qanastek/EMEA-V3 huggingface dataset:
Outer Wrapper Label on Multipacks Wrapped in Transparent Foil - Including the Blue Box
It- tikketta ta ’ fuq il- kisja ta ’ barra fuq pakketti multipli miksijin filfojl trasparenti - inkluza l- kaxxa ċ- ċelesti
Multipack comprising 2 packs, each containing 5 pre-filled syringes.
Pakkett multiplu li fih 2 pakketti li kull wieħed minnhom fih 5 siringi mimlijin għal- lest.
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA.
EXP
42 JIS:
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Read the package leaflet before use.
Aqra sew il- fuljett kollu qabel ma tibda tuża din il- mediċina
45 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Multipack Carton - Without the Blue Box
Pakkett multiplu – Mingħajr il- kaxxa ċ- ċelesti
5 pre-filled syringes with 0.5 ml
5 siringi mimlijin għal- lest b’ 0. 5 ml
Component of a multipack comprising 2 packs, each containing 5 pre-filled syringes
Parti minm pakkett multiplu li fih 2 pakketti li kull wieħed minnhom fih 5 siringi mimlijin għal- lest.
EXP
46 JIS:
Biograstim 30 MIU/ 0.5 ml
Biograstim 30 MIU/ 0. 5 ml
47 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
5 pre-filled syringes with 0.8 ml
5 siringi mimlijin għal- lest b’ 0. 8 ml
EXP
48 JIS:
Biograstim 48 MIU/ 0.8 ml
Biograstim 48 MIU/ 0. 8 ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Pre-filled syringe
Siringa mimlija għal- lest
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
52 PACKAGE LEAFLET:
52 FULJETT TA ’ TAGĦRIF:
Biograstim 30 MIU/ 0.5 ml solution for injection or infusion Biograstim 48 MIU/ 0.8 ml solution for injection or infusion
Biograstim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni Biograstim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
What Biograstim is and what it is used for 2.
X’ inhu Biograstim u għalxiex jintuża 2.
Before you use Biograstim 3.
Qabel ma tuża Biograstim 3.
How to use Biograstim 4.
Kif għandek tuża Biograstim 4.
How to store Biograstim 6.
Kif taħżen Biograstim 6.
WHAT Biograstim IS AND WHAT IT IS USED FOR
X’ INHU Biograstim U GĦALXIEX JINTUŻA
What Biograstim is Biograstim contains the active substance filgrastim.
X’ inhu Biograstim Biograstim fih is- sostanza attiva filgrastim.
Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli.
Filgrastim huwa proteina magħmul permezz ta ’ proċess bioteknoloġiku ġol- batterju Escherichia coli.
It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Jifforma parti minn grupp ta ’ protejini msejħa ċitokini u jixbaħ ħafna poteina naturali (il- fattur uman li jistimola l- kolonji ta ’ granuloċiti [G- CSF]) li jiġi magħmul f’ ġismek.
Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells.
Filgrastim jistimula l- mudullun (it- tessut li tipproduċi ċelluli tad- demm ġodda) biex jipproduċi iktar ċelluli tad- demm, speċjalment ċerti tipi ta ’ celluli bojod.
White cells are important as they help your body fight infection.
Dawn iċ- ċelluli bojod tad- demm huma importanti għax jgħinu ‘ l ġismek jiġġieled l- infezzjonijiet.
What Biograstim is used for Your doctor has prescribed Biograstim for you to help your body make more white blood cells.
Għalxiex jintuża Biograstim It- tabib tiegħek tak Biograstim biex jgħin il- ġismek jipproduċi aktar ċelluli bojod.
Your doctor will tell you why you are being treated with Biograstim.
It- tabib tiegħek ser jgħidlek il- għaliex qed tingħata kura b’ Biograstim.
Biograstim is useful in several different conditions which are:
Biograstim huwa ta ’ benefiċju f’ ħafna kundizzjonijiet differenti li huma:
- chemotherapy,
- kimoterapija,
- bone marrow transplantation,
- trapjant tal- mudullun,
- severe chronic neutropenia,
- newtropenja qawwija u kronika,
- neutropenia in patients with HIV infection,
- newtropenja f’ pazjenti li huma infettati bl- HIV,
- peripheral blood stem cell mobilisation.
- mobilizzazzjoni taċ’ ċelluli proġenitriċi tad- demm periferali.
BEFORE YOU USE Biograstim
QABEL MA TUŻA Biograstim
Do not use Biograstim
Tużax Biograstim
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Biograstim.
