FrancophonIA/ELRC3.0 huggingface dataset:
English: e. Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Sa 10 ml ta' soluzzjoni għandhom jinġibdu bil-mod minn kull kunjett u jiġu dilwiti b'soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Reported in ≥ 2 patients receiving KANUMA
Maltese: Irrappurtati f'≥ 2 pazjenti li rċivew KANUMA
English: Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with sebelipase alfa; see section 4.8.
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jinkludu anafilassi Reazzjonijiet ta' sensittività eċċessiva, li jinkludu anafilassi, ġew irrappurtati f'pazjenti kkurati b'sebelipase alfa; ara sezzjoni 4.8.
English: Tmax = Time to maximum concentration CL = Clearance
Maltese: Tmax = Ħin sa konċentrazzjoni massima CL = Tneħħija Vc = Volum ċentrali ta' distribuzzjoni T1/2 = Half-life
English: If not used immediately, the diluted solution may be stored up to 24 hours at 2°C to 8°C or up to 12 hours below 25°C.
Maltese: Jekk ma tintużax immedjatament, issoluzzjoni dilwita tista' tinħażen sa 24 siegħa f'temperatura ta' 2 °C sa 8 °C jew sa 12-il siegħa f'temperatura taħt 25 °C.
English: Consistent with what was observed in KANUMA-treated patients during the double-blind period, initiation of treatment with KANUMA during the open-label period produced rapid improvements in ALT levels and in lipid parameters including LDL-cholesterol and HDL-cholesterol levels.
Maltese: B'mod konsistenti ma' dak li kien osservat f'pazjenti kkurati b'KANUMA matul il-perjodu double-blind, il-bidu ta' kura b'KANUMA matul il-perjodu open-label wassal għal titjib rapidu fil-livelli ta' ALT u fil-parametri tal-lipidi inkluż fil-livelli ta' LDL kolesterol u HDL kolesterol.
English: In LAL-CL03, 6 of 9 KANUMA-treated infants survived beyond 12 months (67% 12-month survival, 95% CI: 30% to 93%).
Maltese: L-effikaċja kienet evalwata billi tqabblet l-esperjenza ta' sopravivenza ta' pazjenti kkurati b'KANUMA li baqgħu ħajjin wara l-età ta' 12-il xahar f'LAL-CL03 ma' koorti storiku ta' trabi mhux ikkurati li kellhom defiċjenza ta' LAL b'karatteristiċi kliniċi simili. f'LAL-CL03, 6 minn 9 trabi kkurati b'KANUMA baqgħu ħajjin wara 12-il xahar (sopravivenza ta' 12-il xahar ta' 67%, CI ta' 95%: 30% sa 93%).
English: Sebelipase alfa has not been investigated in patients 2 to 4 years of age or patients aged 65 years or older.
Maltese: Sebelipase alfa ma ġiex investigat f'pazjenti b'età minn sentejn sa 4 snin jew f'pazjenti b'età ta' 65 sena jew aktar.
English: It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.
Maltese: Ittejjeb ukoll il-livelli ta' xaħmijiet fid-demm, inklużi livell għoli ta' LDL (kolesterol ħażin) u trigliċeridi.
English: For study entry, patients were required to have ALT levels of ≥1.5 X upper limit of normal (ULN).
Maltese: Biex jidħlu fl-istudju, il-pazjenti kienu meħtieġa li jkollhom livelli ta' ALT ta' ≥ 1.5 X il-limitu ta' fuq tan-normal (ULN - upper limit of normal).
English: Signs and symptoms included chest discomfort, conjunctival injection, dyspnoea, generalised and itchy rash, hyperaemia, mild eyelid oedema, rhinorrhoea, severe respiratory distress, tachycardia, tachypnoea and urticaria.
Maltese: Sinjali u sintomi jinkludu skonfort fis-sider, injezzjoni filkonġuntiva, qtugħ ta' nifs, raxx ġeneralizzat bil-ħakk, iperimija, edima ħafifa fil-kappell tal-għajn, rinorea, distress respiratorju sever, takikardija, takiapnea u urtikarja.
