qanastek/EMEA-V3 huggingface dataset:
Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) are similar to those of normal controls.
Il- farmakokinetiċi ta ’ doża waħda ta ’ ribavirin f’ pazjenti b’ każi ħfief, moderati jew severi ta ’ fwied mhux qed jaħdem normali (Klassifikazzjoni Child- Pugh A, B jew Ċ) jixbħu lil dawk tal- kontrolli normali.
Elderly patients (≥ 65 years of age):
Pazjenti anzjani (≥ 65 sena):
However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Madankollu fi studju farmakokinetiku dwar il- popolazzjoni, l- età ma kinetx fattur importanti fil - kinetika ta ’ ribavirin; il- funzjoni renali hija l- fattur determinanti.
Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Analiżi farmakokinetika tal- popolazzjoni saret permezz ta ’ valuri tal- konċentrazzjoni fis- serum miġbura minn ftit kampjuni ’ l bogħod minn xulxin minn erba ’ provi kliniċi kkontrollati.
The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Il- mudell ta ’ tneħħija li żviluppa wera li l- piż tal- ġisem, is- sess, l- età u l- kreatinina fis- serum kienu kovarjanti ewlenin.
For males, clearance was approximately 20% higher than for females.
Għall- irġiel, it- tneħħija kienet ta ’ madwar 20% ogħla milli għan- nisa.
Clearance increased as a function of body weight and was reduced at ages greater than 40 years.
It- tneħħija żdidiet skont il- piż tal- ġisem u tnaqqset f’ etajiet akbar minn 40.
Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Effetti ta ’ dawn il- kovarjetajiet fuq it- tneħħija ta ’ ribavirin jidhru li huma ta ’ importanza klinika minħabba l- varjabilità sostanzjali residwa li ma tteħditx in konsiderazzjoni il- mudell.
Children and adolescents:
23 Tfal u adoloxxenti:
Multiple-dose pharmacokinetic properties for Ribavirin capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 12.
Il- karatteristiċi tal- farmakokinetiċi b’ ħafna dożi għal kapsuli Ribavirin u interferon alfa- 2b fi tfal u adoloxxenti b’ epatite Ċ kronika ta ’ età bejn 5 u 16- il sena qed jintwerew fil- qosor f’ Tabella 12.
The pharmacokinetics of Ribavirin and interferon alfa-2b (dose- normalized) are similar in adults and children or adolescents.
Il- farmakokinetika ta ’ Ribavirin u interferon alfa- 2b (doża normalizzata) huma simili fl- adulti jew adoloxxenti.
Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to children or adolescents with chronic hepatitis C
Medja (% CV) ta ’ parametri farmakokinetiċi b’ ħafna dożi għal for interferon alfa- 2b u kapsuli Ribavirin meta jingħataw lil tfal u adoloxxenti b’ epatite Ċ kronika
15 mg/ kg/ day as 2 divided doses (n = 17)
15 mg/ kg/ jum maqsuma f’ żewġ dożi (n = 17)
3 MIU/ m2 3 times a week (n = 54)
3 MIU/ m2 3 darbiet fil- ġimgħa (n = 54)
clearance l/ hr/ kg
Tneħħija apparenti l/ hr/ kg
Not done
Ma sarx
*AUC12 (ng. hr/ ml) for Ribavirin; AUC0-24 (IU. hr/ ml) for interferon alfa-2b
* AUC12 (ng. hr/ ml) għal Ribavirin; AUC0- 24 (IU. hr/ ml) għal interferon alfa- 2b
Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Ribavirin huwa tossiku għall- embriju jew teratoġeniku, jew it- tnejn, f’ dożi ħafna inqas mid- dożi rakkomandati fil- bniedem fl- ispeċi kollha tal- annimali li fuqhom saru l- istudji.
Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted.
Kienu nnutati suriet difettużi tal- kranju, tas- saqaf tal- ħalq, tal- għajnejn, tax- xedaq, fir- riġlejn/ dirgħajn, tal- iskeletru u tas- sustema tal- passaġġ gastrointestinali.
The incidence and severity of teratogenic effects increased with escalation of the dose.
L- inċidenza u s- severità tal- effetti teratoġeniċi żdiedu maż- żieda fid- doża.
Survival of foetuses and offspring was reduced.
Iż- żmien li damu ħajjin il- feti u l- frieħ kien inqas.
23 In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/ kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
Fi studju war it- tossiċità fuq firien, frieħ li ngħataw doża ta ’ bejn 7 sa 63 jum wara t- twelid b’ 10, 25 u 50 mg/ kg ta ’ ribavirin urew tnaqqis ġenerali fit- tkabbir skont id- doża, li wara deher bħala tnaqqis żgħir fil- piż tal- ġisem, it- tul tal- crown- rump (bejn ir- ras u l- patata) u t- tul tal- għadam.
At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Fi tmiem il - perijodu ta ’ konvalexxenza, bidliet fit- tibja u fil- femur kienu żgħar ħafna għalkemm statistikament sinifikanti b’ mod ġenerali meta mqabbla ma ’ dawk tal- irġiel fid- dożi kollha u fin- nisa li ngħataw l - ogħla żewġ dożi meta mqabbla mal- kontrolli.
No histopathological effects on bone were observed.
Ma dehrux effetti istopatoloġiċi fuq l- għadam.
No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Ribavirin ma kellux effetti fuq l- iżvilupp newrokomportattiv jew riproduttiv.
Plasma concentrations achieved in rat pups were below human plasma concentrations at the therapeutic dose.
Il- konċentrazzjonijiet fil- plażma li nkisbu fil- frieħ ta ’ firien kienu inqas mill- konċentrazzjonijiet fil- plażma li jintlaħqu mill- bniedem bid - doża terapewtika.
Erythrocytes are a primary target of toxicity for ribavirin in animal studies.
Eritroċiti huma l- bersall ewlieni ta ’ tossiċità għal ribavirin fi studji fuq l- annimali.
Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
L- anemija sseħħ ftit wara li tingħata d- doża, iżda hija riversibbli malajr wara l- waqfien tat- trattament.
In 3- and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/ kg and above.
Fi studji ta ’ 3 u 6 xhur fuq il- ġrieden sabiex jiġu mistħarrġa l- effetti fuq it- testikuli u fuq l- isperma kkaġunati minn ribavirin, anormalitajiet fl- isperma seħħew f’ dożi ta ’ 15 mg/ kg u aktar.
