qanastek/EMEA-V3 huggingface dataset:
One vial of IntronA solution for injection or infusion, multiple dose vial, contains 18 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 3 ml of solution.
Kunjett wieħed ta ’ IntronA soluzzjoni għall- injezzjoni jew infużjoni, kunjett b’ doża waħda, fih 18 - il miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 3 ml ta ’ soluzzjoni.
One ml of solution contains 6 million IU of interferon alfa-2b.
Millilitru wieħed fih 6 miljun IU interferon alfa- 2b.
 191 Combination therapy:
Terapija kombinata:
 192 (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
(Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
 193 Chronic Myelogenous Leukaemia:
Lewkimja tal- Mudullun Kronika:
 194 Children and adolescents:
Tfal u adolexxenti:
 195 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall- mewt, kienu innutati f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ IntronA.
 196 Chronic Hepatitis C:
Epatite Ċ Kronika:
The most commonly reported potentially life-threatening or fatal adverse events
L- aktar każijiet avversi komuni li huma potenzjalment ta ’ theddida għall- ħajja jew fatali li kienu rrappurtati jinkludu mukożite, dijarrea, newtropenja, indeboliment tal- kliewi, u disturbi fl- elettroliti.
 198 Women of childbearing potential have to use effective contraception during treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt il- kura.
 199 Very rarely:
Rari ħafna:
Psychiatric disorders§
Rari ħafna: § Disturbi psikjatriċi
 201 that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
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 sezzjoni 4. 4).
 204 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.
L- esperjenza klinika attwali f’ pazjenti li jibqgħu fuq l- interferon alfa- 2b minn 4 sa 6 xhur tindika li t - terapija tista ’ tipproduċi l- eliminazzjoni ta ’ l- HBV- DNA mis- serum.
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/ week) plus ribavirin (800 mg/day) or IntronA (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Il- pazjenti kienu randomized biex jirċievu interferon alfa- 2b pegilat (1. 5 µg/ kg/ ġimgħa) flimkien ma ’ ribavirin (800 mg/ jum) jew inkella IntronA (3 MIU TIW) flimkien ma ’ ribavirin (800 mg/ jum) għal 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur.
 206 Table 4
Tabella 4
Sustained virological response based on genotype ribavirin versus pegylated interferon alfa-2b in HCV/HIV co-infected patients
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara IntronA flimkien ma ’ ribavirin kontra interferon alfa- 2b pegilat flimkien ma ’ ribavirin f’ pazjenti ko- infettati b’ HCV/ HIV Studju 11 Studju 22 interferon alfa- 2b pegilat( 100 interferon jew 150c alfa- 2b pegilat IntronA (1. 5 µg/ kg / µg/ ġimgħa) + IntronA (3 MIU TIW) ġimgħa) + ribavirin + ribavirin (3 MIU TIW) + ribavirin ribavirin Valur (800 - (800 - 1, 200 mg) d pa 1, 200 mg) d (800 mg) (800 mg)
IntronA
valur pb
27% (56/205) 20% (41/205) 0.047 44% (23/52) 17% (21/125) 6% (8/129) 0.006 38% (12/32)
27% (56/ 205) 20% (41/ 205) 0. 047 44% (23/ 52) 21% (9/ 43) 17% (21/ 125) 6% (8/ 129) 0. 006 38% (12/ 32) 7% (2/ 27)
53% (10/19)
44% (35/ 80) 43% (33/ 76) 0. 88 53% (10/ 19) 47% (7/ 15)
 207, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
 208 Table 6.
Tabella 6.
After first opening the container:
Wara li jinfetaħ il- kontenitur għall- ewwel darba:
Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC – 8ºC.
L- istabilità kimika u fiżika waqt l- użu intweriet għal 28 jum f’ 2ºC – 8ºC.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2ºC – 8ºC.
