qanastek/EMEA-V3 huggingface dataset:
Commonly reported side effects (at least 1 in every 100 patients, but less than 1 in every 10 patients): thirst, dehydration, high blood pressure, migraines, swollen glands, flushing, menstrual problems, decreased sexual drive, vaginal problem, breast pain, pain in testicle, problems with thyroid gland, red na
Pr
gums, dry mouth, red or sore mouth or tongue, tooth ache or tooth disorder, herpes simplex (fever blisters), taste change, upset stomach, dyspepsia (heartburn), constipation, enlargement of liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, i dic
għatx, deidratazzjoni, pressjoni għolja, attakki tal- migranja, glandoli minfuħin, fwawar, problemi mestrwali, tnaqqis fix- xewqa sesswali, prblemi fil- vaġina, uġigħ tas- sider, uġigħ fit- testikoli, problemi bil- glandola tat- tirojde, ħanek jiħmar, ħalq xott, il- ħalq jew l- ilsien jiħmaru jew jinstelħu, uġigħ fis - snien jew disturbi fis- snien, herpes simplex (nuffati tad- deni), tibdil fit- togħma, taqlib ta ’ l- istonku, dispepsja (ħruq ta ’ stonku), stitikezza, tkabbir tal- fwied (problemi bil- fwied, kultant severi), ippurgar maħlul, tixrib tas- sodda fit- tfal, infjammazzjoni tas- sinus, bronkite, uġigħ fl- għajnejn, problema bit - tubi tad- dmugħ, konġunktivite (“ għajn roża ”), aġitazzjoni, ngħas, ħmar il- lejl, problema bl- imġieba, nervi, imnieħer imblukkat jew inixxi, għatis, nifs imgħaġġel, ġilda pallida jew ħamra, tbenġil, swaba ta ’ l- idejn u tar- riġlejn isiru sensittivi ħafna għal kesħa, problema bil- ġilda jew id- dwiefer, prorajiżi (tibda jew tmur għall- agħar), żieda fl- għaraq, żieda fil- bżonn li tgħaddi l- awrina, movimenti ta ’ tregħid
Me
at żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia
izz Effetti sekondarji rrappurtati b’ mod rari (mill- anqas 1 f’ kull 10, 000 pazjent, iżda anqas minn 1 f’ kull 1, 000 pazjent): pulmonite
Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
tor Effetti sekondarji rrappurtati rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent): pressjoni baxxa, wiċċ impaħpaħ, dijabete, bugħawwieġ fir- riġlejn, uġigħ fid- dahar, problemi tal - kliewi, ħsara fin- nervituri, fsada tal- ħanek, anemija aplastika.
Pure red cell aplasia, a condition where the body stopped or reduced the production
Aplasja pura taċ- ċelluli ħomor,
280 of red blood cells, has been reported.
aw kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet irrappurtata.
Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
ux F’ każijiet rari ħafna kienet irrappurtata sarkojdożi (marda kkaratterizzata b’ deni persistenti, telf ta ’ piż, ġogi minfuħa u muġugħa, feriti fil- ġilda u glandoli minfuħa).
Cases of stroke (cerebrovascular events) have been reported.
Każijiet ta ’ puplesija (każ ċerebrovaskulari) kien
s anaphylaxis (a severe, whole-body allergic reaction) have been reported, but their frequency is unknown.
ad irrappurtat.
ori Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with Viraferon use.
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk tħoss xi wieħed minn dawn is - sintomi. ’ għ Minbarra hekk, bl- użu ta ’ Viraferon kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla). im
uth Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. li l
HOW TO STORE VIRAFERON
KIF TAĦŻEN VIRAFERON ina
ge Keep out of the reach and sight of children. lon Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C – 8°C). diċ
If the product is not used during this four-week period, it should be no
Jekk il- prodott ma me
discarded.
jintużax matul dawn l- erba ’ ġimgħat, dan għandu jintrema.
If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours. t uc
Jekk ma tintużax mill- ewwel, għandha tinħażen bejn 2ºC – 8ºC fi friġġ u tintuża fi żmien 24 siegħa. ott
Do not use Viraferon after the expiry date which is stated on the package. rod
Tużax Viraferon wara d- data ta ’ skadenza li tidher fuq il- pakkett.
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. od
Any unused product must be discarded after withdrawal of the dose. lp
Kwalunkwe prodott li ma jintużax għandu jintrema wara li titwaqqaf id- doża.
Medicines should not be disposed of via wastewater or household waste.
Staqsi lill - Pr
These measures will help to protect the environment. na
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
FURTHER INFORMATION i dic
AKTAR TAGĦRIF
What Viraferon contains
X’ fih Viraferon:
- The active substance is recombinant interferon alfa-2b, 1 million IU/ ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 1 miljun IU/ ml.
- Solvent: water for injections 1 ml/ ampoule
- Solvent: ilma għall- injezzjonijiet 1 ml/ ampulla
What Viraferon looks like and contents of the pack
Id- Dehra ta ’ Viraferon u l- kontenuti tal- pakkett:
Viraferon is presented as a powder and solvent for solution for injection The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule with 1 injection syringe, 2 injection needles and 1 cleansing swab.
