qanastek/EMEA-V3 huggingface dataset:
The following dose adjustments are recommended at the start of therapy for patients with moderate or severe impaired renal function or end stage renal disease.
L - aġġustamenti fid- doża li ġejjin huma rakkomandati fil- bidu tat- terapija għal pazjenti b’ indeboliment moderat jew sever fil- funzjoni renali jew end stage renal disease.
Renal Function (CLcr) Moderate renal impairment (30 ≤ CLcr < 50 ml/min)
Funzjoni renali (CLcr) Indeboliment moderat renali (30 ≤ CLcr < 50 ml/ min)
Dose Adjustment 10 mg once daily*
Aġġustament fid- doża 10 mg darba kuljum *
Severe renal impairment (CLcr < 30 ml/min, not requiring dialysis)
Indeboliment sever renali (CLcr < 30 ml/ min, li ma teħtieġx id- dijaliżi)
15 mg every other day**
15 mg kull jumejn **
End Stage Renal Disease (ESRD) (CLcr < 30 ml/min, requiring dialysis)
End Stage Renal Disease (ESRD) (CLcr < 30 ml/ min, li teħtieġ id- dijaliżi)
5 mg once daily.
5 mg darba kuljum.
On dialysis days, the dose should be administered following dialysis.
Fil- jiem meta ssir id- dijaliżi, id- doża għandha tingħata wara d- dijaliżi
* The dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment and is tolerating the treatment. ** The dose may be escalated to 10 mg once daily if the patient is tolerating the treatment
* Id- doża tista ’ tiżdied għal 15 mg darba kuljum wara 2 ċikli jekk il- pazjent ma jkunx qed jirrispondi għall- kura u qed jittollera l- kura. ** Id- doża tista ’ tiżdied għal 10 mg darba kuljum jekk il- pazjent ikun qed jittollera l- kura.
Use in patients with impaired hepatic function Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
L- użu f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied Lenalidomide għadu ma kienx studjat formalment f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied u m’ hemm l- ebda rakkomandazzjonijiet speċifiċi dwar id- doża.
• Women who are pregnant. • Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see sections 4.4 and 4.6). • Hypersensitivity to the active substance or to any of the excipients.
• Nisa tqal. • Nisa li jista ’ jkollhom tfal, ħlief jekk il- kundizzjonijiet kollha tal- Programm tal- Prevenzjoni tat - Tqala jkunu sodisfatti (ara sezzjonijiet 4. 4 u 4. 6). • Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Pregnancy warning Lenalidomide is structurally related to thalidomide.
Twissija dwar it- tqala Lenalidomide hu strutturalment relatat ma ’ thalidomide.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Thalidomide hu sustanza attiva teratoġenika umana magħrufa li tikkawża difetti tat- twelid severi li huma ta ’ periklu għall- ħajja.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3).
Lenalidomide ipproduċa malformazzjonijiet fix- xadini simili għal dawk deskritti b’ thalidomide (ara sezzjonijiet 4. 6 u 5. 3).
If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Jekk lenalidomide jittieħed matul it- tqala, effett teratoġeniku ta ’ lenalidomide fil- bnedmin hu mistenni.
The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Il- kundizzjonijiet tal- Programm tal- Prevenzjoni tat- Tqala jridu jkunu sodisfatti mill- pazjenti kollha, ħlief jekk hemm evidenza affidabbli li l- pazjenta ma jistax ikollha tfal.
Criteria for women of non-childbearing potential A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year* • Premature ovarian failure confirmed by a specialist gynaecologist • Previous bilateral salpingo-oophorectomy, or hysterectomy • XY genotype, Turner syndrome, uterine agenesis. *Amenorrhoea following cancer therapy does not rule out childbearing potential.
Kriterji għal nisa li ma jistax ikollhom tfal Pazjenta, jew sieħba ta ’ pazjent raġel, hija kkunsidrata li jista ’ jkollha tfal ħlief jekk ma tissodisfax mill- inqas wieħed mill- kriterji li ġejjin: • Età ≥ 50 sena u amenorreika għal ≥ 1 sena * • Kollass prematur ta ’ l- ovarji kkonfermat minn ġinekologu speċjalista
Counselling For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met: • She understands the expected teratogenic risk to the unborn child • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
4 • Operazzjoni salpingo- oophorectomy bilaterali, jew isterektomija li jkunu saru fil- passat • Ġenotip XY, sindromu ta ’ Turner, aġenesi ta ’ l- utru. * Amenorrea wara terapija tal- kanċer ma teskludix li l- mara jista ’ jkollha tfal.
4 • She should be capable of complying with effective contraceptive measures • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation • She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
Pariri Għal nisa li jista ’ jkollhom tfal, lenalidomide hu kontra- indikat ħlief jekk dawn li ġejjin kollha jkunu sodisfatti: • Hi tifhem ir- riskju teratoġeniku mistenni lit- tarbija mhix imwielda • Hi tifhem il- ħtieġa għal kontraċezzjoni effettiva mingħajr interruzzjoni, 4 ġimgħat qabel tibda l - kura, matul il- perijodu kollu tal- kura, u 4 ġimgħat wara t- tmiem tal- kura • Anki jekk mara li jista ’ jkollha tfal ikollha l- amenorrea, trid issegwi l- pariri kollha dwar kontraċezzjoni effettiva • Hi għandha tkun kapaċi li tkun konformi b’ miżuri ta ’ kontraċezzjoni effettiva • Hi nfurmata u tifhem il- konsegwenzi potenzjali tat- tqala u l- ħtieġa li tieħu parir malajr jekk hemm riskju ta ’ tqala • Hi tifhem il- ħtieġa li tibda l- kura malli tingħata lenalidomide wara test tat- tqala negattiv • Hi tifhem il- ħtieġa u taċċetta li tagħmel test tat- tqala kull 4 ġimgħat minbarra f’ każ ta ’ sterilizzazzjoni tat- tubi kkonfermata • Tirrikonoxxi li tifhem il- perikli u l- prekawzjonijiet meħtieġa marbuta ma ’ l- użu ta ’ lenalidomide.
