qanastek/EMEA-V3 huggingface dataset:
For short term travelling, 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.
If the product is not used during the seven-day period, it should be discarded.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema.
- The active substance is recombinant interferon alfa-2b, 3 million IU in a single dose vial
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 3 miljun IU f’ kunjett b’ doża waħda.
- The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate
- Is- sustanzi l- oħra huma disodium phosphate anhydrous, sodium dihydrogen phosphate
monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
monohydrate, edetate disodium, sodium chloride, m- cresol, polysorbate 80 u ilma għall - injezzjonijiet.
The clear and colourless solution is contained in a glass vial with 1 injection syringe, 1 injection needle and 1 cleansing swab.
IntronA jiġi bħala soluzzjoni għall- injezzjoni jew infużjoni 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.
Pack of 1, 6 or 12.
Pakkett b’ 1, 6 jew 12.
Vial alone is also available.
Jiġi wkoll kunjett waħdu.
Česká republika Ke Štvanici 3 CZ-186 00 Praha 8 Tel: +420 221771250
Ke Štvanici 3 CZ- 186 00 Praha 8 Tel: +420 221771250
 417 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
Preparation Collect necessary items before you begin:
Preparazzjoni Iġbor l- affarjiet kollha li għandek bżonn qabel tibda:
- a vial of IntronA solution for injection;
- kunjett ta ’ IntronA soluzzjoni għall- injezzjoni;
- a 1 ml syringe;
- siringa ta ’ 1 ml;
- a needle for the subcutaneous injection (for example 0.4 x 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];
- a cleansing swab.
- tajjara għat- tindif
Measuring the dose of IntronA Remove the cap from the vial.
Biex tkejjel id- doża ta ’ IntronA Neħħi l- għatu mill- kunjett.
If this is a multidose vial, you will only have to remove the cap when preparing the first dose.
Jekk dan huwa kunjett b’ ħafna dożi, ikollok tneħħi l- kappa meta tkun se tipprepara l- ewwel doża biss.
Clean the rubber stopper on the top of the vial containing the IntronA solution with a cleansing swab.
Naddaf it- tapp fil- parti ta ’ fuq tal- kunjett li jkun fih is- soluzzjoni IntronA b’ tajjara għat- tindif.
Remove the syringe from the wrapping.
Neħħi s- siringa mill- kisja.
Take the needle and place it firmly onto the tip of the syringe.
Ħu l- labra u poġġiha sew fuq il- ponta tas- siringa.
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.
Neħħi t- tokka tal- labra mingħajr ma tmiss il- labra, u imla s- siringa bl- arja billi tiġbed il- planġer sal - livell li jindika d- doża kif ordnalek it- tabib.
Hold the IntronA vial upright without touching the cleaned top of the vial with your hands.
Żomm il- kunjett ta ’ IntronA rasu ‘ l fuq mingħajr ma tmiss b’ idejk il- parti tal- kunjett li naddaft.
Insert the needle into the vial containing the IntronA solution and inject air into the vial.
Daħħal il- labra fil- kunjett li fih is- soluzzjoni IntronA u injetta l- arja fil- kunjett.
Turn the vial and the syringe upside down in one hand.
Aqleb il- kunjett u s- siringa ta ’ taħt fuq f’ id waħda.
Be sure the tip of needle is in the IntronA solution.
Aċċerta ruħek li l- ponta tal- labra tkun fis - soluzzjoni IntronA.
Your other hand will be free to move the plunger.
L- id l- oħra tkun ħielsa biex tmexxi l- planġer.
Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe.
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 nuffati ta ’ la- rja 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 nuffati, iġbed il- planġer ftit lura, tektek is- siringa ħafif, bil- labra tħares ‘ l fuq, sakemm in- nuffati jisparixxu.
Push up the plunger slowly back to the correct dose.
Imbotta l- planġer ‘ l fuq bil- mod lura għad- doża tajba.
Replace the needle guard and place the syringe with the needle on a flat surface.
Ibdel it- tokka tal- labra u poġġi s- siringa bil- labra fuq superfiċje ċatta.
Examine the solution prior to administration: it should be clear and colourless.
Ifli s- soluzzjoni rikostitwata qabel tagħtiha: għandha tkun ċara u mingħajr kulur.
Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
Remove the needle guard.
Neħħi l- protezzjoni tal- labra.
With one hand, pinch a fold of loose skin.
B’ id waħda oqros biċċa ġilda ’ l barra.
The vial and injection materials intended for single use must be discarded.
Il- kunjett u l- materjali għall- injezzjoni maħsubin għal użu ta ’ darba għandhom jintremew.
Dispose of the syringe and needle safely in a closed container.
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.
