qanastek/EMEA-V3 huggingface dataset:
Corresponding dose (million IU) using Viraferon 25 million IU/2.5 ml solution for injection lp
0. 25
0.25
diċ
2. 5
2. 5
0. 1
0. 5 1
0.5
5 10
dic
1. 5 2 2. 5
1.5
15 20 25
Me
ott od
If the solution is cold, warm the syringe between your
Jekk is- soluzzjoni hija kiesħa, saħħan is- siringa bejn il- pali ta ’ jdejk.
Do not u se if discolouration or particulate matter is present.
Tużahiex jekk tinnota bidla fil- kulur jew xi materjal ta ’ partiċelli żgħar.
ed the arm for injection.
at biss il- koxxa jew in- naħa ta ’ barra tad- driegħ għall- injezzjoni.
s Cleanse and disinfect the skin where the injection is to be made.
izz Naddaf u ddiżinfetta l- ġilda fejn se tagħti l- injezzjoni.
Insert the needle into the pinched skin at an angle of 45° to 90°.
Daħħal il -
uth banda ge or sterile gauze if necessary for several seconds.
tor labra f’ angolu ta ’ bejn 45° u 90° fil- ġilda maqrusa ’ l barra.
Do not massage the injection site.
Injetta s- soluzzjoni billi timbotta l- planġer bil- mod s’ isfel.
If there is bleeding, cover with an adhesive bandage.
Iġbed il- labra dritt ’ l barra mill- ġilda.
The vial and injec tion materials intended for single use must be discarded.
Agħfas il- post ta ’ l- injezzjoni b’ faxxa żgħira jew b’ garża sterili jekk hemm bżonn għal diversi sekondi.
Dispose of the syringe and needle
Timmassaġġjax il- post ta ’ l- injezzjoni.
ra safely in a closed container.
aw demm, għatti b’ faxxa li teħel.
366 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 18 million IU solution for injection, multidose pen Interferon alfa-2b
Viraferon 18- il miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
368 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tieħu xi mediċina.
369 Viraferon is usually intend ed for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
Do not exceed the recommended dosa ge, and take Viraferon
Tiħux dożaġġ aktar minn dak rakkomandat, u ibqa ’ ħu Viraferon għat- tul taż- żmien skond kif ordnalek it- tabib.
370 treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
at uġigħ fin- naħa t’ isfel tad- dahar jew fil- ġenb, diffikultà biex tagħmel l- awrina, problemi fl - għajnejn jew fil- vista jew fis- smigħ, telf tas- smigħ, ħmura qawwija jew li tweġġa ’ jew feriti
A maximum of 48 hours (two days) of exposure to 25°C is permitted over the four-week period to cover accidental delays in
Huwa permess li jkun hemm esponiment ta ’ mhux aktar minn 48 siegħa (jumejn)
ori Depending upon your dose, you may have extra needles and swabs left in the pack.
ad f’ 25ºC fuq perijodu ta ’ 4- ġimgħat sabiex ikunu koperti ittardjar aċċidentali li jista ’ jkun hemm biex il - pinna titpoġġa lura fil- friġġ. ’ għ Skond id- doża tiegħek, jista ’ jkollok aktar labar u tajjar li jibqgħu fil- pakkett.
ra Do not use Viraferon if you notice changes in the appearance of Viraferon.
M’ għandekx tuża Viraferon jekk tinnota xi tibdil fid- dehra ta ’ Viraferon. li l
What Viraferon contains lon
X’ fih Viraferon:
- The active substance is recombinant interferon alfa-2b, 18 million IU/ pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 18- il miljun IU/ pinna
edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections. no
diċ
What Viraferon looks like and contents of the pack t
monohydrate, edetate disodium, sodium chloride, m- cresol, polysorbate 80 u ilma għall - injezzjonijiet. me
The clear and colourless solution is contained in a glass cartridge.
Viraferon jiġi bħala soluzzjoni għall- injezzjoni Is- soluzzjoni ċara u mingħajr kulur tiġi fi skartoċċ tal- ħġieġ.
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 f’ medda ta ’ minn 1. 5 sa ott
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks. rod
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 1. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. od
Viraferon is available in three different pack sizes:
Viraferon jiġi fi tlett daqsijiet ta ’ pakketti differenti:
Viraferon, 18 million IU/pen, solution for injection: lp
Viraferon, 18- il miljun IU/ pinna, soluzzjoni għall- injezzjoni:
SP Europe 73, rue de Stalle B-1180 Bruxelles Me
Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe 73, rue de Stalle B- 1180 Bruxelles
Luxembourg/Luxemburg Rue de Stalle 73 B-1180 Bruxelles/Brüssel Belgique/Belgien
Rue de Stalle 73 B- 1180 Bruxelles/ Brüssel Belgique/ Belgien
372 Tél/Tel: + 32-(0)2 370 92 11
aw Tél/ Tel: + 32 - (0) 2 370 92 11
ed Na Příkopě 25 CZ-110 00 P raha 1 Tel: + 420 221771250
ad Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250
s ori Danmark Lautrupbjerg 2 DK-2750 Ballerup
Danmark Lautrupbjerg 2
ge Eesti Österreich Järvevana tee 9 EE-11314 Tallinn
Eesti Järvevana tee 9 diċ
Tel: + 372 654 96 86
EE- 11314 Tallinn Tel: + 372 654 96 86 me
Ελλάδα Αγίου Δημητρίου 63
Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος Tηλ: + 30- 210 98 97 300 ott
Nacional I E-28750 San Agustín de Guadalix – Madrid Tel: + 34-91 848 85 00 rod lp i na dic Me
Nacional I E- 28750 San Agustín de Guadalix – Madrid od
373 France 92 rue Baudin F-92300 Levallois-Perret Tél: + 33-(0)1 41 06 35 00
92 rue Baudin F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00
uth IS-210 Garðabær Sími: + 354 535 70 00
izz Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
ra Italia Via fratelli Cervi snc, Centro Direzionale Milano Due
tor Italia Via fratelli Cervi snc,
ge Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1
aw Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία
ux Κύπρος Οδός Αγίου Νικολάου, 8
Τηλ: + 357-22 757188 Latvija Bauskas 58a -401
ad CY- 1055 Λευκωσία Τηλ: +357- 22 757188
t
’ għ
Rīga, LV-1004
Latvija Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25
Welwyn Garden City
United Kingdom Shire Park Welwyn Garden City Hertfordshire AL7 1TW - UK
65/40 LT-08124 Vilnius lp
65/ 40 li l
Tel. + 370 52 101868 na
LT- 08124 Vilnius Tel. + 370 52 101868 ina
This leaflet was last approv ed on i dic
Dan il- fuljett kien approvat l- aħħar f ’ diċ
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ Me
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
- the Viraferon multidose pen;
- il- pinna b’ ħafna dożi ta ’ Viraferon;
Use the injection needles provided in the packaging only for Viraferon.