For male patients taking lenalidomide, there is no clinical data available on the presence of lenalidomide in human semen.
Għal pazjenti rġiel li qed jieħdu lenalidomide, m’ hemm l- ebda informazzjoni klinika disponibbli dwar il- preżenza ta ’ lenalidomide fis- semen uman.
Male patients taking lenalidomide must meet the following conditions: • Understand the expected teratogenic risk if engaged in sexual activity with a woman of childbearing potential • Understand the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential.
Pazjenti rġiel li qed jieħdu lenalidomide jridu jissodisfaw il- kundizzjonijiet li ġejjin: • Jifhmu r- riskju teratoġeniku mistenni jekk jagħmlu attività sesswali ma ’ mara li jista ’ jkollha tfal • Jifhmu l- ħtieġa li għandhom jużaw kondom jekk jagħmlu attività sesswali ma ’ mara li jista ’ jkollha tfal.
The prescriber must ensure that for women of childbearing potential: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding • The patient has acknowledged the aforementioned conditions.
Min jagħti r- riċetta għandu jiżgura li għal nisa li jista ’ jkollhom tfal: • Il- pazjenta tkun konformi mal- kundizzjonijiet tal- Programm tal- Prevenzjoni tat- Tqala, li jinkludu konferma li hi għandha livell adegwat ta ’ għarfien • Il- pazjenta rrikonoxxiet il- kundizzjonijiet imsemmija qabel
Contraception Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Kontraċezzjoni Nisa li jista ’ jkollhom tfal iridu jużaw metodu wieħed effettiv ta ’ kontraċezzjoni għal 4 ġimgħat qabel it- terapija, matul it- terapija, u sa 4 ġimgħat wara t- terapija b’ lenalidomide, u anke f’ każ ta ’ interruzzjoni tad- doża, ħlief jekk il- pazjenta tagħmel impenn għal astinenza sesswali assoluta u kontinwa, li tkun ikkonfermata kull xahar.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Jekk ma tkunx stabbilita fuq kontraċezzjoni effettiva, il - pazjenta għandha tiġi riferuta lil professjonist fil- qasam tas- saħħa li jkun imħarreġ kif suppost, għal parir fuq il- kontraċezzjoni biex il- kontraċezzjoni tkun tista ’ tinbeda.
The following can be considered to be examples of suitable methods of contraception: • Implant • Levonorgestrel-releasing intrauterine system (IUS) • Medroxyprogesterone acetate depot • Tubal sterilisation • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
Dawn li ġejjin jistgħu jiġu kkunsidrati bħala eżempji ta ’ metodi ta ’ kontraċezzjoni adattati: • Impjant • Sistema ta ’ ġo l- utru li terħi levonorgestrel (intrauterine system - IUS) • Medroxyprogesterone acetate depot • Sterilizzazzjoni tat- tubi • Kopulazzjoni sesswali li tkun biss ma ’ raġel li kellu vasektomija; il- vasektomija trid tkun ikkonfermata minn żewġ analiżi negattivi tas- semen • Pilloli li jkun fihom il- progesterone biss li jinibixxu l- ovulazzjoni (i. e. desogestrel)
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Minħabba ż- żieda fir- riskju ta ’ tromboemboliżmu venuż f’ pazjenti b’ mjeloma multipla li jkunu qed jieħdu lenalidomide u dexamethasone, it- teħid flimkien ta ’ pilloli orali tal- kontraċezzjoni kombinati mhuwiex rakkomandat (ara wkoll sezzjoni 4. 5).
If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above.
Jekk pazjenta tkun qed tuża kontraċezzjoni kombinata orali, il- pazjenta għandha taqleb għal wieħed mill- metodi effettivi elenkati hawn fuq.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Ir- riskju ta ’ tromboemboliżmu venuż jibqa ’ sejjer għal 4−6 ġimgħat wara t- twaqqif tal- kontraċezzjoni kombinata
The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
L- effikaċja ta ’ sterojdi kontraċettivi tista ’ titnaqqas matul il- kura flimkien ma ’ dexamethasone (ara sezzjoni 4. 5).
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Impjanti u sistemi ta ’ ġo l- utru li jerħu levonorgestrel huma assoċjati ma ’ żieda fir- riskju ta ’ infezzjoni fil- ħin ta ’ l- inserzjoni u ma ’ ħruġ irregolari ta ’ demm vaġinali.
Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Anti- bijotiċi profilattiċi għandhom jiġu kkunsidrati partikularment f’ pazjenti b’ newtropenja.
Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
Sistemi ta ’ ġo l- utru li jerħu r- ram ġeneralment mhumiex rakkomandati minħabba r- riskji potenzjali ta ’ infezzjoni fil- ħin ta ’ l- inserzjoni u t- telf ta ’ demm mestrwali li jista ’ jikkomprometti pazjenti b’ newtropenja jew bi tromboċitopenja.
This
Ittestjar għat- tqala Skond il- prattika lokali, testijiet tat- tqala li jkunu sorveljati medikament b’ minimu ta ’ sensittività ta ’ 25 mIU/ ml għandhom jitwettqu għal nisa li jista ’ jkollhom tfal kif spjegat hawn taħt.
5 requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Din il- ħtieġa tinkludi nisa li jista ’ jkollhom tfal li jipprattikaw astinenza sesswali assoluta u kontinwa.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Idealment, l - ittestjar għat- tqala, il- ħruġ tar- riċetta u l- għoti tal- mediċina għandhom iseħħu fl- istess jum.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
L- għoti ta ’ lenalidomide lin- nisa li jista ’ jkollhom tfal għandu jseħħ fi żmien 7 ijiem minn meta tingħata r- riċetta.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Qabel ma tibda l- kura Test tat- tqala li jkun sorveljat medikament għandu jitwettaq matul il- konsultazzjoni, meta tingħata riċetta għal lenalidomide, jew fit- 3 ijiem qabel ma jsir l- eżami mediku mill- persuna li ser tagħti r - riċetta, ġaladarba l- pazjenta kienet tuża kontraċezzjoni effettiva għal mill- inqas 4 ġimgħat.
