FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Acrescent, intended for the treatment of moderate to moderately severe Alzheimer's disease in patients who are already taking memantine and donepezil.
Maltese: Fit-18 ta' Ottubru 2012 il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Acrescent, li kien maħsub għall-kura tal-marda tal-Alzheimer moderata għal moderatament severa f'pazjenti li diġà jkunu qegħdin jieħdu l-memantina u d-donepeżil.
English: One main study involved 404 patients with moderate to severe Alzheimer's disease who were already taking donepezil.
Maltese: Studju ewlieni involva 404 pazjenti bil-marda tal-Alzheimer moderata għal severa li diġà kienu qegħdin jieħdu d-donepeżil.
English: What was Acrescent expected to be used for?
Maltese: Għal xiex kien mistenni jintuża Acrescent?
English: Memantine works by blocking types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Maltese: Il-memantina taħdem billi timblokka tipi ta' riċetturi msejħa riċetturi NMDA, li magħhom normalment jeħel in-newrotrażmettitur glutammat.
English: It presented the results of seven main studies, including patients (or a subset of patients) who received memantine and donepezil together.
Maltese: Ippreżentat ir-riżultati ta' seba' studji ewlenin, li kienu jinkludu pazjenti (jew sottogrupp ta' pazjenti) li ngħataw il-memantina u d-donepeżil flimkien.
English: The effects of Acrescent were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Acrescent ġew l-ewwel analizzati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: The company also presented information intended to show the use of memantine and donepezil in combination to treat Alzheimer's disease across the European Union, including the available guidelines for treating Alzheimer's disease in different European countries.
Maltese: Il-kumpanija ppreżentat ukoll informazzjoni maħsuba biex turi l-użu tal-mamantina u d-donepeżil flimkien fil-kura tal-marda tal-Alzheimer fl-Unjoni Ewropea kollha, inklużi l-linji gwida disponibbli għallkura tal-marda tal-Alzheimer f'pajjiżi Ewropej differenti.
English: By blocking NMDA receptors, memantine helps to reduce the symptoms of Alzheimer's disease.
Maltese: Billi timblokka r-riċetturi tal-NMDA, il-memantina tgħin fit-tnaqqis tas-sintomi tal-marda tal-Alzheimer.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Maltese: In-newrotrażmettituri huma kimiċi fissistema nervuża li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: Donepezil works by blocking the action of an enzyme which normally breaks down a neurotransmitter called acetylcholine.
Maltese: Barra dan il-kumpanija ġabret u analizzat ir-riżultati tal-istudji differenti flimkien.
English: What consequences does this refusal have for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi ta' dan ir-rifjut għall-pazjenti fi provi kliniċi?
English: What were the CHMP's main concerns that led to the refusal?
Maltese: Kif kien mistenni jaħdem Acrescent?
English: By slowing down the breakdown of acetylcholine, donepezil helps to reduce the symptoms of Alzheimer's disease.
Maltese: Il-kumpanija ma għamlitx studji ġodda fuq pazjenti bil-marda tal-Alzheimer.
English: The Committee was concerned that the studies presented by the company had negative results except for one main study, in which patients already taking donepezil performed better in cognitive tests and in daily living activities when memantine was added to donepezil treatment.
Maltese: Il-Kumitat innota wkoll li l-analiżi addizzjonali ma wrietx titjib sinifikanti f'pazjenti li kienu qegħdin jieħdu l-kura ta' assoċjazzjoni apparagun mal-kura bil-memantina biss.
English: It is authorised to treat patients with mild to moderately severe forms of Alzheimer's disease.
Maltese: Din is-sustanza hija awtorizzata biex tikkura pazjenti b'forom moderati għal severi tal-marda tal-Alzheimer.
English: EMA/711301/2014 EMEA/V/C/002781
Maltese: EMEA/V/C/002781
English: The full EPAR for Zulvac SBV can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Zulvac SBV contains the active substance inactivated (killed) Schmallenberg virus strain BH80/11-4.
Maltese: Zulvac SBV fih is-sustanza attiva inattivata (maqtula), ir-razza BH80/11-4 tal-virus ta' Schmallenberg.
English: Schmallenberg virus vaccine (inactivated)
Maltese: Vaċċin tal-virus ta' Schmallenberg (inattivat)
English: This is a summary of the European public assessment report (EPAR) for Zulvac SBV.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zulvac SBV.
English: Zulvac SBV is a vaccine.
Maltese: Zulvac SBV huwa vaċċin.
