.
English: A single injection of 250 micrograms recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final follicular maturation.
Maltese: gonadotropins korjoniċi umani (hCG, human chorionic gonadotropin) rikombinanti, jew 5,000 IU hCG tingħata biex tinduċi l-maturazzjoni follikulari finali.
English: • Ovarian hyperstimulation syndrome (see above)
Maltese: • Sindrome tal-iperstimulazzjoni tal-ovarji (ara hawn fuq)
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Maltese: tiżvela ipovolemija, emokonċentrazzjoni, żbilanċi fl-elettroliti, axxite, emoperitonew, ħruġ ta' likwidu mill-plewra, idrotoraċi jew problemi pulmonari akuti.
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Maltese: Rari ħafna, OHSS severa tista' tkun ikkumplikata minn torsjoni tal-ovarji jew avvenimenti tromboemboliċi bħal emboliżmu pulmonari, aċċessjoni iskemika jew infart mijokardijaku.
English: Puh/Tel: +358 207 401 440 info@ferring.fi
Maltese: +358 207 401 440 info@ferring.fi
English: In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa (N=643) at a starting dose of 150 IU followed by dose adjustments.
Maltese: Fil-popolazzjoni globali tal-provi, il-medja tan-numru ta' ooċiti miksuba kien ta' 10.0 ± 5.6 b'REKOVELLE (N=636) fil-kors ta' dożaġġ individwalizzat u 10.4 ± 6.5 b'follitropin alfa (N=643)
English: How to store REKOVELLE 6.
Maltese: Kif taħżen REKOVELLE 6.
English: No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins.
Maltese: L-ebda riskju teratoġeniku ma kien irrappurtat wara stimulazzjoni kkontrollata tal-ovarji, fl-użu kliniku b'gonadotropins.
English: See “Examples of how to dial a dose” at Page 20 to 211.
Maltese: Ara “Eżempji ta' kif tiddajalja doża” fuq Paġna 20 sa 211.
English: • ovarian, uterine or mammary carcinoma (see section 4.4)
Maltese: • karċinoma tal-ovarji, tal-utru jew tas-sider (ara sezzjoni 4.4)
English: Before use - (Step 1)
Maltese: Qabel l-użu - (Pass 1) Pass 1:
English: • Keep the pen cap on the pen when it is not in use.
Maltese: • Iċċekkja d-data ta' skadenza fuq it-tikketta tal-pinna.
English: Priming - (Step 7 to 9)
Maltese: Kif tipprepara l-labra (Priming) - (Pass 7 sa 9)
English: Do not use REKOVELLE if:
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ:
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see section 5.1).
Maltese: M'hemm l-ebda esperjenza ta' provi kliniċi b'REKOVELLE fil-protokoll ta' agonist GnRH twil (ara sezzjoni 5.1).
English: • If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.
Maltese: • Jekk ma tidher l-ebda qatra(qtar), irrepeti Passi 7 sa 9 (Priming) sakemm tidher qatra.
English: For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight.
Maltese: Għan-nisa b'AMH ta' <15 pmol/L, id-doża ta' kuljum hi ta' 12il mikrogramma, irrispettivament mill-piż tal-ġisem.
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol.
Maltese: M'hemm l-ebda esperjenza ta' provi kliniċi b'REKOVELLE fil-protokoll ta' agonist GnRH twil.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2016
Maltese: 12 diċembru 2016
English: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Zone POB 571
Maltese: Bio-Technology General (Israel) Ltd.
English: • Store the pen in a refrigerator at 2 °C to 8 °C.
Maltese: • Aħżen il-pinna fi friġġ f'temperatura bejn 2°C sa 8°C.
English: The amino acid sequences of the two FSH subunits in follitropin delta are identical to the endogenous human FSH sequences.
Maltese: Is-sekwenzi ta' amino acids taż-żewġ sottounitajiet ta' FSH f'follitropin delta huma identiċi għas-sekwenzi FSH umani endoġeni.
English: • Keep pressing the injection button in and when you see the number ‘0' lined up with the dose indicator, wait for 5 seconds (slowly count to 5).
Maltese: • Kompli agħfas il-buttuna tal-injezzjoni 'l isfel, u meta tara n-numru ‘0' bi dritt mal-indikatur tad-doża, stenna għal 5 sekondi (bil-mod għodd sa 5).
English: The trial demonstrated that REKOVELLE was at least as effective as follitropin alfa in terms of ongoing pregnancy rate and ongoing implantation rate, as shown in Table 3.
Maltese: Il-prova wriet li REKOVELLE kien mill-inqas effettiv daqs follitropin alfa f'termini ta' rata ta' tqala kurrenti u rata ta' impjantazzjoni kurrenti, kif muri f'Tabella 3.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Maltese: REKOVELLE 12-il mikrogramma/0.36 ml soluzzjoni għall-injezzjoni follitropin delta