These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
Dawn id- dożi fl- annimali jipproduċu espożizzjonijiet sistematiċi ħafna inqas minn dawk li ntlaħqu fil- bniedem f’ dożi terapewtiċi.
Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Wara l- waqfien tal- kura, l- irkupru tista ’ tgħid totali mit- tossiċità testikulari kkaġunata minn ribavirin seħħet fi żmien wieħed jew żewġ ċikli spermatoġeniċi (ara sezzjoni 4. 6).
Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Studji ġenotossiċi wrew li ribavirin għandu xi effetti ġenotossiċi.
Ribavirin was active in the Balb/ 3T3 in vitro Transformation Assay.
Ribavirin kien attiv fl- Assaġġ tat- Trasformazzjoni tal- Balb/ 3T3 in vitro.
Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/ kg in a mouse micronucleus assay.
Attività ġenotossika kienet osservata fl- assaġġ tal- limfoma tal- ġrieden, u b’ dożi ta ’ 20- 200 mg/ kg f’ assaġġ tal- mikronukleju tal- ġrieden.
A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.
Assaġġ letali dominanti li jikkaġuna l- mewt ta ’ firien kien negattiv, li jindika li jekk iseħħu mutazzjonijiet fil- firen, dawn ma jkunux trasmessi permezz tal- gamiti tar- raġel.
Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Studji konvenzjonali dwar il- karċinoġeniċità f’ annimali gerriema f’ espożizzjonijiet baxxi meta mqabbla ma espożizzjonijiet fil- bniedem skont kundizzjonijiet terapewtiċi (fattur 0. 1 fil- firien u 1 fil - ġrieden) ma wrewx tumoriġeniċità ta ’ ribavirin.
In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/ -) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/ kg (plasma exposure factor approximately 2.5 compared to human exposure).
Barra minn hekk, fi studju dwar il- karċinoġeniċità fuq 26 ġimgħa bl- użu tal- mudell heterozygous p53( + / -) tal- ġurdien, ribavirin ma kkawżax tumuri fid - doża massima ttollerata ta ’ 300 mg/ kg (fattur tal- espożizzjoni tal- plażma ta ’ madwar 2. 5 meta mqabbel
These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Dawn l- istudji jissuġerixxu li l- potenzjal karċinoġeniku ta ’ ribavirin fil- bniedem x’ aktarx ma jseħħx.
Ribavirin plus interferon alfa-2b:
Ribavirin ma ’ interferon alfa- 2b:
When used in combination with peginterferon alfa-2b or interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Meta ntuża flimkien ma ’ peginterferon alfa- 2b jew interferon alfa- 2b, ribavirin ma kkawżax xi effetti li ma kienux innotati b’ xi waħda miż- żewġ sustanzi attivi waħidhom.
The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Il- bidla ewlenija marbuta mat- trattament kienet anemija bejn ħafifa u moderata li kienet riversibbli, li s- severità tagħha kienet akbar minn dik prodotta minn xi wieħed mis- sustanzi attivi waħdu.
Calcium hydrogen phosphate Croscarmellose sodium Povidone Magnesium stearate
Calcium hydrogen phosphate Croscarmellose sodium Povidone Magnesium stearate
Titanium dioxide (E171) Gelatin
Titanium dioxide (E171) Gelatin
24 Capsule imprint:
Impronta fuq il- kapsula:
Shellac Titanium dioxide (E171) Indigo carmine
Shellac Titanium dioxide (E171) Indigo carmine
6.4 Special precautions for storage
Ma jgħoddx f’ dan il- każ
Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/ polyethylene (PE)/ polyvinylidene chloride (PVdC)-aluminium blister packs
Il- kapsuli ribavirin huma ppakkjati ġo folji li jikkonsistu minn polyvinyl chloride (PVC) / polyethylene (PE) / polyvinylidene chloride (PVdC) - pakketti ta ’ folji tal- aluminju
Packs of 84, 112, 140 and 168 capsules Not all pack sizes may be marketed.
Pakketti f’ daqsijiet ta ’ 84, 112, 140 u 168 kapsula Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Teva Pharma B. V.
25 Teva Pharma B. V.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13 H-4042 Debrecen Hungary
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13 H- 4042 Debrecen L- Ungerija
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82 H-2100 Gödöllo Hungary
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82 H- 2100 Gödöllo L- Ungerija
Swensweg 5, 2031 GA Haarlem The Netherlands
Swensweg 5, 2031 GA Haarlem L- Olanda
TEVA Santé SA Rue Bellocier, 89107 Sens France
TEVA Santé SA Rue Bellocier, 89107 Sens Franza
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 4. 0 iddatata Novembru 2007 ippreżentata f’ Moduli 1. 8. 1 ta ’ l- Applikazzjoni dwar l- Awtorizzazjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
28 ANNEX III
28 Pjan ta ’ Ġestjoni tar- Riskju
LABELLING AND PACKAGE LEAFLET
Ma jgħoddx f’ dan il- każ
29 A.
29 ANNESS III
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Outer Carton 84, 112, 140, 168 hard capsules
Kartuna ta ’ Barra ta ’ 84, 112, 140, 168 kapsula iebsa
Ribavirin Teva 200 mg hard capsules ribavirin
Ribavirin Teva 200 mg kapsuli iebsin ribavirin
Each capsule contains 200mg of ribavirin
Kull kapsula fiha 200 mg of ribavirin
84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
84 kapsula 112 kapsula 140 kapsula 168 kapsula
Do not store above 30oC
Taħżinx f’ temperatura ’ l fuq minn 30oC
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Immediate packaging (blister foil)
Pakkett li jmiss mal- prodott (strixxa nuffata)
Ribavirin Teva 200mg hard capsules ribavirin
Ribavirin Teva 200 mg kapsuli iebsin ribavirin
What Ribavirin Teva is and what it is used for 2.
X’ inhu Ribavirin Teva u għal xiex jintuża 2.
Before you take Ribavirin Teva 3.
Qabel ma tieħu Ribavirin Teva 3.
How to take Ribavirin Teva 4.
Kif għandek tieħu Ribavirin Teva 4.
