qanastek/EMEA-V3 huggingface dataset:
Detail ed instructions for subcutaneous administration are provided with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).
Tagħrif dettaljat dwar l - għoti taħt il- ġilda huwa pprovdut ma ’ dan il- fuljett (ara KIF TINJETTA VIRAFERON LILEK
One dose of Viraferon is given on each scheduled day.
izz Doża waħda ta ’ Viraferon tingħata f’ kull ġurnata li jkun imissha.
Viraferon is given three times a week, every other day, for example on Monday, Wednesday, and Friday.
Viraferon jingħata jew kuljum (5 jew 7 darbiet fil- ġimgħa), jew tliet darbiet fil- ġimgħa, kull jumejn, per eżempju t- Tnejn, l- Erbgħa u l - Ġimgħa.
Interferon s may cause unusual tiredness; if you are injecting this
L- interferoni jistgħu jikkawżaw għeja mhux tas- soltu; jekk qed tinjetta din il- mediċina inti
ed medicine yourself, or giving it to a child, use it at bedtime.
tor stess, jew jekk qed tgħatiha lit- tifel/ tifla, użaha fil- ħin ta ’ l- irqad.
Do not exceed the recommended dosage, and take Vi raferon
Tiħux dożaġġ aktar minn dak rakkomandat, u ibqa ’ ħu Viraferon għat- tul taż- żmien skond kif ordnalek it- tabib.
s for as long as prescribed.
aw Jekk tuża Viraferon aktar milli suppost:
ori If you use more Viraferon than you should Contact your doctor or healthcare professional as soon as possible.
Għamel kuntatt mat- tabib jew lill- professjonist fil- kura tas- saħħa tiegħek mill- aktar fis possibbli.
uth If you for get to take Viraferon If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination
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
ra with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Contact
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.
ge your doctor or pharmacist if needed. lon 4.
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek jekk ikun ’ għ meħtieġ.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU im
Although not all of these side effects may occur, they may need medical attention if they do. no
Għalkemm jistgħu ma jseħħux dawn l- effetti sekondarji kollha, jekk iseħħu jistgħu jkunu jeħtieġu li l
Some patients have t
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu Viraferon waħdu jew flimkien ma ’ ribavirin, u ina
actually committed suicide.
Xi pazjenti fil- fatt għamlu suwiċidju.
Be sure to seek emergency care if you notice that you are becoming depressed or have uc
Aċċerta ruħek li tfittex kura ta ’ emerġenza jekk tinnota li qed taqbdek dipressjoni jew qed jiġuk ħsibijiet dwar suwiċidju jew tara xi tibdil fl- imġieba tiegħek.
suicidal thoughts or change in your behaviour.
sinjali ta ’ dipressjoni jew tibdil fl- imġieba tiegħek.
Children are particularly prone to develop depression when being treated with Viraferon and ribavirin.
It- tfal huma aktar suxxettibli li taqbadhom dipressjoni meta jkun qed jiġu kkurati me
Immediately contact the doctor or seek emergency care if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others. lp
Għamel kuntatt mat- tabib minnufih jew fittex kura ta ’ emerġenza jekk tara li qed juru sintomi ta ’ mġieba mhux tas- soltu, jħossuhom dipressi, jew iħossu li jridu jgħamlu l- ħsara lilhom infushom jew lil- oħrajn.
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: na
Jekk iseħħu xi wħud mill- effetti sekondarji li ġejjin, tibqax tieħu Viraferon u għid lit- tabib tiegħek ott
• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
immedjatament jew mur id- dipartiment ta ’ l- emerġenza ta ’ l- eqreb sptar: • 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. od
If you have them, you may have had a serious allergic reaction to i dic
Jekk ikollok minnhom, jista ’ jkun li kellek reazzjoni allerġika serja għal Viraferon.
Check with your doctor immediately if any of the following side effects occur: • chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk xi wieħed minn dawn l- effetti sekondarji iseħħ: • uġigħ fis- sider jew sogħla qawwija u persistenti; taħbit tal- qalb irregolari jew mgħaġġel; qtugħ ta ’ nifs, konfużjoni, tbatija biex toqod attent, tnemnim jew tingiż fl- idejn jew fis- saqajn; aċċessjoni (konvulżjoni); tbati biex torqod, taħseb jew tikkonċentra; stat mentali mibdul; ħsibijiet dwar suwiċidju, attentati ta ’ suwiċidju, imġieba aggressiva jew mibdula (kultant indirizzata lejn l- oħrajn); alluċinazzjonijiet; uġigħ qawwi fl- istonku; ippurgar iswed jew jixbah lill- qatran; demm fl- ippurgar jew fl- awrina, tinfaraġ bil- qawwa; issir abjad karti, livell għoli ta ’ zokkor fid- demm, deni jew tkexkix ta ’ bard jibdew wara ftit ġimgħat ta ’ trattament,
323 treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful r eddening 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
Your doctor will te st your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
It- tabib tiegħek se jeżaminalek id- demm biex jaċċerta li l- għadd taċ- ċelluli bojod fid- demm (iċ -
At the beginning of treatment with Viraferon, you may experience a flu-like reaction, with fever, fatigue,
tor ċelluli li jiġġieldu lill- infezzjoni) u taċ- ċelluli ħomor fid- demm (iċ- ċelluli li jġorru l- ħadid u l - ossiġnu), tal- plejtlets (iċ- ċelluli li bihom jagħqad id- demm) u l- valuri l- oħra tal- laboratorju huma f’ livelli aċċettabbli.