The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Il- test irid jiżgura li l- pazjenta ma tkunx tqila meta tibda l- kura b’ lenalidomide.
Follow-up and end of treatment A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Follow- up u t- tmiem tal- kura Test tat- tqala li jkun sorveljat medikament għandu jkun ripetut kull 4 ġimgħat, inkluż 4 ġimgħat wara t- tmiem tal- kura, minbarra f’ każ ta ’ sterilizzazzjoni tat- tubi kkonfermata.
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Dawn it- testijiet tat- tqala għandhom jitwettqu fil- jum ta ’ l- eżami mediku meta tingħata r- riċetta għall- mediċina jew fit- 3 ijiem qabel ma jsir l- eżami mediku mill- persuna li ser tagħti r- riċetta għall- mediċina.
Men It is not known whether lenalidomide is present in semen.
Irġiel Mhux magħruf jekk lenalidomide jinstabx fis- semen.
Therefore all male patients should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is of childbearing potential and has no contraception.
Għalhekk, il- pazjenti rġiel kollha għandhom jużaw il- kondoms sakemm iddum il- kura, matul l- interruzzjoni tad- doża u għal ġimgħa wara l- waqfien tal- kura, jekk is- sieħba tagħhom jista ’ jkollha t- tfal u ma tkunx qed tuża kontraċezzjoni.
Additional precautions Patients should be instructed never to give this medicinal product to a nother person and to return any unused capsules to their pharmacist at the end of treatment.
Prekawzjonijiet addizzjonali Il- pazjenti għandhom jingħataw struzzjonijiet biex qatt ma jagħtu dan il- prodott mediċinali lil xi persuna oħra u biex jieħdu lura kwalunkwe kapsuli mhux użati lill- ispiżjar tagħhom fit- tmiem tal- kura.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of lenalidomide.
Il- pazjenti m’ għandhomx jagħtu demm jew semen matul it- terapija jew għal ġimgħa wara t- twaqqif tal- kura b’ lenalidomide.
Educational materials In order to assist patients in avoiding foetal exposure to lenalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of lenalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Materjal edukattiv Biex tgħin lil pazjenti jevitaw l- espożizzjoni tal- fetu għal lenalidomide, id- Detentur ta ’ L - Awtorizzazzjoni għat- tqegħid fis- suq ser jipprovdi materjal edukattiv lil professjonisti fil- qasam tas - saħħa biex isaħħaħ it- twissijiet dwar it- teratoġeniċità mistennija ta ’ lenalidomide, biex jipprovdi parir fuq il- kontraċezzjoni qabel ma tinbeda t- terapija, u biex jipprovdi gwida fuq il- ħtieġa għall- ittestjar għat- tqala.
Full patient information about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
L- informazzjoni sħiħa tal- pazjent dwar ir- riskju teratoġeniku mistenni u l- miżuri stretti tal - prevenzjoni tat- tqala kif speċifikati fil- Programm tal- Prevenzjoni tat- Tqala, għandhom jingħataw mit - tabib lin- nisa li jista ’ jkollhom tfal u, lill- pazjenti rgiel, kif ikun xieraq.
Other special warnings and precautions for use
Twissijiet speċjali oħrajn u prekawzjonijiet għall- użu
Venous thromboembolism The combination of lenalidomide with dexamethasone is associated with an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma (see sections 4.5 and 4.8).
L- għoti fl- istess ħin ta ’ sustanzi
Concomitant administration of erythropoietic agents or previous history of DVT may also increase thrombotic risk in these patients.
6 eritropojetiċi jew storja medika ta ’ DVT fil- passat, jistgħu wkoll iżidu r- riskju trombotiku f’ dawn il - pazjenti.
Therefore, erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone.
Għalhekk, sustanzi eritropojetiċi, jew sustanzi oħrajn li jistgħu jżidu r- riskju ta ’ trombożi, bħat- terapija tas- sostituzzjoni ta ’ l- ormoni, għandhom jintużaw bl- attenzjoni f’ pazjenti b’ mjeloma multipla li jkunu qed jirċievu lenalidomide ma ’ dexamethasone.
A haemoglobin concentration above 13 g/dl should lead to discontinuation of erythropoietic agents.
Konċentrazzjoni tal- emoglobina ta ’ aktar minn 13 g/ dl għandha twassal għat- twaqqif ta ’ sustanzi eritropojetiċi.
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Il- pazjenti u tobba huma avżati biex joqogħdu attenti għal sinjali u sintomi ta ’ tromboemboliżmu.
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Il- pazjenti għandhom jingħataw struzzjonijiet biex ifittxu kura medika jekk jiżviluppaw sintomi bħal qtugħ ta ’ nifs, uġigħ fis- sider, nefħa fid- dirgħajn jew fir- riġlejn.
Prophylactic antithrombotic medicines, such as low molecular weight heparins or warfarin, should be recommended, especially in patients with additional thrombotic risk factors.
Mediċini antitrombotiċi profilattiċi, bħal eparini b’ piż molekulari baxx jew warfarin, għandhom ikunu rakkomandati, b’ mod speċjali f’ pazjenti b’ fatturi ta ’ riskju trombotiċi addizzjonali.
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’s underlying risk factors.
Id- deċiżjoni biex jittieħdu miżuri antitrombotiċi profilattiċi għandha ssir wara evalwazzjoni bir- reqqa tal- fatturi tar- riskju bażiċi ta’ pazjent individwali.