How to store Ribavirin Teva 6.
Kif taħżen Ribavirin Teva 6.
WHAT RIBAVIRIN TEVA IS AND WHAT IT IS USED FOR
X’ INHU RIBAVIRIN TEVA U GĦAL XIEX JINTUŻA 1.
Ribavirin Teva is a medicine that can inhibit the multiplication of some viruses.
Ribavirin Teva huwa mediċina li tista ’ timpedixxi l- multiplikazzjoni ta ’ xi virusis.
Ribavirin Teva is used in adults, in combination with either peginterferon alfa-2b or interferon alfa-2b, to treat patients who have chronic hepatitis C.
Ribavirin Teva jintuża f’ adulti, flimkien ma ’ jew peginterferon alfa- 2b jew interferon alfa- 2b, sabiex jittratta pazjenti li għandhom epatite Ċ kronika.
The situations where Ribavirin Teva can be used with adults are listed below:
Is- sitwazzjonijiet meta Ribavirin Teva jista ’ jintuża f’ adulti huma elenkati hawn isfel:
In combination with either interferon alfa-2b or peginterferon alfa-2b in adults who have not previously been treated for chronic hepatitis C or who have previously responded to treatment with an alpha interferon, but whose condition has recurred.
F’ kombinazzjoni ma ’ jew interferon alfa- 2b jew peginterferon alfa- 2b f’ adulti li ma kinux ġew ittrattati qabel għal epatite Ċ kronika jew li rrispondew għal trattament mogħti qabel b’ alpha interferon, imma li l- kundizzjoni tagħhom reġgħet tfaċċat.
In combination with peginterferon alfa-2b in adults who have been not previously been treated for chronic hepatitis C and who are co-infected with clinically stable HIV.
F’ kombinazzjoni ma ’ peginterferon alfa- 2b f’ adulti li ma kinux ittrattai qabel għal epatite Ċ kronika u li huma ko- infettati b’ HIV klinikament stabbli.
In combination with peginterferon alfa-2b in adults who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy.
F’ kombinazzjoi ma ’ peginterferon alfa- 2b f’ adulti li t- trattament li ngħatalhom qabel b’ interferon alfa (pegilat jew mhux pegilat) flimkien ma ’ ribavirin jew b’ monoterapija ta ’ interferon alfa kien falla.
Ribavirin Teva can also be used in combination with interferon alfa-2b in children and adolescents 3 years of age and older, who have previously untreated chronic hepatitis C.
Ribavirin Teva jista ’ jintuża wkoll ma ’ interferon alfa- 2b fi tfal u adoloxxenti minn 3 snin ’ il fuq li għandhom epatite Ċ kronika li ma ġietx ittrattata qabel.
Ribavirin Teva should not be used on its own.
Ribavirin Teva m’ għandux jintuża waħdu.
BEFORE YOU TAKE RIBAVIRIN TEVA
QABEL MA TIEĦU RIBAVIRIN TEVA
You must read the patient leaflet for peginterferon alfa -2b or interferon alfa-2b before you start treatment with Ribavirin Teva and either peginterferon alfa-2b or interferon alfa-2b.
Għandek taqra il- fuljett ta ’ tagħrif tal- pazjent għal peginterferon alfa- 2b jew interferon alfa- 2b qabel tibda tieħu t- trattament b’ Ribavirin Teva u jew peginterferon alfa- 2b jew interferon alfa- 2b.
Do not take Ribavirin Teva
Tieħux Ribavirin Teva jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ribavirin jew sustanzi oħra ta ’
35
-
- if you are allergic (hypersensitive) to ribavirin or any of the other ingredients of Ribavirin Teva
Ribavirin Teva Capsules (ara sezzjoni 6, Aktar tagħrif)
Ribavirin Teva can harm both the embryo
Ribavirin Teva jista ’ jikkaġuna ħsara
(unborn baby) and the male sperm.
lill- embriju (tarbija mhix mwielda) u lill- isperma tar- raġel.
Female patients of childbearing age must produce a negative pregnancy test immediately prior to treatment.
Pazjenti nisa li għad jista ’ jkollok it- tfal għandek tipproduċi test negattiv tat- tqala qabel tibda it- trattament.
It is essential that Routine pregnancy tests should also be performed monthly during treatment and for four months after treatment has stopped.
Huwa essenzjali li t - test tat- tqala ssir kull xahar waqt it- trattament u għal erba ’ xhur wara li jintemm it- trattament.
Female partners of male patients should also have routine pregnancy tests monthly during treatment, and for seven months after treatment has stopped.
Partners nisa ta ’ pazjenti rġiel ukoll għandu jkollhom testijiet ta ’ tqala kull xahar waqt it- trattament, u għal seba ’ xhur wara li jkun waqaf it- trattament.
- if you have any severe medical conditions that leave you very weak, including severe kidney
- jekk għandek xi kundizzjoni medika serja li tħallik dgħajjef ħafna, li tinkludi mard serju
disease.
tal- kliewi.
- if you are breast-feeding
- jekk qed tredda ’
- if you have had any previous severe heart problems, or have had any problems with the heart in
Huwa
the last six months.
rakkomandat għal dawn il- pazjenti li jieħdu elettrokardjogrammi qabel u waqt il- kors tat - trattament.
- if you have had severe liver problems, which are not related to hepatitis C
- jekk għandek jew kellek xi problema serja fil- fwied, li ma kinetx marbuta mal- epatite Ċ
- if you have suffered from any blood dis order, for example anaemia, thalassemia or sickle-cell
- jekk qattx kellek xi disturbi marbuta mad- demm, pereżempju anemija, talessimja jew anemija
anaemia
tat- tip sickle cell
- if you have suffered from autoimmune disease in the past, or suffer from autoimmune hepatitis,
- jekk qattx kellek mard awtoimmuni fil- passat, jew tbati minn epatite awtoimmuni, jew qed tieħu
or are taking other medicines that suppress your immune system
mediċini oħra li jrażżnu s- sistema immunitarja tiegħek
- If you have suffered from severe depression, suicidal thoughts or have attempted suicide in the
- jekk qatt batejt minn dipressjoni severa, ħsibijiet suwiċidali jew kellek xi tentattiv suwiċidali
past
fil- passat
You should tell your doctor if you have suffered from any other serious illness in the past.