Għal kunjetti b’ ħafna dożi, kun ċert li terġa tpoġġi l- kunjett lura fil- friġġ.
 418 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 5 million IU/0.5 ml solution for injection or infusion Interferon alfa-2b
IntronA 5 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 420 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 421 Multiple myeloma:
Majeloma Multipla:
 422 Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu IntronA waħdu jew flimkien ma ’ ribavirin, u f’ xi każijiet kien hemm nies li kellhom ħsibijiet li jheddu l- ħajja ta ’ nies oħra, ħsibijiet dwar suwiċidju jew imġieba aggressiva (kultant lejn l- oħrajn).
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 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  423 liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, 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.
Effetti sekondarji rrappurtati b’ mod komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull 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 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 żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
- The active substance is recombinant interferon alfa-2b, 5 million IU in a single dose vial
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 5 miljun IU f’ kunjett b’ doża waħda.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/  426 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 427 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 10 million IU/ml solution for injection or infusion Interferon alfa-2b
IntronA10 miljun IU/ ml soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 429 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 430 Multiple myeloma:
Majeloma Multipla:
 431 Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu IntronA waħdu jew flimkien ma ’ ribavirin, u f’ xi każijiet kien hemm nies li kellhom ħsibijiet li jheddu l- ħajja ta ’ nies oħra, ħsibijiet dwar suwiċidju jew imġieba aggressiva (kultant lejn l- oħrajn).
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 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  432 liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, 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.
Effetti sekondarji rrappurtati b’ mod komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull 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 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 żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
- The active substance is recombinant interferon alfa-2b, 10 million IU in a single dose vial
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 10 miljun IU f’ kunjett b’ doża waħda.
 435 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 436 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 18 million IU/3 ml solution for injection or infusion Interferon alfa-2b
IntronA 18- il miljun IU/ 3 ml soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 438 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 439 Multiple myeloma:
Majeloma Multipla:
 440 Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu IntronA waħdu jew flimkien ma ’ ribavirin, u f’ xi każijiet kien hemm nies li kellhom ħsibijiet li jheddu l- ħajja ta ’ nies oħra, ħsibijiet dwar suwiċidju jew imġieba aggressiva (kultant lejn l- oħrajn).
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 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  441 liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, 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.
Effetti sekondarji rrappurtati b’ mod komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull 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 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 żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
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 anaphylaxis (a severe, whole-body allergic reaction)have been reported, but their frequency is unknown.
Disturbi perjodontal (li jaffettwaw il- ħanek) u tas- snien, stat mentali alterat, telf tal- koxjenza, reazzjonijiet ta ’ sensittività eċċessiva inkluża urtikarja (ħorriqija), anġjoedema (nefħa ta ’ l- idejn, riġlejn, għekiesi, wiċċ, xofftejn, ħalq, jew grieżem li jista ’ jikkawża tbatija biex tibla jew tieħu n - nifs), bronkokostrizzjoni u anafilassi (reazzjoni allerġika severa, li teffettwa l- ġisem kollu) kienu rrappurtati, iżda l- frekwenza tagħhom mhiex magħrufa.
Once opened, the product may be stored for a maximum of 28 days at 2ºC – 8ºC.
Ladarba jinfetaħ, il- prodott jista ’ jinħażen għal mhux aktar minn 28 jum bejn 2ºC – 8ºC.
 442 What IntronA contains
X’ fih Intron A
- 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- il miljun IU f’ kunjett b’ doża waħda.
- One ml of solution contains 6 million IU of interferon alfa-2b
- Millilitru wieħed tas- soluzzjoni fiha 6 miljun IU ta ’ interferon alfa- 2b
The clear and colourless solution is contained in a glass vial.
IntronA jiġi bħala soluzzjoni għall- injezzjoni jew infużjoni Is- soluzzjoni ċara u mingħajr kulur tiġi f’ kunjett tal- ħġieġ.
IntronA is available in six different pack sizes:
IntronA jiġi f’ sitt daqsijiet ta ’ pakketti differenti:
- Pack of 1 vial
- Pakkett b’ kunjett 1
- Pack of 1 vial, 6 injection syringes, 6 injection needles and 12 cleansing swabs
- Pakkett b’ kunjett 1, 6 siringi għall- injezzjoni, 6 labar għall- injezzjoni u 12- il tajjara għat- tindif
- Pack of 2 vials
- Pakkett b’ 2 kunjetti
- Pack of 2 vials, 12 injection syringes, 12 injection needles and 24 cleansing swabs
- Pakkett b’ 2 kunjetti, 12- il siringa għall- injezzjoni, 12- il labra għall- injezzjoni u 24 tajjara għat -
- Pack of 12 vials
- Pakketti b’ 12- il kunjett
- Pack of 12 vials, 72 injection syringes, 72 injection needles and 144 cleansing swabs
- Pakketti bi 12- il kunjett, 72 siringa għall- injezzjoni, 72 labar għall- injezzjoni u 144 tajjara għat -
Not all pack sizes may be marketed.
