qanastek/EMEA-V3 huggingface dataset:
Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Pazjenti kkurati b’ Viraferon u ribavirin f’ terapija kombinata u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija. li l
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic t
Pazjenti ko- infettati li għandhom ċirrosi avanzata u li qed jirċievu l- HAART jista ’ jkollhom riskju akbar ta ’ dikompensazzjoni tal- fwied u tal- mewt.
Adding treatment with alfa interferons alone or in combination with ribavirin may uc
Iż- żieda ta ’ trattament bl- interferoni alpha waħidhom jew flimkien ma ’ ribavirin jista ’ jkabbar ir- riskju f’ dan il- grupp ta ’ pazjenti. ina
been reported in patients receiving Viraferon and ribavirin combination therapy.
Mard tas- snien u madwar is- snien, li jista ’ jwassal għal telf tas - snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu Viraferon u ribavirin f’ terapija kombinata.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Viraferon and ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel ħsara lis- snien u l- membrani tal- ħalq waqt kura fuq tul ta ’ żmien diċ
regular dental examinations.
bil- kombinazzjoni ta ’ Viraferon u ribavirin.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. na
Jekk isseħħ din ir- reazzjoni, għandhom jingħataw parir sabiex jaħslu ħalqhom sew wara. me
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all i dic
Testijiet standard ematoloġiċi u tal- komponenti kimiċi tad- demm (l- għadd totali u d- differenzjal tad - demm, l- għadd tal- plejlets, l- elettroliti, l- enżimi tal- fwied, il- proteina fis- serum, il- bilirubin fis- serum u l- kreatinina fis- serum) għandhom isiru lill- pazjenti kollha qabel u b' mod perijodiku matul it - ott
patients prior to and periodically during systemic treatment with Viraferon.
trattament sistemiku b’ Viraferon.
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
Matul it- trattament għall- epatite B jew Ċ, l- iskeda rrakkomandata għat- testijiet hija fil- ġimgħat numru od
If ALT flares during Viraferon therapy to greater than or Me
1, 2, 4, 8, 12, 16, u wara dan kull xahrejn tul iż- żmien kollu tat- trattament.
equal to 2 times baseline, Viraferon therapy may be continued unless signs and symptoms of liver failure are observed.
Jekk matul it- terapija b’ Viraferon l- ALT jogħla f’ daqqa u jilħaq jew jaqbeż id- doppju tal- livelli bażi, it- terapija b’ Viraferon tista ’ titkompla sakemm ma jkunux innutati sinjali u sintomi ta ’ indebolimet qawwi tal- fwied.
During ALT flare, liver function tests:
Waqt il - Pr
ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin must be monitored at two-week intervals.
qabża kbira fl- ALT, testijiet ta ’ kif qed jaħdem il- fwied, ALT, ħin tal- protrombina, alkaline phosphatase, albumina u bilirubin iridu jkunu mkejjla f’ intervalli ta ’ ġimagħtejn.
182 Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ Viraferon.
Interactions between Viraferon and other medicinal products have not been fully evaluated.
at Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
This must be considered during concomitant therapy
tor L- interferoni jistgħu jaffettwaw il- proċess metaboliku ossidattiv.
ed with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Dan għandu jkun ikkunsidrat waqt terapija konkomitanti ma ’ prodotti mediċinali li jkunu metabolati permezz ta ’ din ir- rotta, bħal ma huma d- derivattivi ta ’ xanthine, theophylline jew aminophylline.
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary.
Matul it- terapija konkomitanti ma ’ sustanzi ta ’ xanthine, il- livelli ta ’ theophylline fis- serum iridu jkunu mkejjla, u d- dożaġġ ikun aġġustat
s ori Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li xi kultant wasslu għall- mewt, kienu innutati f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ Viraferon.
The aetiology has not been defined.
L- etjoloġija
uth administered concomitantly with interferon alpha (see section 4.4).
ux ma kinetx mfissra.
(Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with
Dawn is- sintomi kienu rrappurtati aktar ta ’ spiss meta shosaikoto, mediċina tal - ħxejjex Ċiniża, ingħatat fl- istess ħin ma ’ l- interferon alpha (ara sezzjoni 4. 4).
ra chronic hepatitis C).
ad (Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika). ’ għ Tqala u Treddigħ 4. 6
ge Women of childbearing potential have to use effective contraception during treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt il- kura.
Decreased serum estradiol and progesterone concentrations have been lon reported in women treated with human leukocyte interferon.
serum kienu rrappurtati fin- nisa ttrattati bl- interferon tal- lewkoċiti tal- bniedem.