English: IV use after dilution
Maltese: Użu IV wara d-dilwizzjoni
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/10 ml
Maltese: INDIVIDWALI 20 mg/10 ml
English: Evaluated in patients with MEGE-MRI assessments performed (n = 32 for KANUMA; n = 25 for placebo).
Maltese: Evalwat f'pazjenti b'valuri mhux normali fil-linja bażi (n=36 għal KANUMA; n=29 għallplaċebo). ċ Evalwat f'pazjenti b'valutazzjonijiet ta' MEGE-MRI mwettqa (n=32 għal KANUMA; n=25 għallplaċebo).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, or up to 12 hours below 25°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma tintużax immedjatament, iż-żminijiet u l-kondizzjonijiet ta' ħażna qabel l-użu huma r-responsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2 °C sa 8 °C, jew sa 12-il siegħa f'temperatura taħt 25 °C, sakemm id-dilwizzjoni ma tkunx saret taħt kondizzjonijiet asettici kkontrollati u validati.
English: Adverse reactions are listed by System Organ Class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-Klassi tas-Sistemi u tal-Organi u l-frekwenza.
English: In patients who had received KANUMA during the double-blind period, reductions in ALT levels during the first 20 weeks of treatment were maintained and further improvements were seen in lipid parameters including LDL-cholesterol and HDL-cholesterol levels.
Maltese: Fil-pazjenti li kienu rċivew KANUMA matul il-perjodu double-blind, inżamm it-tnaqqis fil-livelli ta' ALT ta' matul l-ewwel 20 ġimgħa ta' kura u kien osservat aktar titjib fil-parametri tal-lipidi inkluż fil-livelli ta' LDL kolesterol u HDL kolesterol.
English: No patients developed antibodies that inhibited in vitro enzyme activity and one patient developed antibodies that inhibited cellular uptake of the enzyme in vitro.
Maltese: L-ebda pazjent ma żviluppa antikorpi li inibixxew l-attività in vitro tal-enzima u pazjent wieħed żviluppa antikorpi li inibixxew itteħid ċellulari tal-enzima in vitro.
English: Deficient LAL enzyme activity results in the lysosomal accumulation of cholesteryl esters and triglycerides.
Maltese: Attività mnaqqsa tal-enzima LAL twassal għall-akkumulazzjoni ta' lisosomi ta' cholesteryl esters u trigliċeridi.
English: Very common Chills, hyperthermia, pyrexia b,
Maltese: Komuni ħafna Dehxa ta' bard, ipertermija, deni b,
English: Placebo patients had persistently elevated serum transaminase and abnormal serum lipid levels during the double-blind period.
Maltese: Matul il-perjodu double-blind pazjenti fuq il-plaċebo kellhom b'mod persistenti livelli ta' transaminase fis-serum elevati u livelli ta' lipidi fis-serum mhux normali.
English: Based on these data, the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dose.
Maltese: Ibbażat fuq din id-dejta, il-farmakokinetika ta' sebelipase alfa dehret li mhix lineari b'żieda akbar minn proporzjonali mad-doża fl-esponiment osservata bejn id-doża ta' 1 u 3 mg/kg.
English: It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).
Maltese: Dan jintuża biex jikkura pazjenti ta' kull età b'defiċjenza ta' lysosomal acid lipase (defiċjenza ta' LAL).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KANUMA 2 mg/ml sterile concentrate sebelipase alfa
Maltese: KANUMA 2 mg/ml konċentrat sterili sebelipase alfa
English: In the liver, this accumulation leads to hepatomegaly, increased hepatic fat content, transaminase elevation signaling chronic liver injury, and progression to fibrosis, cirrhosis, and complications of end stage liver disease.
