FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Maltese: Dan hu test li fih ilpazjenti b'allerġija li attwalment ma jkunux qed juru sinjali allerġiċi, jingħataw doża definita ta' allerġen (is-sustanza li għaliha jkunu allerġiċi) biex tiġi stimulata reazzjoni allerġika.
English: Emadine is used in adults and children aged three years and older.
Maltese: Emadine jintuża f'adulti u tfal minn tliet snin ‘il fuq.
English: If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Maltese: Jekk qed jintużaw aktar minn tip wieħed ta' trattament talgħajnejn, kull wieħed għandu jingħata tal-inqas 10 minuti bogħod minn xulxin u kwalunkwe ingwent tal-għajnejn għandu jingħata l-aħħar.
English: It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Maltese: L-istamina hija sustanza fil-ġisem li tikkawża sintomi allerġiċi.
English: Avoid the introduction of contamination.
Maltese: Evita`l-introduzzjoni ta'kontaminazzjoni.
English: Liquid paraffin : 941.4 mg
Maltese: Paraffina likwida: 941.4mg
English: Classical Swine Fever vaccine, ATC vet code: QI09AA06
Maltese: Classical Swine Fever vaċċin, ATCvet code: QI09AA06D
English: Pigs.
Maltese: Biss.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Korverstraat 35 5831 AN Boxmeer Olanda
English: The active substance stimulates active immunity against Classical Swine Fever (CSF).
Maltese: Is-sustanza attiva tistimola l-immunita` attiva kontra Classical Swine Fever (CSF).
English: Manufacturer of the biological active substance:
Maltese: -Manufattur tas-sustanza bioloġika attiva
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001 - EU/2/99/016/006
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/99/016/001 - EU/2/99/016/006
English: 120 Elisa Units CSF-E2 antigen.
Maltese: Elisa Units CSF-E2 antiġen
English: According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:
Maltese: Skont il-leġislazzjoni tal-komunita` fuq il-Classical swine fever (Council Directive 80/217/EEC, kif amendata, fl-Unjoni Ewropeja:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI 120 Elisa Units CSF E2 antiġen/2ml
English: METHOD AND ROUTE(S) OF ADMINISTRATION IM injection of 2 ml
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu intramoskulari injezzjoni ta' 2 ml
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fil-friġġ (2°C - 8°C)
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva hija fil-prinċipju ta' oriġni bijoloġika maħsubha biex tipproduċi immunita attiva mhix fl-iskop tal-Regolament (EC) No 470/2009
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs
Maltese: VETERINARJU Porcilis Pesti emulsjoni għall-injezzjoni
English: Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU)
Maltese: Classical Swine Fever Virus (CSFV) E2 subunit tal-antiġen: 120
English: PACKAGE SIZE 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
Maltese: DAQS TAL-PAKKETT 50ml (25 dożi) - 100ml (50 dożi) - 250ml (125 dożi)
English: To the user:
Maltese: Vaċċinazzjoni basika:
English: Polysorbate 80
Maltese: Polisorbejt 80 Sorbitan oleate
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001-006
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/99/016/001-006
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the whole or part of their territory if it is established that:
Maltese: Skond l-Artiklu 71 tad-direttiva 2001/82/EC tal-Parlament Ewropew u tal-Kunsill, Stati Membri jiprojbixxu jew/jistgħu jiprojbixxu l-importazzjoni, bejgħ, provista u/jew l-użu tal-Porcilis Pesti fuq itteritorju kollu jew parti mit-teritorju jekk jiġi stabbilit li:
English: INDICATION(S) Vaccine against Classical Swine Fever
Maltese: INDIKAZZJONI(JIET) Vaċċin kontra l-virus Classical Swine Fever (deni tal-ħnieżer)
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhux attivi (inkluż l-adġuntivi) msemmija f'sezzjoni 6.1 tal-KPQ huma sustanzi permessi liema tabella 1 tal-anness tar-Regolamenti tal-Kummissjoni (EU) No37/2010 jindikaw li m'hemmx bżonn tal-MRLs jew huma kunsidrati li ma jaqawx fl-iskop tar-Regoli (EC) No 470/2009 bħal meta użati f'dan il-prodott veterinarju mediċinali.