ed headache, muscle ache, joint pain and chills/rigors.
aw 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.
Your doctor may recommend that you take pa racetamol if you develop these symptoms.
It- tabib jista ’ jtik parir biex tieħu paracetamol jekk jaqbduk dawn is- sintomi.
s Other side effects that may occur include:
ux Effetti sekondarji oħra li jistgħu jseħħu jinkludu:
ori Very commonly reported side effects (at least 1 in every 10 patients): pain, swelling and redness or skin dama ge at site of injection, hair loss, dizziness, changes in appetite,
Effetti sekondarji rrappurtati komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti):
uth stomach or abdominal pains, diarrhoea, nausea (feeling sick), viral infection, depression, emotional lability, 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
Xi tfal kellhom im
ra (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, musculoskeletal pain, changes in laboratory blood values including decreased white blood cell count.
Effetti sekondarji rrappurtati b’ mod komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull li l
Some children have had a decrease in their rate of growth (height and weight).
10 pazjenti): 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 ina
ge 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, lon decreased sexual drive, vaginal problem, breast pain, pain in testicle, problems with thyroid gland, red 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, no
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 - diċ
problem with your tear ducts, conjunctivitis (“pink eye”), agitation, sleepiness, sleepwalking, problem with behaviour, nervousness, stuffy or runny nose, sneezing, rapid breathing, pale or reddened skin, bruising, fingers and toes very sensitive to cold, problem with skin or nails, psoriasis (new or worsened), increased sweating, increased need to pass urine, fine shaking movements, decreased sensitivity to touch, arthritis. t uc
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 me
Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia rod
(tibda jew tmur għall- agħar), żieda fl- għaraq, żieda fil- bżonn li tgħaddi l- awrina, movimenti ta ’ tregħid żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
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.
Effetti sekondarji rrappurtati b’ mod rari (mill- anqas 1 f’ kull 10, 000 pazjent, iżda anqas minn 1 f’ kull 1, 000 pazjent): ott
of red blood cells, has been reported.
pulmonite
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy. na
Effetti sekondarji rrappurtati rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent): od
Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
pressjoni baxxa, wiċċ impaħpaħ, dijabete, bugħawwieġ fir- riġlejn, uġigħ fid- dahar, problemi tal - kliewi, ħsara fin- nervituri, fsada tal- ħanek, anemija aplastika.
Loss of consciousness has occurred very rarely, mostly in i
Aplasja pura taċ- ċelluli ħomor, kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet Pr
elderly patients treated at high doses.
irrappurtata.
Check dic
Din twassal għal anemija severa, li s- sintomi tagħha jkunu jinkludu għeja mhux tas- soltu u nuqqas ta ’ enerġija.
with your doctor immediately if you have any of these symptoms.
Telf mis- sensi seħħet rari ħafna, l - aktar f’ pazjenti anzjani li ngħataw dożi għoljin.
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, Me
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk tħoss xi wieħed minn dawn is - sintomi.
lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported, but their frequency is unknown.
Minbarra hekk, bl- użu ta ’ Viraferon kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada
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.
at (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
Other side effects not listed above may also occur in some patients.
izz 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
HOW TO STORE VIRAFERON
KIF TAĦŻEN VIRAFERON
Keep out of the reach and sight of children.
aw Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
ed Do not freeze.
ux Aħżen fil- friża.
Viraferon can be put back in the refrigerator at any time during this seven-day period.
Viraferon jista ’ jitpoġġa lura fil- friġġ fi
s If the product is not used during the seven-day period, it should be discarded.
ad kwalunkwe ħin f’ dawn is- sebat ijiem.
ori Do not use Viraferon after the expiry date which is stated on the package.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema. ’ għ Tużax Viraferon wara d- data ta ’ skadenza li tidher fuq il- pakkett.
uth 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. im
ra Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall - li l
FURTHER INFORMATION lon What Viraferon contains
AKTAR TAGĦRIF
- The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate,
- Is- sustanzi l- oħra huma disodium phosphate anhydrous, sodium dihydrogen phosphate
edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
monohydrate, edetate disodium, sodium chloride, m- cresol, polysorbate 80 u ilma għall - me
What Viraferon looks like and contents of the pack t uc
injezzjonijiet.
