FrancophonIA/ELRC3.0 huggingface dataset:
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
Maltese: Żidiet fil-livelli tal-kolesterol u tat-trigliċeridi ġew assoċjati mat-terapija dijuretika thiazide; madankollu b'doża ta' 12.5 mg ta' Karvezide, l-effetti li ġew irrapportati kienu minimi jew xejn.
English:  The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides (E172).
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, ferric oxide aħmar u isfar (E172).
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Karvezide is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali affettwati b'tibdil tal-potassium fis-serum: osservazzjoni perjodika tal- potassium fis-serum hija rrikmandata meta Karvezide jiġi mogħti flimkien ma' prodotti mediċinali oħra affettwati b'disturbi tal-potassium fis-serum (p.e. digitalis glycosides, antiarritmiċi).
English: Karvezide 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Karvezide 150 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: What Karvezide contains  The active substances are irbesartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
English: EU/1/98/085/008 - 14 tablets EU/1/98/085/004 - 28 tablets EU/1/98/085/005 - 56 tablets EU/1/98/085/010 - 56 x 1 tablets EU/1/98/085/006 - 98 tablets
Maltese: EU/1/98/085/008 - 14-il pillola EU/1/98/085/004 - 28 pillola EU/1/98/085/005 - 56 pillola EU/1/98/085/010 - 56 x 1 pillola EU/1/98/085/006 - 98 pillola
English: Excipient with known effect: Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 65.8 mg ta' lactose (bħala lactose monohydrate).
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week toirbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Maltese: B'kollox 697 pazjent intagħżlu b'mod każwali fi proporzjon ta' 2:1 jew għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg jew għal irbesartan 150 mg u ġew titrati bil-forza b'mod sistematiku (qabel ma r-rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/hydrochlorothiazide 300 mg/25 mg jew irbesartan 300 mg, rispettivament.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Karvezide (see section 4.5).
Maltese: Id-dijuretiċi li ma jnaqqsux il-potassium, supplimenti tal-potassium jew sostituti li fihom il-potassium għandhom jingħataw b'attenzjoni flimkien ma' Karvezide (ara sezzjoni 4.5).
English: Karvezide 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Il-pilloli Karvezide 300 mg/12.5 mg huma pprovduti f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: EU/1/98/085/011-015 EU/1/98/085/021 EU/1/98/085/029 EU/1/98/085/032
Maltese: EU/1/98/085/021 EU/1/98/085/029 EU/1/98/085/032
English: EU/1/98/085/007 - 14 tablets EU/1/98/085/001 - 28 tablets EU/1/98/085/002 - 56 tablets EU/1/98/085/009 - 56 x 1 tablets EU/1/98/085/003 - 98 tablets
Maltese: EU/1/98/085/007 - 14-il pillola EU/1/98/085/001 - 28 pillola EU/1/98/085/002 - 56 pillola EU/1/98/085/009 - 56 x 1 pillola EU/1/98/085/003 - 98 pillola
English: EU/1/98/085/004-006 EU/1/98/085/008 EU/1/98/085/010
Maltese: EU/1/98/085/008 EU/1/98/085/010
English: Each film-coated tablet of Karvezide 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Karvezide 150 mg/12.5 mg fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Karvezide should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Maltese: Karvezide m'għandux jintuża f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina < 30 ml/min) (ara sezzjoni 4.3).
English: Karvezide should not be given to children under 18 years of age.
Maltese: Karvezide ma għandux jingħata lil tfal iżgħar minn 18-il sena.
English: Karvezide 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Karvezide 150 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Karvezide 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Karvezide 300 mg/25 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Each film-coated tablet of Karvezide 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Karvezide 300 mg/25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
English: EU/1/98/085/023 - 14 tablets EU/1/98/085/024 - 28 tablets EU/1/98/085/031 - 30 tablets EU/1/98/085/025 - 56 tablets EU/1/98/085/028 - 56 x 1 tablets EU/1/98/085/026 - 84 tablets EU/1/98/085/034 - 90 tablets EU/1/98/085/027 - 98 tablets
Maltese: EU/1/98/085/023 - 14-il pillola EU/1/98/085/024 - 28 pillola EU/1/98/085/031 - 30 pillola EU/1/98/085/025 - 56 pillola EU/1/98/085/028 - 56 x 1 pillola EU/1/98/085/026 - 84 pillola EU/1/98/085/034 - 90 pillola EU/1/98/085/027 - 98 pillola
English: Children and adolescents Karvezide should not be given to children and adolescents (under 18 years).