tindif Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
This leaflet was last approved on  444 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Dan il- fuljett kien approvat l- aħħar f ’
 445 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
Volume to be withdrawn according to the dose:
Il- Volum li għandu jinġibed skond id- doża:
Corresponding dose (million IU) using IntronA 18 million IU/3 ml solution for injection or infusion
Doża li tikkorrispondi (miljun IU) b’ IntronA 18- il miljun IU/ 3 ml soluzzjoni għall - injezzjoni jew infużjoni
1.5
0. 25 0. 5 1 1. 5 2 2. 5 3
1.5
1. 5 3 6 9 12 15 18
 446 Do not use if discolouration or particulate matter is present.
Tużahiex jekk tinnota bidla fil- kulur jew xi materjal ta ’ partiċelli żgħar.
 447 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 25 million IU/2.5 ml solution for injection or infusion Interferon alfa-2b
IntronA 25- il miljun IU/ 2. 5 ml soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 449 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 450 Multiple myeloma:
Majeloma Multipla:
 451 Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu IntronA waħdu jew flimkien ma ’ ribavirin, u f’ xi każijiet kien hemm nies li kellhom ħsibijiet li jheddu l- ħajja ta ’ nies oħra, ħsibijiet dwar suwiċidju jew imġieba aggressiva (kultant lejn l- oħrajn).
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 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  452 liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, 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.
Effetti sekondarji rrappurtati b’ mod komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull 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 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 żgħir, nuqqas ta ’ sensittività biex tħoss, artrite.
 453 What IntronA contains
X’ fih Intron A
- 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- il miljun IU f’ kunjett b’ doża waħda.
- One ml of solution contains 10 million IU of interferon alfa-2b
- Millilitru wieħed tas- soluzzjoni fiha 10 miljun IU ta ’ interferon alfa- 2b
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1
Ísland 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
Suomi/Finland PL 86/PB 86 FIN-02151 Espoo/Esbo Puh/Tel: + 358-(0)20-7570 300
Slovenská republika Strakova 5 SK- 811 01 Bratislava Tel: + 421 (2) 5920 2712 Suomi/ Finland PL 86/ PB 86 FIN- 02151 Espoo/ Esbo Puh/ Tel: + 358 - (0) 20- 7570 300
This leaflet was last approved on  455 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Dan il- fuljett kien approvat l- aħħar f ’
 456 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
(million IU) using IntronA ml solution for injection or infusion
Doża li tikkorrispondi (miljun IU) b’ IntronA 25- il miljun IU/ 3 ml soluzzjoni għall - injezzjoni jew infużjoni
5
0. 25 0. 5 1 1. 5 2 2. 5
10
2. 5 5 10 15 20 25
 457 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 458 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 18 million IU solution for injection, multidose pen Interferon alfa-2b
IntronA 18- il miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
 460 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 461 Multiple myeloma:
Majeloma Multipla:
 462 Paediatric Use:
L- użu pedjatriku:
 463 Uncommonly reported side effects (at least 1 in every 1000 patients, but less than 1 in every 100 patients): bacterial infection and feeling of pins and needles.
Effetti sekondarji irrappurtati b’ mod mhux komuni (mill- anqas 1 f’ kull 1, 000 pazjent, iżda anqas minn 1 f’ kull 100 pazjent): infezzjoni tal- batteri u sensazzjoni ta ’ tingiż.
Each pen is intended for a maximum four-week use period and must then be discarded.
Kull pinna qegħda biex tintuża għal mhux aktar minn perijodu ta ’ użu ta ’ 4- ġimgħat u imbagħad għandha tintrema.
A maximum of 48 hours (two days) of exposure to 25°C is permitted over the four-week period to cover accidental delays in returning the pen to the refrigerator.
Huwa permess li jkun hemm esponiment ta ’ mhux aktar minn 48 siegħa (jumejn) f’ 25ºC fuq perijodu ta ’ 4- ġimgħat sabiex ikunu koperti ittardjar aċċidentali li jista ’ jkun hemm biex il - pinna titpoġġa lura fil- friġġ.
Depending upon your dose, you may have extra needles and swabs left in the pack.
Skond id- doża tiegħek, jista ’ jkollok aktar labar u tajjar li jibqgħu fil- pakkett.
Please discard these appropriately and safely.
Jekk jogħġbok armihom kif jixraq b’ mod sigur.