Mill- aspett mikrobijoloġiku, ladarba jinfetaħ, il- prodott jista ’ jinħażen għall- mhux aktar minn 28 jum bejn 2ºC – 8ºC.
Other in-use storage times and conditions are the responsibility of the user.
Perijodi u kundizzjonijiet oħra tal- ħażna jkunu r- responsabbilità ta ’ min qed jużah.
3 ml of solution (corresponding to 18 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
soluzzjoni ta ’ 3 ml (li jikkorrispondi għal 18- il MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene).
Pack sizes of 1, 2 or 12
Pakketti ta ’ daqsijiet b’ 1, 2 jew 12
3 ml of solution (corresponding to 18 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
soluzzjoni ta ’ 3 ml (li jikkorrispondi għal 18- il MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene). b’ 6 siringi għall- injezzjoni, 6 labar għall- injezzjoni u 12- il tajjara għat- tindif.
Pack sizes of 1, 2 or 12 Not all pack sizes may be marketed.
Pakketti ta ’ daqsijiet b’ 1, 2 jew 12.
The appropriate dose of
Jista ’ jintuża kull daqs ta ’ kunjett biex titkejjel id- doża l- meħtieġa; madankollu, il- konċentrazzjoni finali ta ’ l- interferon fis- soluzzjoni tas- sodium chloride ma ’ tistax tkun inqas minn 0. 3 miljun IU/ ml.
 210 IntronA is withdrawn from the vial(s), added to 50 ml of 9 mg/ml (0.9%) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
Id- doża korretta ta ’ IntronA tinġibed mill- kunjett/ i, tiżdied ma ’ 50 ml ta ’ 9 mg/ ml (0. 9%) sodium chloride soluzzjoni għall- injezzjoni f’ borża tal- PVC jew fi flixkun tal- ħġieġ għall- użu fil- vini, u tingħata fuq medda ta ’ 20 minuta.
As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection or infusion, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, IntronA, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
EU/1/99/127/023 EU/1/99/127/024 EU/1/99/127/025 EU/1/99/127/026 EU/1/99/127/041 EU/1/99/127/042
EU/ 1/ 99/ 127/ 023 EU/ 1/ 99/ 127/ 024 EU/ 1/ 99/ 127/ 025 EU/ 1/ 99/ 127/ 026 EU/ 1/ 99/ 127/ 041 EU/ 1/ 99/ 127/ 042 9.
 211 1.
1.
IntronA 25 million IU/2.5 ml solution for injection or infusion
IntronA 25- il miljun IU/ 2. 5 ml soluzzjoni għall- injezzjoni jew infużjoni
One vial of IntronA solution for injection or infusion, multiple dose vial, contains 25 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 2.5 ml of solution.
Kunjett wieħed ta ’ IntronA soluzzjoni għall- injezzjoni jew infużjoni, kunjett b’ doża waħda, fih 25 - il miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 2. 5 ml ta ’ soluzzjoni.
One ml of solution contains 10 million IU of interferon alfa-2b.
Millilitru wieħed fih 10 miljun IU interferon alfa- 2b.
 212 Combination therapy:
Terapija kombinata:
 213 (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
(Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
 214 Chronic Myelogenous Leukaemia:
Lewkimja tal- Mudullun Kronika:
 215 Children and adolescents:
Tfal u adolexxenti:
 216 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall- mewt, kienu innutati f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ IntronA.
 217 Chronic Hepatitis C:
Epatite Ċ Kronika:
 219 Women of childbearing potential have to use effective contraception during treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt il- kura.
 220 Very rarely:
Rari ħafna:
 222 that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
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 sezzjoni 4. 4).
 224 4.9 Overdose
4. 9 Doża eċċessiva
 225 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.
L- esperjenza klinika attwali f’ pazjenti li jibqgħu fuq l- interferon alfa- 2b minn 4 sa 6 xhur tindika li t - terapija tista ’ tipproduċi l- eliminazzjoni ta ’ l- HBV- DNA mis- serum.
