qanastek/EMEA-V3 huggingface dataset:
After control of the disease the vaccine should be administered. • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this As with all vaccines, Infanrix Penta may not completely protect all people who are vaccinated.
Wara li l- marda tiġi kkontrollata, il- vaċċin għandu jingħata. • jekk bintek/ ibnek għandhom problema ta 'fsada (ħruġ ta' demm) jew jitbenġlu malajr • jekk ibnek/ bintek għandhom tendenza għall- aċċessjonijiet meta jitlagħlhom id- deni, jew jekk hemm min ibati jew kien ibati min hekk fil- familja Bħal vaċċini l- oħra kollha, Infanrix Penta jista 'ma jipproteġix kompletament in- nies kollha li jkunu mlaqqma.
Important information about some of the ingredients of Infanrix Penta Please tell your doctor if your child has had an allergic reaction to neomycin and polymyxin (antibiotics).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Infanrix Penta Jekk jogħġbok għid lit- tabib tiegħek jekk bintek/ ibnek qatt kellhom xi reazzjoni allerġika għal neomycin u polymyxin (antibijotiċi)
HOW Infanrix Penta IS GIVEN
KIF TINGĦATA Infanrix Penta
Your child will receive a total of two or three injections with an interval of at least one month between each one.
Ibnek/ bintek ser jieħdu total ta 'żewġ jew tliet injezzjonijiet b' intervall ta' mill- anqas xahar bejn waħda u oħra.
Each injection is given on a separate visit.
Kull injezzjoni tingħata f' vista tat- tabib separata.
You will be informed by the doctor or nurse when you should come back for subsequent injections.
It- tabib jew l- infermier jgħidulek meta għandek terġa ’ tmur għall- injezzjoni li jmiss.
If additional injections or “ booster” are necessary, the doctor will tell you.
It- tabib jgħidlek jekk ikun hemm bżonn ta 'aktar dożi (dożi booster).
If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Jekk ibnek/ bintek jaqbżu xi vista li jkun imisshom għall- injezzjoni, kellem lit- tabib biex tirranġa għal vista oħra.
Make sure your child finishes the complete vaccination course of three injections.
21 Kun żgur li ibnek/ bintek jispiċċaw il- kors kollu ta 'tliet injezzjonijiet.
If not, your child may not be fully protected against the diseases.
Jekk le, ibnek/ bintek jista 'jkun li ma jkunux imħarsa biżżejjed kontra dan il- mard.
20 The doctor will give Infanrix Penta as an injection into the muscle.
It- tabib jagħti Infanrix Penta permezz ta 'injezzjoni fil- muskolu.
The vaccine should never be given into blood vessels or into the skin.
It- tilqima m' għandha qatt tingħata f' xi arterja tad- demm jew fil- ġilda.
Like all medicines, Infanrix Penta can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Infanrix Penta jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
As with all injectable vaccines, there is an extremely small risk of serious allergic reactions (anaphylactic and anaphylactoid reactions).
Bħal ma jista ’ jiġri b’ kull vaċċin li jingħata b’ injezzjoni, hemm riskju zgħir ħafna ta ’ reazzjonijiet allerġiċi serji (reazzjonijiet anafilettiċi u anafilolattiċi).
Signs of serious allergic reactions may be: • rashes that may be itchy or blistering • swelling of the eyes and face • difficulty in breathing or swallowing • a sudden drop in blood pressure and loss of consciousness.
Sinjali ta ’ reazzjonijiet allerġiċi serji jistgħu ikunu: • raxx li jista ’ jkun bil- ħakk jew bl- infafet • nefħa fl- għajnejn u fil- wiċċ • diffikultajiet tan- nifs kif ukoll biex tibla • il- pressjoni tad- demm tinżel f’ daqqa u tintilef minn sensik.
Such reactions will usually occur before leaving the doctor’ s surgery.
Dawn ir- reazzjonijiet normalment tħosshom qabel ma toħroġ mill- klinika tat- tabib.
However, if your child gets any of these symptoms you should contact a doctor urgently.
Madankollu, jekk it- tarbija tiegħek ikolla xi wieħed minn dawn is- sintomi għandek tikkuntattja it- tabib mill- ewwel.
Common (These may occur in up to 1 in 10 doses of the vaccine) • diarrhoea, vomiting • fever greater than 39.5°C • swelling larger than 5 cm at the injection site, hard lump at the injection site.
Komuni (Dawn jistgħu jiġru f’ sa 1 minn 10 dożi tat- tilqima) • dijarrea, rimettar • deni ta ’ aktar minn 39. 5˚C • nefħa ta ’ aktar minn 5cm fis- sit ta ’ l- injezzjoni, għoqda iebsa fis- sit ta ’ l- injezzjoni.
Uncommon (These may occur in up to 1 in 100 doses of the vaccine) • sleepiness • cough • dermatitis, rash • large swelling at the injected limb • nervousness.
Mhux komuni (Dawn jistgħu jiġru f’ sa 1 minn 100 doża tat- tilqima) • ħedla tan- nagħas • sogħla • dermatite, raxx • nefħa kbira fid- driegħ fejn tkun ingħatat l- injezzjoni • tħossok nervuż.
Very rare (These may occur in up to 1 in 10,000 doses of the vaccine) • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination • hives • swelling of the entire injected limb.
Rari ħafna (Dawn jistgħu jiġru f' sa 1 minn kull 10, 000 doża tat- tilqima) • fi trabi li jitwieldu ħafna qabel iż- żmien (fi jew qabel it- 28 ġimgħa ta ’ ġestazzjoni) jista ’ jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2- 3 ijiem wara t- tilqima • urtikarja • nefħa tad- driegħ kollu fejn tkun ingħatat l- injezzjoni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
22 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Infanrix Penta
KIF TAĦŻEN Infanrix Penta
21 Do not use Infanrix Penta after the expiry date which is stated on the carton.
Tużax Infanrix Penta wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Freezing destroys the vaccine.
Il- vaċċin jispiċċa bil- friża.