Maltese: Tfal u adolexxenti Karvezide m'għandux jingħata lit-tfal u lill-adoloxxenti (inqas minn 18-il sena).
English: Food does not affect the bioavailability of Karvezide.
Maltese: L-ikel ma jaffettwax il-biodisponibilità ta' Karvezide.
English: Each tablet of Karvezide 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola ta' Karvezide 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: EU/1/98/085/011 - 14 tablets EU/1/98/085/012 - 28 tablets EU/1/98/085/029 - 30 tablets EU/1/98/085/013 - 56 tablets EU/1/98/085/014 - 56 x 1 tablets EU/1/98/085/021 - 84 tablets EU/1/98/085/032 - 90 tablets EU/1/98/085/015 - 98 tablets
Maltese: EU/1/98/085/011 - 14-il pillola EU/1/98/085/012 - 28 pillola EU/1/98/085/029 - 30 pillola EU/1/98/085/013 - 56 pillola EU/1/98/085/014 - 56 x 1 pillola EU/1/98/085/021 - 84 pillola EU/1/98/085/032 - 90 pillola EU/1/98/085/015 - 98 pillola
English: EU/1/98/085/016 - 14 tablets EU/1/98/085/017 - 28 tablets EU/1/98/085/030 - 30 tablets EU/1/98/085/018 - 56 tablets EU/1/98/085/019 - 56 x 1 tablets EU/1/98/085/022 - 84 tablets EU/1/98/085/033 - 90 tablets EU/1/98/085/020 - 98 tablets
Maltese: EU/1/98/085/016 - 14-il pillola EU/1/98/085/017 - 28 pillola EU/1/98/085/030 - 30 pillola EU/1/98/085/018 - 56 pillola EU/1/98/085/019 - 56 x 1 pillola EU/1/98/085/022 - 84 pillola EU/1/98/085/033 - 90 pillola EU/1/98/085/020 - 98 pillola
English: Karvezide 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Karvezide 150 mg/12.5 mg irbesartan/hydrochlorothiazide
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Karvezide.
Maltese: U wkoll, tneħħija renali ta' lithium titnaqqas b'thiazides u għalhekk, ir-riskju ta' tossiċita' minn lithium tista' tiżdied b'Karvezide.
English: Karvezide 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Karvezide 300 mg/25 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: Karvezide 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Karvezide 300 mg/12.5 mg irbesartan/hydrochlorothiazide
English: Karvezide 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Karvezide 300 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita.
English: Excipient with known effect: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 89.5 mg ta' lactose (bħala lactose monohydrate).
English: Each tablet of Karvezide 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: 150 mg/12.5 mg fiha 150 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Maltese: Mhux irrikmandati dożi ogħla minn 300 mg irbesartan/25 mg hydrochlorothiazide darba kuljum.
English: Excipient with known effect: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 53.3 mg ta' lactose (bħala lactose monohydrate).
English: Renal impairment and kidney transplantation: when Karvezide is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Karvezide jintuża f'pazjenti b'indeboliment tal-funzjoni renali, hija rrikmandata osservazzjoni perjodika tal-livelli tal-potassium fis-serum, tal-krejatinina u taluric acid.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II. ONTARGET kien studju li twettaq f'pazjenti bi storja medika ta' mard kardjovaskulari jew ċerebrovaskulari, jew dijabete mellitus tip 2 akkumpanjat minn evidenza ta' ħsara fl-organu aħħari. VA NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: Karvezide 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Karvezide 150 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: While this is not documented with Karvezide, a similar effect should be anticipated.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Karvezide, effetti simili għandhom ikunu mistennija.
English: Due to the hydrochlorothiazide component, Karvezide is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Maltese: Minħabba li fih il-komponent ta' hydrochlorothiazide, Karvezide mhux irrikmandat għall-pazjenti b'disfunzjoni renali severa (tneħħija tal-krejatinina < 30 ml/min).