 227 Table 4
Tabella 4
Sustained virological res ponse based on genotype ribavirin versus pegylated interferon alfa-2b in HCV/HIV co-infected patients
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara IntronA flimkien ma ’ ribavirin kontra interferon alfa- 2b pegilat flimkien ma ’ ribavirin f’ pazjenti ko- infettati b’ HCV/ HIV Studju 11 Studju 22 interferon alfa- 2b pegilat( 100 interferon jew 150c alfa- 2b pegilat IntronA (1. 5 µg/ kg / µg/ ġimgħa) + IntronA (3 MIU TIW) ġimgħa) + ribavirin + ribavirin (3 MIU TIW) + ribavirin ribavirin Valur (800 - (800 - 1, 200 mg) d pa 1, 200 mg) d (800 mg) (800 mg)
 228, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
 229 Table 6.
Tabella 6.
2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
soluzzjoni ta ’ 2. 5 ml (li jikkorrispondi għal 25- il MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene).
2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
soluzzjoni ta ’ 2. 5 ml (li jikkorrispondi għal 25- il MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene). b’ 6 siringi għall- injezzjoni, 6 labar għall- injezzjoni u 12- il tajjara għat- tindif.
 231 IntronA is withdrawn from the vial(s), added to 50 ml of 9 mg/ml (0.9%) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
Id- doża korretta ta ’ IntronA tinġibed mill- kunjett/ i, tiżdied ma ’ 50 ml ta ’ 9 mg/ ml (0. 9%) sodium chloride soluzzjoni għall- injezzjoni f’ borża tal- PVC jew fi flixkun tal- ħġieġ għall- użu fil- vini, u tingħata fuq medda ta ’ 20 minuta.
EU/1/99/127/027 EU/1/99/127/028 EU/1/99/127/029 EU/1/99/127/030 EU/1/99/127/043 EU/1/99/127/044
EU/ 1/ 99/ 127/ 027 EU/ 1/ 99/ 127/ 028 EU/ 1/ 99/ 127/ 029 EU/ 1/ 99/ 127/ 030 EU/ 1/ 99/ 127/ 043 EU/ 1/ 99/ 127/ 044 9.
 232 1.
1.
IntronA 18 million IU solution for injection, multidose pen
IntronA 18- il miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
One cartridge contains 18 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Kull skartoċċ fih 18- il miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
One ml contains 15 million IU of interferon alfa-2b.
Millilitru wieħed fih 15- il miljun IU interferon alfa- 2b.
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 b’ mod li tinjetta l- kontenuti tagħha ta ’ 18- il miljun IU f’ dożi fuq medda ta bejn 1. 5 sa 6 miljun IU.
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
Il- pinna tinjetta massimu ta ’ 12- il doża ta ’ 1. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
Solution for injection Solution is clear and colourless.
Soluzzjoni għall- injezzjoni jew infużjoni Is- soluzzjoni hi ċara u bla kulur.
 233 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
L- esperjenza klinika tindika li rispons maġġuri/ minuri ematoloġiku u ċitoġenetiku jtista ’ jinkiseb fil - maġġoranza tal- pazjenti ttrattati.
Multidose presentations must be for individual patient use only.
Forom b’ ħafna dożi għandhom jintużaw għal pazjenti individwali biss.
IntronA is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with
IntronA jingħata taħt il- ġilda f’ doża ta ’ 3 miljun IU tliet darbiet fil- ġimgħa (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
For
Id- dożaġġ rakkomandat huwa ta ’ 2 miljun IU/ m2 mogħti taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) kemm għall- pazjenti splenektomizzati kif ukoll għal dawk li mhumiex.
 235 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Fil- biċċa l- kbira tal- pazjenti bil- Lewkimja tal- hairy cell, in- normalizzazzjoni ta ’ kwantità varjabbli ematoloġika waħda jew aktar isseħħ fi żmien xahar sa xahrejn tat- trattament b’ IntronA.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  237 to ketoacidosis.