Għandek tgħid lit- tabib tiegħek jekk inti batejt minn xi mard serju fil- passat.
Please also read the “do not use” section of the package leaflet for peginterferon alfa-2b or interferon alfa-2b
Jekk jogħġbok aqra wkoll is- sezzjoni “ Tieħux ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b
Take special care with Ribavirin Teva
Oqgħod attent ħafna b’ Ribavirin Teva
- if you suffer from severe mental disorders, then the use of Ribavarin Teva in combination with
Jekk kellek fl- imgħoddi disturbi mentali severi, l- użu ta ’ Ribavarin Teva flimkien ma ’
either peginterferon alfa -2b or interferon alfa-2b should only begin after the appropriate individualised treatment regimen has been set up by your doctor.
peginterferon alfa- 2b jew interferon alfa- 2b għandu jibda biss wara li programm xieraq individwalizzat ikun ġie stabbilit mit- tabib tiegħek.
- You may need to have your kidneys tested before you begin your treatment, especially if you
- Għandu mnejn ikun hemm bżonn li jkollok il- kliewi ttestjati qabel ma tibda t- trattament,
are older than 65 years or if you have problems with your kidneys.
speċjalment jekk inti għandek aktar minn 65 sena jew għandek problemi marbuta mal- kliewi tiegħek.
- Ribavirin capsules should not be used by children weighing less than 47 kg.
- Il- kapsuli Ribavirin m’ għandhomx jintużaw minn tfal li jiżnu inqas minn 47 kg.
- You should tell your doctor if you have ever had a heart attack or a heart problem (it may be
- Għandek tgħarraf lit- tabib tiegħek jekk qatt kellek xi attakk f’ qalbek jew problemi bil- qalb
advisable to have electrocardiograms before and during the course of treatment).
(jista ’ jkun rakkomandat li jkollok elettrokardjogrammi qabel u waqt il- kors tat- trattament).
- Inform your doctor if you have severe liver diseases (excluding chronic hepatitis C), thyroid
- Informa lit- tabib tiegħek jekk għandek mard tal- fwied sever (li jeskludi l- epatite Ċ kronika),
problems; if you have ever been treated for depression or any other psychiatric disorder, confusion, unconsciousness, or have had thoughts of suicide or have attempted suicide.
problemi bit- tirojdi; Jekk inti qatt ġejt ittrattat għal dipressjoni jew xi disturbi psikjattriċi oħra, konfużjoni, inkoxjenza, jew kellek ħsibijiet ta ’ suwiċidju jew ippruvajt tagħmel suwiċidju.
Tell your doctor of any serious illness you have or have had, as this may determine whether Ribavirin Teva is suitable for you.
Għarraf lit- tabib tiegħek dwar mard serju li għandek jew li kellek, peress li dan jiddetermina jekk Ribavirin Teva hux adattat għalik.
- seek medical advice immediately if you develop symptoms of a severe allergic reaction (such as
- fittex parir mediku minnufih jekk waqt li qed tieħu dan it- trattament jiżviluppaw sintomi ta ’
difficulty in breathing, wheezing or hives) while taking this treatment.
reazzjoni allerġika severa (bħal diffikultà biex tieħu n- nifs, tħarħir jew ħurrieqija).
- standard blood tests will be taken to check your blood, kidney, and liver function.
testijiet tad- demm standard ser jittieħdu biex jiġi ċċekkjat id- demm, u l- funzjoni tal- kliewi u
If you have a
-
kidney disease, your doctor should monitor you more carefully for a decrease in red blood cell count.
Jekk għandek mard tal- kliewi, it- tabib tiegħek għandu jżommok taħt osservazzjoni aktar bir- reqqa għal xi tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm.
36 Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving ribavirin and peginterferon alfa-2b or interferon alfa-2b combination therapy.
37 Mard tas- snien u tal- ħanek, li jista ’ jwassal sabiex jinqalgħu xi snien, kienu rrapurtati f’ pazjenti li kienu qed jirċievu terapija b’ ribavirin flimkien ma ’ peginterferon alfa- 2b jew interferon alfa- 2b.
Dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Il - ħalq xott jista ’ jikkawża ħsara lis- snien u lir- riti tal- ħalq waqt trattament fit- tul bil- kombinazzjoni ta ’ ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b.
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Inti għandek taħsel snienek sew darbtejn kuljum u jkollok snienek eżaminati b’ mod regolari.
In addition some patients may experience vomiting.
Barra minn hekk xi pazjenti jistgħu jirremettu.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Jekk jiġri hekk, kun żgur li tlaħlaħ ħalqek sew wara.
During the one year of treatment, many children did not grow or gain weight as much as expected.
Matul is- sena ta ’ trattament, ħafna tfal ma kibrux jew żdiedu fil- piż daqs kemm kien mistenni.
However, during the 6 months after treatment, this trend was generally reversed, although a few children did not return to their previous rate of growth within the first year after completing treatment.
Madankollu, waqt is- 6 xhur wara t- trattament, din ix- xejra kienet ġeneralment riversjata, għalkemm xi tfal ma rritornawx għar- rata ta ’ żvilupp ta ’ qabel fi żmien sena wara li temmew it- trattament.
Please also read the “take special care” section of the package leaflet for peginterferon alfa-2b or interferon alfa-2b
Jekk jogħġbok aqra wkoll is- sezzjoni “ Oqgħod attent ħafna ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you take zidovudine or stavudine as a treatment for HIV or AIDS, it is possible that ribavirin will affect the way these medicines work.
Jekk tkun qed tieħu zidovudine jew stavudine bħala trattament għal HIV jew AIDS, huwa possibbli li ribavirin jista ’ jaffettwa kif jaħdmu dawn il- mediċini.
Therefore, your blood will be checked regularly to ensure that the HIV infection does not get any worse.
Għalhekk, id- demm tiegħek ser ikun regolarment iċċekkjat sabiex jiġi żgurat li l- infezzjoni bl- HIV ma tmurx għall- agħar.
If it does get worse, then your doctor may decide to alter or stop your ribavirin treatment.
Jekk tmur għall - agħar, it- tabib tiegħek għandu jiddeċiedi jekk it- trattament b’ ribavirin hemmx bżonn jinbidel jew le.
