qanastek/EMEA-V3 huggingface dataset:
Precautions must be taken to avoid accidental injection into a vein.
Għandhom jittieħdu prekawzjonijiet biex tiġi evitata injezzjoni aċċidentali ġo vina.
The site of injection is likely to vary within the abdominal region.
Is- sit tal- injezzjoni x’ aktarx li se jvarja fiż- żona addominali.
If you forget to use FIRMAGON
Jekk tinsa tuża FIRMAGON
If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.
Jekk taħseb li tkun insejt id- doża tiegħek ta ’ kull xahar ta ’ FIRMAGON, jekk jogħġbok kellem lit - tabib tiegħek.
If you have any further questions on the use of this medicine, ask your doctor.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din il- mediċina, staqsi lit- tabib tiegħek.
Like all medicines, FIRMAGON can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, FIRMAGON jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: − very common (affects more than 1 user in 10) − common (affects 1 to 10 users in 100) − uncommon (affects 1 to 10 users in 1,000) − rare (affects 1 to 10 users in 10,000) − very rare (affects less than 1 user in 10,000) − not known (frequency cannot be estimated from the available data)
Il- frekwenza tal- effetti sekondarji li jista ’ jkun hemm elenkati hawn taħt hi definita bl- użu tal - konvenzjoni li ġejja: – komuni ħafna (jaffettwaw iktar minn persuna 1 minn kull 10 li jużawh) – komuni (jaffettwaw minn persuna 1 sa 10 persuni minn kull 100 li jużawh) – mhux komuni (jaffettwaw minn persuna 1 sa 10 persuni minn kull 1, 000 li jużawh) – rari (jaffettwaw minn persuna 1 sa 10 persuni minn kull 10, 000 li jużawh) – rari ħafna (jaffettwaw inqas minn persuna 1 minn kull 10, 000 li jużawh) – mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Very common Hot flushes, injection site pain and redness.
Komuni ħafna Fwawar, uġigħ fis- sit tal- injezzjoni u ħmura.
Common − injection site swelling, node and hardness − chills, fever or influenza-like illness after the injection − trouble sleeping, tiredness, weakness, dizziness, headache − increased weight, nausea, elevated levels of some liver enzymes − excessive sweating (including night sweats)
Komuni − nefħa, għoqod u ebusija fis- sit tal- injezzjoni − tkexkix ta ’ bard, deni jew mard bħal dak tal- influwenza wara l- injezzjoni − problemi biex torqod, għeja, dgħjufija, sturdament, uġigħ ta ’ ras − żieda fil- piż, nawsja, livelli għolja ta ’ xi enzimi tal- fwied − għaraq eċċessiv (li jinkludi għaraq matul il- lejl)
Uncommon − loss of sexual desire, impotence, reduced size of testicles, testicular pain, breast swelling, pelvic pain, prostatitis (inflammation of the prostate gland), prostate tenderness, backwards ejaculation (ejaculation to urinary bladder) − depression, anxiety − rash, skin redness, locally changed skin color, loss of hair, soft nails − allergic reactions, hives − cough − decreased appetite, constipation, diarrhoea, vomiting, dry mouth, abdominal discomfort − anaemia
Mhux komuni − telf ta ’ aptit sesswali, impotenza, tnaqqis fid- daqs tat- testikoli, uġigħ testikulari, nefħa fis- sider, uġigħ pelviku, prostatite (infjammazzjoni tal- glandola tal- prostata), sensittività fil- prostata, eġakulazzjoni lura (eġakulazzjoni ġol- bużżieqa tal- awrina) − dipressjoni, ansjetà − raxx, ħmura fil- ġilda, kulur tal- ġilda lokalment mibdul, jaqa ’ x- xagħar, dwiefer rotob
37 − high blood pressure, changes in ECG (1st degree atrio-ventricular block, QT-prolongation), fainting − varicose vein (enlarged and twisted vein), localised oedema (localised swelling) − musculoskeletal pain, muscular weakness − frequent urination, urinary urgency (must hurry to pass urine), impaired renal function, decreased weight − tinnitus
40 − reazzjonijiet allerġiċi, ħorriqija − sogħla − nuqqas t’ aptit, stitikezza, dijarea, rimettar, ħalq xott, skonfort addominali − anemija pressjoni tad- demm għolja, tibdil fl- ECG (imblokk atrioventrikulari tal- 1el grad, titwil tal- QT), − ħass ħażin − vini varikużi (vini kbar u mgħawġin), edima lokalizzata (nefħa lokalizzata) − uġigħ muskoluskeletrali, dgħjufija fil- muskoli − tagħmel l- awrina b’ mod frekwenti, urġenza biex tagħmel l- awrina (trid tgħaġġel biex tagħmel l - awrina), indeboliment fil- funzjoni tal- kliewi, tnaqqis fil- piż − żanżin fil- widnejn
Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.
Effetti sekondarji fis- sit tal- injezzjoni huma l- iktar komuni bid- doża tal- bidu u anqas komuni bid- doża tal- manteniment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE FIRMAGON
KIF TAĦŻEN FIRMAGON
Do not use FIRMAGON after the expiry date which is stated on the vials and outer packaging.
Tużax FIRMAGON wara d- data ta ’ skadenza li tidher fuq il- kunjetti u fuq l- ippakkjar ta ’ barra.
Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Wara r- rikostituzzjoni L- istabbiltà kimika u fiżika waqt l- użu ntweriet li ddum sagħtejn f’ temperatura ta ’ 25ºC.
What FIRMAGON contains
X’ fih FIRMAGON
− The active substance is degarelix, each vial contains 80 mg degarelix.
Kull kunjett fih 80 mg ta ’ degarelix.
After reconstitution 1 ml of the reconstituted solution contains 20 mg degarelix. − The other ingredient of the powder is mannitol (E 421). − The solvent is water for injections.
Is- sustanza l- oħra tat- trab hi mannitol (E 421). – Is- solvent hu ilma għall- injezzjonijiet.