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml f’ siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex
281 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder:
Sid l- Awtorizzazzjoni għall- Kummerċ
SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
ux SP Europe 73, rue de Stalle B- 1180 Bruxelles
ed For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - ’ għ Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
s ori België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B-1180 Bruxelles/ Brussel/ Brüssel
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73
uth Tél/ Tel: + 32-(0)2 370 92 11
B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11
Č eská republika
diċ
Malta lon
H- 1123 Budapest Tel.: +36 1 457- 8500
Na Př íkopě 25 CZ-110 00 Praha 1 Tel: + 420 221771250
Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250 me
Danmark Lautrupbjerg 2 DK-2750 Ballerup
Danmark Lautrupbjerg 2 DK- 2750 Ballerup ott
Tlf: + 45-44 39 50 00
Tlf: + 45- 44 39 50 00
Deutschland Thomas-Dehler-Straße 27
Deutschland od
31-0
Thomas- Dehler- Straße 27 D- 81737 München Tel: + 49 - (0) 89 627 31- 0 Pr
s ori España Km.
at España
Portugal Rua Agualva dos Açores 16 P-2735-557 Agualva-Cacém
Rua Agualva dos Açores 16 P- 2735- 557 Agualva- Cacém Tel: +351- 21 433 93 00
ge Tel. + 40 21 233 35 30 Ireland Shire Park
aw F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00
Slovenija Dunajska 22 lon
Băneasa Center, et.
Welwyn Garden City Hertfordshire AL7 1TW Tel: + 44-(0)1 707 363 636
ux Ireland Shire Park Welwyn Garden City
SI-1000 Ljubljana Tel. + 386 01 3001070 no
Slovenija Dunajska 22 SI- 1000 Ljubljana
Ísland Hörga tún 2 IS-210 Garðabær
ad Tel: + 386 01 3001070 Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636 ’ għ Slovenská republika Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
uc
im
Italia Via fratelli Cervi snc,
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due
rod
li l
Centro Direzionale Milano Palazzo Borromini I-20090 Segrate (Milano)
Palazzo Borromini I- 20090 Segrate (Milano)
Due lp
ina
Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: + 357-22 757188 i dic
CY- 1055 Λευκωσία Τηλ: +357- 22 757188 me
Box 6185 S-102 33 Stockholm Tel: + 46-(0)8 522 21 500
S- 102 33 Stockholm Tel: + 46 - (0) 8 522 21 500
Rīga, LV-1004 Tel: + 371-7 21 38 25
United Kingdom Latvija Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25 ott
283 Lietuva Kęstučio g.
65/ 40 od
65/40 LT-08124 Vilniu s Tel. + 370 52 101868
LT- 08124 Vilnius Tel. + 370 52 101868 Pr
ed This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’
s ori Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
284 HOW TO SELF INJECT VIRAFERON
KIF TINJETTA VIRAFERON LILEK INNIFSEK
The following instructions explain how to inject Viraferon yourself.
It- tagħrif li ġej jispjegalek kif tinjetta Viraferon inti stess.
Your doctor or his/her assistant will instruct you how to self-inject Viraferon.
It- tabib tiegħek jew l- assistent tiegħu se jgħidulek kif tinjetta Viraferon lilek innifsek.
Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self - injection.
Tippruvax tinjetta lilek innifsek jekk m’ intix ċert li fhimt il- proċedura u l -
ed Preparation Collect nece ssary items before you begin:
izz Preparazzjoni Iġbor l- oġġetti li se jkollok bżonn qabel tibda:
- a vial of Viraferon powder for injection;
- kunjett ta ’ Viraferon, trab għall- injezzjoni;
- an ampoule of solvent for Viraferon (water for injections 1 ml);
- ampulla ta ’ solvent għal Viraferon (ilma għall- injezzjonijiet 1 ml);
- a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water for injections to
labra twila (per eżempju 0. 8 × 40 mm [21 gauge 1. 5 pulzieri]) biex iżżid l- ilma għall -
the Viraferon powder vial;
injezzjonijiet ġol- kunjett tat- trab ta ’ Viraferon;
- a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection;
aw labra qasira (per eżempju 0. 3 × 13 mm [30 gauge 0. 5 pulzieri]) għall- injezzjoni taħt il- ġilda;
ra Reconstituting Viraferon powder for injection Remove the protective cap from the Viraferon vial.
ux Biex tirrikostitwixxi Viraferon trab għall- injezzjoni Neħħi l- kappa protettiva mill- kunjett ta ’ Viraferon.
ge You can save the swab to clean the skin area where you will inject the dose.
Tista ’ terfa ’ t- tajjara biex tnaddaf il- ġilda fejn se tinjetta d- doża.
Remove the syringe from the wrapping.
Neħħi s- siringa
Remove the needle guard without touching the needle and keep the syringe with the needle in your lon hand.
Neħħi l- protezzjoni tal- labra mingħajr ma tmiss il- labra u żomm is- siringa bil- labra magħha f’ idek.
Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Tektek bil- mod il- parti ta ’ fuq ta ’ l- ampulla tas- solvent biex tagħmel fiċ- ċert li l- likwidu kollu jinsab ’ għ fil- qiegħ ta ’ l- ampulla.
Insert the needle in the ampoule of solvent and withdraw the total amount of solvent. no
Daħħal il- labra fl- ampulla tas - solvent u iġbed l- ammont sħiħ ta ’ solvent.
To prepare the Viraferon solution insert the needle through the rubber top of the Viraferon vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands. t
Biex tipprepara s- soluzzjoni ta ’ Viraferon deffes il- labra mill- parti ta ’ fuq tal- gomma tal- kunjett ta ’ im
Slowly inject the diluent, aiming the stream of liquid at the glass wall of the vial in order to avoid production uc
Injetta d- dilwent bil- mod, u mmira n- nixxiegħa tal- likwidu lejn il- ħajt tal- ħġieġ tal- kunjett sabiex li l
of air bubbles.
tevita milli jiffurmaw bżieżaq ta ’ l- arja.
