qanastek/EMEA-V3 huggingface dataset:
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: • Educational material • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiftiehem fuq id- dettalji ta ’ programm edukattiv ma ’ l- Awtoritajiet Kompetenti Nazzjonali u għandu jimplimenta programm bħal dan b’ mod nazzjonali biex jiżgura li qabel jiġi preskritt, it- tobba kollha huma pprovduti b’ pakkett ta ’ informazzjoni għall- professjonisti fil- qasam tas- saħħa li jkun fih dan li ġej: • Materjal edukkattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
Key elements to be included in the educational material
Punti prinċipali li għandhom ikunu nklużi fil- materjal edukkattiv
The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
L- inċidenza ta ’ tromboċitopenija fil- provi kliniċi u ċ- ċans li terġa ’ sseħħ wara li titwaqqaf il- kura.
Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Twissija li, waqt li m’ hemm l- ebda data disponibbli, depożizzjoni ta ’ reticulin bħala rispons għal romiplostim tista ’ twassal għal fibrosi tal- mudullun tal- għadam.
Advice on when further investigations and a bone marrow biopsy might be appropriate.
Parir dwar meta jistgħu jkunu xierqa aktar investigazzjonijiet u bijopsija tal- mudullun tal- għadam.
The incidence in clinical trials of thrombotic/ thromboembolic complications.
L- inċidenza ta ’ kumplikazzjonijiet trombotiċi / tromboemboliċi fil- provi kliniċi.
Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Romiplostim jista ’ jikkawża l- progressjoni ta ’ tumuri malinni ematoloġiċi eżistenti u tas - sindrome mijelodisplastika (MDS).
Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Għandha tiġi pprovduta kalkulatriċi tad- dożaġġ biex il- kejl tad- doża t- tajba jkun eħfef, u gwida dwar rikostituzzjoni u għoti tajbin.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3, dated 26 June 2008 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 għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 3, datata 26 ta ’ Ġunju 2008, ippreżentata f’ Modulu 1. 8. 1 ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija f’ postha u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5, dated 14 November 2008 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 għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn iddettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 5, datata 14 ta ’ Novembru 2008 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l - Applikazzjoni għal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess waqt mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) li jmiss.
Nplate 250 micrograms powder for solution for injection romiplostim
Nplate 250 mikrogramma trab għal soluzzjoni għall- injezzjoni romiplostim
Vial containing 250 micrograms of romiplostim.
Kunjett fih 250 mikrogramma ta ’ romiplostim.
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ ml).
Wara r- rikostituzzjoni, volum ta ’ soluzzjoni li jista ’ jingħata ta ’ 0. 5 ml fih 250 mikrogramma ta ’ romiplostim (500 mikrogramma/ ml).
Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Mannitol (E421), sucrose, l- histidine, hydrochloric acid (għall- aġġustmament tal- pH) u polysorbate 20.
1 vial.
Kunjett wieħed.
4 vials.
4 kunjetti.
24 hours when stored at 25°C or in a refrigerator (2°C – 8°C) if kept in the original vial and protected from light.
24 siegħa meta maħżun f’ 25°C jew fi friġġ (2°C – 8°C) jekk miżmum fil - kunjett oriġinali u protett mid- dawl.
Nplate 250 µg powder for injection romiplostim SC
Nplate 250 µg trab għall- injezzjoni romiplostim SC
Nplate 500 micrograms powder for solution for injection romiplostim
Nplate 500 mikrogramma trab għal soluzzjoni għall- injezzjoni romiplostim
Vial containing 500 micrograms of romiplostim.
Kunjett fih 500 mikrogramma ta ’ romiplostim.
After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ ml).
Wara r- rikostituzzjoni, volum ta ’ soluzzjoni li jista ’ jingħata ta ’ 1 ml fih 500 mikrogramma ta ’ romiplostim (500 mikrogramma/ ml).
35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Nplate 500 µg powder for injection romiplostim SC
Nplate 500 µg trab għall- injezzjoni romiplostim SC
Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection Romiplostim
Nplate 250 mikrogramma trab għal soluzzjoni għall- injezzjoni Nplate 500 mikrogramma trab għal soluzzjoni għall- injezzjoni Romiplostim
- If you have any further questions, ask your doctor.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Nplate is and what it is used for 2.
X’ inhu Nplate u għalxiex jintuża 2.
Before you use Nplate 3.
Qabel ma tuża Nplate 3.
How to use Nplate 4.
Kif għandek tuża Nplate 4.
How to store Nplate 6.
Kif taħżen Nplate 6.
WHAT NPLATE IS AND WHAT IT IS USED FOR
X’ INHU NPLATE U GĦALXIEX JINTUŻA
Nplate is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Nplate huwa proteina wżata għall- kura ta ’ għadd baxx ta ’ plejtlits f’ pazjenti b’ purpura tromboċitopenika immuni (idjopatika) (msejħa ITP).
ITP is a disease in which your body’ s immune system destroys its own platelets.
ITP hija marda fejn is- sistema immuni tal- ġisem tiegħek tiddistruġġi l- plejtlits tagħha stess.
Platelets are the cells in your blood that help seal cuts and form blood clots.
Plejtlits huma ċ- ċelluli fid- demm tiegħek li jgħinu jagħlqu feriti u jiffurmaw demm magħqud.
Very low platelet counts can cause bruising and serious bleeding.
Għadd ta ’ plejtlits baxx ħafna jista ’ jikkawża tbenġil u fsada ta ’ natura serja.
Nplate is used to treat adult patients (aged 18 years and over) who have had their spleen removed for chronic ITP and who have been previously treated with corticosteroids or immunoglobulins, where these drugs don ’ t work.
Nplate jintuża għall- kura ta ’ pazjenti adulti (b’ età minn 18- il sena ’ l fuq) li tneħħitilhom il- milsa minħabba ITP kronika u li kienu kkurati minn qabel b’ kortikosterojdi jew immunoglobulini, fejn dawn il- mediċini ma jaħdmux.