IntronA għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
 238 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Waqqaf il- kura b’ IntronA f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied.
In clinical trials using Intron A therapy, 2.8% patients overall developed thyroid abnormalities.
Fi provi kliniċi bl- użu tat- terapija b’ IntronA, 2. 8% tal- pazjenti kollha żviluppaw anormalitajiet tat- tirojde.
 239 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
L- għoti ta ’ IntronA flimkien ma ’ sustanzi kemoterapewtiċi oħra (eż., Ara- C, cyclophosphamide, doxorubicin, teniposide) jista ’ jwassal għal riskju akbar ta ’ tossiċità (severità u żmien), li jista ’ jkun ta ’ theddida għall- ħajja jew fatali minħabba l- prodott mediċinali li jkun ingħata miegħu.
 240 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
(Ara wkoll l- SPC ta ’ ribavirin jekk IntronA se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika).
 241 Uncommon:
Mhux komuni:
Bacterial infection Pneumonia§, sepsis
Farinġite *, infezzjoni virali * Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Infezzjoni tal- batteri Pnewmonja§, sepsi
 Very rarely:
Rari ħafna:
242 Peripheral ischaemia, hypotension§
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66% and 14% of
Per eżempju, fi provi ta ’ trattament awżiljarju b’ doża għolja ta ’ IntronA f’ pazjenti bil- melanoma, inċidenzi ta ’ għeja, deni, uġigħ fil- muskoli, newtropenja/ anemija, anoreksja, tqalligħ u rimettar, dijarrea, irjiħat, sintomi li jixbħu l- influwenza, dipressjoni, alopeċja, togħma mibdula, u ta ’ sturdament kienu aktar milli fil- provi ta ’ l- epatite Ċ.
 243 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Is- severità żdiedet ukoll bit- terapija b’ doża għolja (Grad 3 u 4 tal- WHO, f’ 66% u 14% tal- pazjenti, rispettivament) imqabbla mas- severità bejn ħafifa u moderata normalment assoċjata mad- dożi baxxi.
245 Growth rate decrease (height and/or weight decrease for age)§
Uġigħ fis- sider, astenja, edema, uġigħ tas- sit mnejn tingħata l - injezzjoni Titnaqqas ir- rata ta ’ tkabbir (tul u/ jew piż aktar baxx għall- età) §
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell  246 metabolism.
Għalkemm il- metodu eżatt ta ’ l- azzjoni anti- virali ta ’ l- interferon alfa- 2b rikombinanti mhuwiex magħruf, jidher li dan ibiddel il- metaboliżmu taċ- ċellula fejn ikun.
3 2% in trial C/I98-580).
32% fil- prova C/ I98- 580).
C/ I98-580
C95- 132/ I95- 143
 247 Genotype 1
Ġenotip 1
 248 Table 4
Tabella 4
 249, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
Defined as HCV-RNA below limit of detection using a research based R T-PCR assay at end of treatment and during follow-up period
Defimit bħala HCV- RNA taħt il- limitu li jista ’ jitkejjel b’ assay RT- PCR bażat fuq riċerka fl- aħħar tal- kura u waqt il - perijodu ta ’ follow- up
 250 Table 6.
Tabella 6.
Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC – 8ºC.
L- istabilità kimika u fiżika waqt l- użu intweriet għal 27 jum f’ 2ºC – 8ºC.
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC.
Mill- aspett mikrobijoloġiku, ladarba jinfetaħ, il- prodott jista ’ jinħażen għall- mhux aktar minn 27 jum bejn 2ºC – 8ºC.
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.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali
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 sa 6 miljun IU.
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.
IntronA, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
IntronA, 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.
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).
Detailed instructions for the use of the product is provided with the package leaflet (refer to “How to self inject IntronA”).