In addition, patients treated with ribavirin and zidovudine could be at an increased risk of developing anaemia.
Barra minn hekk, pazjenti trattati b’ ribavirin u zidovudine jistgħu jkunu f’ riskju ogħla li jiżviluppaw anemija.
It is not recommended to take ribavirin with didanosine and/or stavudine, as this can lead to the build up of lactic acid and the inflammation of the pancreas.
Mhux rakkomandat li ribavirin jittieħed ma ’ didanosine u / jew stavudine, peress li dan jista ’ jwassal għal akkumulazzjoni ta ’ aċidu lattiku u l- infjammazzjoni tal- frixa.
Any potential interactions with other medicines may continue for up to two months after the patient stops taking ribavirin.
Effetti potenzjali ma ’ mediċini oħra jistgħu jibqgħu sejrin għal xahrejn wara li l- pazjent jieqaf jieħu ribavirin.
Taking Ribavirin Teva with food and drink
Meta tieħu Ribavirin Teva mal- ikel u x- xorb
Ribavirin Teva must be taken with food
Ribavirin Teva għandu jittieħed mal- ikel
Ribavirin Teva must not be taken during pregnancy.
Ribavirin Teva m’ għandux jittieħed waqt it- tqala.
Ribavirin Teva must not be taken by women who are breast-feeding.
Ribavirin Teva m’ għandux jittieħed minn mara li qed tredda ’.
As noted in the “do not take” section, Ribavirin Teva can be very harmful to the unborn baby.
Kif ġie nnutat fis- sezzjoni “ Tieħux ”, Ribavirin Teva jista ’ jagħmel ħafna ħsara lit- tarbija mhix mwielda.
Extreme care should be taken to ensure that effective contraceptives (e.g. a condom) are used to ensure that female patients, or the partners of male patients, do not become pregnant.
Attenzjoni kbira trid tittieħed sabiex jiġi żgurat li kontraċettivi effettivi (eż. kondom) jintużaw sabiex jiġi żgurat li pazjenti nisa, jew l- imsieħba ta ’ pazjenti rġiel, ma jinqabdux tqal.
Females of childbearing age who are taking ribavirin should have a negative pregnancy test before treatment begins, and then every month during treatment, and for 4 months after treatment has stopped.
Nisa li għad jista ’ jkollhom it- tfal li qed jieħdu ribavirin għandu jkollhom jippreżentaw test negattiv qabel ma jibda t- trattament, u mbagħad kull xahar waqt it- trattament, u għal 4 xhur wara li t- trattament ikun waqaf.
Males who are taking ribavirin should not have unprotected sex.
L- irġiel li jkunu fuq ribavirin m’ għandhomx jagħmlu sess mingħajr protezzjoni.
As a precaution, if the female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment, and for 7 months after treatment has stopped.
Bħala prekawzjoni, jekk l- imsieħba mara mhix tqila imma hi ta ’ età li tista ’ tinqabad tqila, għandha tiġi ttestjata għat- tqala għal kull xahar waqt it- trattament, u għal 7 xhur wara li t- trattament ikun waqaf.
This can be discussed with a doctor (see “Do not take Ribavirin” section).
Dan jista ’ jiġi diskuss ma ’ tabib (ara s- sezzjoni “ Tieħux Ribavirin ”).
37 Driving and using machines
38 Sewqan u tħaddim ta ’ magni
Ribavirin Teva has no effect on your ability to drive or use machines.
Ribavirin Teva m’ għandux effett fuq il- ħila biex issuq jew tħaddem magni.
However, peginterferon alfa-2b or interferon alfa-2b may cause sleepiness, tiredness or confusion.
Madankollu, peginterferon alfa- 2b jew interferon alfa- 2b jista ’ jikkawża ħedla, għeja jew konfużjoni.
Do not drive or use any tools or machines if you feel tired or sleepy, or are confused.
M’ għandekx issuq jew tuża għodda jew inġenji jekk tħossok għajjien jew bi ngħas, jew inti konfuż.
HOW TO TAKE RIBAVIRIN TEVA
KIF GĦANDEK TIEĦU RIBAVIRIN
Always take Ribavirin Teva exactly as your doctor has told you.
Dejjem għandek tieħu Ribavirin Teva eżatt skont il- parir tat- tabib.
The dose of ribavirin given to you is determined by your doctor and is based on your weight.
Id- doża ta ’ ribavirin mogħtija lilek hija stabbilita mit- tabib tiegħek skont il- piż tal- ġisem.
This may be adjusted depending on the duration of the treatment and the response obtained.
Din tista ’ tiġi aġġustata skont it- tul tat - trattament u r- rispons miksub.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib tiegħek jekk ikollok xi dubju.
If you have or develop severe kidney or liver problems, the treatment will be stopped.
Jekk għandek jew tiżviluppa problemi fil- kliewi jew fil- fwied severi, it- trattament ser jitwaqqaf.
Ribavirin Teva should be used in combination with either pegioterferon alfa-2b (1.5 micrograms per kg each week) or interferon alfa-2b (3 million international units (MIU) three times a week, every other day.
Ribavirin Teva għandu jintuża flimkien ma ’ jew pegioterferon alfa- 2b (1. 5 mikrogrammi għal kull kg kull ġimgħa) jew interferon alfa- 2b (3 miljun unità internazzjonali (MIU) tliet darbiet fil- ġimgħa, darba iva u darba le.
Peginterferon alfa-2b and interferon alfa-2b are injected subcutaneously (under the skin).
Peginterferon alfa- 2b u interferon alfa- 2b jiġu injettati taħt il- ġilda.
Ribavirin Teva should be used in combination with interferon alfa-2b (3 million international units (MIU) per m2 body surface three times a week, every other day.
Ribavirin Teva għandu jintuża flimkien ma ’ interferon alfa- 2b (3 miljun unità internazzjonali (MIU) għal kull m2 ta ’ superfije korporali tliet darbiet fil- ġimgħa, darba iva u darba le.
Interferon alfa-2b is injected subcutaneously (under the skin).
Interferon alfa- 2b jiġi injettat taħt il- ġilda.
Ribavirin capsules should be taken orally twice a day with food, in the morning and evening.
Il- kapsuli Ribavirin għandhom jinbelgħu mill- ħalq dartejn kuljum mal- ikel, filgħodu u filgħaxija.
