FrancophonIA/ELRC3.0 huggingface dataset:
English: SPC Section 4.4 - Special Warnings and Precautions for Use The MAH was asked to harmonise Section 4.4, for which the following differences between SPCs needed to be evaluated: - the mentioning of reports of aggression in relation to starting and discontinuing treatment; - treatment of children and adolescents under the age of 18, which was recommended by the CHMP in 2005 to be included in Section 4.4 of the SPC (Commission Decision of 19-VIII-2005); With regards to the aggression reports, it was agreed to introduce a wording to indicate that aggression may occur in patients receiving venlafaxine, under initiation, dose changes and discontinuation of treatment.
Maltese: Sezzjoni 4.4 tal-SPC - Twissijiet Speċjali u Prekawzjonijiet għall-Użu Il-MAH intalab jarmonizza s-Sezzjoni 4.4, li għaliha kellhom jiġu evalwati d-differenzi li ġejjin bejn l-SPCs: - li jissemmew rapporti ta' aggressjoni b'rabta mal-bidu u t-twaqqif tat-trattament; - it-trattament ta' tfal u adolexxenti taħt it-18-il sena, li ġie rrakkomandat mis-CHMP fl-2005 li għandu jiġi inkluż fis-Sezzjoni 4.4 tal-SPC (Deċiżjoni tal-Kummissjoni tad-19-VIII-2005);
English: Efectin ER 75 mg - Kapseln 75 mg Modified-release capsule, hard
Maltese: Efectin ER 75 mg - Kapseln 75 mg Kapsula li terħi il-mediċina b'mod modifikat, iebsa
English: Efectin ER 37,5 mg - Kapseln 37.5 mg Modified-release capsule, hard
Maltese: Efectin ER 37,5 mg - Kapseln 37.5 mg Kapsula li terħi il-mediċina b'mod modifikat, iebsa
English: Patients received doses in a range of 75 to 225 mg/day.
Maltese: Il-pazjenti rċivew dożi fil-medda ta' 75 sa 225 mg/kuljum.
English: • Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
Maltese: • Problemi fin-nervaturi: bħal sturdament, sensazzjoni ta' tingiż, disturb tal-moviment, aċċessjonijiet.
English: PACKAGE LEAFLET
Maltese: Kura rakkomandata
English: The concomitant use of venlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended (see section 4.4).
Maltese: L-użu fl-istess ħin ta' venlafaxine ma' prekursuri ta' serotonin (bħal supplimenti ta' tryptophan) mhuwiex rakkomandat (ara sezzjoni 4.4).
English: In vitro and in vivo studies indicate that venlafaxine is metabolised to a minor, less active metabolite, N-desmethylvenlafaxine, by CYP3A4.
Maltese: Studji in vitro u in vivo jindikaw li venlafaxine ikun metabolizzat għal metabolit minuri, inqas attiv, N
English: Treatment of major depressive episodes.
Maltese: Għall-kura ta' episodji dipressivi maġġuri.
English: Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see sections 4.4 and 4.5).
Maltese: Venlafaxine għandu jitwaqqaf għal mill-inqas 7 ijiem qabel ma tinbeda l-kura bi kwalunkwe MAOI irriversibbli (ara sezzjonijiet 4.4 u 4.5).
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for panic disorder was established in two double-blind, 12-week, multi-center, placebo-controlled studies in adult outpatients with panic disorder, with or without agoraphobia.
Maltese: L-effikaċja tal-kapsuli ta' venlafaxine li jerħu l-mediċina bil-mod bħala kura għal disturb ta' paniku kienet stabbilita f'żewġ studji li damu 12-il ġimgħa, li kienu double-blind, multi-ċentriċi, ikkontrollati bil-plaċebo, f'pazjenti adulti outpatients b'disturb ta' paniku, bi jew mingħajr agorafobija.
English: The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated: - monoamine oxidase inhibitors.
Maltese: Il-MAH intalab jarmonizza s-Sezzjoni 4.5 fis-Sommarju tal-Karatterisiċi tal-Prodott, li għalihom ħtieġu li jiġu evalwati dawn id-differenzi bejn l-SPCs: - inibituri tal-monoamine oxidase.
English: You should avoid alcohol while you are taking Efexor depot.
Maltese: Għandek tevita l-alkoħol meta tkun qed tieħu Efexor depot.
English: Also, you must wait at least 7 days after you stop taking Efexor depot before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).