What FIRMAGON looks like and contents of the pack
Id- dehra ta ’ FIRMAGON u l- kontenuti tal- pakkett
The powder is white to off-white.
FIRMAGON hu trab għal soluzzjoni għall- injezzjoni It- trab hu minn abjad sa off- white.
The solvent is a clear, colourless solution.
Is- solvent hu soluzzjoni ċara u bla kulur.
1 pack contains:
Pakkett wieħed fih:
1 vial with powder containing 80 mg of degarelix and 1 vial with 6 ml of solvent.
Kunjett wieħed bit- trab li fih 80 mg ta ’ degarelix u kunjett wieħed b’ 6 ml ta ’ solvent.
1 syringe, 1 reconstitution needle and 1 injection needle.
Siringa waħda, labra waħda tar- rikostituzzjoni u labra waħda tal- injezzjoni.
Marketing Authorisation Holder and Manufacturer
41 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder:
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK-2300 Copenhagen S Denmark Tel. +45 8833 8834 38 Manufacturer:
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK- 2300 Copenhagen S Id- Danimarka Tel. +45 8833 8834
Ferring GmbH Wittland 11 D-24109 Kiel Germany
Ferring GmbH Wittland 11 D- 24109 Kiel Il- Ġermanja
For any information about this medicine, 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 tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
Instructions for proper use
Istruzzjonijiet biex tużah kif suppost
NOTE: • KEEP THE VIALS VERTICAL AT ALL TIMES • DO NOT SHAKE THE VIALS
NOTA: • ŻOMM IL- KUNJETTI F’ POŻIZZJONI VERTIKALI L- ĦIN KOLLU • TĦAWWADX IL- KUNJETTI
5. Exchange the green needle with the white needle for deep subcutaneous injection (27G / 0.4 x 25 mm).
5. Ibdel il- labra l- ħadra mal- labra l- bajda li qegħda għal injezzjoni profonda taħt il- ġilda (27G / 0. 4 x 25 mm).
Inject 4.0 ml of FIRMAGON 80 mg immediately after reconstitution. * 8.
Injetta 4. 0 ml ta ’ FIRMAGON 80 mg immedjatament wara r- rikostituzzjoni. * 8.
FIRMAGON 120 mg powder and solvent for solution for injection Degarelix
FIRMAGON 120 mg trab u solvent għal soluzzjoni għall- injezzjoni Degarelix
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Degarelix jimita ormon naturali (ormon li jerħi l- gonadotrophin, GnRH) u direttament jimblokka l- effetti tiegħu.
FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e. g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e. g. methadone, cisapride, moxifloxacine, antipsychotics).
FIRMAGON jista ’ jinterferixxi ma ’ xi mediċini li jintużaw biex jikkuraw problemi fir- ritmu tat- taħbit tal- qalb (eż. quinidine, procainamide, amiodarone u sotalol) jew mediċini oħrajn li jista ’ jkollhom effett fuq ir- ritmu tal- qalb (eż. methadone, cisapride, moxifloxacine, mediċini antipsikotiċi).
Driving and using machines
46 Sewqan u tħaddim ta ’ magni
43 Tiredness and dizziness are common side effects that may impaire your ability to drive and use machines.
L- għeja u l- isturdament huma effetti sekondarji komuni li jistgħu jindebolixxu l- ħila tiegħek li ssuq u tħaddem il- magni.
The injected liquid forms a gel from which a continuous release of degarelix takes place over a period of one month.
Il- likwidu injettat jifforma ġell li minnu jseħħ ħruġ kontinwu ta ’ degarelix fuq perjodu ta ’ xahar.
FIRMAGON must NOT be given into a blood vessel (intravenously).
FIRMAGON M’ GĦANDUX jingħata ġo vina jew arterja (għal ġol- vini).
44 − high blood pressure, changes in ECG (1st degree atrio-ventricular block, QT-prolongation), fainting − varicose vein (enlarged and twisted vein), localised oedema (localised swelling) − musculoskeletal pain, muscular weakness − frequent urination, urinary urgency (must hurry to pass urine), impaired renal function, decreased weight − tinnitus
47 − reazzjonijiet allerġiċi, ħorriqija − sogħla − nuqqas t’ aptit, stitikezza, dijarea, rimettar, ħalq xott, skonfort addominali − anemija pressjoni tad- demm għolja, tibdil fl- ECG (imblokk atrioventrikulari tal- 1el grad, titwil tal- QT), − ħass ħażin − vini varikużi (vini kbar u mgħawġin), edima lokalizzata (nefħa lokalizzata) − uġigħ muskoluskeletrali, dgħjufija fil- muskoli − tagħmel l- awrina b’ mod frekwenti, urġenza biex tagħmel l- awrina (trid tgħaġġel biex tagħmel l - awrina), indeboliment fil- funzjoni tal- kliewi, tnaqqis fil- piż − żanżin fil- widnejn
− The active substance is degarelix.
– Is- sustanza attiva hi degarelix.
Each vial contains 120 mg degarelix.
Kull kunjett fih 120 mg ta ’ degarelix.
After reconstitution 1 ml of the reconstituted solution contains 40 mg degarelix. − The other ingredient of the powder is mannitol (E 421). − The solvent is water for injections.
Wara r- rikostituzzjoni 1 ml tas- soluzzjoni rikostitwita jkun fih 40 mg ta ’ degarelix. – Is- sustanza l- oħra tat- trab hi mannitol (E 421). – Is- solvent hu ilma għall- injezzjonijiet.
FIRMAGON is a powder for solution for injection.
FIRMAGON hu trab għal soluzzjoni għall- injezzjoni.
The powder is white to off-white.
It- trab hu minn abjad sa off- white.
2 vials with powder containing 120 mg of degarelix and 2 vials with 6 ml of solvent.
2 kunjetti bit- trab li jkun fihom 120 mg ta ’ degarelix u 2 kunjetti b’ 6 ml ta ’ solvent.