Nplate may also be used in previously treated adult patients (aged 18 years and over) with chronic ITP in whom surgery is not an option.
Nplate jista ’ jintuża wkoll f’ pazjenti adulti (b’ età minn 18- il sena ’ l fuq) b’ ITP kronika kkurati minn qabel li għalihom ma tistax tiġi kkunsidrata kirurġija.
Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets.
Nplate jaħdem billi jistimola l- mudullun tal- għadam (parti tal- għadam li tagħmel ċelluli tad- demm) biex jipproduċi aktar plejtlits.
This should help to prevent bruising and bleeding associated with ITP.
Dan għandu jgħin biex jipprevjeni tbenġil u fsada assoċjati ma ’ ITP.
BEFORE YOU USE NPLATE
QABEL MA TUŻA NPLATE
DO NOT use Nplate
TUŻAX Nplate
• if you are allergic (hypersensitive) to romiplostim or to any of the other ingredients of Nplate.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal romiplostim jew sustanzi oħra ta ’ Nplate.
• if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
• jekk inti allerġiku/ a għall- mediċini oħra magħmula minn teknoloġija tad- DNA bl- użu tal- mikro - organiżmu Escherichia coli (E. coli).
Take special care with Nplate
38 Oqgħod attent ħafna b’ Nplate
• If you stop taking Nplate a low blood platelet count (thrombocytopenia) is likely to reoccur.
Jekk tieqaf tieħu Nplate x’ aktarx li jerġa ’ jkun hemm għadd tal- plejtlits tad- demm baxx • (tromboċitopenija).
If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Jekk tieqaf tieħu Nplate l- għadd tal- plejtlits tiegħek se jkollu jiġi ssorveljat, u t- tabib tiegħek se jiddiskuti miegħek prekawzjonijiet xierqa.
38 • If you have very high blood platelet counts, as this may increase the risk of blood clotting.
Jekk għandek għadd tal- plejtlits tad- demm għoli ħafna għax dan jista ’ jżid ir- riskju li jagħqad • id- demm.
Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.
It- tabib tiegħek se jaġġusta d- doża tiegħek ta ’ Nplate sabiex jassigura li l- għadd tal - plejtlits ma jsirx għoli wisq.
If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Jekk qed tieħu wkoll mediċini li jipprevjenu tagħqid tad- demm (sustanzi kontra il- koagulazzjoni tad - demm jew terapija kontra l- plejtlits) hemm riskju akbar ta ’ fsada.
Your doctor will discuss this with you.
It- tabib tiegħek se jiddiskuti dan miegħek.
If you are taking corticosteroids, danazol, and/ or azathioprine these may be reduced or stopped when given together with Nplate.
Jekk qed tieħu kortikosterojdi, danazol, u/ jew azathioprine dawn jistgħu jitnaqqsu jew jitwaqqfu meta jingħataw flimkien ma ’ Nplate.
It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Huwa importanti li tgħid lit- tabib tiegħek jekk inti tqila; taħseb li tista ’ tkun tqila; jew qed tippjana li toħroġ tqila.
Nplate is not recommended for use if you are pregnant unless indicated by your doctor.
Nplate mhux irrakkomandat jekk inti tqila sakemm mhux indikat mit- tabib tiegħek.
It is not known whether romiplostim is present in human milk.
Mhux magħruf jekk romiplostim jinstabx fil- ħalib uman.
Nplate is not recommended for use if you are breast-feeding.
Nplate mhux irrakkomandat għall- użu jekk qed tredda ’.
A decision on whether to discontinue breast-feeding or discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to your child and the benefit of romiplostim therapy to you.
Deċiżjoni dwar jekk għandux jitwaqqaf it- treddigħ jew jekk għandhiex titwaqqaf it - terapija b’ romiplostim għandha tittieħed b’ kunsiderazzjoni tal- benefiċċju tat- treddigħ għat- tarbija tiegħek u l- benefiċċju ta ’ terapija b’ romiplostim għalik.
You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Għandek tkellem lit- tabib tiegħek qabel issuq jew tħaddem magni peress li xi effetti sekondarji jistgħu jnaqqsu l- ħila tiegħek biex tagħmel dan b’ mod sikur.
HOW TO USE NPLATE
KIF GĦANDEK TUŻA NPLATE
Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Nplate se jingħata taħt is- superviżjoni diretta tat- tabib tiegħek, li se jikkontrolla mill- viċin l- ammont ta ’ Nplate li se jingħatalek.
Nplate is administered as an injection under the skin (subcutaneous).
Nplate jingħata bħala injezzjoni taħt il- ġilda.
Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week.
Id- doża tal- bidu hija mikrogramma ta ’ Nplate kull kilogramma ta ’ piż tal- ġisem tiegħek darba fil - ġimgħa.
Your doctor will tell you how much you must take.
It- tabib tiegħek se jgħidlek kemm għandek tieħu.
Nplate should be injected once per week in order to keep your platelet counts up.
Nplate għandu jiġi injettat darba fil- ġimgħa biex iżomm l- għadd tal- plejtlits tiegħek għoli.
Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
It- tabib tiegħek se jieħu kampjuni tad- demm b’ mod regolari biex ikejjel kif qed jirrispondu l- plejtlits tiegħek u jista ’ jaġġusta d- doża tiegħek skond il - bżonn.
Once your platelet count is under control, your doctor will continue to regularly check your blood.
Ladarba l- għadd ta ’ plejtlits tiegħek huwa kkontrollat it- tabib tiegħek se jkompli jiċċekkja d- demm tiegħek b’ mod regolari.
Your dose may be adjusted further in order to maintain long-term control of your platelet count.
Id- doża tiegħek tista ’ tiġi aġġustata aktar biex jinżamm kontroll ta ’ l- għadd ta ’ plejtlits fit- tul.
If you use more Nplate than you should
39 Jekk tuża Nplate aktar milli suppost
Your doctor will ensure that you receive the right amount of Nplate.