Maltese: Flimkien ma' dan, trid tistenna mill-inqas 7 ijiem wara li tieqaf tieħu Efexor depot qabel ma tieħu kwalunkwe MAOI (ara wkoll is-sezzjonijiet “Is-Sindrome ta' serotonin” u “Meta tuża mediċini oħra”).
English: Efexor depot should be taken with food (see section 3 “HOW TO TAKE EFEXOR DEPOT”).
Maltese: Efexor depot jista' jittieħed ma' l-ikel (ara Sezzjoni 3 “KIF GĦANDEK TIEĦU EFEXOR DEPOT”).
English: Efexor depot and associated names (see Annex I) 37.5 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 75 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 150 mg hard prolonged-release capsules
Maltese: Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 37.5 mg li jerħu lmediċina bil-mod Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 75 mg li jerħu lmediċina bil-mod Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 150 mg li jerħu lmediċina bil-mod
English: However, the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.4 and Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Maltese: Madankollu, is-CHMP qies li l-MAOIs irriversibbli mhux selettivi biss kellhom ikunu kontraindikati u li twissija qawwija fis-Sezzjoni 4.4 u s-Sezzjoni 4.5 tal-SPC għandhom ikunu suffiċjenti għallMAOIs riversibbli.
English: What Efexor depot looks like and contents of the pack
Maltese: Id-dehra ta' Efexor depot u l-kontenuti tal-pakkett [Biex timtela mill-pajjiż partikolari]
English: Efectin ER 150 mg cps plg 150 mg Prolonged-release capsules
Maltese: Efectin ER 150 mg cps plg 150 mg Kapsuli li jerħu l-mediċina bil-mod Użu orali
English: Efectin ER 37,5mg cps plg 37.5mg Prolonged-release capsules
Maltese: Efectin ER 37,5mg cps plg 37.5mg Kapsuli li jerħu l-mediċina bil-mod Użu orali
English: Patients then received fixed doses of 75 or 150 mg/day in one study and 75 or 225 mg/day in the other study.
Maltese: Il-pazjenti imbagħad rċivew dożi fissi ta' 75 jew 150 mg/kuljum fi studju wieħed, u 75 jew 225 mg/kuljum fl-istudju lieħor.
English: Slovak Republic Wyeth-Lederle Pharma GmbH Storchengasse 1
Maltese: Is-Slovakkja Wyeth-Lederle Pharma GmbH Storchengasse 1
English: Altered taste sensation, Tinnitus
Maltese: Disturb ta' ansjetà soċjali
English: • Chest tightness, wheezing, trouble swallowing or breathing
Maltese: • Disturbi tal-vista u tas-smigħ
English: • Muscle disorders Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Maltese: • Disturbi tal-muskoli Mhux magħrufa: uġigħ mhux spjegabbli fil-muskoli, sensittività jew dgħjufija (rabdomijolosi)
English: Efectin ER 150 mg trde kapsules podaljšanim sproščanjem
Maltese: EFECTIN ER 150 mg trde kapsule s podaljšanim sproščanjem
English: Medicinal products that inhibit serotonin uptake may lead to reduced platelet function.
Maltese: Prodotti mediċinali li jinibixxu l-assorbiment ta' serotonin jistgħu jwasslu għal tnaqqis fil-funzjoni tal-plejtlits.
English: Slovak Republic
Maltese: Ir-Repubblika tas-Slovakja
English: In vitro and in vivo studies indicate that venlafaxine is a weak inhibitor of CYP2D6.
Maltese: Studji in vitro u in vivo jindikaw li venlafaxine hu inibiturdgħajjef ta' CYP2D6.
English: The initial dose in panic disorder studies was 37.5 mg/day for 7 days.
Maltese: Id-doża talbidu fi studji dwar disturb ta' paniku kienet ta' 37.5 mg/kuljum għal 7 ijiem.
English: Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
Maltese: Reazzjonijiet Extrapiramidali (li jinkludu distonja u diskinesija), Diskinesija tardiva, Ħsieb biex jitwettaq suwiċidju u mġiba suwiċidali**
English: Respiratory
Maltese: Sistema Respiratorja
English: Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI (see sections 4.3 and 4.4).
Maltese: Venlafaxine għandu jitwaqqaf għal mill-inqas 7 ijiem qabel ma tinbeda l-kura b'MAOI irriversibbli u mhux selettiv (ara sezzjonijiet 4.3 u 4.4).