If air bubbles do form, wait until the solution has settled and rod
Biex iddewweb il- kontenut l- abjad, dawwar bil- galbu l- kunjett ta ’ Viraferon b’ moviment forma ta ’ ċirku filwaqt li tħalli l- labra tas- siringa fil- kunjett, sakemm il- kontenut ikun dab għal kollox. ina
all bubbles have risen to the top of the solution and disappeared before withdrawing your dose from the vial.
Jekk xorta waħda jiffurmaw il- bżieżaq ta ’ l- arja, stenna sakemm is- soluzzjoni tkun qagħdet u l- bżieżaq kollha jkunu telgħu fil- wiċċ tas- soluzzjoni u jkunu sparixxew qabel ma tiġbed id- doża tiegħek mill- kunjett.
If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours. lp
Jekk ma tintużax mill- ewwel, għandha tinħażen f’ temperatura ta ’ 2ºC – 8ºC fi friġġ u tintuża fi diċ
Measuring the dose of Viraferon from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Biex tkejjel il- doża ta ’ Viraferon mit- trab rikostitwit għall- injezzjoni me
reconstituted solution.
Dawwar il- kunjett u s- siringa rashom ’ l isfel f’ id waħda.
Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe.
Iġbed il - planġer lura bil- mod biex ittella ’ d- doża l- korretta li qallek it- tabib għal ġos- siringa.
Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle leaving the i dic
Aqbad il- labra l- qasira u waħħalha ott
needle in the vial and without touching the tip of the syringe.
tajjeb mat- tarf tas- siringa.
Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Neħħi l- protezzjoni tal- labra minn mal- labra tas- siringa u ċċekkja għal xi bżieżaq ta ’ l- arja fis- siringa.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Jekk tara xi bżieżaq, iġbed il- planġer ftit lura; tektek is- siringa bil- galbu, bil- labra tipponta ’ l fuq, sakemm il- bżieżaq jisparixxu.
Push up the plunger slowly back to the correct dose.
Imbotta l- planġer bil- mod ’ il fuq lura lejn id - od
Replace the Me
doża l- korretta.
needle guard and place the syringe with the needle on a flat surface.
Kun ċert li s- soluzzjoni għandha t- temperatura tal- kamra ta ’ mhux aktar minn 25°C.
If the solution is cold, warm the syringe between your palms.
hija kiesħa, saħħan is- siringa bejn il- pali ta ’ jdejk.
285 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
ed Cleanse and disinfect the skin where the injection is to be made.
at Naddaf u ddiżinfetta l- ġilda fejn se tagħti l- injezzjoni.
With your other hand hold the syringe as you would a
Neħħi l- protezzjoni tal- labra.
s pencil.
izz B’ id waħda oqros biċċa ġilda ’ l barra.
Inject the solution by pushing the
Injetta s- soluzzjoni billi timbotta l- planġer bil- mod s’ isfel.
Pull the needle straight out of the skin.
tor Iġbed il- labra dritt ’ l barra mill- ġilda.
If there is bleeding, cover with an adhesive
Jekk ikun ħiereġ id - demm, għatti b’ faxxa li teħel.
ra ge lon
aw Armi s- siringa u l- labar ġo kontenitur magħluq mingħajr ma toħloq periklu.
286 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 3 million IU/ml powder and solvent for solution for injection Interferon alfa -2b
Viraferon 3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni Interferon alfa- 2b
Before you use Vi raferon 3.
Qabel ma ’ tuża Viraferon 3.
WHAT VIRAFERON IS AND WHAT IT IS USED FOR lon Viraferon (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe d iseases.
X’ INHU VIRAFERON U GĦALXIEX JINTUŻA
- if you have severe heart disease.
ina
lp
Viraferon.
(other than short -term treatment with cortisone-type medicine).
- jekk għandek l- epatite u jekk dan l- aħħar kont ittrattat b’ medikazzjonijiet li jrażżnu s- sistema
The use of interferon alfa -2b in children and
L- użu ta ’ interferon alfa- 2b fi tfal u
adolescents with existence of or history of severe psychiatric conditions is contraindicated (see “Do not use Viraferon”)
adolexxenti b’ mard jew passat mediku ta ’ kunidzzjonijiet psikjatriċi huwa kontra- indikat (ara “ Tużax Viraferon ”)
- if you have ever had depression or develop symptoms associated with depression (e.g. feelings of sadness,
- jekk qatt kellek dipressjoni jew tiżviluppa sintomi assoċjati mad- dipressjoni (eż dwejjaq, swied
- if you notice unusual ble eding or bruising check with your doctor immediately.
- jekk tinnota ħruġ tad- demm jew tbenġil mhux tas- soltu aċċerta ruħek mat- tabib tiegħek
- if you are al so being treated for HIV, please see Using other medicines.
- jekk qiegħed ukoll tkun ttrattat għall- HIV, jekk jogħġbok ara Meta tuża mediċini oħra.
drowsiness.
Viraferon jżid ma ’ l- effetti tas- sustanzi li jbaxxulek ir- ritmu tas- sistema nervuża, u dan jista ’ jqabbdek in- nagħas.
288 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.
If you are prescrib ed Viraferon in combination with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur:
Jekk jordnawlek Viraferon flimkien ma ’ ribavirin, ribavirin jista ’ jgħamel ħsara kbira lit- tarbija mhux imwielda, għalhekk kemm pazjenti nisa kif ukoll irġiel għandhom jieħdu prekawzjonijiet speċjali fl -
You and your partner mu st each use an effective contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment.
