qanastek/EMEA-V3 huggingface dataset:
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
L- għoti ta ’ l- immunoglobulin jista ’ jikkawża indeboliment ta ’ mill- anqas 6 ġimgħat u sa 3 xhur fl - effikaċja ta ’ vaċċini b’ viri ħajjin attenwati, bħal dawk tal- ħosba, ħosba Ġermaniża, gattone u l- ġidri r - riħ.
After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Wara l- għoti ta ’ dan il- prodott, għandu jitħalla jgħaddi intervall ta ’ 3 xhur qabel it- tilqima b’ vaċċini b’ viri ħajjin attenwati.
In the case of measles, this impairment may persist for up to 1 year.
Fil- każ tal- ħosba, dan l- indeboliment jista ’ jippersisti sa sena.
Therefore patients receiving measles vaccine should have their antibody status checked.
Għalhekk, il- pazjenti li jkunu qed jieħdu l- vaċċin kontra l- ħosba, għandu jkollhom l- istat ta ’ l - antikorpi tagħhom iċċekkjat.
Interference with serological testing
Interferenza ma ’ l- ittestjar seroloġiku
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.
Wara l- injezzjoni ta ’ l- immunoglobulin, iż- żieda transitorju tad- diversi antikorpi li jkunu ttrasferiti b’ mod passiv fid- demm tal- pazjenti, tista ’ tirriżulta f’ riżultati pożittivi li jqarrqu b’ dak li jkun fl- ittestjar seroloġiku.
Passive transmission of antibodies to erythrocyte antigens, e. g.
It- trasmissjoni passiva ta ’ antikorpi lil antiġeni eritroċiti, eż.
A, B, D, may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coomb’ s test).
A, B, D, jistgħu jinterferixxu ma ’ xi testijiet seroloġiċi għall- antikorpi taċ- ċelluli ħomor, pereżempju t- test ta ’ l- antiglobulina (it- test Coomb).
Pregnancy and lactation
Tqala u treddigħ
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Is- sigurtà ta ’ dan il- prodott mediċinali għall- użu fit- tqala umana ma kinitx stabbilita fi provi kliniċi kkontrollati, u għalhekk għandu jingħata biss bl- attenzjoni lin- nisa tqal u lill- ommijiet li qed ireddgħu.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
L- esperjenza klinika bl- immunoglobulini tissuġġerixxi li l- ebda effetti ta ’ ħsara m’ huma mistennija matul il- kors tat- tqala, jew fuq il- fetu u t- tarbija tat- twelid.
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
6 L- immunoglobulini jitneħħew fil- ħalib u jistgħu jikkontribwixxu għat- trasferiment ta ’ antikorpi protettivi lit- tarbija tat- twelid.
Effects on ability to drive and use machines
Effetti fuq il- ħila biex issuq u tħaddem magni
6 No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Since Flebogammadif might induce dizziness, patients should be cautioned when driving or operating machines.
Minħabba li Flebogammadif jista ’ jikkaġuna l- isturdament, il- pazjenti għandhom jiġu mwissija biex joqogħdu attenti waqt is- sewqan jew it- tħaddim tal- magni.
Undesirable effects
Effetti mhux mixtieqa
Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Reazzjonijiet avversi bħal tertir ta ’ bard, uġigħ ta ’ ras, deni, rimettar, reazzjonijiet allerġiċi, nawseja, artralġja, pressjoni tad- demm baxxa u uġigħ moderat fin- naħa t’ isfel tad- dahar jistgħu jseħħu kultant.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
B’ mod rari, l- immunoglobulini normali umani jistgħu jikkawżaw tnaqqis għal għarrieda fil- pressjoni tad- demm u, f’ każijiet iżolati, xokk anafilattiku, anki meta l- pazjent ma jkun wera l- ebda sensittività eċcessiva meta jkun ingħata l- mediċina fil- passat.
Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/ haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.
Il- każijiet ta ’ meninġite asettika riversibbli, każijiet iżolati ta ’ anemija/ emolisi emolitika riversibbli u każijiet rari ta ’ reazzjonijiet temporanji tal- ġilda, kienu osservati bl- immunoglobulin normali uman.
Increase in serum creatinine level and/ or acute renal failure have been observed.
Żieda fil- livell tal- krejatinina fis- serum u/ jew insuffiċjenza renali akuta kienu osservati.
Very rarely:
Rari ħafna:
Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.
Reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari, trombożi profonda tal- vini.
Two multicenter clinical trials were performed, one of them in children and adults with primary immune deficiency and the second one in patients with chronic immune thrombocytopenic purpura in acute phase.
Twettqu żewġ provi kliniċi multiċentriċi, wieħed fi tfal u adulti li kellhom defiċjenza immuni primarja, u t- tieni waħda f’ pazjenti b’ purpura tromboċitopenika immuni kronika fil- fażi akuta.
Forty-six patients were included in the first trial and 41 completed the study.
Sitta u erbgħin pazjent kienu inklużi fl- ewwel prova, u 41 temmew l- istudju.
They were followed during 1 year of treatment at a dose of 300-600 mg/ kg every 3 to 4 weeks.
Dawn kienu segwiti matul sena ta ’ kura f’ doża ta ’ 300- 600 mg/ kg kull 3 sa 4 ġimgħat.
A total of 20 patients were included in the second study.
Total ta ’ 20 pazjent kienu inklużi fit- tieni studju.
Patients received a total dose of 400 mg/ kg body weight for 5 consecutive days and were followed for 3 months.
Il- pazjenti rċievew doża totali ta ’ 400 mg/ kg ta ’ piż tal- ġisem għal 5 ijiem konsekuttivi, u kienu segwiti għal 3 xhur.
