qanastek/EMEA-V3 huggingface dataset:
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 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.
qtugħ ta ’ nifs, konfużjoni, tbatija biex toqod attent, tnemnim jew tingiż fl- idejn jew fir- riġlejn; 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, 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 fuq il- ġilda jew fuq il- membrana mukuża.
These 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 - 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.
Moderate and usually reversible reduction in all three blood elements-white blood cells, red blood cells and platelets, has been reported.
Tnaqqis moderat li ssoltu jkun riversibbli fit- tlett elementi kolla tad- demm – ċelluli bojod tad- demm, ċelluli ħomor tad- demm u plejtlets, kien irrappurtat.
 348 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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 paracetamol if you develop these symptoms.
It- tabib jista ’ jtik parir biex tieħu paracetamol jekk jaqbduk dawn is- sintomi.
Other side effects that may occur include:
Effetti sekondarji oħra li jistgħu jseħħu jinkludu:
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, 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 (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 komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti): uġigħ, nefħa u ħmura jew ħsara fil- ġilda fis- sit mnejn tingħata l- injezzjoni, telf tax- xagħar, sturdament, tibdil fl- aptit, weġgħat fl- istonku jew fl- addome, dijarea, tqalligħ (tħossok marid), infezzjoni virali, depressjoni, burdati emozzjonali, nuqqas ta ’ rqad, ansjetà, grieżem misluħa u uġigħ biex tibla, għeja, dehxiet/ tregħid, deni, reazzjoni bħal ta ’ l- influwenza, tħossok skomdu b’ mod ġenerali, attakki ta ’ uġigħ ta ’ ras, telf tal- piż, rimettar, irritabilità, dgħjufija, tibdil fil- burdati, sogħla (kultant qawwija), qtugħ ta ’ nifs, ħakk, ġilda xotta, raxx, uġigħ muskolari sever f’ salt, uġigħ fil- ġogi, uġigħ muskolu - skeletali, bidliet fil- valuri tal- laboratorju inkluż tnaqqis fl- għadd taċ- ċelluli bojod.
Some children have had a decrease in their rate of growth (height and weight).
Xi tfal kellhom tnaqqis fir- rata ta ’ tkabbir tagħhom (tul u piż).
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 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.  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 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.
Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia.
Effetti sekondarji rrappurtati b’ mod rari (mill- anqas 1 f’ kull 10, 000 pazjent, iżda anqas minn 1 f’ kull 1, 000 pazjent): pulmonite
Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Effetti sekondarji rrappurtati rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent): pressjoni baxxa, wiċċ impaħpaħ, dijabete, bugħawwieġ fir- riġlejn, uġigħ fid- dahar, problemi tal - kliewi, ħsara fin- nervituri, fsada tal- ħanek, anemija aplastika.
Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Aplasja pura taċ- ċelluli ħomor, kundizzjoni fejn il- ġisem ikun waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm, kienet irrappurtata.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Din twassal għal anemija severa, li s- sintomi tagħha jkunu jinkludu għeja mhux tas- soltu u nuqqas ta ’ enerġija.
Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
F’ każijiet rari ħafna kienet irrappurtata sarkojdożi (marda kkaratterizzata b’ deni persistenti, telf ta ’ piż, ġogi minfuħa u muġugħa, feriti fil- ġilda u glandoli minfuħa).
Loss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses.
Telf mis- sensi seħħet rari ħafna, l - aktar f’ pazjenti anzjani li ngħataw dożi għoljin.
Cases of stroke (cerebrovascular events) have been reported.
Każijiet ta ’ puplesija (każ ċerebrovaskulari) kien irrappurtat.
Check with your doctor immediately if you have any of these symptoms.
Aċċerta ruħek mat- tabib tiegħek immedjatament jekk tħoss xi wieħed minn dawn is - sintomi.
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.
Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement) have been reported with IntronA use.
Minbarra hekk, bl- użu ta ’ IntronA kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s - sinsla), ħsibijiet li jheddu l- ħajja ta ’ nies oħra, manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l- karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament).