Viraferon is presented as a solution for injection
Id- Dehra ta ’ Viraferon u l- kontenuti tal- pakkett:
- The clear and colourless solution is contained in a glass vial with 1 injection syringe, 1 injection
Viraferon jiġi bħala soluzzjoni għall- injezzjoni ott
needle and 1 cleansing swab.
Is- soluzzjoni ċara u mingħajr kulur tiġi f’ kunjett tal- ħġieġ b’ siringa 1 għall- injezzjoni, labra 1 għall - injezzjoni u tajjara 1 biex tnaddaf.
Vial alone is also available. rod
Jiġi wkoll kunjett waħdu.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali. od
Marketing Authorisation Holder: lp
Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe Pr
SP Europe 73, rue de Stalle B-1180 Bruxelles
73, rue de Stalle B- 1180 Bruxelles
For any information about this medicinal product, please contact the local representative of the Marketing i dic
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
België/Belgique/Belgien Rue de Stalle/Stallestraat 73 Me
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
at B- 1180 Bruxelles/ Brüssel B- 1180 Bruxelles/ Brussel/ Brüssel Belgique/ Belgien Tél/ Tel: + 32 - (0) 2 370 92 11
B-1180 Bruxelles/Brüssel Belgique/Belgien Tél/Tel: + 32-(0)2 370 92 11
izz Tél/ Tel: + 32 - (0) 2 370 92 11
325 Česká republika Na Příkopě 25 CZ-110 00 Praha 1 Tel: + 420 221771250
aw Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250
Danmark
ux Danmark
ed Lautrupbjerg 2 DK-2750 BallerupTlf: + 45-44 39 50 00
ad Lautrupbjerg 2 DK- 2750 Ballerup Tlf: + 45- 44 39 50 00
Norge
’ għ
Pb.
Maarssenbroeksedijk 4 NL- 3542 DN Utrecht Tel: + 31 - (0) 800 778 78 78
Jerozolimskie 195a PL-02-222 Warszawa lon
Jerozolimskie 195a Αγίου Δημητρίου 63 PL- 02- 222 Warszawa GR- 174 55 Άλιμος diċ
Tel.: + 48-(0)22 478 41 50
Tel.: + 48 - (0) 22 478 41 50 Tηλ: + 30- 210 98 97 300
36, Ctra.
me
E-28750 San Agustín de Guadalix – Madrid Tel: + 34-91 848 85 00 t
Nacional I E- 28750 San Agustín de Guadalix – Madrid Tel: + 34- 91 848 85 00
France
France ott
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 od
Tel. + 40 21 233 35 30 lp i na dic Me
Tel. + 40 21 233 35 30
326 Ireland Shire Park Welwyn Garden City Hertford shire AL7 1TW Tel: + 44-(0)1 707 363 636
Ireland Pr
Slovenija Dunajska 22 SI-1000 Ljubljana Tel. + 386 01 3001070
Slovenija
ed Ísland Hörgatún 2 IS-210 Garðabær
Dunajska 22 Shire Park SI- 1000 Ljubljana Welwyn Garden City Tel: + 386 01 3001070 Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636 Slovenská republika Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
ori Italia Via f ratelli Cervi snc,
at Italia Via fratelli Cervi snc,
uth Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano)
izz Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano)
ra Tel: + 39-02 21018.1
tor Tel: + 39- 02 21018. 1
ge Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: + 357-22 757188
aw Οδός Αγίου Νικολάου, 8 CY- 1055 Λευκωσία Τηλ: +357- 22 757188
Box 6185 S-102 33 S tockholm Tel: + 46-(0)8 522 21 500 lon
Box 6185 S- 102 33 Stockholm Tel: + 46 - (0) 8 522 21 500
Latvija Bauskas 58a -401 Rīga, LV-1004
ux Latvija Bauskas 58a - 401 Rīga, LV- 1004
Tel: + 371-7 21 38 25
ad Tel: + 371- 7 21 38 25 Lietuva Kęstučio g.
This leaflet was last approved on lp
Dan il- fuljett kien approvat l- aħħar f ’ li l
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: na
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. ina diċ me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
Plea se read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet bl - attenzjoni u segwihom pass pass.
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 necessary items before you begin:
izz Preparazzjoni Iġbor l- affarjiet kollha li għandek bżonn qabel tibda:
- a vial of Viraferon solution for injection;
- kunjett ta ’ Viraferon soluzzjoni għall- injezzjoni;
- a needle for the subcutaneous injection (for example 0.4 × 13 mm [27 gauge 0.5 inch]);
- labra biex tinjetta taħt il- ġilda (per eżempju 0. 4 x 13 mm [27 gauge 0. 5 pulzieri];
uth Measuring the dose of Viraferon Remove the cap from the vial.
aw Biex tkejjel id- doża ta ’ Viraferon Neħħi l- għatu mill- kunjett.