Uża biss il- labar għall- injezzjoni pprovduti fil- pakkett għal Viraferon.
Be sure the solution is at room temperature at the time of injection.
Kun ċert li s- soluzzjoni għandha t- temperatura tal- kamra fil- ħin ta ’ l -
uth Diagrams A and B show you all the different parts of the pen and the injection needle.
Id- Dijagrammi A u B juruk il- partijiet differenti kollha tal- pinna u tal- labra għall- injezzjoni.
ra
ux
- The colour coding strip brown and the push button are at the bottom of the pen as it is held cap up.
- L- istrixxa bil- kodiċi tal- kulur kannella u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal- pinna
ge
ad meta din tinżamm bil- kappa ’ l fuq.
indicator on the barrel. lon no
ma ’ l- indikatur tad- dożaġġ fuq il- bettija. ’ għ Kappa ta ’ barra tal- labra im
Cap t
ina
Cap uc
Labra
scale
diċ
Needle rod
kappa Membrana tal- gomma
Rubber membrane lp
gewwa tal - labra
Reservoir na
Gibjun me
Dosage indicator i dic
Barrel tal - pinna ott
Pen barrel Me
Kodici tal - kulur od
Colour coding Push button
Skala tal -
Pu sh button scale
protettiv
375 Measuring the dose of Viraferon Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Biex tkejjel id- doża ta ’ Viraferon Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
When you are ready to give your injection prepare your pen as follows:
at Meta tkun lest biex tagħti l- injezzjoni pprepara l- pinna kif ġej:
ed Check that Viraferon, solution for injection, is clear and colourless in appearance prior to use.
izz Aċċerta ruħek li Viraferon, soluzzjoni għall- injezzjoni, għandu dehra ċara qabel tużah.
s Pull off the cap of the pen and disinfect the rubber membrane (see Diagram C) with one cleansing swab.
Buttuna mnejn taghfas
ori uth ra ge Diagram C lon Remove the protective tab from the injection needle.
ux ad Disinn Ċ ’ għ Neħħi t- tapp protettiv mil- labra għall- injezzjoni.
Note that the rear portion of the injection needle is revealed once the protective tab is removed (see Diagram D).
Innota li l- parti ta ’ wara tal- labra għall- injezzjoni tinkixef meta jitneħħa t- tapp protettiv (ara d- Disinn D). im li l ina
D iagram D
Disinn D diċ
Now screw the lp
(Innota li l- parti ta ’ wara tal- labra għall- injezzjoni se ttaqqab il- membrana tal- gomma li ddiżinfettajt ftit qabel).
injection needle onto the pen securely by turning it in a clockwise direction (see Diagram F).
Issa invita tajjeb il- labra għall- injezzjoni għal fuq il- pinna billi ddawwarha fid- direzzjoni skond l- arloġġ (ara d - me
dic
Disinn F). ott od Pr
376 First, pull off the outer injection needle cap (Diagram G).
L- ewwel, neħħi l- kappa ta ’ barra tal- labra għall- injezzjoni (Disinn G).
Then, pull off the inner injection needle cap carefully, bearing in mind that the injection needle will now be exposed (Diag ram H).
Imbagħad, neħħi bl- attenzjoni l - kappa ta ’ ġewwa tal- labra għall- injezzjoni, u żomm f’ moħħok li l- labra għall- injezzjoni issa se tkun mikxufa (Disinn H).
ed
at izz tor
ra The pen is now ready to use.
aw Il- pinna issa tinsab lesta biex tintuża.
Since a small amount of air may collect in the injection needle and reservoir during storage, the next step is to remove any air bubbles.
Billi tista ’ tinġema ’ xi ftit arja fil- labra għall- injezzjoni u fil - ġibjun waqt il- ħażna, il- pass li jmiss hu li jitneħħew xi bżieżaq ta ’ l- arja li jista ’ jkun hemm.
This is called performing the Air-Shot.
Din tissejjaħ l- Isparatura ta ’ l- Arja.
ge Hold the Viraferon, solution for injection, multidose pen with the injection needle point upwards.
ux Żomm il- pinna b’ ħafna dożi ta ’ Viraferon, soluzzjoni għall- injezzjoni, bil- labra għall- injezzjoni tipponta ’ l fuq.
Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the lon injection needle (Diagram I).
ad Tektek il- ġibjun b’ sebgħek sabiex xi bżieżaq ta ’ l- arja li jista ’ jkun hemm jitilgħu fil- wiċċ, eżatt taħt il - labra għall- injezzjoni (Disinn I). ’ għ Gibjun im li l ina
Diagram I lp
Disinn I
Hold the pen by the barrel and turn the re servoir in the direction as indicated by the arrow in Diagram J (clockwise) until you feel it click.
Żomm il- pinna mill- barrel u dawwar il- ġibjun fid- direzzjoni indikata bil- vleġġa fid- Disinn J (fid - diċ
Me
direzzjoni skond l- arloġġ) sakemm tħossha tikklikkja. me ott od
Diagram J
Disinn J Pr
377 Keeping the pen pointing upwards, press the push button up fully and see if a drop of Viraferon, solution for injection, appears at the injection needle tip (Notice the drop at the tip of injection needle in Diagram K below).
Żomm il- pinna tipponta ’ l fuq, agħfas il- buttuna kollha ’ l fuq u ara jekk titfaċċax qatra ta ’ Viraferon, soluzzjoni għall- injezzjoni, fil- ponta tal- labra (Innota l- qatra fil- ponta tal- labra għall- injezzjoni fid - Disinn K taħt). at izz tor Disinn K
ra If no drop appears, use a different pen, and return the faulty pen to your provider.