 349 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
HOW TO STORE INTRONA
KIF TAĦŻEN INTRONA
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2C – 8C).
For short term travelling, the non-reconstituted product can be kept out of the refrigerator at or below 25°C for a period up to four weeks before use.
Għal ivvjaġġar għal perijodu qasir, il- prodott mhux rikostitwit jista ’ jinżamm barra mill- friġġ f’ temperatura ta ’ 25°C jew inqas għal mhux iktar minn erba ’ ġimgħat qabel l- użu.
If the product is not used during this four-week period, it should be discarded.
Jekk il- prodott ma jintużax matul dawn l- erba ’ ġimgħat, dan għandu jintrema.
The solution should be used immediately after reconstitution.
Is- soluzzjoni għandha tintuża mill- ewwel wara r- rikostituzzjoni.
If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours.
Jekk ma tintużax mill- ewwel, għandha tinħażen bejn 2ºC – 8ºC fi friġġ u tintuża fi żmien 24 siegħa.
Do not use IntronA after the expiry date which is stated on the package.
Tużax IntronA wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Do not use IntronA if you notice changes in the appearance of IntronA.
M’ għandekx tuża IntronA jekk tinnota xi tibdil fid- dehra ta ’ IntronA.
What IntronA contains
X’ fih Intron A
- The active substance is recombinant interferon alfa-2b, 1 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 1 miljun IU/ ml.
- The other ingredients are glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate
- Is- sustanzi l- oħra huma glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate
monohydrate, and human albumin solution.
monohydrate, u soluzzjoni ta ’ albumina tal- bniedem.
- Solvent: water for injections 1 ml/ampoule
- Solvent: ilma għall- injezzjonijiet 1 ml/ ampulla
What IntronA looks like and contents of the pack
Id- Dehra ta ’ IntronA u l- kontenuti tal- pakkett
IntronA is presented as a powder and solvent for solution for injection or infusion.
IntronA jiġi bħala trab u solvent għal soluzzjoni għall- injezzjoni jew infuzjoni.
The white to cream coloured powder is contained in a 2 ml glass vial, and the clear and colourless solvent is presented in a 2 ml glass ampoule with 1 injection syringe, 2 injection needles and 1 cleansing swab.
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml f’ siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
Pack size of 1 or 12.
Id- daqsijiet tal- pakkett huma 1 jew 12.
SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
Sid l- Awtorizzazzjoni għall- Kummerċ SP Europe 73, rue de Stalle B- 1180 Bruxelles
SP Labo N.V.
Manifattur SP Labo N. V.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Latvija Bauskas 58a -401 Rīga, LV-1004 Tel: + 371-7 21 38 25
Bauskas 58a - 401 Rīga, LV- 1004 Tel: + 371- 7 21 38 25
 352 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
The following instructions explain how to inject IntronA yourself.
It- tagħrif li ġej jispjegalek kif tinjetta IntronA inti stess.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet bl - attenzjoni u segwihom pass pass.
Your doctor or his/her assistant will instruct you how to self- inject IntronA.
It- tabib tiegħek jew l- assistent tiegħu se jgħidulek kif tinjetta IntronA lilek innifsek.
Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.
Tippruvax tinjetta lilek innifsek jekk m’ intix ċert li fhimt il- proċedura u l- ħtieġa għall- injezzjoni.
Preparation Collect necessary items before you begin:
Preparazzjoni Iġbor l- oġġetti li se jkollok bżonn qabel tibda:
- a vial of IntronA powder for injection;
- kunjett ta ’ IntronA, trab għall- injezzjoni;
- an ampoule of solvent for IntronA (water for injections 1 ml);
- ampulla ta ’ solvent għal IntronA (ilma għall- injezzjonijiet 1 ml);
- a 2 ml syringe;
- siringa ta ’ 2 ml;
- a long needle (for example 0.8 x 40 mm [21 gauge 1.5 inch]) to be used to add water for
labra twila (per eżempju 0. 8  40 mm [21 gauge 1. 5 pulzieri]) biex iżżid l- ilma għall -
- a short needle (for example 0.3 x 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection;
injezzjonijiet ġol- kunjett tat- trab ta ’ IntronA; labra qasira (per eżempju 0. 3  13 mm [30 gauge 0. 5 pulzieri]) għall- injezzjoni taħt il- ġilda;
- a cleansing swab.