It- tabib tiegħek se jiżgura li tirċievi l- ammont xieraq ta ’ Nplate.
If you have been given more Nplate than you should, contact your doctor immediately.
Jekk ingħatajt aktar Nplate milli suppost, ikkuntattja lit- tabib tiegħek minnufih.
It is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Huwa rrakkomandat li tiġi sorveljat għal xi sinjali jew sintomi ta ’ effetti sekondarji u li tingħata l- kura xierqa immedjatament.
39 If you forget to use Nplate
Jekk tinsa tuża Nplate
If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
Jekk insejt doża ta ’ Nplate, it- tabib tiegħek se jiddiskuti miegħek meta għandek tieħu d- doża li jmiss.
If you stop using Nplate
Jekk tieqaf tuża Nplate
If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur.
Jekk tieqaf tuża Nplate x’ aktarx li jerġa ’ jkollok għadd baxx ta ’ plejtlits fid- demm (tromboċitopenija).
Your doctor will decide if you should stop using Nplate.
It- tabib tiegħek se jiddeċiedi jekk għandekx tieqaf tuża Nplate.
Like all medicines, Nplate can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Nplate jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (seen in more than 1 in 10 people taking Nplate): • headache.
Effetti sekondari komuni ħafna (osservati f’ aktar minn persuna waħda minn kull 10 li jieħdu Nplate): • uġigħ ta ’ ras.
Common side effects (seen in more than 1 in 100 people taking Nplate): • bone marrow disorder, including increased bone marrow fibres (reticulin); • trouble sleeping (insomnia); • dizziness; • tingling or numbness of the hands or feet (paraesthesia); • migraine; • redness of the skin (flushing); • blood clot in a lung artery (pulmonary embolism); • nausea; • diarrhoea; • abdominal pain; • indigestion (dyspepsia); • constipation; • itching of the skin (pruritis); • bleeding under the skin (ecchymosis); • bruising (contusion); • rash; • joint pain (arthralgia); • muscles pain or weakness (myalgia); • pain in your hands and feet; • muscle spasm; • back pain; • bone pain; • tiredness (fatigue); • injection site bruising; • injection site pain; • injection site swelling; • swelling in the hands and feet (oedema peripheral); • flu like symptoms (influenza like illness); • pain; • weakness (asthenia); • fever (pyrexia); • chills; • contusion; • low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia) after stopping Nplate; • higher than normal platelet counts (thrombocytosis).
Effetti sekondari komuni (osservati f’ aktar minn persuna waħda minn kull 100 li qed jieħdu Nplate): • disturb fil- mudullun tal- għadam, inkluż żjieda fil- fibri tal- mudullun tal- għadam (reticulin); • diffikultà biex torqod (insomnja); • sturdament; • tingiż jew tnemnim fl- idejn u s- saqajn (parasteżija); • emigranja; • ħmura fil- ġilda (fwawar); • demm magħqud f’ arterja tal- pulmun (emboliżmu pulmonari); • tqalligħ; • dijarea; • uġigħ addominali; • indigestjoni (dispepsja); • stitikezza; • ħakk fil- ġilda (prurite); • fsada taħt il- ġilda (ekkimosi); • tbenġil (kontużjoni); • raxx; • uġigħ fil- ġogi (artralġja); • uġigħ jew debbulizza fil- muskoli (majalġja); • uġigħ f’ idejk u f’ saqajk; • spażmi fil- muskoli; • uġigħ fid- dahar; • uġigħ fl- għadam; • għeja; • tbenġil fil- lok ta ’ l- injezzjoni; • uġigħ fil- lok ta ’ l- injezzjoni; • nefħa fil- lok ta ’ l- injezzjoni; • nefħa fl- idejn u s- saqajn (edima periferali); • sintomi li jixbħu lill- influwenza (marda li tixbaħ lill- influwenza); • uġigħ;
40 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.
40 • debbulizza (astenja); • deni; • sirda; • tbenġil; • għadd ta ’ plejtlits fid- demm baxx (tromboċitopenija), u għadd ta ’ plejtlits fid- demm baxx (tromboċitopenija) wara li jitwaqqaf Nplate; • għadd ta ’ plejtlits ogħla min- normal (tromboċitosi).
HOW TO STORE NPLATE
KIF TAĦŻEN NPLATE
Do not use Nplate after the expiry date which is stated on the carton and vial label after EXP.
Tużax Nplate wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- kunjett wara JIS.
What Nplate contains
X’ fih Nplate
- The active substance is romiplostim.
Is- sustanza attiva hija romiplostim.
Each vial of Nplate 250 micrograms powder for solution for injection contains 250 micrograms of romiplostim.
Kull kunjett ta ’ Nplate 250 mikrogramma trab għal soluzzjoni għall- injezzjoni fih 250 mikrogramma ta ’ romiplostim.
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ ml).
Wara r- rikostituzzjoni, volum li jista ’ jingħata ta ’ 0. 5 ml ta ’ soluzzjoni fih 250 mikrogramma ta ’ romiplostim (500 mikrogramma/ ml).
Each vial of Nplate 500 micrograms powder for solution for injection contains 500 micrograms of romiplostim.
Kull kunjett ta ’ Nplate 500 mikrogramma trab għal soluzzjoni għall- injezzjoni fih 500 mikrogramma ta ’ romiplostim.
After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ ml).
Wara r- rikostituzzjoni, volum li jista ’ jingħata ta ’ 1 ml ta ’ soluzzjoni fih 500 mikrogramma ta ’ romiplostim (500 mikrogramma/ ml).
- The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH
Is- sustanzi l- oħra huma mannitol (E421), sucrose, L- histidine, hydrochloric acid (għal
adjustment) and polysorbate 20.
aġġustament tal- pH) u polysorbate 20.
What Nplate looks like and contents of the pack
Id- Dehra ta ’ Nplate u l- kontenuti tal- pakkett
Nplate is a white powder for solution for injection supplied in a 5 ml glass vial.
