FrancophonIA/ELRC3.0 huggingface dataset:
English: It is though known that the second generation fluoroquinolones (ciprofloxacin, ofloxacin and levofloxacin) show higher serum concentrations and a more favourable tissue distribution than norfloxacin.
Maltese: Madankollu huwa magħruf li l-fluworokinoloni tat-tieni ġenerazzjoni (ciprofloxacin, ofloxacin u levofloxacin) juru konċentrazzjoni tas-serum ogħla u distribuzzjoni fit-tessuti aktar favorevoli minn norfloxacin.
English: • The Committee, as a consequence, concluded that the benefit/risk balance of oral norfloxacin containing medicinal products is negative in the above indication.
Maltese: • Il-Kumitat, għaldaqstant, ikkonkluda li r-relazzjoni bejn il-benefiċċju u r-riskju ta' prodotti mediċinali orali li fihom norfloxacin huwa negattiv fl-indikazzjoni msemmija hawn fuq.
English: The data submitted did not demonstrate that serum levels after oral treatment with norfloxacin are adequate for eradicating pathogens involved in bacteraemia associated with complicated pyelonephritis.
Maltese: Id-dejta ppreżentata ma wrietx li, wara trattament orali b'norfloxacin, il-livelli tas-serum huma adegwati għall-eradikazzjoni tal-aġenti patoġeni involuti fil-batterjemija assoċjata mal-pjelonefrite kumplikata.
English: Further to the discussion held in May 2008, the CHMP agreed that the second generation of fluoroquinolones result in higher serum concentrations than norfloxacin.
Maltese: Wara d-diskussjoni li saret f'Mejju 2008, is-CHMP qabel li l-fluworokinoloni tat-tieni ġenerazzjoni jirriżultaw f'konċentrazzjonijiet tas-serum ogħla minn norfloxacin.
English: - Complicated pyelonephritis can be treated orally or intravenously (according to local treatment policy and diagnostic criteria used for defining complicated infection).
Maltese: - Il-pjelonefrite kumplikata tista' tiġi ttrattata b'formulazzjonijiet orali jew intravenużi (skont irregoli lokali dwar it-trattamenti u l-kriterji dijanjostiċi użati għad-definizzjoni ta' infezzjoni kumplikata).
English: Merck Sharp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Belgium
Maltese: Il-Lussemburgu Merck Sharp & Dohme Chaussée de Waterloo 1135
English: Additionally, the relationship between the Pharmacokinetic and the Pharmacodynamic of orally administered norfloxacin in the treatment of complicated pyelonephritis was been established.
Maltese: Barra minn hekk, ġiet stabbilita r-rabta bejn il-farmakokinetika u l-farmakodinamika ta' norfloxacin amministrat oralment fit-trattament ta' pjelonefrite kumplikata.
English: Capsule
Maltese: Pillola
English: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Maltese: Sandoz GmbH, Biochemiestrasse 10, 6250
English: Norfloxacin 400mg 400mg
Maltese: Norfloxacin 400mg
English: • The Committee considered that Marketing Authorisation Holders did not present data demonstrating that norfloxacin taken orally presents efficacy in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms;
Maltese: • Il-Kumitat ikkonkluda li ma setax jibqa' jiġi appoġġjat l-użu orali ta' prodotti mediċinali li fihom norfloxacin fit-trattament ta' pjelonefrite akuta jew kronika kumplikata minħabba organiżmi suxxettibbli;
English: Norfloxacin 400 mg 400mg
Maltese: Norfloxacin 400 mg
English: Luxembourg
Maltese: Italy
English: Whereas
Maltese: So.
English: Norfloxacine Arrow 400 mg
Maltese: Norfloxacine Arrow 400 mg Pillola
English: Norfloxacin Sandoz 200 mg
Maltese: Norfloxacin Sandoz
English: Coated tablet
Maltese: Uroctal Comprimidos
English: 18 May 2018
Maltese: Laqgħa tas-CMDh Marzu 2018
English: 18 April 2018
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri: 18/05/2018
English: 1082 MA Amsterdam The Netherlands
Maltese: 1082 MA Amsterdam
English: • The active substance is lutropin alfa.
Maltese: • Is-sustanza attiva hi lutropin alfa.