Therefore, a total of 66 patients have been exposed to Flebogammadif and they have received 806 infusions.
Għalhekk, total ta ’ 66 pazjent kienu esposti għal Flebogammadif u rċievew 806 infużjoni.
Data from both studies indicate a good tolerability of the product as incidence of adverse events was low and most of them were mild to moderate in intensity.
Informazzjoni miż- żewġ studji jindikaw tollerabilità tajba tal- prodott għax l- inċidenza ta ’ avvenimenti avversi kienet baxxa u l- biċċa l- kbira tagħhom kienu ta ’ intensità minn ħafifa sa moderata.
Of the 806 infusions administered in patients enrolled in both studies 10.8% (1-sided 95% CI upper bound = 12.9%) were associated with an adverse event suspected to be related to the product.
Mit- 806 infużjoni li ngħataw lil pazjenti rreġistrati fiż- żewġ studji 10. 8% (1- sided 95% CI upper bound = 12. 9%) kienu assoċjati ma ’ avveniment avvers li kien issuspettat li kien relatat mal- prodott.
No patients died, only 6 patients withdrew from the studies but none of them because of potentially related adverse events.
Ħadd mill- pazjenti ma miet, u 6 pazjenti biss ma komplewx l- istudji, iżda ħadd minnhom m’ għamel hekk minħabba avvenimenti avversi li kienu potenzjalment relatati.
Four patients experienced 8 serious adverse events that were considered not related to the study medicinal product.
Erba ’ pazjenti kellhom 8 avvenimenti avversi serji kkunsidrati li ma kinux relatati ma ’ l- istudju tal- prodott mediċinali.
Pyrexia and headache were the most frequently reported adverse events potentially related to the medicinal product in both studies.
Id- deni u uġigħ ta ’ ras kienu l- aktar avvenimenti avversi rrappurtati b’ mod frekwenti, li kienu potenzjalment relatati mal- prodott mediċinali fiż- żewġ studji.
The adverse drug reactions reported in the 2 trials by at least the 5% of the patients are summarised and categorised according to the MedDRA system organ class in the table below:
Ir- reazzjonijiet avversi tal- mediċina rrappurtati fiż- 2 provi li affwettwaw mill- anqas 5% tal- pazjenti, huma deskritti fil- qosor u huma kkategorizzati skond il- klassi ta ’ l- organi tas- sistema MedDRA fit - tabella hawn taħt:
Frequency has been determined using the following criteria:
Il- frekwenza kienet stabbilita billi intużaw il- kriterji li ġejjin:
- very common: > 1/ 10
- komuni ħafna: > 1/ 10
- common: > 1/ 100 to < 1/ 10
- komuni: > 1/ 100 sa < 1/ 10
- uncommon: > 1/ 1,000 to < 1/ 100
- mhux komuni: > 1/ 1, 000 sa < 1/ 100
- rare: > 1/ 10,000 to < 1/ 1,000
- rari: > 1/ 10, 000 sa < 1/ 1, 000
- very rare: < 1/ 10,000, not known (cannot be estimated from the available data.)
- rari ħafna: < 1/ 10, 000, mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Within each frequency grouping, undesirable effects are presented in order of decreasing of seriousness.
L - effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
System Organ Class
Evalwazzjoni tal - Klassi ta ’ l- Organi tas -
Body System Preferred Term
Terminu Ppreferut tas- Sistema tal -
ADR frequency evaluation
frekwenza ta ’ l -
7 System Organ Class
Sistema
Body System Preferred Term
Ġisem
ADR frequency evaluation
ADR
Coombs test positive, blood pressure systolic decreased, blood pressure systolic increased, body temperature increased
Test Coombs pożittiv, tnaqqis fil- pressjoni sistolika tad- demm, żieda fil- pressjoni sistolika tad- demm, żieda fit- temperatura tal- ġisem
Nervous system disorder
Disturbi fis- sistema nervuża
Common Uncommon
Komuni Mhux Komuni
Respiratory, thoracic and mediastinal disorder
Disturbi respiratorji, toraċiċi u medjastinali
Bronchitis, cough, wheezing
Bronkite, sogħla, tħarħir
Diarrhoea, nausea, vomiting, abdominal pain, abdominal pain upper
Dijarea, nawseja, rimettar, uġigħ addominali, uġigħ fin- naħa ta ’ fuq taż - żaqq
Urticaria, rash pruritic, dermatitis contact
Urtikarja, raxx pruritiku, dermatite tal - kuntatt
Musculoskeletal and connective tissue disorder
Disturbi muskolu- skeltrali u tal- connective tissue
Back pain, arthralgia, myalgia, muscle cramp
Uġigħ fid- dahar, artralġja, mijalġja, bugħawwieġ fil- muskoli
Hypotension, hypertension, diastolic hypertension, blood pressure fluctuations
Pressjoni tad- demm baxxa ħafna, pressjoni tad- demm għolja, pressjoni tad- demm għolja dijastolika, fluttwazzjonijiet fil - pressjoni tad- demm
General disorders & administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Pyrexia, injection site reaction Rigors, asthenia, pain, infusion site inflammation, injection site oedema, injection site pain, injection site pruritus, injection site swelling, migration of implant
Deni, reazzjoni fil- post ta ’ l- injezzjoni Tertir, astenja, uġigħ, infjammazzjoni fis - sit ta ’ l- infużjoni, edema fis- sit ta ’ l - injezzjoni, uġigħ fis- sit ta ’ l- injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, nefħa fis- sit ta ’ l- injezzjoni, ċaqliq ta ’ l- impjant
For safety with respect to transmissible agents, see section 4.4.