Viraferon is to be no
Mhux magħruf ir- riskju potenzjali fuq in - nies.
used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Viraferon m’ għandux jintuża waqt it- tqala ħlief jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu. ina
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of t uc
Minħabba l- potenzjal ta ’ reazzjonijiet avversi minn Viraferon fit- trabi li qegħdin jerdgħu, it- treddigħ għandu jitwaqqaf qabel tinbeda l- kura. diċ
Ribavirin causes serious birth defects when administered during rod
Ribavirin jikkawża difetti tat- twelid serji meta jingħata waqt it - tqala.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with ribavirin.
partikolari sabiex tiġi evitata t- tqala f’ pazjenti nisa jew sieħba nisa ta ’ pazjenti rġiel li jkunu qed jieħdu Viraferon f’ kombinazzjoni ma ’ ribavirin.
Females of childbearing potential and their partners must each use an effective contraceptive during lp
Nisa li jista ’ jkollhom it- tfal u s- sieħba rġiel tagħhom għandhom it- tnjen li huma jużaw kontraċezzjoni effettiva waqt il- kura u fl- 4 xhur ta ’ wara t- twaqqif tal- kura.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC). na
Pazjenti rġiel u s- sieħba nisa tagħhom għandhom it- tnejn li huma jużaw kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara t- twaqqif tal- kura (ara l- SPC ta ’ ribavirin). ott
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with Viraferon, and therefore it is recommended that they avoid driving or operating machinery.
Pr
See ribavirin SPC for ribavirin-related undesirable effects if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara l- SPC ta ’ ribavirin għall- effetti mhux mixtieqa konnessi ma ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika.
183 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very
Fost il- klassijiet tas - sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt it- titli tal- frekwenza skond il- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf.
ed common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not known.
aw skond is- serjetà ta ’ tagħhom.
184 Common:
Komuni:
185 Very common:
tor Komuni ħafna:
186 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
187 breast disorders Common:
ad Komuni:
188 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
189 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
190 All Genotype 1, 4
Kollox Ġenotip 1,
191 Genotype 1 (n=92)
Ġenotip 1 (n=92)
192 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
M-cresol, Polysorbate 80, Water for injections q. s. rod
aw M- cresol, Polysorbate 80, Ilma għall- injezzjonijiet.
6.3 Shelf life
ad 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali ’ għ 15- il xahar
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC.
Perijodi u im
Me
kundizzjonijiet oħra tal- ħażna jkunu r- responsabbilità ta ’ min qed jużah.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna li l
Do not freeze.
Aħżen fil- friża. ina
193 1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
Soluzzjoni ta ’ 1. 2 ml (jikkorrispondi għal 18 MIU) f’ pinna mgħamula minn skartoċċ (ħġieġ tat- tip I) siġillata minn naħa waħda b’ għatu (aluminium) li għandu kisja (lasktu tal- bromobutyl) u fuq in- naħa l- oħra bi planġer (lasktu tal- bromobutyl) bi 12- il labra għall- injezzjonijiet u 12 il- tajjara għat- tindif. me
ed The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 18- il miljun IU f’ dożi fuq medda ta ’ minn 1. 5 ott
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 1. 5 miljun IU fuq perijodu li m’ għandux jaqbeż l- 4 ġimgħat. od
s 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
ori Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom kollha tad- dożaġġi u qawwiet ikunu xierqa għal xi indikazzjonijiet.
uth Viraferon, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Viraferon, soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi ikun injettat taħt il- ġilda wara t- twaħħil ta ’ labra għall- injezzjoni u biex taqqas il- konċentrazzjoni tad- doża preskritta.
ra Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).
Neħħi l- pinna mill- friġġ madwar 30 minuta qabel l- għoti sabiex is- soluzzjoni għall- injezzjoni tkun tista ’ tilħaq it- temperatura tal- kamra (mhux aktar minn 25°C).
ge Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”). lon Each pen is intended for a maximum four-week use period and must then be discarded.
Istruzzjonijiet dettaljati dwar l- użu għal taħt il- ġilda tal- prodott qed jingħataw fil- fuljett ta ’ tagħrif (irreferi għal “ Kif tinjetta lilek innifsek b’ Viraferon ”).
A new injection needle must be used for each dose.
izz Għandha tintuża labra għall- injezzjoni ġdida għal kull doża.
