FrancophonIA/ELRC3.0 huggingface dataset:
English: • All educational brochures for patients should contain the following information o That thalidomide is teratogenic o That thalidomide may cause ischaemic heart disease, (including myocardial infarction) o Description of the patient card and its use in the individual Member State o Guidance on handling Thalidomide Celgene for patients, caregivers and family members o National or other applicable specific arrangements for a prescription for thalidomide to be dispensed o That thalidomide must not be given to any other person o That the patient should not donate blood o That the patient should tell their doctor about any adverse events o That any unused capsules should be returned to the pharmacist at the end of the treatment
Maltese: • Il-fuljetti edukattivi għall-pazjenti kollha għandu jkun fihom dawn l-elementi li ġejjin: o Li thalidomide huwa teratoġeniku o Li thalidomide għandu mnejn jikkawża mard iskemiku tal-qalb (inkluż infart mijokardijaku) o Deskrizzjoni tal-kard tal-pazjent u l-użu tagħha fl-Istat Membru Individwali o Gwida dwar l-immaniġġjar ta' Thalidomide Celgene għall-pazjenti, persuni li jieħdu ħsiebhom u membri tal-familja o Arranġamenti nazzjonali jew oħrajn applikabbli speċifiċi sabiex ikun jista' jingħata thalidomide b'riċetta o Li m'għandekx tagħti thalidomide lil ħaddieħor o Li l-pazjent m'għandux jagħti d-demm o Li l-pazjent għandu javża lit-tabib tiegħu b'kull effett avvers li jkollu o Li kwalunkwe kapsuli mhux użati għandhom jingħataw lura lill-ispiżjar fi tmiem tat-trattament
English: The extent of thalidomide metabolism by the liver cytochrome P450 system is minimal and intact thalidomide is not excreted by the kidney.
Maltese: Il-grad ta' metaboliżmu ta' thalidomide mis-sistema ta' ċitokrom P450 tal-fwied hu minimu u thalidomide intatt ma jitneħħiex mill-kliewi.
English: Thalidomide may cause fatigue (very common), dizziness (very common), somnolence (very common) and blurred vision (common) (see section 4.8).
Maltese: Thalidomide jista' jikkawża għeja (komuni ħafna), sturdament (komuni ħafna), ngħas (komuni ħafna) u vista mċajpra (komuni) (ara sezzjoni 4.8).
English: • Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing potential status o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if woman of childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if woman of childbearing potential) o pregnancy test dates and results
Maltese: • Kards tal-pazjent u/jew għodda ekwivalenti: o verifika li ngħata servizz adattat ta' pariri o dokumentazzjoni tal-istat jekk tistax toħroġ tqila o kaxxa (jew simili) li t-tabib jittikkja biex jikkonfirma li l-pazjent qed juża kontraċettiv effettiv (jekk hi mara li jista' jkollha t-tfal) o Il-fuljetti jistgħu jkunu ta' 3 tipi, jew fuljett ta' pazjent wieħed li jgħaqqad o verifika ta' test inizjali negattiv tat-tqala qabel il-bidu tat-trattament (jekk hi mara li jista' jkollha t-tfal) o dati u riżultati tat-test tat-tqala
English: PVC/PCTFE/aluminium blister containing 14 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Strixxa tal-PVC/PCTFE/aluminju li fiha 14-il kapsula Daqsijiet tal-pakketti: 28 kapsula (f'żewġ strixxi) f'kard ta' kartiera.
English: Thalidomide is present in the semen of male patients at levels similar to plasma concentrations (see section 4.4).
Maltese: Thalidomide huwa preżenti wkoll fis-semen tal-pazjenti rġiel f'livelli simili bħal tal-konċentrazzjonijiet tal-plażma (ara sezzjoni 4.4).
English: Thalidomide Celgene 50 mg hard capsules thalidomide
Maltese: Thalidomide Celgene 50 mg kapsuli ibsin thalidomide
English: The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high.