Maltese: Din il-mediċina taħdem billi tnaqqas lakkumulazzjoni ta' xaħam li jikkawża komplikazzjonijiet mediċi, inkluż indeboliment fit-tkabbir, ħsara fil-fwied u komplikazzjonijiet tal-qalb.
English: Sebelipase alfa binds to cell surface receptors via glycans expressed on the protein and is subsequently internalized into lysosomes.
Maltese: Sebelipase alfa jeħel ma' riċetturi fis-superfiċje taċ-ċellula permezz ta' glycans espressi fuq il-proteina u sussegwentement jiġi assimilat fil-lisosomi.
English: The age range of patients with biopsy evidence of cirrhosis was 4-21 years old.
Maltese: Żommu fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: KANUMA 2 mg/ml concentrate for solution for infusion
Maltese: KANUMA 2 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: ADA titres decreased to undetectable levels during continued treatment in 3 of the 4 patients.
Maltese: Titres ta' ADA naqsu għal livelli li ma setgħux jitkejlu matul kura kontinwa fi 3 mill-4 pazjenti.
English: Four (4) of 65 patients in the open label period were dose escalated to 3 mg/kg once every other week based on clinical response.
Maltese: Erbgħa (4) minn 65 pazjent fil-perjodu open label kellhom żieda fid-doża għal 3 mg/kg darba kull ġimagħtejn skont irrispons kliniku.
English: The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, swelling of the throat, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, and hives.
Maltese: L-aktar effetti sekondarji serji jistgħu jinkludu reazzjoni allerġika (osservata b'mod komuni ħafna [tista' taffettwa aktar minn persuna waħda minn kull 10] fi trabi iżgħar minn 6 xhur, jew b'mod komuni [tista' taffettwa sa persuna waħda minn kull 10] fi tfal u adulti b'sintomi li jinkludu diffikultà biex tieħu n-nifs, nefħa tal-gerżuma, nifs mgħaġġel, taħbit tal-qalb mgħaġġel, skonfort fis-sider, nefħa ħafifa tal-kpiepel tal-għajnejn, għajnejn ħomor, imnieħer iqattar, fwawar, u ħorriqija.
English: The educational material should contain:
Maltese: Kunjetti mhux miftuħa:
English: How KANUMA is given
Maltese: Mediċini oħra u KANUMA
English: In clinical studies, doses of sebelipase alfa were explored up to 5 mg/kg once weekly and no specific signs or symptoms were identified following the higher doses.
Maltese: Fi studji kliniċi, ġew esplorati dożi ta' sebelipase alfa sa 5 mg/kg darba fil-ġimgħa u ma kinux identifikati sinjali jew sintomi speċifiċi wara li ngħataw l-ogħla dożi.
English: Children and adults with LAL deficiency
Maltese: Tfal u adulti b'defiċjenza ta' LAL
English: Anaphylactic reaction, eyelid oedema
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: No adverse findings were observed in rat and rabbit embryofoetal development studies at doses up to at least 10 times the adult/children recommended dose and in rat fertility and peri- postnatal development studies at doses up to 10 times the adult/children recommended dose.
Maltese: Ma kinux osservati sejbiet ta' ħsara fi studji dwar l-iżvilupp tal-embriju u l-fetu fil-firien u fniek b'dożi sa mill-inqas 10 darbiet id-doża rakkomandata fl-adulti/tfal u fi studji dwar il-fertilità u dwar l-iżvilupp ta' qabel u wara t-twelid fil-firien b'dożi sa 10 darbiet id-doża rakkomandata fl-adulti/tfal.
English: • Details on how to monitor for potential ADA formation following initiation of treatment with Kanuma, particularly in patients on Kanuma who experience clinically important hypersensitivity reactions or potential loss of clinical response.
Maltese: • Dettalji dwar kif wieħed għandu jissorvelja għall-formazzjoni ta' ADA potenzjali wara l-bidu talkura b'Kanuma, b'mod partikolari f'pazjenti fuq Kanuma li jkollhom reazzjonijiet ta' sensittività eċċessiva klinikament importanti jew telf potenzjali ta' rispons kliniku.