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal filgrastim jew sustanzi oħra ta ’
It could be a consequence of a
- Jekk ikollok sogħla, deni u tbati biex tieħu n- nifs; dawn jistgħu jkunu konsegwenza ta ’ disturb
POSSIBLE SIDE EFFECTS ”).
pulmonarju (ara sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ”).
- if you have sickle cell disease; or
- Jekk għandek il- marda taċ- ċelluli Sickle; jew
- if you get left upper abdominal pain or pain at the tip of your shoulder.
- Jekk ikollok uġigħ addominali fin- naħa ta ’ fuq tax- xellug jew uġigħ fit- tarf ta ’ l- ispalla.
It could be a consequence
Dan
POSSIBLE SIDE EFFECTS ”).
jista ’ jkun konsegwenza ta ’ disturb fil- milza tiegħek (ara sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ”)
53 You will need to have regular blood tests whilst being treated with Biograstim to count the number of neutrophils and other white blood cells in your blood.
Ikollok bżonn tagħmel analiżi tad- demm regolari waqt il- kura b’ Biograstim biex isir magħruf l- għadd ta ’ newtrofili u l- għadd ta ’ celluli bojod oħra ġo demmek.
This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Ir- riżultati minn dawn l- analiżi jgħinu lit- tabib tiegħek jiddetermina kemm qed tkun effettiva l- kura kif ukol jindikaw jekk il- kura għandiex titkompla jew le.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Biograstim has not been tested in pregnant women.
Biograstim ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Huwa importanti li tgħid lit- tabib tiegħek jekk inti tqila, taħseb li tista ’ tkun tqila, jew qed tippjana li toħroġ tqila, għax it- tabib jista ’ jiddeċidi li m’ għandekx tuża dil - mediċina.
It is unknown whether filgrastim passes over to the breast milk.
Mhux magħruf jekk filgrastim jgħaddix għal ġol- ħalib uman.
Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Għalhekk, it- tabib tiegħek jista ’ jiddeċidi li m’ għandekx tuża dil- mediċina jekk qegħda tredda ’ tarbija.
Driving and using machines If you experience fatigue, do not drive or use any tools or machines.
Sewqan u tħaddim ta ’ magni Jekk tħoss l- għeja, issuqx u tħaddimx xi għodda jew magni.
Important information about some of the ingredients of Biograstim This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Biograstim Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek informak illi għandek intolleranza għal xi tipi ta ’ zokkor, tkellem mat- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO USE Biograstim
KIF GĦANDEK TUŻA Biograstim
Always use Biograstim exactly as your doctor has told you.
Dejjem għandek tuża Biograstim skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The amount of Biograstim you need will depend on the condition you are taking Biograstim for and on your bodyweight.
Id- doża li ssoltu tingħata hija … L- ammont ta ’ Biograstim li għandek bżonn ser jiddependi fuq il- kundizzjoni tiegħek, ir- raġuni għaliex trid tieħu Biograstim, u fuq il- piz ta’ ġismek.
Your doctor will tell you when to stop using Biograstim.
It- tabib tiegħek jgħidlek meta għandek tieqaf tieħu Biograstim.
It is quite normal to have a number of courses of Biograstim treatment.
Hija ħaġa normali li jkollok bżonn numru ta ’ korsijiet ta ’ kura b’ Biograstim
Biograstim and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Biograstim u kimoterapija Id- doża li tintuża normali hija 0. 5 miljun international units (MIU) għal kull kilogramm ta ’ piż tal - ġisem, kuljum.
For example, if you weigh 60 kg your daily dose will be 30 million international units (MIU).
Per eżempju, jekk tiżen 60 kg, id- doża tiegħek ta ’ kuljum hi ta ’ 30 miljun international units (MIU).
Your treatment will usually last for about 14 days.
Is- soltu, il- kors tal- kura tiegħek jieħu madwar 14- il ġurnata.
In some disease types however, longer treatment lasting up to about one month may be required.
Madankollu, f’ ċerti każi ta ’ mard, jista ’ jkun hemm bżonn ta ’ kors iktar fit- tul, li jdum sa madwar xahar.
Biograstim and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Biograstim u trapjant tal- mudullun Id- doża tal- bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
For example, if you weigh 60 kg your daily dose will be 60 million international units (MIU).
Per eżempju, jekk tiżen 60 kg, id- doża tiegħek ta ’ kuljum hi ta ’ 60 miljun international units (MIU).
You will normally receive your first dose of Biograstim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Normalment, tirċievi l- ewwel doża tiegħek ta ’ Biograstim mill- inqas 24 siegħa wara l- kimoterapija imma qabel 24 hours li tirċievi t- trasfużjoni tal- mudullun.