2 syringes, 2 reconstitution needles and 2 injection needles.
2 siringi, 2 labar tar- rikostituzzjoni u 2 labar tal- injezzjoni.
Marketing Authorisation Holder and Manufacturer
48 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK-2300 Copenhagen S Denmark Tel. +45 8833 8834 45 Manufacturer:
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK- 2300 Copenhagen S Id- Danimarka Tel. +45 8833 8834
France Ferring S. A. S.
Franza Ferring S. A. S.
The pack contains 2 sets of powder and solvent that must be prepared for subcutaneous injection.
Il- pakkett fih 2 settijiet ta ’ trab u solvent li jridu jiġu ppreparati għal injezzjoni taħt il- ġilda.
48 5.
IVA
Exchange the green needle with the white needle for deep subcutaneous injection (27G / 0.4 x 25 mm).
5. Ibdel il- labra l- ħadra mal- labra l- bajda li qegħda għal injezzjoni profonda taħt il- ġilda (27G / 0. 4 x 25 mm).
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għall- Użu mill - Bniedem (CHMP), abbażi ta 'l- istudji mwettqa, wasslet għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar tagħrif relatata mal- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek.
What is Flebogammadif?
X' inhu Flebogammadif?
Flebogammadif is a solution for infusion (drip into a vein).
Flebogammadif hu soluzzjoni għall- infużjoni (dripp f' vina).
It contains the active substance human normal immunoglobulin.
Fih is- sustanza attiva magħrufa bħala immunoglobulina normali tal- bniedem.
What is Flebogammadif used for?
Għal xiex jintuża Flebogammadif?
Flebogammadif is used in three main groups of patients: • Patients who are at risk of infection because they do not have sufficient antibodies (proteins naturally found in the blood that help the body to fight infections and other diseases).
Flebogammadif jintuża għal tliet gruppi ta 'pazjenti: • Pazjenti li jkollhom riskju ta' infezzjoni għax ma jkollhomx biżżejjed antikorpi (proteini li jinsabu naturalment fid- demm li jgħinu lill- ġisem jikkumbatti infezzjonijiet u mard ieħor).
These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID).
Dawn jistgħu jkunu persuni mwielda b' nuqqas ta 'antikorpi (sindromu ta' l- immunodefiċjenza primarja, PID).
It also includes patients whose lack of antibodies is due to a cancer of the blood (myeloma or chronic lymphoid leukaemia) or children born with acquired immune deficiency syndrome (AIDS), who suffer from frequent infections.
Jinkludu wkoll persuni li n- nuqqas ta 'antikorpi tagħhom ikun ikkawżat minn kanċer fid- demm (mjeloma jew lewċemija linfomtika kronika) jew tfal imwielda bis- sindromu minn immunodefiċjenza akkwiżita (AIDS), li jkunu jsofru minn infezzjonjiet frekwenti.
These types of conditions are called ‘ immunodeficiency syndromes’ and their treatment is called ‘ replacement therapy ’. • Patients with certain immune disorders.
Dawn it- tipi ta 'kundizzjonijiet jissejħu' sindromi ta 'l- immunodefiċjenza' u t- trattament tagħhom jissejjaħ 'terapija sostituttiva'. • Pazjenti b' ċerti problemi immunoloġiċi.
These patients have an abnormal immune system (the body’ s defence system) that needs to be adjusted.
Dawn il- pazjenti li jkollhom sistema immunitarja (is - sistema difensiva tal- ġisem) anomala li tkun trid tiġi aġġustata.
They include patients with idiopathic thrombocytopenic purpura (ITP) who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding, and patients with certain diseases (Guillain- Barré syndrome or Kawasaki disease).
Dawn jinkludu pazjenti b' purpura tromboċitopenika idjopatika (ITP) li ma jkollhomx biżżejjed platelets (komponenti tad- demm li jgħinuh jagħqad) u li jkollhom riskju ta 'fsada, u pazjenti b' ċertu mard (is- sindromu Guillain- Barré jew il- marda ta' Kawasaki).
This type of treatment is called ‘ immunomodulation’ (immune adjustment). • Patients who have had a bone marrow transplant.
Dan it- tip ta 'trattament jissejjaħ' immunomodulazzjoni '(aġġustament immunoloġiku). • Pazjenti li jkunu ngħataw trapjant tal- mudullun.
How is Flebogammadif used?
Kif jintuża Flebogammadif?
Flebogammadif is usually given by intravenous infusion by a doctor or nurse, but patients (or their carers) may administer it themselves once they have been trained.
Flebogammadif ġeneralment jingħata b' infużjoni intravenuża minn tabib jew infermier( a), iżda l - pazjenti (jew min jieħu ħsiebhom) jistgħu jagħtuha huma stess ladarba jkunu tħarrġu f' dan.
The dose and frequency of infusion (how often it is given) depend on the disease being treated.
Id- doża u l- frekwenza ta 'l- infużjoni (kemm tingħata ta' spiss) jiddependu mill- marda li tkun qed tiġi ttrattata.
In replacement therapy, the dose may need to be adjusted for patients depending on their response.
Fit- terapija sostituttiva, id- doża jista 'jkollha tiġi aġġustata għal pazjenti skond ir- rispons tagħhom.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Għad- dettalji kollha, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
It contains immunoglobulin G (IgG), which is a type 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. of antibody.
Kif jaħdem Flebogammadif?
IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection.
Ikun fiha l- immunoglobulina G (IgG), li hi tip ta 'antikorp.
Flebogammadif works by restoring abnormally low IgG levels to their normal range in the blood.
Flebogammadif jaħdem billi jreġġa 'għan- normal livelli baxxi ħafna ta' l- IgG fid- demm.
At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.
F' dożi ogħla jista 'jgħin fl- aġġustament ta' sistema immunoloġika anomala u fil- modulazzjoni tar- rispons tal- bniedem.
Flebogammadif is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.