- tajjara għat- tindif.
Wash your hands carefully.
Aħsel idejk sew.
Reconstituting IntronA powder for injection Remove the protective cap from the IntronA vial.
Biex tirrikostitwixxi IntronA trab għall- injezzjoni Neħħi l- kappa protettiva mill- kunjett ta ’ IntronA.
Clean the rubber top of the vial with a cleansing swab.
Naddaf il- parti ta ’ fuq tal- gomma tal- kunjett b’ tajjara għat- tindif.
You can save the swab to clean the skin area where you will inject the dose.
Tista ’ terfa ’ t- tajjara biex tnaddaf il- ġilda fejn se tinjetta d- doża.
Remove the syringe from the wrapping.
Neħħi s- siringa mill- karta.
Do not touch the tip of the syringe.
Tmissx it- tarf tas- siringa.
Take the long needle and place it firmly onto the tip of the syringe.
Aqbad il- labra t- twila u waħħalha tajjeb mat- tarf tas- siringa.
Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Neħħi l- protezzjoni tal- labra mingħajr ma tmiss il- labra u żomm is- siringa bil- labra magħha f’ idek.
Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Tektek bil- mod il- parti ta ’ fuq ta ’ l- ampulla tas- solvent biex tagħmel fiċ- ċert li l- likwidu kollu jinsab fil- qiegħ ta ’ l- ampulla.
Break the top of the ampoule of solvent.
Aqsam il- parti ta ’ fuq ta ’ l- ampulla tas- solvent.
Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
Daħħal il- labra fl- ampulla tas - solvent u iġbed l- ammont sħiħ ta ’ solvent.
To prepare the IntronA solution insert the needle through the rubber top of the IntronA vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Biex tipprepara s- soluzzjoni ta ’ IntronA deffes il- labra mill- parti ta ’ fuq tal- gomma tal- kunjett ta ’ IntronA u miss il- ponta tal- labra bil- galbu mal- ħajt tal- ħġieġ tal- kunjett mingħajr ma tmiss il- parti l - imnaddfa ta ’ fuq tal- kunjett b’ idejk.
Slowly inject the diluent, aiming the stream of liquid at the glass wall of the vial in order to avoid production of air bubbles.
Injetta d- dilwent bil- mod, u mmira n- nixxiegħa tal- likwidu lejn il- ħajt tal- ħġieġ tal- kunjett sabiex tevita milli jiffurmaw nuffati ta ’ l- arja.
Do not aim the stream at the white powder at the bottom of the vial.
Timmirax in- nixxiegħa lejn it- trab l- abjad fil- qiegħ tal- kunjett.
To dissolve the white contents, swirl the IntronA vial with a gentle rotary motion leaving the syringe needle in the vial, until the contents are completely dissolved.
Biex iddewweb il- kontenut l- abjad, dawwar bil- galbu l- kunjett ta ’ IntronA b’ moviment forma ta ’ ċirku filwaqt li tħalli l- labra tas- siringa fil- kunjett, sakemm il- kontenut ikun dab għal kollox.
Do not shake.
Tħawwadx bis - saħħa.
If air bubbles do form, wait until the solution has settled and all bubbles have risen to the top of the solution and disappeared before withdrawing your dose from the vial.
Jekk xorta waħda jiffurmaw in- nuffati ta ’ l- arja, stenna sakemm is- soluzzjoni tkun qagħdet u n - nuffati kollha jkunu telgħu fil- wiċċ tas- soluzzjoni u jkunu sparixxew qabel ma tiġbed id- doża tiegħek mill- kunjett.
If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours.