Your doctor will test your blood daily to see how well the treatment is working and to find the dose that is best for you.
It- tabib tiegħek ser janaliżża demmek ta ’ kuljum biex jiddetermina kemm qed tkun effettiva l- kura u liema hi l- aħjar doża għalik.
The treatment will be discontinued when white cells in your blood reach a certain number.
Il- kura ser titwaqqaf meta l- għadd ta ’ ċelluli bojod ġo demmek ikun laħaq ċertu livell.
Biograstim and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
54 Id- doża tal- bidu li tintuża normali hija bejn 0. 5 miljun u 1. 2 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum, mogħtija bħala doża waħda jew ħafna.
Your doctor will then test your blood to see how well your treatment is working and to find the dose that is best for you.
Imbagħad it- tabib tiegħek jagħmel analiżi ta ’ demmek biex jiddetermina kemm qed tkun effettiva l- kura u biex jistabilixxi l- aħjar doża għalik.
Long-term treatment with Biograstim is required for neutropenia.
Għat- trattament ta ’ newtropenja, ikun hemm bżonn ta ’ kura b’ Biograstim fit- tul.
54 The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Biograstim u newtropenja f’ pazjenti bl- infezzjoni ta ’ HIV Id- doża tal- bidu li tintuża normali hija bejn 0. 1 u 0. 4 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Your doctor will test your blood at regular intervals to see how well the treatment is working.
It- tabib tiegħek ser jagħmel analiżi ta ’ demmek regolarment sabiex jiddetermina kemm qed tkun effettiva l- kura.
Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day.
La darba n- numru taċ- ċelluli bojod f’ demmek ikunu reġgħu lura għan- normal, il- frekwenza tad- doża tiegħek tkun tista ’ titnaqqas għal inqas minn darba kuljum.
Your doctor will continue to test your blood regularly and will recommend the best dose for you.
It- tabib tiegħek ser jkompli bl- analiżi ta ’ demmek regolari u jirrikmanda l- aħjar doża għalik.
Long term treatment with Biograstim may be required to maintain a normal number of white cells in your blood.
Jista ’ jkun hemm bżonn ta ’ kura b’ Biograstim fit- tul sabiex jinżammu livelli normali ta ’ l- għadd ta ’ ċelluli bojod f’ demmek.
Biograstim and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Biograstim u mobilizzazzjoni ta ’ ċelluli proġenitriċi tad- demm periferali Jekk inti donatur ta ’ PBPC għalik innifsek, id- doża li tintuża komunement hija 0. 5 miljun sa 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Biograstim treatment will last for up to 2 weeks and in exceptional cases longer.
Kura b’ Biograstim ser idum sa ġimgħatejn jew, f’ każijiet eċċezzjonali, anki iktar.
Your doctor will monitor your blood to determine the best time to collect the stem cells.
It- tabib tiegħek ser jimmonitorjalek demmek regolarment sabiex jiddetermina l- aħjar ħin meta għandhom jinġabru iċ- ċelluli proġenitriċi tad- demm periferali.
If you are acting as a stem cell donor for another person, the usual dose is 1 million international units (MIU) per kilogram bodyweight each day.
Jekk inti donatur ta ’ stem cells għal persuna oħra, id- doża li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Biograstim treatment will last for 4 to 5 days.
Kura b’ Biograstim ser jieħu minn 4 sa 5 ijiem.
Method of administration This medicine is given by injection, either through an intravenous infusion (drip) or into the tissue just under the skin.
Metodu ta ’ amministrazzjoni Din il- mediċina tingħata permezz ta ’ injezzjoni, jew b’ infużjoni ġol- vina (drip) jew inkella fit- tessuti eżatt taħt il- ġilda.
This is known as a subcutaneous (SC) injection.
Din hi magħrufa bħala injezzjoni taħt il- ġilda (SC).
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Jekk qed tirċievi din il- mediċina permezz ta ’ injezzjoni taħt il- ġilda, it- tabib tiegħek jista ’ jissuġġerilek li titgħallem kif tagħti l- injezzjonijiet lilek innifsek.
Your doctor or nurse will give you instructions on how to do this.
It- tabib jew infermiera tiegħek ser jagħtik taħriġ fuq kif għandek tagħmel dan.
Do not attempt to self-administer without this training.
Tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt dan it- taħriġ.
Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Tista ’ ssib xi informazzjoni li jkollok bżonn fit- tmiem ta ’ dan il- fuljett ta ’ tagħrif, iżda il- kura korretta tal- marda tiegħek tirrikjedi kollaborazzjoni mill- qrib u kontinwa mat- tabib tiegħek.