A maximum of 48 hours (two days) of exposure to 25°C is no
Huwa permess ħin massimu ta ’ 48 siegħa (jumejn) ta ’ espożizzjoni għal temperatura
permitted over the four-week use period to cover accidental delays in returning the pen to the refrigerator.
tor ta ’ 25°C matul il- perijodu ta ’ l- użu ta ’ erba ’ ġimgħat, biex jagħmel tajjeb għal dewmien aċċidentali sakemm il- pinna titpoġġa lura fil- friġġ.
Sufficient needles and swabs are provided to use the Viraferon pen for administering the smallest measurable doses.
Hemm ipprovduti biżżejjed labar u tajjar għall- użu tal- pinna ta ’ Viraferon bl- iżgħar dożi li jistgħu jitkejjlu.
Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen, must be discarded appropriately and safely. t uc
aw mill- pinna tintrema kif suppost u mingħajr ma jinħoloq periklu.
As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, Viraferon, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
The solution should be clear and colourless. rod
Is- soluzzjoni għandha tkun ċara u
MARKETING AUTHORISATION HOLDER lp
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
SP Europe 73, rue de Stalle na
SP Europe 73, rue de Stalle B- 1180 Bruxelles Il- Belġju
B-1180 Bruxelles Belgium i dic
’ għ
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ li l
EU/ 1/ 99/ 128/ 030 EU/ 1/ 99/ 128/ 031
EU/ 1/ 99/ 128/ 029 EU/ 1/ 99/ 128/ 030 EU/ 1/ 99/ 128/ 031 ina
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI diċ
23 May 2005
23 Mejju 2005 me
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. ott od Pr 1.
Viraferon 30 million IU solution for injection, multidose pen
Viraferon 30 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
ed One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
izz Kull skartoċċ fih 30 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
s One ml contains 25 million IU of interferon alfa-2b.
tor Millilitru wieħed fih 25- il miljun IU interferon alfa- 2b.
ori The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Il- pinna hi magħmula b’ mod li tinjetta l- kontenuti tagħha ta ’ 30 miljun IU f’ dożi fuq medda ta bejn 2. 5
196 Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom tad- dożaġġi u qawwiet kollha jkunu xierqa għal xi indikazzjonijiet.
197 Viraferon alone:
Viraferon waħdu:
198 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
199 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
200 Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
It- twaqqif tat- terapija ta ’ Viraferon ma reġġax lura l- funzjoni ħażina tat- tirojde li seħħet matul it- trattament (ara wkoll Tfal u adolexxenti, monitoraġġ tat- Tirojde).
201 Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ Viraferon.
202 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
s ori Table 1.
Tabella 1:
Adverse reactions reported during clinical trials or following the marketing use of Viraferon alone or in combination with ribavirin System Organ Class
ux Viraferon waħdu jew ma ’ ribavirin Klassi tas- Sistema ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
uth Infections and infestations Very common:
ad Komuni ħafna:
ra Rarely:
Rari:
Pneumonia§
Farinġite *, infezzjoni virali * Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Pnewmonja§ ’ għ
Immune system disorders§
li l
Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, lon thrombotic thrombocytopenic purpura
Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika Aplasja taċ- ċelluli ħomor puri, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
Very rarely:
Disturbi fis- sistema immuni§ Rari ħafna:
Not known:
ina
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid no
Sarkojdożi, tiħrax s- sarkojdożi
arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Lupus erythematosus sistemika, vaskulite, artrite rewmatika (tibda jew taggrava), sindrome Vogt- Koyanagi- Harada, reazzjonijiet ta ’ sensittività eċċessiva akuti li jinkludu urtikarja, anġjoedema, bronkokostrizzjoni, anafilassi§
Endocrine disorders uc
Disturbi fis- sistema endokrinarja Ipotajrojdiżmu§, ipertajrojdiżmu§ Komuni:
§ Psychiatric disorders Very common:
Disturbi psikjatriċi§ Komuni ħafna: od
Suicide, suicide attempts, aggressive behaviour (sometimes
Konfużjoni, disturbi ta ’ l- irqad, tnaqqis fil- libido Ħsibijiet dwar suwiċidju Suwiċidju, attentati ta’ suwiċidju, imġieba aggressiva
Nervous system disorders Me
(kulltant indirizzata lejn l- oħrajn), psikożi inklużi alluċinazzjonijiet Tibdil fl- istat mentali§ Mhux magħruf Disturbi fis- sistema nervuża§ Komuni ħafna:
203 Very common:
izz Komuni ħafna:
Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Vista mċajpra Konġuntivite, vista anormali, disturbi fil- glandola tad - dmugħ, uġigħ fl- għajnejn
ed Ear and labyrinth Common:
Vertigo, tisfir fil- widnejn