Jekk ma titfaċċax qatra, uża pinna differenti u ħu lura l- pinna difettuża minn għand min ġibtha.
ge injection needle and the dose will be accurate.
aw Nota: jista ’ jibqa xi arja fil- pinna, iżda dan mhux importanti billi l- arja mil- labra għall- injezzjoni kienet tneħħiet u d- doża se tkun preċiża.
Replace the Viraferon, solution for injection, multidose pen cap with the ‘triangle’ opposite the dosage lon indicator as seen in Diagram L.
ux Poġġi lura f’ postha l- kappa tal- pinna b’ ħafna dożi ta ’ Viraferon, soluzzjoni għall- injezzjoni, bit - ‘ trijanglu ’ biswit l- indikatur tad- dożaġġ kif muri fid- Disinn L.
no
ad ’ għ im li l
Diagram L lp
Disinn L ina
This will allow the push button to move freely, ensuring that the correct dose is set. na
Dan jippermetti li l- buttuna mnejn tagħfas tkun tista ’ titmexxa liberalment, u b’ hekk taċċerta li tista ’ tkun issettjata d- doża korretta. diċ
You will observe the push button rising, i
Bl- id l - oħra, dawwar il- kappa fid- direzzjoni bħall- arloġġ kif indikat bil- vleġġa fid- Disinn M.
indicating the dose set.
Tinnota li l - buttuna mnejn tagħfas se togħla, u tindika d- doża ssettjata.
To set the correct dose, turn the cap as many times as indicated as follows: dic Me
Biex tissettja d- doża l- korretta, dawwar il - kappa għal kemm hemm bżonn drabi kif inhu indikat hawn taħt: me ott od Pr Numru ta ’ “ dawriet ” u “ tfaqqih ”
Corresponding doses (million IU) using Viraferon, solution for injection, multidose pen 18 million IU/pen
Dożi li jikkorrispondu (miljun IU) meta tuża Viraferon, soluzzjoni għall - injezzjoni, pinna b’ ħafna dożi 18 -
1 full turn (5 clicks)
at il miljun IU/ pinna
6 clicks
Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat
1.8
1. 5 1. 8 2. 1
8 clicks
8 tfaqqihat 9 tfaqqihat
2.4
2. 4 2. 7
uth
aw
2 full turns (10 clicks)
2 dawriet sħaħ (10 tfaqqihat)
Diagram M
3. 3 3. 6
12 clicks
13- il tfaqqiha 14- il tfaqqiha
3.6
3. 9 4. 2
13 clicks
3 dawriet
14 clicks
sħaħ (15- il tfaqqiha) 16- il tfaqqiha
4.8
4. 5 4. 8
17 clicks
17- il tfaqqiha 18- il tfaqqiha 19- il tfaqqiha
5.1
5. 1 5. 4 5. 7
18 clicks uc
4 dawriet
rod
6
5.7
* 4 dawriet sħaħ jikkorrispondu għad- doża massima li tista ’ tingħata b’ injezzjoni waħda.
4 full turns (20 clicks)*
Il- pinna hi magħmula biex tinjetta l - li l
*4 full turns correspond to the maximum dose to be administered in one injection.
kontenuti kollha 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 lp
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 1. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. ina diċ me
dic
Disinn M ott
379 The push button scale will show you the dose set (see Diagram N below).
L- iskala tal- buttuna mnejn tagħfas se turik id- doża ssettjata (ara d- Disinn N taħt).
For doses corresponding to full turns, the scale should line up with the correct dose marking.
Għal od
For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
dożi li jikkorrispondu għal tfaqqih bejn tidwir sħaħ, l- iskala għandha tiddelinja ruħha mal- marki bejn żewġ dożi xierqa għal tidwir sħieħ.
ori uth ra Diagram N
Pr at izz tor Disinn N
ge After each complete turn make sure that the triangle is opposite the dosage indicator (see Diagram O).
aw Wara kull dawra sħiħa kun ċert li t- trijanglu jinsab biswit l- indikatur tad- dożaġġ (ara d- Disinn O).
If you have set a wrong dose, simply turn the cap back (anti-clockwise) as far as you can until the push button is lon fully home and start again.
Jekk issettjajt doża ħażina, dawwar il- kappa lura (kontra d- direzzjoni ta ’ l- arloġġ) kemm tista ’ sakemm il- buttuna mnejn tagħfas tmur lura għall- pożizzjoni tal- bidu, u erga ’ ibda.
Once the correct dose is set you are ready to give the injection.
Meta tkun ssettjata
rod
ux d- doża l- korretta, tkun lest biex tagħti l- injezzjoni.
uc
ad ’ għ im
t
Disinn O li l
no
Biex tinjetta s- soluzzjoni ina
Diagram O Injecting the solution Select the injection site.
Agħżel il- post fejn se tinjetta.
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), lp
L- aħjar postijiet għall- injezzjoni huma t- tessuti b’ saff ta ’ xaħam bejn il - ġilda u l- muskolu: il- koxxa, in- naħa ta ’ barra fil- parti ta ’ fuq tad- driegħ (jista ’ jkollok bżonn l - għajnuna ta ’ persuna oħra biex tuża dan il- post), iż- żaqq (’ l isfel mill- qadd).
Change your injection site each time. na
Ibdel il- post ta ’ l- injezzjoni kull darba. diċ
With your other hand, pick up the pen and hold it as you would a i
Bl- id l- oħra aqbad il- pinna qisek qed iżżomm lapes.
Insert the needle into the pinched skin at an angle of approximately 45°. dic Me
Daħħal il- labra f’ angolu ta ’ madwar 45° fil - ġilda maqrusa ’ l barra. me
380 Then press the push button down fully (see Diag ram P).
Imbagħad agħfas il- buttuna ’ l isfel kollha (ara d- Disinn P). ott od Pr
ori Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon,
Disinn P Bil- buttuna mniżżla s’ isfel, ħalli l- labra għall- injezzjoni fil- post għal ftit sekondi biex tippermetti lil Viraferon, soluzzjoni għall- injezzjoni, tinfirex taħt il- ġilda, imbagħad neħħiha.