English: In cattle, an increase in body temperature of up to 1.5°C during the 48 hours after vaccination and the appearance of small lumps of up to 0.7 cm in diameter at the vaccination site that resolve within 10 days are very common (seen in more than 1 animal in 10).
Maltese: °C fit-temperatura tal-ġisem waqt it-48 siegħa ta' wara t-tilqima u d-dehra ta' boċċi żgħar b'dijametru sa 0.7cm fis-sit tat-tilqima li jmorru fi żmien 10 ijiem.
English: Zulvac SBV is a veterinary vaccine used to protect cattle and sheep from 3.5 months of age against Schmallenberg virus by reducing viraemia (presence of virus in the blood).
Maltese: Zulvac SBV huwa vaċċin veterinarju li j intuża biex jipproteġi l-ifrat u n-nagħaġ mill-età ta' 3.5 xhur 'il fuq kontra l-virus ta' Schmallenberg billi jnaqqas il-viremija (virus preżenti fid-demm).
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (l-idrossidu tal-aluminju u s-saponina) li jtejbu r-rispons immunitarju.
English: More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, which may last for at least 97 days as granules less than 0.5 cm in diameter.
Maltese: Iktar minn annimal wieħed minn kull għaxra jista' juri nefħiet jew boċċi b'dijametru sa 8 ċm taħt il-ġilda fis-sit tal-injezzjoni, li jistgħu jdumu għal tal-inqas 97 ġurnata bħala granuli b'dijametru inqas minn 0.5 ċm.
English: The vaccine is given to cattle as two injections of 2 ml into the neck muscle three weeks apart and to sheep as a single injection of 1 ml under the skin behind the elbow.
Maltese: Il-vaċċin jingħata lill-ifrat bħala 2 injezzjonijiet ta' 2 ml fil-muskolu tal-għonq tliet ġimgħat bejn doża u oħra u lin-nagħaġ bħala injezzjoni waħda ta' 1 ml taħt il-ġilda wara l-minkeb.
English: In the future if the animals are exposed to Schmallenberg virus, the immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-virus ta' Schmallenberg, is-sistema immunitarja tkun tista' tipproduċi antikorpi b'mod aktar mgħaġġel.
English: Schmallenberg virus is transmitted by midges and causes stillbirths and birth defects in cattle and sheep.
Maltese: Il-virus ta' Schmallenberg jiġi trażmess permezz ta' insetti u jikkawża mwiet mat-twelid u difetti fit-twelid fl-ifrat u n-nagħaġ.
English: In pregnant ewes vaccination reduced viraemia and infection of the embryo.
Maltese: Fin-nagħaġ tqal it-tilqima naqqset il-viremija u l-infezzjoni fl-embrijun.
English: In pregnant ewes more than one in ten animals may have an increase in body temperature of up to 0.8 °C during 4 hours after vaccination.
Maltese: Fin-nagħaġ tqal, iktar minn annimal wieħed minn kull għaxra jista' jkollu żieda fit-temperatura tal-ġisem sa 0.8 °C waqt l-4 sigħat ta' wara t-tilqima.
English: The effectiveness of Zulvac SBV has been investigated in laboratory studies in cattle and sheep.
Maltese: SBV ġiet investigata fi studji fil-laboratorju fl-ifrat u n-nagħaġ.
English: Zulvac SBV is available as a suspension for injection and can only be obtained with a prescription.
Maltese: Zulvac SBV jiġi bħala suspensjoni għal injezzjoni u jista' jinkiseb biss b'riċetta ta' tabib.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zulvac SBV on 6 February 2015.
Maltese: SBV fis-6 ta' Frar 2015.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zulvac SBV's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: SBV huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Other information about Zulvac SBV:
Maltese: Informazzjoni oħra dwar Zulvac
English: 27 January 2011
Maltese: 27 ta' Jannar 2011
English: Indications restricted following review procedure under Article 31 of Directive 2001/83/EC as amended
Maltese: Indikazzjonijiet ristretti wara proċedura ta' reviżjoni skont l-Artikolu 31 tadDirettiva 2001/83/KE kif emendata
English: EMA/725532/2010 rev. EMEA/H/A-31/1186
Maltese: EMEA/H/A-31/1186
English: They are available in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and the United Kingdom.
Maltese: Huma disponibbli flAwstrija, fil-Belġju, f'Ċipru, fir-Repubblika Ċeka, fid-Danimarka, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Islanda, fl-Irlanda, fl-Italja, fil-Lussemburgu, fil-Pajjiżi l-Baxxi, fil-Portugall, fis-Slovakkja, fi Spanja, fl-Isvezja u fir-Renju Unit.