Each pre-filled syringe is for single use only.
Kull siringa mimlija għal- lest tintuża darba biss.
If you use more Biograstim than you should If you use more Biograstim than you should, contact your doctor or pharmacist as soon as possible.
Jekk tuża Biograstim aktar milli suppost Jekk tuża Biograstim aktar milli suppost, għandek tgħarraf lit- tabib jew l- ispiżjar tiegħek mill- iktar fis possibbli.
If you forget to use Biograstim Do not use a double dose to make up for a forgotten injection.
Jekk tinsa tuża Biograstim M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Biograstim Before you stop using Biograstim, talk to your doctor.
Jekk tieqaf tuża Biograstim Qabel ma tieqaf tuża Biograstim, tkellem mat- tabib tiegħek.
Like all medicines, Biograstim can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Biograstim jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following frequency conventions are used in the evaluation of side effects:
Il- frekwenza ta ’ l- effetti sekondarji elenkati hawn isfel hija definita skond dawn il- konvenzjonijiet:
Very common:
Komuni ħafna:
more than 1 user in 10 1 to 10 users in 100 1 to 10 users in 1,000 1 to 10 users in 10,000 less than 1 user in 10,000 frequency cannot be estimated from the available data.
talanqas 1 minn kull 10 pazjent f’ 10, 000 anqas minn 1 minn kull 10, 000 pazjent ma tistax tittieħed stima mid- data disponibbli
Allergic-type reactions to filgrastim, including skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing and swelling of the face) have been reported.
Reazzjonijiet ta ’ allerġija għal filgrastim, inklużi raxx tal- ġilda, partijiet tal- ġilda minfuħ li jqabbdu l - ħakk u anafilassi (indeboliment, tbaxxija tal- pressjoni tad- demm, tbatija biex tieħu n- nifs, nefħa fil- wiċċ), ġew irrapportati.
If you think you are having this type of reaction, stop your Biograstim injection and get medical help immediately.
Jekk taħseb li qed ikollok xi reazzjoni minn dawn, waqqaf l- injezzjoni ta ’ Biograstim u fittex għajnuna medika immedjatament.
Some cases of splenic rupture were fatal.
Żjieda fid- daqs tal- milza u każijiet rari ħafna ta 'milza mifqugħha ġew irrapportati Ftit każijiet ta' milza mifqugħha kienu fatali.
55 It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Huwa importanti li tgħarraf lit- tabib tiegħek immedjatament jekk jkollok uġigħ fin- naħa ta 'fuq fix- xellug ta' l- addome jew ikollok uġigħ fl- ispalla xellugija, peress li dan jista 'jkun relatat ma' problema fil- milza tiegħek.
It is also very important that you call your doctor if you think you may have an infection.
Importanti ħafna wkoll li iċċempel lit- tabib tiegħek jekk taħseb li għandek infezzjoni.
There are many ways an infection may show itself.
Hemm ħafna modi kif infezzjoni tista ’ timmanifesta ruha.
You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing.
Oqogħod attent għal temperatura ta ’ 37. 8 °C jew iktar, sirdat u sinjali oħrajn ta ’ infezzjoni bħal raxx, uġigħ fil- grieżem, dijarreja, uġigħ tal- widnejn, diffikulta ’ jew uġigħ biex tieħu nifs jew disturbi bħal sogħla jew tisfir ma- nifs.
If you have a fever or any of these symptoms, contact your doctor immediately and go straight to your hospital.
Sintomi bħal dawn jistgħu jkunu effetti sekondarji severi, bħal pneumonja u sindromu respiratorju fl- adulti, li jista jkun fatali.. Jekk ikollok deni jew xi wieħed minn dawn is- sintomi, għarraf it- tabib tiegħek immedjatament u mur l- isptar minnufih.
If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Biograstim.
Jekk tbati mill- marda ta ’ Sickle Cell, kun żgur li tgħarraf it- tabib tiegħek qabel ma tibda kura b’ Biograstim.
Sickle cell crisis has happened in some patients with Sickle Cell Disease who have been given filgrastim.
Xi każi ta kriżi ta ’ Sickle Cell seħħew meta pazjenti bil- marda ta ’ Sickle Cell ngħataw filgrastim.
As a very common side effect, filgrastim may cause bone and muscle pain.
Effett sekondarju komuni ħafna li filgrastim jista ’ jikkawża huwa l- uġigħ fl- għadam u fil- muskoli.
Ask your doctor which medicine you can take to help with this.
Staqsi lit- tabib tiegħek liema mediċina tista tieħu biex ittaffi dan l- uġigħ.