Int u sieħbek tridu tużaw kull wieħed kontraċettiv effettiv waqt iż- żmien li tkun qed tieħu ribavirin u għal 4 xhur wara li titwaqqaf il- kura.
ori This will lessen the chance for ribavirin to be left in the woman’s body.
Dan inaqqas ir- riskju li ribavirin jitħalla fil- ġisem tal- mara.
uth and your partner must each use an effective cont raceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Jekk int pazjent raġel, int u seħbitek għandkom tużaw kull wieħed kontraċezzjoni effettiva waqt il- ħin li tkun qed tieħu ribavirin u għal 7 xhur wara li l- kura titwaqqaf.
ge Driving and using machines Do not drive or use machinery if you become drowsy, tired, or confused from this medicine. lon Important information about some of the ingredients of Viraferon Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived albumin. no
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Viraferon It- tabib tiegħek jista ’ jirrakomanda li titlaqqam għall- epatite A u B jekk int tirċievi b’ mod im
and the testing of each donation and pools of plasma for signs of virus/infections.
plażma miġbura għal sinjali ta ’ virus/ infezzjonijiet.
289 The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
at jistgħu jvarjaw, u t- tabib jista ’ jibdillek id- doża skond il- ħtiġijiet partikolari tiegħek:
s ori Your doctor may prescribe a different dose of Viraferon alone or in combination with other medicines (e.g. ribavirin).
aw It- tabib tiegħek jista ’ jippreskrivi doża differenti ta ’ Viraferon, waħdu jew flimkien ma ’ mediċini oħra (eż., cytarabine, ribavirin).
and you accidentally missed a full day’s dose, continue treatment at the usual dose the following day.
Jekk imissek tinjetta dan il- prodott kuljum, u bi żball taqbeż id- doża ta ’ ġurnata sħiħa, kompli bit- trattament tas- soltu fil- jum li jmiss.
290 If any of the following side effects happen, stop taking Viraferon and tell your doctor immediately or go to the casualty department at your nearest hospital: • swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
tor • nefħa ta ’ l- idejn, is- saqajn, l- għekiesi, il- wiċċ, ix- xufftejn, il- ħalq jew il- gerżuma li jista ’ jikkawża diffikultà biex tibla ’ jew biex tieħu n- nifs; urtikarja; ħass ħażin.
If you have them, you may have had a serious allergic reaction to Viraferon.
Jekk ikollok minnhom, jista ’ jkun li kellek
You may ne ed urgent medical attention or hospitalisation.
Jista ’ jkun li teħtieġ attenzjoni medika urġenti jew li tittieħed l- isptar.
These may signal serious side effects that may need ur gent medical attention.
Dawn jistgħu jkunu s- sinjal ta ’ effetti sekondarji serji li jistgħu jeħtieġu attenzjoni medika urġenti.
At the beginning of treatment with Viraferon, you may experience a flu-like reaction, with fever, fatigue, lon headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ Viraferon, jista ’ jkollok reazzjoni tixbaħ lill- influenza, bid- deni, bl- għeja, bl - uġigħ ta ’ ras, bl- uġigħ fil- muskoli, bl- uġigħ fil- ġogi u bit- tkexkix jew bir- rogħda tal- bard.
insomnia, anxiety, sore throat and painful swallowing, fatigue, chills/rigors, fever, flu-like reaction, feeling of general discomfort, headaches, weight loss, vomiting, irritability, weakness, mood swings, coughing (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, rod
uġigħ, nefħa u ħmura jew ħsara fil- ġilda fis- sit mnejn tingħata l- injezzjoni, telf tax- xagħar, sturdament, tibdil fl- aptit, weġgħat fl- istonku jew fl- addome, dijarea, tqalligħ (tħossok marid), infezzjoni virali, depressjoni, burdati emozzjonali, nuqqas ta ’ rqad, ansjetà, grieżem misluħa u uġigħ biex tibla, għeja, dehxiet/ tregħid, deni, reazzjoni bħal ta ’ l- influwenza, tħossok skomdu b’ mod ġenerali, attakki ta ’ uġigħ ta ’ ras, telf tal- piż, rimettar, irritabilità, dgħjufija, tibdil fil- burdati, sogħla (kultant qawwija), ott
291 of red blood cells, has been reported.
aw kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet irrappurtata.
Cases of stroke (cerebrovascular events) have been report ed.
Każijiet ta ’ puplesija (każ ċerebrovaskulari) kien
ed Periodontal (affecting gums) and dental disorders, altered mental status, loss of consciousness, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and
ad irrappurtat.
Viraferon is presented as a powder and solvent for solution for injection The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml.