Diagram Q rod
at izz tor aw ux ad Disinn Q
Then carefully lift it off the pen and discard the capped injection needle (see Diagram S). lp
Imbagħad għollih minn mal- pinna bl- attenzjoni u armi l- labra għall- injezzjoni ’ għ mgħottija bil- kappa (ara d- Disinn S). im li l ina diċ me
Diag ram R
Disinn R
381 Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
Poġġi l- kappa tal- pinna lura f’ postha bit- trijanglu għal darb’ oħra biswit l- indikatur tad- dożaġġ kif muri fid- Disinn T.
Then re turn the pen to the refrigerator.
Imbagħad poġġi l- pinna lura fil- friġġ. ott od Pr
ori uth Diagram T
Disinn T FULJETT TA ’ TAGĦRIF:
Viraferon, 30 million IU solution for injection, multidose pen Interferon alfa-2b
Viraferon 30 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
384 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tieħu xi mediċina.
385 Viraferon is usually intend ed for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
386 treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
at uġigħ fin- naħa t’ isfel tad- dahar jew fil- ġenb, diffikultà biex tagħmel l- awrina, problemi fl - għajnejn jew fil- vista jew fis- smigħ, telf tas- smigħ, ħmura qawwija jew li tweġġa ’ jew feriti
- The active substance is recombinant interferon alfa-2b, 30 million IU/ pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 30 miljun IU/ pinna
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 f’ medda ta ’ minn 2. 5 sa ott
The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks. rod
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 2. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. od
Viraferon, 30 million IU/pen, solution for injection: lp
Viraferon, 30 miljun IU/ pinna, soluzzjoni għall- injezzjoni:
- Pack of 1 pen, 12 injection needles and 12 cleansing swabs
Pakkett b’ pinna 1, 12- il labra għall- injezzjoni u 12- il tajjara għat- tindif
388 Tél/Tel: + 32-(0)2 370 92 11
aw Tél/ Tel: + 32 - (0) 2 370 92 11
389 France 92 rue Baudin F-92300 Levalloi s-Perret Tél: + 33-(0)1 41 06 35 00
92 rue Baudin F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00
Τηλ: + 357-22 757188
ad CY- 1055 Λευκωσία Τηλ: +357- 22 757188
Bauskas 58a -401
Latvija Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25
Shire Park
United Kingdom Shire Park Welwyn Garden City Hertfordshire AL7 1TW - UK
65/40 lp
65/ 40 li l
LT-08124 Vilnius Tel. + 370 52 101868 na
LT- 08124 Vilnius Tel. + 370 52 101868 ina
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ Me
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. me ott od Pr KIF TINJETTA Viraferon LILEK INNIFSEK
- The colour coding strip blue and the push button are at the bottom of the pen as it is held cap up.
- L- istrixxa bil- kodiċi tal- kulur ċelesti u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal- pinna
391 Measuring the dose of Viraferon Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Biex tkejjel id- doża ta ’ Viraferon Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
392 First, pull off the outer injection needle cap (Diagram G).
L- ewwel, neħħi l- kappa ta ’ barra tal- labra għall- injezzjoni (Disinn G).
393 Keeping the pen pointing upwards, press the push button up fully and see if a drop of Viraferon, solution for injection, appears at the injection needle tip (Notice the drop at the tip of injection needle in Diagram K below).
Żomm il- pinna tipponta ’ l fuq, agħfas il- buttuna kollha ’ l fuq u ara jekk titfaċċax qatra ta ’ Viraferon, soluzzjoni għall- injezzjoni, fil- ponta tal- labra (Innota l- qatra fil- ponta tal- labra għall- injezzjoni fid - Disinn K taħt). at izz tor Disinn K
This will allow the push button to move freely, ensuring that the correct dose is set. i na dic Me
Dan jippermetti li l- buttuna mnejn tagħfas tkun tista ’ titmexxa liberalment, u b’ hekk taċċerta li tista ’ tkun issettjata d- doża korretta. diċ
394 To set the required dose, hold the pen horizontally by the barrel with one hand.
Biex tissettja d- doża meħtieġa, aqbad il- pinna b’ id waħda mill- barrel u żommha mimduda.
With the other hand, turn the cap in a clockwise direction indicat ed by the arrow in Diagram M.
Bl- id l - oħra, dawwar il- kappa fid- direzzjoni bħall- arloġġ kif indikat bil- vleġġa fid- Disinn M.
To set the correct dose, turn the cap as many times as indicated as follows:
Biex tissettja d- doża l- korretta, dawwar il - kappa għal kemm hemm bżonn drabi kif inhu indikat hawn taħt. me ott od Pr:
Number of “turn s” and
Numru ta ’ “ dawriet ” u “ tfaqqih ”
Viraferon, solution for injection, multidose pen 30 million IU/pen:
at tuża Viraferon, soluzzjoni għall - injezzjoni, pinna b’ ħafna dożi
ed
izz 30 miljun IU/ pinna
1 full turn (5 clicks)
Tidwira 1 sħiħa (5 tfaqqihat)
6 clicks
6 tfaqqihat
7 clicks
7 tfaqqihat 8 tfaqqihat
3.5
3. 5 4
9 clicks
9 tfaqqihat
ra
2 dawriet
2 full turns (10 clicks)
sħaħ (10 tfaqqihat)
Diagram M
11- il tfaqqiha
ge
5. 5
5.5
ux
12 clicks
12- il tfaqqiha
lon
13- il tfaqqiha
13 clicks
6. 5
6.5
ad
14 clicks
14- il tfaqqiha
3 full turns (15 clicks)
3 dawriet sħaħ (15- il tfaqqiha)
16 clicks
’ għ
uc
7. 5
17 clicks
16- il tfaqqiha 17- il tfaqqiha
rod
im
8.5
8 8. 5
19 clicks
18- il tfaqqiha 19- il tfaqqiha 4 dawriet sħaħ (20 tfaqqiha) *
lp
li l
9.5
9 9. 5 10
The pen i s designed to deliver its contents of na
Il- pinna ser tinjetta massimu ta ’ ina
The pen will deliver a maximum of 12 doses of 2.5 million IUover a period not to exceed 4 weeks. i dic Me
12- il doża ta ’ 2. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. diċ me ott
395 The push button scale will show you the dose set (see Diagram N below).
L- iskala tal- buttuna mnejn tagħfas se turik id- doża ssettjata (ara d- Disinn N taħt).