- The active substance is recombinant interferon alfa-2b, 18 million IU/pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 18- il miljun IU/ pinna
 464 What IntronA looks like and contents of the pack
Id- Dehra ta ’ IntronA u l- kontenuti tal- pakkett
The clear and colourless solution is contained in a glass cartridge.
IntronA jiġi bħala soluzzjoni għall- injezzjoni Is- soluzzjoni ċara u mingħajr kulur tiġi fi skartoċċ tal- ħġieġ.
The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 18- il miljun IU f’ dożi f’ medda ta ’ minn 1. 5 sa 6 miljun IU.
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 1. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
IntronA is available in three different pack sizes:
IntronA jiġi fi tlett daqsijiet ta ’ pakketti differenti:
IntronA, 18 million IU/pen, solution for injection:
IntronA, 18- il miljun IU/ pinna, soluzzjoni għall- injezzjoni:
- Pack of 1 pen, 12 injection needles and 12 cleansing swabs
- Pakkett b’ pinna 1, 12- il labra għall- injezzjoni u 12- il tajjara għat- tindif
- Pack of 2 pens, 24 injection needles and 24 cleansing swabs
- Pakkett b’ 2 pinen, 24 labra għall- injezzjoni u 24 tajjara għat- tindif
- Pack of 8 pens, 96 injection needles and 96 cleansing swabs
- Pakkett bi 8 pinen, 96 labra għall- injezzjoni u 96 tajjara għat- tindif
Česká republika Ke Štvanici 3 CZ-186 00 Praha 8 Tel: +420 221771250
Česká republika Ke Štvanici 3 CZ- 186 00 Praha 8 Tel: +420 221771250 Danmark Lautrupbjerg 2
Danmark Lautrupbjerg 2 DK-2750 Ballerup Tlf: + 45-44 39 50 00
Tlf: + 45- 44 39 50 00
Nederland Walmolen 1 NL-3994 DL Houten Tel: + 31-(0)800 9999000
Tel: + 31 - (0) 800 9999000
 466 HOW TO SELF INJECT INTRONA
KIF TINJETTA IntronA LILEK INNIFSEK
- the IntronA multidose pen;
- il- pinna b’ ħafna dożi ta ’ IntronA;
- a needle for subcutaneous injection (provided in the packaging);
- labra għall- injezzjoni taħt il- ġilda (ipprovduta fil- pakkett);
Use the injection needles provided in the packaging only for IntronA.
Uża biss il- labar għall- injezzjoni pprovduti fil- pakkett għal IntronA.
Use a new injection needle for each dose.
Uża labra għall - injezzjoni ġdida għal kull doża.
Be sure the solution is at room temperature at the time of injection.
Kun ċert li s- soluzzjoni għandha t- temperatura tal- kamra fil- ħin ta ’ l - injezzjoni.
Diagrams A and B show you all the different parts of the pen and the injection needle.
Id- Dijagrammi A u B juruk il- partijiet differenti kollha tal- pinna u tal- labra għall- injezzjoni.
The most important parts to note are as follows:
L- aktar partijiet importanti li għandek tinnota huma dawn:
- The push button scale tells you what dose has been set.
- L- iskala tal- buttuna mnejn tagħfas turik id- doża li kienet issettjata.
- The colour coding strip brown and the push button are at the bottom of the pen as it is held cap
- L- istrixxa bil- kodiċi tal- kulur kannella u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal- pinna
up.
meta din tinżamm bil- kappa ’ l fuq.
- The pen can only be fully capped when the triangle on the cap scale is aligned with the dosage
- Il- kappa tal- pinna tista ’ titpoġġa sew biss meta t- trijanglu fuq l- iskala tal- kappa jkun allineat
indicator on the barrel.
Kappa ta ’ barra tal- labra
Cap
Labra
Cap scale
Gibjun
Needle Rubber membrane
Barrel tal - pinna
Reservoir
Indikatur tad- dożagg
Dosage indicator
Kodici tal - kulur
Pen barrel
Skala tal -
Colour coding Push button
buttuna
Push button scale
mnejn taghfas
Diagram A
Disinn A
Diagram B
Disinn B
 467 Measuring the dose of IntronA Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
When you are ready to give your injection prepare your pen as follows:
Meta tkun lest biex tagħti l- injezzjoni pprepara l- pinna kif ġej:
Check that IntronA, solution for injection, is clear and colourless in appearance prior to use.
Aċċerta ruħek li IntronA, soluzzjoni għall- injezzjoni, għandu dehra ċara qabel tużah.
If it does not have a clear uniform appearance or if it contains any particles, do not use.
Jekk ma jkollux dehra ċara u uniformi, tużahx.
Pull off the cap of the pen and disinfect the rubber membrane (see Diagram C) with one cleansing swab.