Flebogammadif hu magħmul bħal Flebogamma, mediċina oħra li jkun fiha l- immunoglobulina normali tal- bniedem, b' xi fażijiet addizzjonali fil - purifikazzjoni tal- prodott mill- plażma tal- bniedem.
How has Flebogammadif been studied?
Kif ġie studjat Flebogammadif?
As human normal immunoglobulin has been used to treat these diseases for some time, only two small studies were needed to establish the effectiveness and safety of Flebogammadif in patients.
Billi l- immunoglobulina normali tal- bniedem ilha tintuża biss tittratta dan il- mard, kellhom isiru biss żewġ studji żgħar biex jistabbilixxu l- effikaċja u s- sigurtà ta 'Flebogammadif fil- pazjenti.
In the first study, Flebogammadif was used as replacement therapy in 46 patients with PID, with the medicine being infused every 21 to 28 days.
Fl- ewwel studju, Flebogammadif intuża bħala terapija sostituttiva f' 46 pazjent li jbatu minn PID, bil - mediċina tingħata bejn kull 21 jum u kull 28 jum.
The main measure of effectiveness was the number of serious bacterial infections over a year’ s treatment.
Il- kejl ewlieni ta 'l- effikaċja kien l- għadd ta' infezzjonijiet batteriċi serji matul is- sena tat- trattament.
The second study looked at using Flebogammadif for immunomodulation in 20 patients with ITP.
It- tieni studju eżamina l- użu ta 'Flebogammadif għall- immunomodulazzjoni f' 20 pazjent bl- ITP.
The main measure of effectiveness was the highest blood platelet level that was achieved during the three- month study.
Il- kejl ewlieni ta 'l- effikaċja kien l- ogħla għadd ta' platelets fid- demm li ntlaħaq matul l- istudju ta 'tliet xhur.
Flebogammadif was not compared with any other treatment in either study.
Flebogammadif ma tqabbel ma 'ebda trattament ieħor fl- ebda mill- istudji.
What benefit has Flebogammadif shown during the studies?
X' inhu l- benefiċċju ta 'Flebogammadif li ntwera f' dawn l- istudji?
In the first study, the patients had an average of 0.021 serious infections per year.
Fl- ewwel studju, il- pazjenti kellhom medja ta '0. 021 infezzjonijiet serji kull sena.
Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective as replacement therapy.
Billi dan hu inqas mill- kriterju predefinit ta 'infezzjoni waħda kull sena, dan juri li l- mediċina hi effikaċi bħala terapija sostituttiva.
In the second study, up to 14 (73%) of the 19 patients who remained in the study had a platelet count above 50 million platelets per millilitre at least once during the study.
Fit- tieni studju, sa 14 (73%) mid- 19- il pazjent li kienu għadhom qed jieħdu sehem fl- istudju kellhom għadd ta 'platelets ta' iktar minn 50 miljun platelet għal kull millilitru ta 'l- inqas darba waqt l- istudju.
This confirmed that Flebogammadif is effective in immunomodulation.
Dan ikkonferma li Flebogammadif hu effettiv fl- immunomodulazzjoni.
What is the risk associated with Flebogammadif?
X' inhu r- riskju assoċjat ma 'Flebogammadif?
The most common side effects with Flebogammadif (seen in between 1 and 10 patients in 100) are headache, pyrexia (fever) and injection site reactions (pain and inflammation at the site of injection).
L- aktar effetti sekondarji komuni ma 'Flebogammadif (li dehru f' bejn pazjent wieħed u għaxar pazjenti minn kull 100) huma wġigħ ta' ras, piressija (deni) u reazzjonijiet fil- punt fejn tingħata l- injezzjoni (uġigħ u infjammazzjoni fil- punt ta 'l- injezzjoni).
Some side effects are more likely to occur when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Flebogammadif before or for a long time.
Uħud mill- effetti sekondarji aktarx iseħħu fil- każ li l- infużjoni tingħata b' rata għolja, fil- każ ta 'pazjenti b' livelli baxxi ta' immunoglobulina, jew f' pazjenti li ma jkunux ingħataw Flebogammadif qabel jew għal żmien twil.
For the full list of all side effects reported with Flebogammadif, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati ma' Flebogammadif, ara l- Fuljett ta 'Tagħrif.
Flebogammadif should not be used in people who may be allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Flebogammadif m' għandux jintuża minn persuni li jistgħu jkunu allerġiċi għall- immunoglobulina normali tal- bniedem jew għal kwalunkwe mill- ingredjenti l- oħra, jew fil- pazjenti allerġiċi għal tipi oħra ta 'immunoglobulina tal- bniedem normali, speċjalment meta jkollhom defiċjenza (livelli baxxi ħafna) ta' immunoglobulina A (IgA) u jkollhom antikorpi kontra l- IgA.
Flebogammadif must not be used in patients who are intolerant to fructose (a type of sugar).
Flebogammadif m' għandux jintuża f' pazjenti li jkunu intolleranti għall- fruttożju (tip ta 'zokkor).
Special precautions should be taken with babies and young children because fructose intolerance may not have been diagnosed and could be fatal.
Iridu jittieħdu xi prekawzjonjiet speċjali fil- każ ta 'trabi u tfal żgħar għax jista' ma jkunx għad hemm dijanjożi ta 'l- intolleranza għall - fruttożju u din tista' tkun fatali.
Why has Flebogammadif been approved?
Għaliex ġie approvat Flebogammadif?
According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Skond il- linji gwida attwali, il- mediċini li ntwerew li huma effikaċi fil- pazjenti fil- PID u fil- pazjenti bl- ITP jistgħu jiġu approvati wkoll għall- użu fit- trattament ta 'kull tip ta' immunodefiċjenza primarja, kif ukoll għal- livelli baxxi ta 'antikorpi minħabba kanċer tad- demm jew minħabba l- AIDS fit- tfal.
They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing a bone marrow transplant, without the need for specific studies in these diseases.