Neutropenia and thrombocytopenia The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients
Newtropenja u tromboċitopenja Il- kumbinazzjoni ta ’ lenalidomide ma ’ dexamethasone f’ pazjenti b’ mjeloma multipla hi marbuta ma ’ inċidenza ogħla ta ’ newtropenja ta ’ grad 4 (5. 1% f’ pazjenti kkurati b’ lenalidomide/ dexamethasone meta mqabbla ma ’ 0. 6% ta ’ pazjenti kkurati bil- plaċebo/ dexamethasone; ara sezzjoni 4. 8).
Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Episodji ta ’ newtropenja bid- deni ta ’ grad 4 kienu osservati b’ mod mhux frekwenti (0. 6% f’ pazjenti kkurati b’ lenalidomide/ dexamethasone meta mqabbla ma ’ 0. 0% f’ pazjenti kkurati bil- placebo/ dexamethasone; ara sezzjoni 4. 8).
Patients should be advised to promptly report febrile episodes.
Il- pazjenti għandhom jingħataw parir biex jirrappurtaw mill- ewwel episodji ta ’ deni.
A dose reduction may be required (see section 4.2).
Tnaqqis fid- doża jista ’ jkun meħtieġ (ara sezzjoni 4. 2).
In case of neutropenia, the physician should consider the use of growth factors in patient management.
F’ każ ta ’ newtropenja, it- tabib għandu jikkunsidra l- użu ta ’ fatturi tat- tkabbir fl- immaniġġjar tal- pazjent.
The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
Il- kumbinazzjoni ta ’ lenalidomide ma ’ dexamethasone f’ pazjenti b’ mjeloma multipla hi marbuta ma ’ inċidenza ogħla ta ’ tromboċitopenja ta ’ grad 3 u grad 4 (9. 9% u 1. 4%, rispettivament, f’ pazjenti kkurati b’ lenalidomide/ dexamethasone meta mqabbla ma ’ 2. 3% u 0. 0% f’ pazjenti kkurati bil - plaċebo/ dexamethasone; ara sezzjoni 4. 8).
Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes especially in case of concomitant medication susceptible to induce bleeding (see Section 4.8 Haemorrhagic disorders).
Il- pazjenti u tobba huma avżati biex joqogħdu attenti għal sinjali u sintomi ta ’ ħruġ ta ’ demm, li jinkludu tbenġil u friġ, speċjalment f’ każ ta ’ mediċina li tingħata fl- istess ħin li hi suxxettibbli li tikkaġuna ħruġ ta ’ demm (ara Sezzjoni 4. 8 Disturbi emorraġiċi).
A dose reduction of lenalidomide may be required (see section 4.2).
Tnaqqis fid- doża ta ’ lenalidomide jista ’ jkun meħtieġ (ara sezzjoni 4. 2).
A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Għadd sħiħ taċ- ċelluli tad- demm, li jinkludi l- għadd taċ- ċelluli tad- demm bojod bl- għadd differenzjali, l- għadd tal- plejtlits, emoglobina u ematokrit, għandhom jitwettqu fil- linja bażi kull ġimgħa, għall - ewwel 8 ġimgħat tal- kura b’ lenalidomide, u kull xahar wara dak il- perijodu, biex isir monitoraġġ għal ċitopeniji.
The major dose limiting toxicities of lenalidomide include neutropenia and thrombocytopenia.
It- tossiċitajiet maġġuri li jillimitaw id- doża ta ’ lenalidomide jinkludu n- newtropenja u t - tromboċitopenja.
Therefore, co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Għalhekk, l- għoti flimkien ta ’ lenalidomide ma ’ sustanzi oħrajn li jrażżnu l- attività tal- mudullun għandu jsir b’ attenzjoni.
Renal impairment Lenalidomide is substantially excreted by the kidney.
Indeboliment renali Lenalidomide jitneħħa b’ mod sostanzjali mill- kliewi.
Therefore care should be taken in dose selection and monitoring of renal function is advised in patients with renal impairment (see section 4.2).
Għalhekk, għandha tingħata attenzjoni fl- għażla tad- doża u l- monitoraġġ tal- funzjoni renali hu rakkomandat f’ pazjenti b’ indeboliment fil- funzjoni renali (ara sezzjoni 4. 2).
Thyroid function Cases of hypothyroidism have been reported and monitoring of thyroid function should be considered.
Funzjoni tat- tirojde Każijiet ta ’ ipotirojdiżmu kienu rrappurtati u monitoraġġ tal- funzjoni tat- tirojde għandu jiġi kkunsidrat.
Peripheral neuropathy Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Newropatija periferali Lenalidomide hu strutturalment relatat ma ’ thalidomide li hu magħruf li jikkawża newropatija periferali severa.
At this time, the neurotoxic potential of lenalidomide associated with long-term use cannot be ruled out.
F’ dan iż- żmien, il- potenzjal newrotossiku ta ’ lenalidomide assoċjat mal- użu fit- tul ma jistax jiġi eskluż.
Tumour Lysis Syndrome Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome may occur.
Sindrome tal- Lisi tat- Tumur Minħabba li lenalidomide għandu attività anti- neoplastika, il- kumplikazzjonijiet tas- sindrome tal- lisi tat- tumur jistgħu jseħħu.
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
7 tumur kbir jew estensiv qabel il- kura.
These patients should be monitored closely and appropriate precautions taken.
Dawn il- pazjenti għandhom ikunu mmonitorjati mill- qrib u għandhom jittieħdu prekawzjonijiet xierqa.
Lactose intolerance Revlimid capsules contain lactose.
Intollerenza għal lactose Il- kapsuli Revlimid fihom il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, id- defiċjenza ta ’ Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose, m’ għandhomx jieħdu dan il- prodott mediċinali.
Unused capsules Patients should be advised never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of the treatment.
Kapsuli mhux użati Il- pazjenti għandhom jingħataw struzzjonijiet biex qatt ma jagħtu dan il- prodott mediċinali lil xi persuna oħra u biex jieħdu lura kwalunkwe kapsuli mhux użati lill- ispiżjar tagħhom fit- tmiem tal- kura.