Palpitation, tachycardia Cardiomyopathy Myocardial infarction, cardiac ischaemia
Palpitazzjoni, takikardija
uth Not known:
Mhux magħruf:
Arrhythmia
Infart majokardijaku, iskemija kardijaka Arritmija ’ għ
ra Very rarely:
Rari ħafna:
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi u
Peripheral ischaemia, hypotension§
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
ge Very common:
Komuni ħafna:
Dyspnoea*, coughing* Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive lon
Dispneja *, sogħla * Epistassi, disturbi respiratorji, konġestjoni fl- imnieħer,
Nausea/ vomiting, abdominal pain, diarrhoea, stomatitis, dyspepsia no
Tqalligħ/ rimettar, uġigħ fl- addome, dijarea, stomatite, dispepsja
Very rarely:
diċ
t
Stomatite b’ ulċera, uġigħ fil- kwadrant lemini ta ’ fuq,
Pancreatitis, ischaemic colitis, ulcerative colitis, gingival
glossite, infjammazzjoni tal- ħanek, stitikezza, ippurgar maħlul Rari ħafna:
Very common: lp
ġilda Komuni ħafna:
Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder
Alopeċja, ħakk *, ġilda xotta *, raxx *, żieda fl- għaraq Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx
Very rarely:
bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
Stevens Johnson syndrome, toxic epidermal necrolysis,
Sindrome Stevens Johnson, nekroliżi tossika tal- ġilda, erythema multiforme
Very common:
Disturbi muskolu- skeletrali u tal - connective tissue Komuni ħafna:
Myalgia, arthralgia, musculoskeletal pain Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite Rabdomajelożi, majożite, bugħawwieġ fir- riġlejn, uġigħ fid -
Renal and urinary disorders Common:
dahar Disturbi fil- kliewi u fis- sistema urinarja Komuni:
General disorders and administration
Amenorreja, uġigħ fis- sider, dismenorreja, menorraġja,
204 site conditions Very common:
tor Komuni ħafna:
ed Very common:
ux Komuni ħafna
*These events were only common with Viraferon alone § See section 4.4
* Dawn il- każijiet kienu komuni biss b’ Viraferon waħdu § Ara sezzjoni 4. 4
s ori These undesirable effects have also been reported with Viraferon alone.
ad Dawn l- effetti mhux mixtieqa kienu ukoll irrappurtati ma ’ Viraferon waħdu. ’ għ Każijiet avversi kardjovaskulari (CVS), b' mod partikolari arritmija, dehru li kienu korrelati l- aktar mal- mard CVS li kien jeżisti minn qabel u mat- terapija b’ sustanzi kardjotossiċi li saret qabel (ara sezzjoni 4. 4).
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-
Kardjomajopatija li tista ’ tkun riversibbli bit- twaqqif ta ’ interferon alpha, kienet irrappurtata f’ każijiet rari f’ pazjenti li ma kellhomx evidenza minn qabel ta ’ mard tal- qalb (ara im
uth existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
sezzjoni 4. 4).
ra A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated),
Varjetà kbira ta ’ problemi awtoimmunitarji u ta ’ problemi konnessi ma ’ l- immunità kienu irrappurtati bl- interferoni alpha, u jinkludu disturbi tat- tirojde, lupus erythematosus sistemika, artrite rewmatika li l
ge idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
(tibda jew taggrava), purpura idjopatika u tromboċitopenika trombotika, vaskulite, u newropatiji li jinkludu mononewropatiji (ara wkoll sezzjoni 4. 4). ina
Increase in serum ALT/ AST (SGPT/ SGOT) levels have been noted as an abnormality in some non-hepatitis no
Anormalitajiet tal- laboratorju klinikament sinifikanti, li l- aktar li jseħħu f’ dożi ta ’ aktar minn 10 miljun IU kuljum, jinkludu t- tnaqqis fl- għadd tal- granuloċiti u taċ- ċelluli bojod tad- demm; tnaqqis fil- livell ta ’ l- emoglobina u ta ’ l- għadd tal- plejtlets; żidiet fil- livelli ta ’ alkaline phosphatase, LDH, diċ
subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Żieda fil- livelli fis- serum ta ’ l- ALT/ AST (SGPT/ SGOT) kienu innutati bħala anormalità f’ xi suġġetti mhux bl- epatite u wkoll f’ xi pazjenti bl - epatite B kronika li kkoinċidiet mat- tneħħija tad- DNAp virali. me
Paediatric population t uc
Popolazzjoni pedjatrika
Children and adolescents – Chronic Hepatitis C In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
Tfal u adolexxenti – Epatite Ċ Kronika Fi provi kliniċi b’ 118 tfal jew adolexxenti ta ’ 3 sa 16- il sena, 6% waqfu t- terapija minħabba każijiet ott
Furthermore, suicidal ideation or attempts were lp
B’ mod ġenerali, il- profil ta ’ każijiet avversi fil- popolazzjoni pedjatrika limitata kien jixbah lill- dak ta ’ l- adulti, għalkemm hemm tħassib speċifiku għat- tfal dwar l- inibizzjoni tat- tkabbir bħal tnaqqis fit- tul (perċentwali medja ta ’ tnaqqis fir- rata ta ’ tkabbir b’ 9%) u fil- piż (perċentwali medja ta ’ od
reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
Minbarra hekk, ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fis- 6 xhur tal- follow- up wara l- kura.