Neħħi l- kappa tal- pinna u ddiżinfetta l- membrana tal- gomma (ara d- Disinn Ċ) b’ tajjara għat- tindif.
Diagram C
Disinn Ċ
Remove the protective tab from the injection needle.
Neħħi t- tapp protettiv mil- labra għall- injezzjoni.
Note that the rear portion of the injection needle is revealed once the protective tab is removed (see Diagram D).
Innota li l- parti ta ’ wara tal- labra għall- injezzjoni tinkixef meta jitneħħa t- tapp protettiv (ara d- Disinn D).
Diagram D
Disinn D
Gently push the injection needle onto the pen as shown in Diagram E.
Imbotta bil- mod il- labra għall- injezzjoni għal fuq il- pinna kif muri fid- Disinn E.
(Notice that the rear portion of the injection needle will pierce through the rubber membrane that you disinfected previously).
(Innota li l- parti ta ’ wara tal- labra għall- injezzjoni se ttaqqab il- membrana tal- gomma li ddiżinfettajt ftit qabel).
Now screw the injection needle onto the pen securely by turning it in a clockwise direction (see Diagram F).
Issa invita tajjeb il- labra għall- injezzjoni għal fuq il- pinna billi ddawwarha fid- direzzjoni skond l- arloġġ (ara d - Disinn F).
Diagram E
Diagramma E
Diagram F
Diagramma F
Then, pull off
L- ewwel, neħħi l- kappa ta ’ barra tal- labra għall- injezzjoni (Disinn G).
carefully, bearing in mind that the injection needle will now be exposed (Diagram H).
Imbagħad, neħħi bl- attenzjoni l - kappa ta ’ ġewwa tal- labra għall- injezzjoni, u żomm f’ moħħok li l- labra għall- injezzjoni issa se tkun mikxufa (Disinn H).
Keep the outer injection needle cap for later use.
Żomm il- kappa ta ’ barra tal- labra għall- injezzjoni biex tużaha wara.
Diagram G
Disinn G
Diagram H
Disinn H
Since a small amount of air may collect in the
Il- pinna issa tinsab lesta biex tintuża.
reservoir during storage, the next step is to remove any air bubbles.
Billi tista ’ tinġema ’ xi ftit arja fil- labra għall- injezzjoni u fil - ġibjun waqt il- ħażna, il- pass li jmiss hu li jitneħħew xi nuffati ta ’ l- arja li jista ’ jkun hemm.
This is called performing the Air- Shot.
Din tissejjaħ l- Isparatura ta ’ l- Arja.
Hold the IntronA, solution for injection, multidose pen with the injection needle point upwards.
Żomm il- pinna b’ ħafna dożi ta ’ IntronA, soluzzjoni għall- injezzjoni, bil- labra għall- injezzjoni tipponta ’ l fuq.
Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the injection needle (Diagram I).
Tektek il- ġibjun b’ sebgħek sabiex xi nuffati ta ’ l- arja li jista ’ jkun hemm jitilgħu fil- wiċċ, eżatt taħt il - labra għall- injezzjoni (Disinn I).
Diagram I
Disinn I
Hold the pen by the barrel and turn the reservoir in the direction as indicated by the arrow in Diagram J (clockwise) until you feel it click.
Żomm il- pinna mill- barrel u dawwar il- ġibjun fid- direzzjoni indikata bil- vleġġa fid- Disinn J (fid - direzzjoni skond l- arloġġ) sakemm tħossha tikklikkja.
Diagram J
Disinn J
Keeping the pen pointing upwards, press the push button up fully and see if a drop of IntronA, solution for injection, appears at the injection needle tip (Notice the drop at the tip of injection needle in Diagram K below).
Żomm il- pinna tipponta ’ l fuq, agħfas il- buttuna kollha ’ l fuq u ara jekk titfaċċax qatra ta ’ IntronA, soluzzjoni għall- injezzjoni, fil- ponta tal- labra (Innota l- qatra fil- ponta tal- labra għall- injezzjoni fid - Disinn K taħt).
 469 Diagram K
Disinn K
If no drop appears, use a different pen, and return the faulty pen to your provider.
Jekk ma titfaċċax qatra, uża pinna differenti u ħu lura l- pinna difettuża minn għand min ġibtha.
Note: some air may remain in the pen, but this is not important as you have removed the air from the injection needle and the dose will be accurate.
Nota: jista ’ jibqa xi arja fil- pinna, iżda dan mhux importanti billi l- arja mil- labra għall- injezzjoni kienet tneħħiet u d- doża se tkun preċiża.
Replace the IntronA, solution for injection, multidose pen cap with the ‘triangle’ opposite the dosage indicator as seen in Diagram L.