If this is a multidose vial, you will only have to remove the cap when
Jekk dan huwa kunjett b’ ħafna dożi, ikollok tneħħi l- kappa meta tkun se tipprepara l- ewwel doża biss.
ra preparing the first dose.
ux Viraferon b’ tajjara għat- tindif.
Take the needle and place it
Ħu l- labra u poġġiha sew fuq il- ponta tas- siringa.
ge firmly onto the tip of the syringe.
ad livell li jindika d- doża kif ordnalek it- tabib.
Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor. lon Hold the Viraferon vial upright without touching the cleaned top of the vial with your hands.
Żomm il- kunjett ta ’ Viraferon rasu ‘ l fuq mingħajr ma tmiss b’ idejk il- parti tal- kunjett li naddaft.
Turn the vial and the syringe upside down in one hand.
Daħħal il- labra fil- kunjett li fih is- soluzzjoni Viraferon u injetta l- arja fil- kunjett. ’ għ Aqleb il- kunjett u s- siringa ta ’ taħt fuq f’ id waħda.
Be sure the tip of needle is in the Viraferon solution.
Aċċerta ruħek li l- ponta tal- labra tkun fis - soluzzjoni Viraferon.
Pull back on the plunger slowly to draw the correct dose as no
Iġbed lura l- planġer bil- mod sabiex tiġbed id- doża hekk kif ordnalek it- tabib fis- siringa.
Remove the needle from the vial and check for air bubbles in the syringe.
Neħħi l- abra mill- kunjett u ara jekk ikunx hemm bżieżaq ta ’ la- rja fis- siringa.
Push t
Jekk tara xi bżieżaq, im
Replace the needle guard and place the syringe with the uc
iġbed il- planġer ftit lura, tektek is- siringa ħafif, bil- labra tħares ‘ l fuq, sakemm il- bżieżaq jisparixxu.
Be sure the solution is at room temperature up to 25°C.
Imbotta l- planġer ‘ l fuq bil- mod lura għad- doża tajba.
If the solution is cold, warm the syringe between your rod
Ibdel it- tokka tal- labra u poġġi s- siringa bil - labra fuq superfiċje ċatta. li l
Examine the solution prior to administration: it should be clear and colourless.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
You are now ready to inject the dose. lp
L- aħjar postijiet għall- injezzjoni huma t- tessuti b’ saff ta ’ xaħam bejn il - ina
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), na
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. i dic
Ibdel il- post ta ’ l- injezzjoni kull darba. diċ
Insert the needle into the pinched skin at an angle of 45° to 90°.
Daħħal il - me
plunger all the way down gently.
Injetta s- soluzzjoni billi timbotta l- planġer bil- mod s’ isfel.
If there is bleeding, cover with an adhesive bandage.
Jekk ikun ħiereġ id - demm, għatti b’ faxxa li teħel. ott
For multidose vials, be sure to return the vial to the refrigerator.
Għal kunjetti b’ ħafna dożi, kun ċert li terġa tpoġġi l- kunjett lura fil- friġġ. od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 5 million IU/0.5 ml solution for injection Interferon alfa -2b
Viraferon 5 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni Interferon alfa- 2b
- If you have any further que stions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- if you have hepatitis and have been treated recently with me dications that suppress the immune system
- jekk għandek mard avanzat ta ’ dikompensazzjoni (mhux kontrollata) tal- fwied.
- if you notice unu sual bleeding or bruising check with your doctor immediately.
- jekk tinnota ħruġ tad- demm jew tbenġil mhux tas- soltu aċċerta ruħek mat- tabib tiegħek
330 Pregnancy and breast-fe eding 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 pre scribed 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 -
- if you are a girl or a wo man of childbearing age, you must 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,
331 Viraferon is usually intended for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
If you are injecting this m edicine yourself, you will be instructed how to prepare and give the injection.
Jekk se tinjetta din il- mediċina inti stess, se tingħata istruzzjonijiet dwar il- preparazzjoni u dwar l- għoti ta ’ l- injezzjoni.
Detailed instructions for subcutaneous administration are provided with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).
Tagħrif dettaljat dwar l - għoti taħt il- ġilda huwa pprovdut ma ’ dan il- fuljett (ara KIF TINJETTA VIRAFERON LILEK
Viraferon i s given three times a week, every other day, for example on Monday, Wednesday, and Friday.
Viraferon jingħata jew kuljum (5 jew 7 darbiet fil- ġimgħa), jew tliet darbiet fil- ġimgħa, kull jumejn, per eżempju t- Tnejn, l- Erbgħa u l - Ġimgħa.
Interferons may cause unusual tiredness; if you are injecting this
L- interferoni jistgħu jikkawżaw għeja mhux tas- soltu; jekk qed tinjetta din il- mediċina inti
Use Vi raferon exactly as prescribed by your doctor.
