qanastek/EMEA-V3 huggingface dataset:
Rebetol can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur:
Rebetol jista ’ jagħmel ħafna ħsara lit- tarbija mhux imwielda, għalhekk kemm pazjenti nisa u kemm dawk irġiel għandhom jieħdu prekawzjonijiet speċjali fl- attività sesswali tagħhom jekk hemm xi ċans li t- tqala sseħħ.
- if you are pregnant you must not take Rebetol
- jekk inti ħriġt tqila m’ għandekx tieħu Rebetol.
- if you are a girl or a woman of childbearing age, you must have a negative pregnancy test
- jekk inti mara jew tifla fl- età li fiha jista ’ jkollok it- tfal, irid ikollok riżultat negattiv tat- test tat -
before treatment, each month during treatment, and for the 4 months after treatment is stopped.
tqala qabel tibda l- kura, kull xahar waqt li qed tieħu l- kura, u għal 4 xhur wara li l- kura titwaqqaf.
This c an be discussed with your doctor.
Dan jista ’ jkun diskuss mat- tabib tiegħek.
- if you are a man who is taking Rebetol, do not have sex with a pregnant woman unless you use
- jekk inti raġel li qed tieħu Rebetol, m’ għandekx ikollok x’ taqsam sesswalment ma ’ mara li
a condom.
ħarġet tqila ħlief jekk tuża kondom.
This will lessen the chance for ribavirin to be left in the woman’s body.
Dan inaqqas iċ- ċans li ribavirin jibqa ’ fil- ġisem tal- mara.
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy 53 each month during treatment and for the 7 months after treatment has stopped.
56 Jekk is- sieħba tiegħek mhijiex tqila bħal issa, imma hija f’ età li fiha jista ’ jkollha t- tfal, hi trid tkun ittestjata għat- tqala kull xahar waqt il- kura u għal 7 xhur wara li l- kura tkun waqfet.
If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment.
Jekk inti pazjent raġel, int u s- sieħba tiegħek għandkom it - tnejn tużaw kontraċettivi effettivi matul iż- żmien li int tkun qed tieħu Rebetol u għal 7 xhur wara li l- kura titwaqqaf.
This can be discussed with your doctor (see “Do not take Rebetol”).
(ara “ Tieħux Rebetol ”).
Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Fittex għajnuna medika minnufih jekk waqt li tkun qed tieħu din il- kura tiżviluppa sintomi ta ’ reazzjoni serja allerġika (bħal diffikultà biex tieħu n- nifs, tħarħir jew dbabar ta ’ l- allerġija).
Standard blood tests will be taken to check your blood, kidney, and liver function.
Testijiet tad- demm stàndard ser jittieħdu biex jiċċekkjaw id- demm, il- kliewi u l- funzjoni tal- fwied.
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 tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Rebetol and peginterferon alfa-2b or interferon alfa-2b combination therapy.
Mard tas- snien u tal- ħalq li minħabba fih jistgħu jaqgħu s- snien, kienu rrapurtati f’ pazjenti li kienu qed jirċievu terapija kombinata b’ Rebetol u peginterferon alfa- 2b jew interferon alfa- 2b.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara lis- snien u ’ l- membrani tal- mukoża fil- ħalq waqt kura kombinata fit - tul b’ Rebetol u peginterferon alfa- 2b jew interferon alfa- 2b.
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Il- pazjenti għandhom jaħslu snienhom sew darbtejn kuljum u jkollhom snienhom eżaminati b’ mod regolari.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Jekk jiġri hekk, għandhom ilaħalħu ħalqhom wara.
During the one year of treatment, many children did not grow or gain weight as much as expected.
Waqt kura ta ’ sena, tfal ma kibrux jew żiedu fil- piż 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 ta ’ wara l- kura, din it- tendenza fil- biċċa l- kbira ġiet imxejjna, għalkemm numru żgħir ta ’ tfal ma reġgħux lura għar- rata ta ’ tkabbir ta ’ qabel fi żmien sena wara li temmew il- kura.
Also, be sure to read the “Take special care” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Ma ’ dan, kun żgur li taqra is- sezzjoni “ Oqgħod attent ħafna ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b.
If you are also being treated for Human Immunodeficiency Virus (HIV) infection (AIDS) w ith zidovudine or stavudine, it is not certain if Rebetol will change the way these medicines work.
Jekk inti qed tkun ikkurat ukoll għall- infezjoni tal- Vajrus ta ’ l- Immunodefiċjenza Uman (HIV) (AIDS) b’ zidovudine u stavudine, m’ hemmx ċertezza jekk Rebetol ibiddilx il- mod ta ’ kif jaħdmu dawn il - mediċini.
Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Għalhekk, isiru testijiet tad- demm ta ’ sikwit biex ikun żgurat li l- infezzjoni ta ’ l- HIV mhix sejra għall- agħar.
If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Jekk tmur għall- agħar, it- tabib tiegħek għandu jiddeċiedi jekk il- kura b’ Rebetol hemmx bżonn tinbidel jew le.
Additionally, patients treated with ribavirin and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Minbarra hekk pazjenti kkurati b’ ribavirin u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija (numru baxx ta ’ ċelluli ħomor tad- demm).
Co-administration of Rebetol and didanosine and/or stavudine is not recommended due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis.
L- użu ta ’ Rebetol ma ’ didanosine u/ jew stavudine mhux ikkunsiljat minħabba r- riskju ta ’ aċidożi lattika (akkumulu ta ’ lactic acid fil- ġisem) u pankrejatite.
Also, be sure to read the “Taking other medicines” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Ma 'dan, kun żgur li taqra is- sezzjoni “ Użu ta ’ mediċini oħra ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b.
Taking Rebetol with food and drink Rebetol must be taken with food.
Meta tieħu Rebetol ma ’ l- ikel u max- xorb Rebetol għandu jittieħed ma ’ l- ikel.
Pregnancy and breast-feeding Rebetol must not be used by a girl or a woman who is pregnant (see “Take special care with Rebetol”).
Tqala u treddigħ Rebetol m’ għandux jintuża minn mara jew tfajla li ħarġet tqila (ara “ Oqgħod attent ħafna b’ Rebetol ”).