Jekk ma tintużax mill - ewwel, għandha tinħażen f’ temperatura ta ’ 2ºC – 8ºC fi friġġ u tintuża fi żmien24 siegħa.
Measuring the dose of IntronA from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Biex tkejjel il- doża ta ’ IntronA mit- trab rikostitwit għall- injezzjoni Dawwar il- kunjett u s- siringa rashom ’ l isfel f’ id waħda.
Be sure the tip of needle is in the IntronA reconstituted solution.
Kun ċert li l- ponta tal- labra tinsab fis - soluzzjoni rikostitwita ta ’ IntronA.
Your other hand will be free to move the plunger.
Idek l- oħra trid 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 il- planġer lura bil- mod biex ittella ’ d- doża l- korretta li qallek it- tabib għal ġos- siringa.
Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle leaving the needle in the vial and without touching the tip of the syringe.
Żomm is- siringa bil- labra fil- kunjett jippontaw ’ il fuq, u neħħi s- siringa minn mal- labra t- twila filwaqt li tħalli l- labra fil- kunjett, u mingħajr ma tmiss it- tarf tas- siringa.
Take the short needle and place it firmly onto the tip of the syringe.
Aqbad il- labra l- qasira u waħħalha tajjeb mat- tarf tas- siringa.
Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Neħħi l- protezzjoni tal- labra minn mal- labra tas- siringa u ċċekkja għal xi nuffati ta ’ l- arja fis- siringa.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Jekk tara xi nuffati, iġbed il- planġer ftit lura; tektek is- siringa bil- galbu, bil- labra tipponta ’ l fuq, sakemm in- nuffati jisparixxu.
Push up the plunger slowly back to the correct dose.
Imbotta l- planġer bil- mod ’ il fuq lura lejn id - doża l- korretta.
Replace the needle guard and place the syringe with the needle on a flat surface.
Erġa ’ waħħal il- protezzjoni tal- labra u poġġi s- siringa bil- labra fuq wiċċ ċatt.
Be sure the solution is at room temperature up to 25°C.
Kun ċert li s- soluzzjoni għandha t- temperatura tal- kamra ta ’ mhux aktar minn 25°C.
If the solution is cold, warm the syringe between your palms.
Jekk is- soluzzjoni hija kiesħa, saħħan is- siringa bejn il- pali ta ’ jdejk.
Examine the reconstituted solution prior to administration: it should be clear and colourless.
Ifli s- soluzzjoni rikostitwata qabel tagħtiha: għandha tkun ċara u mingħajr kulur.
Do not use if discolouration or particulate matter is present.
Tużahiex jekk tinnota bidla fil- kulur jew xi materjal ta ’ partiċelli żgħar.
You are now ready to inject the dose.
Issa tinsab lest biex tinjetta d- doża.
 353 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
L- aħjar postijiet għall- injezzjoni huma t- tessuti b’ saff ta ’ xaħam bejn il - ġilda u l- muskolu: il- koxxa, in- naħa ta ’ barra fil- parti ta ’ fuq tad- driegħ (jista ’ jkollok bżonn l - għajnuna ta ’ persuna oħra biex tuża dan il- post), iż- żaqq (’ l isfel mill- qadd).
If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Jekk int irqiq/ a ħafna, uża biss il- koxxa jew in- naħa ta ’ barra tad- driegħ għall- injezzjoni.
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.
Naddaf u ddiżinfetta l- ġilda fejn se tagħti l- injezzjoni.
Wait for the area to dry.
Stenniha tinxef.
Remove the needle guard.With one hand, pinch a fold of loose skin.
B’ id waħda oqros biċċa ġilda ’ l barra.
With your other hand hold the syringe as you would a pencil.
Bl- id l- oħra żomm is- siringa qisek qed iżżomm lapes.
Insert the needle into the pinched skin at an angle of 45° to 90°.
Daħħal il - labra f’ angolu ta ’ bejn 45° u 90° fil- ġilda maqrusa ’ l barra.
Inject the solution by pushing the plunger all the way down gently.
Injetta s- soluzzjoni billi timbotta l- planġer bil- mod s’ isfel.