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Sustanzi eritropojetiċi, jew sustanzi oħrajn li jistgħu jżidu r- riskju ta ’ trombożi, bħat- terapija tas - sostituzzjoni ta ’ l- ormoni, għandhom jintużaw bl- attenzjoni f’ pazjenti b’ mjeloma multipla li jkunu qed jirċievu lenalidomide ma ’ dexamethasone (ara sezzjonijiet 4. 4 u 4. 8).
Oral contraceptives No interaction study has been performed with oral contraceptives.
Kontraċettivi orali Ma saru l- ebda studji dwar l- azzjoni reċiproka ta ’ kontraċettivi orali.
Lenalidomide is not an enzyme inducer.
Lenalidomide mhuwiex enzyme inducer.
Therefore, induction leading
Fi studju in vitro b’ epatoċiti umani, lenalidomide, f’ diversi konċentrazzjonijiet li kienu ttestjati, ma stimulax CYP1A2, CYP2B6, CYP2C9, CYP2C19 u CYP3A4/ 5.
7 to reduced efficacy of drugs, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Għalhekk, l- induzzjoni li twassal għal tnaqqis fl- effikaċja tal- mediċini, li jinkludu kontraċettivi ormonali, mhijiex mistennija jekk lenalidomide jingħata waħdu.
However, dexamethasone is known to be a weak to moderate inducer of CYP3A4 and is likely to also affect other enzymes as well as transporters.
Madankollu, dexamethasone hu magħruf li hu inducer minn dgħajjef sa moderat ta ’ CYP3A4 u x’ aktarx li jaffettwa wkoll enzymes oħrajn kif ukoll it- trasportaturi.
It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Ma jistax jiġi eskluż li l- effikaċja ta ’ kontraċettivi orali tista ’ titnaqqas matul il- kura.
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Miżuri effettivi għandhom jittieħdu biex it- tqala tiġi evitata (ara sezzjonijiet 4. 4 u 4. 6).
Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with drugs that inhibit cytochrome P450 enzymes is not likely to result in metabolic drug interactions in man.
Riżultati minn studji dwar il- metaboliżmu uman in vitro jindikaw li lenalidomide ma jkunx metaboliżat mill- enzymes ta ’ ċitokrom P450 li tissuġġerixxi li l- għoti ta ’ lenalidomide ma ’ prodotti mediċinali li jinibixxu l- enzymes ta ’ ċitokrom P450 x’ aktarx li mhux ser tirriżulta f’ interazzjonijiet metaboliċi tal- mediċina fil- bniedem.
In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A.
Studji in vitro jindikaw li lenalidomide m’ għandu l- ebda effett inibitorju fuq CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A.
Warfarin Co-administration of multiple doses of 10 mg of len alidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Warfarin L- għoti flimkien ta ’ dożi multipli ta ’ 10 mg ta ’ lenalidomide ma kellu l- ebda effett fuq il - farmakokinetiċi ta ’ dożi waħidhom ta ’ R - u S - warfarin.
Co-administration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of lenalidomide.
L- għoti flimkien ta ’ dożi waħidhom ta ’ 25 mg ta ’ warfarin ma kellu l- ebda effett fuq il- farmakokinetiċi ta ’ lenalidomide.
However, it is not known whether there is an interaction during clinical use (concomitant treatment with dexamethasone).
Madankollu, mhuwiex magħruf jekk hemmx interazzjoni waqt l- użu kliniku (kura fl- istess ħin b’ dexamethasone).
Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Dexamethasone hu inducer minn dgħajjef sa moderat ta ’ l- enzymes u l- effett tiegħu fuq warfarin mhuwiex magħruf.
Close monitoring of warfarin concentration is advised during the treatment.
Il- monitoraġġ mill- qrib tal- konċentrazzjoni ta ’ warfarin hu rakkomandat matul il - kura.
Digoxin Concomitant administration with lenalidomide 10 mg/day increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Digoxin L- għoti fl- istess ħin b’ 10 mg/ kuljum ta ’ lenalidomide żied l- espożizzjoni tal- plażma ta ’ digoxin (0. 5 mg, doża waħda) b’ 14% b’ 90% CI (intervall tal- kunfidenza) [0. 52% - 28. 2%].
It is not known whether the effect will be different in the therapeutic situation (higher lenalidomide doses and concomitant treatment with dexamethasone).
Mhux magħruf jekk l- effett hux ser ikun differenti fis- sitwazzjoni terapewtika (dożi ogħla ta ’ lenalidomide u kura fl- istess ħin b’ dexamethasone).
Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
Għalhekk, il- monitoraġġ tal- konċentrazzjoni ta ’ digoxin hu rakkomandat matul il- kura b’ lenalidomide.
Pregnancy (see also sections 4.3 and 4.4) Lenalidomide is structurally related to thalidomide.
Tqala (ara wkoll sezzjonijiet 4. 3 u 4. 4) Lenalidomide hu strutturalment relatat ma ’ thalidomide.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see section 5.3).
8 Lenalidomide ipproduċa malformazzjonijiet fix- xadini simili għal dawk deskritti b’ thalidomide (ara sezzjoni 5. 3).
Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Għalhekk, effett teratoġeniku ta ’ lenalidomide hu mistenni u lenalidomide huwa kontra - indikat waqt it- tqala (ara sezzjoni 4. 3).
Women of childbearing potential should use effective method of contraception.
Nisa li jista ’ jkollhom tfal iridu jużaw metodu effettiv ta ’ kontraċezzjoni.
If pregnancy occurs in a woman treated with lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Jekk it- tqala sseħħ f’ mara kkurata b’ lenalidomide, il- kura trid titwaqqaf u l- pazjenta tiġi riferuta għand tabib speċjalizzat jew li għandu esperjenza fit- teratoloġija għal evalwazzjoni u parir.