Maltese: Ir-riskju ta' mewt intra-uterina jew mankamenti severi mat-twelid, prinċipalment fokomelija hija estremament għolja.
English: Sexual dysfunction
Maltese: Teratoġeniċità
English: Thalidomide Celgene 50 mg hard capsules
Maltese: Thalidomide Celgene 50 mg kapsuli ibsin
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma (MM), combined oral contraceptive pills are not recommended (see section 4.5).
Maltese: Minħabba r-riskju ogħla ta' tromboemboliżmu fil-vini f'pazjenti b'majeloma multipla (MM), pilloli kontraċettivi orali kkombinati mhumiex rakkomandati (ara sezzjoni 4.5).
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Maltese: Il-pazjenti u tobba huma avżati biex joqogħdu attenti għal sinjali u sintomi ta' tromboemboliżmu.
English: 200 mg daily 0.25 mg/kg daily 2 mg/kg daily
Maltese: 200 mg kuljum 0.25 mg/kg kuljum2 mg/kg kuljum
English: Previously infected patients should be closely monitored for signs and symptoms of viral reactivation, including active HBV infection, throughout therapy.
Maltese: Il-pazjenti li fil-passat kienu infettati għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' infezzjoni mill-ġdid virali, li jinkludu infezzjoni attiva bl-HBV matul il-perjodu kollu tat-terapija.
English: Patients involved should be preferably naïve to the history of thalidomide.
Maltese: Il-pazjenti involuti, preferibbilment m'għandhom qatt ma kienu ħadu thalidomide qabel.
English: • The collection of detailed data to understand demographics of target population, indication and number of women of child bearing potential in order to monitor closely the off-label use within national territory.
Maltese: • Il-ġbir ta' tagħrif dettaljat biex wieħed jifhem id-demografiji tal-popolazzjoni fil-mira, l-indikazzjoni u n-numru ta' nisa li jistgħu joħorġu tqal sabiex jiġi monitorat mill-qrib l-użu off-label fi ħdan it-territorju nazzjonali
English: • you have a fall in the number of platelets.
Maltese: • għandek tnaqqis fin-numru tal-plejtlits fid-demm.
English: Cases of PRES/RPLS have been reported.
Maltese: Aqrah bir-reqqa u imxi mal-istruzzjoni relatati.
English: Renal failure
Maltese: Tqala u treddigħ
English: 28 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 kapsula iebsa
English: Marketing Authorisation Holder Celgene Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Celgene Europe B.V.
English: Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide Celgene (see also section 4 “Possible side effects”).
Maltese: It-tabib tiegħek għandu jevalwa jekk tiżviluppa tipi addizzjonali ta' tumuri malinni ematoloġiċi (imsejħa lewkimja majelojde akuta u sindromi majelodisplastiċi) waqt it-trqattament tiegħek b'Thalidomide Celgene (ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: Neutropenia Leukopenia Anaemia
Maltese: Disturbi psikjatriċi
English: Peripheral neuropathy*, Tremor, Dizziness, Paraesthesia, Dysaesthesia, Somnolence
Maltese: Komuni Ħafna Newropatija periferali*, Rogħda, Sturdament, Parastesija, Disestesija, Ngħas
English: Thalidomide Celgene with food, drink and alcohol Do not drink alcohol while you are taking Thalidomide Celgene.
Maltese: Thalidomide Celgene ma' ikel, xorb u alkoħol M'għandekx tieħu alkoħol meta qed tieħu Thalidomide Celgene.
English: Other side effects include:
Maltese: Jekk inti tista' tinqabad tqila:
English: Immune System Disorders Not Known
Maltese: Disturbi fis-sistema immuni
English: Peripheral neuropathy generally occurs following chronic use over a period of months.
Maltese: Newropatija periferali ġeneralment isseħħ wara l-użu kroniku fuq perijodu ta' xhur.
English: Hard capsule.
Maltese: Mhux applikabbli.
English: Due to thalidomide's potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents.