Għas- sigurtà fir- rigward ta ’ mediċini trasmissibbli, ara taqsima 4. 4.
Overdose
Doża eċċessiva
Overdose may lead to fluid overload and hyper viscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.
Doża eċċessiva tista ’ twassal għal ammont eċċessiv ta ’ fluwidu u iper- viskosità, partikularment f’ pazjenti f’ riskju, li jinkludi pazjenti anzjani jew pazjenti b’ indeboliment renali.
Pharmacodynamic properties
Tagħrif farmakodinamiku
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code:
Sera immuni u immunoglobulini: immunoglobulini normali umani, għall- għoti intravaskulari, Kodiċi ATC:
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
L- immunoglobulin normali uman primarjament fih immunoglobulin G (IgG) b’ firxa wiesgħa ta ’ antikorpi kontra organiżmi infettivi.
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
L- immunoglobulina normali umana fiha l- antikorpi IgG preżenti fil- popolazzjoni normali.
It is usually prepared from pooled plasma from not fewer than 1000 donors.
Tkun normalment ippreparata minn plażma miġbura minn mhux inqas minn 1000 donatur.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Għandha distribuzzjoni ta ’ sottoklassijiet ta ’ immunoglobulina G li tixbah proporzjonalment lil dik li tinsab b’ mod naturali fil- plażma umana.
Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
8 Dożi adegwati ta ’ dan il- prodott mediċinali jistgħu jreġġgħu lura għan- normal livelli baxxi u anormali ta ’ immunoglobulina G.
8 The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Il- mekkaniżmu ta ’ l- azzjoni f’ indikazzjonijiet oħrajn minbarra t- terapija tas- sostituzzjoni, ma jistgħux jiġu spjegati b’ mod sħiħ, iżda jinkludu effetti immunomodulatorji.
A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/ µl) although it did not reach normal levels.
Żieda sinifikanti fil- medjan tal - livelli tal- plejtlits intlaħqet fi prova klinika f’ pazjenti b’ ITP kronika (64, 000/ µl), għalkemm ma laħqitx il- livelli normali.
Two clinical trials were performed with Flebogammadif, one for replacement therapy in patients with primary immunodeficiency (both in adults and in children above 10 years) and another for immunomodulation in adults patients with immune thrombocytopenic purpura.
Żewġ provi kliniċi twettqu bil- Flebogammadif, waħda għat- terapija tas- sostituzzjoni f’ pazjenti b’ immunodefiċjenza primarja (it- tnejn f’ adulti u fi tfal ta ’ aktar minn 10 snin), u l- oħra għall - immunomodulazzjoni f’ pazjenti adulti b’ purpura tromboċitopenika immuni.
Pharmacokinetic properties
Tagħrif farmakokinetiku
Human normal immunoglobulin is immediately and completely bioavailable in the recipient’ s circulation after intravenous administration.
L- immunoglobulina normali umana hi immedjatament u kompletament bijodisponibbli fiċ - ċirkolazzjoni tal- pazjent wara l- għoti ġol- vini.
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Hu ddistribwit relattivament malajr bejn il- plażma u l - fluwidu extra- vaskulari, u wara madwar 3- 5 ijiem l- ekwilibriju jintlaħaq bejn il- kompartimenti intra - u extra- vaskulari.
Flebogammadif has a half-life of about 30-32 days.
Il- flebogammadif għandu half- life ta ’ madwar 30- 32 jum.
This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Din il- half- life tista ’ tvarja minn pazjent għall- ieħor, b’ mod partikulari f’ immunodefiċjenza primarja.
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
IgG u kumplessi IgG jitkissru fiċ- ċelluli tas- sistema retikuloendoteljali.
Preclinical safety data
Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Single dose toxicity studies were carried out in rats and mice.
Saru studji dwar it- tossiċità minn doża waħda fil- firien u fil- ġrieden.
The absence of mortality in the non-clinical studies performed with Flebogammadif with dosages up to 2500 mg/ kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system, of the treated animals supports the safety of Flebogammadif.
L- assenza ta ’ mortalità fl- istudji mhux kliniċi li saru bil- Flebogammadif b’ dożaġġi sa 2500 mg/ kg, u n- nuqqas ta ’ kwalunkwe sinjal avvers rilevanti kkonfermat li jaffettwa s- sistema respiratorja, ċirkolatorja u s- sistema nervuża ċentrali, fl- annimali kkurati, jissapportja s- sigurtà ta ’ Flebogammadif.
Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
L- eżaminazzjoni tat- tossiċità ta ’ dożi ripetuti u t- tossiċità embrijo- fetali ma kienx prattikabbli minħabba l- induzzjoni ta ’, u l- interferenza ma ’ l- antikorpi.
Effects of the product on the immune system of the newborn have not been studied.
L- effetti tal- prodott fuq is- sistema immuni tat- tarbija tat- twelid ma kinux studjati.
List of excipients
Lista ta ’ sustanzi mhux attivi
D-sorbitol Water for injections
D- sorbitol Ilma għall- injezzjonijiet
Incompatibilities
Inkompatibilitajiet
This medicinal product must not be mixed with other medicinal products or intravenous fluids.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn jew fluwidi li jingħataw ġol- vini.
It should be administered by a separate intravenous line.
Għandu jingħata permezz ta ’ linja separata ġol- vini.
Shelf life
Żmien kemm idum tajjeb il- prodott mediċinali
Do not store above 30 ºC.
Taħżinx f’ temperatura ’ l fuq minn 30ºC.