In addition, injection na
Bħal f’ pazjenti adulti, tfal u Pr
site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Minbarra hekk, disturbi fis- sit mnejn tingħata l- injezzjoni, deni, anoressija, rimettar u burdati emozzjonali seħħew aktar ta ’ spiss fi tfal u adolexxenti meta mqabbla ma ’ pazjenti adulti.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following Me
Bil- klassijiet tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt it- titli tal- frekwenza bil- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10).
categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
205 Common:
Komuni:
Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Infezzjoni virali, farinġite Infezzjonijiet tal- fungu, infezzjoni tal- batteri, infezzjoni fil - pulmun, otite medja, ħofra fis- snien, herpes simplex, infezzjoni fil- passaġġ ta ’ l- awrina, gastro- enterite
Common:
ad Komuni:
ed Blood and lymphatic system disorders Very common:
sistema limfatika Komuni ħafna:
Thrombocytopaenia, lymphadenopathy
’ għ Anemija, newtropenja Tromboċitopenja, limfadenopatija im
ori Endocrine disorders Very common:
Komuni ħafna:
ra Common:
Komuni:
Hypertriglyceridemia§, hyperuricemia, increased appetite
Anoressija Ipertrigliċeridemika§, iperuriċemija, żieda fl- aptit
Very common:
ina
Depression, emotional lability, insomnia
§ Disturbi psikjatriċi Komuni ħafna:
Nervous system disorders§
diċ
Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy lon
Depressjoni, burdati emozzjonali, nuqqas ta ’ rqad Ħsiebijiet dwar suwiċidju, reazzjoni aggressiva, konfużjoni, disturbi fl- imġieba, aġitazzjoni, ħmar il- lejl, ansjetà, nervi,
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder t
Konġuntivite, uġigħ fl- għajnejn, vista anormali, disturb fil -
Raynaud’ s disease, flushing, pallor uc
Disturbi respiratorji, toraċiċi u medjastinali Pr
Respiratory, thoracic and mediastinal disorders rod
Marda ta ’ Raynaud, fwawar, pallidità
Very common: lp
Komuni ħafna:
Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal
Dijarea, rimettar, tqalligħ, uġigħ fl- addome Ulċeri fil- ħalq, stomatite b’ ulċera, stomatite, uġigħ fil- kwadrant lemini ta ’ fuq, dispepsja, glossite, ittella ’ mill- istonku, disturbi fir- rektum, disturbi gastro- intestinali, stitikezza, ippurgar maħlul, uġigħ fis- snien, disturbi fis- snien
Common:
at marrara Komuni:
Skin and subcutaneous tissue disorders Very
izz ta ’ taħt il- ġilda Komuni ħafna:
common:
Komuni:
Musculoskeletal and connective tissue disorders
Alopeċja, raxx Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema,
Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
tor akne, disturbi fil- ġilda, disturbi fid- dwiefer, telf tal- lewn tal - ġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl- għaraq Disturbi muskolu- skeletali u
Very common:
aw tal- connective tissue Komuni ħafna:
206 Reproductive system and breast disorders Common:
ad Komuni:
General disorders and administration site
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
ed conditions Very common:
Komuni ħafna:
uth Common: § See section 4.4
Komuni: § Ara sezzjoni 4. 4
ra 4.9 Overdose
4. 9 Doża eċċessiva me
However, as for any
Ma kien rrappurtat l- ebda każ ta ’ doża eċċessiva li wasslet għal manifestazzjonijiet kliniċi akuti.
ge pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Madankollu, bħal f’ kull sustanza farmakoloġikament attiva, huwa indikat li jsir trattament sintomatiku b’ monitoraġġi spissi tas- sinjali vitali u osservazzjoni mill- qrib tal- pazjent. ott
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Viraferon huwa formulazzjoni sterili u stabbli ta ’ interferon alfa- 2b ippurifikat sa grad għoli ħafna magħmul bit- teknika tad- DNA rikombinanti.