Nplate huwa trab abjad għal soluzzjoni għall- injezzjoni pprovdut f’ kunjett tal- ħġieġ ta ’ 5 ml.
Carton containing 1 or 4 vials of either 250 micrograms or 500 micrograms of romiplostim.
Kartuna fiha kunjett wieħed jew 4 kunjetti ta ’ 250 mikrogramma jew 500 mikrogramma romiplostim.
Marketing Authorisation Holder and Manufacturer Amgen Europe B. V.
41 Amgen Europe B. V.
Tel/ Tél: +32 (0)2 7752711
Tél/ Tel: +32 (0) 2 7752711
Amgen Belgique/ Belgien Tel/ Tél: +32 (0)2 7752711
Amgen Belgique/ Belgien Tél/ Tel: +32 (0) 2 7752711
Č eská republika Amgen s. r. o Tel: +420 2 21 773 500
Ceská republika Amgen s. r. o Tel: +420 2 21 773 500
The Netherlands Tel: +31 (0) 76 5732500
The Netherlands Tel.: +31 (0) 76 5732500
Tel: +31 (0) 76 5732500
Tel.: +31 (0) 76 5732500
Deutschland AMGEN GmbH Tel: +49 (0)89 1490960
Deutschland AMGEN GmbH Tel.: +49 (0) 89 1490960
Eesti Amgen Switzerland AG Eesti filiaal Tel: +372 5125 501
Eesti Amgen Switzerland AG Eesti filiaal Tel.: + 372 5125 501
Österreich Amgen GmbH Tel: +43 (0) 1 50 217
Österreich Amgen GmbH Tel.: +43 (0) 1 50 217
Τηλ.: +30 210 3447000
Τηλ: +30 210 3447000
Tel: +351 21 4220550
Tel.: +351 21 4220550
France Amgen S. A. S Tél: +33 (0)1 40 88 27 00
France Amgen S. A. S Tel.: +33 (0) 1 40 88 27 00
Ireland Amgen Limited United Kingdom Tel: +44 (0)1223 420305
Ireland Amgen Limited United Kingdom Tel.: +44 (0) 1223 420305
Tel: +386 1 585 1767
Tel.: +386 1 585 1767
Slovenská republika Amgen Switzerland AG, Slovakia Tel: +42 1 25939 6456
Slovenská republika Amgen Switzerland AG, Slovakia Tel.: +42 1 25939 6456
Italia Amgen Dompé S. p. A.
42 Italia Amgen Dompé S. p. A.
Tel: +39 02 6241121
Tel.: +39 02 6241121
Suomi/ Finland Amgen AB, sivuliike Suomessa/ Amgen AB, filial i Finland Puh/ Tel: +358 (0)9 54900500
Suomi/ Finland Amgen AB, sivuliike Suomessa/ Amgen AB, filial i Finland Tél/ Tel: +358 (0) 9 54900500
Sverige Amgen AB Tel: +46 (0)8 6951100
Sverige Amgen AB Tel.: +46 (0) 8 6951100
42 Latvija Amgen Switzerland AG Rī gas filiā le Tel: +371 29284 807
Latvija Amgen Switzerland AG Rīgas filiāle Tel.: + 371 29284 807
United Kingdom Amgen Limited Tel: +44 (0)1223 420305
United Kingdom Amgen Limited Tel.: +44 (0) 1223 420305
Lietuva Amgen Switzerland AG Vilniaus filialas Tel. +370 6983 6600
Lietuva Amgen Switzerland AG Vilniaus filialas Tel.: + 370 6983 6600
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
It- tagħrif li ġej huwa maħsub biss għall- professjonisti fil- qasam mediku:
Nplate is a sterile but unpreserved product and is intended for single use only.
Nplate huwa prodott sterili iżda mhux ippreservat u huwa maħsub biex jintuża darba biss.
• Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 ml sterile water for injections, yielding a deliverable volume of 0.5 ml.
Nplate 250 mikrogramma trab għal soluzzjoni għall- injezzjoni għandu jiġi rrikostitwit b’ 0. 72 ml ta ’ ilma sterili għall- injezzjoni, li jirriżulta f’ volum li jista ’ jingħata ta ’ 0. 5 ml.
An additional overfill is included in each vial to ensure that 250 µg of romiplostim can be delivered. or • Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 ml sterile water for injections, yielding a deliverable volume of 1 ml.
Kull kunjett fih spażju żejjed li jista ’ jimtela sabiex jiġi żgurat li jista ’ jingħata 250 µg ta ’ romiplostim. jew Nplate 500 mikrogramma trab għal soluzzjoni għall- injezzjoni għandu jiġi rrikostitwit b’ 1. 2 ml ta ’ ilma sterili għall- injezzjoni, li jirriżulta f’ volum li jista ’ jingħata ta ’ 1 ml.
43 ANNEX IV
43 ANNESS IV
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
44 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
44 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI MILL- ISTATI MEMBRI
Background information on reticulin in the bone marrow.
Informazzjoni eżistenti dwar reticulin fil- mudullun tal- għadam.
Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Rati eżistenti ta ’ reticulin fil- mudullun tal- għadam f’ pazjenti b’ ITP u l- inċidenza osservata u l- mekkaniżmu potenzjali ta ’ azzjoni ta ’ depożizzjoni ta ’ reticulin bħala rispons għal romiplostim.
Pharmaceutical form
G amla farma ewtika
Solution for injection
soluzzjoni g all- injezzjoni
3 cartridges
skarto 1
EU/ 1/ 00/ 164/ 005
EU/ 1/ 00/ 164/ 004 EU/ 1/ 00/ 164/ 005
NutropinAq
NutropinAq NutropinAq
10 mg/
10 mg / 10 mg /
2 ml
2 ml 2 ml
Solution for injection
U u g al ta t il - ilda U u g al ta t il - ilda
Subcutaneous use
skarto (tal - skarto (tal -
cartridge (glass) 2 ml
2 ml 2 ml
6 cartridges
3 skrata 6 skrata
NutropinAq 10 mg/ 2 ml (30 IU) solution for injection
NutropinAq 10 mg/ 2 ml (30 IU) soluzzjoni għall- injezzjoni
One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Skartoċċ wieħed fih 10 mg (30 IU) ta ’ somatropin * * Ormon tat- tkabbir uman prodott f’ ċelloli ta ’ Escherichia coli permezz ta ’ teknoloġija DNA rikombinata.