For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
Għal dożi li jikkorrispondu għal tfaqqih bejn tidwir sħaħ, l- iskala għandha tiddelinja ruħha mal- marki bejn Pr
s
żewġ dożi xierqa għal tidwir sħieħ.
ori uth ra Diagram N
F’ dan il- punt aċċerta ruħek li għandek id- doża l- korretta. at izz tor Disinn N
396 Then press the push button down fully (see Diag ram P).
Imbagħad agħfas il- buttuna ’ l isfel kollha (ara d- Disinn P). ott od Pr
397 Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
Poġġi l- kappa tal- pinna lura f’ postha bit- trijanglu għal darb’ oħra biswit l- indikatur tad- dożaġġ kif muri fid- Disinn T.
ori Diagram T
Disinn T FULJETT TA ’ TAGĦRIF:
Viraferon, 60 million IU solution for injection, multidose pen Interferon alfa-2b
Viraferon 60 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
400 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tieħu xi mediċina.
401 Viraferon is usually intend ed for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
402 treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
at uġigħ fin- naħa t’ isfel tad- dahar jew fil- ġenb, diffikultà biex tagħmel l- awrina, problemi fl - għajnejn jew fil- vista jew fis- smigħ, telf tas- smigħ, ħmura qawwija jew li tweġġa ’ jew feriti
- The active substance is recombinant interferon alfa-2b, 60 million IU/ pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 60 miljun IU/ pinna
- The other ingredients are disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate,
- Is- sustanzi l- oħra huma disodium phosphate anhydrous, sodium dihydrogen phosphate
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 f’ 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. rod
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. od
Viraferon, 60 million IU/pen, solution for injection: lp
Viraferon, 60 miljun IU/ pinna, soluzzjoni għall- injezzjoni:
404 Tél/Tel: + 32-(0)2 370 92 11
aw Tél/ Tel: + 32 - (0) 2 370 92 11
Tel: + 372 654 96 86 Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος
EE- 11314 Tallinn Tel: + 372 654 96 86 me
405 Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: + 357-22 757188
ux Κύπρος Οδός Αγίου Νικολάου, 8
ge Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ lon
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. me ott od Pr KIF TINJETTA Viraferon LILEK INNIFSEK
- The colour coding strip pink and the push button are at the bottom of the pen as it is held cap up.
- L- istrixxa bil- kodiċi tal- kulur ċelesti/ roża u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal -
ge
ad pinna meta din tinżamm bil- kappa ’ l fuq.
Cap t
Kappa ta ’
407 Measuring the dose of Viraferon Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Biex tkejjel id- doża ta ’ Viraferon Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
D iagram D
Disinn D
Now screw the lp
(Innota li l- parti ta ’ diċ
injection needle onto the pen securely by turning it in a clockwise direction (see Diagram F).
Issa invita tajjeb il- labra għall- injezzjoni għal fuq il- pinna billi ddawwarha fid- direzzjoni skond l- arloġġ (ara d - Disinn F). me ott od Pr
408 First, pull off the outer injection needle cap (Diagram G).
L- ewwel, neħħi l- kappa ta ’ barra tal- labra għall- injezzjoni (Disinn G).
Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the lon injection needle (Diagram I).
ad Tektek il- ġibjun b’ sebgħek sabiex xi bżieżaq ta ’ l- arja li jista ’ jkun hemm jitilgħu fil- wiċċ, eżatt taħt il - labra għall- injezzjoni (Disinn
rod
Gibjun li l ina
no
’ għ
Diagram I lp
Disinn I diċ
Hold the pen by the barrel and turn the re servoir in the direction as indicated by the arrow in Diagram J (clockwise) until you feel it click.
Żomm il- pinna mill- barrel u dawwar il- ġibjun fid- direzzjoni indikata bil- vleġġa fid- Disinn J (fid - direzzjoni skond l- arloġġ) sakemm tħossha tikklikkja. me ott od
409 Keeping the pen pointing upwards, press the push button up fully and see if a drop of Viraferon, solution for injection, appears at the injection needle tip (Notice the drop at the tip of injection needle in Diagram K below).
Żomm il- pinna tipponta ’ l fuq, agħfas il- buttuna kollha ’ l fuq u ara jekk titfaċċax qatra ta ’ Viraferon, soluzzjoni għall- injezzjoni, fil- ponta tal- labra (Innota l- qatra fil- ponta tal- labra għall- injezzjoni fid - Disinn K taħt). at izz tor Disinn K
410 To set the required dose, hold the pen horizontally by the barrel with one hand.
Biex tissettja d- doża meħtieġa, aqbad il- pinna b’ id waħda mill- barrel u żommha mimduda.
To set the correct dose, turn the cap as many times as indicated as follows:
Biex tissettja d- doża l- korretta, dawwar il - kappa għal kemm hemm bżonn drabi kif inhu indikat hawn taħt: me ott od Pr Numru ta ’ “ dawriet ” u “ tfaqqih ”
Corresponding doses (million IU) using
Dożi li jikkorrispondu (miljun IU) meta tuża Viraferon, soluzzjoni għall - injezzjoni, pinna b’ ħafna dożi
Viraferon, solution for injection, multidose pen 60 million IU/pen:
at 60 miljun IU/ pinna
1 full turn (5 clicks)
Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat
6 clicks
8 tfaqqihat 9 tfaqqihat
ori
8 9
8 clicks
2 dawriet sħaħ (10 tfaqqihat) 11- il tfaqqiha 12- il tfaqqiha
9 clicks
10 11 12
9
ux
ra 2 full turns (10 clicks)
13- il tfaqqiha 14- il tfaqqiha
10
13 14
Diagram M
3 dawriet
12 clicks
sħaħ (15- il tfaqqiha) 16- il tfaqqiha
13
15 16
14 clicks
17- il tfaqqiha 18- il tfaqqiha 19- il tfaqqiha
17
17 18 19
19 clicks
4 dawriet
20
sħaħ (20 tfaqqiha) *
The pen will deliver a maximum of 12 doses of 5 million IU over a period not to exceed 4 weeks. i dic Me
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat. ina diċ me
411 The push button scale will show you the dose set (see Diagram N below).
L- iskala tal- buttuna mnejn tagħfas se turik id- doża ssettjata (ara d- Disinn N taħt).