You may experience the following additional side effects:
Tista 'tesperjenza wkoll l- effetti sekondarji li ġejjin:
- reduction in red blood cells which can make the skin pale and cause weakness or breathlessness,
- tnaqqis fin- numru taċ- ċelluli ħomor li tista ’ ġġiegħelek tidher pallida u tħoss l- għeja jew qtugħ
reduction in blood platelets, which increases risk of bleeding or bruising, rise in white blood cells
ta ’ nifs, tnaqqis fl- għadd tal- plejtlits fid- demm, li jżid il- possibbilita ’ ta ’ tifriġ u tbenġil, żjieda fl- għadd taċ- ċelluli bojod
- elevated levels of some liver or blood enzymes, high blood levels of uric acid, low blood levels
- żjidiet fil- livelli ta ’ xi enżimi tal- fwied u tad- demm, livelli għolja ta ’ uric acid fid- demm, livelli
of glucose
baxxi ta ’ glucose fid- demm
- headache
- uġigħ ta ’ ras
- transient low blood pressure, vascular disorders (which can cause pain, redness and swelling in
- tnaqqis reversibbli fil- pressjoni tad- demm, disturbi vaskulari (li jistgħu jikkawżaw ugigħ, ħmura
the limbs)
u nefħa fid- dirgħajn u riġlejn)
- nosebleed, cough, sore throat
- tinfaraġ, sogħla, uġigħ fil- grieżem
- feeling sick, vomiting, constipation, diarrhoea, loss of appetite, mucositis (painful inflammation
- ħass ħażin, rimettar, stitikezza, dijarjeja, telf ta ’ l- aptit, mukożite (infjammazzjoni, uġigħ u
and ulceration of the mucous membranes lining the digestive tract)
ulċerazjoni fil- mukoża tal- musrana)
- pains or difficulties in passing urine (very rare), blood in the urine, protein in the urine
- uġigħ jew diffikulta biex tgħaddi l- awrina (rari ħafna), demm fl- awrina, protejn fl- awrina
- enlarged liver
- żieda fid- daqs tal- fwied
- inflammation of blood vessels, often with skin rash (very rare); the appearance of plum-
- infjammazzjoni tal- vini, ta ’ spiss akkompanjat b’ raxx (rari ħafna); id- dehra ta ’ leżjonijiet
coloured, raised, painful lesions on the limbs (sometimes the face and neck) with fever (Sweet's syndrome, very rare); hair loss; pain at the site of injection; rash
ibbuzzati, li jweġgħu, kulur aħmar skur fil- vjola fuq ir- riġlejn (xi drabi fil- wiċċ u fl- ghonq) u bid- deni (is- Sindromu ta ’ Sweet, rari ħafna); telf ta ’ xagħar; uġigħ fis- sit ta ’ l- injezzjoni; raxx
- joint pain, chest pain, worsening of rheumatic conditions, loss of calcium from the bones
- uġigħ fl- għadam, uġigħ fis- sider, aggravament ta ’ kundizzjonijiet rewmatiċi, tnaqqis tal- kalċju
- fatigue, generalised weakness, unspecified pain.
- għeja, debbulizza, uġigħ ġenerali.
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 imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Biograstim
KIF TAĦŻEN Biograstim
Do not use Biograstim after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Tużax Biograstim wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq is- siringa mimlija għal- lest wara “ JIS ”.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
Do not use Biograstim if you notice it is cloudy or there are particles in it.
Tużax Biograstim jekk tinnota li s- soluzzjoni mhix ċara jew jekk hemm xi frak fiha.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’ l- ambjent.
FURTHER INFORMATION
AKTAR TAGĦRIF
What Biograstim contains
X’ fih Biograstim:
- The active substance is filgrastim.
- Is- sustanza attiva hija filgrastim.
Each ml of solution for injection or infusion contains
Kull ml ta ’ soluzzjoni għall- injezzjoni jew infużjoni fiha
60 million international units [MIU] (600 µicrogram) of filgrastim.
60 miljun international units [MIU] (600 mikrogrammi) ta ’ filgrastim.
Biograstim 30 MIU/ 0.5 ml:
Biograstim 30 MIU/ 0. 5ml:
Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml solution.
Kull siringa mimlija għal- lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f’ 0. 5 ml soluzzjoni.
Biograstim 48 MIU/ 0.8 ml:
Biograstim 48 MIU:
Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml solution.
Kull siringa mimlija għal- lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f’ 0. 8 ml soluzzjoni
- The other ingredients are:
- Is- sustanzi l- oħra huma:
Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water
Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, ilma
for injections.
għall- injezzjoni.