Istruzzjonijiet dettaljati dwar l- użu għal taħt il- ġilda tal- prodott qed jingħataw fil- fuljett ta ’ tagħrif (irreferi għal “ Kif tinjetta lilek innifsek b’ IntronA ”).
Each pen is intended for a maximum four-week use period and must then be discarded.
Kull pinna hi maħsuba biex tintuża għal perijodu massimu ta ’ erba ’ ġimgħat u wara għandha tintrema.
A new injection needle must be used for each dose.
Għandha tintuża labra għall- injezzjoni ġdida għal kull doża.
After each use, the injection needle must be discarded safely and the pen must be returned immediately to the refrigerator.
Wara kull użu, il- labra għall- injezzjoni għandha tintrema b’ mod li ma joħloqx periklu u l- pinna għandha titpoġġa lura fil- friġġ immedjatament.
A maximum of 48 hours (two days) of exposure to 25°C is permitted over the four-week use period to cover accidental delays in returning the pen to the refrigerator.
Huwa permess ħin massimu ta ’ 48 siegħa (jumejn) ta ’ espożizzjoni għal temperatura 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 IntronA pen for administering the smallest measurable doses.
Hemm ipprovduti biżżejjed labar u tajjar għall- użu tal- pinna ta ’ IntronA 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.
Agħti parir lill- pazjent biex kull labra u tajjara li jibqa’ wara li tkun ittieħdet l- aħħar doża mill- pinna tintrema kif suppost u mingħajr ma jinħoloq periklu.
 252 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, IntronA, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
 253 1.
1.
IntronA 30 million IU solution for injection, multidose pen
IntronA 30 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Kull skartoċċ fih 30 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
One ml contains 25 million IU of interferon alfa-2b.
Millilitru wieħed fih 25- il miljun IU interferon alfa- 2b.
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 sa 10 miljun IU.
The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks.
Il- pinna tinjetta massimu ta ’ 12- il doża ta ’ 2. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
PH ARMACEUTICAL FORM
GĦAMLA FARMAĊEWTIKA
 254 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
L- esperjenza klinika tindika li rispons maġġuri/ minuri ematoloġiku u ċitoġenetiku jtista ’ jinkiseb fil - maġġoranza tal- pazjenti ttrattati.
 256 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Fil- biċċa l- kbira tal- pazjenti bil- Lewkimja tal- hairy cell, in- normalizzazzjoni ta ’ kwantità varjabbli ematoloġika waħda jew aktar isseħħ fi żmien xahar sa xahrejn tat- trattament b’ IntronA.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  258 to ketoacidosis.
IntronA għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
 259 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Waqqaf il- kura b’ IntronA f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied.
Infrequently, adult patients treated for chronic hepatitis C with Intron A developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
F’ każijiet mhux tas- soltu, pazjenti ttrattati b’ IntronA għall- epatite Ċ kronika żviluppaw anormalitajiet fit- tirojde, ipotirojdiżmu jew ipertirojdiżmu.
 260 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
L- għoti ta ’ IntronA flimkien ma ’ sustanzi kemoterapewtiċi oħra (eż., Ara- C, cyclophosphamide, doxorubicin, teniposide) jista ’ jwassal għal riskju akbar ta ’ tossiċità (severità u żmien), li jista ’ jkun ta ’ theddida għall- ħajja jew fatali minħabba l- prodott mediċinali li jkun ingħata miegħu.
 261 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
(Ara wkoll l- SPC ta ’ ribavirin jekk IntronA se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika).
 262 Uncommon:
Mhux komuni:
263 Peripheral ischaemia, hypotension§
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
 264 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Is- severità żdiedet ukoll bit- terapija b’ doża għolja (Grad 3 u 4 tal- WHO, f’ 66% u 14% tal- pazjenti, rispettivament) imqabbla mas- severità bejn ħafifa u moderata normalment assoċjata mad- dożi baxxi.