English: What Karvezide looks like and contents of the pack Karvezide 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Maltese: Il-pilloli miksijin b'rita Karvezide 300 mg/25 mg huma roża, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2788 fuq in-naħa l-oħra.
English: Karvezide 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Karvezide 300 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: Package leaflet: Information for the patient Karvezide 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent Karvezide 300 mg/25 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Maltese: Kull pillola fiha 300 mg ta' irbesartan u 12.5 mg ta' hydrochlorothiazide.
English: There is no clinical experience with Karvezide in patients with hepatic impairment.
Maltese: Għad m'hemmx esperjenza klinika b'Karvezide f'pazjenti b'indeboliment epatiku.
English: Each film-coated tablet of Karvezide 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Karvezide 300 mg/12.5 mg fiha 300 mg irbesartan u 12.5 mg hydrochlorothiazide.
English: No dosage adjustment of Karvezide is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Maltese: M'hemmx bżonn aġġustar fid-doża ta' Karvezide f'pazjenti b'indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4.3).
English: Uncommon side effects -may affect up to 1 in 100 people): diarrhoea low blood pressure fainting heart rate increased flushing swelling sexual dysfunction (problems with sexual performance) blood tests may show lowered levels of potassium and sodium in your blood.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) dijarea pressjoni baxxa ħass ħażin taħbit mgħaġġel tal-qalb fwawar nefħa disturb sesswali (problemi fl-attività sesswali) testijiet tad-demm jistgħu juru livelli aktar baxxi ta' potassium u sodium fid-demm tiegħek.
English: These lesions were not observed in macaques;  decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Maltese: Dawn il-leżjonijiet ma ġewx osservati fil-makakki; tnaqqis tal-potassium fis-serum minħabba hydrochlorothiazide u mfixkla parzjalment meta hydrochlorothiazide ingħata flimkien ma' irbesartan.
English: Side effects reported in clinical studies for patients treated with Karvezide were:
Maltese: L-effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b'Karvezide kienu:
English: Package leaflet: Information for the patient Karvezide 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent Karvezide 150 mg/12.5 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: Package leaflet: Information for the patient Karvezide 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent Karvezide 300 mg/12.5 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Maltese: Kull pillola fiha 150 mg ta' irbesartan u 12.5 mg ta' hydrochlorothiazide.
English: 20 December 2012
Maltese: 20 ta' Diċembru 2012
English: What is Loraxin?
Maltese: X'inhu Loraxin?
English: The company wanted the authorisation to be recognised in the Czech Republic , Denmark, Estonia, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia and Slovakia (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tiġi rikonoxxuta fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fl-Ungerija, fil-Litwanja, fil-Latvja, fin-Norveġja, filPolonja, fl-Isvezja, fis-Slovenja u fis-Slovakkja (l-'Istati Membri kkonċernati').
English: The active substance in Loraxin, loratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Loraxin, loratadine, hija antistamina.
English: Vitabalans Oy submitted an application for Loraxin for mutual recognition, on the basis of an initial authorisation granted by Finland on 31 August 2010.
Maltese: Vitabalans Oy issottomettiet applikazzjoni għal Loraxin għar-rikonoxximent reċiproku, fuq il-bażi ta' awtorizzazzjoni inizjali mogħtija mill-Finlandja fil-31 ta' Awwissu 2010.
English: Loraxin is a medicine used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itchy rash).
Maltese: Loraxin hija mediċina użata sabiex isserraħ is-sintomi ta' rinite allerġika (infjammazzjoni tal-passaġġi nasali kkawżata minn allerġija bħal hay fever jew allerġija għal dud tat-trab) u urtikarja idjopatika fittul (raxx bil-ħakk).
English: Questions and answers on Loraxin and associated names (loratadine, 10 mg tablets)
Maltese: Mistoqsijiet u tweġibiet dwar Loraxin u ismijiet assoċjati (loratadine, 10 mg pilloli)
English: On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loraxin.
Maltese: Fil-21 ta' Ġunju 2012, l-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim bejn Stati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Loraxin.
English: The CHMP noted that the published data that was submitted with this application were limited, and not sufficient to support this well-established use application for Loraxin.