English: Efectin ER 75 mg cps plg 75 mg Prolonged-release capsules
Maltese: Efectin ER 75 mg cps plg 75 mg Kapsuli li jerħu l-mediċina bil-mod Użu orali
English: Venlafaxine has been shown not to increase the impairment of mental and motor skills caused by ethanol.
Maltese: Intwera li venlafaxine ma jżidx l-indeboliment tal-ħiliet mentali u tal-moviment ikkawżat millethanol.
English: Haematological / Lymphatic
Maltese: Sistema Ematoloġika / Limfatika
English: Efexor depot is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks).
Maltese: Efexor depot hu wkoll kura għal adulti b'dawn iddisturbi ta' l-ansjetà li ġejjin: disturb ta' ansjetà ġeneralizzata, disturb ta' ansjetà soċjali (biża' jew li wieħed jevita sitwazzjonijiet soċjali), u disturb ta' paniku (attakki ta' paniku).
English: Take special care with Efexor depot
Maltese: KIF TAĦŻEN EFEXOR DEPOT
English: Member State Marketing Authorisation Holder (Invented) name
Maltese: Stat Membru Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Abnormality of accommodation, Mydriasis, Visual disturbance,
Maltese: Anormalità ta' lakkomodazzjoni, Midrijasi, Disturb talvista
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Maltese: Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 150 mg kapsuli iebsin li jerħu l-mediċina bilmod [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Maltese: Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 37.5 mg kapsuli iebsin li jerħu l-mediċina bilmod [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: Panic disorder
Maltese: Sistema Diġestiva
English: Efexor depot is a treatment for adults with depression.
Maltese: Efexor depot hu kura għal adulti b'dipressjoni.
English: Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Maltese: Il-kura fl-istess ħin b'inibituri irriversibbli ta' monoamine-oxidase (MAOIs) hi kontra-indikata minħabba r-riskju tas-sindrome ta' serotonin b'sintomi bħal aġitazzjoni, tregħid, u ipertermija.
English: Panic Disorder:.
Maltese: Disturb ta' paniku
English: Do not stop taking Efexor depot without talking to your doctor (see the section “If you stop taking Efexor depot”).
Maltese: Tiqafx tieħu Efexor depot mingħajr ma tkellem lit-tabib tiegħek (ara s-sezzjoni “Jekk tieqaf tieħu Efexor depot”).
English: Do not take Efexor depot
Maltese: Tiħux Efexor depot
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Maltese: Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 75 mg kapsuli iebsin li jerħu l-mediċina bilmod [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: Inside Efexor depot capsules are spheroids or small white balls that contain the venlafaxine active ingredient.
Maltese: Ġol-kapsuli ta' Efexor depot hemm sferojdi jew blalen żgħar bojod li fihom is-sustanza attiva ta' venlafaxine.
English: The usual recommended starting dose for treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg per day.
Maltese: Id-doża rakkomandata tal-bidu għall-kura tad-dipressjoni, disturb ta' ansjetà ġeneralizzata u disturb ta' ansjetà soċjali hi ta' 75 mg kuljum.
English: As with other serotonergic agents, serotonin syndrome may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, or St. John's Wort [Hypericum perforatum]), with medicinal agents which impair metabolism of serotonin (including MAOIs), or with serotonin precursors (such as tryptophan supplements).
Maltese: Bħal ma jiġri b'mediċini serotonerġiċi oħrajn, is-sindrome ta' serotonin jista' jseħħ bil-kura ta' venlafaxine, partikolarment bl-użu fl-istess ħin ta' mediċini li jistgħu jaffettwaw lis-sistema tannewrotrasmettitur serotonerġiku (li jinkludu triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, jew St.
English: Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible nonselective MAOI.
Maltese: Venlafaxine m'għandux jinbeda għal mill-inqas 14-il jum wara t-twaqqif tal-kura b'MAOI irriversibbli u mhux selettiv.
English: Your doctor will advise you on how you should gradually discontinue Efexor depot treatment.
Maltese: Tużax Efexor depot wara d-data ta' skadenza li tidher fuq l-ippakkjar.
English: Patients continued to receive the same dose of venlafaxine prolonged-release that they had taken at the end of the open-label phase (75, 150, or 225 mg).
Maltese: Il-pazjenti komplew jirċievu l-istess doża ta' venlafaxine li jerħi bil-mod li kienu ħadu fit-tmiem tal-fażi open-label (75, 150, jew 225 mg).