English: What is modafinil?
Maltese: X'inhu modafinil?
English: Which data has the CHMP reviewed?
Maltese: Liema data irreveda s-CHMP?
English: What are the conclusions of the CHMP?
Maltese: X'inhuma l-konklużjoniiet tas-CHMP?
English: In 2007, the CHMP's Pharmacovigilance Working Party (PhVWP) reviewed the safety of modafinilcontaining medicines because of concerns that the medicines were associated with serious psychiatric disorders (suicidal thoughts, mania and symptoms of psychosis such as delusion) and with skin reactions, including severe reactions such as Stevens-Johnson syndrome, a life-threatening type of allergic reaction affecting the skin and mucous membranes.
Maltese: Fl-2007, il-Grupp ta' Ħidma tal-Farmakoviċilanza tas-CHMP (PhVWP) irreveda s-sigurtà ta' mediċini li fihom modafinil minħabba tħassib li l-mediċini kienu assoċjati ma' disturbi psikjatriċi serji (ħsibijiet ta' suwiċidju, manija u sintomi ta' psikożi bħal delużjonijiet) u ma' reazzjonijiet tal-ġilda, inklużi reazzjonijiet serji bħas-sindromu ta' Stevens-Johnson, tip ta' reazzjoni allerġika li tista' twassal għallmewt u li taffettwa l-ġilda u l-membrani mukużi.
English: They are available under the following invented names: Modasomil, Modiodal, Provigil and Vigil, and as generic medicines.
Maltese: Huma disponibbli taħt l-ismijiet ivvintati li ġejjin: Modasomil, Modiodal, Provigil u Vigil, u bħala mediċini ġeneriċi.
English: The European Medicines Agency has completed a review of the safety and effectiveness of modafinil.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' modafinil.
English: The CHMP also reviewed all the side effects reported with modafinil-containing medicines.
Maltese: Is-CHMP irreveda wkoll l-effetti sekondarji kollha irrapportati b'mediċini li fihom modafinil.
English: The Committee also noted a link between modafinil and psychiatric adverse reactions, such as suicidal thoughts, depression, psychotic episodes, and between modafinil and cardiovascular adverse reactions, such as hypertension (high blood pressure) and irregular heart beat.
Maltese: Il-Kumitat innota wkoll rabta bejn modafinil u reazzjonijiet psikjatriċi avversi, bħal ħsibijiet ta' suwiċidju, dipressjoni, episodji psokotiċi, u bejn modafinil u reazzjonijiet avversi kardjovaskulari, bħal ipertensjoni (pressjoni tad-demm għolja) u tħabbit tal-qalb irregolari.
English: The exact way modafinil works is not fully understood, but it most likely interacts with some chemicals in the brain called neurotransmitters such as dopamine and norepinephrine.
Maltese: Mhux mifhum il-mod preċiż kif jaħdem modafinil, iżda l-aktar probabbli huwa li jinteraġixxi ma' kimiċi fil-moħħ imsejħin newrotrasmettituri bħal dopamine u norepinephrine.
English: Why was modafinil reviewed?
Maltese: Għalxiex ġie rivedut modafinil?
English: The Committee looked at all the data from the clinical trials of modafinil in narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and at articles from the published literature.
Maltese: Il-Kumitat ħares lejn id-dejta kollha minn provi kliniċi ta' modafinil fin-nekrolepsija, apneja tal-irqad ostruttiva, disturbi tal-irqad minħabba xogħol tax-xift u ipersomnija idjopatika, u artikli minn riċensjonijiet.
English: For obstructive sleep apnoea (including in patients with excessive sleepiness despite correctly using a Continuous Positive Airway Pressure machine), shift-work sleep disorder and idiopathic hypersomnia, the CHMP concluded that the data on the effectiveness were not sufficient to outweigh the risks, and that therefore the benefit-risk balance was negative.
Maltese: Għal apneja tal-irqad ostruttiva (inklużi pazjenti b'ngħas eċċissiv minkejja l-użu korrett ta' magna ta' Pressjoni Pożittiva Kontinwa għall-Passaġġi tal-Arja), disturb tal-irqad minħabba xogħol bix-xift u ipersomnija idjopatika, is-CHMP ikkonkluda li d-dejta dwar l-effikaċja ma kinitx biżżejjed biex tegħleb ir-riskji, u li għalhekk il-bilanċ tal-benefiċċju riskju kien negattiv.