Poġġi lura f’ postha l- kappa tal- pinna b’ ħafna dożi ta ’ IntronA, soluzzjoni għall- injezzjoni, bit - ‘ trijanglu ’ biswit l- indikatur tad- dożaġġ kif muri fid- Disinn L.
Diagram L
Disinn L
The pen is now ready to set the dose.
Il- pinna issa tinsab lesta biex tissettja d- doża.
For the next step hold the pen in the middle of the barrel.
Għall- pass li jmiss żomm il- pinna min- nofs il- barrel.
This will allow the push button to move freely, ensuring that the correct dose is set.
Dan jippermetti li l- buttuna mnejn tagħfas tkun tista ’ titmexxa liberalment, u b’ hekk taċċerta li tista ’ tkun issettjata d- doża korretta.
To set the required dose, hold the pen horizontally by the barrel with one hand.
Biex tissettja d- doża meħtieġa, aqbad il- pinna b’ id waħda mill- barrel u żommha mimduda.
With the other hand, turn the cap in a clockwise direction indicated by the arrow in Diagram M.
Bl- id l - oħra, dawwar il- kappa fid- direzzjoni bħall- arloġġ kif indikat bil- vleġġa fid- Disinn M.
You will observe the push button rising, indicating the dose set.
Tinnota li l - buttuna mnejn tagħfas se togħla, u tindika d- doża ssettjata.
To set the correct dose, turn the cap as many times as indicated as follows:
Biex tissettja d- doża l- korretta, dawwar il - kappa għal kemm hemm bżonn drabi kif inhu indikat hawn taħt:
 470 Number of “turns” and “clicks”
Numru ta ’ “ dawriet ” u “ tfaqqih ”
Corresponding doses (million IU) using
Dożi li jikkorrispondu (miljun IU) meta
IntronA, solution for injection, multidose pen 18 million IU/pen
tuża IntronA, soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi 18- il miljun IU/ pinna
1 full
Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat 8 tfaqqihat 9 tfaqqihat 2 dawriet sħaħ (10 tfaqqihat) 11- il tfaqqiha 12- il tfaqqiha 13- il tfaqqiha 14- il tfaqqiha
7 clicks
1. 5 1. 8 2. 1 2. 4 2. 7 3 3. 3 3. 6 3. 9 4. 2
9 clicks
3 dawriet
2 full turns (10 clicks)
sħaħ (15- il tfaqqiha) 16- il tfaqqiha 17- il tfaqqiha 18- il tfaqqiha 19- il tfaqqiha
3 full turns (15 clicks)
4. 5 4. 8 5. 1 5. 4 5. 7
18 clicks
4 dawriet
19 clicks
sħaħ (20 tfaqqiha) *
*4 full turns correspond to the maximum dose to be administered in one injection.
* 4 dawriet sħaħ jikkorrispondu għad- doża massima li tista ’ tingħata b’ injezzjoni waħda.
The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Il- pinna hi magħmula biex tinjetta l - kontenuti kollha tagħha ta ’ 18- il miljun IU f’ dożi fuq medda ta ’ bejn 1. 5 sa 6 miljun IU.
The push button scale will show you the dose set (see Diagram N below).
L- iskala tal- buttuna mnejn tagħfas se turik id- doża ssettjata (ara d- Disinn N taħt).
For doses corresponding to full turns, the scale should line up with the correct dose marking.
Għal dożi li jikkorrispondu ma ’ tidwir komplet, l- iskala għandha tiddelinja ruħha mal- marka tad- doża t- tajba.
For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
Għal dożi li jikkorrispondu għal tfaqqih bejn tidwir sħaħ, l- iskala għandha tiddelinja ruħha mal- marki bejn żewġ dożi xierqa għal tidwir sħieħ.
At that point check that you have the correct dose.
F’ dan il- punt aċċerta ruħek li għandek id- doża l- korretta.
 471 Diagram N
Disinn N
After each complete turn make sure that the triangle is opposite the dosage indicator (see Diagram O).
Wara kull dawra sħiħa kun ċert li t- trijanglu jinsab biswit l- indikatur tad- dożaġġ (ara d- Disinn O).
If you have set a wrong dose, simply turn the cap back (anti-clockwise) as far as you can until the push button is fully home and start again.
Jekk issettjajt doża ħażina, dawwar il- kappa lura (kontra d- direzzjoni ta ’ l- arloġġ) kemm tista ’ sakemm il- buttuna mnejn tagħfas tmur lura għall- pożizzjoni tal- bidu, u erga ’ ibda.
Once the correct dose is set you are ready to give the injection.
Meta tkun ssettjata d- doża l- korretta, tkun lest biex tagħti l- injezzjoni.
Diagram O Injecting the solution Select the injection site.