What Infanrix Penta contains
X’ fih Infanrix Penta:
adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
adsorbit fuq aluminium hydroxide idradat (Al( OH) 3) 2
2 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3
manifatturat fuq ċelloli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rekombinanti tad - DNA 3
4 propagated in VERO cells
4 propogat f’ ċelloli VERO
- The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing
- Is- sustanzi l- oħra f’ Infanrix Penta huma: sodium chloride (NaCl), medium 199 li fih
principally amino acids, mineral salts, vitamins and water for injections.
prinċipalment amino acids, mineral salts, vitamini u ilma għall- injezzjonijiet
What Infanrix Penta looks like and contents of the pack
Id- Dehra ta ’ Infanrix Penta u l- kontenuti tal- pakkett:
Suspension for injection
Suspensjoni għall- injezzjoni.
Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
Infanrix Penta hija suspensjoni, bajda u mdardra ġo siringa mimlija lesta (0. 5ml).
Infanrix Penta is available in packs of 1, 10, 20 and 50 with or without needles.
Infanrix Penta tinsab ġo pakketti ta ’ 1, 10, 20 u 50 bil- labar jew mingħajr labar.
GlaxoSmithKline Biologicals s. a.
23 GlaxoSmithKline Biologicals s. a.
Rue de l’ Institut 89 B-1330 Rixensart Belgium
Rue de l' Institut 89 B- 1330 Rixensart Il- Belġju
Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
24 Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0) 1 4955000
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. -------------------------------------------------------------------------------------------------------------------------------
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------------------
Upon storage, a white deposit and clear supernatant can be observed.
Meta jinħażen, depożitu abjad u sustanza ċara f' wiċċ l- ilma jistgħu jidhru.
This does not constitute a sign of deterioration.
Dan ma jfissirx li qiegħed jiħżien.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/ or variation of physical aspect.
Is- suspensjoni tal- vaċċin kontra d- difterite, tetnus, pertussis (partijiet taċ- ċellola), epatite B, poljomelite inattivat (DTPa- HBV- IPV) għandha tkun spezzjonata viżwalment għal xi frak jew/ u xi dehra fiżika mhux normali.
In the event of either being observed, discard the container.
F’ każ li jiġri hekk, il- vaċċin għandu jintrema.
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropew (EPAR).
What is INOmax?
X’ inhu INOmax?
INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 parts per million (ppm).
INOmax huwa gass għal inalazzjoni li fih is- sustanza attiva nitric oxide dilwita f’ gass nitroġenu f’ 400 partijiet kull miljun (ppm).
What is INOmax used for?
Għal xiex jintuża INOmax?
INOmax is used to treat newborn babies with hypoxic respiratory failure who have evidence of pulmonary hypertension (lung failure associated with high blood pressure in the lungs).
INOmax jintuża biex jikkura trabi tat- twelid b’ indeboliment respiratorju ipoksiku li għandhom evidenza ta ’ pressjoni għolja pulmonari (indeboliment tal- pulmun assoċjat ma ’ pressjoni tad- demm għolja fil- pulmuni).
It is used in combination with artificial ventilation and other medicines in babies from 34 weeks gestation (time since conception).
Huwa jintuża flimkien ma ’ ventilazzjoni artifiċjali u mediċini oħra fi trabi minn ġestazzjoni ta ’ 34- il- ġimgħa (żmien mill- konċepiment).
INOmax is used to improve oxygen levels and reduce the need for extracorporeal membrane oxygenation (ECMO, a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).
INOmax jintuża biex itejjeb il- livelli ta ’ l - ossiġnu u jnaqqas il- ħtieġa għal ossiġenazzjoni ta ’ membrana ekstrakorporali (ECMO, teknika biex tagħti l- ossiġnu lid- demm barra l- ġisem permezz ta ’ l- użu ta ’ tagħmir simili għal magna tal- qalb - pulmun).
How is INOmax used?
Kif jintuża INOmax?
INOmax treatment should be supervised by a doctor who has experience in neonatal (newborn) intensive care.
Il- kura INOmax għandha tkun sorveljata minn tabib li għandu esperjenza fil- kura intensiva tat- trabi tat- twelid (trabi tat- twelid ġodda).
INOmax should only be used in neonatal units where staff have been trained in the use of a nitric oxide delivery system after prescription by a specialist neonatal doctor.
INOmax għandu jintuża biss f’ dipartimenti tat- trabi tat- twelid fejn il- ħaddiema ġew imħarrġa fl- użu tas- sistema ta ’ forniment ta ’ nitric oxide fuq għoti ta ’ riċetta minn tabib speċjalista tat- trabi tat- twelid.
INOmax is used in babies who are undergoing artificial ventilation, once the ventilation is optimised, and provided that the baby will remain ventilated for at least 24 hours.
INOmax jintuża fi trabi li tkun qed issirilhom ventilazzjoni artifiċjali, ġa la darba l- ventilazzjoni tkun ottimizzata, u diment li t- tarbija tibqa ’ ivventilata għal mill- inqas 24 siegħa.
INOmax is given after being diluted in the oxygen/ air mixture supplied to the baby through the ventilator.
INOmax jingħata wara li jkun ġie mħallat ma ’ l- ossiġnu/ arja mogħtija lit- tarbija permezz tal- ventilatur.
The maximum recommended concentration of INOmax is 20 ppm.
Il- konċentrazzjoni massima irrakomandata ta ’ INOmax hija ta ’ 20 ppm.
Within four to 24 hours after the start of treatment, this should be reduced to 5 ppm, provided that the blood in the arteries contains enough oxygen.
Fi żmien erba ’ sa 24 siegħa wara l- bidu tal- kura, din tista ’ titnaqqas għal 5 ppm, diment li d- demm fl- arterji ikun fih biżżejjed ossiġnu.
Treatment can be continued at this dose until there is improvement in oxygen levels, for a maximum of 96 hours.
Il- kura tista ’ titkompla f’ din id- doża sakemm ikun hemm titjib fil- livelli ta ’ l- ossiġnu, għal massimu ta ’ 96 siegħa.