If you
aw Wara kull dawra sħiħa kun ċert li t- trijanglu jinsab biswit l- indikatur tad- dożaġġ (ara d- Disinn O).
ge have set a wrong dose, simply turn the cap back (anti-clockwise) as far as you can until the push button is fully home and start again.
Jekk issettjajt doża ħażina, dawwar il- kappa lura (kontra d- direzzjoni ta ’ l- arloġġ) kemm tista ’ sakemm il- buttuna mnejn tagħfas tmur lura għall- pożizzjoni tal- bidu, u erga ’ ibda.
Once the correct dose is set you are ready to give the injection. lon
Meta tkun ssettjata
uc
ux d- doża l- korretta, tkun lest biex tagħti l- injezzjoni.
no
ad ’ għ im
Diagram O Injecting the solution rod
Disinn O li l
Select the injection site.
Agħżel il- post fejn se tinjetta.
Change your injection site each time. lp
Ibdel il- post ta ’ l- injezzjoni kull darba. diċ
Wait for the area to dry. na
Stenniha tinxef.
With one hand, pinch a fold of loo se skin.
B’ id waħda oqros biċċa ġilda ’ l barra.
Insert the needle into the pinched skin at an angle of approximately 45°. i
Daħħal il- labra f’ angolu ta ’ madwar 45° fil - ġilda maqrusa ’ l barra. me
Then press the push button down fully (see Diagram P). dic Me
Imbagħad agħfas il- buttuna ’ l isfel kollha (ara d- Disinn P). ott od Pr
412 Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon, solution for injection, to distribute under the skin, then remove.
Disinn P Bil- buttuna mniżżla s’ isfel, ħalli l- labra għall- injezzjoni fil- post għal ftit sekondi biex tippermetti lil Viraferon, soluzzjoni għall- injezzjoni, tinfirex taħt il- ġilda, imbagħad neħħiha.
ori uth ra Diagram Q
at izz tor aw ux ad Disinn Q
ge Completely unscrew the injection needle assembly using an anti-clockwise turning motion as shown in Diagram R.
Ħoll għal kollox l- immuntar tal- labra għall- injezzjoni billi ddawwar kontra d- direzzjoni ta ’ l- arloġġ kif muri fid- Disinn R.
Then carefully l ift it off the pen and discard the capped injection needle (see Diagram S). lon
Imbagħad għollih minn mal- pinna bl- attenzjoni u armi l- labra għall- injezzjoni ’ għ mgħottija bil- kappa (ara d- Disinn S). im li l ina diċ me
413 Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
Poġġi l- kappa tal- pinna lura f’ postha bit- trijanglu għal darb’ oħra biswit l- indikatur tad- dożaġġ kif muri fid- Disinn T.
ori uth Diagram T
Disinn T
What is ViraferonPeg?
X’ inhi ViraferonPeg?
ViraferonPeg is a medicine containing the active substance peginterferon alfa-2b.
ViraferonPeg hija mediċina li fiha s- sustanza attiva peginterferon alfa- 2b.
It is available as a powder and solvent to be made up into a solution for injection, and as a single use pre-filled pen.
Tiġi bħala trab u solvent biex titħallat f’ soluzzjoni għall- injezzjoni, u bħala pinna mimlija għal- lest sabiex tintuża darba biss.
These all contain 50, 80, 100, 120, or 150 micrograms of peginterferon alfa-2b per 0.5 ml.
Dawn kollha fihom 50, 80, 100, 120, jew 150 mikrogrammi ta ’ peginterferon alfa- 2b kull 0. 5 ml.
What is ViraferonPeg used for?
Għal x’ hiex tintuża ViraferonPeg?
ViraferonPeg is used to treat adult patients with chronic (long-term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
ViraferonPeg tintuża biex tittratta pazjenti adulti b’ epatite Ċ kronika (fuq tul ta ’ żmien) (marda tal - fwied minħabba infezzjoni bil- vajrus tal- epatite Ċ).
ViraferonPeg is used in patients whose liver is still functioning but who have signs of the disease (raised transaminases [liver enzymes] and markers of infection in the blood, such as viral RNA or antibodies against the virus).
ViraferonPeg tintuża f’ pazjenti li l- fwied tagħhom għadu jiffunzjona iżda li jkollhom sinjali tal- marda (żieda fit- transaminases [enzimi tal- fwied] u fil - markaturi ta ’ l- infezzjoni fid- demm, bħal RNA virali jew antikorpi kontra l- vajrus).
It can be used in patients also infected with human immunodeficiency virus (HIV).
Tista ’ tintuża f’ pazjenti infettati bil- vajrus ta ’ l- immunodefiċjenza tal- bniedem (HIV) ukoll.
The best way to use ViraferonPeg is with ribavirin (an antiviral medicine).
L- aħjar mod kif tuża ViraferonPeg huwa flimkien ma ’ ribavirin (mediċina antivirali).
This combination is suitable for treatment-naïve patients (who have not been treated before) and for patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Din il- kumbinazzjoni hija adatta għal pazjenti li jkunu ġodda għat- trattament (li ma jkunux ġew ittrattati qabel) u għal pazjenti li fihom ma jkunx ħadem trattament preċedenti, inluż kull tip ta ’ interferon alfa, bi jew mingħajr ribavarin.
ViraferonPeg can be used alone if the patient does not tolerate or should not take ribavirin.
ViraferonPeg tista ’ tintuża waħidha jekk il- pazjent ma jittollerax jew mhux suppost jieħu ribavirin.
How is ViraferonPeg used?
Kif tintuża ViraferonPeg?
ViraferonPeg treatment should be initiated and supervised by a doctor who has experience in the management of patients with hepatitis C.
Trattament ViraferonPeg għandu jinbeda u jiġi sorveljat minn tabib li għandu esperjenza fil- kura ta ’ pazjenti bl- epatite Ċ.