Uża Viraferon eżatt kif qallek it- tabib tiegħek.
Do not exceed the recommended dosage, and take Viraferon
Tiħux dożaġġ aktar minn dak rakkomandat, u ibqa ’ ħu Viraferon għat- tul taż- żmien skond kif ordnalek it- tabib.
uth If you forget to take Viraferon If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination
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
Check with your doctor imm ediately if any of the following side effects occur: • chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk xi wieħed minn dawn l- effetti sekondarji iseħħ: • uġigħ fis- sider jew sogħla qawwija u persistenti; taħbit tal- qalb irregolari jew mgħaġġel; qtugħ ta ’ nifs, konfużjoni, tbatija biex toqod attent, tnemnim jew tingiż fl- idejn jew fis- saqajn; aċċessjoni (konvulżjoni); tbati biex torqod, taħseb jew tikkonċentra; stat mentali mibdul; ħsibijiet dwar suwiċidju, attentati ta ’ suwiċidju, imġieba aggressiva jew mibdula (kultant indirizzata lejn l- oħrajn); alluċinazzjonijiet; uġigħ qawwi fl- istonku; ippurgar iswed jew jixbah lill- qatran; demm fl- ippurgar jew fl- awrina, tinfaraġ bil- qawwa; issir abjad karti, livell għoli ta ’ zokkor fid- demm, deni jew tkexkix ta ’ bard jibdew wara ftit ġimgħat ta ’ trattament,
332 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 se may signal serious side effects that may need urgent medical attention.
Dawn jistgħu jkunu s- sinjal ta ’ effetti sekondarji serji li jistgħu jeħtieġu attenzjoni medika urġenti.
Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
It- tabib tiegħek se jeżaminalek id- demm biex jaċċerta li l- għadd taċ- ċelluli bojod fid- demm (iċ -
ori Very commonly reported side effects (at least 1 in every 10 patients): pain, swelling and redness or skin damage at site of injection, hair loss, dizziness, changes in appetite,
Effetti sekondarji rrappurtati komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti):
Other side effects not listed above may also occur in some patients.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin
If any of the side effects gets serious, or if you notice any side effects not list ed in this leaflet, please tell your doctor or pharmacist.
tor f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Vi raferon can be put back in the refrigerator at any time during this seven-day period.
Viraferon jista ’ jitpoġġa lura fil- friġġ fi
uth Do not use Viraferon if you notice chan ges in the appearance of Viraferon.
M’ għandekx tuża Viraferon jekk tinnota xi tibdil fid- dehra ta ’ Viraferon. im
334 Česká republika Na Příkopě 25 CZ-110 00 Praha 1 Tel: + 420 221771250
aw Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250
335 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: + 44-(0)1 707 363 636
Ireland Pr
ori Italia Via fratelli Cervi snc,
at Italia Via fratelli Cervi snc,
Box 6185 S-102 33 Stockholm Tel: + 46-(0)8 522 21 500 lon
Box 6185 S- 102 33 Stockholm Tel: + 46 - (0) 8 522 21 500
The following in structions explain how to inject Viraferon yourself.
It- tagħrif li ġej jispjegalek kif tinjetta Viraferon inti stess.
Viraferon, 10 million IU/ml solution for injection Interferon alfa -2b
Viraferon 10 miljun IU/ ml soluzzjoni għall- injezzjoni Interferon alfa- 2b
WHAT VIRAFERON IS AND WHAT IT IS USED FOR lon Viraferon (interferon alfa -2b) mod ifies the response of the body's immune system to help fight infections and severe diseases.
X’ INHU VIRAFERON U GĦALXIEX JINTUŻA
ori Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Vi raferon and ribavirin combination therapy.
Mart tas- snien jew tal- ħanek, li jista ’ jwassal għal telf tas- snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu Viraferon u ribavirin f’ terapija kombinata.
Using Viraferon with food and drink While being treat ed with Viraferon, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża Viraferon ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ Viraferon, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
339 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.
The effect on human pregnancy i s not known.
L- effett fuq it- tqala fil- bniedem mhuwiex magħruf.
340 Viraferon is usually intended for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
This means that Viraferon is inject ed with a short needle into the fatty tissue just under the skin.
Dan ifisser li Viraferon ikun injettat b’ labra qasira għal ġot- tessut imxaħħam eżatt taħt il- ġilda.
One do se of Viraferon is given on each scheduled day.
izz Doża waħda ta ’ Viraferon tingħata f’ kull ġurnata li jkun imissha.
Children are particularly prone to develop depression when being treated with Viraferon and ribavirin.
b’ Viraferon u ribavirin.