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Biograstim”.
Tista ’ ssib informazzjoni dettaljata dwar l- ingredjent sorbitol (tip ta ’ zokkor) f’ sezzjoni 2 taħt it - titlu “ Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Biograstim ”.
What Biograstim looks like and contents of the pack Biograstim is a solution for injection or infusion in a pre-filled syringe.
Biograstim huwa soluzzjoni għall- injezzjoni jew infużjoni ġo siringa mimlija għal- lest.
Biograstim is a clear and colourless solution.
Biograstim huwa soluzzjoni ċar u mingħajr kulur.
Each pre-filled syringe contains 0.5 ml or 0.8 ml of solution.
Kull siringa mimlija għal- lest fiha 0. 5 ml jew 0. 8 ml soluzzjoni.
Biograstim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Biograstim jiġi f’ pakketti ta ’ 1, 5 jew 10 siringi mimlijin għal- lest jew f’ pakkett multiplu ta’ 10 (2 pakketti ta ’ 5).
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin Germany info@ct-arzneimittel. de
CT Arzneimittel GmbH Lengeder Straße 42a D- 13407 Berlin Il- Ġermanja info@ ct- arzneimittel. de
Manufacturer Merckle Biotec GmbH Dornierstraße 10 D-89079 Ulm Germany
Merckle Biotec GmbH Dornierstraße 10 D- 89079 Ulm Il- Ġermanja
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
INFORMATION FOR INJECTING YOURSELF
TAGĦRIF DWAR KIF TINJETTA LILEK INNIFSEK
This section contains information on how to give yourself an injection of Biograstim.
Din il- parti tal- fuljett fiha tagħrif dwar kif tagħti injezzjoni ta ’ Biograstim lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Huwa importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt taħriġ speċjali 57 mingħand it- tabib jew infermiera tiegħek.
It is also important that you dispose of the syringe in a puncture-proof container.
Huwa importanti ukoll illi tarmi is- siringi f’ reċipjent li ma jittaqqabx.
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Jekk m’ intix ċert dwar kif għandek tinjetta lilek innifsek jew jekk għandek xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- infermiera tiegħek għall- għajnuna.
How do I inject Biograstim myself?
Kif ninjetta Biograstim lili innifsi?
You will need to give yourself the injection into the tissue just under the skin.
Ikollok bżonn tagħti injezzjoni lilek innifsek eżatt taħt il- ġilda.
This is known as a subcutaneous injection.
Dan jissejjaħ “ injezzjoni taħt il- ġilda ”.
You will need to have your injections at about the same time every day.
Ikollok bżonn tagħti l- injezzjonijiet lilek innifsek kuljum kważi fl- istess ħin.
Equipment that you need To give yourself a subcutaneous injection you will need:
Apparat li teħtieġ Biex tagħti injezzjoni taħt il- ġilda lilek innifsek teħtieġ:
- a pre-filled syringe of Biograstim,
- siringa mimlija għal- lest b’ Biograstim;
- alcohol wipes or similar,
- msielaħ ta ’ l- alkoħol jew simili;
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can
- reċipjent li ma jitaqqabx (reċipjent tal- plastik li jinkiseb min sptar jew spiżerija) sabiex tarmi is -
dispose of used syringes safely.
siringi fis- sigurta ’.
What should I do before I give myself a subcutaneous injection of Biograstim?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Biograstim?
Try to self-inject at approximately the same time every day.
Ipprova innjetta lilek innifsek kuljum kważi fl- istess ħin tal- ġurnata.
Take your Biograstim pre-filled syringe out of the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Biograstim mill- friġġ.
Check the expiry date on the pre-filled syringe label (EXP).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tas- siringa mimlija għal- lest (JIS).
Do not use it if the date has passed the last day of the month shown.
Tużax jekk id- data tkun qabżet l- aħħar ġurnata tax- xahar muri fuq it- tikketta.
Check the appearance of Biograstim.
Iċċekkja d- dehra ta ’ Biograstim.
It must be a clear and colourless liquid.
Din għandha tkun likwidu ċar u mingħajr kulur.
If there are particles in it, you must not use it.
Jekk ikun fiha xi frak, m’ għandekx tużha.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Għal injezzjoni aktar komda, ħalli is- siringa mimlija għal- lest toqgħod għal 30 minuta sabiex tilħaq temperatura ambjentali, jew żomm is- siringa mimlija għal- lest delikatament f’ idejk għal ftit minuti.
Do not warm Biograstim in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Biograstim bl’ ebda mod ieħor (eżempju: issaħħanx fil- forn majkrowejv jew f’ ilma jaħraq).