English: INFORMATION IN BRAILLE luveris 75 iu
Maltese: INFORMAZZJONI BIL-BRAILLE luveris 75 iu
English: EU/1/00/155/001 (1 vial/ 1 ampoule) EU/1/00/155/002 (3 vials/ 3 ampoules) EU/1/00/155/003 (10 vials/ 10 ampoules) EU/1/00/155/004 (1 vial/ 1 vial) EU/1/00/155/005 (3 vial/ 3 vials) EU/1/00/155/006 (10 vials/ 10 vials)
Maltese: EU/1/00/155/002 (3 kunjetti/ 3 ampulli) EU/1/00/155/003 (10 kunjetti/ 10 ampulli) EU/1/00/155/004 (1 kunjett/ 1 kunjett) EU/1/00/155/005 (3 kunjetti/ 3 kunjetti) EU/1/00/155/006 (10 kunjetti/10 kunjetti)
English: Marketing Authorisation Holder Merck Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Merck Europe B.V.
English: No severe OHSS was reported (section 4.4).
Maltese: Ma ġewx irrappurtati każi serji ta' OHSS (sezzjoni 4.4).
English: Do not use Luveris:
Maltese: Tużax Luveris:
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins.
Maltese: Ormoni sesswali u modulaturi tas-sistema ġenitali, gonadotropini.
English: It is essentially “sodium free”.
Maltese: Huwa essenzjalment “ħieles mis-sodium”.
English: Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS
Maltese: Disturbi vaskulari Rari ħafna: Tromboemboliżmu, normalment assoċjat ma' OHSS sever.
English: (≥ 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), frequency not known (cannot be estimated from the available data).
Maltese: Id-definizzjonijiet li ġejjin japplikaw għat-terminoloġija tal-frekwenza użata minn hawn 'il quddiem: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Other ingredients: polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid concentrated, sodium hydroxide, L-methionine and nitrogen.
Maltese: Sustanzi oħra: polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid, concentrated sodium hydroxide, L-methionine u nitrogen.
English: Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress.
Maltese: Evalwazzjoni klinika tista' tiżvela sinjali bħal ipovolemija, emokonċentrazzjoni, żbilanċi tal-elettroliti, axxite, effużjonijiet plewrali, jew uġigħ pulmonari akut.
English: • malformations of sexual organs incompatible with pregnancy
Maltese: • malformazzjonijiet tal-organi sesswali li jkunu inkompatibbli mat-tqala
English: Manufacturer Merck Serono S.p.A.
Maltese: Merck Serono S.p.A.
English: Name and address of the manufacturer of the biological active substance Merck Serono SA
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Merck Serono S.A.
English: Tumours of sexual organs
Maltese: Tumuri tal-organi sesswali
English: In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4 % and 0.9 % of the injections, respectively.
Maltese: Fi studju kliniku, reazzjonijiet ħfief u moderati fis-sit tal-injezzjoni (tbenġil, uġigħ, ħmura, ħakk jew nefħa) ġew irrappurtati f'7.4% u 0.9% tal-injezzjonijiet, rispettivament.
English: Phosphoric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment) L-methionine
Maltese: Phosphoric acid, konċentrat (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH) L-methionine
English: ATC code: G03GA07
Maltese: G03G A07.
English: 37.5-75 IU at 7 to 14-day intervals.
Maltese: f'intervalli ta' 7 sa 14-il ġurnata.
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 sever jista' jkun ikkumplikat minn brim tal-ovarji jew avvenimenti tromboemboliċi, bħal emboliżmu pulmonari, puplesija iskemika jew infart mijokardijaku.
English: • The usual starting dose is 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
Maltese: • Id-doża normali tal-bidu hi ta' 75 IU (1 kunjett) ta' Luveris flimkien ma' 75 IU jew 150 IU
English: • The other ingredients of the powder are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, L-methionine and nitrogen.
Maltese: • Is-sustanzi l-oħra tat-trab huma polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid concentrated sodium hydroxide, L-methionine u nitrogen.
English: Absorption Following subcutaneous administration, the absolute bioavailability is approximately 60 %.
Maltese: Assorbiment Meta jingħata minn taħt il-ġilda, il-bijodisponibilità assoluta hi ta' madwar 60%.
English: November 2005.
Maltese: Data tal-aħħar tiġdid: 30 ta' Novembru, 2005.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: one vial of powder contains: lutropin alfa 75 IU.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kompożizzjoni: kunjett ta' trab fih: lutropin alfa 75
English: In these trials the ovulation rate per cycle was 70-75 %.
Maltese: F'dawn l-istudji ir-rata ta' ovulazzjoni f'kull ċiklu kienet ta' 70-75%.
English: The first injection of Luveris should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni ta' Luveris għandha tingħata taħt supervizazzjoni medika diretta.