341 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
At the beginning of treatment with Vi raferon, you may experience a flu-like reaction, with fever, fatigue,
tor ċelluli li jiġġieldu lill- infezzjoni) u taċ- ċelluli ħomor fid- demm (iċ- ċelluli li jġorru l- ħadid u l - ossiġnu), tal- plejtlets (iċ- ċelluli li bihom jagħqad id- demm) u l- valuri l- oħra tal- laboratorju huma f’ livelli aċċettabbli.
Other side effects not list ed above may also occur in some patients.
izz Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
For short term t ravelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use.
Għal ivvjaġġar għal perijodu qasir, is- soluzzjoni tista ’ tinżamm barra mill- friġġ f’ temperatura ta ’ 25°C jew inqas għal mhux iktar minn sebat ijiem qabel l- użu.
ori Do not use Viraferon after the expiry date which is stated on the packa ge.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema. ’ għ Tużax Viraferon wara d- data ta ’ skadenza li tidher fuq il- pakkett.
uth 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. im
What Viraferon looks like and contents of the pack t uc
Id- Dehra ta ’ Viraferon u l- kontenuti tal- pakkett:
Viraferon is presented as a solution for injection
Viraferon jiġi bħala soluzzjoni għall- injezzjoni ott
- The clear and colourless solution is contained in a glass with 1 injection syringe, 1 injection needle and
Is- soluzzjoni ċara u mingħajr kulur tiġi f’ kunjett tal- ħġieġ b’ siringa 1 għall- injezzjoni, labra 1 għall - injezzjoni u tajjara 1 biex tnaddaf.
343 Če ská republika Na Příkopě 25 CZ-110 00 Praha 1 Tel: + 420 221771250
aw Malta Česká republika Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250
ed Lautrupbjerg 2 DK-2750 Ballerup Tlf: + 45-44 39 50 00
ad Lautrupbjerg 2 DK- 2750 Ballerup Tlf: + 45- 44 39 50 00
Eesti
Eesti Österreich Järvevana tee 9
Badener Strasse 23 A-2514 Traiskirchen Tel: + 43-(0)2252 502-0
ina
ge Ελλάδα Αγίου Δημητρίου 63
A- 2514 Traiskirchen Tel: + 43 - (0) 2252 502- 0
Jerozolimskie 195a lon
Jerozolimskie 195a Αγίου Δημητρίου 63 PL- 02- 222 Warszawa GR- 174 55 Άλιμος diċ
PL-02-222 Warszawa Tel.: + 48-(0)22 478 41 50
Tel.: + 48 - (0) 22 478 41 50 Tηλ: + 30- 210 98 97 300
Madrid t uc
France ott
France 92 rue Baudin F-92300 Levallois-Perret
92 rue Baudin F- 92300 Levallois- Perret Tél: + 33 - (0) 1 41 06 35 00 od
344 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: + 44-(0)1 707 363 636
Ireland Pr
Detail ed information on this medicine is available on the European Medicines Agency (EMEA) web site: na
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. ina diċ me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
Viraferon, 18 million IU/3 ml solution for injection Interferon alfa-2b
Viraferon 18 miljun IU/ 3 ml soluzzjoni għall- injezzjoni Interferon alfa- 2b
- if you have severe he art disease.
ina
- if you have had serious nervous or mental problems, such as s evere depression or thoughts of suicide.
- jekk kellek problemi tas- sistema nervuża jew mentali, bħal dipressjoni severa jew ħsibijiet dwar
- if you have ever had depression or develop symptoms associated with depression (e.g. feelings of s adness,
- jekk qatt kellek dipressjoni jew tiżviluppa sintomi assoċjati mad- dipressjoni (eż dwejjaq, swied
Please tell your doctor or pharmacist if you are taking or have recently taken any other m edicines, including medicines obtained without a prescription.
Pr
348 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.
349 Viraferon is usually intend ed for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
Detailed in structions for subcutaneous administration are provided with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).
Tagħrif dettaljat dwar l - għoti taħt il- ġilda huwa pprovdut ma ’ dan il- fuljett (ara KIF TINJETTA VIRAFERON LILEK
ra with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
ad kompli bit- trattament bħas- soltu.
350 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
Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other labo ratory values are at acceptable levels.
It- tabib tiegħek se jeżaminalek id- demm biex jaċċerta li l- għadd taċ- ċelluli bojod fid- demm (iċ -
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 report ed with Viraferon use.
at (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
Viraferon can be put back in the refri gerator at any time during this seven-day period.
Viraferon jista ’ jitpoġġa lura fil- friġġ fi
ori Once opened, the product may be stored for a maximum of 28 days at 2ºC – 8ºC.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema. ’ għ Ladarba jinfetaħ, il- prodott jista ’ jinħażen għal mhux aktar minn 28 jum bejn 2ºC – 8ºC.
uth Do not use Viraferon after the expiry date which is stated on the package.