ViraferonPeg is given once a week as a subcutaneous injection (under the skin).
ViraferonPeg tingħata darba fil- ġimgħa bħala injezzjoni taħt il- ġilda (subcutaneous injection).
It used on its own at a dose of 0.5 or 1 microgram per kilogram body weight per week, or at a dose of 1.5 micrograms/ kg/ week when used with ribavirin.
Tintuża waħidha f’ doża ta ’ 0. 5 jew mikrogramm kull kilogram piż korporali fil- ġimgħa, jew f’ doża ta ’ 1. 5 mikrogrammi/ kg/ ġimgħa meta wżata ma ’ ribavirin.
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
It- tul ta ’ żmien tat - trattament jiddependi fuq il - kondizzjoni u r- reazzjoni għat- trattament tal- pazjent, u jvarja minn 24 ġimgħa sa sena.
For full dosing information, see the Summary of Product Characteristics (also part of the EPAR).
Għal tagħrif sħiħ fuq id- dożaġġ, ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti ukoll mill- EPAR).
ViraferonPeg has to be stored in a refrigerator (2°C - 8°C).
ViraferonPeg għandha tinħażen fil- friġġ (2°C - 8°C).
How does ViraferonPeg work?
Kif taħdem ViraferonPeg?
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘ interferons’.
Is- sustanza attiva f’ ViraferonPeg, peginterferon alfa- 2b, tagħmel parti mil- grupp ta ’ ‘ interferons ’.
The exact way alpha interferons work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the
L - interferons huma sustanzi naturali magħmula mill- ġisem biex jgħinuh jiġġieled kontra attakki bħal ma ’ huma infezzjonijiet ikkaġunati minn vajrusis.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- mod eżatt kif l- alfa interferons jaħdmu f’ mard virali m’ huwiex mifhum għal kollox, iżda huwa maħsub li jaħdmu bħala immunomodulaturi (sustanzi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged immune system, the body’ s defence system, works).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged li jimmodifikaw kif taħdem is- sistema immunitarja, li hija s- sistema tad- difiża tal- ġisem).
Alpha interferons may also block the multiplication of viruses.
L- Alfa interferons jistgħu jimblokkaw ukoll il- multiplikazzjoni tal- vajrusis.
Peginterferon alfa-2b is similar to interferon alfa-2b, which is already available in the European Union (EU) as IntronA.
Peginterferon alfa- 2b huwa simili għal interferon alfa- 2b, li diġà jinstab fl- Unjoni Ewropea (UE) bħala IntronA.
In ViraferonPeg, the interferon alfa-2b has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
F’ ViraferonPeg, l- interferon alfa- 2b ġiet ‘ pegylated ’ (miksija b’ kimika magħrufa bħala polyethylene glycol).
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Dan inaqqas ir- rata li biha s- sustanza titneħħa mill- ġisem u jippermetti li l - mediċina tingħata anqas ta ’ spiss.
The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
L- interferon alfa- 2b f’ ViraferonPeg hija magħmula b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: l- interferon alfa- 2b hija magħmula minn batterju li rċieva ġene (DNA), li jagħmlu kapaċi li jipproduċiha.
The replacement acts in same way as naturally produced interferon alpha.
Is- sostituzzjoni taħdem bl- istess mod bħal interferon alfa magħmul b’ mod naturali.
How has ViraferonPeg been studied?
Kif ġiet studjataViraferonPeg?
The use of ViraferonPeg alone in chronic hepatitis C has been studied in one study in 1,224 treatment- naïve adult patients.
L- użu ta ’ ViraferonPeg waħidha f’ epatite Ċ kronika ġie studjat fi studju f’ 1, 224 pazjent adult li kienu ġodda għat- trattament (li ma kienux ħadu trattament qabel).
ViraferonPeg used once a week for 48 weeks (at 0.5, 1 or 1.5 micrograms/ kg) was compared with interferon alfa-2b used at 3 million international units (IU) three times a week.
ViraferonPeg użata darba fil- ġimgħa għal 48 ġimgħa (f’ 0. 5, 1 jew 1. 5 mikrogrammi/ kg) ġiet imqabbla ma ’ interferon alfa- 2b użat fi 3 miljun unità internazzjonali (IU) tliet darbiet fil- ġimgħa.
The use of ViraferonPeg with ribavirin has been studied over 48 weeks in 1,580 treatment-naïve patients.
L- użu ta ’ ViraferonPeg ma ’ ribavirin ġie studjat tul 48 ġimgħa fuq 1, 580 pazjent li kienu ġodda għat- trattament (li ma kienux ħadu trattament qabel).
This study compared two schedules of ViraferonPeg used with ribavirin with the combination of interferon alfa-2b and ribavirin.
L - istudju qabbel żewġ skedi ta ’ ViraferonPeg użata ma ’ ribavirin mal- kumbinazzjoni ta ’ interferon alfa - 2b u ribavirin.
An additional two studies have looked at the use of ViraferonPeg in combination with ribavirin in 565 patients also infected with HIV, and a further study looked at the use of this combination in 1,354 patients whose previous treatment including interferon alfa (pegylated or non-pegylated) did not work or whose disease had come back after previous treatment.
Żewġ studji addizzjonali ħarsu lejn l- użu ta ’ ViraferonPeg f’ kumbinazzjoni ma ’ ribavirin f’ 565 pazjent infettati wkoll bl- HIV, u studju ieħor ħares lejn l- użu ta ’ din il- kumbinazzjoni fi 1, 354 pazjent li ma kienx ħadmilhom it- trattament preċedenti inkluż l- interferon alfa (‘ pegylated ’ jew mhux ‘ pegylated ’) jew dawk il- pazjenti li reġgħet feġġitilhom il- marda wara li jkunu diġà ħadu trattament.
The main measure of effectiveness was the level of hepatitis C virus RNA circulating in the blood before and during treatment, and at ‘ follow-up’, 24 weeks later.
Il- miżura ewlenija ta ’ l- effikaċja kienet il- livell ta ’ RNA tal- vajrus tal- epatite Ċ li kien qed jiċċirkola fid- demm qabel u waqt it- trattament, u waqt il- vista segwenti, 24 ġimgħa aktar tard.