Rebetol must not be used by a woman who is breast-feeding a baby.
Rebetol m’ għandux jintuża minn mara li qed tredda ’ tarbija.
Discontinue breast-feeding before starting to take Rebetol.
Waqqaf it- treddigħ qabel tibda tieħu Rebetol.
Driving and using machines Rebetol does not affect your ability to drive or use machines; however, peginterferon alfa-2b or interferon alfa-2b may have an effect.
57 Sewqan u tħaddim ta ’ magni Rebetol ma jaffettwax il- ħila tiegħek biex issuq jew biex tħaddem magni; madankollu, peginterferon alfa- 2b jew interferon alfa- 2b jista ’ jkollhom effett.
Do not drive or use machines if you become tired from this treatment.
Issuqx jew tħaddimx magni jekk tgħejja minħabba din il- kura.
Important information about some of the ingredients of Rebetol 54 Each Rebetol capsule contains a small amount of lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rebetol Kull kapsula ta ’ Rebetol fiha ammont żgħir ta ’ lactose.
If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li jista ’ jkollok intolleranza għal xi tipi ta ’ zokkor, iddiskuti mat- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE REBETOL
KIF GĦANDEK TIEĦU REBETOL
Your doctor has determined the correct dose of Rebetol based on your weight.
It- tabib tiegħek iddetermina d- doża korretta ta ’ Rebetol bbażata fuq il- piż tiegħek.
Your doctor may adjust your dose and the length of time you take this treatment according to your response.
It- tabib tiegħek jista ’ jaġġusta d- doża u t- tul ta ’ żmien li matulu tieħu din il- kura skond ir- rispons tiegħek.
Blood tests will be done regularly to help your doctor to know if this treatment is working.
Testijiet tad- demm se jsiru regolarment biex jgħinu lit- tabib tiegħek isir jaf jekk din il- kura hijiex qed taħdem.
Depending upon the results of these tests, your doctor may change the number of capsules you take and prescribe a different pack size of Rebetol.
Mir- riżultati ta ’ dawn it- testijiet jiddependi jekk tabib tiegħek ibiddilx in- numru ta ’ kapsuli li tieħu jew jekk jippreskrivix qis ta ’ pakkett differenti ta ’ Rebetol.
If you have or develop severe kidney or liver problems, this treatment will be stopped.
Jekk int tiżviluppa problemi serji tal- kliewi jew tal- fwied, din il- kura ser titwaqqaf.
Rebetol hard capsules for oral use:
Kapsuli ibsin ta ’ Rebetol li jittieħdu mill- ħalq:
Adults who weigh
Adulti li jiżnu:
- less than 65 kg, the usual dose is 2 capsules in the morning and 2 capsules in the evening (total
- inqas minn 65 kg, id- doża tas- soltu hija ta ’ 2 kapsuli filgħodu u 2 kapsuli filgħaxija (total ta ’
of 800 mg each day);
800 mg kuljum);
- 65 kg to 85 kg, the usual dose is 2 capsules in the morning and 3 capsules in the evening (total
- 65 kg sa 85 kg, id- doża tas- soltu hija ta ’ 2 kapsuli filgħodu u 3 kapsuli filgħaxija (total ta ’
of 1,000 mg each day);
1, 000 mg kuljum);
- 86 kg to 105 kg, the usual dose is 3 capsules in the morning and 3 capsules in the evening (total
- 86 kg sa 105 kg, id- doża tas- soltu hija ta ’ 3 kapsuli filgħodu u 3 kapsuli filgħaxija (total ta ’
of 1,200 mg each day);
1, 200 mg kuljum);
- more than 105 kg, the usual dose is 3 capsules in the morning and 4 capsules in the evening
- aktar minn 105 kg, id- doża tas- soltu hija 3 kapsuli filgħodu u 4 kapsuli filgħaxija (total ta ’
(total of 1,400 mg each day).
1, 400 mg kuljum).
Children or adolescents who weigh
Tfal jew adolexxenti li jiżnu
- 47 to 49 kg, the usual dose is 1 capsule in the morning and 2 capsules in the evening (total of
- 47 sa 49 kg, id- doża tas- soltu hija kapsula 1 filgħodu u żewġ kapsuli filgħaxija (total ta ’ 600 mg
600 mg each day);
kuljum)
- 50 to 65 kg, the usual dose is 2 capsules in the morning and 2 capsules in the evening (total of
- 50 sa 65 kg, id- doża tas- soltu hija 2 kapsuli filgħodu u 2 kapsuli filgħaxija (total ta ’ 800 mg
800 mg each day);
kuljum)
- more than 65 kg: see adult dose.
- aktar minn 65 kg: ara d- doża ta ’ l- adulti.
Take your prescribed dose by mouth with water and during your meal.
Ibla ’ d- doża li ordnawlek ma ’ l- ilma u waqt l- ikel.
Do not chew the capsules.
Tomgħodx il- kapsuli.
For children or adolescents who cannot swallow a capsule, an oral solution of ribavirin is available.
Għal tfal u adolexxenti li ma jistgħux jibilgħu kapsula, hemm soluzzjoni orali ta ’ ribavirin.
Rebetol is used in combination with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children and adolescents).
Rebetol huwa użat flimkien ma ’ peginterferon alfa- 2b (adulti) jew interferon alfa- 2b (adulti, tfal u adolexxenti).
For complete information be sure to read the “How to take” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Għat- tagħrif kollu kun żgur li taqra s- sezzjoni “ Kif għandek tieħu ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b.
The usual dose is 1.5 microgram/kg once a week, injected subcutaneously (under the skin).
Id- doża tas- soltu hija ta’ 1. 5 mikrogrammi/ kg darba f’ ġimgħa, injettata taħt il - ġilda.
In terferon alfa-2b for subcutaneous use:
Interferon alfa- 2b għall- użu taħt il- ġilda:
The usual dose in adults is 3 million International Units (IU) three times a week, every other day, injected subcutaneously (under the skin).
Id- doża tas- soltu għall- adulti hija ta ’ 3 miljun Unitajiet Internazzjonali (IU) tliet darbiet f’ ġimgħa, darba iva u darba le, injettata taħt il- ġilda.