Treatment should not be stopped abruptly.
Il- kura m’ għandhiex titwaqqaf f’ daqqa.
How does INOmax work?
Kif jaħdem INOmax?
The active substance in INOmax, nitric oxide, is a naturally-occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax.
Is- sustanza attiva f’ Inomax, nitric oxide, hija kimika li sseħħ b’ mod naturali fil- ġisem, li tagħmel il - muskoli ta ’ l- inforra tal- vini u ta ’ l- arterji sabiex jirrilassaw.
When given by inhalation, it allows the vessels in the lungs to dilate (widen), reducing pulmonary hypertension and allowing blood to get to the tissues more easily, improving the supply of oxygen and removal of waste carbon dioxide.
Meta jingħata permezz ta ’ inalazzjoni, huwa jħalli l- vini fil- pulmuni li jinfetħu, inaqqas il- pressjoni għolja pulmonari u jħalli d- demm jidħol fit- tessuti aktar faċilment, u jtejjeb il- forniment ta ’ l- ossiġnu u t- tneħħija tal- carbon dioxide l- ħażin.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has INOmax been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Huwa jgħin ukoll biex jibgħat demm f’ żoni tal- pulmun li fihom l- aktar ossiġnu u biex inaqqas l - infjammazzjoni fil- pulmuni.
Because nitric oxide is well-known chemical, the company used data from the published literature to support the use of INOmax.
Minħabba li nitric oxide huwa kimika magħrufa sewwa, il- kumpanija użat dejta mil- letteratura ippubblikata biex issostni l- użu ta ’ INOmax.
INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
INOmax ġie studjat ukoll f’ 421 tarbija tat- twelid minn ġestazzjoni ta ’ 34 ġimgħa bi pressjoni pulmonari għolja f’ żewġ studji ewlenin.
In the first study, 235 neonates with respiratory failure received either INOmax or placebo (a dummy treatment).
Fl- ewwel studju, 235 tarbija tat- twelid b’ indeboliment respiratorju irċievew jew INOmax jew plaċebo (kura finta).
The main measure of effectiveness was the proportion of neonates who died or needed ECMO over the first 120 days in hospital.
Il- miżura ewlenija ta ’ l- effikaċja kien il - proporzjon ta ’ trabi tat- twelid li mietu jew li ħtieġu ECMO fuq l- ewwel 120 jum fl- isptar.
In the second study, 186 neonates with respiratory failure received either INOmax or placebo.
Fit- tieni studju, 186 tarbija tat- twelid b’ indeboliment respiratorju irċievew jew INOmax jew plaċebo.
The main measure of effectiveness was the proportion of neonates who needed ECMO.
Il- miżura ewlenija ta ’ l- effikaċja kienet il- proporzjon ta ’ trabi tat- twelid li ħtieġu ECMO.
What benefit has INOmax shown during the studies?
X’ benefiċċju wera INOmax waqt l- istudji?
INOmax was more effective than placebo.
INOmax kien aktar effettiv minn plaċebo.
In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
Fl- ewwel studju ewlieni, 52 (46%) mill- 114- il tarbija tat - twelid li kienu qed jirċievu INOmax mietu jew kellhom bżonn ECMO, meta mqabbla ma ’ 77 (64%) mill- 121 li kienu qed jirċievu plaċebo.
This was mainly due to a reduction in the need for ECMO, rather than a reduction in death rates.
Dan kien prinċipalment minħabba tnaqqis fil- ħtieġa għal ECMO, aktar milli għal tnaqqis fir- rati ta ’ l- imwiet.
In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
Fit- tieni studju ewlieni, 30 (31%) mit- trabi tat - twelid li kienu qed jirċievu INOmax ħtieġu ECMO, meta mqabbla ma ’ 51 (57%) mid- 89 li kienu qed jirċievu plaċebo.
What is the risk associated with INOmax?
X’ inhu r- riskju assoċjat ma ’ INOmax?
The most common side effect with INOmax (seen in more than 1 patient in 10) is thrombocytopenia (low blood platelet counts).
L- aktar effett sekondarju komuni b’ INOmax (deher f’ aktar minn pazjent 1 f’ 10) huwa tromboċitopinja (għadd baxx ta ’ pjastrini).
For a more complete list of the side effects reported with INOmax, see the Package Leaflet.
Għal lista aktar sħiħa ta ’ l- effetti sekondarji irrapportati b’ INOmax, ara l - Fuljett ta ’ Tagħrif.
INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
INOmax m’ għandux jintuża fi trabi li jistgħu jkunu sensittivi żżejjed (alleġiċi) għal nitric oxide jew għal xi sustanza oħra tiegħu (nitroġenu).
It should also not be used in babies who have right-to-left or significant left-to- right shunting of blood (abnormal circulation of blood in the heart).
M’ għandux jintuża ukoll fi trabi li għandhom ċaqliq ta ’ demm mil- lemin għax- xellug jew mix- xellug għal- lemin sinjifikanti (ċirkolazzjoni anormali ta ’ demm fil- qalb).
Why has INOmax been approved?
Għaliex ġie approvat INOmax?
The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax’ s benefits are greater than its risks for the treatment of newborns at or more than 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Inomax huma akbar mir- riskji tiegħu għall- kura ta ’ trabi tat- twelid fi jew wara 34 ġimgħa ta ’ ġestazzjoni b’ indeboliment respiratorju ipoksiku assoċjat ma ’ evidenza klinika jew ekokardjografika ta ’ pressjoni għolja pulmonari.
The Committee recommended that INOmax be given marketing authorisation.
Il- Kumitat irrakomanda li INOmax jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about INOmax:
Tagħrif ieħor dwar INOmax:
The European Commission granted a marketing authorisation valid throughout the European Union for INOmax on 1 August 2001.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal INOmax valida fl- Unjoni Ewropea kollha fl- 1 ta ’ Awwissu 2001.