English: In patients with porphyria or a family history of porphyria Luveris may increase the risk of an acute attack.
Maltese: Fil-pazjenti li jkollhom porfirja jew storja ta' porfirja fil-familja, Luveris jista' jżid ir-riskju ta' attakk akut.
English: The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU.
Maltese: It-tagħrif farmakokinetiku ta' lutropin alfa nkiseb minn studji li saru fuq voluntiera nisa li kellhom ilpitwitarja desensitizzata minn 75 IU sa 40,000
English: Lutropin alfa shows linear pharmacokinetics, as assessed by area under curve (AUC) which is directly proportional to the dose administered.
Maltese: Lutropin alfa juri farmakokinetika lineari, kif osservata mill-erja taħt il-kurva (AUC) li tvarja proporzjonalment skont id-doża mogħtija.
English: Other medicines and Luveris
Maltese: Mediċini oħra u Luveris
English: In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa.
Maltese: Fi provi kliniċi, Luveris intwera li jżid is-sensittività tal-ovarji għal follitropin alfa.
English: (EU/1/00/155/004-006)
Maltese: EU/1/00/155/001 (1 kunjett/ 1 ampulla)
English: Ovarian Hyperstimulation Syndrome (OHSS)
Maltese: Sindromu tal-Istimulazzjoni Eċċessiva tal-Ovarji (OHSS)
English: Luveris 75 IU powder and solvent for solution for injection Lutropin alfa
Maltese: Luveris 75 IU trab u solvent għal soluzzjoni għall-injezzjoni Lutropin alfa
English: Nervous system disorders Common: Headache
Maltese: Disturbi fis-sistema nervuża Komuni: Uġigħ ta' ras.
English: Name and address of the manufacturer responsible for batch release Merck Serono S.p.A.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Merck Serono S.p.A.
English: Up to 3 containers of powder may be dissolved in 1 ml of solvent.
Maltese: Sa 3 kontenituri ta' trab jistgħu jinħallu f'1 ml ta' solvent.
English: • Lutropin alfa is recombinant human Luteinising Hormone (r-hLH), produced by recombinant DNA technology.
Maltese: • Lutropin alfa hu Ormon Lutejniku uman rikombinanti (r-hLH), magħmul minn teknoloġija tadDNA rikombinanti.
English: • primary ovarian failure
Maltese: • insuffiċjenza primara tal-ovarji
English: Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles.
Maltese: Il-fatturi indipendenti ta' riskju għall-iżvilupp ta' OHSS jinkludu l-età żagħżugħa, il-massa tal-ġisem mingħajr xaħam, is-sindromu poliċistiku tal-ovarji, dożi ogħla ta' gonadotropini esoġeni, livelli assoluti għolja jew li jiżdiedu malajr ta' estradijol fis-serum u episodji preċedenti ta' OHSS, numru kbir ta' follikuli tal-ovarji li jkunu qegħdin jiżviluppaw u numru kbir ta' ooċiti rkuprati f'ċikli ART.
English: Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules.
Maltese: Pakketti ta' 1, 3 jew 10 kunjetti bl-istess ammont ta' kunjetti jew ampulli bis-solvent.
English: Solvent Batch
Maltese: Lott tas-Solvent
English: Blood clotting problems (thromboembolic events)
Maltese: Problemi ta' tagħqid tad-demm (każijiet tromboemboliċi)
English: Following subcutaneous administration of Luveris, lutropin alfa is eliminated from the body with a terminal half-life of about 10-12 hours.
Maltese: Meta Luveris jingħata minn taħt il-ġilda, lutropin alfa jitnehħa mill-ġisem b'half life terminali ta' madwar 10-12-il siegħa.
English: You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Maltese: Tista' wkoll tħallat Luveris ma' follitropin alfa minflok ma tinjetta ż-żewġ prodotti separatament.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Birth defects after Assisted Reproductive Technology (ART) may be slightly higher than after spontaneous conceptions.
Maltese: Difetti tat-twelid wara Teknoloġija Riproduttiva Assistita (ART) jistgħu jkunu ftit ogħla milli wara konċepimenti spontanji.
English: • hypersensitivity to active substances or to any of the excipients listed in section 6.1.
Maltese: • għandhom sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill eċċipjenti elenkati fis-sezzjoni 6.1
English: A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
Maltese: IU ta' lutropin alfa (ie. kunjett wieħed ta' Luveris) kuljum flimkien ma' 75-150
English: This LH/CG transmembrane receptor is a member of the super-family of G proteincoupled receptors; specifically, it has a large extra-cellular domain.