Do not remove the cover from the syringe until you are ready to inject.
Tneħħix l- għatu mis- siringa sakemm tkun lest/ a biex tinjetta..
Wash your hands thoroughly.
Aħsel idejk sew.
Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
(is- siringa mimlija għal- lest b’ Biograstim, msielaħ ta ’ l- alkoħol u r- reċipjent li ma jitaqqabx).
How do I prepare my Biograstim injection?
Kif nipprepara l- injezzjoni ta ’ Biograstim?
Before you inject Biograstim you must do the following:
Qabel ma tinjetta ratiogratim trid tagħmel dan li ġej:
Hold the syringe barrel and gently take the cover from the needle without twisting.
Żomm it- tubu tas- siringa u aqla ’ bil- mod l- għatu minn mal- labra mingħajr ma tgħawweġ.
Pull straight as shown in pictures 1 and 2.
Iġbed dritt kif muri fi stampi 1 u 2.
Do not touch the needle or push the plunger.
Tmissx il- labra u timbuttax il- planġer.
You may notice a small air bubble in the pre-filled syringe.
Jista 'jkun li tinnota buzzieqa ta' l- arja żgħira ġewwa s- siringa mimlija għal- lest.
If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Jekk ikun hemm xi bżieżaq tal- arja preżenti, taptap is- siringa bil- mod sakemm il- bżieżaq ta ’ l- arja jitilgħu fil- wiċċ ġot- tubu tas- siringa.
With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.
Bil- labra tas- siringa tipponta l- fuq, neħħi l- arja kollu mit- tubu billi timbotta l- planġer il- fuq.
The syringe has a scale on the syringe barrel.
Fuq it- tubu tas- siringa hemm skala.
Push the plunger up to the number (ml) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Imbotta l- planġer san- numru (ml) fuq it- tubu tas- siringa li jikkorispondi mad- doża ta ’ Biograstim preskritta mit- tabib tiegħek.
Check again to make sure the correct dose of Biograstim is in the syringe.
Erġa iċċekkja li hemm id- doża preskritta ta’ Biograstim fis- siringa.
You can now use the pre-filled syringe.
Issa tista 'tuża is- siringa mimlija għal- lest.
Where should I give my injection?
Fejn għandi nagħti l- injezzjoni lili nnifsi?
The most suitable places to inject yourself are:
L- aħjar postijiet fejn tinjetta lilek innifsek huma:
- the top of your thighs; and
- in- naħa ta ’ fuq ta ’ kuxxtejk; u
- the abdomen, except for the area around the navel (see picture 3).
- l- addome, minbarra l- parti ta 'madwar iż- żokkra (ara stampa 3)
4
4 Jekk xi ħadd ieħor qed jinjettak, jista ’ wkoll juża in- naħa ta ’ wara ta ’ idejk (ara stampa 4).
It is better to change the injection site every day to avoid the risk of soreness at any one site.
Tajjeb li kuljum tibdel is- sit fejn tingħata l- injezzjoni sabiex tnaqqas ir- riskju ta ’ uġigħ f’ xi sit partikolari.
How do I give my injection?
Kif nagħti l- injezzjoni lili nnifsi?
2.
Iddisinfetta l- ġilda billi tuża msielaħ ta ’ l- akoħol u oqros il- ġilda bejn sebgħek il- kbir u sebgħek il- werrej, mingħajr ma tagħfas (ara stampa 5) 2.
Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Daħħal il- labra għal kollox fil- ġilda kif urewk l- infermiera jew it- tabib tiegħek (ara stampa 6).
Pull slightly on the plunger to check that a blood vessel has not been punctured.
Iġbed il- planġer tas- siringa kemm kemm sabiex tara li ma ttaqbitx xi vina jew arterja.
If you see blood in the syringe, remove the needle and re-insert it in another place.
Jekk tara d- demm fis- siringa, neħħi l- labra u erġa 'daħħalha f’ post ieħor.
Inject the liquid slowly and evenly, always keeping your skin pinched.
Injetta l- likwidu bil- mod u bl- istess ritmu, filwaqt li dejjem iżżomm il- ġilda maqrusa.
Inject only the dose your doctor has told you.
Injetta biss id- doża preskritta mit- tabib tiegħek.
After injecting the liquid, remove the needle and let go of your skin.
Wara li tinjetta l- likwidu, neħħi l- labra u itlaq il- ġilda.
Only use each syringe for one injection.
Uża kull siringa għal injezzjoni darba waħda.
Do not use any Biograstim that is left in the syringe.
M’ għandekx tuża xi Biograstim li jkun baqa ’ fis- siringa.