The actual number of capsules that should be taken per day will depend on the individual patient, and will be decided by the doctor or pharmacist, but as a guide, the usual dose will depend on your body weight as shown below:
In- numru reali ta ’ kapsuli li għandhom jittieħdu kuljum jiddependi mill- pazjent individwali, u jiġi deċiż mit- tabib jew spiżjar, imma bħala gwida, id- doża tiddependi skont il- piż tal- ġisem kif murija hawn isfel:
Patients body weight
Piż korporali tal- pazjent
Daily dosage 2 x 200 mg in morning,
Doża ta ’ kuljum 2 x 200 mg filgħodu,
2 x 200 mg in evening 2 x 200 mg in morning,
2 x 200 mg filgħaxija 2 x 200 mg filgħodu,
3 x 200 mg in evening 3 x 200 mg in morning,
3 x 200 mg filgħaxija 3 x 200 mg filgħodu,
– 105 kg
86 – 105 kg
4 x 200 mg in evening
4 x 200 mg filgħaxija
Children age 3 years old or over, and adolescents:
Tfal ta ’ 3 snin u fuqhom, u adoloxxenti:
Patients who weigh less than 47 kg should not take Ribavirin Capsules.
Pazjenti li jiżnu inqas minn 47 kg m’ għandhomx jieħdu il- Kapsuli Ribavirin.
Dosage instructions for children age three or over and adolescents is detailed below
Struzzjonijiet dwar id- doża għat- tfal li għandhom tliet snin jew aktar u adoloxxenti huma mogħtija hawn isfel:
body weight
Piż korporali tal- pazjent
Daily dosage 1 x 200 mg in morning,
Doża ta ’ kuljum 1 x 200 mg filgħodu,
2 x 200 mg in evening
2 x 200 mg filgħaxija
Refer to the adult dosage instructions
Irreferi għall- istruzzjonijiet dwar dożaġġi
38
39 tal- adulti
Duration of treatment in combination with pegylated interferon alfa-2b
Tul ta ’ żmien ta ’ trattament meta jingħata flimkien ma ’ interferon alfa- 2b pergilat
The treatment can last for between three months and one year, depending on how the patient responds to treatment.
It- trattament jista ’ jdum sejjer għal bejn tliet xhur u sena, skont kif jirrispondii l- pazjent għat - trattament.
For patients who are co-infected with HCV/HIV, then treatment will last for 48 weeks.
Għal pazjenti li huma infettati b’ HCV/ HIV, allura it- trattament idum sejjer għal 48 ġimgħa.
Duration of treatment in combination with interferon alfa-2b
Tul ta ’ żmien meta jingħata ma ’ interferon alfa- 2b
Adults, children aged three years and older and adolescents:
Adulti, tfal ta ’ tliet snin jew akbar u adoloxxenti:
The treatment will last for a minimum of six months, and can last for up to 1 year.
It- trattament idum sejjer għal mhux inqas minn sitt xhur, u jista ’ jieħu sa sena.
Dose modifications If patients suffer a severe reaction to taking Ribavirin Teva with either peginterferon alfa-2b or interferon alfa-2b, then it may be necessary to modify the dosage regimen of one or both of the products.
Modifikazzjonijiet tad- doża Jekk pazjenti ibatu minn reazzjoni severa meta jieħdu Ribavirin Teva ma ’ jew peginterferon alfa- 2b jew interferon alfa- 2b, allura jista ’ jkun meħtieġ li tinbidel id- doża ta ’ wieħed jew iż- żewġ prodotti.
The doctor will assess this for each individual patient.
It - tabib janalizza dan ma ’ kull pazjent individwali.
If you take more Ribavirin Teva than you should
Jekk tieħu Ribavirin Teva aktar milli suppost
Tell your doctor or pharmacist immediately
Għid lit- tabib jew spiżjar tiegħek minnufih
If you forget to take Ribavirin Teva
Jekk tinsa tieħu Ribavirin Teva
Take the missed dose as soon as possible during the same day.
Ħu d- doża li ma ħadtx kemm jista ’ jkun malajr matul l- istess jum.
Should you forget to take Ribavirin for a whole day, then consult your doctor or pharmacist for advise.
Jekk tinsa tieħu Ribavirin għal ġurnata sħiħa, ikkonsulta t- tabib jew l- ispiżjar tiegħek għal parir.
Do not take a double dose to make up for a forgotten dose
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you have any further questions on the use of this product, ask your doctor or pharmacist
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek
Please also read the “Possible side effects” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b
Jekk jogħġbok, ma ’ dan kun żgur li taqra s- sezzjoni “ Effetti sekodarji li jista ’ jkollu ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b
Like all medicines, Ribavirin Teva used in combination with an alpha interferon product can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ribavirin Teva meta tintuża f’ kombinazzjoni ma ’ peginterferon alfa- 2b jew interferon alfa- 2b jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You should consult your doctor immediately if any of the following side effects occur during treatment with Ribavirin and either peginterferon alfa-2b or interferon alfa-2b:
Għandek tikkonsulta lit- tabib tiegħek minnufih jekk xi wieħed minn dawn l- effetti sekondarji li ġejjin iseħħu waqt it- trattament b’ Ribavirin u jew peginterferon alfa- 2b jew interferon alfa- 2b:
Some people get depressed when taking ribavirin in combination treatment with an interferon, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi persuni jaqaw f’ dipressjoni meta jkunu qed jieħdu kura kombinata ta ’ ribavirin flimkien ma ’ interferon, u kien hemm każijiet ta ’ persuni li kellhom ħsibijiet ta ’ suwiċidju jew mġieba aggressiva (kultant kontra persuni oħra).
Some patients have actually committed suicide.
Xi pazjenti fil- fatt wettqu suwiċidju.
Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Aċċerta ruħek li tfittex kura ta ’ emerġenza jekk tinduna li qed taqa ’ f’ dipressjoni jew jekk ikollok ħsibijiet ta ’ suwiċidju jew qed tibdel l- imġieba tiegħek.
You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Jista ’ jkun li tikkonsidra lil xi membru tal- familja jew ħabib intimu biex jgħinek iżżomm għajnejk fuq sinjali ta ’ dipressjoni jew bidliet fl- imġieba.