292 Viraferon is available in two different pack sizes:
aw Viraferon jiġi f’ żewġ daqsijiet ta ’ pakketti differenti:
- Pack of 1 vial of powder for solution for injection, 1 ampoule of water for injections, 1 injection
- Pakkett b’ kunjett 1 ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni, ampulla 1 bl- ilma
syringe, 2 injection needles and 1 cleansing swab
għall- injezzjonijiet, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
- Pack of 6 vials of powder for solution for injection and 6 ampoules of water for injections
- Pakkett b’ 6 kunjetti ta ’ trab għal soluzzjoni għall injezzjoni jew infużjoni u 6 ampulli bl- ilma
Not all pack sizes may be marketed.
għall- injezjonijiet Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
SP Europe 73, rue de Stalle
ad Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe
Manufacturer:
’ għ
Industriepark 30
Manifattur SP Labo N. V.
s B-1180 Bruxelles
73, rue de Stalle B- 1180 Bruxelles
ori Belgium
Il- Belġju
Belgium
Il- Belġju
For any information about this medicinal product, please contact the local representative of the Marketing
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq: li l
ra Rue de Stalle/Stallestraat 73 B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel ina
Rue de Stalle 73 B-1180 Bruxelles/Brüssel Belgique/Belgien
Luxembourg/ Luxemburg Rue de Stalle 73 B- 1180 Bruxelles/ Brüssel
ge Tél/Tel: + 32-(0)2 370 92 11
Belgique/ Belgien Tél/ Tel: + 32 - (0) 2 370 92 11 Tél/ Tel: + 32 - (0) 2 370 92 11
Милко Бичев" № 7, ет.3 BG-София 1504 Тел.: +359 2 944 1073
Милко Бичев "№ 7, ет. 3 BG- София 1504 Тел.: +359 2 944 1073 me
Česká republika Na Příkopě 25 CZ-110 00 Praha 1
Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250 ott
Malta 168 Christopher Street MT-VLT02 Valletta
168 Christopher Street MT- VLT02 Valletta Tel: + 356- 21 23 21 75
Danmark Lautrupbjerg 2
Danmark Lautrupbjerg 2 od
DK-2750 BallerupTlf: + 45-44 39 50 00 lp i na dic Me
DK- 2750 Ballerup Tlf: + 45- 44 39 50 00 Pr
293 Deutschland Thomas-Dehler-Straße 27 D-81737 München Tel: + 49-(0)89 627 31-0
Deutschland Thomas- Dehler- Straße 27 D- 81737 München Tel: + 49 - (0) 89 627 31- 0 Eesti
ed Järvevana tee 9 EE-11314 Tallinn Tel: + 372 654 96 86
Järvevana tee 9 EE- 11314 Tallinn Tel: + 372 654 96 86
s ori Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος
at Ελλάδα
uth Tηλ: + 30-210 98 97 300
Jerozolimskie 195a Αγίου Δημητρίου 63 PL- 02- 222 Warszawa GR- 174 55 Άλιμος Tel.: + 48 - (0) 22 478 41 50 Tηλ: + 30- 210 98 97 300
Rua Agualva dos Açores 16 P-2735-557 Agualva-Cacém Tel: + 351-21 433 93 00
Portugal Rua Agualva dos Açores 16
F-92300 Levallois-Perret Tél: + 33-(0)1 41 06 35 00
ux F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00
Slovenija no
ad Tel. + 40 21 233 35 30
Shire Park Welwyn Garden City Hertfordshire AL7 1TW
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
Dunajska 22 SI-1000 Ljubljana Tel. + 386 01 3001070
Slovenija ’ għ Dunajska 22 SI- 1000 Ljubljana Tel: + 386 01 3001070
Tel: + 44-(0)1 707 363 636 uc
Slovenská republika
Ísland Hörgatún 2
Hörgatún 2 IS- 210 Garðabær
Slovenská republika Strakova 5
Strakova 5 SK- 811 01 Bratislava
lp
ina
Via fratelli Cervi Centro Direzionale
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini diċ
PL 3/PB 3 FIN-02201 Espoo/Esbo
Suomi/ Finland PL 3/ PB 3 FIN- 02201 Espoo/ Esbo Puh/ Tel: + 358 - (0) 20- 7570 300
Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1 i dic Me
I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1 me
294 Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: + 357-22 757188
Sverige Κύπρος Box 6185 Οδός Αγίου Νικολάου, 8 S- 102 33 Stockholm CY- 1055 Λευκωσία Τηλ: +357- 22 757188 ott
Latvija Bauskas 58a -401
Latvija Bauskas 58a - 401 Rīga, LV- 1004 od
ed Rīga, LV-1004 Tel: + 371-7 21 38 25
Tel: + 371- 7 21 38 25 Pr
ra This leaflet was last approved on
65/ 40 LT- 08124 Vilnius Tel. + 370 52 101868 Dan il- fuljett kien approvat l- aħħar f ’
ge De tailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
295 HOW TO SELF INJECT VIRAFERON
at izz tor aw ux ad ’ għ im li l ina diċ me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
Your doctor or his/her assistant will instruct you how to self -inject Vir aferon.
It- tabib tiegħek jew l- assistent tiegħu se jgħidulek kif tinjetta Viraferon lilek innifsek.
Do not attempt to inject your self unless you are sure you understand the procedure and requirement of self- injection.
Tippruvax tinjetta lilek innifsek jekk m’ intix ċert li fhimt il- proċedura u l -
ed Preparation Collect necessary items before you begin:
izz Preparazzjoni Iġbor l- oġġetti li se jkollok bżonn qabel tibda:
296 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni 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 ne ed the assistance of another person to use this site), abdomen (except the navel or waistline).
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).
297 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 5 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Viraferon 5 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni Interferon alfa- 2b
Read all of this leaflet carefully before you start using this m edicine.
at Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
Do not pa ss it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
What Vi raferon is and what it is used for 2.
X’ inhu Viraferon u għalxiex jintuża 2.
- if you have hep atitis and have been treated recently with medications that suppress the immune system
- jekk għandek mard avanzat ta ’ dikompensazzjoni (mhux kontrollata) tal- fwied.