In children and adolescents, the usual dose is 3 million IU/m2 three times a week, every other day, injected subcutaneously (under the skin).
Fi tfal u adolexxenti, id- doża tas- soltu hija 3 miljun IU/ m2 tliet darbiet fil- ġimgħa, darba iva u darba le, injettati taħt il- ġilda.
One dose of interferon alfa-2b is given on each scheduled day.
Doża waħda ta ’ interferon alfa- 2b hija mogħtija kull ġurnata skedata.
It is given three times a week, every other day; for example, on Monday, Wednesday and Friday.
Hija mogħtija tliet darbiet f’ ġimgħa, darba iva u darba le; per eżempju, nhar ta ’ Tnejn, l- Erbgħa u l- Ġimgħa.
Interferons may cause unusual tiredness; if you are injecting this medicine yourself, use it at bedtime.
Interferons jistgħu jikkawżaw għeja mhux tas- soltu; jekk qed tinjetta din il- mediċina inti stess, użaha fil- ħin ta ’ l- irqad.
Rebetol in combination therapy with peginterferon alfa-2b or interferon alfa-2b is administered for 3 to 6 months, and sometimes for one year depending on your physician’s judgement.
58 It- terapija b’ Rebetol ikkombinat ma ’ peginterferon alfa- 2b jew interferon alfa- 2b tingħata għal perijodu ta ’ bejn 3 u 6 xhur, u kultant għal sena, skond il- ġudizzju tat- tabib tiegħek.
For HCV/HIV co- infected patients, the duration of treatment of Rebetol in combination with peginterferon alfa-2b is 48 weeks.
Għall- pazjenti ko - infettati b’ HCV/ HIV, it- terapija ikkombinata ta ’ Rebetol ma ’ peginterferon alfa- 2b għandha tingħata għal 48 ġimgħa.
55 Always take Rebetol exactly as your doctor has told you.
Dejjem għandek tieħu Rebetol skond il- parir eżatt tat- tabib.
Do not take more than the recommended dosage and take the medicine for as long as prescribed.
M’ għandekx tieħu aktar mid- dożaġġ ikkunsiljat u ħu l- mediċina tiegħek għal perijodu li ordnawlek.
If you take more Rebetol th an you should Tell your doctor or pharmacist as soon as possible.
Jekk tieħu Rebetol aktar milli suppost Għid lit- tabib jew lill- ispiżjar tiegħek malajr kemm jista ’ jkun.
If you forget to take Rebetol Take the missed dose as soon as possible during the same day.
Jekk tinsa tieħu Rebetol Ħu d- doża li insejt kemm jista ’ jkun malajr fl- istess ġurnata.
If an entire day has gone by, check with your doctor.
Jekk tgħaddi ġurnata sħiħa, iċċekkja mat - tabib tiegħek.
Also, be sure to read the “Possible side effects” section of the Package Leaflet for peginterferon alfa- 2b or interferon alfa-2b.
Ma 'dan, kun żgur li taqra s- sezzjoni “ Effetti sekondarji li jista ’ jkollu ” tal- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b.
Like all medicines, Rebetol used in combination with an alpha interferon product can cause side effects, although not everybody gets them.
Bħal kull mediċini oħra, Rebetol użat flimkien ma ’ prodott alfa interferon jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Għalkemm mhux l- effetti kollha mhux mixtieqa għandhom mnejn iseħħu, jekk iseħħu dawn jista ’ jkollhom bżonn attenzjoni medika.
Some people get depressed when taking Rebetol in combination treatment with an interferon, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies jaqaw f’ dipressjoni meta jkunu fuq kura kombinata ta ’ Rebetol ma ’ xi interferon, u kien hemm xi każijiet ta ’ nies li kellhom ħsibijiet ta ’ suwiċidju jew imġieba aggressiva (kultant kontra nies oħra).
Some patients have actually committed suicide.
Xi pazjenti fil- fatt qatlu ruħhom b’ idejhom.
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 tinnota li qed taqa ’ f’ dipressjoni jew jekk qed tgħamel 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 ssaqsi xi membru tal- familja jew ħabib intimu biex jgħinek iżżomm għajnejk fuq sinjali ta ’ dipressjoni jew bidliet fl- imġieba
Use in children:
L- użu fit- tfal:
Children are particularly prone to develop depression when being treated with Rebetol and interferon alpha.
It- tfal huma aktar pridisposti li jiżviluppaw dipressjoni waqt il- kura b’ Rebetol 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.
Għamel kuntatt mat- tabib jew fittex kura ta ’ emerġenza mill- ewwel jekk ikollhom xi sintomi ta ’ mġieba mhux tas- soltu, iħossuhom dipressi, jew jekk tħoss li jridu jgħamlu ħsara lilhom infushom.
Check with your doctor immediately if any of the following side effects occur during treatment with Rebetol 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.
Iċċekkja mat- tabib tiegħek minnufih jekk xi waħda minn dawn l- effetti oħra jseħħu waqt il- kura b’ Rebetol flimkien ma ’ prodott alfa interferon: uġigħ tas- sider jew sogħla persistenti; tibdil fit- taħbit tal- qalb; konfużjoni, tħossok dipress; ħsibijiet ta ’ suwiċidju jew imġieba aggressiva, attentat ta ’ suwiċidju, tnemnim jew sensazzjoni ta ’ tingiż; problemi ta ’ l- irqad, issibha bi tqila biex taħseb jew tikkonċentra; uġigħ sever fl- istonku; ippurgar iswed jew qisu qatran; demm fil- purgar jew fl- awrina; tinfaraġ ħafna; ikollok deni jew dehxiet li jibdew wara ftit ġimgħat minn meta bdiet 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.
The following side effects have occurred with the combination of Rebetol capsules and an alpha interferon product in adults:
Dawn l- effetti li ġejjin seħħew b’ kombinazzjoni ta ’ kapsuli Rebetol u prodott alfa interferon:
Very commonly reported side effects (at least 1 in every 10 patients): irritation or redness at the site of injection, headache, tired feeling, shaking chills, fever, flu-like symptoms, cough, weakness, loss of weight, dizziness, nausea, loss of appetite, diarrhoea, stomach pain, vomiting, dry mouth, muscle aches, pain in joints and muscles, feeling depressed or irritable, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, virus infection, hair loss, itching, dry skin, rash, pharyngitis (sore throat), shortness of breath, and decreases in the number of red blood cells or certain white blood cells called neutrophils that fight infection.