Children are particularly prone to develop depression when being treated with Ribavirin Teva and interferon alpha.
It- tfal huma aktar predisposti li jiżviluppaw dipressjoni waqt it- trattament b’ Ribavirin u interferon alfa.
Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Agħmel kuntatt mat- tabib jew fittex trattament ta ’ emerġenza mill- aktar fis jekk ikollhom xi sintomi ta ’ mġieba mhux tas- soltu, iħossuhom dipressi, jew jekk tħoss li jridu jagħmlu ħsara lilhom nfushom.
39 Check with your doctor immediately if any of the following side effects occur during treatment with Ribavirin Teva in combination with an alpha interferon product: chest pain or persistent cough; changes in the way your heart beats; confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide, feelings of numbness or tingling, trouble sleeping, thinking or concentrating; severe stomach pain; black or tar-like stools; blood in stool or urine; severe bleeding from your nose; fever or chills beginning after a few weeks of treatment; lower back or side pain; painful or difficult urination; problems with your eyesight or hearing, severe skin rash or redness.
40 Iċċekkja mat- tabib tiegħek minnufih jekk xi waħda minn dawn l- effetti oħra jseħħu wat it- trattament b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b jew interferon alfa- 2b: uġigħ fis- sider jew sogħla persistenti; tibdil fil- mod kif tħaabbat il- qalb; konfużjoni, tħossok dipress; ħsibijiet ta ’ suwiċidju jew imġieba aggressiva, tentattiv ta ’ suwiċidju, tnemnim jew sensazzjoni ta ’ tingiż, problemi ta ’ rqad, issibha bi tqila biex taħseb jew tikkonċentra; uġigħ sever fl- istonku; ippurgar sewdieni jew qisu qatran; demm fl- ippurgar jew fl- awrina; tinfaraġ b’ mod qawwi; deni u sirdat li jibdew wara ftit ġimgħat minn meta bdejt il- kura; uġigħ fin- naħa t’ isfel tad- dahar jew fil- ġenbejn; uġigħ jew diffikultà biex tgħaddi l- awrina, problemi tal- vista jew tas- smigħ, raxx sever jew ħmura.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza tal- effetti sekondarji possibbli elenkati hawn isfel huma mfissra skont il- konvenzjoni li ġejja: komuni ħafna (jaffettwaw aktar minn persuna waħda f’ kull 10) komuni (jaffettwaw minn persuna 1 sa 10 f’ kull 100) mhux komuni (jaffettwaw minn persuna 1 sa 10 f’ kull 1, 000) rari (jaffettwaw minn persuna 1 sa 10 f’ kull 10, 000) rari ħafna (jaffettwaw inqas minn persuna 1 f’ 10, 000) mhux magħruf (frekwenza li ma tistax tiġi stabbilita mit- tagħrif disponibbli).
In adults taking ribavirin and an alpha interferon product:
F’ adulti li qed jieħdu Ribavirin jew ma ’ interferon alfa- 2b jew ma ’ peginterferon alfa- 2b:
- Viral infection
Infezzjoni virali
- Difficulty in swallowing accompanied by earache and swollen glands, sore throat, dry mouth,
- Diffiċli biex tibla ’ b’ uġigħ fil- widnejn u glandoli minfuħin, uġigħ fil- griżmejn, ħalq xott, sogħla,
cough, flu-like symptoms
sintomi bħal tal- influwenza
- Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
- Tnaqqis fl- għadd ta ’ ċelluli ħomor tad- demm li jista ’ jagħmel il- ġilda pallida u joħloq dgħufija
- Blood disorder which may be characterised by fever or chills, sore throat, ulcers in your mouth or
- Disturbi tad- demm li jistgħu jkunu karaterizzati b’ deni jew sirdat, uġigħ fil- griżmejn, ulċeri fil -
throat
ħalq jew fil- griżmejn
- Depression, difficulty in sleeping, mood swings, anxiety, tiredness, lethargy, irritability
- Dipressjoni, diffikultà biex torqod, bidliet fil- burdati, ansjetà, għeja, letarġija, irritabilità
- Headache, dizziness, impaired concentration, shaking
- Uġigħ ta ’ ras, sturdament, konċentrazzjoni indebolita, rogħda
- Loss of appetite, nausea, diarrhoea, abdominal pain, vomiting, weight loss
- Tnaqqis fl- aptit, tqalligħ, dijarea, uġigħ addominali, remettar, telf fil- piż
- Hair loss, itching, dry skin, rash
- Telf ta ’ xagħar, ħakk, ġilda xotta, raxx
- Pain in the muscles, joints or bones
- Uġigħ fil- muskoli, ġogi jew għadam
- Inflammation or reaction at the site of injection, fever
- Infjammazzjoni jew reazzjoni fis- sit tal- injezzjoni, deni
- Heart murmur, abnormal urine.
- Qalb tħaxwex, awrina abnormali.