Jistgħu jiġu approvati wkoll għat- trattament ta 'pazjenti bis- sindromu Guillain- Barré, pazjenti bil - marda ta' Kawasaki u pazjenti li jkunu ħadu trapjant tal- mudullun, mingħajr il- ħtieġa għal studji speċifiċi għal dawn il- mardiet.
Therefore, the Committee for Medicinal Products for Human Use (CHMP) concluded that Flebogammadif’ s benefits are greater than its risks for patients who require IgG for replacement therapy, for immunomodulation or because of bone marrow transplantation.
Għalhekk, il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l - benefiċċji ta 'Flebogammadif huma ikbar mir- riskji għal pazjenti li jkunu jeħtieġu l- IgG għat- terapija sostituttiva, għall- immunomodulazzjoni jew minħabba trapjant tal- mudullun.
The Committee recommended that Flebogammadif be given marketing authorisation.
Il- Kumitat irrakkomanda li Flebogammadif jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Flebogammadif:
Tagħrif ieħor dwar Flebogammadif:
The European Commission granted a marketing authorisation valid throughout the European Union for Flebogammadif to Instituto Grifols, S. A. on 23 August 2007.
2/ 3 Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal għal Flebogammadif lil Instituto Grifols, S. A. fit- 23 ta 'Awissu 2007.
The full EPAR for Flebogammadif can be found here.
L- EPAR sħiħ għal Flebogammadif jista 'jiġi kkonsultat hawn.
Pharmaceutical Form
Użu għal ġol- vini
Route of Administration
Kunjett (ħġieġ)
Packaging
1 kunjett
Solution for infusion Solution for infusion Solution for infusion Solution for infusion Solution for infusion
Soluzzjoni għall - infużjoni
Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use
Soluzzjoni għall - infużjoni
Vial (glass) Vial (glass) Vial (glass) Vial (glass) Vial (glass)
Kunjett (ħġieġ)
1 vial 1 vial 1 vial 1 vial 1 vial
1 kunjett
Flebogammadif 50 mg/ ml solution for infusion
Flebogammadif 50 mg/ ml soluzzjoni għall- infużjoni
One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Millilitru wieħed fih 50 mg ta ’ immunoglobulin normali uman (IVIg), li minnha, mill- anqas 97% hi IgG.
The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Il- perċentwali ta ’ sottoklassijiet IgG hu ta ’ madwar 66. 6% IgG1, 28. 5% IgG2, 2. 7% IgG3 u 2. 2% IgG4.
It contains trace amounts of IgA (lower than 0.05 mg/ ml).
Fiha traċċi ta ’ IgA (inqas minn 0. 05 mg/ ml).
One ml contains 50 mg of D-sorbitol.
Millilitru wieħed fih 50 mg ta ’ D- sorbitol.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara taqsima 6. 1.
Solution for infusion.
Soluzzjoni għall- infużjoni
The solution is clear or slightly opalescent and colourless or pale yellow.
Is- soluzzjoni hi ċara jew ftit opalexxenti u bla kulur jew isfar ċar.
Flebogammadif is indicated for:
Flebogammadif hu indikat għal:
Replacement therapy in:
Terapija tas- sostituzzjoni f ’:
Primary immunodeficiency syndromes such as:
Sindromi ta ’ immunodefiċjenza primarja bħal:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- agammaglobulinemija u ipogammaglobulinemija konġenitali
- common variable immunodeficiency
- immunodefiċjenza varjabbli komuni
- severe combined immunodeficiency
- immunodefiċjenza kombinata severa
- Wiskott Aldrich syndrome
- is- sindrome ta ’ Wiskott Aldrich
Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Mijeloma jew lewkimja limfoċitika kronika b’ ipogammaglobulinemija severa sekondarja u infezzjonijiet rikorrenti.
Children with congenital AIDS and recurrent infections.
Tfal b’ AIDS konġenitali u infezzjonijiet rikorrenti.
Immunomodulation
Immunomodulazzjoni
Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
Purpura idjopatika tromboċitopenika (idiopathic thrombocytopenic purpura - ITP), fit- tfal jew fl - adulti li qegħdin f’ riskju għoli ta ’ ħruġ ta ’ demm jew li kellhom operazzjoni fil- passat biex l- għadd tal - plejtlits jiġi kkoreġut.
Guillain Barré syndrome.
Sindrome ta ’ Guillain Barré.
Kawasaki disease.
Il- marda Kawasaki.
Allogeneic bone marrow transplantation.
Trapjant alloġenejku tal- mudullun.
Posology and method of administration
Pożoloġija u metodu ta ’ kif għandu jingħata
The dose and dosage regimen is dependent on the indication.
Id- doża u l- kors tad- dożaġġ jiddependu fuq l- indikazzjoni.
In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.
Fit- terapija tas- sostituzzjoni id- dożaġġ jista ’ jkollha bżonn li tkun individwalizzata għal kull pazjent skond ir- rispons farmakokinetiku u kliniku.
The following dosage regimens are given as a guideline.
Il- korsijiet tad- dożaġġ li ġejjin qed jingħataw bħala linja gwida.
Replacement therapy in primary immunodeficiency syndromes
Terapija tas- sostituzzjoni f’ sindromi ta ’ l- immunodefiċjenza primarja
The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 - 6 g/ l.
Il- kors tad- dożaġġ għandu jilħaq livell minimu ta ’ IgG (imkejjel qabel l- infużjoni li jmiss) ta ’ mill - anqas 4 - 6 g/ l.
Three to six months are required after the initiation of therapy for equilibration to occur.
Hemm bżonn minn tlieta sa sitt xhur wara l- bidu tat- terapija għall- ekwilibrazzjoni biex isseħħ.
The recommended starting dose is 0.4 - 0.8 g/ kg followed by at least 0.2 g/ kg every three weeks.
Id- doża inizjali rakkomandata hi ta ’ 0. 4 - 0. 8 g/ kg segwita minn ta ’ mill- anqas 0. 2 g/ kg kull tliet ġimgħat.