It is obtained from a clone of E. coli, which harbours a genetically engineered rod
Huwa jinkiseb minn klonu ta ’ E. coli, li għandu ġo fih ibridu plażmidu mfassal ġenetikament imdawwar ma ’ ġene ta ’ interferon alfa- 2b minn lewkoċiti umani.
plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
L- attività ta ’ Viraferon hija mfissra f’ termini ta ’ IU, u 1 mg ta ’ proteina ta ’ interferon alfa- 2b rikombinanti li tikkorrispondi għal 2. 6 x l08 IU.
The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein lp
at bejn l- attività ta ’ l- interferon alfa- 2b rikombinanti u l- attività ta ’ preparazzjoni għar- referenza internazzjonali ta ’ l- interferon tal- lewkoċita tal- bniedem stabbilita mill- Organizzazzjoni Dinjija tas -
corresponding to 2.6 x l08 IU.
izz Saħħa.
and biological inducers.
tor 21, 000 dalton.
Me
Kienu identifikati aktar minn 14- il interferon
Viraferon has been classified as recombinant interferon alfa-2b.
Viraferon kienet ikklassifikata bħala interferon alfa- 2b rikombinanti.
207 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
It has demonstrated significant
L- interferon alfa- 2b rikombinanti wera effetti antiproliferattivi fi studji fejn intużaw kemm sistemi ta ’ kultura ta ’ ċelluli umani u ta ’ l- annimali kif ukoll xenografts ta ’ tumur uman fl- annimali.
s immunomodulatory activity in vitro.
Huwa wera attività immunomodulatorja sinifikattiva in vitro. diċ
ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
L- interferon alfa- 2b rikombinanti wkoll jiskoraġġixxi r- replikazzjoni virali in vitro u in vivo.
uth This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
replikazzjoni virali jew jekk ir- replikazzjoni sseħħ, il- virjoni proġeni ma jkunux jistgħu joħorġu miċ - ċellula.
ra Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
terapija tista ’ tipproduċi l- eliminazzjoni ta ’ l- HBV- DNA mis- serum.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has
F’ pazjenti adulti bi tnaqqis ta ’ HBeAg u ta ’ HBV- DNA, kien innutat tnaqqis sinifikattiv fil - morbidità u fil- mortalità. od
Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active lon hepatitis B.
Interferon alfa- 2b (6 MIU/ m² tlett darbiet fil- ġimgħa għal 6 xhur) ingħata lil tfal b’ epatite B attiva kronika.
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
ittrattati b’ interferon alfa- 2b kellhom rata mnaqqsa ta ’ tkabbir u kienu innutati xi każijiet ta ’ dipressjoni.
Chronic hepatitis C: no
Epatite Ċ kronika:
The trials compared the efficacy of rod
Viraferon waħdu jew flimkien ma ’ ribavirin kien studjat f’ 4 provi kliniċi ta’ Fażi III
Viraferon used alone or in combination with ribavirin.
Il- provi qabblu l - effettività ta ’ Viraferon użat waħdu jew flimkien ma ’ ribavirin.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum lp
tor kellhom epatite Ċ kronika kkonfermata minn analiżi pożittiva (> 100 kopji/ ml) tar- reazzjoni katina tal - polimerat (PCR) HCV- RNA, bijopsija tal- fwied konsistenti ma ’ dijanjosi istoloġika ta ’ epatite kronika bla ebda kawża oħra għall- epatite kronika, u ALT fis- serum anormali.
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
aw Viraferon ingħata f’ doża ta ’ 3 MIU tlett darbiet fil- ġimgħa bħala monoterapija jew flimkien ma ’ ribavirin.
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response. i
Il- pazjenti kollha kienu segwiti għal 6 xhur oħra wara t- tmiem tat- trattament biex tkun iddeterminata r- rispons viroloġiku sostnut.
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in dic
Ir- rati ta ’ rispons viroloġiku sostnuti għall- gruppi ttrattati għal sena b’ Viraferon
Co-administration of Viraferon with ribavirin increased the efficacy of Viraferon by at least two fold for the Me
L- għoti flimkien ta ’ Viraferon ma ’ ribavirin żied l- effettività ta ’ Viraferon f’ pazjenti naive mill- inqas
treatment of chronic heptatitis C in naïve patients.
ad bid- doppju għat- trattament - ta ’ l- epatite Ċ kronika.