The marketing authorisation was renewed on 1 August 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 1 ta ’ Awwissu 2006.
The marketing authorisation holder is INO Therapeutics AB.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fus- suq huwa INO Therapeutics AB.
The full EPAR for INOmax can be found here.
L- EPAR sħiħ għal INOmax jista ’ jinstab minn hawn.
This summary was last updated in 10-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 10- 2007.
EU Number EU/ 1/ 01/ 194/ 001 EU/ 1/ 01/ 194/ 002
Numru ta ’ l- EU
Invented name INOmax INOmax
Isem inventat
Strength 400 ppm 400 ppm
Għamla farmaċewtika
Pharmaceutical form Inhalation gas Inhalation gas
Mnejn jingħata
Route of administration Endotracheopulmonary use Endotracheopulmonary use
Il- pakkett
Inovelon 100 mg film-coated tablets
Inovelon 100 mg pilloli miksija b’ rita
100 mg Each film-coated tablet contains 100 mg rufinamide.
100 mg Kull pillola miksija b’ rita fiha 100 mg rufinamide.
20 mg lactose monohydrate/ film coated tablet.
20 mg lactose monohydrate/ pillola miksija b’ rita.
For a full list of excipients, see Section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
100 mg Pink, ‘ ovaloid’, slightly convex, scored on both sides, embossed ‘Є 261’ on one side and blank on the other side.
100 mg Pillola roża, forma ovali, daqsxejn mżaqqa, imnaqqxa fuq iż- żewġ naħat, fuq naħa minnhom hemm ‘ Є261 ’ imbuzzati u xejn fuq in- naħa l- oħra.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ żewg nofsijiet indaqs.
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years and older.
Inovelon huwa indikat bhala terapija aġġuntiva fit- trattament ta ’ aċċessjonijiet assoċjati mas- sindromu Lennox- Gastaut f’ pazjenti li għandhom 4 snin jew aktar.
Treatment with Inovelon should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
It- trattament b’ Inovelon għandu jiġi mibdi minn tabib speċjalizzat fil- pedjatrija jew in- newroloġija b’ esperjenza fit- trattament ta ’ l- epilessija.
Inovelon is for oral use.
Inovelon qiegħed għal użu orali.
It should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Dan għandu jittieħed darbtejn kuljum bl- ilma, filgħodu u filgħaxija, f’ żewġ dożi mqassmin indaqs.
If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Bħala effett ta ’ l- ikel ġiet osservata, li aħjar jekk Inovelon jingħata ma ’ l- ikel (Ara Sezzjoni 5. 2) Jekk il- pazjent ikollu xi diffikultà biex jibla ’, il- pilloli jistgħu jiġu mfarrka u mogħtija ma ’ nofs tazza ilma.
Use in children four years of age or older and less than 30 kg Patients < 30 kg not receiving valproate:
Użu fi tfal ta ’ erba ’ snin jew aktar u li jiżnu nqas minn 30 kg Pazjenti < 30 kg li ma jirċevux valproate:
Treatment should be initiated at a daily dose of 200 mg.
It- trattament għandu jibda b’ doża ta ’ 200 mg kuljum.
According to clinical response and tolerability, the dose may be increased by 200 mg/ day increments, as frequently as every two days, up to a maximum recommended dose of 1000 mg/ day.
Skond ir- rispons kliniku u t- tolerabbilità, id - doża tista ’ tiżdied b’ 200 mg/ kuljum, fi frekwenza ta ’ kull jumejn, sa doża massima rrakkomandata ta ’ 1000 mg/ kuljum.
Doses of up to 3600 mg/ day have been studied in a limited number of patients.
Dożi sa 3600 mg/ kuljum ġew studjati f’ għadd limitat ta ’ pazjenti.
As valproate significantly decreases clearance of Inovelon, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Pazjenti < 30 kg li ma jirċevux mediċina ta ’ valproate Peress li valproate inaqqas b’ mod sinifikanti t- tneħħija ta ’ Inovelon, doża massima mnaqqsa ta ’ Inovelon hi rakkomandata għal pazjenti < 30 kg li jingħataw valproate wkoll.
Treatment should be initiated at a daily dose of 200 mg.
It- trattament għandu jiġi mibdi b’ doża ta ’ kuljum ta ’ 200 mg.
According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/ day, to the maximum recommended dose of 600 mg/ day.
Skond ir- rispons kliniku u t- tolerabilità, wara minimu ta ’ jumejn, id- doża tista ’ tiġi miżjuda għal 200 mg/ kuljum, għad- doża massima rakkomandata ta ’ 600 mg/ kuljum
2 Use in adults and children four years of age or older of 30 kg or over Treatment should be initiated at a daily dose of 400 mg.
2 It- trattament għandu jinbeda b’ doża ta ’ 400 mg kuljum.
According to clinical response and tolerability, the dose may be increased by 400 mg/ day increments, as frequently as every two days, up to a maximum recommended dose as indicated in the table below.
Skond ir- rispons kliniku u t- tolerabbilità, id - doża tista ’ tiżdied b’ 400 mg/ kuljum, fi frekwenza ta ’ kull jumejn, sa doża massima rrakkomandata kif hemm indikat fit- tabella t’ hawn isfel.
Weight range Maximum recommended dose (mg/ day)
Doża massima rakkomandata (mg/ kuljum)
Doses of up to 4000 mg/ day (in the 30-50 kg range) or 4800 mg/ day (over 50 kg) have been studied in a limited number of patients.
Dożi sa 4000 mg/ kuljum (f’ piz ta ’ bejn 30 – 50 kg) jew 4800 mg/ kuljum (’ il fuq minn 50 kg) ġew studjati f’ numru limitat ta ’ pazjenti.
Elderly There is limited information on the use of Inovelon in the elderly.
Anzjani Hemm informazzjoni limitata fuq l- użu ta ’ Inovelon fl- anzjani.
Since, the pharmacokinetics of rufinamide are not altered in the elderly (see Section 5.2), dosage adjustment is not required in patients over 65 years of age.