English: The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Maltese: L-importazzjoni, bejgħ, provista u / jew l-użu ta' Porcilis Pesti huwa biss permess taħt kundizzjonijiet partikolari stabbiliti mill-leġislazzjoni tal-komunita Ewropeja fuq il-kontroll of CSF (direttiva talkunsill 80/217/EEC, kif amendati).
English: 120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg
Maltese: Elisa Units Classical Swine Fever Virus-E2 subunit antiġen Paraffina likwida bħala sustanza mhux attiva:
English: The product contains Classical Swine Fever virus E2 immunogen incorporated in an emulsion in order to prolong stimulation of the immune system of the target species.
Maltese: Il-prodott fiħ Classical Swine Fever virus E2 immunoġen inkorporat f'emulsjoni sabiex itawwal lis-stimulazzjoni tas-sistema immunitarja ta' l-ispeċi li fuqhom jintuża l-prodott.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 50ml (25 dożi) - 100ml (50 doża) - 250ml (125 dożi)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.,
Maltese: Intervet International B.V.
English: Excipients: For a full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' l-ingredjenti mhux attivi, ara sezzjoni 6.1.
English: 50 ml/100 ml/250 ml multidose PET bottle
Maltese: 50ml/100ml/250ml dożi multipli flixken tal-ħġieġ 50ml/100ml/250ml dożi multipli flixken PET
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI
English: It is recommended to use a closed multiject vaccination system.
Maltese: Huwa rakkomandat li tuża sistema magħluqa multiject.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U SID LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: 4.8 Interaction with other medicinal product and other forms of interaction
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the product is intended to confer immunity is largely absent from the territory.
Maltese: a) L-amministrazzjoni tal-prodott se jfixkel l-implimentazzjoni ta' programmi nazzjonali għalldijanjosi, kontroll jew l-eliminazzjoni tal-mard tal-annimali, jew joħloq diffikultajiet fiċ-ċertifikazzjoni ta' nuqqas ta' kontaminazzjoni fl-anniamli ħajja jew fl-ikel jew fi prodotti oħra li ġew minn annimali trattati.
English: 6.5 Nature and composition of immediate packaging Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses, 100 ml for 50 doses and 250 ml for 125 doses presentation.
Maltese: Flixken tat-tip I ħġieġ idrolitiku jew polyethylene terephthalate (PET) li fihom 50ml għall 25 doża, 100ml għall 50 doża u 250ml għall 125 dożi.
English: To be supplied only on veterinary prescription.
Maltese: Tħallatx ma l-ebda prodott veterinarju mediċinali ieħor.
English: However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever;
Maltese: Ma dana kollu, l-użu tal-vaċċin jista jiġi awtorizzat fil-qafas ta' pjan ta'vaċċinazzjoni ta' emerġenza, implimentat minn awtorita` kompitenti ta' l-Istat Membru wara li tiġi konfermata l-marda, bi qbil mal-leġislazzjoni tal-Komunita` fuq il-kontroll u leradikazzjoni of classical swine fever;
English: b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State;
Maltese: b) L-ħażna, provista, distribuzzjoni u bejgħ ta' classical swine fever għandu jsir biss permess taħt il-kontroll u fuq struzzjonijiet eventwali stabbiliti mill- awtorita` kompitenti ta' l-Istat Membru;
English: BATCH NUMBER <Batch> <Lot> <BN> {number}
Maltese: FULJETT TA' TAGĦRIF
English: Transient hyperthermia may occur post the second dose.
Maltese: Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Għall kull doża ta' 2 ml:
English: Sorbitan oleate
Maltese: TA' PRODOTT MHUX
English: Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
Maltese: Għal-immunizzazzjoni attiva tal-ħnieżer minn eta` ta' 5 ġimgħat il-fuq biex jipprevjeni l-imwiet u sabiex jitnaqqas is-sinjali kliniċi tal-Classical Swine Fever , u sabiex ukoll biex jitnaqqas it-tixrid talvirus fl-ippurgar tal-CSF virus.