English: Questions and answers on the review of medicines containing modafinil
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni tal-mediċini li fihom modafinil
English: Once the PhVWP had received and started its assessment of the data, the working party had further concerns about the medicines, and consequently, on 14 May 2009, the UK medicines regulatory agency asked the CHMP to carry out a full assessment of the benefit-risk balance of modafinilcontaining medicines, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Maltese: Ladarba il-PhVWP irċieva d-dejta u beda l-valutazzjoni tagħha, il-grupp ta' ħidma kellu aktar tħassib dwar il-mediċini, u għalhekk, fl-14 ta' Mejju 2009, l-aġenzija regolatorja tal-mediċini tar-Renju Unit talbet lis-CHMP sabiex jagħmel valutazzjoni sħiħa tal-bilanċ tal-benefiċċju-riskju ta' mediċini li fihom modafinil, u sabiex joħroġ opinjoni jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati madwar l-Unjoni Ewropea.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of modafinil-containing medicines continue to outweigh their risks only in the treatment of narcolepsy.
Maltese: Dan wassal għal aġġornament tal-informazzjoni talprodott għal mediċini li fihom modafinil madwar l-Ewropa sabiex jissaħħu t-twissijiet dwar dawn irriskji.
English: Medicines containing modafinil were first marketed in Europe in 1992.
Maltese: Mediċini li fihom modafinil tqegħdu fis-suq għall-ewwel darba fl-Ewropa fl-1992.
English: EU/1/09/600/001
Maltese: EU/1/09/600/001 Zutectra
English: 5 pre-filled syringes
Maltese: 5 siringi mimlijin għal-lest
English: Pre-filled syringe (glass) 1 ml
Maltese: Użu għal taħt il-ġilda siringa mimlija għal-lest (ħġieġ)
English: 500 IU Solution for injection
Maltese: IU soluzzjoni għall-injezzjoni
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: Zutectra
Maltese: Mnejn jingħata
English: Date of latest renewal: 13 April 2009
Maltese: Data tal-aħħar tiġdid: 13 ta' April 2009
English: Uncommon: Severe OHSS (WHO grade III)
Maltese: Mhux komuni: OHSS sever (WHO grad III).
English: Congenital anomalies
Maltese: Anomaliji konġenitali
English: INFORMATION IN BRAILLE cetrotide 0.25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cetrotide 0.25 mg
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier code 18.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: • In the powder: mannitol.
Maltese: • Fit-trab: mannitol
English: The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).
Maltese: Ir-reazzjonijiet avversi rrappurtati hawn taħt huma kklassifikati skont il-frekwenza tal-okkorrenza kif ġej: 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).
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 Manifattur
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 April 1999
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13 ta' April 1999
English: Cetrotide contains a medicine called ‘cetrorelix'.
Maltese: Cetrotide fih mediċina msejħa ‘cetrorelix'.
English: In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.
Maltese: Fi studji kliniċi, dawn l-effetti kienu osservati bi frekwenza ta' 9.4% wara injezzjonijiet multipli ta' Cetrotide 0.25 mg.
English: Repeated ovarian stimulation procedure
Maltese: Proċeduri ripetuti tal-istimulazzjoni tal-ovarji
English: DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {JJ/XX/SSSS}
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/100/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/100/001
English: Manufacturer Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany
Maltese: Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, il-Ġermanja Dan il-fuljett kien rivedut l-aħħar f'{XX/SSSS}.
English: What Cetrotide is
Maltese: Tużax Cetrotide
English: • LHRH controls another hormone, called LH (‘luteinising hormone').
Maltese: • LHRH jikkontrolla ormon ieħor, imsejjaħ LH (‘ormon ta' lutejinazzazzjoni').
English: Elimination The total plasma clearance and the renal clearance are 1.2 mL x min x kg and 0.1 mL x min x kg respectively.
Maltese: Eliminazzjoni It-tneħħija għal kollox mill-plasma u t-tneħħija mill-kliewi huma ta' 1.2 mL x min-1 x kg-1 u
English: Uncommon: Nausea
Maltese: Mhux komuni: Nawżja
English: Appearance of the powder: white lyophilisate Appearance of the solvent: clear and colourless solution The pH of the reconstituted solution is 4.0-6.0.
Maltese: Apparenza tat-trab: lajofilizzat abjad Apparenza tas-solvent għal soluzzjoni: soluzzjoni ċara u mingħajr kulur Il- pH tas-soluzzjoni rrikostitwita hija 4.0-6.0.
English: What Cetrotide contains - The active substance is cetrorelix.