Disinn O
With your other hand, pick up the pen and hold it as you would a pencil.
Bl- id l- oħra aqbad il- pinna qisek qed iżżomm lapes.
Insert the needle into the pinched skin at an angle of approximately 45°.
Daħħal il- labra f’ angolu ta ’ madwar 45° fil - ġilda maqrusa ’ l barra.
Then press the push button down fully (see Diagram P).
Imbagħad agħfas il- buttuna ’ l isfel kollha (ara d- Disinn P).
Keeping the push button down, leave the injection needle in place for a few seconds to allow the IntronA, solution for injection, to distribute under the skin, then remove.
Disinn P Bil- buttuna mniżżla s’ isfel, ħalli l- labra għall- injezzjoni fil- post għal ftit sekondi biex tippermetti lil IntronA, soluzzjoni għall- injezzjoni, tinfirex taħt il- ġilda, imbagħad neħħiha.
Carefully replace the outer injection needle cap (See Diagram Q).
Poġġi lura bl- attenzjoni l- kappa ta ’ barra tal- labra għall- injezzjoni (ara d- Disinn Q).
 472 Diagram Q
Disinn Q
Completely unscrew the injection needle assembly using an anti-clockwise turning motion as shown in Diagram R.
Ħoll għal kollox l- immuntar tal- labra għall- injezzjoni billi ddawwar kontra d- direzzjoni ta ’ l- arloġġ kif muri fid- Disinn R.
Then carefully lift it off the pen and discard the capped injection needle (see Diagram S).
Imbagħad għollih minn mal- pinna bl- attenzjoni u armi l- labra għall- injezzjoni mgħottija bil- kappa (ara d- Disinn S).
Diagram R
Disinn R
Diagram S
Disinn S
Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
Poġġi l- kappa tal- pinna lura f’ postha bit- trijanglu għal darb’ oħra biswit l- indikatur tad- dożaġġ kif muri fid- Disinn T.
Then return the pen to the refrigerator.
Imbagħad poġġi l- pinna lura fil- friġġ.
 473 PACKAGE LEAFLET:
Disinn T FULJETT TA ’ TAGĦRIF:
IntronA 30 million IU solution for injection, multidose pen Interferon alfa-2b
IntronA 30 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
 475 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 476 Multiple myeloma:
Majeloma Multipla:
 477 Paediatric Use:
L- użu pedjatriku:
 478 Uncommonly reported side effects (at least 1 in every 1000 patients, but less than 1 in every 100 patients): bacterial infection and feeling of pins and needles.
Effetti sekondarji irrappurtati b’ mod mhux komuni (mill- anqas 1 f’ kull 1, 000 pazjent, iżda anqas minn 1 f’ kull 100 pazjent): infezzjoni tal- batteri u sensazzjoni ta ’ tingiż.
- The active substance is recombinant interferon alfa-2b, 30 million IU/pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 30 miljun IU/ pinna
 479 What IntronA looks like and contents of the pack
Id- Dehra ta ’ IntronA u l- kontenuti tal- pakkett
The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 30 miljun IU f’ dożi f’ medda ta ’ minn 2. 5 sa 10 miljun IU.
The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 2. 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
IntronA, 30 million IU/pen, solution for injection:
IntronA, 30 miljun IU/ pinna, soluzzjoni għall- injezzjoni:
 481 HOW TO SELF INJECT INTRONA
KIF TINJETTA IntronA LILEK INNIFSEK
- The colour coding strip blue and the push button are at the bottom of the pen as it is held cap
- L- istrixxa bil- kodiċi tal- kulur ċelesti u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal- pinna
 482 Measuring the dose of IntronA Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Biex tkejjel id- doża ta ’ IntronA Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
 4 84 Diagram K
Disinn K
Number of “turns” and
Numru ta ’ “ dawriet ” u “ tfaqqih ”
IntronA, solution for injection, multidose pen 30 million IU/pen:
tuża IntronA, soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi 30 miljun IU/ pinna
1 full turn (5 clicks)
Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat 8 tfaqqihat 9 tfaqqihat 2 dawriet sħaħ (10 tfaqqihat) 11- il tfaqqiha 12- il tfaqqiha 13- il tfaqqiha 14- il tfaqqiha
7 clicks
2. 5 3 3. 5 4 4. 5 5 5. 5 6 6. 5 7
5
7. 5 8 8. 5 9 9. 5
* 4 full turns correspond to the maximum dose to be administered in one injection.
* 4 dawriet sħaħ jikkorrispondu għad- doża massima li tista ’ tingħata b’ injezzjoni waħda.
The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Il- pinna hi magħmula biex tinjetta l - kontenuti kollha tagħha ta ’ 30 miljun IU f’ dożi fuq medda ta ’ bejn 2. 5 sa 10 miljun IU.