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: ROUTE(S) OF ADMINISTRATION IM injection
Maltese: MOD TA' AMMINISTRAZZJONI Injezzjoni IM
English: Each dose of 2 ml contains:
Maltese: U INGREDJENT(I) OĦRA Kull doża ta' 2 ml:
English: Adjuvant: 941.4 mg liquid paraffin
Maltese: 4mg paraffina likwida
English: MINIMUM PARTICULARS TO APPEAR ON Bottle Label {50ml/100ml/250ml }
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IT-Tiketta tal-flixkun {,50ml/100ml/250ml }
English: As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2.
Maltese: Minħabba n-natura tas-subunit tal-vaċċin, il-vaċċinazzjoni ma twassalx għall-produzzjoni ta' antikorpi kontra l-antiġeni tas- CSF virus,ħlief dik tal-E2.
English: Pigs
Maltese: Lott
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effiċjenza ta' din it-tilqima jekk tintuża flimkien ma kwalunkwe prodott ieħor mediċinali veterinarju.
English: To the physician:
Maltese: Għat-Tabib:
English: Via delle Magnolie 15 70026 Modugno (Bari) Italy
Maltese: Via delle Magnolie 15 70026 Modugno (Bari)
English: Ovarian Hyperstimulation Syndrome (OHSS)
Maltese: Sindromu tal-Iperstimulazzjoni tal-Ovarji (OHSS)
English: INFORMATION IN BRAILLE ovitrelle 250 pen
Maltese: INFORMAZZJONI BIL-BRAILLE ovitrelle 250 pinna
English: INFORMATION IN BRAILLE ovitrelle 250/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE ovitrelle 250/0.5 mL
English: Headache Vascular disorders Very rare:
Maltese: Disturbi vaskulari Rari ħafna:
English: The following definitions apply to the frequency terminology used hereafter: 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: Id-definizzjonijiet li ġejjin japplikaw għat-terminoloġija tal-frekwenza li tintuża 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 magħrufa (ma tistax tittieħed stima middata disponibbli).
English: The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
Maltese: Il- pH tas-soluzzjoni hija 7.0 ± 0.3, b'osmolalità ta' 250-400 mOsm/kg.
English: Manufacturer Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy
Maltese: Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), L-Italja
English: Uncommon: Depression, irritability, restlessness Nervous system disorders
Maltese: Depressjoni, irritabilità, irrekwitezza Disturbi fis-sistema nervuża Komuni:
English: Date of latest renewal: 02 February 2006
Maltese: Data tal-aħħar tiġdid: 02 ta' Frar 2006
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, in-Netherlands
English: Fertility Ovitrelle is indicated for use in infertility (see section 4.1).
Maltese: Fertilità Ovitrelle huwa indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA08
Maltese: Ormoni tas-sess u modulatori tas-sistema ġenitali, gonadotropins, Kodiċi ATC:
English: However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.
Maltese: Madankollu, instab li dan ilprodott jibqa' tajjeb biex jintuża sa 24 siegħa f'temperatura li tvarja minn +2°C sa 8°C.
English: Posology The maximum dose is 250 micrograms.
Maltese: Pożoloġija Id-doża massima hija ta' 250 mikrogramma.
English: Mild or moderate OHSS
Maltese: OHSS ħafif jew moderat
English: Blood clotting problems (thromboembolic events)
Maltese: Problemi b'emboli tad-demm (avvenimenti tromboemboliċi)
English: • The active substance is choriogonadotropin alfa, produced by recombinant DNA technology.
Maltese: • Is-sustanza attiva hi choriogonadotropin alfa, prodotta minn teknoloġija ta' DNA rikombinanti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/165/007
English: Ovitrelle contains sodium
Maltese: Ovitrelle fih is-sodium
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/165/008
English: What Ovitrelle is
Maltese: Tużax Ovitrelle
English: 6.1 Check that the dose display shows ‘0'
Maltese: 6.1 Iċċekkja li d-displej tad-doża tkun turi ‘0'
English: • Active thromboembolic disorders
Maltese: • Problemi trombo-emboliċi attivi
English: • Each pen contains 0.5 mL of solution.