Maltese: Is-CHMP innota li d-dejta ppubblikata li ġiet sottomessa ma' din l-applikazzjoni ma kinitx limitata, u ma kinitx suffiċjenti sabiex din l-applikazzjoni ta' użu stabbilit sew għal Loraxin tiġi appoġġata.
English: Why was Loraxin reviewed?
Maltese: Għaliex ġie rivedut Loraxin?
English: However, the Member States were not able to reach an agreement and the Finnish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 December 2011.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini tal-Finlandja, irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-23 ta' Diċembru 2011.
English: It works by blocking receptors for histamine, a substance in the body that causes allergic symptoms.
Maltese: Taħdem billi timblokka r-riċetturi għallistamina, sustanza fil-ġisem li tikkawża sintomi allerġiċi.
English: The initial authorisation was based on a wellestablished use application.
Maltese: L-awtorizzazzjoni inizjali kienet ibbażata fuq applikazzjoni ta' użu stabbilit sew.
English: In addition, the Committee recommended that the marketing authorisation for Loraxin in Finland should be suspended.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq fil-Finlandja għandha tiġi sospiża.
English: Tres Cantos E-28760 Madrid Spain
Maltese: Tres Cantos E-28760 Madrid Spanja
English: Polysorbate 20
Maltese: Polysorbat 20
English: ATC code: G03GA30.
Maltese: G03GA30.
English: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Maltese: Zone Industrielle de l'Ouriettaz CH-1170 Aubonne L-Iżvizzera
English: After the injection 8.1.
Maltese: Wara l-injezzjoni 8.1.
English: N/A
Maltese: IU N/A
English: Via delle Magnolie 15 (Zona Industriale) I-70026 Modugno (Bari) Italy
Maltese: Via delle Magnolie 15 (Zona Industriale) I-70026 Modugno (Bari)
English: Dose Feedback Window
Maltese: Feedback Window tad
English: Date of latest renewal: 8 May 2017
Maltese: Data tal-aħħar tiġdid: 8 ta' Mejju 2017
English: Manufacturer Merck Serono S.p.A, Via delle Magnolie 15 (Zona industriale), I-70026 Modugno (Bari), Italy
Maltese: Manifattur Merck Serono S.p.A, Via delle Magnolie 15 (Zona industriale), I-70026 Modugno (Bari), L-Italja
English: Store in refrigerator (2°C- 8°C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: Marketing Authorisation Holder Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, L-Olanda
English: Amount to Be Set for a Second Injection if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if "0", injection complete ifnot"0",needsecond injection Injectthis amount..........usingnewpen if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using new pen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen if"0", injectioncomplete ifnot"0",needsecond injection Injectthisamount..........usingnewpen
Maltese: Ammont li Għandu Jiġi Ssettjat għat-Tieni Injezzjoni jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "0", tkun teħtieġ ittieni injezzjoni Injetta dan l-ammont..........billi tuża pinna ġdida jekk "0", injezzjoni lesta jekk mhux "
English: INFORMATION IN BRAILLE pergoveris 150 iu/75 iu
Maltese: INFORMAZZJONI BIL-BRAILLE pergoveris 150 iu/75 iu
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 stat aħħari wara 3-4t ijiem.
English: The frequency categories used are: 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), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza użati huma: 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: Ovarian hyperstimulation syndrome (OHSS)
Maltese: Sindrome ta' iperstimulazzjoni tal-ovarji (OHSS)
English: Following subcutaneous administration, the absolute bioavailability is about 70%.
Maltese: Wara li jingħata taħt il-ġilda, il-biodisponibbilita assoluta hija ta' madwar 70%.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins.
Maltese: Ormoni sesswali u modulatori tas-sistemi ġenitali, gonadotropins.
English: The pH of the solution is 6.5 - 7.5, its osmolality is 250 - 400 mOsm/kg.
Maltese: Il-pH tas-soluzzjoni hi ta' 6.5-7.5, l-osmolalità tagħha hi ta' 250-400 mOsm/kg.
English: 1 vial of solvent.
Maltese: 1 kunjett ta' solvent.
English: The pH of the reconstituted solution is 6.5-7.5.
Maltese: Il-pH tas-soluzzjoni rrikostitwita hu ta' 6.5-7.5.