- Faster heart beat, palpitation, breathing difficulties
- Qalb tħabbat aktar mgħaġġla, diffikultajiet biex tieħu n- nifs
- Decrease in normal amounts of different blood cells, which can result in increased risk of
- Tnaqqis fl- ammonti normali ta ’ ċelluli ta ’ demm differenti, li jista ’ jirriżulta f’ riskju ogħla ta ’
infections, bruising, bleeding, swollen glands
infezzjonijiet, tbenġil, emorraġija, glandoli minfuħin
- Unusual, increased or altered sensitivity to sensory stimulation, tingling or numbness feeling,
- Sensittività mhix tas- soltu, ogħla jew mibdula għal stumulazzjoni mis- sensi, tnemnim jew mewt,
distorted sense of taste, flushing (become very red in the face), sleepiness, fainting, a feeling of dizziness or “spinning”, migraine, increased muscle tension, difficulty in controlling movements, hoarseness
sens stort ta ’ togħma, fwawar (issir aħmar ħafna fil- wiċċ), ngħas, ħass ħażin, stordut jew tħoss “ rasek iddur ”, emigranja, żieda fit- tensjoni muskolari, diffikultà biex tikkontrolla ċ- ċaqlieq, ħanqaess
- Blurred vision, conjunctivitis, eye pain, swollen gland on the eyelids
- Vista mċajpra, konġuntivite, uġigħ fl- għajnejn, glandola minfuħa tal- kappell tal- għajn
- Loss/impairment of hearing, ringing in the ears, earache
- Telf/ indeboliment bies tisma ’, ċenċil fil- widnejn, uġigħ fil- widnejn
- Problems with your oral cavity, inflammation of the tongue, gums, mouth ulcers
- Problemi bil- kavità orali tiegħek, infjammazzjoni tal- ilsien, ġanek, ulċeri fil- ħalq
- Constipation, indigestion, bloating, pain on the right side around the ribs, inflammation which
- Stitikezza, indiġestjoni, nefħa, uġigħ fuq in- naħa leminija madwar il- kustilji, infjammazzjoni li
causes abdominal pain or diarrhoea
tikkawża uġigħ addominali jew dijarea
- Passing more urine than usual
- Tgħaddi aktar awrina min- normal
- Abnormal hair texture, sun allergy, eczema, increased sweating, red-purple swelling on the legs,
- Tessut mhux normali ta ’ xagħar, allerġija tax- xemx, ekżema, żieda fl- għaraq, nefħa ta ’ lewn
red rash, acne, dermatitis, psoriasis (patches of thickened and sore skin), skin disorders
ħamrani- vjola fir- riġlejn, raxx ħamrani, akne, dermatite, psorijasi (dbabar ta ’ ġilda ħoxna u bl- uġigħ), disturbi tal- ġilda
- Underactive thyroid gland which can cause tiredness or weight gain, overactive thyroid gland
- Glandola tat- tirojde anqas attiva milli suppost li tista ’ toħloq għeja jew żieda fil- piż, glandola
which can cause increased appetite, weight loss or sweating
tat- tirojde aktar attiva milli suppost li tista ’ tikkawża żieda fl- aptit, telf ta ’ piż jew għaraq
- Changes in different laboratory parameters, including increase in liver enzymes, renal parameters
- Tibdil f’ parametri tal- laboratorju differenti, li jinkludu enżimi tal- fwied, parametri tal- kliewi bħal
such as blood sugar, calcium and uric acid, dehydration, increased appetite, feeling thirsty
zokkor fid- demm, kalċju u aċidu uriku, diżidrazzjoni, żieda fl- aptit u tħossok bil- għatx
- Runny and itchy nose, wheezing, blocked nose, bleeding of the nose, cold sores, fungal infection,
- Imnieħer iqattar jew li trid tħokk, tħarħir, imnieħer imblukkat, l- imnieħer jinfaraġ, uġigħ
urinary tract infection, build up of fluid in the ear
minħabba l- kesħa, infezzjoni fungali, infezzjoni tal- passaġġ awrinarju, akkumulazzjoni ta ’ fluwidu fil- widnejn
- Tumour of unspecified nature
- Tumur ta ’ natura mhix speċifika
- Irregular blood pressure
- Pressjoni tad- demm irregolari
- General feeling of being unwell, chest pain, swelling of the ankles, pain at the site of injection
- Tħossok m’ intix f’ sikktek, uġigħ fis- sider, nefħa fl- għekiesi, uġigħ fis- sit mnejn ingħatat l -
- Enlarged liver, yellowing of the skin or whites of the eyes caused by liver or blood problems
injezzjoni
- Abnormal or painful menstruation, pain in the breasts, disorder of ovary or vagina, impotence,
- Fwied minfuh, sfurija tal- ġilda jew tal- abjad tal- għajnejn minħabba problemi tal- fwied jew
inflammation of the prostate
- Menstruwazzjoni abnormali jew bl- uġigħ, uġigħ fil- biżlejn, disturbi fl- ovarju jew fil- vaġina,
- Feeling agitated or nervous, aggressive behaviour, feelings of apathy, confusion, unusual dreams,
impotenza, infjammazzjoni tal- prostata Tħossok aġitat jew nervuż, mġieba aggressiva, tħossok b’ apatija, konfużjoni, ħolm mhux tas -
mental disorder, suicidal thoughts, abnormal crying, decreased sexual desire
soltu, disturbi mentali, ħsibijiet suwiċidali, biki mhux normali, tnaqqis fix- xewqat sesswali
The following side effects have been noticed with children and adolescents taking ribavirin and interferon alfa -2b
L- effetti sekondarji li ġejjin ġew innuttati fi tfal u adoloxxenti li qed jieħdu ribavirin u interferon alfa- 2b
- Viral infection
- Infezzjoni virali
- Difficulty in swallowing accompanied by earache and swollen glands, sore throat
- Diffikultà biex tibla ’ akkumpanjat b’ uġigħ fil- widnejn u glandoli minfuħin, uġigħ fil- griżmejn
- Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
- Tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm li jista ’ jagħmel il- ġilda pallida u joħloq dgħufija
- Blood disorder which may be characterised by fever or chills, sore throat, ulcers in your mouth or
- Disturbi tad- demm li jistgħu jkunu kkaraterizzati b’ deni jew sirdat, uġigħ fil- griżmejn, ulċeri
throat
f’ ħalqek jew fi griżmejk
- Underactive thyroid gland which can cause tiredness or weight gain
- Glandola tat- tirojde anqas attiva li tista ’ toħloq għeja jew żieda fil- piż
- Overactive thyroid gland has been reported commonly
- Glandola tat- tirojde aktar attiva ġiet rapportata b’ mod aktar ta ’ spiss
- Loss of appetite, nausea, diarrhoea, abdominal pain, vomiting
- Nuqqas t’ aptit, tqalligħ, dijarea, uġigħ addominali, remettar
- Depression, difficulty in sleeping, mood swings, tiredness, irritability, general feeling of being
Dipressjoni, diffikultà biex torqod, bidliet fil- burdati, għeja, irritabilità, tħossok m’ intix f’ siktek
- Headache, dizziness
- Uġigħ ta ’ ras, sturdament
- Hair loss, rash
- Telf ta ’ xagħar, raxx
- Pain in the muscles or joints
- Uġigħ fil- muskoli jew fil- ġogi
- Reaction or inflammation at the site of injection, fever
- Reazzjoni jew infjammazzjoni fis- sit tal- injezzjoni, deni
- Reduced increase in height or weight, compared to age.
- Tnaqqis f’ kemm jikber jew iżid fil- piż, meta mqabbel mal- età.