266 Growth rate decrease (height and/or weight decrease for age)§
Uġigħ fis- sider, astenja, edema, uġigħ tas- sit mnejn tingħata l - injezzjoni Titnaqqas ir- rata ta ’ tkabbir (tul u/ jew piż aktar baxx għall- età) §
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell  267 metabolism.
Għalkemm il- metodu eżatt ta ’ l- azzjoni anti- virali ta ’ l- interferon alfa- 2b rikombinanti mhuwiex magħruf, jidher li dan ibiddel il- metaboliżmu taċ- ċellula fejn ikun.
C95-132/ I95-143 C95-132/I95-143
C95- 132/ I95- 143
 268 Genotype 1
Ġenotip 1
The duration of thera py was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
It - terapija damet 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur ħlief għall- pazjenti li kienu infettati b’ ġenotipi 2 jew 3 u viral load < 800, 000 IU/ ml (Amplicor) li kienu kkurati għal 24 ġimgħa b’ perijodu ta 6 xhur follow- up.
 270, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
 271 Table 6.
Tabella 6.
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.
Pakketti ta ’ daqsijiet 1, 2 jew 8.
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 sa 10 miljun IU.
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.
 273 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, IntronA, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
 274 1.
1.
IntronA 60 million IU solution for injection, multidose pen
IntronA 60 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Kull skartoċċ fih 60 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
One ml contains 50 million IU of interferon alfa-2b.
Millilitru wieħed fih 50 miljun IU interferon alfa- 2b.
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 sa 20 miljun IU.
The pen will deliver a maximum of 12 doses of 5 million IU over a period not to exceed 4 weeks.
Il- pinna tinjetta massimu ta ’ 12- il doża ta ’ 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
 275 Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
L- esperjenza klinika tindika li rispons maġġuri/ minuri ematoloġiku u ċitoġenetiku jtista ’ jinkiseb fil - maġġoranza tal- pazjenti ttrattati.
 277 most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Fil- biċċa l- kbira tal- pazjenti bil- Lewkimja tal- hairy cell, in- normalizzazzjoni ta ’ kwantità varjabbli ematoloġika waħda jew aktar isseħħ fi żmien xahar sa xahrejn tat- trattament b’ IntronA.
Some patients have been shown to benefit from IntronA 5 million IU/m2 administered daily subcutaneously in association with cytarabine (Ara -C) 20 mg/m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Intwera li xi pazjenti bbenefikaw minn 5 miljun IU/ m2 IntronA mogħtija kuljum taħt il- ġilda flimkien ma ’ 20 mg/ m2 cytarabine (Ara- C) mogħtija kuljum taħt il- ġilda għal 10 ijiem kull xahar (sa doża massima ta ’ 40 mg kuljum).
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone  279 to ketoacidosis.
IntronA għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
 280 Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Waqqaf il- kura b’ IntronA f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied.
 281 Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
L- għoti ta ’ IntronA flimkien ma ’ sustanzi kemoterapewtiċi oħra (eż., Ara- C, cyclophosphamide, doxorubicin, teniposide) jista ’ jwassal għal riskju akbar ta ’ tossiċità (severità u żmien), li jista ’ jkun ta ’ theddida għall- ħajja jew fatali minħabba l- prodott mediċinali li jkun ingħata miegħu.
 282 (Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
(Ara wkoll l- SPC ta ’ ribavirin jekk IntronA se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika).
 283 Uncommon:
Mhux komuni:
284 Peripheral ischaemia, hypotension§
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
 285 patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Is- severità żdiedet ukoll bit- terapija b’ doża għolja (Grad 3 u 4 tal- WHO, f’ 66% u 14% tal- pazjenti, rispettivament) imqabbla mas- severità bejn ħafifa u moderata normalment assoċjata mad- dożi baxxi.
Additional adverse events were reported rarely (> 1/10,000, < 1/1,000) or very rarely (< 1/10,000) Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
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).