If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Jekk it- tqala sseħħ f’ sieħba ta ’ pazjent raġel li jkun qed jieħu lenalidomide, hu rakkomondat li s- sieħba tiġi riferuta għand tabib speċjalizzat jew li għandu esperjenza fit- teratoloġija għal evalwazzjoni u parir.
Therefore male patients taking lenalidomide should use condoms if their partner is of childbearing potential and has no contraception.
Għalhekk, il- pazjenti rġiel li qed jieħdu lenalidomide għandhom jużaw il- kondoms jekk is- sieħba tagħhom jista ’ jkollha t- tfal u ma jkollhiex kontraċezzjoni.
Lactation It is not known whether lenalidomide is excreted in human milk.
Treddigħ Mhux maghruf jekk lenalidomide jitneħħiex fil- ħalib uman.
Therefore breast-feeding should be discontinued during therapy with lenalidomide.
Għalhekk it- treddigħ għandu jitwaqqaf matul it- terapija b’ lenalidomide.
Lenalidomide may have minor or moderate influence on the ability to drive and use machines.
Lenalidomide jista ’ jkollu effett żgħir jew moderat fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
Fatigue, dizziness, somnolence and blurred vision have been reported with the use of lenalidomide.
Għeja kbira, sturdament, ngħas u vista mċajpra kienu irrappurtati bl- użu ta ’ lenalidomide.
Therefore, caution is recommended when driving or operating machines.
Għalhekk, l- attenzjoni hi rakkomandata meta ssuq jew tħaddem il- magni.
In two Phase III placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
F’ żewġ studji ta ’ Fażi III, ikkontrollati bil- plaċebo, 353 pazjent b’ mjeloma multipla kienu esposti għall- kumbinazzjoni lenalidomide/ dexamethasone u 351 għall- kumbinazzjoni plaċebo/ dexamethasone.
The median duration of exposure to study treatment was significantly longer (44.0 weeks) in the lenalidomide/dexamethasone group as compared to placebo/dexamethasone (23.1 weeks).
Il- medjan tat- tul ta ’ żmien ta ’ espożizzjoni għall- kura ta ’ l- istudju kien itwal b’ mod sinifikanti (44. 0 ġimgħa) fil- grupp ta ’ lenalidomide/ dexamethasone meta mqabbel mal- grupp tal- plaċebo/ dexamethasone (23. 1 ġimgħa).
The difference was accounted for by a lower rate of discontinuation from study treatment due to lower progression of disease in patients exposed to lenalidomide/dexamethasone (39.7%) than in placebo/dexamethasone patients (70.4%).
Id- differenza tista ’ tiġi spjegata minn rata iktar baxxa ta ’ twaqqif mill- kura ta ’ l- istudju minħabba progressjoni iktar baxxa tal- marda f’ pazjenti esposti għal lenalidomide/ dexamethasone (39. 7%) milli fil- pazjenti esposti għall- plaċebo/ dexamethasone (70. 4%).
325 (92%) of the patients in the lenalidomide/dexamethasone group experienced at least one adverse reaction compared to 288 (82%) in the placebo/dexamethasone group.
325 (92%) tal- pazjenti fil- grupp ta ’ lenalidomide/ dexamethasone kellhom mill- inqas reazzjoni avversa waħda meta mqabbla ma ’ 288 (82%) fil- grupp tal- plaċebo/ dexamethasone.
The most serious adverse reactions were: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4) • Grade 4 neutropenia (see section 4.4).
L- iktar reazzjonijiet avversi serji kienu: • Tromboemboliżmu venuż (trombożi fonda tal- vini, emboliżmu pulmonari (ara sezzjoni 4. 4)) • Newtropenja ta ’ grad 4 (ara sezzjoni 4. 4)
The most frequently observed adverse reactions which occurred significantly more frequently in the lenalidomide/dexamethasone group compared to the placebo/dexamethasone group were neutropenia (39.4%), fatigue (27.2%), asthenia (17.6%), constipation (23.5%), muscle cramp (20.1%), thrombocytopenia (18.4%), anaemia (17.0%), diarrhoea (14.2%) and rash (10.2%).
L- iktar reazzjonijiet avversi li kienu osservati b’ mod frekwenti fil- grupp ta ’ lenalidomide/ dexamethasone meta mqabbla mal- grupp tal- plaċebo/ dexamethasone kienu newtropenja (39. 4%), għeja kbira (27. 2%), astenja (17. 6%), stitikezza (23. 5%), bugħawwieġ fil- muskoli (20. 1%), tromboċitopenja (18. 4%), anemija (17. 0%), dijarea (14. 2%) u raxx (10. 2%).
The adverse reactions observed in patients treated with lenalidomide/dexamethasone are listed below by system organ class and frequency.
Ir- reazzjonijiet avversi osservati f’ pazjenti kkurati b’ lenalidomide/ dexamethasone huma elenkati hawn taħt skond il- klassi ta ’ l- organu tas- sistema u l- frekwenza.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, ir - reazzjonijiet avversi mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Frequencies are defined as: 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 including isolated reports).
Il- frekwenzi huma definiti 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 inklużi rapporti iżolati).
In the majority of cases, there was no significant difference in the incidence of specific adverse events between the two treatment arms.
Fil - maġġoranza tal- każijiet, ma kien hemm l- ebda differenza sinifikanti fl- inċidenza tar- reazzjonijiet avversi speċifiċi bejn iż- żewġ partijiet ta ’ l- istudju dwar il- kura.
Only those adverse reactions marked with * occurred significantly more frequently in the lenalidomide/dexamethasone arm compared to the placebo/dexamethasone arm.
Dawk ir- reazzjonijiet avversi biss li huma mmarkati b’ asterisk (*) seħħew iktar frekwentement b’ mod sinifikanti fil- parti ta ’ l- istudju dwar lenalidomide/ dexamethasone meta mqabbla mal- parti ta ’ l- istudju dwar il- plaċebo/ dexamethasone.