 486 Diagram N
Disinn N
 487 Diagram Q
Disinn Q
 488 PACKAGE LEAFLET:
Disinn T FULJETT TA ’ TAGĦRIF:
IntronA 60 million IU solution for injection, multidose pen Interferon alfa-2b
IntronA 60 miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi Interferon alfa- 2b
 490 Using IntronA with food and drink While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Meta tuża IntronA ma ’ l- ikel u max- xorb Meta tkun qed tiġi kkurat b’ IntronA, it- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi sabiex jevita li titbaxxielek il- pressjoni.
 491 Multiple myeloma:
Majeloma Multipla:
 492 Paediatric Use:
L- użu pedjatriku:
 493 Uncommonly reported side effects (at least 1 in every 1000 patients, but less than 1 in every 100 patients): bacterial infection and feeling of pins and needles.
Effetti sekondarji irrappurtati b’ mod mhux komuni (mill- anqas 1 f’ kull 1, 000 pazjent, iżda anqas minn 1 f’ kull 100 pazjent): infezzjoni tal- batteri u sensazzjoni ta ’ tingiż.
- The active substance is recombinant interferon alfa-2b, 60 million IU/pen
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 60 miljun IU/ pinna
 494 What IntronA looks like and contents of the pack
Id- Dehra ta ’ IntronA u l- kontenuti tal- pakkett
The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Il- pinna hi magħmula biex tinjetta l- kontenuti tagħha ta ’ 60 miljun IU f’ dożi f’ medda ta ’ minn 5 sa 20 miljun IU.
The pen will deliver a maximum of 12 doses of 5 million IU over a period not to exceed 4 weeks.
Il- pinna ser tinjetta massimu ta ’ 12- il doża ta ’ 5 miljun IU fuq perijodu ta ’ mhux aktar minn 4 ġimgħat.
IntronA, 60 million IU/pen, solution for injection:
IntronA, 60 miljun IU/ pinna, soluzzjoni għall- injezzjoni:
 496 HOW TO SELF INJECT INTRONA
KIF TINJETTA IntronA LILEK INNIFSEK
- The colour coding strip pink and the push button are at the bottom of the pen as it is held cap
- L- istrixxa bil- kodiċi tal- kulur roża u l- buttuna mnejn tagħfas jinsabu n- naħa t’ isfel tal- pinna
 497 Measuring the dose of IntronA Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Biex tkejjel id- doża ta ’ IntronA Oħroġ il- pinna mill- friġġ madwar nofs siegħa qabel tagħti d- doża sabiex is- soluzzjoni jkollha l- istess temperatura tal- kamra fil- ħin ta ’ l- injezzjoni.
 4 99 Diagram K
Disinn K
 500 Number of “turns” and
Numru ta ’ “ dawriet ” u “ tfaqqih ”
IntronA, solution for injection, multidose pen 60 million IU/pen:
tuża IntronA, soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi 60 miljun IU/ pinna
1 full turn (5 clicks)
Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat 8 tfaqqihat 9 tfaqqihat
5
5 6 7 8 9
2 full turns (10 clicks)
2 dawriet sħaħ (10 tfaqqihat) 11- il tfaqqiha 12- il tfaqqiha 13- il tfaqqiha 14- il tfaqqiha
10
10 11 12 13 14
14 clicks
3 dawriet
3 full turns (15 clicks)
sħaħ (15- il tfaqqiha) 16- il tfaqqiha 17- il tfaqqiha 18- il tfaqqiha 19- il tfaqqiha
19 clicks
15 16 17 18 19
19
4 dawriet
4 full turns (20 clicks)*
sħaħ (20 tfaqqiha) *
The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Il- pinna hi magħmula biex tinjetta l - kontenuti kollha tagħha ta ’ 60 miljun IU f’ dożi fuq medda ta ’ bejn 5 sa 20 miljun IU.
 501 Diagram N
Disinn N
 502 Diagram Q
Disinn Q
Diagram T
Disinn T
INVANZ 1 g powder for concentrate for solution for infusion.
INVANZ 1g trab għal konċentrat għal- soluzzjoni għall- infużjoni
Each vial contains 1.0 g ertapenem equivalent to 1.046 g ertapenem sodium.
Kull kunjett fih 1. 0g ertapenem ekwivalenti għal 1. 046g ta ’ ertapenem sodium
Excipients: each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg).
Sustanzi mhux attivi: kull doża ta ’ 1. 0g fiha madwar 6. 0 mEq ta ’ sodium (madwar 137mg).
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Powder for concentrate for solution for infusion.
Trab għall- konċentrat għal- soluzzjoni għall- infużjoni.