Effetti sekondarji li kienu rrapurtati komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti): irritazzjoni jew ħmura fis- sit ta ’ l- injezzjoni, uġigħ ta ’ ras, tħossok għajjien, dehxiet bi tregħid, deni, sintomi bħal ta ’ l- influwenza, sogħla, dgħjufija, tnaqqis fil- piż, sturdament, dardir, nuqqas t’ aptit, dijarea, uġigħ fl- istonku, rimettar, ħalq xott, weġgħat tal- muskoli, uġigħ fil- ġogi u fil- muskoli, tħossok dipress jew irritabili, problemi biex torqod jew biex tibqa ’ rieqed, tħossok anzjuż jew nervuż, tbati
Commonly reported side effects (at least 1 in every 100 patients, but less than 1 in every 10 patients): pain at the place of injection, increased sweating, flushing, feeling unwell, chest pain, rapid heart rate, low or high blood pressure, palpitations (pounding heart beat), puffy or swollen hands and ankles,
59 biex tikkonċentra, tibdil fil- burdati, infezzjoni virali, telf ta ’ xagħar, ħakk tal- ġilda, ġilda xotta, raxx, farinġite (grieżem misluħa), qtugħ ta ’ nifs, u tnaqqis fin- numru ta ’ ċelluli ħomor tad- demm jew ċerti ċelluli bojod li jissejħu newtrofili li jiġġieldu l- infezzjoni.
The following side effects have occurred with the combination of Rebetol and interferon alfa-2b in children and adolescents:
L- effetti sekondarji li ġejjin seħħew bil- kombinazzjoni ta ’ Rebetol u interferon alfa- 2b fi tfal u adolexxenti:
Very commonly reported side effects (at least 1 in every 10 patients): irritation or redness at the site of injection, headache, tired feeling, shaking chills, fever, flu-like symptoms, dizziness, nausea, loss of appetite, diarrhoea, stomach pain, vomiting, muscle aches, pain in joints and muscles, feeling depressed or irritable, trouble falling asleep or staying asleep, mood swings, virus infection, hair loss, rash, pharyngitis (sore throat), decreases in the number of red blood cells or certain white blood cells called neutrophils that fight infection, change in thyroid gland activity (which may make you feel tired or, less commonly, energetic), feeling unwell, and decrease in their rate of growth (height and weight).
Effetti rrappurtati komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti): irritazzjoni jew ħmura fis- sit mnejn tingħata l- injezzjoni, uġigħ ta ’ ras, sensazzjoni ta ’ għeja, dehxiet ta ’ bard, deni, sintomi bħal ta ’ l- influwenza, sturdament, dardir, nuqqas ta ’ aptit, dijarea, uġigħ fl - istonku, rimettar, weġgħat fil- muskoli, uġigħ fil- ġogi u l- muskoli, tħossok depress jew irritabbli, tbati biex torqod jew biex tibqa rieqed, tibdil fil- burdati, infezzjoni b’ virus, telf tax- xagħar, raxx, farinġite (grieżem misluħa), tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm jew f’ ċerti ċelluli bojod tad- demm imsejħa newtrofili li jiġġieldu l- infezzjoni, tibdil fl- attività tal- glandola tat- tirojde (li tista ’ tgħamlek tħossok għajjien jew, b’ mod anqas komuni, aktar enerġetiku), tħossok ma tiflaħx, u tnaqqis fir- rata ta ’ tkabbir tagħhom (tul jew piż).
The attempt to harm yourself has also been reported in adults, children, and adolescents.
L- attentat li tgħamel ħsara lilek innifsek kien rappurtat ukoll fl- adulti, tfal u adolexxenti.
Rebetol in combination with alpha interferon product may also cause:
Rebetol f’ kombinazzjoni ma ’ prodott alfa interferon jista ’ jikkawża wkoll:
57 Aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy, seizure (convulsions), inflammation of the pancreas, severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin), and delusions.
Anemija aplastika, aplażja pura taċ- ċelluli ħomor( kundizzjoni fejn il- ġisem waqaf jew naqqas il - produzzjoni ta ’ ċelluli ħomor tad- demm); dan jikkawża anemija severa, li s- sintomi tagħha jinkludu għeja mhux tas- soltu u nuqqas ta ’ enerġija) attakki ta ’ puplesija (aċċessjonijiet), infjammazzjoni tal - frixa, raxxijiet severi li jistgħu jkunu assoċjati ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn jew membrani mukużi oħrajn (erythema multiforme, sindrome ta ’ Stevens Johnson), nekroliżi tossika tal- ġilda (bżieżaq u tqaxxir tas- saff ta ’ fuq tal- ġilda), u delużjonijiet.
Intense pain in an appendage, loss of range of motion, stiffness, abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation, leg or thigh pain, constant cough, trouble having bowel movement or painful bowel movement, bruises, heartburn, enlarged abdominal area, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported.
Uġigħ qawwi f’ xi appendiċi, il- medda tal- moviment tonqos, ebusija, ħsibijiet anormali, tisma ’ jew tara affarijiet li ma jeżistux, stat mentali mibdul, disorjentament, uġigħ fir- riġlejn jew koxxtejn, sogħla kontinwa, problemi biex tipporga jew tbatija biex tipporga, tbenġil, ħruq ta ’ stonku, żona addominali tikber, reazzjonijiet ta ’ sensittività eċċessiva akuta inkluża urtikarja (ħorriqija), anġjo- edema (nefħa ta ’ l- idejn, saqajn, għekiesi, wiċċ, xofftejn, ħalq, jew il- gerżuma li tista ’ ġġib diffikultà biex tibla ’ jew tieħu n- nifs), jingħalqu l- bronki, u anafilassi (reazzjoni allerġika severa, tal- ġisem kollu) kienu irrappurtati.
Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported.
Minbarra hekk, sindrome ta ’ Vogt- Koyanagi- Harada (disturb awto- immunitarju infjammatorju li taffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, il- moħħ u s- sinsla) kienu rrappurtati.
Sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
Sarkojdożi, (marda karatterizzata b’ deni persistenti, telf tal- piż, uġigħ fil- ġogi u nefħa, leżjoni tal- ġilda u glandoli minfuħin) kienu rrappurtati.
Cases of stroke (cerebrovascular events) have been reported.
Każijiet ta ’ puplesija (komplikazzjoni ċerebrovaskulari) kienu rrappurtati.
Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, loss of consciousness, loss of vision, difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain, dark, cloudy or abnormally coloured urine.
Rebetol flimkien ma ’ peġinterferon alfa jew interferon alfa- 2b jista ’ jikkawża wkoll: telf ta ’ l- użu tal- muskoli u għalhekk togħtor jew titlef is- saħħa tal- muskoli tal- wiċċ, titlef is - sensazzjoni li tħoss, tintilef minn- sensik, titlef il- vista, tbati biex tieħu n- nifs, tibdil fil- mod kif tħabbat qalbek, uġigħ f’ sidrek, uġigħ li jinżel ma ’ dirgħajk ix- xellugija, uġigħ fil- mandibola, awrina skura, imdarda jew ta ’ lewn mhux normali.
You or your caregiver should call your doctor immediately if you have any of these symptoms.
Int jew min jieħu ħsieb il- kura ta ’ saħħtek għandu jċempel minnufih jekk tintebah bi kwalunkwe minn dawn is- sintomi.
Diabetes and pneumonia have been reported rarely.
Dijabete u pnewmonja kienu rrappurtati rari.
Suicide has been reported very rarely.
Suwiċidju kien irrappurtat rari ħafna.
If you are receiving HAART, the addition of Rebetol and peginterferon alfa-2b may increase your risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Jekk qed tirċievi kura b’ HAART, iż- żieda ta ’ Rebetol u peginterferon alfa- 2b jista ’ jżid ir- riskju ta ’ aċidożi lattika, insuffiċjenza tal- fwied, u żvilupp ta ’ anormalitajiet tad- demm (tnaqqis fin- numru ta ’ ċelluli ħomor tad- demm li jġorru l- oxygen, ċerti ċelluli bojod tad- demm li jiġġieldu l- infezzjoni, u ċelluli li jgħinu d- demm biex jagħqad li jissejħu plejtlits).
Oral candidiasis (oral thrush), defective metabolism of fat, CD4 lymphocytes decreased, appetite decreased, back pain, hepatitis, limb pain and various laboratory blood values abnormalities.
L- effetti sekondarji li ġejjin (mhux elenkati hawn fuq) seħħew bil- kombinazzjoni ta ’ kapsuli Rebetol u peginterferon alfa- 2b (adulti) f’ pazjenti ko- infettati b’ HCV/ HIV li kienu qed jirċievu HAART: kandidijasi orali (traxx orali), metaboliżmu tax- xaħam difettuż, tnaqqis fil- limfoċiti CD4, tnaqqis fl - aptit, uġigħ fid- dahar, epatite, uġigħ fir- riġlejn jew driegħ, u anormalitajiet tal- valuri tad- demm varji tal- laboratorju.
HOW TO STORE REBETOL
KIF TAĦŻEN REBETOL
Do not use Rebetol after the expiry date which is stated on the carton.
Tużax Rebetol wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Do not use Rebetol without advice of your doctor or pharmacist if you notice any change in the appearance of the capsules.
Tużax Rebetol mingħajr il- parir tat- tabib jew l- ispiżjar tiegħek jekk tinnota xi tibdil fid- dehra tal - kapsuli.
What Rebetol contains
X’ fih Rebetol
- The active substance is ribavirin 200 mg.
- Is- sustanza attiva hi ribavirin 200 mg
- The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose
- Is- sustanzi l- oħra huma microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
sodium, magnesium stearate.
magnesium stearate.
The capsule shell contains gelatine, titanium dioxide.
Il- qoxra tal- kapsula fiha gelatine, titanium dioxide.
The capsule shell imprint contains shellac, propylene glycol, ammonium hydroxide, colouring agent (E 132).
It- timbru tal- qoxra tal - kapsula fih shellac, propylene glycol, ammonium hydroxide, colouring agent (E 132).
What Rebetol looks like and contents of the pack
Id- Dehra ta Rebetol u l- kontenuti tal- pakkett
Rebetol is a white, opaque, hard capsule imprinted with blue ink.
Rebetol huwa kapsula bajda, opaka, iebsa ttimbrata b’ linka ċelesti.
Rebetol is available in different pack sizes containing 84, 112, 140 or 168 capsules of 200 mg to be swallowed.
Rebetol jiġi f’ pakketti ta ’ qisien differenti li jkun fihom 84, 112, 140 jew 168 kapsuli ta ’ 200 mg li għandhom jinbelgħu.
Your physician will prescribe the pack size which is best for you.
It- tabib tiegħek ser jordnalek il- pakkett tad- daqs li jgħodd għalik.
2 BG-София 1407 Тел.: +359 2 806 301
2 BG- София 1407
8, sector 1 RO-013682 Bucureşti Tel. + 40 21 233 35 30
8, sector 1 F- 92300 Levallois- Perret RO- 013682 Bucureşti Tél: + 33 - (0) 1 41 06 35 00 Tel. + 40 21 233 35 30
Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: +357-22 757188
63 Κύπρος Οδός Αγίου Νικολάου, 8 CY- 1055 Λευκωσία Τηλ: +357- 22 757188
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
60 PACKAGE LEAFLET:
64 FULJETT TA ’ TAGĦRIF:
This Package Leaflet contains information for the patient child or adolescent, 3 through 17 years of age, or for his or her parent or caregiver.
Dan il- Fuljett ta ’ Tagħrif fih informazzjoni dwar pazjenti tfal u adolexxenti, minn 3 sa 17- il sena, għal ġenitur tiegħu jew tagħha jew min qed jieħu ħsieb il- kura.
Combining Rebetol and interferon alfa-2b has been shown to be a more effective treatment for hepatitis C virus infection than interferon alfa-2b alone.