Nature and contents of container
In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
9 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl- rubber).
10 ml, 50 ml, 100 ml, 200 ml jew 400 ml soluzzjoni f’ kunjett (ħġieġ ta ’ tip II) b’ tapp (chloro- butyl- lastku).
Special precautions for disposal and other handling
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
The product should be brought to room or body temperature before use.
Il- prodott għandu jitħalla jilħaq it- temperatura tal- kamra jew tal- ġisem qabel l- użu.
The solution should be clear or slightly opalescent.
Is- soluzzjoni għandha tkun ċara jew xi ftit opalexxenti.
Do not use solutions that are cloudy or have deposits.
Tużax soluzzjonijiet li jkunu mċajprin jew li jkollhom xi depożiti.
Can Guasch, 2 - Parets del Vallès 08150 Barcelona - Spain
Can Guasch, 2 - Parets del Vallès 08150 Barċellona - Spanja
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Tagħrif dettaljat dwar dan il- prodott tinsab fuq is- websit ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Polígono Levante Can Guasch, 2, E-08150 Parets del Vallès Barcelona, Spain
Polígono Levante Can Guasch, 2, E- 08150 Parets del Vallès Barċellona, Spanja
Polígono Levante Can Guasch, 2 E-08150 Parets del Vallès Barcelona, Spain
Polígono Levante Can Guasch, 2 E- 08150 Parets del Vallès Barċellona, Spanja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 1. 0, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq irid ikun obbligat li jwettaq l- attivitajiet tal- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 1. 1 tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, an updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tinkiseb li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
12 Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
12 Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta ’ l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
OUTER CARTON (0.5 g, 2.5 g, 5 g, 10 g and 20 g)
KAXXA TAL- KARTUN TA ’ BARRA (0. 5 g, 2. 5 g, 5 g, 10 g u 20 g)
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin
Flebogammadif 50 mg/ ml soluzzjoni għall- infużjoni Immunoglobulin normali uman
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 minnu, mill- anqas 97% hu IgG.
D-sorbitol, water for injections.
D- sorbitol, ilma għall - injezzjonijiet.
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL LABEL (2.5 g, 5 g, 10 g and 20 g)
TIKKETTA TAL- KUNJETT (2. 5 g, 5 g, 10 g u 20 g)
D-sorbitol, water for injections.
D- sorbitol, ilma għall- injezzjonijiet.
To hang pull here
Biex iddendel, iġbed hawnhekk
VIAL LABEL (0.5 g)
TIKKETTA TAL- KUNJETT (0. 5 g)
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin For intravenous use
Flebogammadif 50 mg/ ml soluzzjoni għall- infużjoni Immunoglobulin normali umana Użu għal ġol- vini
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin (IVIg)
Flebogammadif 50 mg/ ml soluzzjoni għall- infużjoni Immunoglobulin normali uman (IVIg)
What Flebogammadif is and what it is used for 2.
X’ inhu l- Flebogammadif u għalxiex jintuża 2.
Before you use Flebogammadif 3.
Qabel ma tuża l- Flebogammadif 3.
How to use Flebogammadif 4.
Kif għandek tuża l- Flebogammadif 4.
How to store Flebogammadif 6.
Kif taħżen il- Flebogammadif 6.
WHAT FLEBOGAMMADIF IS AND WHAT IT IS USED FOR
X’ INHU FLEBOGAMMADIF U GĦALXIEX JINTUŻA
Flebogammadif is one of the group of medicines called intravenous immunoglobulins.
Il- Flebogammadif hu wieħed mill- gruppi ta ’ mediċini msejjħa immunoglobulini li jingħataw ġol- vini.
These are used to treat conditions where the body’ s defence system against disease is not working properly.
Dawn jintużaw biex jikkuraw kundizzjonijiet fejn is- sistema tad- difiża tal- ġisem kontra l- mard ma tkunx taħdem kif suppost.
It is used to raise antibody levels in your blood.
Jintuża biex iżid il- livell ta ’ l- antikorpi fid- demm tiegħek.
A lower than normal level of antibodies in your blood results in the incorrect functioning of your body’ s defence (immune) system.
Livell ta ’ antikorpi fid- demm tiegħek li jkun inqas minn dak normali, jirriżulta f’ sitwazzjoni fejn is- sistema (immuni) tad- difiża ta ’ ġismek ma taħdimx kif suppost.
The low levels of antibodies may be inherited or may have developed as you have grown older.
Il- livelli baxxi ta ’ antikorpi jistgħu jintirtu jew jistgħu jkunu żviluppaw mal - medda taż- żmien.
Other medical conditions such as myeloma or chronic lymphocytic leukaemia can also reduce the level of antibodies in your blood.
Kundizzjonijiet mediċi oħrajn bħal mjeloma jew lewkimja limfoċitika kronika tista ’ wkoll tnaqqas il- livell ta ’ l- antikorpi fid- demm tiegħek.
Raising antibody levels by regular injections of Flebogammadif will help your body fight off infections.
Li żżid il- livelli ta ’ l- antikorpi permezz ta ’ injezzjonijiet regolari ta ’ Flebogammadif, ser jgħin lill- ġismek jiġġieled l- infezzjonijiet.
It is used to treat Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.
Jintuża għall- kura tas- sindrome ta ’ Guillain Barré, fejn is- sistema immuni tagħmel ħsara lin- nervaturi u ma tħallihomx jaħdmu kif suppost.
It is used to treat Kawasaki disease, an illness in children where the blood vessels (arteries) in the body become enlarged.
Jintuża għall- kura tal- marda Kawasaki, marda fit- tfal fejn il- vini (arterji) fil- ġisem jikbru.