Maltese: Minħabba l-potenzjal ta' thalidomide li jinduċi bradikardja, kawtela għandha tiġi eżerċitata bi prodotti mediċinali li għandhom l-istess effett farmakodinamiku bħal sustanzi attivi magħrufa li jikkawżaw torsade de pointes, beta blockers jew aġenti anticholinesterase.
English: What Thalidomide Celgene is
Maltese: Tiħux Thalidomide Celgene:
English: • Pregnancy reporting requirements o Instruction to stop thalidomide immediately upon suspicion of pregnancy, if female patient o Need to refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation o Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” o Local contact details for reporting of any suspected pregnancy
Maltese: • Rekwiżiti dwar raportaġġ ta' tqala o Istruzzjonijiet biex twaqqaf thalidomide minnufih malli hemm suspett ta' tqala, jekk tkun pazjenta mara o Il-ħtieġa li tirreferi lil pazjent għand tabib speċjalizzat jew b'esperjenza fil-qasam tat-teratoloġija għal parir u evalwazzjoni o Imla l-formola tar-rappurtaġġ li tingħata fil-“Kitt Edukattiv tal-Professjonist fil-Qasam tal-Kura tas-Saħħa” o Dettalji fejn wieħed jista' jikkontattja biex jirraporta dwar suspett ta' tqala
English: Cases of allergic reactions/angioedema and serious cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Thalidomide.
Maltese: Sindrome ta' Stevens-Johnson*,†, Nekrolisi epidermali tossika*,†, Reazzjoni tal-mediċina b'eosinofilja u sintomi sistemiċi*,†, Vaskulite lewkoċitoklastika†
English: • Safety advice relevant to all patients o Description and management of ischaemic heart disease (including myocardial infarction) o Disposal of unwanted medicinal product o Not to donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Maltese: • Rakkomandazzjoniet dwar is-sigurtà lil kull pazjent o Deskrizzjoni u ġestjoni ta' mard iskemiku tal-qalb (inkluż infart mijokardijaku) o Ir-rimi ta' prodott mediċinali mhux meħtieġ o M'għandekx tagħti d-demm waqt it-trattament (inkluż waqt l-interruzzjonijiet tad-doża) u għal mill-inqas 7 ijiem mill-waqfien ta' thalidomide
English: • Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection.
Maltese: • Deni, tertir ta' bard, uġigħ fil-griżmejn, sogħla, ulċeri tal-ħalq jew kwalunkwe sintomi oħrajn ta' infezzjoni.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: For patients > 75 years of age, the thalidomide recommended starting dose is 100 mg per day.
Maltese: Għal pazjenti li jkollhom > 75 sena, id-doża tal-bidu rakkomandata ta' thalidomide hi ta' 100 mg kuljum.
English: • Kidney disease (renal failure).
Maltese: • Mard tal-kliewi (insuffiċjenza renali).
English: • Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick).
Maltese: • Infezzjonijiet virali, li jinkludu herpes zoster (magħrufa wkoll bħala “ħruq ta' Sant'Antnin”, marda virali li tikkawża raxx fil-ġilda bl-uġigħ u bl-infafet) u r-rikorrenza tal-infezzjoni bl-epatite B (li jistgħu jikkawżaw sfurija tal-ġilda u l-għajnejn, awrina ta' kulur kannella skur, uġigħ fl-istonku fuq in-naħa tal-lemin, deni u li tħossok imdardar jew li tirremetti).
English: Posterior reversible encephalopathy syndrome (PRES)*
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli (PRES - Posterior reversible encephalopathy syndrome)*,†, Aggravament tas-sintomi tal-marda ta' Parkinson†
English: • Severe blood infection (sepsis) accompanied by fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (septic shock).
Maltese: • Infezzjoni severa tad-demm (sepsis) akkompanjata minn deni, tertir ta' bard u rogħda severa u possibbilment ikkumplikata minn pressjoni tad-demm baxxa u konfużjoni (xokk settiku).