 Investigations
Investigazzjonijiet Komuni ħafna:
Injury and poisoning
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura
 288 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.
 289 All Genotypes
Il- Ġenotipi kollha
 290 Table 4
Tabella 4
Sustained virological res ponse based on genotype ribavirin versus pegylated interferon alfa-2b in HCV/HIV co-infected patients
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara IntronA flimkien ma ’ ribavirin kontra interferon alfa- 2b pegilat flimkien ma ’ ribavirin f’ pazjenti ko- infettati b’ HCV/ HIV Studju 11 Studju 22 interferon alfa- 2b pegilat( 100 interferon jew 150c
Study 22 pegylated
alfa- 2b pegilat (1. 5 µg/ kg /
 291, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
Genotype 2/ 3/4 (n=26) *Number (%) of patients
Ġenotip 2/ 3/ 4 (n=26) * Numru (%) ta ’ pazjenti
 292 Table 6.
Tabella 6.
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.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali
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 20 miljun IU.
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.
 294 As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, IntronA, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
 295 ANNEX II
ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ A.
SP (Brinny) Company Innishannon - County Cork Ireland
SP (Brinny) Company Innishannon - County Cork L- Irlanda
Industriepark 30 B-2220 Heist-op-den-Berg Belgium
Industriepark 30 B- 2220 Heist- op- den- Berg Il- Belġju
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE OF THE MEDICINAL PRODUCT
 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
 297 ANNEX III
ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA ’ TAGĦRIF A.
 299 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton
Kartuna ta ’ barra
IntronA 1 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 1 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b
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.
Excipients: glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, and human albumin solution One ampoule of solvent contains 1 ml of water for injections.
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.
1 million IU/ml powder and solvent for solution for injection or infusion 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs
1 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif 12- il kunjett ta ’ trab, 12- il ampulla ta ’ solvent, 12- il siringa għall- injezzjoni, 24 labra għall- injezzjoni u 12- il tajjara għat- tindif
Subcutaneous or intravenous use.
Użu għal taħt il- ġilda jew użu għal ġol- vini.
Dilute prior to intravenous use.
Iddilwixxi qabel l- użu ġol- vini.
EXP After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
JIS Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta jinħażen fi friġġ (2°C - 8°C).
After withdrawal of the dose, any remaining solution must be discarded.
Wara li tinġibed id- doża, kwalunkwe soluzzjoni li jifdal għandha tintrema.
SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
SP Europe, 73, rue de Stalle, B- 1180 Bruxelles, Il- Belġju
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 99/ 127/ 001 EU/ 1/ 99/ 127/ 040
EU/1/99/127/001 1 vial of powder EU/1/99/127/040 12 vials of powder
kunjett 1 ta ’ trab 12- il kunjett ta ’ trab
 301 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
IntronA 1 MIU trab TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
IntronA 1 million IU/ml powder for injection or infusion interferon alfa-2b SC/IV
IntronA 1 miljun IU/ ml trab għall- injezzjoni jew infużjoni interferon alfa- 2b SC/ IV
1 million IU/ml
1 miljun IU/ ml
 302 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
IntronA 3 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b
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.
3 million IU/ml powder and solvent for solution for injection or infusion 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
3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif 6 kunjetti ta ’ trab u 6 ampulli ta ’ solvent
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD - DETENTUR TA ’ LA- WTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 99/ 127/ 002 EU/ 1/ 99/ 127/ 003
EU/1/99/127/002 1 vial of powder EU/1/99/127/003 6 vials of powder
kunjett 1 ta ’ trab 6 kunjetti ta ’ trab
 304 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
IntronA 3 MIU trab TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial label
Tikketta tal- kunjett)
IntronA 3 million IU/ml powder for injection or infusion interferon alfa-2b SC/IV
IntronA 3 miljun IU/ ml trab għall- injezzjoni jew infużjoni interferon alfa- 2b SC/ IV
3 million IU/ml
3 miljun IU/ ml
 305 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
IntronA 5 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 5 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b
One vial of powder contains 5 million IU of interferon alfa-2b and provides 5 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Kunjett wieħed ta ’ trab fih 5 miljun IU ta ’ interferon alfa- 2b u jipprovdi 5 miljun IU kull ml ta ’ interferon alfa- 2b meta jkun rikostitwit kif rakkomandat.