NutropinAq is a solution for subcutaneous use.
NutropinAq huwa soluzzjoni għall- użu għal taħt il- ġilda.
The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal.
Is- soluzzjoni ċara, bla kulur, sterili għall- użu ta ’ aktar minn doża waħda tinstab fi skartoċċ tal- ħġieġ, magħluq b’ tapp tal- lasktu u siġill tal- lasktu.
- Long-term treatment of children with growth failure due to inadequate endogenous growth
- Kura fit- tul ta ’ tfal b’ falliment tat- tkabbir minħabba sekrezzjoni inadegwata ta ’ ormon ta ’
hormone secretion.
tkabbir endoġenu.
- Long-term treatment of growth failure associated with Turner syndrome.
- Kura fit- tul ta ’ falliment tat- tkabbir assoċjat mas- sindromu ta ’ Turner.
- Treatment of prepubertal children with growth failure associated with chronic renal
- Kura fit- tfal ta ’ qabel il- pubertà b’ falliment tat- tkabbir assoċjat ma ’ insuffiċjenza kronika tal -
insufficiency up to the time of renal transplantation.
kliewi sa meta jkun iż- żmien għal trapjant tal- kliewi.
- Replacement of endogenous growth hormone in adults with growth hormone deficiency of
- Sostituzzjoni ta ’ l- ormon tat- tkabbir endoġenu f’ adulti b’ defiċjenza ta ’ l- ormon tat- tkabbir li
either childhood or adult-onset etiology.
jibda ’ jew fit- tfulija jew f’ età adulta.
Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4).
Nuqqas ta ’ l- ormon tat- tkabbir għandu jiġi kkonfermat kif suppost qabel ma tinbeda l- kura (ara sezzjoni 4. 4).
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use.
Dijanjożi u terapija b’ somatropin għandha tinbeda u tiġi sorveljata minn tobba li għandhom kwalifiki xierqa u esperjenza fid- dijanjożi u l- immaniġġjar ta ’ pazjenti bl- indikazzjoni terapewtika ta ’ l- użu.
The NutropinAq dosage and administration schedule should be individualised for each patient.
Id- dożaġġ u l- programm ta ’ l- għotja ta ’ NutropinAq għandha tiġi ndividwalizzata għal kull pazjent.
Growth failure in children due to inadequate growth hormone secretion:
Falliment tat- tkabbir fi tfal b’ sekrezzjoni inadegwata ta ’ l- ormon tat- tkabbir:
0.025 - 0.035 mg/ kg bodyweight given as a daily subcutaneous injection.
0. 025 - 0. 035 mg/ kg piż tal- ġisem mogħtija bħala injezzjoni taħt il- ġilda darba kuljum.
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Terapija b’ somatropin għandha titkompla fit- tfal u adolexxenti sakemm l- epifisis tagħhom jingħalqu.
Growth failure associated with Turner syndrome:
Falliment tat- tkabbir assoċjat mas- sindromu ta ’ Turner:
Up to 0.05 mg/ kg bodyweight given as a daily subcutaneous injection.
Sa 0. 05 mg/ kg piż tal- ġisem mogħti bħala injezzjoni taħt il- ġilda darba kuljum.
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Kura b’ somatropin għandha titkompla fit- tfal u adolexxenti sakemm l- epifisis tagħhom jingħalqu.
Growth failure associated with chronic renal insufficiency:
Falliment tat- tkabbir assoċjat ma ’ insuffiċjenza kronika tal- kliewi:
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed, or up to the time of renal transplantation.
Kura b ’ somatropin għandha titkompla fit- tfal u adolexxenti sakemm l- epifisis tagħhom jingħalqu jew sa ’ meta jkun iż- żmien għal trapjant tal- kliewi.
Growth hormone deficiency in adults:
Nuqqas ta ’ l- ormon tat- tkabbir fl- adulti:
2 At the start of somatropin therapy, low initial doses of 0.15 - 0.3 mg are recommended, given as a daily subcutaneous injection.
2 Fil- bidu tal- kura b’ somatropin, dożi baxxi tal- bidu ta ’ 0. 15 - 0. 3 mg huma rakkomandati, mogħtija bħala injezzjoni taħt il- ġilda darba kuljum.
The dose should be adjusted stepwise, controlled by serum Insulin-like Growth Factor-1 (IGF-1) values.
Id- doża għandha tiġi aġġustata pass wara pass, ikkontrollata mill- valuri ta ’ Fattur tat- Tkabbir- 1 Jixbaħ lill- Insulina (IGF- 1) fis- serum.
The recommended final dose seldom exceeds 1.0 mg/ day.
Id- doża finali rakkomandata rarament taqbeż 1. 0 mg/ kuljum.
In general, the lowest efficacious dose should be administered.
Ġeneralment, l- anqas doża effikaċji għandha tingħata.
In older or overweight patients, lower doses may be necessary.
F’ pazjenti akbar jew b’ piż żejjed, jista ’ jkun hemm bżonn ta ’ dożi aktar baxxi.
Administration
Għotja
The solution for injection should be administered subcutaneously each day.
Is- soluzzjoni għall- injezzjoni għandha tingħata taħt il- ġilda kuljum.
The site of injection should be changed.
Il- post fejn tingħata għandu jinbidel.
For instructions for use and handling, see section 6.6.
Għall- istruzzjonijiet dwar l- użu u l- immaniġġjar, ara sezzjoni 6. 6.
Somatropin should not be used for growth promotion in patients with closed epiphyses.
Somatropin m’ għandux jintuża biex jippromovi tkabbir f’ pazjenti b’ epifises magħluqa.