English: The absolute reduction in mean ALT level was -57.9 U/l (-53%) in the sebelipase alfa-treated group and -6.7 U/l (-6%) in the placebo group.
Maltese: Titjib statistikament sinifikanti f'punti finali multipli kien osservat fil-grupp ikkurat b'sebelipase alfa meta mqabbel mal-grupp tal-plaċebo meta tlesta l-perjodu double-blind tal-istudju ta' 20 ġimgħa, kif jidher f'Tabella 3. It-tnaqqis assolut fil-livell medju ta' ALT kien ta' -57.9 U/l (-53%) fil-grupp ikkurat b'sebelipase alfa u ta' -6.7 U/l (-6%) fil-grupp tal-plaċebo.
English: Keep this leaflet.
Maltese: DATA TA' SKADENZA
English: The recommended dose in children and adults who do not present with rapidly progressive LAL deficiency prior to 6 months of age is 1 mg/kg administered as an intravenous infusion once every other week.
Maltese: Id-doża rakkomandata fi tfal u adulti li ma jkollhomx defiċjenza ta' LAL li tavanza b'mod rapidu qabel l-età ta' 6 xhur hija ta' 1 mg/kg mogħtija bħala infużjoni fil-vini darba kull ġimagħtejn.
English: KANUMA should be started at as young an age as possible and is intended for long-term use.
Maltese: KANUMA għandu jinbeda fl-iżgħar età possibbli u huwa maħsub għall-użu fit-tul.
English: dry heaving diarrhoea hives rash vomiting itching raised rash red swollen skin fever swelling chills rapid breathing not enough oxygen in the blood fast heartbeat irritability
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti fil-firien u fix-xadini, effett tossiku fuq il-fertilità, żvilupp tal-embriju u l-fetu u żvilupp ta' qabel u wara t-twelid fil-firien u fil-fniek, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Patients with known egg allergies were excluded from clinical studies (see section 4.3).
Maltese: Pazjenti magħrufa li għandhom allerġiji għall-bajd kienu esklużi minn studji kliniċi (ara sezzjoni 4.3).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed ta' 10 ml
English: Date of latest renewal: 16 May 2018.
Maltese: Data tal-aħħar tiġdid: 16 ta 'Mejju, 2018.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Germany
Maltese: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Il-Ġermanja
English: In adult men
Maltese: F'nisa adulti
English: Gynaecomastia, varicocele
Maltese: Ġinekomastija, varikoċele
English: Benzyl alcohol may cause allergic reactions.
Maltese: Benzyl alcohol jista' jikkawża reazzjonijiet allerġiċi.
English: The pH of the solution is 6.8-7.2.
Maltese: Il-pH tas-soluzzjoni hu 6.8-7.2.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2013.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Settembru, 2013.
English: • Acne
Maltese: • Akne
English: Table 2: Adverse reactions in men System organ class
Maltese: Tabella 2: Reazzjonijiet avversi fl-irġiel Sistema tal-klassifika talorgani
English: Ovaleap is a biosimilar medicinal product.
Maltese: Ovaleap huwa prodott mediċinali bijoloġiku simili.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati taħt il-kategoriji ta' frekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 1: Adverse reactions in women System organ class
Maltese: Tabella 1: Reazzjonijiet avversi fin-nisa Sistema tal-klassifika talorgani
English: The maximum daily dose is 450 IU.
Maltese: Id-doża massima ta' kuljum hi ta' 450 IU.
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Maltese: Wara li jingħata minn taħt il-ġilda, il-bijodisponibbilità assoluta hi ta' madwar 70%.
English: • primary testicular insufficiency.
Maltese: • insuffiċenzja primarja tat-testikoli.
English: Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Maltese: Meta jingħata ripetutament, follitropin alfa jakkumula sa 3 darbiet aktar u jilħaq l-istat fiss wara 3-4 ijiem.