Pull the needle straight out of the skin.
Iġbed il- labra dritt ’ l barra mill- ġilda.
Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Agħfas il- post ta ’ l- injezzjoni b’ faxxa żgħira jew b’ garża sterili jekk hemm bżonn għal diversi sekondi.
Do not massage the injection site.
Timmassaġġjax il- post ta ’ l- injezzjoni.
If there is bleeding, cover with an adhesive bandage.
Jekk ikun ħiereġ id - demm, għatti b’ faxxa li teħel.
The vial, ampoule and injection materials intended for single use must be discarded.
Il- kunjett, l- ampulla u l- materjali għall- injezzjoni maħsubin għal użu ta ’ darba għandhom jintremew.
Dispose of the syringe and needles safely in a closed container.
Armi s- siringa u l- labar ġo kontenitur magħluq mingħajr ma toħloq periklu.
 354 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 3 million IU/ml powder and solvent for solution for injection or infusion Interferon alfa-2b
IntronA 3 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 356 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.
 357 If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 358 Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 359 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
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 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.
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.
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.
 360 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
For short term travelling, the non -reconstituted product can be kept out of the refrigerator at or below 25°C for a period up to four weeks before use.
Għal ivvjaġġar għal perijodu qasir, il- prodott mhux rikostitwit jista ’ jinżamm barra mill- friġġ f’ temperatura ta ’ 25°C jew inqas għal mhux iktar minn erba ’ ġimgħat qabel l- użu.
- The active substance is recombinant interferon alfa-2b, 3 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 3 miljun IU/ ml.
The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml.
IntronA is available in two different pack sizes:
IntronA jiġi f’ żewġ daqsijiet ta ’ pakketti differenti:
- Pack of 1 vial of powder for solution for injection or infusion, 1 ampoule of water for injections,
- Pakkett b’ kunjett 1 ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni, ampulla 1 bl- ilma
1 injection syringe, 2 injection needles and 1 cleansing swab
għall- injezzjonijiet, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
- Pack of 6 vials of powder for solution for injection or infusion and 6 ampoules of water for
- Pakkett b’ 6 kunjetti ta ’ trab għal soluzzjoni għall injezzjoni jew infużjoni u 6 ampulli bl- ilma
injections Not all pack sizes may be marketed.
għall- injezjonijiet Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il mediċina, jekk jogħġbok ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
8, sector 1 RO -013682 Bucureşti Tel. + 40 21 233 35 30
7, sector 1 RO- 013682 Bucureşti Tel. + 40 21 233 35 30
 363 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 364 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 365 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 5 million IU/ml powder and solvent for solution for injection or infusion Interferon alfa-2b
IntronA 5 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 367 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.
 368 If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 369 Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 370 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
 371 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
- The active substance is recombinant interferon alfa-2b, 5 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 5 miljun IU/ ml.
The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml.
Eesti Österreich Järvevana tee 9 EE-11314 Tallinn Tel: + 372 654 96 86
Järvevana tee 9 EE- 11314 Tallinn Tel: + 372 654 96 86
 374 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 375 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 376 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 10 million IU/ml powder and solvent for solution for injection or infusion Interferon alfa-2b
IntronA 10 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 378 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.
 379 If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 380 Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 381 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
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.
 382 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
- The active substance is recombinant interferon alfa-2b, 10 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 10 miljun IU/ ml.
IntronA is available in three different pack sizes:
IntronA jiġi f’ żewġ daqsijiet ta ’ pakketti differenti:
- Pack of 1 vial of powder for solution for injection or infusion, 1 ampoule of water for
- Pakkett b’ kunjett 1 ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni, ampulla 1 bl- ilma
injections, 1 injection syringe, 2 injection needles and 1 cleansing swab
għall- injezzjonijiet, siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
injections
għall- injezjonijiet
- Pack of 10 vials of powder for solution for injection or infusion, 10 ampoules of water for
- Pakkett b’ 10 kunjetti ta ’ trab għal soluzzjoni għall- injezzjoni jew infużjoni, 10 ampulli bl- ilma
injections, 10 injection syringes, 20 injection needles and 10 cleansing swabs Not all pack sizes may be marketed.
għall- injezzjonijiet, 10 siringi għall- injezzjoni, 20 labra għall- injezzjoni u 10 tajjar biex tnaddaf.