Growth hormone should not be used in patients with active neoplasm.
L- ormon tat- tkabbir m’ għandux jintuża b’ pazjenti b’ neoplażma attiva.
NutropinAq therapy should be discontinued if evidence of tumour growth develops.
Terapija b’ NutropinAq għandha titwaqqaf jekk ikun hemm żvilupp ta ’ evidenza ta ’ kobor ta ’ tumur.
Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open-heart or abdominal surgery, multiple accidental traumas or to treat patients having acute respiratory failure.
L- ormon tat- tkabbir m’ għandux jinbeda sabiex jiġu kkurati pazjenti b’ kondizzjoni kritika akuta minħabba komplikazzjonijiet wara kirurġija open- heart jew kirurġija addominali, korrimenti multipli aċċidentali jew biex jikkura pazjenti li għandhom falliment respiratorju akut.
In adults with growth hormone deficiency the diagnosis should be established depending on the etiology:
F’ adulti b’ insuffiċjenza ta ’ l- ormon tat- tkabbir id- dijanjosi għandha tiġi stabilita mill- etjoloġija:
Adult-onset:
Bidu f’ età adulta:
The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin).
Il- pazjent irid ikollu defiċjenza tal- ormon tat- tkabbir bħala riżultat ta ’ mard fl - ipotalamu jew fil- pitwitarja, u ta ’ l- inqas dijanjożi ta ’ defiċjenza ta ’ ormon ieħor (minbarra prolactin).
Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted.
M’ għandux isir test għal defiċjenzafl- ormon ta ’ tkabbir sakemm kura ta ’ sostituzzjoni xierqa għal defiċjenzata ’ l- ormoni l- oħra ma tkunx inbdiet.
Childhood-onset:
Bidu fit- tfulija:
Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Pazjenti li kellhom defiċjenza fl- ormon tat- tkabbir meta kienu tfal għandhom jerġu jiġu ttestjati sabiex tiġi kkonfermata id- defiċjenza fl- ormon tat- tkabbir f’ età adulta qabel ma tinbeda kura ta ’ sostituzzjoni b’ NutropinAq.
In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse.
F’ pazjenti li diġà kellhom mard malinni, għandha tingħata attenzjoni speċjali għal sinjali u sintomi ta ’ rkadar.
Patients with a history of an intracranial lesion should be examined frequently for progression or recurrence of the lesion.
Pazjenti b’ passat ta ’ feriti fil- kranju għandhom jiġu nvistati ta ’ spiss għall- iżvilupp jew rikorrenza tal - ferita.
NutropinAq is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome, unless they also have a diagnosis of growth hormone deficiency.
NutropinAq mhux indikat għall- kura fit- tul ta ’ pazjenti pedjatriċi li għandhom falliment tat- tkabbir minħabba s- sindromu ta ’ Prader- Willi kkonfermat ġenetikament, sakemm m’ għandhomx ukoll dijanjożi ta ’ defiċjenza ta ’ l- ormon tat- tkabbir.
There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Kien hemm rapporti ta ’ apneja waqt l- irqad u mewt f’ daqqa wara bidu ta ’ kura bl- ormon tat- tkabbir f’ pazjenti pedjatriċi bis- sindromu ta ’ Prader- Willi li kellhom wieħed jew aktar minn dawn il- fatturi ta ’ riskju li ġejjin: ħxuna severa, passat ta ’ sadd tal - parti ta ’ fuq tal- passaġġ tal- arja jew apneja waqt l- irqad, jew infezzjoni respiratorja mhux identifikata.
The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open-heart or abdominal surgery, multiple accidental traumas, or who were having acute respiratory failure.
L- effetti ta ’ l- ormon tat- tkabbir fuq l- irkupru kienu studjati f’ żewġ provi klinċi kkontrollati bil- plaċebo li nvolvew 522 pazjent adult li kienu morda b’ mod kritiku minħabba komplikazzjonijiet wara kirurġija open- heart jew kirurġija addominali, korrimenti multipli aċċidentali, jew li kellhom falliment
3 Mortality was higher (41.9% vs.
3 respiratorju akut.
19.3%) among growth hormone treated patients (doses 5.3 - 8 mg/ day) compared to those receiving placebo.
19. 3%) fost il- pazjenti kkurati bl- ormon tat- tkabbir (dożi 5. 3 - 8 mg/ kuljum) meta mqabbla ma ’ dawk li kienu qed jirċievu l- plaċebo.
The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
Is- sikurtà tal- kontinwazzjoni ta ’ kura b’ somatropin f’ pazjenti b’ kondizzjoni kritika akuta fi swali ta ’ kura intensiva minħabba komplikazzjonijiet wara kirurġija open- heart jew kirurġija addominali, korrimenti multipli aċċidentali, jew falliment respiratorju akut li qed jirċievu dożi ta ’ sostituzzjoni għall- indikazzjonijiet approvati ma ġietx stabbilita.
Therefore, the benefit-risk assessment for continuing treatment should be performed carefully.
Għalhekk, studju tal- benefiċċju u r- riskji irid isir b’ attenzjoni sabiex titkompla l- kura.
Patients with growth hormone failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
Pazjenti b’ falliment ta ’ l- ormon tat- tkabbir wara CRI għandhom jiġu nvistati kull tant żmien għall - evidenża ta ’ progressjoni ta ’ ostejodistrofija tal- kliewi.
Slipped capital femoral epiphyses and aseptic necrosis of the femoral head may be seen in children with advanced renal osteodystrophy and in growth hormone deficiency, and it is uncertain whether these problems are affected by GH therapy.
Fit- tfal b’ ostejodistrofija avvanzata tal- kliewi u b’ defiċjenza ta ’ l- ormon tat- tkabbir jista ’ jkun hemm epifisis tar- ras tal- femur mċaqalqa minn posta u nekrożi asettika tar- ras tal- femur, u mhux ċert jekk dawn il- problemi humiex affettwati minn terapija GH.
Physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in patients treated with NutropinAq.
Tobba u ġenituri għandhom ikunu attenti għall- iżvilupp ta ’ mixja mzappa jew ilmenti ta ’ uġigħ fil- ġenbejn jew l- irkoppa f’ pazjenti kkurati b’ NutropinAq.
Scoliosis may progress in any child during rapid growth.
Skoljożi tista ’ tiżviluppa f’ kull tifel jew tifla waqt tkabbir mgħaġġel.
Signs of scoliosis should be monitored during treatment.
Sinjali ta ’ skoljożi għandhom jiġu sorveljati waqt il- kura.
However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis.
Iżda, kura bl- ormon tat- tkabbir ma ntwerietx li żżid l- inċidenza jew is - severità ta ’ l- iskoljożi.
Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance.
Minħabba li somatropin jista ’ jnaqqas is- sensitività għall- insulina, il- pazjenti għandhom jiġu sorvejlati għall- evidenza ta ’ intolleranza għall- glukożju.
For patients with diabetes mellitus, the insulin dose may require adjustment after NutropinAq therapy is instituted.
Għal pazjenti li għandhom dijabete mellitus, id- doża ta ’ insulina jista ’ jinħtieġ li tiġi aġġustata wara li tinbeda t- terapija b’ NutropinAq.
Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
Pazjenti bid- dijabete jew intolleranza għall- glukożju iridu jiġu sorveljati mill- viċin waqt kura b’ somatropin.
Intracranial hypertension with papilloedema, visual changes, headache, nausea and/ or vomiting has been reported in a small number of patients treated with somatropin.
Ipertensjoni fil- kranju b’ papilledema, tibdil fil- vista, uġigħ ta ’ ras, dardir u/ jew remettar ġiet irrappurtata f’ numru żgħir ta ’ pazjenti kkurati b’ somatropin.
Symptoms usually occur within the first eight weeks of the initiation of NutropinAq therapy.
Is- sintomi ġeneralment iseħħu fl- ewwel tmin ġimgħat mill- bidu tal- kura b’ NutropinAq.
In all reported cases, intracranial hypertension-associated signs and symptoms resolved after reduction of the somatropin dose or termination of the therapy.
F’ kull każ irrappurtat, sinjali u sintomi assoċjati ma ’ ipertensjoni fil- kranju għaddew wara tnaqqis tad- doża ta ’ somatropin jew twaqqif tal- kura.
Funduscopic examination is recommended at the initiation and periodically during the course of treatment.
Eżami fundoskopiku huwa rakkomandat fil- bidu u kull tant żmien waqt il- kors ta ’ kura.
Hypothyroidism may develop during treatment with somatropin, and untreated hypothyroidism may prevent optimal response to NutropinAq.
Ipotirojdiżmu jista ’ jiżviluppa waqt kura b’ somatropin, u ipotirojdiżmu mhux ikkurat jista ’ jtellef ir - rispons ottimali għal NutropinAq.
Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.
Għalhekk, kull tant żmien il- pazjenti għandhom jaġħmlu testijiet tal- funzjoni tat- tirojde u meta ndikat għandhom jiġu kkurati bl- ormon tat- tirojde.
Patients with severe hypothyroidism should be treated accordingly prior to the start of NutropinAq therapy.
Pazjenti b’ ipotirojdiżmu sever iridu jiġu kkurati skond il- bżonn qabel ma tinbeda terapija b’ NutropinAq.
Since somatropin therapy following renal transplantation has not been adequately tested, NutropinAq treatment should be terminated after that surgery.
Minħabba li kura b’ somatropin wara trapjant tal- kliewi għada ma ġietx studjata biżżejjed, kura b’ NutropinAq għandha titwaqqaf wara dik il- kirurġija.
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of NutropinAq.
Kura fl- istess ħin bi glukokortikojdi tinibixxi l- effetti li jipromovu t- tkabbir ta ’ NutropinAq.
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Pazjenti b’ defiċjenza ta ’ ACTH għandu jkollhom il- kura ta ’ sostituzzjoni ta ’ glukokorikojdi aġġustata b’ attenzjoni sabiex jiġi evitat kull effett ta ’ inibizzjoni fuq it- tkabbir.
The use of NutropinAq in patients with chronic renal insufficiency receiving glucocorticoid therapy has not been evaluated.
L- użu ta ’ NutropinAq f’ pazjenti b’ insuffiċjenza kronika tal- kliewi li qed jirċievu terapija bi glukokortikoji ma ġiex evalwat.
Limited published data indicate that growth hormone treatment increases cytochrome P450 mediated antipyrine clearance in man.
Tagħrif ippublikat limitat jindika li kura bl- ormon tat- tkabbir iżid it- tneħħija ta ’ antipyrine medjata miċ- ċitokromju P450 fil- bniedem.
Monitoring is advisable when NutropinAq is administered in combination with medicinal products known to be metabolised by CYP450 liver enzymes, such as corticosteroids, sex steroids, anticonvulsants, and cyclosporin.
Sorveljanza hija rrikkmandata meta NutropinAq jingħata flimkien ma ’ prodotti mediċinali li huma magħrufa li jiġu metabolizzati mill- enżimi CYP450 tal- fwied, bħal kortikosterojdi, sterojdi tas- sess, antikonvulsivi u cyclosporin.
For NutropinAq, no clinical data on exposed pregnancies are available.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ NutropinAq waqt it- tqala.
Thus, the risk for humans is unknown.
Għalhekk, ir- riskju għall - bniedem mhux magħruf.
Although animal studies do not point to a potential risk during pregnancy, NutropinAq should be discontinued if pregnancy occurs.
Għalkhemm studji fl- annimali ma jissuġġerux riskju potenzjali waqt it- tqala, NutropinAq għandu jitwaqqaf jekk ikun hemm tqala.
During pregnancy, maternal somatropin will largely be replaced by placental growth hormone.
Waqt it- tqala, somatropin ta ’ l- omm jiġi fil- biċċa l- kbira sostitut mill- ormon tat- tkabbir tal- plaċenta.