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see sections 4.4, 4.5 and 4.8).
Maltese: Id-deċiżjoni biex jittieħdu miżuri profilattiċi antitrombotiċi għandha ssir wara evalwazzjoni bir-reqqa tal-fatturi tar-riskju bażiċi ta' pazjent individwali (ara sezzjonijiet 4.4, 4.5 u 4.8).
English: The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State.
Maltese: L-MAH għandu jimplimenta Programm ta' Prevenzjoni ta' Tqala (PPP - Pregnancy Prevention
English: Despite the small number of cases of DRESS, considering that this adverse reaction is a known risk listed in the EU SmPC of the structural analogues lenalidomide and pomalidomide and taking into consideration that other severe cutaneous adverse reactions (SCARs) are already listed in the thalidomide EU SmPC (SJS and TEN), the PRAC concluded that a causal relationship between thalidomide and DRESS cannot be excluded.
Maltese: Minkejja n-numru żgħir ta' każjijiet ta' DRESS, meta wieħed jikkunsidra li din ir-reazzjoni avversa hija riskju magħruf elenkata fl-SmPC (Sommarju tal-Karatteristiċi tal-Prodott) tal-UE tal-analogi strutturali lenalidomide u pomalidomide u meta jiġi kkunsidrat li reazzjonijiet tal-ġilda avversi u severi (SCARs, severe cutaneous adverse reactions) oħra huma diġà elenkati fl-SmPC tal-UE ta' thalidomide (SJS u TEN), il-PRAC ikkonkluda li ma tistax tiġi eskluża relazzjoni kawżali bejn thalidomide u DRESS.
English: †, Pancytopenia
Maltese: Popolazzjoni Pedjatrika
English: Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended.
Maltese: Prodotti mediċinali antitrombotiċi profilattiċi, bħal eparini ta' piż molekulari baxx jew warfarin, għandhom ikunu rakkomandati.
English: • Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment.
Maltese: • Sindrome tal-lisi Tat-tumur - kumplikazzjonijiet metaboliċi li jistgħu jseħħu waqt il-kura tal-kanċer u xi kultant anki mingħajr il-kura.
English: • Bleeding from the stomach or bowels (gastrointestinal haemorrhage).
Maltese: • Ħruġ ta' demm mill-istonku jew mill-imsaren (emorraġija gastrointestinali).
English: • All treatment initiation forms and/or equivalent tool should contain the following elements: o Teratogenicity warning o Patients receive appropriate counselling prior to treatment initiation o Date of counselling o Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures o Patient details, signature and date o Prescriber name, signature and date o Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
Maltese: • Kull formola biex jinbeda t-trattament u/jew għodda ekwivalenti għandu jkollha l-elementi li ġejjin: o Twissija dwar teratoġeniċità o Li l-pazjenti jingħataw servizz adattat ta' pariri qabel ma jinbeda t-trattament o Data ta' servizz ta' pariri o Affermazzjoni tal-fehim mill-pazjent dwar ir-riskju ta' thalidomide u l-miżuri PPP o Dettalji dwar il-pazjent, firma u data o Il-persuna li qed tikteb ir-riċetta, firma u data o L-għan ta' dan id-dokument i.e. hekk kif inhu ddikjarat fil-PPP: “L-għan tal-formola tal-bidu tat-trattament hu li jipproteġi l-pazjenti u kwalunkwe fetu li jista' jkun hemm billi jiżgura li l-pazjenti jkunu informati kompletament dwar u jifhmu r-riskju tat-teratoġeniċità u reazzjonijiet effetti avversi oħra marbuta ma' l-użu ta' thalidomide.
English: • Periodic Safety Update Reports (PSUR)
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: Infections Patients should be monitored for severe infections including sepsis and septic shock.
Maltese: Infezzjonijiet Il-pazjenti għandhom jiġu mmonitorjati għal infezzjonijiet severi li jinkludu sepsis u xokk settiku.
English: • Women who are pregnant (see section 4.6).