The dose required to achieve a trough level of 6 g/ l is of the order of 0.2 - 0.8 g/ kg/ month.
Id- doża meħtieġa biex jintlaħaq livell minimu ta ’ 6 g/ l hu ta ’ 0. 2 - 0. 8 g/ kg/ xahar.
The dosage interval when steady state has been reached varies from 2 - 4 weeks.
L- intervall tad - dożaġġ meta l- istat fiss ikun intlaħaq, ivarja minn 2 - 4 ġimgħat.
Trough levels should be measured in order to adjust the dose and dosage interval.
L- inqas livelli għandhom jitkejjlu sabiex id- doża u l- intervall tad- dożaġġ ikunu aġġustati.
Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections.
It- terapija tas- sostituzzjoni f’ mijeloma jew lewkimja limfoċitika kronika b’ ipogammaglobulinemija sekondarja severa u infezzjonijiet rikorrenti; it- terapija tas- sostituzzjoni fi tfal bl- AIDS u infezzjonijiet rikorrenti.
The recommended dose is 0.2 - 0.4 g/ kg every three to four weeks.
Id- doża rakkomandata hi ta ’ 0. 2 - 0. 4 g/ kg kull tlieta sa erba ’ ġimgħat.
Idiopathic thrombocytopenic purpura
Purpura tromboċitopenika idjopatika
For the treatment of an acute episode, 0.8 - 1 g/ kg on day one, which may be repeated once within 3 days, or 0.4 g/ kg daily for two to five days.
Għall- kura ta ’ episodju akut, 0. 8 - 1 g/ kg fl- ewwel jum, li tista ’ tkun ripetuta darba fi żmien 3 ijiem, jew 0. 4 g/ kg kuljum għal minn tnejn sa ħamest ijiem.
The treatment can be repeated if relapse occurs.
Il- kura tista ’ tkun ripetuta jekk isseħħ rikaduta.
Guillain Barré syndrome
Sindrome ta ’ Guillain Barré
0.4 g/ kg/ day for 3 to 7 days.
0. 4 g/ kg/ kuljum għal minn 3 sa 7 ijiem.
Experience in children is limited.
L- esperjenza dwar l- użu fit- tfal hija limitata.
Kawasaki disease
Il- marda Kawasaki
1.6 - 2.0 g/ kg should be administered in divided doses over two to five days or 2.0 g/ kg as a single dose.
1. 6 - 2. 0 g/ kg għandha tingħata f’ dożi maqsuma fuq perijodu ta ’ minn jumejn sa ħamest ijiem jew 2. 0 g/ kg bħala doża waħda.
Patients should receive concomitant treatment with acetylsalicylic acid.
Il- pazjenti għandhom jirċievu l- kura fl- istess ħin b’ acetylsalicylic acid.
Allogeneic bone marrow transplantation
Trapjant alloġeneiku tal- mudullun
Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.
Il- kura bl- immunoglobulin normali uman jista ’ jintuża bħala parti mill- kors ta ’ kondizzjonar u wara t - trapjant.
For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored.
Għal kura ta ’ infezzjonijiet u l- profilassi tat- trapjant kontra l- marda ospitu, id- dożaġġ għandu jingħata fuq bażi individwali.
The starting dose is normally 0.5 g/ kg/ week, starting seven days before transplantation and for up to 3 months after transplantation.
Id- doża tal- bidu hi normalment ta ’ 0. 5 g/ kg/ ġimgħa, li tibda sebat ijiem qabel it- trapjant u sa 3 xhur wara t- trapjant.
In case of persistent lack of antibody production, dosage of 0.5 g/ kg/ month is recommended until antibody level returns to normal.
F’ każ ta ’ nuqqas persistenti ta ’ produzzjoni ta ’ antikorpi, dożaġġ ta ’ 0. 5 g/ kg/ xahar hu rakkomandat sakemm il- livell ta ’ l- antikorpi jerġa ’ lura għan- normal.
3 The dosage recommendations are summarised in the following table:
3 Ir- rakkomandazzjonijiet tad- dożaġġ huma deskritti fil- qosor fit- tabella li ġejja:
Indication
Indikazzjoni
Replacement therapy in primary immunodeficiency
Terapija tas- sostituzzjoni f’ immunodefiċjenza primarja
- starting dose:
- doża tal- bidu:
0.4 - 0.8 g/ kg - thereafter:
0. 4 - 0. 8 g/ kg - wara:
0.2 - 0.8 g/ kg
0. 2 - 0. 8 g/ kg
every 2 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/ l
kull 2 - 4 ġimgħat biex tikseb livell minimu ta ’ IgG ta ’ mill- anqas 4 - 6 g/ l
Replacement therapy in secondary immunodeficiency
Terapija tas- sostituzzjoni f’ immunodefiċjenza sekondarja
0.2 - 0.4 g/ kg
0. 2 - 0. 4 g/ kg
every 3 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/ l
kull 3 - 4 ġimgħat biex tikseb livell minimu ta ’ IgG ta ’ mill- anqas 4 - 6 g/ l
Children with AIDS Immunomodulation:
Tfal bl- AIDS Immunomodulazzjoni:
every 3 - 4 weeks
kull 3 - 4 ġimgħat
0.8 - 1 g/ kg or
0. 8 - 1 g/ kg jew
on day 1, possibly repeated once within 3 days
f’ jum 1, possibilment ripetuta fi żmien 3 ijiem
for 2 - 5 days
0. 4 g/ kg/ kuljum għal 2 - 5 ijiem
for 3 - 7 days
0. 4 g/ kg/ kuljum għal 3 - 7 ijiem
in several doses for 2 - 5 days in association with acetylsalicylic acid
1. 6 - 2 g/ kg f’ diversi dożi għal 2 - 5 ijiem jew flimkien ma ’ acetylsalicylic acid
Allogeneic bone marrow transplantation:
Trapjant alloġeneiku tal- mudullun:
in one dose in association with acetylsalicylic acid
f’ doża waħda flimkien ma ’ acetylsalicylic acid
treatment of infections and prophylaxis of graft versus host disease
- kura ta ’ infezzjonijiet u profilassi ta ’ trapjanti versus l- marda ospitu
0.5 g/ kg
0. 5 g/ kg
every week from day -7 up to 3 months after transplantation
kull ġimgħa minn jum - 7 sa 3 xhur wara t- trapjant
persistent lack of antibody production
nuqqas persistenti ta ’ produzzjoni ta ’ antikorpi
every month until antibody levels return to normal
kull xahar sakemm il- livelli ta ’ l - antikorpi jerġgħu lura għan- normal
Method of administration
ta ’ kif għandu jingħata
Flebogammadif should be infused intravenously at an initial rate of 0.01 - 0.02 ml/ kg/ min for the first thirty minutes.