It is used in bone marrow transplantation, when you are given bone narrow cells from another person.
Jintuża fi trapjant tal- mudullun, meta jingħatawlek ċelluli tal- mudullun mingħand persuna oħra.
The antibodies in Flebogammadif help to stop infections and help to stop your body rejecting the new cells.
L- antikorpi fil- Flebogammadif jgħinu biex iwaqqfu l- infezzjonijiet u jgħinu biex iwaqqfu lil ġismek biex ma jirrifjutax iċ- ċelluli l- ġodda.
It is used to treat a condition called idiopathic thrombocytopenic purpura (ITP), where the number of platelets in your blood stream is greatly reduced.
Jintuża biex jikkura kundizzjoni msejħa purpura tromboċitopenika idjopatika (idiopathic thrombocytopenic purpura - ITP), fejn in- numru ta ’ plejtlits fiċ- ċirkolazzjoni tad- demm tiegħek jonqos bil- kbir.
Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising.
Il- plejtlits jiffurmaw parti importanti mill- proċess tat- tagħqid tad- demm, u tnaqqis fin- numri tagħhom jikkawża ħruġ ta ’ demm mhux mixtieq u tbenġil.
Injection of Flebogammadif results in an increase in the number of platelets, and an improvement in your condition.
Injezzjoni ta ’ Flebogammadif tirriżulta f’ żieda fin- numru ta ’ plejtlits, u titjib fil- kundizzjoni tiegħek.
In children with the acquired immune deficiency syndrome (AIDS), it can be used to prevent troublesome infections.
Fit- tfal bis- sindrome tad- defiċjenza immuni miksuba (AIDS), jista ’ jintuża biex jiġu evitati infezzjonijiet li jikkawżaw problemi.
If you have any question about use of Flebogammadif please ask your doctor.
Jekk ikollok xi mistoqsijiet dwar l- użu ta ’ Flebogammadif, jekk jogħġbok staqsi lit- tabib tiegħek.
BEFORE YOU USE FLEBOGAMMADIF
QABEL MA TUŻA FLEBOGAMMADIF
Do not use Flebogammadif
Tużax Flebogammadif:
- if you are allergic (hypersensitive) to human normal immunoglobulin or any of the other
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal immunoglobulin normali uman jew
ingredients of Flebogammadif (see special warnings about excipients at the end of this section).
xi wieħed mis- sustanzi ta ’ Flebogammadif (ara t- twissijiet speċjali dwar is- sustanzi mhux attivi fl- aħħar ta ’ din is- taqsima).
- if you have immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- jekk għandek defiċjenza ta ’ immunoglobulin A (IgA) ma ’ antikorpi anti- IgA.
- fructose intolerance.
- intolleranza għall- fructose.
Take special care with Flebogammadif
Oqgħod attent ħafna bi Flebogammadif:
Certain adverse reactions may occur more frequently: • in case of high rate of infusion. • if you have hypo- or agammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) with or without IgA deficiency. • if you are having Flebogammadif for the first time, or it is a long time since your last infusion (e. g. several weeks).
Ċerti reazzjonijiet avversi jistgħu jseħħu aktar b’ mod frekwenti: • f’ każ ta ’ rata għolja ta ’ infużjoni. • jekk għandek ipo - jew ipogammaglobulinemija (kundizzjoni li fiha jkollok livelli baxxi ta ’ immunoglobulin fid- demm tiegħek) bi jew mingħajr defiċjenza ta ’ IgA. • jekk qed tirċievi Flebogammadif għall- ewwel darba, jew jekk għadda żmien twil mill- aħħar infużjoni tiegħek (eż. diversi ġimgħat).
You will be watched carefully until an hour after the infusion to detect potential adverse signs.
Inti ser tkun immonitorjat/ a bl- attenzjoni sa siegħa wara l- infużjoni, biex ikunu osservati sinjali avversi potenzjali.
True hypersensitivity reactions are rare.
Reazzjonijiet reali ta ’ sensittività huma rari.
Rarely, human normal immunoglobulin can induce a fall in blood pressure with allergic reaction, even if you had tolerated previous treatment with human normal immunoglobulin.
B’ mod rari, l- immunoglobulin normali uman tista ’ tikkaġuna tnaqqis fil- pressjoni tad- demm b’ reazzjoni allerġika, anki jekk inti tkun ittollerajt il- kura b’ immunoglobulin normali uman fil- passat.
Patient with pre-existing risk factors
Pazjenti b’ fatturi ta ’ riskju li kienu jeżistu minn qabel
Please tell your doctor if you have any other condition and/ or illness, as caution is required.
Jekk jogħġbok għid lit- tabib tiegħek jekk għandek xi kundizzjoni u/ jew mard ieħor, għax l- attenzjoni hi meħtieġa.
In particular, tell your doctor if you have: • diabetes • high blood pressure • history of vascular disease or thrombosis • overweight • blood volume decrease • diseases which increase blood viscosity • advanced age
B’ mod partikulari għid lit- tabib tiegħek jekk għandek: • id- dijabete • il- pressjoni tad- demm għolja • storja medika ta ’ mard jew trombożi vaskulari • il- piż żejjed • it- tnaqqis fil- volum tad- demm • mard li jżidu l- viskosità tad- demm • età avvanzata
Patients with a kidney problem
Pazjenti bi problemi tal- kliewi
If you have a kidney problem, your doctor should consider whether to stop treatment since cases of acute renal failure have been reported in patients receiving IVIg therapy, generally in patients with risk factors.