What benefit has ViraferonPeg shown during the studies?
X’ benefiċċju weraViraferonPeg waqt l- istudji?
In the first study, ViraferonPeg was more effective than interferon alfa-2b.
Fl- ewwel studju, ViraferonPeg kienet aktar effettiva minn interferon alfa- 2b.
More patients had no circulating viral RNA after 24 weeks of treatment with ViraferonPeg than with interferon alfa-2b:
Wara 24 ġimgħa ta ’ trattament b’ ViraferonPeg aktar pazjenti ma kellhomx RNA virali jiċċirkola milli dawk il- pazjenti b’ interferon alfa- 2b:
46% with ViraferonPeg 1.5 microgram/ kg/ week compared with 24% with the comparator.
46% b’ ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa imqabbla ma ’ 24% mal - mediċina li ġiet imqabbla magħha.
Combining ribavirin and ViraferonPeg (as a once-weekly injection of 1.5 micrograms/ kg) was more effective than the combination with interferon alfa-2b (3 million IU three times a week): more patients had responded to treatment at the end of the study (65% compared with 54%).
Ribavirin u ViraferonPeg ikkumbinati flimkien (bħala injezzjoni ta ’ darba fil- ġimgħa ta ’ 1. 5 mikrogrammi/ kg/ piż korporali) kienu aktar effettivi mill- kumbinazzjoni ma ’ interferon alfa- 2b (3 miljun IU tliet darbiet fil- ġimgħa): aktar pazjenti irrispondew għat- trattament fi tmiem l- istudju (65% imqabbla ma ’ 54%).
The combination of ViraferonPeg with ribavirin was also effective for the treatment of hepatitis C in patients also infected with HIV.
Il- kumbinazzjoni ta ’ ViraferonPeg ma ’ ribavirin kienet ukoll effettiva għat- trattament ta ’ l- epatite Ċ f’ pazjenti infettati ukoll b’ HIV.
In the study of patients whose previous treatment did not work, around a fifth of the patients responded to treatment with ViraferonPeg and ribavirin.
Fl- istudju tal- pazjenti li ma kienx ħadmilhom it- trattament preċedenti, madwar wieħed minn kull ħames pazjenti rrispondew għat- trattament ViraferonPeg u ribavirin.
What is the risk associated with ViraferonPeg?
X’ inhu r- riskju assoċjat ma ’ ViraferonPeg?
The most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, weight loss, depression, irritability, insomnia (difficulty sleeping), anxiety, impaired concentration, emotional lability (mood swings), headache, dry mouth, dyspnoea (difficulty breathing), pharyngitis (sore throat), coughing, vomiting, nausea (feeling sick), abdominal (tummy) pain, diarrhoea, anorexia (loss of appetite), alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, injection site reaction (pain and redness), dizziness, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms and asthenia (weakness).
L- aktar effetti sekondarji komuni b’ ViraferonPeg (li ġew innutati f’ aktar minn pazjent 1 f’ 10) huma infezzjoni virali, telf fil- piż, depressjoni, irritabbilità, insomnja (diffikultà fl- irqad), ansjetà, diffikultajiet fil- konċentrazzjoni, instabilità emozzjonali (tibdil fil- burdata), uġigħ ta ’ ras, ħalq niexef, qtugħ ta ’ nifs, farinġite (uġigħ fil- griżmejn), sogħla, rimettar, nawsja (dardir), uġigħ addominali (taż - żaqq), dijarea, anoressja (telf ta ’ l- aptit), alopeċija (telf ta ’ xagħar), pruritus (ħakk), ġilda niexfa, raxx, mijalġja (uġigħ fil- muskoli), artralġja (uġigħ fil- ġogi), uġigħ muskoluskeletali (uġigħ fil- muskoli u l - għadam), infjammazzjoni fis- sit ta ’ l- injezzjoni, reazzjoni ta ’ ħmura u uġigħ fil- post fejn tingħata l - injezzjoni, sturdamenti, għeja kbira, rigors (rogħda bil- bard), deni, sintomi bħal ta ’ l- influwenza u astenja (dgħjufija).
For the full list of all side effects reported with ViraferonPeg, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ ViraferonPeg, ara l - Fuljett ta ’ Tagħrif.
ViraferonPeg should not be used in people who may be hypersensitive (allergic) to any interferon or any of the other ingredients.
ViraferonPeg m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal kwalunkwe interferon jew għal kwalunkwe sustanza oħra tiegħu.
For a list of all restrictions with ViraferonPeg, see the Package Leaflet.
ViraferonPeg m’ għandux jintuża f ’: • pazjenti bi storja ta ’ mard tal- qalb serju, • pazjenti b’ kondizzjonijiet mediċi serji, • pazjenti b’ mard awto- immunitarju (meta l- ġisem jattakka lilu nnifsu), • pazjenti bi problemi serji tal- fwied, • pazjenti b’ mard tat- tirojde sakemm mhux ikkontrollat, • pazjenti bl- epilessija jew problemi tas- sistema nervuża ċentrali oħra,
The Committee for Medicinal Products for Human Use (CHMP) decided that ViraferonPeg’ s benefits are greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum hepatitis C virus (HCV) RNA or anti-HCV including naïve patients with clinically stable HIV co-infection.
Il- Kumitat Għal Prodotti Mediċinali għall- Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ ViraferonPeg huma akbar mir- riskji tagħha għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika li għandhom transaminases għolja mingħajr dekompensazzjoni tal- fwied u li huma pożittivi għal RNA vajrus tas- serum ta ’ l- epatite Ċ (HCV) jew anti- HCV inklużi pazjenti li jkunu għadom ġodda għat - trattament b’ ko- infezzjoni HIV klinikament stabbli.
The Committee recommended that ViraferonPeg be given marketing authorisation.
Il- Kumitat irrakkomanda li ViraferonPeg tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about ViraferonPeg:
Other information about ViraferonPeg:
The European Commission granted a marketing authorisation valid throughout the European Union for ViraferonPeg to SP Europe on 29 May 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal ViraferonPeg lil SP Europe fid- 29 ta ’ Mejju 2000.
The marketing authorisation was renewed on 29 May 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 29 ta ’ Mejju 2005.