Flebogammadif għandu jingħata bħala infużjoni fil- vini b’ rata inizjali ta ’ 0. 01 - 0. 02 ml/ kg/ min għall - ewwel tletin minuta.
If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/ kg/ min.
Jekk ikun ittollerat tajjeb, ir- rata ta ’ l- għoti tista ’ tiżdied gradwalment sa massimu ta ’ 0. 1 ml/ kg/ min.
Contraindications
Kontra- indikazzjonijiet
Hypersensitivity to any of the components (see section 4.4).
Sensittività eċċessiva għal xi wieħed mill- komponenti (ara taqsima 4. 4).
Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA.
Sensittività eċċessiva għal immunoglobulini omologi, speċjalment f’ każijiet rari ħafna ta ’ defiċjenza ta ’ IgA, meta l- pazjent ikollu antikorpi kontra IgA.
Fructose intolerance (see section 4.4).
Intolleranza għall- fructose (ara taqsima 4. 4).
Special warnings and precautions for use
Twissijiet speċjali u prekawzjonijiet għall- użu
Certain severe adverse drug reactions may be related to the rate of infusion.
Ċerti reazzjonijiet avversi severi għall- mediċina, jistgħu jkunu marbuta mar- rata ta ’ l- infużjoni.
The recommended infusion rate given under “ 4.2.
Ir- rata rakkomandata ta ’ l- infużjoni mogħtija taħt “ 4. 2.
Posology and method of administration” must be closely followed.
Pożoloġija u metodu ta ’ kif għandu jingħata ” għandhom ikunu segwiti mill- qrib.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Il- pazjenti jridu jkunu mmonitorjati mill- qrib u jkunu osservati bl - attenzjoni għal kwalunkwe sintomi matul il- perijodu ta ’ l- infużjoni.
4 Certain adverse reactions may occur more frequently
4 Ċerti reazzjonijiet avversi jistgħu jseħħu aktar b’ mod frekwenti
- in case of high rate of infusion,
- f’ każ ta ’ rata għolja ta ’ infużjoni,
- in patients with hypo- or agammaglobulinaemia with or without IgA deficiency,
- f’ pazjenti b’ ipo - jew agammaglobulinemija b ’ defiċjenza ta ’ IgA jew mingħajr defiċjenza ta ’
- in patients who receive human normal immunoglobulin for the first time, or in rare cases, when
- f’ pazjenti li jirċievu immunoglobulin normali uman għall- ewwel darba, jew f’ każijiet rari, meta
the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
l- prodott ta ’ l- immunoglobulin normali uman jinbidel ma ’ ieħor, jew meta kien hemm intervall twil mill- aħħar infużjoni.
True hypersensitivity reactions are rare.
Reazzjonijiet reali ta ’ sensittività eċċessiva huma rari.
They can occur in the very seldom cases of IgA deficiency with anti-IgA antibodies.
Dawn jistgħu jseħħu f’ każijiet rari ħafna ta ’ defiċjenza ta ’ IgA ma ’ antikorpi anti- IgA.
Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
B’ mod rari, l- immunoglobulin normali uman jista ’ jikkaġuna tnaqqis fil- pressjoni tad- demm b’ reazzjoni anafilattika, anki f’ pazjenti li ttolleraw kura b’ immunoglobulin normali uman fil- passat.
Potential complications can often be avoided by ensuring:
Kumplikazzjonijiet potenzjali jistgħu ta ’ spiss jiġu evitati billi tiżgura:
- that patients are not sensitive to human normal immunoglobulin by first injecting the product
- li l- pazjenti ma jkunux sensittivi għal immunoglobulin normali uman billi l- ewwel tinjetta l -
slowly at an initial rate of 0.01 - 0.02 ml/ kg/ min;
prodott bil- mod b’ rata inizjali ta ’ 0. 01 - 0. 02 ml/ kg/ min;
In
- li l- pazjenti jkunu mmonitorjati bl- attenzjoni għal kwalunkwe sintomi matul il- perijodu
particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
B’ mod partikulari, pazjenti li huma naive għal immunoglobulin normali uman, pazjenti li qalbu minn prodott alternattiv IVIg jew fejn kien hemm intervall twil mill- aħħar infużjoni, għandhom ikunu mmonitorjati matul l- ewwel infużjoni u għall- ewwel siegħa wara l- ewwel infużjoni, sabiex ikunu osservati sinjali avversi potenzjali.
All other patients should be observed for at least 20 minutes after administration.
Il- pazjenti l- oħrajn kollha għandhom ikunu osservati għal ta ’ mill- anqas 20 minuta wara l- għoti.
There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Hemm evidenza klinika ta ’ rabta bejn l- għoti ta ’ IVIg u avvenimenti tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari u trombożi profonda tal- vini li hu ssoponut li huma relatati ma żieda relattiva fil- viskosità tad- demm minħabba l- influss qawwi ta ’ immunoglobulin f’ pazjenti li qegħdin f’ riskju.
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, and patients with diseases which increase blood viscosity).