Maltese: Dan ir-riċettur transmembraniku LH/CG jagħmel parti mill-familja ta' riċetturi akkopjaturi tal-proteina G doppja; speċifikament, għandu dominju ekstra-ċellulari kbir.
English: Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH), a glycoprotein composed of noncovalently bound α- and ß-subunits.
Maltese: Lutropin alfa hu Ormon Uman Lutejniku rikombinanti (r-hLH), glikoproteina magħmula minn unitajiet sekondarji α- u ß- marbuta b'mod mhux kovalenti.
English: • tumours of the hypothalamus and pituitary gland
Maltese: • għandhom tumuri fil-glandola ipotalamika u pitwitarja
English: Following subcutaneous administration, the terminal half-life is slightly prolonged.
Maltese: Meta jittieħed minn taħt il-ġilda, il-half life terminali titwal bi ftit.
English: This side effect is very rare (may affect up to 1 in 10,000 people).
Maltese: Dan l-effett sekondarju huwa rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10 000).
English: In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotropin therapy.
Maltese: F'każijiet rari, torsjoni adnessali (kumplikazzjoni ta' meta jikbru l-ovarji), u emoperitoneum kienu assoċjati mat-terapija ta' gonadotropin tal-menopawsa.
English: In vitro the affinity binding of recombinant hLH to the LH/CG receptor on Leydig tumour cells (MA-10) is between that for hCG and that of pituitary hLH, but within the same order of magnitude.
Maltese: In vitro, l-affinità li għandu hLH rikombinanti biex jaqbad mar-riċettur tal-LH/CG li qiegħed fuq iċ-ċelluli tat-tumur ta' Leydig (MA-10) hi bejn dik tal-hCG u dik talpitwitarja hLH iżda fl-istess ordni ta' qawwa.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, thrombophilia or severe obesity (body mass index >30 kg/m2), treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Maltese: F'nisa b'mard tromboemboliku riċenti jew li għadu għaddej jew nisa b'fatturi ta' riskju ġeneralment rikonoxxuti għal każijiet tromboemboliċi, bħal storja medika personali jew tal-familja, trombifilija jew obeżità severa (indiċi tal-massa tal-ġisem ta' >30 kg/m2), il-kura b'gonadotropini tista' tikkawża żieda addizzjonali fir-riskju li dawn il-każijiet jiggravaw jew iseħħu.
English: This increases your risk of developing Ovarian HyperStimulation Syndrome or OHSS.
Maltese: Dan iżidlek ir-riskju li taqbdek is-Sindromu ta' Iperstimulazzjoni tal-Ovarji jew OHSS.
English: Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain
Maltese: Komuni: OHSS ħafif jew moderat (li jinkludi s-sintomatoloġija assoċjata), ċista fl-ovarji, uġigħ fissider, uġigħ fil-pelvis.
English: Nevertheless there is a possibility that OHSS may occur, which is further described in section 4.4.
Maltese: Madankollu hemm il-possibbiltà li jirriżulta OHSS, li huwa deskritt aktar fid-dettall f'sezzjoni 4.4.
English: It belongs to the family of hormones called gonadotropins, which are involved in the normal control of reproduction.
Maltese: Jagħmel parti mill-familja ta' ormoni magħrufa bħala gonadotropini, li huma involuti fil-kontroll normali tarriproduzzjoni.
English: The pharmacokinetic profile of lutropin alfa is similar to that of urinaryderived hLH.
Maltese: Il-profil farmakokinetiku ta' lutropin alfa hu l-istess bħal dak tal-hLH derivat mill-awrina.
English: Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Maltese: Rari ħafna: Reazzjonijiet ħfief sa severi ta' sensittività eċċessiva, fosthom reazzjonijiet anafilattiċi u xokk.
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.
Maltese: Meta tagħmel użu mit-teknoloġija ta' riproduzzjoni assistita, ir-riskju ta' tqala multipla huwa relatat mal-età tiegħek, il-kwalità u n-numru ta' bajd fertilizzat jew embrijuni mpoġġija ġewwa fik.
English: Package leaflet: Information for the user Solvent in vials
Maltese: Informazzjoni għall-utent Solvent fil-kunjetti
English: Important information about some of the ingredients of Luveris Luveris contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) f'kull doża.