Tużax Viraferon wara d- data ta ’ skadenza li tidher fuq il- pakkett. im
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
ge What Viraferon contains
X’ fih Viraferon: ina
- The active substance is recombinant interferon alfa-2b, 18 million IU in a multiple dose vial
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 18 miljun IU f’ kunjett b’ doża waħda.
edetate disodium, sodium chloride, m -cresol, polysorbate 80 and water for injections.
monohydrate, edetate disodium, sodium chloride, m- cresol, polysorbate 80 u ilma għall - diċ
Viraferon is presented as a solution for injection uc
Id- Dehra ta ’ Viraferon u l- kontenuti tal- pakkett:
The clear and colourless solution is contained in a glass vial.
Viraferon jiġi bħala soluzzjoni għall- injezzjoni Is- soluzzjoni ċara u mingħajr kulur tiġi f’ kunjett tal- ħġieġ. ott
Viraferon is available in four different pack sizes: rod
Viraferon jiġi f’ sitt daqsijiet ta ’ pakketti differenti:
- Pack of 2 vials
od
lp
- Pakkett b’ 2 kunjetti
Not all pack sizes may be marketed. na
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
SP Europe 73, rue de Stalle i dic
Pr Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe 73, rue de Stalle B- 1180 Bruxelles
B-1180 Bruxelles Belgium Me
Il- Belġju
B-2220 Heist-op-den-Berg Belgium
Il- Belġju
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
at Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad -
België/Belgique/Belgien Rue de Stalle/Stallestraat 73 B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
tor Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11
Česká republika Na Příkopě 25
ux Тел.: +359 2 944 1073
Malta 168 Christopher Street
Tel.: +36 1 457- 8500
ed CZ-110 00 Praha 1 Tel: + 420 221771250
ad Na Příkopě 25 CZ- 110 00 Praha 1 Tel: +420 221771250
uth Deutschland Thomas-Dehler-Straße 27 D-81737 München
li l
Eesti
Eesti Järvevana tee 9 diċ
ge Järvevana tee 9 EE-11314 Tallinn Tel: + 372 654 96 86
EE- 11314 Tallinn Tel: + 372 654 96 86 me
Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος
Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος Tηλ: + 30- 210 98 97 300 ott
Nacional I
Nacional I E- 28750 San Agustín de Guadalix – Madrid od
P-2735-557 Agualva-Cacém Tel: + 351-21 433 93 00
Tel: +351- 21 433 93 00 Tel: + 34- 91 848 85 00
France 92 rue Baudin F-92300 Levallois-Perret
France Pr
lp
România
Ísland Me
at Slovenská republika Ísland
Hörgatún 2 IS-210 Garðabær Sími: + 354 535 70 00
izz Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano)
tor Italia Via fratelli Cervi snc,
Suomi/Finland PL 3/PB 3 FIN-02201 Espoo/Esbo Puh/Tel: + 358-(0)20-7570 300
Suomi/ Finland PL 3/ PB 3
353 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 Τηλ: + 357-22 757188
ux Κύπρος Οδός Αγίου Νικολάου, 8
ed Latvija Bauskas 58a -401 Rīga, LV-1004
ad CY- 1055 Λευκωσία Τηλ: +357- 22 757188
s Tel: + 371-7 21 38 25
Latvija Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25
Lie tuva
65/ 40 li l
65/40 LT-08124 Vilnius Tel. + 370 52 101868
LT- 08124 Vilnius Tel. + 370 52 101868 ina
ra This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’ diċ
ge Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: lon 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 /. me ott od Pr KIF TINJETTA VIRAFERON LILEK INNIFSEK
up the plunger slowly back to the correct dose. uc
iġbed il- planġer ftit lura, tektek is- siringa ħafif, bil- labra tħares ‘ l fuq, sakemm il- bżieżaq jisparixxu.
Volume to be withdrawn according to the dose: rod
Il- Volum li għandu jinġibed skond id- doża:
Corresponding dose (million IU) using
Doża li tikkorrispondi (miljun IU) b’ Viraferon 18- il miljun IU/ 3 ml soluzzjoni għall - ina
Viraferon 18 million IU/3 ml solution for injection lp
injezzjoni jew infużjoni
0. 1
0. 25
i
diċ
0.6
1. 5
0.5
0. 5 1
dic
me
Me
3 6
1.5
1. 5 2 2. 5
9
9 12 15
2.5
ott
15
od
355 Replace the ne edle guard and place the syringe with the needle on a flat surface.
Pr
Injecting the solution
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
If you are exceptionally thin, use only the thigh or outer surface of
Jekk int irqiq/ a ħafna, uża
s the arm for injection.
at biss il- koxxa jew in- naħa ta ’ barra tad- driegħ għall- injezzjoni.
ori Change your injection site each time.
Ibdel il- post ta ’ l- injezzjoni kull darba.
Cleanse and disinfect the skin where the injection is to be made.
izz Naddaf u ddiżinfetta l- ġilda fejn se tagħti l- injezzjoni.