Intwera li meta Rebetol u interferon alfa- 2b jingħataw b’ mod kombinat, jipprovdu kura aktar effettiva għall- infezzjoni virali ta ’ l- epatite C minn interferon alfa- 2b waħdu.
In children 3 years of age and older who have previously untreated chronic hepatitis C, Rebetol is used in combination with interferon alfa-2b for injection.
Fi tfal ta ’ 3 snin jew akbar li kellhom qabel epatite C kronika li ma kienetx kurata, Rebetol jintuża kombinat ma ’ interferon alfa- 2b għall- injezzjoni.
Rebetol 40 mg/ml oral solution is intended for use in children.
Is- soluzzjoni orali Rebetol 40 mg/ ml hija mgħamula għall- użu fit- tfal.
- You or the child you are caring for may need to have kidney tests before starting treatment,
- Int jew it- tifel/ tifla li qed tieħu ħsieb għandu mnejn ikollok bżonn jagħmlu test tal- kliewi qabel
especially if there are problems with the kidneys.
tibda l- kura, speċjalment jekk għandhom problemi tal- kliewi.
- Rebetol is not recommended for use in patients under 3 years of age.
- Rebetol mhux irrikkmandat għall- użu fi tfal taħt it- 3 snin.
- Tell your doctor if you (or the child you are caring for) have or have had any serious illness.
- Għid lit- tabib tiegħek jekk inti (jew it- tifel/ tifla li qed tieħu ħsieb) għandhom jew kellhom xi
Perhaps Rebetol treatment will not be suitable for you.
Għandu mnejn li l- kura b ’ Rebetol ma tkunx tgħodd għalik/ hom.
- Tell your doctor if you (or the child you are caring for) ever had a heart attack or a heart
- Għid lit- tabib tiegħek jekk inti (jew it- tifel/ tifla li qed tieħu ħsieb) qatt kellhom xi attakk tal- qalb
problem, severe liver diseases excluding chronic hepatitis C, thyroid problems; if you (or the child you are caring for) have ever been treated for depression or any other psychiatric disorder, confusion, unconsciousness, or have had thoughts of suicide or have attempted suicide.
jew xi problema tal- qalb, mard serju tal- fwied minbarra l- epatite C kronika, problemi tat- tirojde; jekk xi darba ngħatat (lilek jew lit- tifel/ tifla li qed tieħu ħsieb) kura għad- dipressjoni jew xi mard psikjatriku ieħor, konfużjoni, intlift minn sensik, jew jekk kellek ħsibijiet ta ’ suwiċidju jew jekk ippruvajt tagħmel suwiċidju.
Be sure to read the Package Leaflet for interferon alfa -2b before you begin treatment with Rebetol and interferon alfa-2b.
Kun żgur li taqra l- Fuljett ta ’ Tagħrif għal interferon alfa- 2b qabel tibda l- kura b’ Rebetol u interferon alfa- 2b.
Do not take Rebetol if you or the child you are caring for
Tieħux Rebetol jekk int jew it- tifel/ tifla li qed tieħu ħsieb
- are allergic (hypersensitive) to ribavirin or any of the other ingredients of Rebetol.
- allerġiku/ a (tbati minn sensittività eċċessiva) għal ribavirin jew sustanzi oħra ta ’ Rebetol.
- are pregnant or planning to become pregnant.
- ħriġt tqila jew jekk qed tippjana li toħroġ tqila.
Rebetol can cause harm to the unborn child if a
Rebetol jista ’ jikkaġuna ħsara lit- tarbija mhux
pregnant woman takes Rebetol herself during pregnancy or has unprotected sex (sex without using a condom) with a man who is taking Rebetol.
imwielda jekk mara tqila tieħu Rebetol waqt it- tqala jew ikollha x’ taqsam sesswalment mingħajr protezzjoni (sess mingħajr ma ’ tuża l- kondom) ma ’ raġel li qed jieħu Rebetol.
Therefore, if you are a female patient, girl or a woman of childbearing age, it is very important to avoid becoming pregnant during treatment and during the 4 months after treatment.
Għalhekk, jekk inti pazjenta mara jew tfala li jista ’ toħroġ tqila, huwa importanti ħafna li tevita li toħroġ tqila waqt il- kura u fl- 4 xhur ta ’ wara l- kura.
- are breast-feeding.
- jekk qed tredda ’.
- had a problem with your heart during the past six months or any previous serious heart
- jekk hemm xi problema tal- qalb fl- aħħar sitt xhur jew xi kundizzjoni serja tal- qalb qabel.
- have severe medic al conditions that leave you very weak, including severe kidney disease.
- jekk hemm xi kundizzjoni medika serja li tħallik dgħajjef ħafna, li tinkludi mard serju tal -
- have a serious problem with your liver other than chronic hepatitis C.
- jekk hemm xi problema serja tal- kliewi minbarra l- epatite C kronika.
- have a blood disorder, including anaemia (low number of red blood cells), thalassemia
- jekk hemm xi mard tad- demm, inkluża l- anemija (għadd baxx ta ’ ċelluli ħomor tad- demm),
(Mediterranean anaemia), sickle -cell anaemia.
talessimja (anemija Mediterranja), anemija tat tip sickle- cell.
- had serious nervous or mental problems, such as severe depression or thoughts of suicide.
- kien hemm problemi serji tan- nervi jew mentali, bħall dipressjoni jew ħsibijiet ta ’ suwiċidju.
- have autoimmune hepatitis or any other problem with your immune system; if you are taking
- jekk hemm epatite awtoimmuni jew xi problema oħra tas- sistema immunitarja; jekk qed tieħu
medicine that suppresses your immune system (Your immune system protects you against infection and some diseases).
(Is- sistema immunitarja tiegħek tipproteġik kontra l- infezzjoni u xi mard).
Also, be sure to read the “Do not take” section of the Package Leaflet for interferon alfa-2b.
Barra ’ dan il- fuljett, kun żgur li taqra is- sezzjoni “ Tieħux ” tal- Fuljett ta ’ Tagħrif għall- interferon alfa - 2b.