208 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
209 All Genotype 1, 4
Kollox Ġenotip 1,
210 Genotype 1 (n=92)
Ġenotip 1 (n=92)
211 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
212 1.2 ml of solution (corresponding to 30 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
Soluzzjoni ta ’ 1. 2 ml (jikkorrispondi għal 30 MIU) f’ pinna mgħamula minn skartoċċ (ħġieġ tat- tip I) siġillata minn naħa waħda b’ għatu (aluminium) li għandu kisja (lasktu tal- bromobutyl) u fuq in- naħa l- oħra bi planġer (lasktu tal- bromobutyl) bi 12- il labra għall- injezzjonijiet u 12 il- tajjara għat- tindif. me
ed The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 30 miljun IU f’ dożi fuq medda ta ’ minn 2. 5 ott
The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 2. 5 miljun IU fuq perijodu li m’ għandux jaqbeż l- 4 ġimgħat. od
EU/ 1/ 99/ 128/ 033 EU/ 1/ 99/ 128/ 034
EU/ 1/ 99/ 128/ 032 EU/ 1/ 99/ 128/ 033 EU/ 1/ 99/ 128/ 034 ina
Viraferon 60 million IU solution for injection, multidose pen
Viraferon 60 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
ed One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
izz Kull skartoċċ fih 60 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
s One ml contains 50 million IU of interferon alfa-2b.
tor Millilitru wieħed fih 50 miljun IU interferon alfa- 2b.
ori The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Il- pinna hi magħmula b’ mod li tinjetta l- kontenuti tagħha ta ’ 60 miljun IU f’ dożi fuq medda ta bejn 5
215 Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom tad- dożaġġi u qawwiet kollha jkunu xierqa għal xi indikazzjonijiet.
216 Viraferon alone:
Viraferon waħdu:
217 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
218 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
219 Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
It- twaqqif tat- terapija ta ’ Viraferon ma reġġax lura l- funzjoni ħażina tat- tirojde li seħħet matul it- trattament (ara wkoll Tfal u adolexxenti, monitoraġġ tat- Tirojde).
220 Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ Viraferon.
221 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
222 Common:
Komuni:
223 Very common:
tor Komuni ħafna:
224 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
toothache, tooth disorder Hepatobiliary disorders Common:
at marrara Komuni:
Hepatic function abnormal
Disturbi fil- ġilda u fit- tessuti
Skin and subcutaneous tissue dic
Funzjoni epatika anormali
225 breast disorders Common:
ad Komuni:
226 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
227 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
228 All Genotype 1, 4
Kollox Ġenotip 1,
229 Genotype 1 (n=92)
Ġenotip 1 (n=92)
230 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
231 1.2 ml of solution (corresponding to 60 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
Soluzzjoni ta ’ 1. 2 ml (jikkorrispondi għal 60 MIU) f’ pinna mgħamula minn skartoċċ (ħġieġ tat- tip I) siġillata minn naħa waħda b’ għatu (aluminium) li għandu kisja (lasktu tal- bromobutyl) u fuq in- naħa l- oħra bi planġer (lasktu tal- bromobutyl) bi 12- il labra għall- injezzjonijiet u 12 il- tajjara għat- tindif. me
ed The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 60 miljun IU f’ dożi fuq medda ta ’ minn 5 sa ott
The pen will deliver a maximum of 12 doses of 5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 5 miljun IU fuq perijodu li m’ għandux jaqbeż l- 4 ġimgħat. od
EU/ 1/ 99/ 128/ 036 EU/ 1/ 99/ 128/ 037
EU/ 1/ 99/ 128/ 035 EU/ 1/ 99/ 128/ 036 EU/ 1/ 99/ 128/ 037 ina
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. ott od Pr at izz tor aw ux ad ’ għ ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION no
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U im
HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT li l
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lp ina dic Me
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ ina diċ me ott od Pr A.
SP (Brinny) Company Innishannon - County Cork
at SP (Brinny) Company
ed Ireland
izz Innishannon - County Cork L- Irlanda
Name and address of the manufacturer responsible for batch release
tor Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
uth Belgium
aw Industriepark 30 B- 2220 Heist- op- den- Berg Il- Belġju
CONDITIONS OF THE MARKETING AUTHORISATION
ux B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
ge MARKETING AUTHORISATION HOLDER
ad • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - ’ għ SUQ
Summary of Product lon Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2). im
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE OF THE MEDICINAL PRODUCT no
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI li l
LABELLING AND PACKAGE LEAFLET t no uc rod lp nai dic Me
Ma jgħoddx f’ dan il- każ. ina diċ me ott od Pr at izz tor aw ux ad ANNESS III ’ għ TIKKETTA U FULJETT TA ’ TAGĦRIF im li l ina diċ me ott od Pr Pr od ott me diċ ina li l im A.