Jekk għandek problema fil- kliewi, it- tabib tiegħek għandu jikkunsidra jekk il- kura għandhiex titwaqqaf, għax kienu rrappurtati każijiet ta ’ insuffiċjenza akuta tal- kliewi f’ pazjenti li kienu qed jirċievu terapija b’ IVIg, ġeneralment f’ pazjenti b’ fatturi ta ’ riskju.
Tell your doctor, even when any of the above-mentioned circumstances had happened to you in the past.
Għid lit- tabib tiegħek, anki meta kwalunkwe miċ- ċirkustanzi imsemmija hawn fuq seħħew fil- passat.
Special safety warning
Twissija speċjali dwar is- sigurtà
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Meta l- mediċini jkunu magħmulin minn demm jew plażma umana, jittieħdu ċerti miżuri biex jiġi evitat li jgħaddu xi infezzjonijiet lil pazjenti.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections.
Dawn jinkludu l- għażla bir- reqqa ta ’ donaturi tad- demm u tal- plażma, biex jiġi żgurat li dawk li qegħdin f’ riskju li jkollhom infezzjonijiet ikunu esklużi, u l- eżaminazzjoni ta ’ kull għotja u ta ’ pools ta ’ plażma għal sinjali ta ’ virus/ infezzjonijiet.
Despite these measures, when
Il- manifatturi ta ’ dawn il- prodotti jinkludu wkoll passi fl- ipproċessar tad- demm jew tal- plażma, li jistgħu
23 medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta l- mediċini ppreparati minn demm jew plażma umana jingħataw, il- possibbiltà li tgħaddi xi infezzjoni ma tistax tiġi totalment eskluża.
This applies to any unknown or emerging viruses or other types of infections.
Dan japplika għal kwalunkwe viruses mhux magħrufa jew ġodda, jew tipi oħrajn ta ’ infezzjonijiet.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Il- miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses enveloped bħal virus ta ’ l- immunodefiċjenza umana (HIV), il- virus ta ’ l- epatite B u l- virus ta ’ l- epatite C, u għal viruses non- enveloped ta ’ l- epatite A u parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
L- immunoglobulini ma kinux assoċjati ma ’ infezzjonijiet ikkawżati minn epatite A jew parvovirus B19, possibilment minħabba li l- antikorpi kontra dawn l- infezzjonijiet, li jinsabu fil- prodott, huma protettivi.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
• Effects on vaccines:
• Effetti fuq il- vaċċini:
Flebogammadif may reduce the effectiveness of certain type of vaccines such as measles, rubella, mumps and varicella.
Flebogammadif jista ’ jnaqqas l- effettività ta ’ ċerti tipi ta ’ tilqim, bħal dawk tal- ħosba, ħosba Ġermaniża, gattone u tal- ġidri r- riħ.
Effects on blood tests
Effetti fuq it- testijiet tad- demm
If you are having a blood test after receiving Flebogammadif, please tell the analyst or your doctor that you have been given this medicine.
Jekk ikun ser ikollok xi test tad- demm wara li tirċievi l- Flebogammadif, jekk jogħġbok għid lill - analista jew lit- tabib tiegħek li int ingħatajt din il- mediċina.
The level of certain antibodies can rise.
Il- livell ta ’ ċerti antikorpi jista ’ jiżdied.
If you are pregnant or breast-feeding you must tell your doctor.
Jekk inti tqila jew qed tredda ’, għandek tgħid lit- tabib tiegħek.
Your doctor will decide if Flebogammadif can be used during pregnancy and lactation.
It- tabib tiegħek ser jiddeċiedi jekk Flebogammadif jistax jintuża matul it- tqala u meta tkun qegħda tredda ’.
Dizziness can sometimes occur and might affect the ability to drive and use machines.
Xi kultant jista ’ jseħħ xi sturdament, u dan jista ’ jaffettwa l- ħila biex issuq u li tuża l- magni.
Important information about some of the ingredients of Flebogammadif
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Flebogammadif
Special warnings about ingredients:
Twissijiet speċjali dwar is- sustanzi:
This medicine contains 50 mg of sorbitol per ml as excipient.
Din il- mediċina fiha 50 mg ta ’ sorbitol f’ kull 1 ml bħala s- sustanza mhux attiva.
Special precautions should be taken with babies and young children because this 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 tkun għadha ma ġietx iddijanjostikata, u tista ’ tkun fatali.
HOW TO USE FLEBOGAMMADIF
KIF GĦANDEK TUŻA FLEBOGAMMADIF
Flebogammadif is given by injection into your veins (intravenous administration).
Il- Flebogammadif jingħata permezz ta ’ injezzjoni ġol- vini tiegħek.
It may be self administered if you have been fully trained by hospital staff.
Jista ’ jingħata minnek stess jekk tkun imħarreġ/ imħarrġa b’ mod sħiħ mill- istaff ta ’ l- isptar.
You must make up the infusion in exactly the way you have been shown in order to stop germs getting in.
Trid tagħmel l- infużjoni eżattament bil- mod li urewk sabiex ma tħallix il- mikrobi jidħlu.
You must never self administer it alone; a responsible adult must be always present.
Qatt m’ għandek tagħti l- infużjoni waħdek; persuna adulta responsabbli għandha dejjem tkun preżenti.
The dose that you will be given will depend on your weight and will be worked out by your doctor.
Id- doża li ser tingħata ser tiddependi fuq il- piż tiegħek, u ser tkun ikkalkulata mit- tabib tiegħek.
At the beginning of your infusion you will receive Flebogammadif at a slow rate (0.01-0.02 ml/ kg/ min).