- if you are a girl or woman of childbearing age, you must have a negative pregnancy test before
- jekk inti mara jew tifla fl- età li fiha jista ’ jkollok it- tfal, irid ikollok riżultat negattiv tat- test tat -
treatment, each month during treatment, and for the 4 months after treatment is stopped.
tqala qabel tibda l- kura, kull xahar waqt li qed tieħu l- kura, u għal 4 xhur wara li l- kura titwaqqaf.
- if you are a male who is taking Rebetol, do not have sex with a pregnant girl or woman unless
- jekk inti raġel li qed tieħu Rebetol, m’ għandekx ikollok x’ taqsam sesswalment ma ’ mara li
you use a condom.
ħarġet tqila ħlief jekk tuża kondom.
This will lessen the chance for ribavirin to be left in her body.
Dan inaqqas iċ- ċans li ribavirin jibqa ’ fil- ġisem tal- mara.
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Jekk is- sieħba tiegħek mhijiex tqila bħal issa, imma hija f’ età li fiha jista ’ jkollha t- tfal, hi trid tkun ittestjata għat- tqala kull xahar waqt il- kura u għal 7 xhur wara li l- kura tkun waqfet.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Rebetol and interferon alfa-2b combination therapy.
66 Mard tas- snien u tal- ħalq li minħabba fihom jistgħu jaqaw is- snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu terapija kombinata b’ Rebetol u interferon alfa- 2b.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Rebetol and interferon alfa-2b.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara lis- snien u ’ l- membrani tal- mukoża fil- ħalq waqt kura kombinata fit- tul b’ Rebetol u interferon alfa- 2b.
You should brush your teeth thoroughly twice daily and have regular
Il- pazjenti għandhom jaħslu snienhom sew darbtejn kuljum u jkollhom snienhom eżaminati b’ mod regolari.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Jekk jiġri hekk, għandhom jiġu kunsiljati sabiex jaħslu ħalqhom wara.
Also, be sure to read the “Take special care” section of the Package Leaflet for interferon alfa-2b.
Ma ’ dan, kun żgur li taqra is- sezzjoni “ Oqgħod attent ħafna ” tal- Fuljett ta ’ Tagħrif għal interferon alfa- 2b.
Additionally, patients treated with ribavirin and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Minbarra hekk pazjenti kurati b’ ribavirin u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija (numru baxx ta ’ ċelluli ħomor tad- demm).
Also, be sure to read the “Taking other medicines” section of the Package Leaflet for interferon alfa- 2b.
Ma 'dan, kun żgur li taqra is- sezzjoni “ Użu ta ’ mediċini oħra ” tal- Fuljett ta ’ Tagħrif għal interferon alfa- 2b.
Pregnancy and breast-feeding Rebetol must not be used by a girl or woman who is pregnant (see “Take special care with Rebetol”).
(ara “ Oqgħod attent ħafna b’ Rebetol ”).
Rebetol must not be used by a female who is breast-feeding a baby.
Rebetol m’ għandux jintuża minn mara li qed tredda ’ tarbija.
Driving and using machines Rebetol does not affect your ability to drive or use machines; however, interferon alfa-2b may have an effect.
Sewqan u tħaddim ta ’ magni Rebetol ma jaffettwax il- ħila tiegħek biex issuq jew biex tħaddem magni; madankollu, interferon alfa - 2b jista ’ jkollhom effett.
Important information about some of the ingredients of Rebetol 40 mg/ml oral solution This medicinal product contains sucrose and sorbitol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rebetol Dan il- prodott mediċinali fih sucrose u sorbitol.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li jista ’ jkollok intolleranza għal xi tipi ta ’ zokkor, iddiskuti mat- tabib tiegħek qabel ma tieħu din il- mediċina.
Your doctor has determined the correct dose of Rebetol for you or the child you are caring for based on body weight.
It- tabib tiegħek iddetermina d- doża korretta ta ’ Rebetol għalik jew għat- tifel/ tifla li qed tieħu ħsieb ibbażata fuq il- piż tal- ġisem.
Your doctor may adjust the dose and the length of time to take this treatment according to the response.
It- tabib tiegħek jista ’ jaġġusta d- doża u t- tul ta ’ żmien li matulu tieħu din il- kura skond ir- rispons tiegħek.
Blood tests will be done regularly to help the doctor to know if this treatment is working.
Testijiet tad- demm se jsiru regolarment biex jgħinu lit- tabib tiegħek isir jaf jekk din il- kura hijiex qed taħdem.
Depending upon the results of these tests, your doctor may change the dose to be taken.
Mir- riżultati ta ’ dawn it- testijiet jiddependi jekk tabib tiegħek ibiddilx id- doża li jkollok tieħu.
If severe kidney or liver problems develop, this treatment will be stopped.
67 Jekk int tiżviluppa problemi serji tal- kliewi jew tal- fwied, din il- kura ser titwaqqaf.
Rebetol oral solution:
Rebetol soluzzjoni orali:
If you are giving this medicine to a child, the doctor will tell you how much to give for each dose.
Jekk qed tagħti din il- mediċina lil tifel jew tifla, it- tabib ser jgħidlek kemm għandek tagħti għal kull doża.
The usual dose, according to how much the patient weighs, is shown in the table below.
Id- doża tas- soltu, skond kemm jiżen il- pazjent, qed tidher fit- tabella hawn taħt.
63 To use this table, look for the line that shows how much the patient weighs.
Biex tuża din it- tabella, sib il- linja li turi kemm jiżen il- pazjent.
Then read across on the same line to see the how much to measure for the usual morning and evening doses.
Imbagħad aqra ma ’ l- istess linja kemm għandek tkejjel għad- dożi tas- soltu filgħodu u filgħaxija.
If your doctor’s instructions are different from the amounts on the table, follow your doctor’s instructions.
Jekk l- istruzzjonijiet tat- tabib tiegħek huma differenti minn dawk li jidhru fit- tabella, imxi ma ’ dak li jgħidlek it- tabib.
If you have any questions about the dose, ask your doctor.
Jekk għandek xi mistoqsijiet dwar id- doża, staqsi lit- tabib tiegħek.