(other than short-term treatment w ith cortisone-type me dicine).
immunitarja (barra t- trattament fuq perijodu qasir ta ’ żmien bil- mediċina tat- tip cortisone).
- if you have had a s evere nervous or mental disorder.
- jekk kellek problemi tas- sistema nervuża jew mentali.
ed while on thi s medication seek medical help immediately.
izz urtikarja) waqt li tkun fuq din il- medikazzjoni, fittex għajnuna medika immedjatament.
299 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.
ed each month during treatment, and for the 4 month s after treatment is stopped.
izz kull xahar waqt il- kura, u għal 4 xhur wara li l- kura titwaqqaf.
300 The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
at jistgħu jvarjaw, u t- tabib jista ’ jibdillek id- doża skond il- ħtiġijiet partikolari tiegħek:
5 to 10 million IU 3 times a week (every other day) inject ed subcutaneously (under the skin).
5 sa 10 miljun IU 3 darbiet fil- ġimgħa (darba kull jumejn) injettati taħt il- ġilda.
Adult s - 3 million IU 3 times a week (every other day) injected subcutaneously (under the
Adulti - 3 miljun IU 3 darbiet fil- ġimgħa (darba kull jumejn) injettati taħt il- ġilda
If you are scheduled to inject this product every day, and lp
Jekk qed tagħti l- kura lilek innifsek, jew jekk int qed tieħu ħsieb il- kura ta ’ tifel jew tifla li qed jieħu/ tieħu Viraferon f’ kombinazzjoni ma ’ ribavirin, injetta d- doża rakkomandata malli tiftakar u me
you accidentally missed a full day’s dose, continue treatment at the usual dose the following day.
Jekk imissek tinjetta dan il- prodott kuljum, u bi żball taqbeż id- doża ta ’ ġurnata sħiħa, kompli bit- trattament tas- soltu fil- jum li jmiss.
301 If any of the following side effects happen, stop taking Viraferon and tell your doctor immediately or go to the casualty department at your nearest hospital: • swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
tor • nefħa ta ’ l- idejn, is- saqajn, l- għekiesi, il- wiċċ, ix- xufftejn, il- ħalq jew il- gerżuma li jista ’ jikkawża diffikultà biex tibla ’ jew biex tieħu n- nifs; urtikarja; ħass ħażin.
The se very serious side effects are very
Dawn l- effetti sekondarji serji ħafna huma rari ħafna.
302 of red blood cells, has been reported.
aw kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet irrappurtata.
Loss of consciousness has occurr ed very rarely, mostly in elderly patients treated at high doses.
Telf mis- sensi seħħet rari ħafna, l - aktar f’ pazjenti anzjani li ngħataw dożi għoljin.
Ca ses of stroke (cerebrovascular events) have been reported.
Każijiet ta ’ puplesija (każ ċerebrovaskulari) kien
ed Periodontal (affecting gums) and dental disorders, altered mental status, loss of consciousness, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mo uth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and
ad irrappurtat.
ori Additionally, Vogt-Koyanagi-Ha rada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with Viraferon use.
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk tħoss xi wieħed minn dawn is - sintomi. ’ għ Minbarra hekk, bl- użu ta ’ Viraferon kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla). im
303 Viraferon is available in two different pack sizes:
aw Viraferon jiġi f’ żewġ daqsijiet ta ’ pakketti differenti:
syringe, 2 injection ne edles and 1 cleansing swab
għall- injezzjonijiet, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
Милко Бичев" № 7, ет.3 BG-София 1504 Тел.: +359 2 944 1073 Česká republika
Милко Бичев "№ 7, ет. 3 BG- София 1504 Тел.: +359 2 944 1073 me
Na Příkopě 25 CZ-110 00 Praha 1 Tel: + 420 221771250
Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250 ott
Danmark Lautrupbjerg 2 DK-2750 BallerupTlf: + 45-44 39 50 00 rod
Danmark Lautrupbjerg 2 od
Tel: + 31-(0)800 778 78 78 Deutschland Thomas-Dehler-Straße 27
DK- 2750 Ballerup Tlf: + 45- 44 39 50 00 Pr
398
NL- 3542 DN Utrecht Tel: + 31 - (0) 800 778 78 78
Tel: + 49-(0)89 627
Deutschland Thomas- Dehler- Straße 27 D- 81737 München Tel: + 49 - (0) 89 627 31- 0 Eesti
31-0 na
Österreich
Eesti Österreich Järvevana tee 9 EE-11314 Tallinn dic
Järvevana tee 9 EE- 11314 Tallinn Tel: + 372 654 96 86
Badener Strasse 23 A-2514 Traiskirchen
Badener Strasse 23 A- 2514 Traiskirchen Tel: + 43 - (0) 2252 502- 0
Tel: + 372 654 96 86
at Ελλάδα
GR-174 55 Άλιμος Tηλ: + 30-210 98 97 300
izz Al.
PL-02-222 Warszawa Tel.: + 48-(0)22 478 41 50
Jerozolimskie 195a Αγίου Δημητρίου 63 PL- 02- 222 Warszawa GR- 174 55 Άλιμος Tel.: + 48 - (0) 22 478 41 50 Tηλ: + 30- 210 98 97 300
España Km.
tor España Km.
Portugal Rua Agualva dos Açores 16 P-2735-557 Agualva-Cacém Tel: + 351-21 433 93 00
Portugal Rua Agualva dos Açores 16
304 France 92 rue Baudin F-92300 Levallois-Perret Tél: + 33-(0)1 41 06 35 00
France 92 rue Baudin
8, sector 1 RO-013682 Bucureşti Tel. + 40 21 233 35 30
ux F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00
Ireland
Băneasa Center, et.