Fil- bidu ta ’ l- infużjoni tiegħek, inti ser tirċievi Flebogammadif b’ rata bil- mod (0. 01- 0. 02 ml/ kg/ min).
Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.1 ml/ kg/ min).
Skond kemm tħossok komdu/ a, it- tabib tiegħek jista ’ mbagħad iżid gradwalment ir- rata ta ’ l- infużjoni (sa 0. 1 ml/ kg/ min).
24 The solution should be clear or slightly opalescent.
24 Is- soluzzjoni għandha tkun ċara jew xi ftit opalexxenti.
Do not use Flebogammadif if you notice that the solution is cloudy or has deposits.
Tużax Flebogammadif jekk tinnota li s - soluzzjoni hi mċajpra jew ikollha xi depożiti.
If you use more Flebogammadif than you should
Jekk tuża Flebogammadif aktar milli suppost
If you get more Flebogammadif than you should, your body may take on too much fluid.
Jekk tingħata aktar Flebogammadif milli suppost, jista ’ jkun li ġismek ikun ħa fluwidu żżejjed.
Tell your doctor immediately.
Għid lit- tabib tiegħek immedjatament.
If you forget to use Flebogammadif
Jekk tinsa tuża Flebogammadif
Tell your doctor or pharmacist immediately and follow his/ her instructions.
Għid lit- tabib jew lill- ispiżjar tiegħek immedjatament u segwi l- istruzzjonijiet tiegħu/ tagħha.
You must not be given a double dose to make up for a forgotten dose.
M’ għandekx tingħata doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Flebogammadif can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, il- Flebogammadif jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor if any of the following side effects happen during or after the infusion: • Chills • Headache • Fever • Nausea • Vomiting • Allergic reaction • Joint pain • Low blood pressure • Moderate low back pain
Għid lit- tabib tiegħek jekk xi wieħed minn dawn l- effetti sekondarji iseħħ waqt jew wara l - infużjoni: • Tregħid • Uġigħ ta ’ ras • Deni • Nawseja • Rimettar • Reazzjoni allerġika • Uġigħ fil- gogi • Pressjoni tad- demm baxxa • Uġigħ moderat fin- naħa t’ isfel tad- dahar
Rare side effects, which are likely to occur in fewer than 1 in 1,000 patients, are: • A sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even if you have shown no hypersensitivity to previous administration. • Cases of temporary meningitis (reversible aseptic meningitis). • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/ haemolysis). • Cases of transient cutaneous reactions. • Increase in serum creatinine level and/ or acute renal failure.
Effetti sekondarji rari, li x’ aktarx iseħħu f’ inqas minn 1 minn kull 1, 000 pazjent, huma: • Tnaqqis għal għarrieda fil- pressjoni tad- demm u, f’ każijiet iżolati, xokk anafilattiku, anki jekk ma kellek l- ebda sensittività eċċessiva meta tkun ingħatajt il- mediċina fil- passat. • Każijiet ta ’ meninġite temporanja (meninġite asettika riversibbli). • Każijiet ta ’ tnaqqis temporanju fin- numru taċ- ċelluli ħomor tad- demm (anemija/ emolisi emolitika riversibbli). • Każijiet ta ’ reazzjonijiet temporanji tal- ġilda. • Żieda fil- livell tal- krejatinina fis- serum u/ jew insuffiċjenza akuta renali.
Very rare side effects, which are likely to occur in fewer than 1 in 10,000 patients or which cannot be estimated from the available data, are: • Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.
Effetti sekondarji rari ħafna, li x’ aktarx li ser iseħħu f’ inqas minn 1 minn kull 10, 000 pazjent jew li ma tistax tittieħed stima mid- data disponibbli, huma: • Reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari, trombożi profonda tal- vini.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE FLEBOGAMMMADIF
KIF TAĦŻEN FLEBOGAMMMADIF
Do not use Flebogammadif after the expiry date which is stated on the label and carton after EXP.
Tużax il- Flebogammadif wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa tal- kartun wara JIS.
Do not store above 30 ºC.
25 Taħżinx f’ temperatura ’ l fuq minn 30ºC.
25 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Medicines should not be disposed via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Flebogammadif contains
X’ fih Flebogammadif
- The active substance is human normal immunoglobulin (IVIg).
- Is- sustanza attiva hi immunoglobulin normali uman (IVIg).
One ml contains 50 mg of
Millilitru wieħed fih 50 mg ta ’
human normal immunoglobulin, of which at least 97% is IgG.
immunoglobulin normali uman (IVIg), li minnu, mill- anqas 97% hi IgG.
It contains trace amounts of IgA (lower than 0.05 mg/ ml).
Fiha ammonti traċċi ta ’ IgA (inqas minn 0. 05 mg/ ml).
- The other ingredients are sorbitol and water for injections (see section 2. ‘ Before you use
- Is- sustanza l- oħra huma sorbitol u ilma għall - injezzjonijiet (ara taqsima 2. ‘ Qabel ma tuża
Flebogammadif’ for further information about ingredients).
Flebogammadif ’ għal aktar tagħrif dwar is- sustanzi).
What Flebogammadif looks like and contents of the pack
Id- dehra ta ’ Flebogammadif u l- kontenuti tal- pakkett
Flebogammadif is a solution for infusion.
Il- Flebogammadif hu soluzzjoni għall- infużjoni.
Flebogammadif is supplied as 0.5 g/ 10 ml, 2.5 g/ 50 ml, 5 g/ 100 ml, 10 g/ 200 ml and 20 g/ 400 ml vials.