Peress li l- farmakokinetiċi ta ’ rufinamide ma jiġux mibdula fl- anzjani (ara Sezzjoni 5. 2), aġġustament fid- doża mhuwiex meħtieġ f’ pazjenti ta ’ iktar minn 65 sena.
Patients with renal impairment A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see Section 5.2).
Pazjenti b’ indeboliment renali Studju li sar f’ pazjenti b’ indeboliment renali severi jindika li l- ebda aġġustament tad- doża m’ hu mehtieġ għal dawn il- pazjenti (ara Sezzjoni 5. 2).
Patients with hepatic impairment Use in patients with hepatic impairment has not been studied.
Pazjenti b’ indeboliment epatiku L- użu f’ pazjenti b’ indeboliment epatiku ma ġiex studjat.
Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment.
Huwa rakkomandat li tintuża l- kawtela u tingħata attenzjoni fit- titrazzjoni tad- doża fit- trattament ta ’ pazjenti li jkollhom indeboliment tal- fwied minn ħafif sa moderat.
Therefore, use in patients with severe hepatic impairment is not recommended.
Għalhekk, l- użu f’ pazjenti b’ indeboliment epatiku se veri mhux irrakomandat.
Effect of food Inovelon should preferably be taken with food (see Section 5.2).
Effett ta ’ l- ikel Inovelon għandu preferibbilment jittieħed ma ’ l- ikel (ara Sezzjoni 5. 2).
Discontinuation of Inovelon When Inovelon treatment is to be discontinued, it should be withdrawn gradually.
Twaqqif ta ’ Inovelon Meta t- terapija b’ Inovelon tkun se tiġi mwaqqfa, din għandha tiġi mnaqqsa bil- mod.
In clinical trials Inovelon discontinuation was achieved by reducing the dose by approximately 25% every two days.
Fi provi kliniċi Inovelon twaqqaf billi d- doża tnaqqset bejn wieħed u ieħor b’ 25% kull jumejn.
In the case of one or more missed doses, individualised clinical judgement is necessary.
F’ kaz li doża waħda jew iktar tigi maqbuża, huwa meħtieġ li jittieħed ġudizzju kliniku individwali.
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Studji mhux ikkontrollati b’ open- label li jidhru jissuġerixxu effikaċja sostnuta fuq perijodu ta ’ żmien twil, għalkemm ma kien hemm l- ebda studju li dam sejjer għal aktar minn tliet xhur.
Hypersensitivity to the active substance, triazole derivatives or to any excipients.
Sensittività eċċessiva għas- sustanza attiva derivattivi ta ’ triazole jew għal xi sustanzi mhux attivi.
Status epilepticus cases have been observed during clinical development studies, under rufinamide whereas no such cases have been observed under placebo.
Każijiet ta ’ status epilepticus kienu osservati waqt l- istudji ta ’ żvilupp kliniku, b’ rufinamide, filwaqt li l- ebda każ ma ġie osservat bi plaċebo.
These events led to rufinamide discontinuation in 20% of the cases.
Dawn il- każijiet wasslu għal waqfien ta ’ rufinamide f’ 20% tal- pazjenti.
If patients develop new seizure types and/ or experience an increased frequency of status epilepticus that is different from the patient ’ s baseline condition, then the benefit risk ratio of the therapy should be reassessed.
Jekk pazjenti jiżviluppaw tipi ġodda ta ’ aċċessjonijiet u/ jew frekwenza akbar ta ’ status epilepticus li hi differenti mill- linja bażi tal- kundizzjoni ta ’ riferiment tal- pazjent, allura l- proporzjon ta ’ riskju ta ’ benefiċċju tat- terapija għandha tiġi assessjata mill- ġdid.
Antiepileptic medicinal products, including Inovelon, should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Prodotti mediċinali anti- epilettiċi, inkluż Inovelon, għandhom jiġu mnaqqsa gradwalment sabiex titnaqqas il- possibbiltà ta ’ aċċessjonijiet hekk kif dawn jitwaqqafu.
In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
Fi provi kliniċi Inovelon twaqqaf billi d- doża tnaqqset bejn wieħed u ieħor b’ 25% kull jumejn.
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of Inovelon.
M’ hemmx bizzejjed data dwar it- twaqqif ta ’ prodotti medicinali anti- epilettiċi oħra li jkunu qegħdin jittieħdu fl- istess waqt, la darba l- kontroll fuq l- aċċessjonijiet ikun sar biż- żieda ta ’ Inovelon.
3 Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see Section 4.8).
3 It- trattament b’ rufinamide kien assoċjat ma ’ sturdamenti, ħedla, atassja u disturbi fil- pass, li jistgħu jżidu l- każijiet ta ’ waqgħat aċċidentali f’ din il- popolazzjoni (ara Sezzjoni 4. 8).
Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product.
Il- pazjenti u dawk li jieħdu ħsiebhom għandhom jeżerċitaw il- kawtela sakemm ikunu familjari ma ’ l- effetti potenzjali ta ’ dan il- prodott mediċinali.
Serious antiepileptic drug hypersensitivity syndrome has occurred in association with rufinamide therapy.
Il- każijiet ta ’ sindromu serju ta ’ sensittività eċċessiva għal- mediċina anti- epilettika ġie assoċjat mat - terapija b’ rufinamide.
Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement.
Is- sinjali u s- sintomi ta ’ dan id- disturb kienu diversi, madankollu, il- pazjenti ġeneralment, għalkemm mhux dejjem, kellhom deni u raxx assoċjat ma ’ l- involviment ta ’ sistemi ta ’ organi oħrajn.
Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Manifestazzjonijiet assoċjati oħra jinkludu n- nefħa tal- glandoli limfatiċi, testijiet tal - funzjoni tal- fwied mhux normali, u demm fl- awrina.
Because the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.
Peress li dan id- disturb jesprimi ruħu b’ modi differenti, jistgħu jseħħu s- sinjali u s- sintomi ta ’ sistemi ta ’ organi oħrajn li mhumiex innutati hawn.
This syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Dan is- sindromu seħħ f’ assoċjazzjoni ta ’ żmien qrib il- bidu tat- teħid tat- terapija b’ rufinamide u fil- popolazzjoni pedjatrika.
If this reaction is suspected, rufinamide should be discontinued and alternative treatment started.
Jekk din ir- reazzjoni tiġi suspettata, rufinamide għandu jiġi mwaqqaf u għandu jinbeda trattament differenti.
All patients who develop a rash while taking rufinamide must be closely monitored.
Kull pazjent li jiżviluppa raxx waqt li jkun qed jieħu rufinamide għandu jkun sorveljat mill- qrib.
In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration.
Fi studju QT magħmul bir- reqqa, rufinamide wera tnaqqis fl- intervall ta ’ QTc proporzjonalment mal- konċentrazzjoni.
Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (eg.
Għalkemm il- mekkaniżmu bażiku u s- sigurtà rilevanti ta ’ dan ir- riżultat mhumiex magħrufa, it- tobba għandhom jużaw l- isfond kliniku biex jiddeċiedu jekk għandhomx jippreskrivu rufinamide lil pazjenti li għandhom riskju li jitnaqqas aktar l- intervall QTc (eż.
Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Sindromu Konġenitali ta ’ QT qasir, jew pazjenti bi storja fil- familja ta ’ sindromu bħal dan).
Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw miżuri kontraċettivi waqt it- trattament b’ Inovelon.
Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Section 4.5).
It- tobba għandhom jipprovaw jiżguraw li tintuża kontraċezzjoni xierqa u għandhom jużaw il- ġudizzju kliniku meta jassessjaw jekk kontraċettivi orali, jew id- dożi tal- komponenti tal- kontraċettiv orali, humiex adegwati msejsa fuq is- sitwazzjoni klinika individwali tal- pazjenti individwali (ara Sezzjoni 4. 5).
Inovelon contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Inovelon fih lactose, għalhekk pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, li jbatu mil- Lapp lactase deficiency jew minn malassorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- medicina.
Potential for other medicinal products to affect Inovelon
Il- potenzjal ta ’ prodotti mediċinali oħrajn li jaffetwaw Inovelon
Other anti-epileptic medicinal products Rufinamide concentrations may be decreased by co-administration with carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone.
Prodotti mediċinali anti- epilettiċi oħrajn Konċentrazzjonijiet ta ’ rufinamide jistgħu jitnaqqsu waqt għoti flimkien ma ’ carbamazepine, phenobarbital, phenytoin, vigabatrin jew primidone.
For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
Għal pazjenti fuq trattament ta ’ Inovelon li għandhom l- għoti ta ’ valproate mibdi, żidiet sinifikanti fil- konċentrazzjonijiet tal- plażma ta ’ rufinamide jistgħu jseħħu.
The most pronounced increases were observed in patients of low body weight (< 30 kg).
L- akbar bidliet nnotati kienu osservati f’ pazjenti li għandhom piż korporali baxx (< 30 kg).
Therefore, consideration should be given to a dose reduction of Inovelon in patients < 30 kg who are initiated on valproate therapy (see Section 4.2).
Għalhekk konsiderazzjonijiet għandhom jingħataw għal doża mnaqqsa ta ’ Inovelon f’ pazjenti < 30 kg li huma mibdija fuq terapija ta ’ valproate (ara Sezzjoni 4. 2).
The addition or withdrawal of these drugs or adjusting of the dose of these drugs during Inovelon therapy may require an adjustment in dosage of Inovelon.
Iż- żieda jew il- waqfien ta ’ dawn il- mediċini jew l- aġġustament tad- doża ta ’ dawn il- mediċini waqt trattament b’ Inovelon jistgħu jeħtiegu aġġustament fid- doża ta ’ Inovelon.
No significant changes in rufinamide concentration are observed following co-administration with lamotrigine, topiramate or benzodiazepines.
L- ebda bidliet sinifikanti fil- konċentrazzjoni ta ’ rufenamide għoti flimkien ma ’ lamotrigine, topiramate jew benzodiazepines.
Potential for Inovelon to affect other medicinal products
Il- potenzjal ta ’ Inovelon li jaffettwa prodotti mediċinali oħrajn 4 Prodotti mediċinali anti- epilettiċi oħrajn
Other anti-epileptic medicinal products The pharmacokinetic interactions between rufinamide and other anti-epileptic drugs have been evaluated in patients with epilepsy using population pharmacokinetic modelling.
L- interazzjonijiet farmakokinetici bejn rufinamide u mediċini anti- epilettici oħrajn ġew evalwati f’ pazjenti bl- epilessija billi ntużaw mudelli farmokokinetiċi fuq il- popolazzjoni.
Rufinamide appears not to have clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate or valproate steady state concentrations.
Rufinamide jidher li ma kellu l- ebda effett klinikament relevanti fuq konċentrazzjonijiet ta ’ fissi ta ’ carbamazepine, lamotrigine, phenobarbital, topiramate jew valproate.
Since rufinamide may decrease phenytoin clearance and increase 4 average steady state plasma concentrations of co-administered phenytoin, consideration should be given to reducing the dose of phenytoin.
Billi rufinamide jista ’ inaqqas ir- rata ta ’ l- tneħħija ta ’ phenytoin u jżid il- medja ta ’ konċentrazzjoni ta ’ stat fiss fil- plażma ta ’ phenytoin li jkun ġie mogħti miegħu, għandu jiġi kkunsidrat li titnaqqas id- doża ta ’ phenytoin.
Oral contraceptives Co-administration of rufinamide 800 mg b. i. d. and a combined oral contraceptive (ethinyloestradiol 35 μ g and norethindrone 1 mg) for 14 days resulted in a mean decrease in the ethinyl estradiol AUC0-24 of 22% and in norethindrone AUC0-24 of 14%.