Slovenija
ad Tel. + 40 21 233 35 30
s Tel: + 44-(0)1 707 363 636
Slovenská republika
ori Ísland Hörgatún 2
Hörgatún 2 IS- 210 Garðabær
uth IS-210 Garðabær Sími: + 354 535 70 00
Sími: + 354 535 70 00
ra Italia Via fratelli Cervi snc, Centro Direzionale Milano Due
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini diċ
ge Palazzo Borromini I-20090 Segrate (Mila no) Tel: + 39-02 21018.1
I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1 me
Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία
Sverige Κύπρος Box 6185 Οδός Αγίου Νικολάου, 8 S- 102 33 Stockholm CY- 1055 Λευκωσία Τηλ: +357- 22 757188 ott
Bauskas 58a -401
Latvija Bauskas 58a - 401 Rīga, LV- 1004 od
Rīga, LV-1004 Tel: + 371-7 21 38 25
Tel: + 371- 7 21 38 25 Pr
ed This leaflet was last approved on
65/ 40 LT- 08124 Vilnius Tel. + 370 52 101868 Dan il- fuljett kien approvat l- aħħar f ’
s Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
306 HOW TO SELF INJECT VIRAFERON
at izz tor aw ux ad ’ għ im li l ina diċ me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
Your doctor or hi s/her assistant will instruct you how to self-inject Viraferon.
It- tabib tiegħek jew l- assistent tiegħu se jgħidulek kif tinjetta Viraferon lilek innifsek.
307 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
ed Clean se and disinfect the skin where the injection is to be made.
at Naddaf u ddiżinfetta l- ġilda fejn se tagħti l- injezzjoni.
308 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 10 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Viraferon 10 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni Interferon alfa- 2b
- Thi s medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek.
- if you have had serious nervous or ment al problems, such as severe depression or thoughts of suicide.
- jekk kellek problemi tas- sistema nervuża jew mentali, bħal dipressjoni severa jew ħsibijiet dwar
- if you develop symptoms associat ed with a cold or other respiratory infection, such as fever, cough, or any
- jekk jaqbduk sintomi assoċjati ma ’ riħ jew ma ’ infezzjoni oħra respiratorja, bħal ma huma d -
uth memb ranes of the mouth during long-term treatment with the combination of Viraferon with ribavirin.
aw lis- snien u l- membrani tal- ħalq waqt kura fuq tul ta ’ żmien b’ kombinazzjoni ta ’ Viraferon ma ’ ribavirin.
310 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.
In studies in pregnant animals, interferons have sometimes caus ed miscarriage.
Fi studji f’ annimali waqt it - tqala, l- interferoni xi kultant ikkawżaw korriment.
- if you are a girl or a woman of childbearing age, you mu st have a negative pregnancy test before treatment,
- jekk int tfajla jew mara li jista ’ jkollok it- tfal, irid ikollok test negattiv għat- tqala qabel il- kura,
311 The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
at jistgħu jvarjaw, u t- tabib jista ’ jibdillek id- doża skond il- ħtiġijiet partikolari tiegħek:
Chronic hepatiti s C:
Epatite Ċ kronika:
If you are prescribed Vi raferon in combination with another medicine, please refer also to the Package Leaflet of the medicine to be used in combination.
Jekk għandek riċetta ta ’ Viraferon li tinkludi magħha mediċina oħra, jekk jogħġbok irreferi wkoll għall- Fuljett ta ’ Tagħrif tal- mediċina l- oħra.
312 If any of the following side effects happen, stop taking Viraferon and tell your doctor immediately or go to the casualty department at your nearest hospital: • swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
tor • nefħa ta ’ l- idejn, is- saqajn, l- għekiesi, il- wiċċ, ix- xufftejn, il- ħalq jew il- gerżuma li jista ’ jikkawża diffikultà biex tibla ’ jew biex tieħu n- nifs; urtikarja; ħass ħażin.
You may need urgent medical attention or ho spitalisation.
Jista ’ jkun li teħtieġ attenzjoni medika urġenti jew li tittieħed l- isptar.
313 of red blood cells, has been reported.
aw kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet irrappurtata.
Very rarely sarcoidosis, (a disease characteris ed by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
ux F’ każijiet rari ħafna kienet irrappurtata sarkojdożi (marda kkaratterizzata b’ deni persistenti, telf ta ’ piż, ġogi minfuħa u muġugħa, feriti fil- ġilda u glandoli minfuħa).
Lo ss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses.
Telf mis- sensi seħħet rari ħafna, l - aktar f’ pazjenti anzjani li ngħataw dożi għoljin.
314 Viraferon is available in three different pack sizes:
aw Viraferon jiġi f’ żewġ daqsijiet ta ’ pakketti differenti:
- Pack of 10 vials of powder for solution for injection, 10 ampoules of water for injections, 10 injection
għall- injezjonijiet
syringes, 20 injection needles and 10 cleansing swabs
- Pakkett b’ 10 kunjetti ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni, 10 ampulli bl- ilma
ed Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali. ’ għ Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe 73, rue de Stalle B- 1180 Bruxelles
Marketing Auth orisation Holder:
im
Manufacturer:
Manifattur SP Labo N. V.
s SP Europe
Il- Belġju
SP Labo N.V.