LABELLING lon ge ra uth ori sed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA ’ għ ad ux aw tor izz at TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ed 1.
at izz 1.
Viraferon 1 million IU/ ml powder and solvent for solution for injection
Viraferon 1 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni
s interferon alfa-2b
tor interferon alfa- 2b
ori 2.
aw 2.
uth One vial of powder contains 1 million IU of interferon alfa-2b and provides 1 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Kunjett wieħed ta ’ trab fih 1 miljun IU ta ’ interferon alfa- 2b u jipprovdi 1 miljun IU kull ml ta ’ interferon alfa- 2b meta jkun rikostitwit kif rakkomandat.
ge Excipients: glycine, disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, and human albumin solution
ad Sustanzi mhux attivi: glycine, disodium phosphate anhydrous, sodium hydrogen phosphate monohydrate, u soluzzjoni ta ’ l- albumina tal- bniedem Ampulla waħda ta ’ solvent fiha 1 ml ta ’ ilma għall- injezzjonijiet. ’ għ 4.
PHARMACEUTICAL FORM AND CONTENTS no
GĦAMLA FARMAĊEWTIKA U KONTENUT im
1 million IU/ ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab t uc
1 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif li l
METHOD AND ROUTE(S) OF ADMINISTRATION rod
MOD TA ’ KIF U MNEJN JINGĦATA ina
Read the package leaflet before use. lp
Aqra l- fuljett ta ’ tagħrif qabel l- użu. diċ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN na
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL me
Keep out of the reach and sight of children. i dic
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. ott
OTHER SPECIAL WARNING(S), IF NECESSARY Me
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA od
EXP After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta jinħażen fi friġġ (2°C - 8°C).
Store in a refrigerator.
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN Aħżen fi friġġ.
ed APPROPRIATE
at UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
After withdrawal of the dose, any remaining solution must be discarded.
izz Wara li tinġibed id- doża, kwalunkwe soluzzjoni li jifdal għandha tintrema.
uth SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
aw SP Europe, 73, rue de Stalle, B- 1180 Bruxelles, Il- Belġju
EU/ 1/ 99/ 128/ 001
ux EU/ 1/ 99/ 128/ 001
BATCH NUMBER ge lon Lot no
NUMRU TAL- LOTT
Medicinal product subject to medical prescription. t uc
Prodott mediċinali jingħata bir- riċetta tat- tabib. li l
INSTRUCTIONS ON USE rod
STRUZZJONIJIET DWAR L- UŻU ina
INFORMATION IN BRAILLE lp
INFORMAZZJONI BIL- BRAILLE diċ
239 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Viraferon 1 MIU trab me ott od Pr TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
1.
at izz 1.
ed Viraferon 1 million IU/ ml powder for injection interferon alfa-2b
Viraferon 1 miljun IU/ ml trab għall- injezzjoni
s SC
tor interferon alfa- 2b SC
ori uth 2.
aw 2.
ge EXP lon 4.
ad JIS ’ għ 4.
Lot no
LOTT im
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT t
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI li l
1 million IU/ ml uc rod
1 miljun IU/ ml ina
240 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN diċ me ott od Pr TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Viraferon 3 million IU/ ml powder and solvent for solution for injection
Viraferon 3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni
uth One vial of powder contains 3 million IU of interferon alfa-2b and provides 3 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Kunjett wieħed ta ’ trab fih 3 miljun IU ta ’ interferon alfa- 2b u jipprovdi 3 miljun IU kull ml ta ’ interferon alfa- 2b meta jkun rikostitwit kif rakkomandat.
ge Excipients: glycine, disodium phosphate anhydrous sodium dihydrogen phosphate monohydrate, and human albumin solution
ad Sustanzi mhux attivi: glycine, disodium phosphate anhydrous, sodium hydrogen phosphate monohydrate, u soluzzjoni ta ’ l- albumina tal- bniedem Ampulla waħda ta ’ solvent fiha 1 ml ta ’ ilma għall- injezzjonijiet. ’ għ 4.
3 million IU/ ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 6 vials of powder and 6 ampoules of solvent t uc
3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif li l
METHOD AND ROUTE(S) OF ADMINISTRATION rod
MOD TA ’ KIF U MNEJN JINGĦATA
Subcutaneous use.
Użu għal taħt il- ġilda. diċ
Read the package leaflet before use. lp
Aqra l- fuljett ta ’ tagħrif qabel l- użu.