It is not known whether somatropin is excreted in human milk, however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
Mhux magħruf jekk somatropin jitneħħix fil- ħalib uman, iżda assorbiment ta ’ proteina sħiħa mill - passaġġ gastro- intestinali tat- tarbija mhux probabbli.
No studies on the effects of NutropinAq on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta ’ NutropinAq fuq il- ħila biex issuq jew tħaddem magni.
Somatropin has no known effect on the ability to drive or to use machines.
Somatropin m’ għandu l- ebda effett mgħaruf fuq il- ħila ta 'sewqan u l- użu ta ’ magni.
Safety data from 9829 patients treated with Nutropin or NutropinAq - derived from a post-marketing surveillance survey in the United States - demonstrate that approximately 2% of patients have been shown to experience drug-related adverse reactions.
Tagħrif dwar is- sikurtà minn 9829 pazjent kkurat b’ Nutropin jew NutropinAq - miġbura minn servej ta ’ sorveljanza wara t- tqegħid fis- suq fl- Istati Uniti - wera li madwar 2% tal- pazjenti kellhom effetti avversi relatati mal- mediċina.
Most of these adverse drug reactions were reported in the “ general disorders and administration site conditions” system organ class.
Ħafna minn dawn l- effetti avversi tal- mediċina kienu rrappurtati fis - sezzjoni “ mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata ” tas- sistema tal- klassifika ta ’ l- organi.
The adverse reactions are listed in the table below, based on experience from clinical trials and a post- marketing surveillance survey.
L- effetti avversi huma mniżżla fit- tabella hawn taħt, ibbażati fuq esperjenza minn provi kliniċi u servej ta ’ sorveljanza wara t- tqegħid fis- suq.
Within the system organ classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000).
Ġewwa kull sistema tal- klassifika ta ’ l- organi, reazzjonijiet avversi huma mniżżla taħt titli ta ’ frekwenza skond il- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000).
5 Neoplasms
5 Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
and Uncommon: neoplasm malignant, neoplasm
Mhux komuni: neoplażmi malinni, neoplażma
unspecified (including cysts and polyps) Blood and lymphatic system disorders Immune system disorders Endocrine disorders Metabolism and nutrition disorders
Mard tad- demm u tas- sistema limfatika Mard tas- sistema immuni Mard fis- sistema endokrinarja Mard marbut mal- metaboliżmu u n - nutrizzjoni
Uncommon: anaemia Common: antibody building Common: hypothyroidism Common: glucose tolerance impaired Uncommon: hypoglycaemia, hyperphosphatemia Rare: diabetes mellitus
Mhux komuni: anemija Komuni: żvilupp ta ’ l- antikorpi Komuni: ipotirojdiżmu Komuni: tnaqqis fit- tolleranza għall- glukożju Mhux komuni: ipogliċemja, ipofosfatemja Rari: dijabete mellitus
Psychiatric disorders Nervous system disorders
Mard psikjatriku Mard tas- sistema nervuża
Uncommon: personality disorder Common: headache, hypertonia Uncommon: somnolence, nystagmus Rare: neuropathy, intracranial pressure increased
Mhux komuni: disturbi fil- personalità Komuni: uġigħ ta ’ ras, ipertonija Mhux komuni: ħedla ta ’ ngħas, nystagmus Rari: newropatija, żieda tal- pressjoni fil- kranju
Eye disorders Ear and labyrinth disorders Cardiac disorders Gastrointestinal disorders
Mard ta ’ l- għajnejn Mard tal- widnejn u tas- sistema labirintika Mard tal- qalb Mard gastro- intestinali
Uncommon: papilloedema, diplopia Uncommon: vertigo Uncommon: tachycardia, hypertension Uncommon: vomiting, abdominal pain, flatulence, nausea Rare: diarrhoea
Mhux komuni: papilledema, diplopija Mhux komuni: vertigo Mhux komuni: takikardja, ipertensjoni Mhux komuni: remettar, uġigħ ta ’ żaqq, gass, dardir Rari: dijarrea
Skin and subcutaneous tissue disorders
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda
Uncommon: lipodystrophy, skin atrophy, dermatitis exfoliative, urticaria, hirsutism, skin hypertrophy
Mhux komuni: lipodistrofija, atrofija tal- ġilda, dermatite bil- qxur, urtikarja, ħirsutiżmu, ipertrofija tal - ġilda
Musculoskeletal and connective tissue Very common in adults, common in children: disorders
Mard muskolu- skeltrali u tal- connective tissue
arthralgia, myalgia Uncommon: muscle atrophy, bone pain, carpal tunnel syndrome
Komuni ħafna fl- adulti, komuni fit- tfal: artralġja, mijalġja Mhux komuni: atrofija tal- muskoli, uġigħ fl- għadam, sindromu carpal tunnel
Renal and urinary disorders
Mard tal- kliewi u tas- sistema urinarja
Uncommon: urinary incontinence, haematuria, polyuria, urine frequency/ pollakiuria, abnormality
Mhux komuni: inkontinenza ta ’ l- awrina, demm fl - awrina, poliurja, żieda fil- frekwenza ta ’ l - awrina/ pollakiuria, urina mhux normali
Reproductive system and breast disorders
Mard tas- sistema riproduttiva u tas- sider Mard ġenerali u kondizzjonijiet ta 'mnejn jingħata
General disorders and administration site Very common in adults, common in children: oedema, conditions
Mhux komuni: nixxija mill- parti ġenitali Komuni ħafna fl- adulti, komuni fit- tfal: edema, edema periferali Komuni: reazzjoni fis- sit ta ’ l- injezzjoni, astenja Mhux komuni: atrofija fis- sit ta ’ l- injezzjoni, fsad fis - sit ta ’ l- injezzjoni, boċċa fis- sit ta ’ l- injezzjoni, ipertrofija
Rare: renal function test abnormal
Rari: test tal- funzjoni tal- kliewi mhux normali