The following adverse reactions have been observed in clinical trials and postmarketing experience: † Reports from post-marketing experience are marked with
Rapporti mill- esperjenza ta ’ wara l- bejgħ huma mmarkati bi †
Pneumonia*, lower respiratory tract infection, Herpes Zoster, Herpes Simplex, urinary tract infection, upper respiratory tract infection, sinusitis, oral candidiasis, oral fungal infection
Pnewmonja *, infezzjoni fl- apparat respiratorju t’ isfel, Herpes Zoster, Herpes Simplex, infezzjoni fl- apparat urinarju, infezzjoni fl- apparat respiratorju ta ’ fuq, sinusite, kandidjasite tal- ħalq, infezzjoni fungali orali
Septic shock, meningitis, neutropenic sepsis, sepsis, Escherichia sepsis, Clostridium difficile sepsis, Enterobacter bacteraemia, subacute endocarditis, bronchopneumonia, lobar pneumonia, bacterial pneumonia, pneumococcal pneumonia, Pneumocystis carinii pneumonia, primary atypical pneumonia, acute bronchitis, respiratory tract infection, herpes zoster ophthalmic, post-herpetic neuralgia, prostate infection, sinobronchitis, oesophageal candidiasis, infective bursitis, erysipelas, cellulitis, tooth abscess, chronic sinusitis, furuncle, pustular rash, ear infection, fungal infection, genital candidiasis, candida infection, influenza, tinea, fungal foot infection, anal warts
Xokk settiku, meninġite, sepsi newtropenika, sepsi, sepsi Escherichia, sepsi Clostridium difficile, batteremija Enterobacter, endokardite sotto- akuta, bronkopnewmonja, pnewmonja lobari, pnewmonja batterjali, pnewmonja pnewmokokkali, pnewmonja Pneumocystis carinii, pnewmonja atipika primarja, bronkite akuta, infezzjoni ta ’ l- apparat respiratorju, herpes zoster oftalmiku, nevralġija post- erpetika, infezzjoni tal- prostata, sinobronkite, kandidjasite esofagali, bursite infettiva, erysipelas, ċellulite, axxess tas- snien, sinusite kronika, furunklu, raxx bil- ponot, infezzjoni fil- widnejn, infezzjoni fungali, kandidjasite ġenitali, infezzjoni tal- kandia, influwenza, tinea, infezzjoni fungali fir- riġel, felul anali
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon:
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni:
Basal cell carcinoma, glioblastoma multiforme
Karċinoma taċ- ċelluli bażali, glioblastoma multiforme
9 Blood and lymphatic system disorders Very Common:
Disturbi tad- demm u tas- sistema limfatika Komuni ħafna:
Anaemia*, neutropenia*, thrombocytopenia*, haemorrhagic disorder Common:
Komuni:
Febrile neutropenia, pancytopenia, leucopenia*, lymphopenia* Granulocytopenia, haemolytic anaemia, autoimmune haemolytic anaemia, haemolysis, hypercoagulation, coagulopathy, monocytopenia, leucocytosis, lymphadenopathy
Anemija *, newtropenja *, tromboċitopenja *, disturb emorraġiku Newtropenja bid- deni, panċitopenja, lewkopenja *, limfopenija * Granuloċitopenja, anemija emolitika, anemija emolitika awtoimmuni, emolisi, koagulazzjoni eċċessiva, koagulopatija, monoċitopenija, lewkoċitosi, limfadenopatija
Acquired hypogammaglobulinaemia
Ipogammaglobulinemija miksuba
Endocrine disorders Common:
Disturbi fis- sistema endokrinarja Komuni:
Cushingoid-like symptoms Adrenal suppression, adrenal insufficiency, acquired hypothyroidism, increased and decreased thyroid stimulating hormone, hirsutism
Sintomi bħal ta ’ Cushingoid Trażżin adrenali, insuffiċjenza adrenali, ipotirojdiżmu miksub, żieda u tnaqqis ta ’ l - ormon li jistimula t- tirojde, ix- xagħar jikber b’ mod eċċessiv u f’ postijiet mhux tas - soltu
Hyperglycaemia, anorexia, hypocalcaemia, hypokalaemia, dehydration, hypomagnesaemia, fluid retention
Ipergliċemija, anoreksja, ipokalċimja, ipokalemija, deidrazzjoni, ipomanjesemija, żamma ta ’ fluwidu
Metabolic acidosis, diabetes mellitus, hyponatraemia, hypercalcaemia, hyperuricaemia, hypoalbuminaemia, cachexia, failure to thrive, gout, hypophosphataemia, hyperphosphataemia, increased appetite
Aċidożi metabolika, dijabete mellitus, iponatremija, iperkalċemija, iperurikemija, ipoalbuminemija, kakessija, piż/ tul taħt in- normal, gotta, ipofosfatemija, iperfosfatemija, żieda fl- aptit
Psychiatric disorders Very Common:
Disturbi psikjatriċi Komuni ħafna:
Insomnia Common:
Komuni:
Confusional state, hallucinations, depression, aggression, agitation, mood alteration, anxiety, nervousness, irritability, mood swings
Nuqqas ta ’ rqad Stat ta ’ konfużjoni, alluċinazzjonijiet, dipressjoni, aggressjoni, aġitazzjoni, burdata ħażina, ansjetà, nervożità, irritabilità, tibdil bejn burdata tajba u burdata ħażina
Psychotic disorder, hypomania, delusion, mental status changes, sleep disorder, abnormal dreams, depressed mood, affect lability, listless, loss of libido, nightmare, personality change, panic attack, restlessness.
Disturbi psikotiċi, ipomanija, delużjoni, tibdil fl- istat mentali, problemi biex torqod, ħolm anormali, burdata dipressa, daħk/ tbissim/ biki patoloġiku, tħossok bla ħeġġa, telf ta ’ libido, ħmar il- lejl, tibdil fil- personalità, attakk ta ’ paniku, nuqqas ta ’ kwiet f’ ġismek.