Maltese: • Nisa li huma tqal (ara sezzjoni 4.6).
English: This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier.
Maltese: Dan minħabba li alkoħol jista' iħeddlek u Thalidomide Celgene jista' jagħmlek aktar bi ngħas.
English: • That he should not donate semen during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Maltese: • Li m'għandux jagħti semen waqt it-trattament (inkluż waqt l-interruzzjonijiet tad-doża) u għal mill-inqas 7 ijiem mill-waqfien ta' thalidomide
English: Lymphopenia Thrombocytopenia
Maltese: Newtropenja Lewkopenja Anemija Limfopenja Tromboċitopenja
English: Thalidomide is a powerful human teratogen, inducing a high frequency of severe and lifethreatening birth defects.
Maltese: Thalidomide huwa teratoġen uman qawwi, li jissensitizza frekwenzi għoljin li jistgħu jkunu ta' periklu għal ħajja b'mankamenti mit-twelid.
English: Counselling
Maltese: Parir
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy.
Maltese: • Salpingo-ooforektomija bilaterali jew isterektomija li saret qabel.
English: Myelodysplastic syndrome*
Maltese: Sindrome majelodisplastiku*,^ Mhux Magħrufa Sindrome tal-lisi tat-tumur†
English: For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “What you need to know before you take Thalidomide Celgene”.
Maltese: Għall-irġiel li jieħdu Thalidomide Celgene li għandhom partner mara li tista' tinqabad tqila, jekk jogħġbok ara sezzjoni 2 “X'għandek tkun taf qabel ma tieħu Thalidomide Celgene”.
English: However, patients with age > 75 years are potentially at risk for a higher frequency of serious adverse reactions.
Maltese: Madankollu, pazjenti li jkollhom >75 sena, potenzjalment ikunu f'riskju għal frekwenza ogħla ta' reazzjonijiet avversi serji.
English: Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or drug reaction with eosinophilia and systemic symptoms (DRESS) is suspected and should not be resumed following discontinuation for these reactions.
Maltese: Reazzjonijiet allerġiċi u reazzjonijiet severi tal-ġilda L-interruzzjoni jew it-twaqqif ta' Thalidomide għandhom jiġu kkunsidrati għal raxx tal-ġilda ta' Grad 2-3. Thalidomide irid jitwaqqaf f'każ ta' anġjoedema, raxx ta' Grad 4, raxx bil-qxur jew bl-imsiemer, jew jekk ikun hemm suspett tas-sindrome ta' Stevens-Johnson (SJS), nekrolisi epidermali tossika (TEN, toxic epidermal necrolysis), jew reazzjoni tal-mediċina b'eosinofilja jew sintomi sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms) u m'għandux jitkompla wara li jkun twaqqaf minħabba dawn ir-reazzjonijiet.
English: Thalidomide Celgene 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Thalidomide Celgene 50 mg
English: Male patients should not donate semen or sperm during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide.
Maltese: Pazjenti rġiel m'għandhomx jagħtu semen jew sperma waqt it-trattament (inkluż waqt l-interruzzjonijiet tad-doża) u għal mill-inqas 7 ijiem mill-waqfien ta' thalidomide.
English: • you experience or have experienced in the past severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms(which is also known as DRESS or drug hypersensitivity syndrome).
Maltese: • għandek jew fil-passat kellek reazzjonijiet tal-ġilda severi msejħa s-sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika, jew is-sindrome DRESS (li huwa magħruf ukoll bħala DRESS jew sindrome ta' sensittività eċċessiva għall-mediċina).
English: • Feeling dizzy.
Maltese: • Stitikezza.
English: During the treatment with Thalidomide Celgene you have an increased risk of developing blood clots in the veins and arteries (see also section 4 “Possible side effects”).