Maltese: • Kull pinna fiha 0.5 mL ta' soluzzjoni.
English: 5.3 Verify once more that the number in the dose display reads ‘250'.
Maltese: 5.3 Iċċekkja għal darb'oħra li n-numru fid-displej tad-doża jkun ‘250'.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Maltese: Dan huwa maħsub li huwa dovut għal differenzi fil-karatteristiċi parentali (eż. età maternali, karatteristiċi tal-isperma) u l-inċidenza ogħla ta' tqaliet multipli.
English: Choriogonadotropin alfa is similar to a hormone found naturally in your body called ‘chorionic gonadotropin', which is involved in reproduction and fertility.
Maltese: Choriogonadotropin alfa huwa simili għal ormon li jinstab b'mod naturali f'ġismek imsejjaħ ‘gonadotropin korjoniku', li huwa involut fir-riproduzzjoni u l-fertilità.
English: Repeated exposure to Ovitrelle was investigated in male patients only.
Maltese: Espożizzjoni ripetuta għal Ovitrelle kienet investigata fuq pazjenti rġiel biss.
English: 6.3 Shelf life
Maltese: 6.3 Rimi
English: The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
Maltese: L-attività farmakodinamika prinċipali fin-nisa hu l-bidu mill-ġdid ta' mejosi ta' l-ooċit, ftuħ follikulari (ovulazzjoni), formazzjoni ta' korpus lutejum u produzzjoni ta' progesterone u estradiol mill-korpus lutejum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 February 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 02 ta' Frar 2001
English: In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol > 3,000 pg/mL (11,000 pmol/L) and 18 or more follicles of 11 mm or more in diameter.
Maltese: Fit-teknika ta' riproduzzjoni assistita, jikber ir-riskju ta' OHSS meta l estradiol fis-serum > 3,000 pikogramma/millitru (11,000 pikomol/litru) u 18-il follikulu jew aktar ta'dijametru ta' 11-il millimetru jew aktar.
English: • Tumours of the hypothalamus or pituitary gland
Maltese: • Tumuri tal-ipotalamu jew tal-glandola pitwarja
English: There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
Maltese: M'hemmx indikazzjoniet li choriogonadotropin alfa jiġi metaboliżżat u maħruġ b'mod differenti mill-hCG endoġeniku.
English: Severe OHSS was reported in less than 0.5% of patients (see section 4.4).
Maltese: OHSS kien osservat f'madwar 4% tal-pazjenti li ngħataw il-kura permezz ta' Ovitrelle. OHSS sever kien irrapurtat f'inqas minn 0.5% tal-pazjenti (sezzjoni 4.4).
English: In comparative trials with different doses of Ovitrelle, the following adverse reactions were found to be associated with Ovitrelle in a dose-related fashion: OHSS, vomiting and nausea.
Maltese: F'testijiet komparattivi b'dożi differenti ta' Ovitrelle, instab li dawn ir-reazzjonijiet avversi segwenti huma marbuta mad-doża ta' Ovitrelle li tkun ingħatat: OHSS, vomtu u nawżea.
English: • Primary ovarian failure
Maltese: • Falliment primarju ta' l-ovarji
English: The steady-state volume of distribution and the total clearance are 6 l and 0.2 L/h, respectively.
Maltese: Il-volum stabbli tad-distribuzzjoni u t-tneħħija kompluta tiegħu huma ta' 6 litri u 0.2 litri/siegħa, rispettivament.
English: 0.5 mL of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) - pack of 1.
Maltese: 0.5 millitru ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp li jitla' u jinżel (lastku talhalobutajl) u planġer (plastik), b'labra ta' l-injezzjoni (azzar li ma jissaddadx) - pakkett ta' 1.