Il- Flebogammadif hu fornut bħala kunjetti ta ’ 0. 5 g/ 10 ml, 2. 5 g/ 50 ml, 5 g/ 100 ml, 10 g/ 200 ml u 20 g/ 400 ml.
Pack size of 1 vial.
Daqs tal- pakkett ta ’ kunjett 1.
Not all sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet kollha jkunu għal skop kummerċjali.
Č eská republika Grifols S. R. O.
26 Česká republika Grifols S. R. O.
Italia Grifols Italia S. p. A.
27 Italia Grifols Italia S. p. A.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu
In replacement therapy the dosage will be adapted dependent on your pharmacokinetic and clinical response.
Fit- terapija tas- sostituzzjoni, id- dożaġġ ser ikun adattat skond ir- rispons farmakokinetiku u kliniku tiegħek.
The following dosage regimens are given as a guideline:
Il- korsijiet tad- dożaġġ li ġejjin qed jingħataw bħala linja gwida:
The dosage recommendations are summarised in the following table:
Ir- rakkomandazzjonijiet tad- dożaġġ huma deskritti fil- qosor fit- tabella li ġejja:
Children with AIDS
Tfal bl- AIDS
28 Immunomodulation:
28 Immunomodulazzjoni:
0.8 - 1 g/ kg or
- 1 g/ kg jew
on day 1, possibly repeated once within 3 days
f’ jum 1, possibilment ripetuta għal darba oħra fi żmien 3 ijiem
0.5 g/ kg
0. 5
every month until antibody levels return to normal
kull xahar sakemm il- livelli ta ’ l - antikorp jerġa ’ lura għan- normal
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 ġol- vini b’ rata inizjali ta ’ 0. 01- 0. 02 ml/ Kg/ min għall - ewwel tletin minuta.
A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/ µl) although it did not reach normal levels.
Żieda sinifikanti fil- medjan tal- livelli tal- plejtlits intlaħqet fi prova klinika f’ pazjenti b’ ITP kronika (64, 000/ µl), għalkemm ma laħqux il- livelli normali.
Flebogammadif should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.
Il- Flebogammadif m’ għandux jitħallat ma ’ mediċini jew soluzzjonijiet ġol- vini oħrajn u għandu jingħata permezz ta ’ linja separata ġol- vini.
Special precautions
Prekawzjonijiet speċjali
It is strongly recommended that every time Flebogammadif is administered, the name and batch number of the product is recorded in order to maintain a record of the batches used.
Hu rakkomandat bil- qawwa li kull darba li jingħata Flebogammadif, l- isem u n- numru tal- lott ikunu rrekordjati sabiex jinżamm rekord tal- lottijiet li ntużaw.
Instructions for handling and disposal
Tagħrif għall- immaniggjar u r- rimi
The product should be brought at room temperature (no more than 30 ºC) before use.
Il- prodott għandu jitħalla jitla ’ sat- temperatura tal- kamra (mhux aktar minn 30ºC) qabel l- użu.
Any unused product or waste material should be disposed of in accordance with local requirements
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
What is Fluticasone Furoate GSK?
X’ inhu Fluticasone Furoate GSK?
Fluticasone Furoate GSK is a nasal spray that contains the active substance fluticasone furoate.
Fluticasone Furoate GSK huwa sprej tal- imnieħer li fih is- sustanza attiva fluticasone furoate.
This medicine is the same as Avamys, which is already authorised in the European Union (EU).
Din il- mediċina hija bħal Avamys, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Avamys has agreed that its scientific data can be used for Fluticasone Furoate GSK.
Il- kumpanija li tipproduċi Avamys qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Fluticasone Furoate GSK.
What is Fluticasone Furoate GSK used for?
Għal xiex jintuża Fluticasone Furoate GSK?
Fluticasone Furoate GSK is used to treat the symptoms of allergic rhinitis.
Fluticasone Furoate GSK jintuża għat- trattament tas- sintomi ta ’ rinite allerġika.
This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing.
Din hija l - infjammazzjoni tal- passaġġi nażali kkawżata minn allerġija li tirriżulta fi tnixxiegħa tal- imħat, l - imblukkar tal- imnieħer, il- ħakk u l- għatis.
It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness.
Ġieli dawn jidhru flimkien ma ’ sintomi li jaffettwaw l - għajnejn, bħall- irritazzjoni, għajnejn imdemmgħa u ħmura.
Fluticasone Furoate GSK is for use in adults and children aged six years and over.
Fluticasone Furoate GSK huwa għall- użu fl- adulti u t- tfal ta ’ età minn sitt snin ‘ il fuq.
How is Fluticasone Furoate GSK used?
Kif jintuża Fluticasone Furoate GSK?
The recommended dose of Fluticasone Furoate GSK for adults and adolescents aged 12 years and over is two sprays in each nostril once a day.
Id- doża rakkomandata ta ’ Fluticasone Furoate GSK għal adulti u adolexxenti ta ’ 12- il sena u ‘ l fuq hija żewġ sprejjaturi f’ kull minħar darba kuljum.
This can be reduced to one spray in each nostril once symptoms are controlled.
Din tista ’ titnaqqas għal sprejjatura waħda f’ kull minħar ladarba jiġu kkontrollati s- sintomi.
For children between six and 12 years of age, the recommended dose is one spray in each nostril once a day, although this can be increased to two sprays if symptoms are not controlled.
Għat- tfal bejn sitt snin u tnax- il sena, id- doża rakkomandata hija sprejjatura waħda f’ kull minħar darba kuljum, minkejja li din tista ’ tiżdied għal żewġ sprejjaturi jekk ma jkunux jistgħu jiġu kkontrollati s- sintomi.