Maltese: Matul il-kura b'Thalidomide ikollok żieda fir-riskju li tiżviluppa emboli tad-demm fil-vini u fl-arterji (ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: ,†, Leukocytoclastic vasculitis
Maltese: Kif għandek tieħu din il-mediċina
English: Thalidomide Celgene is taken daily in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
Maltese: Thalidomide Celgene jittieħed kuljum fiċ-ċikli ta' trattament, kull ċiklu jdum 6 ġimgħat, flimkien ma' melphalan u prednisone li jittieħdu fil-ġranet 1 sa 4 ta' kull ċiklu ta' sitt ġimgħat.
English: Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects - you may need urgent medical treatment:
Maltese: Tibqax tieħu Thalidomide Celgene u ara tabib minnufih jekk tinduna b' xi effetti sekondarji minn dawk li ġejjin - għandek mnejn ikollok bżonn trattament mediku urġenti:
English: Animal studies have demonstrated differences in species susceptibility to the teratogenic effects of thalidomide.
Maltese: Studji fuq l-annimali wrew differenzi fis-suxxetibilità ta' l-effetti teratoġeniċi bejn l-ispeċi għal thalidomide.
English: The latter appears to be related to thalidomide and occurred at exposures greater than 2.4-fold the human exposure.
Maltese: Tal-aħħar kienu jidhru li huma marbuta ma' thalidomide u seħħew f'esponimenti akbar minn 2.4 darba l-esponiment uman.
English: No mutagenic or genotoxic effect has been revealed when thalidomide was assayed in a standard battery of genotoxicity tests.
Maltese: L-ebda effett mutaġeniku jew ġenotossiku ma ġie rivelat meta saru l-analiżi ta' thalidomide fuq batterija standard ta' testijiet ġenotossiċi.
English: In documented case reports with hormone evaluation, the event of amenorrhoea was associated with decreased estradiol levels and elevated FSH/LH levels.
Maltese: F'rapporti ddokumentati ta' każijiet b'evalwazzjoni tal-ormoni, l-avveniment ta' amenorreja ġie assoċjat ma' tnaqqis fil-livelli ta' estradiol u żieda fil-livelli ta' FSH/LH.
English: Patients with known risk factors for MI, including prior thrombosis, should be closely monitored and action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Maltese: Għandha tittieħed azzjoni biex wieħed jipprova jimminimizza l-fatturi ta' riskju modifikabbli kollha (eż. tipjip, pressjoni għolja, u iperlipidemija).
English: †, Pancreatitis Gastrointestinal haemorrhage
Maltese: Mhux Magħrufa Perforazzjoni gastrointestinali†, Pankreatite†, Emorraġija gastrointestinali†
English: The maximum plasma concentrations are reached 1-5 hours after administration.
Maltese: Il-konċentrazzjonijiet massimi fil-plażma intlaħqu wara 1-5 siegħat mill-għoti.
English: • you have had an allergic reaction whilst taking Thalidomide Celgene such as rash, itching, swelling, dizziness or trouble breathing.
Maltese: • kellek reazzjoni allerġika waqt li kont qed tieħu Thalidomide Celgene, bħal raxx, ħakk, nefħa, sturdament jew problemi biex tieħu n-nifs.
English: There are in vitro data indicating that prednisone may give rise to enzyme induction which could reduce the systemic exposure of concomitantly used medicinal products.
Maltese: Hemm dejta in vitro li tindika li prednisone għandu mnejn jikkawża induzzjoni enzimatika li tista' tnaqqas l-esponiment sistematiku ta' prodotti mediċinali li jintużaw fl-istess ħin.
English: Proportion thalidomide, the total mean recovery was 93.6 % of the administered dose by day 8.
Maltese: Wara doża orali waħda ta' 400 mg ta' thalidomide radju-tikkettat, il-medja tal-irkuprar totali kienet ta' 93.6 % tad-doża li ngħatat sa Jum 8.
English: Thalidomide is also a non-barbiturate centrally active hypnotic sedative.
Maltese: Thalidomide huwa wkoll sedattiv ipnotiku mhux barbiturat u ċentralment attiv u.
English: f
Maltese: A.