English: In patients undergoing Assisted Reproductive Technology (ART) procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Maltese: Fil-pazjenti li jkunu għaddejjin minn proċeduri ta' Teknoloġija Riproduttiva Assistita (ART), ir-riskju ta' tqala multipla huwa marbut prinċipalment man-numru ta' embrijuni mibdula, il-kwalità tagħhom u l-età tal-pazjenta.
English: Other common side effects
Maltese: Effetti sekondarji komuni oħra
English: When the desired response has been obtained, a single injection of hCG is given 24 to 48 hours after the last injections of Luveris and FSH.
Maltese: IU hCG għandha tingħata 24-48 siegħa wara l-aħħar injezzjonijiet ta' Luveris u FSH.
English: • Serious blood clotting complications (thromboembolic events) usually with severe OHSS are found very rarely.
Maltese: • Kumplikazzjonijiet serji ta' tagħqid tad-demm (każijiet tromboemboliċi) ġeneralment b'OHSS sever jinstabu b'mod rari ħafna.
English: Package leaflet: Information for the user Solvent in ampoules
Maltese: Informazzjoni għall-utent Solvent fl-ampulli
English: Luveris is indicated for the stimulation of follicular development, in association with FSH (see section 4.1).
Maltese: Luveris hu indikat għall-użu fl-infertilità għall-istimulazzjoni tal-iżvilupp folikulari flimkien ma' FSH (ara sezzjoni 4.1).
English: Children and adolescents Luveris is not for use in children and adolescents below 18 years old.
Maltese: Tfal u adolexxenti Luveris mhuwiex qiegħed għall-użu fit-tfal u adolexxenti taħt 18-il sena.
English: Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Maltese: Agħfas sew il-ġilda u daħħal il-labra f'anglu ta' 45° sa 90° qisek qed twaddab dart.
English: When an optimal response is obtained, a single injection of 250 microgramsof r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections.
Maltese: Meta jintlaħaq l-aħjar effett, injezzjoni waħda ta' 250 mikrogramma ta' r-hCH jew bejn 5,000 IU u 10,000
English: The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Maltese: Is-solvent jinsab f'kunjetti tal-ħġieġ (tip I) bla kulur ta' 2 jew 3 ml b'tapp tal-gomma miksi bit-Teflon jew f'ampulli tal-ħġieġ (tip I) bla kulur ta' 2 ml.
English: • If you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġika għal gonadotropini (bħal ormon luteinising, ormon li jistimula l-follikuli jew gonadotropin korjoniku uman), jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Maltese: • Skond ir-rispons tiegħek, it-tabib jista' jżidlek id-doża ta' FSH preferibbilment bi 37.5-75 IU
English: (EU/1/00/155/001-003) One vial of solvent contains: 1 ml water for injection.
Maltese: Ampulla ta' solvent fiha: 1 ml ilma għall-injezzjonijiet EU/1/00/155/001-003 Kunjett ta' solvent fiha: 1 ml ilma għall-injezzjonijiet EU/1/00/155/004-006
English: • Feeling sick, vomiting, diarrhoea, abdominal discomfort or abdominal pain
Maltese: • Tħossok imdardra, rimettar, dijarea, skonfort addominali jew uġigħ addominali
English: NAME OF THE MEDICINAL PRODUCT Luveris 75 IU powder and solvent for solution for injection Lutropin alfa
Maltese: IL-PRODOTT MEDIĊINALI Luveris 75 IU trab u solvent għal soluzzjoni għall-injezzjoni.
English: Renal and hepatic impairment
Maltese: Reazzjoni allerġika
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LUVERIS 75 IU, VIALS
Maltese: Ż-ŻGĦAR EWLENIN LUVERIS 75 IU, AMPULLI
English: Luveris is recommended for the treatment of adult women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle.
Maltese: Luveris hu rakkomandat għall-kura ta' nisa adulti li jipproduċu livelli baxxi ħafna ta' wħud millormoni involuti fiċ-ċiklu naturali riproduttiv.
English: This medicinal product must not be administered as a mixture in the same injection with other medicinal products except follitropin alfa.
Maltese: Il-prodott mediċinali m'għandux jingħata bħala taħlita fl-istess injezzjoni ma' prodotti mediċinali oħra ħlief follitropin alfa.
English: This may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovarian syndrome.
Maltese: Din tista' tiġi assoċjata ma' fatturi oħra ta' riskju bħal OHSS, tqala, operazzjoni addominali fil-passat, storja medika ta' torsjoni tal-ovarji, ċista tal-ovarji fil-passat jew fil-preżent u sindrome poliċistiku tal-ovarji.
English: Do not shake.
Maltese: ta' FSH.