Remove the needle
Neħħi l- protezzjoni tal- labra.
Insert the needle into the pinched skin at an angle of 45° to 90°.
tor labra f’ angolu ta ’ bejn 45° u 90° fil- ġilda maqrusa ’ l barra.
Press the injection site with a small
Agħfas il- post ta ’ l- injezzjoni b’ faxxa żgħira jew b’ garża sterili jekk hemm bżonn għal diversi sekondi.
ra bandage or sterile gauze if necessary for several seconds.
Timmassaġġjax il- post ta ’ l- injezzjoni.
Do not massage the injection site.
Jekk ikun ħiereġ id -
If there is bleeding, cover with an adhesive bandage.
aw demm, għatti b’ faxxa li teħel.
Dispose of the syringe and needle
Armi s - siringa u l- labar ġo kontenitur magħluq mingħajr ma toħloq periklu.
For multidose vials, be sure to return the vial to the refrigerator. lon
Għal kunjetti b’ ħafna dożi, kun ċert li terġa tpoġġi l- kunjett lura fil- friġġ.
356 PACKAGE LEAFLET:
ux ad ’ għ im li l ina diċ me ott od Pr FULJETT TA ’ TAGĦRIF:
Viraferon, 25 million IU/2.5 ml solution for injection Interferon alfa-2b
Viraferon 25 miljun IU/ 2. 5 ml soluzzjoni għall- injezzjoni Interferon alfa- 2b
358 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.
359 Viraferon is usually intend ed for subcutaneous use.
Viraferon huwa normalment maħsub għall- użu taħt il- ġilda.
360 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, 25 million IU in a multiple dose vial
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 25 miljun IU f’ kunjett b’ doża waħda.
ge Järvevana tee 9 EE-11314 Tallinn Tel: + 372 654 96 86
Eesti Järvevana tee 9 diċ
Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος
EE- 11314 Tallinn Tel: + 372 654 96 86 me
Jerozolimskie 195a PL-02-222 Warszawa no
A- 2514 Traiskirchen Tel: + 43 - (0) 2252 502- 0
Tηλ: + 30-210 98 97 300
Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος Tηλ: + 30- 210 98 97 300 ott
Slovenská republika Strakova 5
at Slovenská republika Ísland
IS-210 Garðabær Sími: + 354 535 70 00
izz Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due 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
363 Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: + 357-22 757188
ux Κύπρος Οδός Αγίου Νικολάου, 8
Latvija
’ għ
United Kingdom
S- 102 33 Stockholm Tel: + 46 - (0) 8 522 21 500
ed Bauskas 58a -401 Rīga, LV-1004 Tel: + 371-7 21 38 25
Latvija Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25
Shire Park Welwyn Garden City Hertfordshire AL7 1TW - UK
United Kingdom Shire Park Welwyn Garden City Hertfordshire AL7 1TW - UK
65/40
65/ 40 li l
uth LT-08124 Vilnius Tel. + 370 52 101868
LT- 08124 Vilnius Tel. + 370 52 101868 ina
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
Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor. lon Hold the Viraferon vial upright without touching the cleaned top of the vial with your hands.
Daħħal il- labra fil- kunjett li fih is- soluzzjoni Viraferon u injetta l- arja fil- kunjett. ’ għ Aqleb il- kunjett u s- siringa ta ’ taħt fuq f’ id waħda.
Insert the needle into the vial containing the Viraferon solution and inject air into the vial.
Aċċerta ruħek li l- ponta tal- labra tkun fis - soluzzjoni Viraferon.
Turn the vial and the syringe upside down in one hand.
L- id l- oħra tkun ħielsa biex tmexxi l- planġer.
Be sure the tip of needle is in the Viraferon solution.
Iġbed lura l- planġer bil- mod sabiex tiġbed id- doża hekk kif ordnalek it- tabib fis- siringa.
Your other hand will be free to move the plunger.
Neħħi l- abra mill- kunjett u ara jekk ikunx hemm bżieżaq ta ’ la- rja fis- siringa.
Pull back on the plunger slowly to draw the correct dose as no
Jekk tara xi bżieżaq, im
Remove the needle from the vial and check for air bubbles in the syringe.
iġbed il- planġer ftit lura, tektek is- siringa ħafif, bil- labra tħares ‘ l fuq, sakemm il- bżieżaq jisparixxu.
Push t
Imbotta l- planġer ‘ l fuq bil- mod lura għad- doża tajba. li l
up the plunger slowly back to the correct dose. uc
Il- Volum li għandu jinġibed skond id- doża:
Volume to be withdrawn according to the dose: rod
Doża li tikkorrispondi (miljun IU) b’ Viraferon 25- il miljun IU/ 3 ml soluzzjoni għall - ina
Volume (ml)
injezzjoni jew infużjoni