 383 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il mediċina, jekk jogħġbok ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Česká republika Ke Štvanici 3 CZ-186 00 Praha 8 Tel: +420 221771250
Malta Česká republika Ke Štvanici 3 CZ- 186 00 Praha 8 Tel: +420 221771250
Ελλάδα Αγίου Δημητρίου 63 GR-174 55 Άλιμος Tηλ: + 30-210 98 97 300
Ελλάδα Αγίου Δημητρίου 63 GR- 174 55 Άλιμος
 385 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 386 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 387 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 18 million IU/ml powder and solvent for solution for injection or infusion Interferon alfa-2b
IntronA 18- il miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 389 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.
 390 If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 391 Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 392 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
 393 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
- The active substance is recombinant interferon alfa-2b, 18 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 18- il miljun IU/ ml.
The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule with 1 injection syringe, 2 injection needles and 1 cleansing swab.
It- trab abjad għal lewn il- krema jinsab f’ kunjett tal- ħġieġ ta ’ 2 ml, u s- solvent ċar u mingħajr kulur jiġi f’ ampulla tal- ħġieġ ta ’ 2 ml f’ siringa 1 għall- injezzjoni, 2 labar għall- injezzjoni u tajjara 1 biex tnaddaf.
 396 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 397 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 398 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 30 million IU/ml powder and solvent for solution for injection or infusion Interferon alfa-2b
IntronA 30 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 400 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.
 401 If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 402 Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 403 At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
 404 Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
- The active substance is recombinant interferon alfa-2b, 30 million IU/ml.
- Is- sustanza attiva hi interferon alfa- 2b rikombinanti, 30 miljun IU/ ml.
 407 HOW TO SELF INJECT INTRONA
KIF TINJETTA INTRONA LILEK INNIFSEK
 408 Injecting the solution Select the injection site.
Biex tinjetta s- soluzzjoni Agħżel il- post fejn se tinjetta.
 409 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
IntronA 3 million IU/0.5 ml solution for injection or infusion Interferon alfa-2b
IntronA 3 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni Interferon alfa- 2b
 411 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.
If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Jekk qed tinjetta IntronA inti stess, jekk jogħġbok kun ċert li d- doża li kienet preskritta għalik hi pprovduta b’ mod ċar mal- pakkett tal- mediċina li tirċievi.
 412 Multiple myeloma:
Majeloma Multipla:
Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/ml.
Jista ’ jintuża kunjett ta ’ kwalunkwe daqs sabiex titkejjel id- doża meħtieġa, madankollu l- konċentrazzjoni ta ’ interferon fis- soluzzjoni ta ’ sodium chloride fl- aħħar m’ għandhiex tkun anqas minn 0. 3 miljun IU/ ml.
The appropriate dose of IntronA is withdrawn from the vial(s), added to 50 ml of 9 mg/ml (0.9%) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
Id- doża xierqa ta ’ IntronA għandha tinġibed mill- kunjett( i), tiġi miżjuda ma ’ 50 ml ta ’ 9 mg/ ml (0. 9%) sodium chloride soluzzjoni għall - injezzjoni f’ borża tal- PVC jew flixkun tal- ħġieġ għall- użu minn ġol- vina u jingħata fuq 20 minuta.
Use IntronA exactly as prescribed by your doctor.
Uża IntronA eżatt kif qallek it- tabib tiegħek.
 413 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).
At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Fil- bidu tat- trattament b’ IntronA, 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.
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  414 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.
Other side effects not listed above may also occur in some patients.
Xi effetti sekondarji oħra li mhumiex imsemmijin hawn fuq jistgħu jseħħu f’ xi pazjenti.
HOW TO STORE INTRONA
KIF TAĦŻEN INTRONA Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.