Il- Belġju
ori 73, rue de Stalle B-1180 Bruxelles Belgium
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - li l
Industriepark 30 B-2220 Heist-op-den-Berg Belgium
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
uth For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/ Belgique/ Belgien
ra België/Belgique/Belgien Rue de Stalle/Stallestraat 73
ina
Luxembourg/Luxemburg Rue de Stalle 73
Luxembourg/ Luxemburg
ge B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11 diċ
B-1180 Bruxelles/Brüssel Belgique/Belgien Tél/Tel: + 32-(0)2 370 92 11 lon
Rue de Stalle 73 B- 1180 Bruxelles/ Brüssel Belgique/ Belgien Tél/ Tel: + 32 - (0) 2 370 92 11
Милко Бичев" № 7, ет.3 BG-София 1504
Милко Бичев "№ 7, ет. 3 me
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Tlf: + 45- 44 39 50 00 Deutschland Thomas- Dehler- Straße 27
Ee sti
Tel: + 31 - (0) 800 778 78 78
Österreich
at Eesti Österreich
ed Järvevana tee 9 EE-11314 Tallinn Tel: + 372 654 96 86
izz Järvevana tee 9 EE- 11314 Tallinn Tel: + 372 654 96 86
s ori Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος
tor Ελλάδα Αγίου Δημητρίου 63
uth Tηλ: + 30-210 98 97 300
aw PL- 02- 222 Warszawa GR- 174 55 Άλιμος Tel.: + 48 - (0) 22 478 41 50 Tηλ: + 30- 210 98 97 300
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t
li l
Tel: + 44-(0)1 707 363 636 uc
Tel: +44 - (0) 1 707 363 636 ina
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lp
diċ
Suomi/Finland
Suomi/ Finland PL 3/ PB 3
Via fratelli Cervi Centro Direzionale
Via fratelli
snc, Milano Due na
Cervi snc, me
Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1 i dic Me
FIN- 02201 Espoo/ Esbo Centro Direzionale Milano Due Puh/ Tel: + 358 - (0) 20- 7570 300 Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1 ott od Pr Κύπρος Οδός Αγίου Νικολάου, 8 CY- 1055 Λευκωσία Τηλ: +357- 22 757188
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ed Rīga, LV-1004 Tel: + 371-7 21 38 25
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tor Lietuva Kęstučio g.
uth Tel. + 370 52 101868
aw LT- 08124 Vilnius Tel. + 370 52 101868
ra This leafle t was last approved on
Dan il- fuljett kien approvat l- aħħar f ’
ge Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
ux Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
317 HOW TO SELF INJECT VIRAFERON
ad ’ għ im li l ina diċ me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
318 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
319 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 3 million IU/0.5 ml solution for injection Interferon alfa-2b
Viraferon 3 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni Interferon alfa- 2b
321 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.
ge Driving and using machines Do not drive or use machinery if you become drowsy, tired, or confused from this medicine. lon 3.
ad Sewqan u tħaddim ta ’ magni M’ għandekx issuq jew tħaddem magni jekk jaqbdek in- ngħas, għeja, jew konfużjoni b’ din il - ’ għ mediċina.
HOW TO USE VIRAFERON no
KIF GĦANDEK TUŻA VIRAFERON im
Your doctor has prescribed Viraferon specifically for you and your current condition; do not share this medicine with anyone else. t
It- tabib tiegħek ordnalek Viraferon speċifikament għalik u għall- kondizzjoni li għandek bħalissa; tħalli lil ebda persuna oħra tuża din il- mediċina. li l
Your doctor has determined the exact dosage for administration of Viraferon according to your individual needs. uc
It- tabib tiegħek iddeċieda dwar id- dożaġġ preċiż ta ’ Viraferon li għandek tieħu skond il- ħtiġijiet individwali tiegħek.
The dosage will vary according to the disease being treated.
Id- dożaġġ se jvarja skond il- marda li qed tkun ittrattata. ina
If you are injecting Viraferon yourself, please be sure that the dose that has been prescribed for you is clearly rod
Jekk qed tinjetta Viraferon inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
Dosages that are to be administered 3 times a week are best given every other day. lp
Dożaġġi li għandhom jingħataw 3 darbiet fil - ġimgħa l- aħjar li jingħataw huwa darba kull jumejn. diċ
The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs: na
Id- dożi normali tal- bidu għal kull kondizzjoni huma dawn li ġejjin; madankollu, id- dożi individwali jistgħu jvarjaw, u t- tabib jista ’ jibdillek id- doża skond il- ħtiġijiet partikolari tiegħek: me
Adults - 3 million IU 3 times a week (every other day) injected subcutaneously (under the i dic
Adulti - 3 miljun IU 3 darbiet fil- ġimgħa (darba kull jumejn) injettati taħt il- ġilda flimkien ma ’ ribavirin jew waħdu.
Me
ġimgħa (darba kull jumejn) injettati taħt il- ġilda flimkien ma ’ ribavirin (Jekk jogħġbok ara wkoll il - fuljett ta ’ tagħrif ta ’ ribavirin). od
Your doctor may prescribe a different dose of Viraferon alone or in combination with other medicines (e.g. ribavirin).
It- tabib tiegħek jista ’ jippreskrivi doża differenti ta ’ Viraferon, waħdu jew flimkien ma ’ mediċini oħra (eż., cytarabine, ribavirin).
Your doctor will determine the exact dosage schedule and regimen according to your needs.
It- tabib tiegħek se jiddeċiedi dwar Pr
If you have the impression that the effect of Viraferon is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Viraferon huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
322 Viraferon is usually intended for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.