Rebetol oral solution Usual Dosage in Children If the patient weighs Measure and give this dose
Rebetol soluzzjoni orali Doża tas- soltu fit- Tfal
this many kg 10-12 13-14 15-17 18-20 21-22 23-25 26-28 29-31 32-33 34-36 37-39 40-41 42-44 45-47
Jekk il- pazjent jiżen daqshekk kg
The plastic oral dosing syringe consists of two parts, an opaque barrel, and a white plunger rod that fits into the barrel.
Is- siringa tal- plastik tad- dożaġġ hija magħmula minn żewġ partijiet, tubu opak, u bastun ta ’ planġer abjad li jidħol f’ dan it- tubu.
The rod is marked with 0.5 ml markings starting at 1.5 ml (at the very top of the rod) and ending at 10 ml.
Il- bastun hu mmarkat b’ marki ta ’ 0. 5 ml li jibdew minn 1. 5 ml (fil- parti ta ’ fuq nett tal- bastun) u jispiċċaw b’ 10 ml.
You can measure the dose with the oral dosing syringe provided
Tista ’ tkejjel id- doża bis- siringa tad- dożaġġ pprovduta.
Insert the assembled dosing syringe into the bottle of Rebetol oral solution.
Daħħal is- siringa tad- dożaġġ bil- planġer fil- flixkun tas- soluzzjoni orali Rebetol.
While keeping the tip in the liquid, pull the rod out.
68 Fil- waqt li żżomm il- ponta fil- likwidu, iġbed il- bastun il- barra.
As the solution fills the syringe, you will see the numbers on the rod go up, such as 1.5 ml, 2.0 ml, 2.5 ml, etc.
Fil- waqt li s- soluzzjoni timla s- siringa, ara n- numri tal- bastun telgħin, bħall 1. 5 ml, 2. 0 ml, 2. 5 ml eċċ.
Pull the rod out until you can read the correct number of ml for the dose you are measuring.
Ibqa iġbed il- bastun sakemm tkun tista ’ taqra in- numru f’ ml tad- doża li qed tkejjel.
Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe.
Oħroġ is- siringa barra mill- flixkun u ara li jkun jidher in- numru tajjeb fil- qiegħ tas- siringa.
If you have too much or too little, try again until you have the correct amount.
Jekk għandek iżżejjed jew in- nieqes, erġa ipprova sakemm ikollok l- ammont tajjeb.
64 Hold the syringe to your mouth and release the dose into your mouth (or the mouth of the patient you are caring for) by pushing in the rod.
Żomm is- siringa f’ ħalqek u itfa bilmod id- doża f’ ħalqek (jew f’ ħalq il - pazjenti li qed tieħu ħsiebu) billi timbotta l- bastun.
Swallow the dose.
Ibla d- doża.
Try not to let the oral syringe touch the inside of the mouth.
Ipprova tħallix il- parti ta ’ barra tas - siringa tmiss ma ’ ġewwa ta ’ ħalqek.
If it does, rinse it with water before inserting it in the bottle again.
Jekk jiġri hekk, aħsilha bl- ilma qabel terġa ddaħħalha fil- flixkun.
The syringe should be rinsed with water after each use to avoid stickiness.
Is- siringa għandha tiġi maħsula wara kull użu biex tevita li twaħħal.
Take or give the prescribed dose by mouth in the morning and evening, with a meal.
Ħu jew agħti d- doża li kienet ordnata mill- ħalq filgħodu u filgħaxija, ma ’ l- ikel.
Rebetol oral solution is used in combination with interferon alfa-2b for injection.
Rebetol soluzzjoni li tittieħed mill- ħalq tintuża flimkien ma ’ interferon alfa- 2b għall- injezzjoni.
For complete information be sure to read the “How to take” section of the Package Leaflet for interferon alfa-2b.
Għal tagħrif komplet aċċerta ruħek li taqra s- sezzjoni “ Kif Għandek Tieħu ” fil- Fuljett Ta ’ Tagħrif ta ’ interferon alfa- 2b.
Interferon alfa-2b for subcutaneous use:
Interferon alfa- 2b għal użu għal taħt il- ġilda:
In children and adolescents, the usual dose is 3 million IU/m2 three times a week, every other day, injected subcutaneously (under the skin).
Fi tfal u adolexxenti, id- doża tas- soltu hija 3 miljun IU/ m2 tliet darbiet fil- ġimgħa, darba iva u darba le, injettati minn taħt il- ġilda.
Interferons may cause unusual tiredness; if you are injecting this medicine yourself or giving it to a child, use it at bedtime.
Interferons jistgħu jikkawżaw għeja mhux tas- soltu; jekk qed tinjetta din il- mediċina inti stess jew jekk qet tgħatiha lil tifel jew tifla, użaha fil- ħin ta ’ l- irqad.
Most patients are treated for 6 to 12 months with the combination of Rebetol and interferon alfa-2b.
69 Il- parti l- kbira tal- pazjenti jkunu kkurati għal 6 sa 12- il xahar bil- kombinazzjoni ta ’ Rebetol u interferon alfa- 2b.
However, at the end of 6 months of treatment, your doctor will decide if the treatment will be continued for the full 12 months.
Madankollu, fl- aħħar tas- 6 xhur ta ’ kura, it- tabib tiegħek ser jiddeċiedi jekk il- kura hux ser titkompla għat- 12- il xahar kollha.
Always take Rebetol exactly as your doctor has told you.
Dejjem għandek tieħu Rebetol skond il- parir eżatt tat- tabib.
Do not take more than the recommended dosage and take the medicine for as long as prescribed.
M’ għandekx tieħu aktar mid- dożaġġ kunsiljat u ħu l - mediċina tiegħek għal perijodu li ordnawlek.
Also, be sure to read the “Possible side effects” section of the Package Leaflet for interferon alfa-2b.
Ma 'dan, kun żgur li taqra s- sezzjoni “ Effetti sekondarji li jista ’ jkollu ” tal- Fuljett ta ’ Tagħrif għal interferon alfa- 2b.
65 Like all medicines, Rebetol used in combination with an alpha interferon product can cause side effects, although not everybody gets them.
Bħal kull mediċini oħra, Rebetol użat flimkien ma ’ prodott alfa interferon jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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 tinnota li qed taqa ’ f’ dipressjoni jew jekk qed tgħamel ħsibijietta ’ suwiċidju jew qed tibdel l- imġieba tiegħek.