Kontraċettivi orali L- għoti ta ’ rufinamide 800 mg b. i. d. flimkien ma ’ kontraċettiv orali kkombinat (ethinyloestradiol 35 μg u norethindrone 1 mg) għal 14- il jum irriżulta fi tnaqqis medju fl - ethinyl estradiol AUC0- 24 ta ’ 22% u norethindrone AUC0- 24 ta ’ 14%.
Studies with other oral or implant contraceptives have not been conducted.
Studji b’ kontraċettivi orali jew impjantati oħra ma sarux.
Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see Section 4.4 and 4.6).
Nisa li jista ’ jkollhom it- tfal li jkunu qed jużaw ormoni kontraċettivi huma avżati biex jużaw metodu kontraċettiv addizzjonali li jkun sikur u effettiv (ara Sezzjoni 4. 4 u 4. 6).
Cytochrome P450 enzymes Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Enżimi tas- ċitokromju P450 Rufinamide jiġi metabollizat b’ idroliżi u mhuwiex metabollizat sa xi grad notevoli minn enżimi tas- ċitokromju P450.
Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see Section 5.2).
Barra minn hekk, rufinamide ma jwaqqafx l- azzjonijiet ta ’ l- enżimi ċitokromju P450 (ara Sezzjoni 5. 2).
Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Għalhekk, interazzjonijiet klinikament sinifikattivi li jsiru permezz ta ’ l- impediment tas- sistema ċitokromju P450 minn rufinamide, aktarx li mhux se jseħħu.
Rufinamide has been shown to induce the cytochrome P450 enzyme CYP3A4 and may therefore reduce the plasma concentrations of drugs which are metabolised by this enzyme.
Rufinamide ġie muri li jinduċi l- enżima ċitokromju P450 tat- tip CYP3A4 u għalhekk jista ’ jnaqqas il- konċentrazzjoni fil- plażma ta ’ mediċini li huma metabolizzati minn din l- enżima.
The effect was modest to moderate.
L- effett kien bejn modest u moderat.
The mean CYP3A activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg b. i. d.
L- attività medja ta ’ CYP3A, imkejla bħala r- rata ta ’ l- tneħħija ta ’ triazolam, ġiet mizjuda b’ 55% wara t- trattament ta ’ 11- il jum b’ rufinamide 400 mg b. i. d.
The exposure of triazolam was reduced by 36%.
L- espożizzjoni ta ’ triazolam ġiet imnaqqsa b’ 36%.
Higher rufinamide doses may result in a more pronounced induction.
Dożi iktar għoljin ta ’ rufinamide jistgħu jirriżultaw f’ induzzjoni iktar qawwija.
It may not be excluded that rufinamide may decrease the exposure also of drugs metabolized by other enzymes, or transported by transport proteins such as P-glycoprotein.
Għandu mnejn li ma jistax jiġi eskluż li rufinamide jista ’ jnaqqas l- espożizzjoni ta ’ mediċini metabolizzati minn enżimi oħra, jew ittrasportati minn proteini ta ’ trasport bħal P- glycoprotein.
It is recommended that patients treated with drugs that are metabolised by the CYP3A enzyme system are to be carefully monitored for two weeks at the start of, or after the end of treatment with Inovelon, or after any marked change in the dose.
Huwa rakkomandat li pazjenti ttrattati b’ mediċini li huma metabolizzati bis- sistema ta ’ enżimi CYP3A għandhom jiġu monitorati b’ reqqa għal ġimgħatejn mill- bidu ta ’, jew wara t- tmiem tat- trattament b’ Inovelon, jew wara kull bidla fid- doża.
A dose adjustment of the concomitantly administered drug may need to be considered.
Għandu menjn li trid jiġi kkonsidrata kull bidla fid- doża ta ’ kull mediċina li tingħata magħha.
These recommendations should also be considered when rufinamide is used concomitantly with drugs with a narrow therapeutic window such as warfarin and digoxin.
Dawn ir- rakkomandazzjonijiet għandhom jiġu kkonsidrati wkoll meta rufinamide jingħata ma ’ mediċini li għandhom tieqa terapewtika ristretta bħal warfarin u digoxin.
A specific interaction study in healthy subjects revealed no influence of rufinamide at a dose of 400 mg bid on the pharmacokinetics of olanzapine, a CYP1A2 substrate.
Studju fuq interazzjoni speċifika fuq suġġetti b’ saħħithom ma werix l- ebda influwenza ta ’ rufinamide f’ doża ta ’ 400 mg b. i. d fuq il- farmakokinetika ta’ olanzapine, li huwa susstrat ta ’ CYP1A2.
No data on the interaction of rufinamide with alcohol are available.
M’ hemm l- ebda tagħrif disponibbli dwar l- interazzjoni ta ’ rufinamide ma ’ l- alkoħol.
Risk related to epilepsy and antiepileptic medicinal products in general:
Riskju relatat ma ’ l- epilessija u mediċinali anti- epilettiċi b’ mod ġenerali:
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Ġie muri li fil- wild ta ’ nisa bl- epilessija, il- prevalenza ta ’ malformazzjonijiet hija minn tnejn sa tliet darbiet ogħla mir- rata ta ’ madwar wieħed u iehor 3% fil- popolazzjoni ġenerali.
In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/ or the illness is responsible has not been elucidated.
Fil- popolazzjoni li tieħu t- trattament, żieda ta ’ malformazzjonijiet ġiet innutata fejn ikun hemm politerapija; madankollu, il - punt sa fejn it- trattament jew/ u l- marda hija responsabbli ma ġiex iċċarat.
Moreover, effective anti-epileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Barra minn hekk, trattament anti- epilettiku effettiv m’ għandux jiġi mwaqqaf, għaliex l- aggravazzjoni tal- marda tagħmel ħsara kemm lill- omm u kemm lill- fetu.
Risk related to rufinamide:
Riskju relatat ma ’ rufinamide:
Studies in animals revealed no teratogenic effect but foetotoxicity in presence of maternal toxicity (see Section 5.3).
5 Studji fl- annimali ma wrewx effetti teratoġenici imma tossicità fil- fetu fil- preżenza ta ’ tossicità fl - omm (ara Sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali ghall- bniedem mhux magħruf.