English: Phosphoric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Phosphoric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: dose setting knob dose display plunger piston reservoir holder threaded needle connector pen cap peel-off seal tab removable needle inner needle shield 10. outer needle cap 11. alcohol swabs 12. sharps disposal container
Maltese: 1. pum tond li jissettja d-doża 2. displej tad-doża 3. pistun tal-planġer 4. ħolder tar-reċipjent 5. konnekter tal-labra bil-kamin 6. għatu tal-pinna
English: Mannitol, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Maltese: Mannitol, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (għal aġġustament tal-pH), sodium hydroxide (għal aġġustament talpH), ilma għall-injezzjonijiet.
English: • Each pre-filled syringe contains 250 micrograms / 0.5 mL (equivalent to 6500 IU).
Maltese: • Kull siringa mimlija għal-lest fiha 250 mikrogrammi / 0.5 millitru (ekwivalenti għal 6,500 IU).
English: • Remove the peel-off seal.
Maltese: • Uġigħ fis-sider.
English: Thromboembolism (both in association with and separate from OHSS) Gastrointestinal disorders
Maltese: Tromboemboliżmu (f'assoċjazzjoni kemm ma' OHSS kif ukoll separat minn OHSS) Disturbi gastro-intestinali
English: • Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Maltese: • Nisa li għaddejjin minn ovulazzjoni mgħaġla qabel l-użu ta' teknika ta' riproduzzjoni assistita bħall-fertiliżżazzjoni in vitro (IVF):
English: In comparative clinical trials, administration of a dose of 250 micrograms of Ovitrelle was as effective as 5,000 IU and 10,000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive techniques, and as effective as 5,000 IU of urinary hCG in ovulation induction.
Maltese: IU ta' hCG urinarja biex iġġiegħel il-maturazzjoni follikulari finali u lutejniżżazzjoni bikrija fit-teknika ta' riproduzzjoni assistita, u effettiva daqs 5,000 IU ta' hCG urinarja biex iġġiegħel l-ovulazzjoni.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 micrograms/0.5 mL
Maltese: INDIVIDWALI 250 mikrogrammi/0.5 millilitru
English: • Gynaecological haemorrhages of unknown aetiology
Maltese: • Emorraġija ginekoloġika ta' etjoloġija mhux magħrufa
English: • After the injection, dispose of the used syringe safely.
Maltese: • Wara l-injezzjoni, armi s-siringa użata b'mod sigur.
English: Setting the dose to 250”).
Maltese: Kif tissettja d-doża għal 250”).
English: The risk of multiple pregnancy following assisted reproductive techniques is related to the number of embryos replaced.
Maltese: Ir-riskju ta' tqala multipla wara l-użu ta' tekniki ta' riproduzzjoni assistita huwa marbut man-numru ta' embrijoni mibdula.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely.
Maltese: • Kumplikazzjonijiet serji ta' emboli tad-demm (avvenimenti tromboemboliċi) xi kultant indipendenti minn OHSS jistgħu jseħħu b'mod rari ħafna.
English: This medicine may increase your risk of developing OHSS.
Maltese: Din il-mediċina tista' żżid ir-riskju li jiżviluppa OHSS.
English: The dose display will show a straight line and you have to keep turning until you can read the number ‘250'.
Maltese: Id-displej tad-doża se turi sinjal dritt u int għandek tkompli ddawwar sakemm tkun tista' taqra n-numru ‘250'.
English: Mannitol, methionine, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Maltese: Mannitol, methionine, poloxamer 188, phosphoric acid (għal aġġustament tal-pH), sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet.
English: In anovulation, the risk of OHSS is increased by a serum estradiol level > 1,500 pg/mL (5,400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
Maltese: Waqt ovulazzjoni, ir-riskju ta' OHSS jiżdied b'livell ta' estradiol fisserum ta' >1,500 pikogramma/millitru (5,400 pikomol/litru) u/jew aktar minn 3 follikuli ta' dijametru ta' 14 millimetru jew aktar.
English: Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Maltese: Wara teħid minn taħt il-ġilda, choriogonadotropin alfa jitneħħa mill-ġisem b'nofs ħajja terminali ta' madwar 30 siegħa, u l-biodisponibilita assoluta hi ta' madwar 40%.