Maltese: X'fih Cetrotide - Is-sustanza attiva hi cetrorelix.
English: Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings.
Maltese: Dejta limitata minn studji kliniċi ta' segwitu fit-316-il tarbija tat-twelid ta' nisa li ngħataw cetrorelix għal trattamenti kontra l-infertilità tissuġġerixxi li cetrorelix ma jżidx ir-riskju ta' anomaliji konġenitali fit-trabi.
English: Merck Healthcare KGaA, Frankfurter Straße 250 D-64293 Darmstadt Germany
Maltese: Merck Healthcare KGaA, Frankfurter Straße 250
English: Distribution The volume of distribution (Vd) is 1.1 L x kg
Maltese: Distribuzzjoni Il-volum fejn jinfirex (Vd) hu ta' 1.1 L x kg
English: 7 injection needles (20 gauge) 7 hypodermic injection needles (27 gauge) 14 alcohol swabs.
Maltese: 7 labar tal-injezzjoni (20 gauge) 7 labar tal-injezzjoni ipodermiċi (27 gauge) 14 tajjara bl-alkoħol
English: • Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew xi analogi strutturali ta' ormon li jillibera gonadotropin fid-demm (GnRH), ormoni estrinsiċi tal-peptide jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Powder Mannitol.
Maltese: Mannitol.
English: Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy.
Maltese: Studji fuq annimali indikaw li cetrorelix jeżerċita influwenza fuq il-fertilità, kapaċità riproduttiva u tqala skont kemm tkun qawwija d-doża li tingħata.
English: Cetrorelix is contraindicated in patients with severe renal impairment (see section 4.3).
Maltese: Cetrorelix hu kontraindikat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.3).
English: Pre-filled syringe (Type I glass) with plunger stopper (siliconised bromobutyl rubber) and tip cap (polypropylene and styrene butadiene rubber).
Maltese: Siringa mimlija għal-lest (ħġieġ ta' Tip I) b'tapp tal-planġer (lastku bromobutyl silikonizzat) u għatu tat-tarf (lastku polypropylene u styrene butadiene).
English: An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
Maltese: OHSS għandu jiġi kkurat b'mod sintomatiku, eż., bil-mistrieħ, elettroliti/kollojdi ġol-vini u terapija bleparina.
English: Pharmacotherapeutic group: anti-gonadotropin-releasing hormones, ATC code: H01CC02.
Maltese: Kategorija farmakoterapewtika: ormoni li jħollu l-irbit ta' anti-gonadotropin, Kodiċi ATC:
English: • if you are allergic to medicines similar to Cetrotide (any other peptide hormones).
Maltese: • jekk inti allerġika għal mediċini simili għal Cetrotide (jew għal xi ormoni peptidi oħrajn).
English: Cetrorelix is a luteinising hormone releasing hormone (LHRH) antagonist.
Maltese: Cetrorelix hu antagonist tal-ormon li jistimula l-produzzjoni tal-ormon ta' lutejinazzazzjoni (LHRH).
English: Cetrotide blocks a natural hormone in your body called LHRH (‘luteinising hormone releasing hormone').
Maltese: Cetrotide jimblokka ormon naturali f'ġismek li jissejjaħ LHRH (‘ormon li jistimula l-produzzjoni talormon ta' lutejinazzazzjoni').
English: In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
Maltese: Fi studji dwar effett tossiku akut fuq annimali gerriema kienu osservati sintomi tossiċi mhux speċifiċi wara l-amministrazzjoni ġol-peritonew ta' dożi ta' cetrorelix ta' 200 darba aktar mid-doża farmakoloġikament effettiva wara l-amministrazzjoni taħt il-ġilda.
English: 7 powder vials with 0.25 mg cetrorelix.
Maltese: 7 kunjetti bit-trab b'0.25 mg cetrorelix.
English: Common:
Maltese: NN:
English: 7 pre-filled syringes with 1 mL of solvent.
Maltese: 7 siringi mimlijin għal-lest b'1 mL ta' solvent.
English: In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Maltese: Fl-annimali kif ukoll fil-bnedmin, l-effetti ormonali antagonistiċi ta' cetrorelix kienu kompletament riversibbli wara t-tmiem tal-kura.
English: Cetrorelix showed no mutagenic or clastogenic potential in gene and chromosome mutation assays.
Maltese: Cetrorelix ma wera l-ebda potenzjal mutaġeniku jew klastoġeniku f'analiżi tal-ġeni u ta' mutazzjoni ta' kromożomi.