For rufinamide, no clinical data on exposed pregnancies are available
Għal rufinamide, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Taking these data into consideration, rufinamide should not be used during pregnancy unless clearly necessary and in women of childbearing age not using contraceptive measures.
B’ konsiderazzjoni ta ’ din id- data, rufinamide m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku u f’ nisa ta ’ età li jista ’ jkollhom it- tfal li ma jkunux qegħdin jieħdu miżuri kontraċettivi.
5 judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see Section 4.5).
It- tobba għandhom jipprovaw li kontraċezzjoni xierqa tiġi wżata u għandhom jużaw il- ġudizzju kliniku meta jassessjaw jekk kontraċettivi orali, jew id- dożi tal- komponenti tal- kontraċettiv orali, humiex adegwati msejsa fuq is- sitwazzjoni klinika individwali tal- pazjenti (ara Sezzjoni 4. 5).
If women treated with rufinamide plan to become pregnant, the indication of this product should be carefully weighed.
Jekk nisa li qegħdin jiġu ttrattati b’ rufinamide qegħdin jippjanaw li joħorgu tqal, l- indikazzjoni ta ’ dan il- prodott trid tiġi mwieżna sewwa.
During pregnancy, an effective antiepileptic rufinamide treatment must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Matul it- tqala, trattament anti- epilettiku effettiv b’ rufinamide m’ għandux jigi interrot, għaliex l- aggravazzjoni tal- marda tagħmel ħsara kemm lill- omm u kemm lill - fetu.
Is not known if rufinamide is excreted in human breast milk.
Mhux magħruf jekk rufinamide jiġix eliminat fil- ħalib ta ’ l- omm.
Due to the potential harmful effects for the breast fed infant, the lactation should be avoided during maternal treatment with rufinamide.
Minħabba l- effetti ta ’ ħsara potenzjali għat- tarbija li tkun qed tiġi mredda ’, it- treddigħ għandu jiġi evitat waqt it- trattament materna b’ rufinamide.
Inovelon may cause dizziness, somnolence and blurred vision.
Inovelon jista ’ jikkawża sturdamenti, ħedla u vista mċajpra.
Depending on the individual sensitivity, Inovelon may have a mild to severe influence on the ability to drive or use machines.
Skond is- sensittività individwali, Inovelon jista ’ jkollu influwenza minn ħafifa sa severi fuq il- ħila biex issuq u tħaddem magni.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e. g., driving or operating machinery.
Sewqan jew tħaddim ta ’ makkinarju.
The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Il- programm ta ’ żvilupp kliniku inkluda ’ l fuq minn 1, 900 pazjent, b’ tipi differenti ta ’ epilessija, esposti għal rufinamide.
The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.
L- iktar reazzjonijiet avversi komuni rrapportati kienu ugigħ ta ’ ras, sturdamenti, għejja u ngħas.
The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
L- iktar reazzjonijiet avversi komuni osservati f’ inċidenza iktar għolja mill- plaċebo f’ pazjenti bis- sindromu Lennox- Gastaut kienu n- ngħas u r- rimettar.
Adverse reactions were usually mild to moderate in severity.
Ir- reazzjonijiet avversi kienu ġeneralment minn ħfief sa moderati fis- severità tagħhom.
The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving Inovelon and 0% for patients receiving placebo.
Ir- rata ta ’ sospensjoni minħabba r- reazzjonijiet avversi fis- sindromu ta ’ Lennox- Gastaut kienet 8. 2% għall- pazjenti li qegħdin jieħdu Inovelon u 0% għall- pazjenti li kienu qegħdin jieħdu l- plaċebo.
The most common adverse reactions resulting in discontinuation from the Inovelon treatment group were rash and vomiting.
L- iktar reazzjonijiet avversi komuni li rriżultaw f’ sospensjoni mill- grupp li kien qiegħed jingħata trattament b’ Inovelon kienu r- raxx u r- rimettar.
Adverse reactions reported with an incidence greater than placebo, during the Lennox-Gastaut syndrome double-blind studies or in the overall rufinamide-exposed population, are listed in the table below by MedDRA preferred term, system organ class and by frequency.
Reazzjonijiet avversi rrapportati, b’ inċidenza ikbar mill- plaċebo, waqt l- istudji double- blind li saru fis- sindromu Lennox- Gastaut jew fil- popolazzjoni esposta ghal rufinamide jinsabu mnizzlin fit- tabella hawn taht skond it- terminoloġija ppreferuta minn MedDRA, il- klassifika tas- sistema ta ’ l- organi u l- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 < 1/ 10), uncommon (≥ 1/ 1,000 < 1/ 100).
Il- frekwenzi huma mfissra bħala: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 < 1/ 10), mhux komuni (≥ 1/ 1, 000 < 1/ 100).
System Organ Class Infections and Infestations Immune system
Klassifika tas- Sistema ta ’
Very
l- Organi
Metabolism and Nutrition disorders Psychiatric disorders
Infezzjonijiet u infestazzjonijiet
Anorexia Eating disorder Decreased appetite Anxiety Insomnia
Pnewmonja Influwenza Nasofarinġite Infezzjonijiet fil- widna
Nervous system disorders
Klassifika tas- Sistema ta ’
Common Nystagmus Psychomotor hyperactivity Tremor
Komuni
Eye Disorders
Disturbi fl - għajnejn
Diplopia Vision blurred
Diplopja Vista mċajpra
Ear and Labyrinth disorders
Disturbi fil - widnejn u s - sistema labirintika
Gastrointestinal disorders
Disturbi gastro - intestinali Disturbi epato -
Nausea Vomiting
Nawsea Remettar
Abdominal pain upper Constipation Dyspepsia Diarrhoea
Uġigħ fin- naħa ta ’ fuq taż - żaqq Stitikezza Dispepsja Dijarrea
Hepato-biliary
biljari
Hepatic enzyme
Żieda fl- enżimi epatiċi