English: If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Maltese: Jekk ikun klinikament meħtieġ minħabba s-severità tas-sintomi, żidiet fid-doża jistgħu jsiru f'intervalli aktar frekwenti, iżda mhux inqas minn 4 ijiem.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba marbuta mas-suwiċidju (attentat ta' suwiċidju u ħsibijiet suwiċidali) u ostilità (il-biċċa l-kbira aggressjoni, imġiba li topponi, u rabja) kienu osservati b'mod aktar frekwenti fi provi kliniċi fost it-tfal u adolexxenti li kienu kkurati b'anti-dipressanti, meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: Asthenia (fatigue), Chills
Maltese: Nuqqas t'aptit (anoreksja), Stitikezza, Rimettar
English: Solvent: 10 ml Matrix: 7.5 x 10 cm
Maltese: Solvent: 10 ml Matriċi: 7.5 x 10 cm
English: 1 vial + 1 vial + 2 matrices + 2 syringes + 2 needles
Maltese: 1 kunjett + 1 kunjett + 2 matriċijiet + 2 siringi + 2 labar
English: 1 vial + 1 vial + 1 matrix + 2 syringes + 2 needles
Maltese: 1 kunjett + 1 kunjett + 1 matriċi + 2 siringi + 2 labar
English: Solvent: 10 ml Matrix: 2 x (2.5 x 5 cm)
Maltese: 2 x (2.5 x 5 cm)
English: Further information on Ogivri can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ogivri.
Maltese: ema.europa.eu/medicines/human/EPAR/Ogivri.
English: A response to treatment after 24 weeks was seen in 70% of the patients given Ogivri (160 of 230) and 64% of the patients given Herceptin (146 of 228).
Maltese: Rispons għall-kura wara 24 ġimgħa deher f'70 % tal-pazjenti li ngħataw Ogivri (160 minn 230) u 64 % tal-pazjenti li ngħataw Herceptin (146 minn 228).
English: Other information about Ogivri
Maltese: Informazzjoni oħra dwar Ogivri
English: The reference medicine for Ogivri is Herceptin.
Maltese: Il-mediċina ta' referenza għal Ogivri hija Herceptin.
English: Ogivri contains the active substance trastuzumab.
Maltese: Ogivri fih is-sustanza attiva trastuzumab.
English: The active substance in Ogivri, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Maltese: Is-sustanza attiva f'Ogivri, it-trastuzumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex tagħraf u teħel mal-proteina HER2.
English: What are the risks associated with Ogivri?
Maltese: X'inhuma r-riskji assoċjati ma' Ogivri?
English: Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li ma jkollhomx reazzjonijiet sinifikanti għallewwel infużjoni ta' 90 minuta jistgħu jirċievu infużjonijiet sussegwenti għal 30 minuta.
English: Laboratory studies comparing Ogivri with Herceptin have shown that the active substance in Ogivri is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Ogivri ma' Herceptin urew li s-sustanza attiva f'Ogivri hija simili ħafna għal dik f'Herceptin f'termini ta' struttura, purità u attività bijoloġika.
English: Ogivri is a ‘biosimilar medicine'.
Maltese: Ogivri huwa "mediċina bijosimili".
English: This means that Ogivri is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Ogivri huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ogivri is used before surgery in combination with chemotherapy and then again after surgery on its own;
Maltese: Għal kanċers li huma lokalment avvanzati (inkluż dawk li huma infjammatorji) jew usa' minn 2 cm, Ogivri jintuża qabel il-kirurġija flimkien mal-kimoterapija mbagħad għal darb'oħra wara l-kirurġija waħdu;
English: Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel).
Maltese: Il-pazjenti rċevew Ogivri jew ilmediċina ta' referenza Herceptin flimkien ma' mediċini oħra kontra l-kanċer (paclitaxel jew docetaxel).
English: • early breast cancer (when the cancer has spread within the breast or to the lymph nodes (‘glands') under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Maltese: • kanċer tas-sider li jkun għadu fil-bidu (meta l-kanċer ikun infirex fis-sider jew fil-limfonodi ('glandoli') taħt id-driegħ iżda mhux f'partijiet oħra tal-ġisem) wara kirurġija, kimoterapija (mediċini għall-kura tal-kanċer), u radjoterapija (kura bir-radjazzjoni) jekk applikabbli.