Excipients: glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, and human albumin solution One ampoule of solvent contains 1 ml of water for injections.
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
5 million IU/ml powder and solvent for solution for injection or infusion 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
5 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif 6 kunjetti ta ’ trab u 6 ampulli ta ’ solvent
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 99/ 127/ 004 EU/ 1/ 99/ 127/ 005
EU/1/99/127/004 1 vial of powder EU/1/99/127/005 6 vials of powder
kunjett 1 ta ’ trab 6 kunjetti ta ’ trab
IntronA 5 MIU powder
IntronA 5 MIU trab TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
IntronA 5 million IU/ml powder for injection or infusion interferon alfa-2b SC/IV
IntronA 5 miljun IU/ ml trab għall- injezzjoni jew infużjoni interferon alfa- 2b SC/ IV
5 million IU/ml
5 miljun IU/ ml
 308 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
IntronA 10 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 10 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b
One vial of powder contains 10 million IU of interferon alfa-2b and provides 10 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Kunjett wieħed ta ’ trab fih 10 miljun IU ta ’ interferon alfa- 2b u jipprovdi 10 miljun IU kull ml ta ’ interferon alfa- 2b meta jkun rikostitwit kif rakkomandat.
10 million IU/ml powder and solvent for solution for injection or infusion 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 10 vials of powder, 10 ampoules of solvent, 10 injection syringes, 20 injection needles and 10 cleansing swabs
10 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif 6 kunjetti ta ’ trab u 6 ampulli ta ’ solvent 10 kunjetti ta ’ trab, 10 ampulli ta ’ solvent, 10 siringi għall- injezzjoni, 20 labra għall- injezzjoni u 10 tajjar għat- tindif.
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 99/ 127/ 006 EU/ 1/ 99/ 127/ 007 EU/ 1/ 99/ 127/ 008
EU/1/99/127/006 1 vial of powder EU/1/99/127/007 6 vials of powder EU/1/99/127/008 10 vials of powder
kunjett 1 ta ’ trab 6 kunjetti ta ’ trab 10 kunjetti ta ’ trab
IntronA 10 MIU powder
IntronA 10 MIU trab TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
IntronA 10 million IU/ml powder for injection or infusion interferon alfa-2b SC/IV
IntronA 10 miljun IU/ ml trab għall- injezzjoni jew infużjoni interferon alfa- 2b SC/ IV
10 million IU/ml
10 miljun IU/ ml
 311 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
IntronA 18 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 18- il miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b
One vial of powder contains 18 million IU of interferon alfa-2b and provides 18 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Kunjett wieħed ta ’ trab fih 18- il miljun IU ta ’ interferon alfa- 2b u jipprovdi 18- il miljun IU kull ml ta ’ interferon alfa- 2b meta jkun rikostitwit kif rakkomandat.
18 million IU/ml powder and solvent for solution for injection or infusion 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab
18- il miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 għat- tindif
 312 Store in a refrigerator.
Aħżen fi friġġ.
 313 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
IntronA 18 MIU trab TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
IntronA 18 million IU/ml powder for injection or infusion interferon alfa-2b SC/IV
IntronA 18- il miljun IU/ ml trab għall- injezzjoni jew infużjoni interferon alfa- 2b
18 million IU/ml
18- il miljun IU/ ml
 314 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
IntronA 30 million IU/ml powder and solvent for solution for injection or infusion interferon alfa-2b
IntronA 30 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni interferon alfa- 2b