Għandha tingħata attenzjoni meta tingħata riċetta u waqt l- infużjuni ta ’ IVIg lil pazjenti ħoxnin, u f’ pazjenti b’ fatturi ta ’ riskju li kienu jeżistu minn qabel għal avvenimenti trombotiċi (bħal età avvanzata, pressjoni tad- demm għolja, dijabete mellitus u storja medika ta ’ mard vaskulari jew episodji trombotiċi, pazjenti b’ disturbi trombofiliċi miksuba jew li ntirtu, pazjenti li jqattgħu perjodi twal ma jitħarrkux, pazjenti li huma ipovolemiċi b’ mod sever, u pazjenti b’ mard li jżid il- viskosità tad- demm).
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Każijiet ta ’ insuffiċjenza akuta renali kienu rrappurtati f’ pazjenti li kienu qed jirċievu terapija b’ IVIg.
In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Fil- biċċa l- kbira tal- każijiet, kienu identifikati fatturi ta ’ riskju, bħal insuffiċjenza renali li kienet teżisti minn qabel, dijabete mellitus, ipovolemija, piż żejjed, użu fl- istess ħin ta ’ prodotti mediċinali nefrotossiċi jew età ta ’ aktar minn 65.
In case of renal impairment, IVIg discontinuation should be considered.
F’ każ ta ’ indeboliment renali, għandu jiġi kkunsidrat it- twaqqif ta ’ IVIg.
While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Filwaqt li dawn ir- rapporti ta ’ disfunzjoni renali u insuffiċjenza akuta renali kienu assoċjati ma ’ l- użu ta ’ ħafna mill- prodotti IVIg liċenzjati, dawk il- prodotti li fihom is- sucrose bħala stabbilizattur, ammontaw għal porzjon sproporzjonat tan- numru totali.
In patients at risk, the use of IVIg products that do not contain sucrose may be considered.
F’ pazjenti li qegħdin f’ riskju, l- użu ta ’ prodotti IVIg li ma fihomx sucrose, jista ’ jiġi kkunsidrat.
In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
F’ pazjenti li qegħdin f’ riskju għal insuffiċjenza akuta renali jew reazzjonijiet avversi tromboemboliċi, il- prodotti IVIg għandhom jingħataw bir- rata minima ta ’ l- infużjoni u jkunu prattikabbli għad- doża.
In all patients, IVIg administration requires:
Fil- pazjenti kollha, l- għoti ta ’ IVIg jeħtieġ:
- adequate hydration prior to the initiation of the infusion of IVIg
- idratazzjoni adegwata qabel il- bidu ta ’ l- infużjoni ta ’ IVIg
- monitoring of urine output
- monitoraġġ ta ’ l- ammont ta ’ awrina
- monitoring of serum creatinine levels
- monitoraġġ tal- livelli tal- krejatinina fis- serum
- avoidance of concomitant use of loop diuretics
- li wieħed jevita l- użu fl- istess ħin użu ta ’ dijuretiċi loop
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
F’ każ ta ’ reazzjoni avversa, jew ir- rata ta ’ l- għoti trid titnaqqas, jew l- infużjoni titwaqqaf.
The treatment required depends on the nature and severity of the side effect.
5 Il- kura meħtieġa tiddependi fuq in- natura u s- severità ta ’ l- effett sekondarju.
5 In case of shock, standard medical treatment for shock should be implemented.
F’ każ ta ’ xokk, il- kura medika normali għal xokk għandha tkun implimentata.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill- użu ta ’ prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l- għażla tad- donaturi, screening ta ’ donazzjonijiet individwali u ta ’ pools tal- plażma għall- markaturi speċifiċi ta ’ infezzjoni u l- inklużjoni ta ’ passi effettivi tal - manifattura għall- inattivazzjoni/ tneħħija ta ’ viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali ppreparati minn demm jew plażma umana, il- possibbiltà li orġaniżmi infettivi jiġu trasmessi, ma tistax tiġi eskluża totalment.
This also applies to unknown or emerging viruses and other pathogens.
Dan japplika wkoll għal viruses u patoġeni oħrajn mhux magħrufa jew ġodda.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Il- miżuri meħuda huma kkunsidrati li huma effettivi għal viruses enveloped bħal HIV, HBV u HCV, u għal viruses non- enveloped HAV u parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
Hemm esperjenza klinika inkoraġġanti dwar in- nuqqas ta ’ trasmissjoni ta ’ epatite A jew ta ’ parvovirus B19 permezz ta ’ l- immunoglobulini, u hu ssoponut ukoll li l- kontenut ta ’ l- antikorpi għandu sehem importanti fis- sigurtà virali.
It is strongly recommended that every time Flebogammadif is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Hu rakkomandat bil- qawwa li kull darba li jingħata l- Flebogammadif lil pazjent, l- isem u n- numru tal - lott tal- prodott ikunu rreġistrati sabiex tinżamm rabta bejn il- pazjent u l- lott tal- prodott.
Special warnings about excipients:
Twissijiet speċjali dwar sustanzi mhux attivi:
This medicinal product contains 50 mg of sorbitol per ml as excipient.
Dan il- prodott mediċinali fih 50 mg ta ’ sorbitol f’ kull ml bħala s- sustanza mhux attiva.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- fructose, m’ għandhomx jieħdu din il- mediċina.
Special precautions should be taken with babies and young children because this fructose intolerance may not yet be diagnosed and may be fatal.
Għandhom jittieħdu prekawzjonijiet speċjali fil- każ ta ’ trabi u tfal żgħar, minħabba li jista ’ jkun li din l- intolleranza għall- fructose tkun għadha ma ġietx iddijanjostikata, u tista ’ tkun fatali.
Interferences with determination of blood glucose levels are not expected.
Interferenzi bid - determinazzjoni tal- livelli tal- glucose fid- demm mhumiex mistennija.
Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Live attenuated virus vaccines
Tilqim b’ virus ħaj attenwat