English: Complication of severe OHSS
Maltese: Kumplikazzjoni ta' OHSS severa
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Maltese: Ormoni sesswali u modulatori tas-sistemi ġenitali, gonadotropins, Kodiċi ATC:
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Maltese: Evalwazzjoni klinika tista' tiżvela ipovolemija, emokonċentrazzjoni, żbilanċ ta' elettroliti, axxite, emoperitonew, effużjoni plewrali, idrotoraċi jew insuffiċjenza akuta pulmonari.
English: INFORMATION IN BRAILLE Ovaleap 300 IU/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Ovaleap 300 IU/0.5 mL
English: Differences between the 2 groups were statistically significant (p < 0.05) for all criteria listed.
Maltese: Differenzi bejn iż-żewġ gruppi kienu statistikament sinifikanti (p < 0.05) għal kriterji kollha elenkati.
English: • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1;
Maltese: • Sensittività eċċessiva għal follitropin alfa, FSH jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1;
English: Excipients: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, water for injections.
Maltese: Eċċipjenti: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (għal aġġustament talpH), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, ilma għallInjezzjonijiet.
English: What Ovaleap contains - The active substance is follitropin alfa.
Maltese: X'fih Ovaleap - Is-sustanza attiva hi follitropin alfa.
English: • primary ovarian failure;
Maltese: • insuffiċjenza primarja tal-ovarji;
English: Independent risk factors for developing OHSS include polycystic ovarian syndrome high absolute or rapidly rising serum oestradiol levels (e.g. > 900 pg/mL or > 3,300 pmol/L in anovulation; > 3,000 pg/mL or > 11,000 pmol/L in ART) and large number of developing ovarian follicles (e.g. > 3 follicles of ≥ 14 mm in diameter in anovulation; ≥ 20 follicles of ≥ 12 mm in diameter in ART).
Maltese: Il-fatturi indipendenti ta' riskju għal żvilupp ta' OHSS jinkludu s-sindrome poliċistiku tal-ovarji, livelli assoluti għoljin ta' oestradiol fis-serum jew li jiżdiedu b'mod mgħaġġel (eż. > 900 pg/mL jew > 3,300 pg/mL mhux f'ovulazzjoni; > 3,000 pg/mL jew > 11,000 pg/mL f'ART) u numru kbir ta' follikuli tal-ovarji li jkunu qed jiżviluppaw (eż. > 3 follikuli b'dijametru ta' ≥ 14 fin-nuqqas ta' ovulazzjoni; ≥ 20 follikolu b'dijametru ta' ≥ 12 mm f'ART).
English: Table 3: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in ART)
Maltese: Tabella 3: Riżultati ta' studju GF 8407 (studju randomised, bi grupp parallel, li jqabbel l-effikaċja u s-sigurtà ta' follitropin alfa ma' FSH urinarju f'ART) follitropin alfa (n = 130)
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
Maltese: • Stimulazzjoni ta' żvilupp follikulari multiplu f'nisa li qed issirilhom ovulazzjoni mgħaġġla għal teknoloġiji ta' riproduzzjoni assistita (ART) bħal fertilizzazzjoni in vitro (IVF), trasferiment ta' gameti fit-tubu fallopjan u trasferiment taż-żigot fit-tubu fallopjan.
English: • malformations of sexual organs incompatible with pregnancy;
Maltese: • malformazzjoni tal-organi sesswali li jkunu inkompatibbli mat-tqala;
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Maltese: Rarament ħafna, OHSS sever jista' jkun ikkomplikat minn brim talovarji jew avvenimenti tromboemboliċi bħal emboliżmu pulmonari, puplesija iskemika jew infart mijokardijaku.
English: Do not use Ovaleap:
Maltese: Tużax Ovaleap:
English: Ovaleap is indicated for use in infertility (see section 4.1).
Maltese: Ovaleap hu indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: *Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.