English: The most common or serious side effects with Ogivri are heart problems, reactions related to the infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Maltese: L-effetti sekondarji l-aktar komuni jew serji b'Ogivri huma problemi fil-qalb, reazzjonijiet relatati mal-infużjoni, livelli mnaqqsa ta' ċelloli tad-demm (speċjalment taċ-ċelloli tad-demm bojod), infezzjonijiet u problemi fil-pulmun.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ogivri has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Ogivri għandu struttura, purità u attività bijoloġika simili ħafna għal Herceptin u jiġi distribwit bl-istess mod fil-ġisem.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Maltese: Billi teħel ma' HER2, trastuzumab tattiva ċ-ċelloli tas-sistema immunitarja, li mbagħad joqtlu liċ-ċelloli tat-tumur.
English: Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.
Maltese: L-istudji wrew ukoll li l-għoti ta' infużjoni ta' Ogivri jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' infużjoni ta' Herceptin.
English: In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition.
Maltese: Barra minn hekk, studju wieħed li involva 500 pazjent b'kanċer metastatiku tas-sider li esprima żżejjed minn HER2 wera li Ogivri kien effettiv biex jikkura l-kondizzjoni.
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Ogivri would behave in the same way as Herceptin in its approved indications.
Maltese: Fid-dawl tad-data kollha pprovduta, id-differenza ma ġietx ivvalutata bħala rilevanti u ġie konkluż li Ogivri jaġixxi bl-istess mod ta' Herceptin flindikazzjonijiet approvati tiegħu.
English: Why is Ogivri authorised in the EU?
Maltese: Għaliex Ogivri huwa awtorizzat fl-UE?
English: How does Ogivri work?
Maltese: Kif jintuża Ogivri?
English: The safety of Ogivri has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Herceptin.
Maltese: Is-sigurtà ta' Ogivri ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Herceptin.
English: How is Ogivri used?
Maltese: Kif jaħdem Ogivri?
English: Because Ogivri is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ogivri.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ogivri hija ssorveljata kontinwament.
English: Ogivri must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Maltese: Ogivri m'għandux jintuża f'persuni li għandhom sensittività eċċessiva (allerġika) għal trastuzumab, għall-proteini tal-ġurdien jew għal kwalunkwe waħda mis-sustanzi l-oħra.
English: Ogivri can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Maltese: Ogivri jista' jintuża biss meta l-kanċer “jesprimi żżejjed minn HER2”: dan ifisser li l-kanċer jipproduċi proteina li tissejjaħ HER2 fi kwantitajiet kbar fuq iċ-ċelloli tal-kanċer.
English: All these data were considered sufficient to conclude that Ogivri will behave in the same way as intravenous Herceptin in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Ogivri ser jaġixxi bl-istess mod bħal Herceptin mogħti fil-vina f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: ATC code: L01XC23.
Maltese: L01XC23.
English: Age < 65 years ≥ 65 years
Maltese: Età < 65 sena ≥ 65 sena
English: Frequency overall
Maltese: Frekwenza globali
English: Paracetamol (650-1000 mg orally).
Maltese: Paracetamol (650-1000 mg mill-ħalq).
English: Probability progression free (%)
Maltese: Probabbiltà mingħajr progressjoni (%)
English: Grade 3/4
Maltese: Gradi 3/4
English: Hypoaesthesia 1
Maltese: Ipoesteżija 1
English: Standard risk Cytogenetic category Presence of del17p
Maltese: Riskju standard Kategorija ċitoġenetika Preżenza ta' del17p
English: The final OS analysis met the protocol-specified boundary for statistical significance (p ≤ 0.046).
Maltese: L-analiżi OS finali ssodisfat il-limitu speċifikat mill-protokoll għal sinifikanza statistika (p ≤ 0.046).
English: United States
Maltese: Stati Uniti
English: Lenalidomide (25 mg) orally
Maltese: Lenalidomide (25 mg) mill-ħalq
English: Dexamethasone (mg) intravenously Dexamethasone (mg) orally  75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally > 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22
Maltese: Dexamethasone (mg) ġol-vina Dexamethasone (mg) mill-ħalq  75 sena 28 28 28 28 28 40 40 40 Dexamethasone (mg) mill-ħalq > 75 sena 8 8 8 8 8 20 20 20
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Maltese: Kategorija farmakoterapewtika: aġenti antinejoplastiċi, antikorpi monoklonali.
English: Date of first authorisation: 11 May 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11 ta' Mejju 2016
English: IV use.
Maltese: Użu IV.