Nervous system disorders Common:
10 Disturbi fis- sistema nervuża Komuni:
Cerebrovascular accident, syncope, peripheral neuropathy, neuropathy, peripheral sensory neuropathy, dizziness, ageusia, dysgeusia, paraesthesia, headache, tremor*, hypoaesthesia*, somnolence, memory impairment
Inċident ċerebrovaskulari, sinkope, newropatija periferali, newropatija, newropatija periferali tas- sensi, sturdament, telf tas- sens tat- togħma, disgewżja, parestesija, uġigħ ta ’ ras, rogħda *, ipoestesija *, ngħas, indeboliment tal- memorja
Intracranial haemorrhage, intracranial venous sinus thrombosis, thrombotic stroke, cerebral ischaemia, transient ischaemic attack, leukoencephalopathy, neurotoxicity, polyneuropathy, peripheral motor neuropathy, dysaesthesia, aphonia, dysphonia, disturbance in attention, ataxia, balance impaired, postural dizziness, burning sensation, cervical root pain, dyskinesia, hyperaesthesia, motor dysfunction, myasthenic syndrome, oral paraesthesia, psychomotor hyperactivity, anosmia
Emorraġija intrakranjali, trombożi venuża tas- sinus intrakranjali, puplesija trombotika, iskemija ċerebrali, attakki iskemiċi li jgħaddu malajr, lewkoenċefalopatija, newrotossiċità, polinewropatija, newropatija motorea periferali, disestesija, afonija, disfonija, disturbi fl- attenzjoni, atassja, indeboliment fil- bilanċ, sturdament li jiddependi mill- qagħda, sensazzjoni ta ’ ħruq, uġigħ fl - għerq ċervikali, diskinesija, iperestesija, disfunzjoni motorea, sindrome mjasteniku, parestesija orali, iperattività psikomotorea, anosmija
Blurred vision, cataract, reduced visual acuity, lacrimation increased Blindness, retinal arteriosclerosis, retinal vein thrombosis, keratitis, visual disturbance, eyelid oedema, conjunctivitis, eye pruritus, eye redness, eye irritation, dry eye
Għama, arterjosklerosi tar- retina, trombożi tal- vini tar- retina, keratite, disturb tal - vista, edema ta ’ tebqet il- għajn, konġuntivite, ħakk fl- għajnejn, ħmura fl- għajnejn, irritazzjoni fl- għajnejn, għajnejn xotti
Ear and labyrinth disorders Common:
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Vertigo Deafness, hypoacusia, tinnitus, ear pain, ear pruritus
Sturdament Truxija, ipoakusija, żanżin fil- widnejn, uġigħ fil- widnejn, ħakk fil- widnejn
Atrial fibrillation, palpitations Congestive cardiac failure, pulmonary oedema, heart valve insufficiency, atrial flutter, arrhythmia, ventricular trigeminy, bradycardia, tachycardia, QT prolongation, sinus tachycardia
Fibrillazzjoni atrijali, palpitazzjonijiet Kollass konġestiv kardijaku, edema pulmonari, insuffiċjenza tal- valv tal- qalb, tperpir atrijali, arritmija, trigeminy ventrikulari, bradikardija, takikardija, titwil tal - QT, takikardija tas- sinus
Deep vein thrombosis*, limb venous thrombosis, hypotension*, hypertension, orthostatic hypotension, flushing, ecchymosis
Trombożi fonda tal- vini *, trombożi venuża fir- riġlejn jew fid- dirgħajn, pressjoni tad- demm baxxa ħafna *, pressjoni tad- demm għolja, pressjoni tad- demm baxxa ħafna meta wieħed ikun bilwieqfa, fwawar, ekkimożi
Circulatory collapse, thrombosis, ischaemia, peripheral ischaemia, intermittent claudication, phlebitis, pallor, petechiae, haematoma, postphlebitic syndrome, thrombophlebitis, superficial thrombophlebitis
Kollass ċirkolatorju, trombożi, iskemija, iskemija periferali, klawdikazzjoni intermittenti, flebite, sfurija, tbenġil, ematoma, sindrome postflebitiku, tromboflebite, tromboflebite superfiċjali
Pulmonary embolism, dyspnoea*, exertional dyspnoea, bronchitis, cough, pharyngitis, nasopharyngitis, hoarseness, hiccups, epistaxis
Emboliżmu pulmonari, dispnea *, dispnea minħabba l- istrapazz, bronkite, sogħla, farinġite, nażofarinġite, ħanqa, sulluzzu, tinfaraġ
Bronchopneumopathy, asthma, respiratory distress, pulmonary congestion, pleuritic pain, nasal congestion, throat secretion increased, laryngitis, sinus congestion, sinus pain, rhinorrhoea, dry throat
Bronkopnewmopatija, ażżma, problemi respiratorji, konġestjoni pulmonari, uġigħ plewritiku, konġestjoni nażali, żieda fit- tnixxija tal- gerżuma, larinġite, konġestjoni tas- sinus, uġigħ fis- sinus, ħruġ ta ’ likwidu mill- imnieħer, gerżuma xotta
Gastrointestinal disorders Very Common:
Disturbi gastro- intestinali Komuni ħafna:
Constipation, diarrhoea, nausea, increase and decrease in weight Common:
Komuni:
Vomiting, dyspepsia, upper abdominal pain, gastritis, abdominal distension, abdominal pain, stomatitis, dry mouth, flatulence, rectal haemorrhage
Stitikezza, dijarea, dardir, żieda u tnaqqis fil- piż Rimettar, dispepsja, uġigħ fin- naħa ta ’ fuq taż- żaqq, gastrite, nefħa taż- żaqq, uġigħ addominali, stomatite, ħalq xott, gass, emorraġija tar- rektum