Maltese: *Follitropin alfa (ormon uman rikombinanti li jistimula l-follikuli [r-hFSH]) hu magħmul fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO DHFR-) mit-teknoloġija tad-DNA rikombinanti.
English: • tumours of the hypothalamus or pituitary gland;
Maltese: • tumuri fl-ipotalamu jew fil-glandola pitwitarja;
English: Thromboembolic events
Maltese: Effetti tromboemboliċi
English: For instructions on the administration with the Ovaleap Pen, see section 6.6.
Maltese: Għal istruzzjonijiet dwar l-għoti bil-Ovaleap Pen, ara sezzjoni 6.6.
English: • This medicine is usually given every day.
Maltese: • Normalment din il-mediċina tingħata kuljum.
English: Sodium dihydrogen phosphate dihydrate Sodium hydroxide (2 M) (for pH adjustment) Mannitol
Maltese: Sodium hydroxide (2 M) (għal aġġustament tal-pH) Mannitol
English: 4.8 Undesirable effects Summary of the safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: • The usual starting dose of Ovaleap is 75 to 150 IU together with 75 IU of lutropin alfa.
Maltese: • Id-doża tal-bidu normali ta' Ovaleap hi ta' 75 sa 150 IU flimkien ma' 75 IU ta' lutropin alfa.
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Maltese: Uġigħ addominali, nefħa addominali, skumdità addominali, dardir, rimettar, dijarea
English: This is a condition that may be passed on from parents to children which means that you have an inability to break down porphyrins (organic compounds).
Maltese: Din hi kundizzjoni li tista' tintiret mill-ġenituri li tfisser li inti ma tkunx kapaċi tkisser ilporphyrins (komposti organiċi).
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Maltese: • Reazzjonijiet lokali fis-sit tal-injezzjoni, bħal uġigħ, ħmura, tbenġil, nefħa u/jew irritazzjoni
English: Benzalkonium chloride content Ovaleap contains 0.02 mg/mL of benzalkonium chloride
Maltese: Ovaleap fih 0.02 mg/mL ta' benzalkonium chloride Kontenut ta' Benzyl alcohol
English: Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½") Pack size of 1 cartridge and 10 injection needles.
Maltese: Labar tal-injezzjoni (stainless steel: 0.33 mm x 12 mm, 29 G x ½") Daqs tal-pakkett ta' skartoċċ 1 u 10 labar tal-injezzjoni.
English: In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Maltese: Fl-istudji kliniċi, intweriet żieda fis-sensittività tal-ovarji għal follitropin alfa meta dan ingħata ma' lutropin alfa.
English: Adherence to recommended follitropin alfa dose and regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Maltese: L-osservanza tad-doża u tal-kors tal-għoti rakkomandati ta' follitropin alfa, jistgħu jnaqqsu r-riskju ta' stimulazzjoni eċċessiva tal-ovarji (ara sezzjonijiet 4.2 u 4.8).
English: • When you get the desired response, you will be given hCG or “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique).
Maltese: • Meta tikseb ir-rispons mixtieq, tingħata hCG jew “hCG rikombinanti” (r-hCG, hCG magħmul f'laboratorju permezz ta' teknika speċjali ta' DNA).
English: In adult men, Ovaleap is used:
Maltese: F'irġiel adulti, Ovaleap jintuża:
English: Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½") Pack size of 1 cartridge and 20 injection needles.
Maltese: Labar tal-injezzjoni (stainless steel: 0.33 mm x 12 mm, 29 G x ½") Daqs tal-pakkett ta' skartoċċ wieħed u 20 labra tal-injezzjoni.
English: For example, following two weeks of treatment with an agonist, 150-225 IU follitropin alfa are administered for the first 7 days.
Maltese: Pereżempju, wara ġimgħatejn ta' kura b'agonist, 150-225 IU ta' follitropin alfa jingħataw għall-ewwel 7 ijiem.