Remember If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Ftakar Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna jew parir.
Disposing of used syringes
Rimi ta’ siringi użati
- Do not put the cover back on used needles.
- Terġax tqiegħed il- għatu fuq labar użati.
- Put used syringes into the puncture-proof container and keep this container out of the reach and
- Poġġi l- labar użati ġo reċipjent li ma ’ jittaqqabx u żomm dan ir- reċipjent il bogħod minn fejn
sight of children.
jistgħu jilħquh jew jarawh it- tfal.
- Dispose of the full puncture-proof container as instructed by your doctor, nurse or pharmacist.
- Armi ir- reċipjent mimli skond l- instruzzjonijiet tat- tabib, l- infermeriera jew l- ispiżjar tiegħek.
- Never put the syringes that you have used into your normal household rubbish bin.
- Qatt m’ għandek tarmi siringi użati flimkien ma ’ l- iskart domestiku.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
L- INFORMAZZJONI LI ĠEJJA HIJA MAĦSUBA BISS GĦAT- TOBBA JEW PROFESSJONISTI OĦRA FIL- KURA TAS- SAĦĦA:
Biograstim does not contain any preservative.
Biograstim ma fihx l- ebda preservattiv.
In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni bil- mikrobi, is- siringi ta ’ Biograstim iridu jintużaw darba biss.
Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Biograstim.
Biograstim should not be diluted with sodium chloride solution.
Biograstim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija hawn taħt.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Filgrastim dilwit jista ’ jiġi adsorbit fuq il- ħġieġ jew ħwejjeġ tal- plastik ħlief meta jiġi dilwit kif imsemmi hawn taħt.
If required, Biograstim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm bżonn, Biograstim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time.
Huwa rakkomandat li d- dilwit fl- ebda ħin ma jwassal għal konċentrazzjoni finali inqas minn 0. 2 MIU (2 μg) / ml.
Only clear solutions without particles should be used.
Is- soluzzjoni għanha tintuża biss jekk tkun ċara u mingħajr frak.
For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μ g) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ ml.
Fejn pazjenti jirċievu soluzzjoni ta ’ filgrastim dilwita sa konċentrazzjoni inqas minn 1. 5 MIU (15 μg) / ml, din trid tiġi miżjuda bl- albumina tas- serum umana (HSA) sabiex il- konċentrazzjoni finali tkun 2 mg/ ml.
In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μ g) should be given with 0.2 ml of 200 mg/ ml (20%) human albumin solution added.
Meta l- volum finali ta ’ l- injezzjoni huwa 20 ml, id- dożi kollha ta ’ filgrastim li fihom inqas minn 30 MIU (300 μg) iridu jingħataw b’ 0. 2 ml soluzzjoni ta ’ 20% albumina umana miżjuda.
60
60 Wara d- dilwit:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT PUBBLIKU EWROPEW TA ’ VALUTAZZJONI (EPAR)
BONDENZA (previously known as Ibandronic Acid Roche)
BONDENZA (li qabel kien magħruf bħala Ibandronic Acid Roche)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta ’ Valutazzjoni (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, aqra d - Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Bondenza?
X' inhu Bondenza?
Bondenza is medicine that contains the active substance ibandronic acid.
Bondenza huwa mediċina li fiha s- sustanza attiva aċidu ibandroniku (ibandronic acid).
It is available as white, oblong tablets (150 mg) and as a solution for injection (3 mg).
Jiġi bħala pilloli oblongi bojod (150 mg) u bħala soluzzjoni għall- injezzjoni (3 mg).
What is Bondenza used for?
Għal xiex jintuża Bondenza?
Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Bondenza jintuża fit- trattament tal- osteoporożi (marda li ddgħajjef l- għadam) fin- nisa li jkunu għaddew mill- menopawża u li hemm ir- riskju li jkollhom ksur fl- għadam.
Its effect in reducing the risk of vertebral (spine) fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
L- effett tiegħu fit- tnaqqis tar- riskju ta ’ ksur vertebrali (tas- sinsla tad- dahar) intwera fi studji, iżda l- effett tiegħu fuq ir- riskju ta ’ ksur fl- għonq tal- wirk (il- parti ta ’ fuq tal- għadam tal- koxxa) kien għadu ma ġiex stabbilit.
How is Bondenza used?
Kif jintuża Bondenza?
Bondenza can be given either by mouth as a tablet or as an injection into a vein.
Bondenza jista ’ jingħata jew mill- ħalq bħala pillola jew bħala injezzjoni f’ vina.
If the tablet is used, the dose is one tablet every month.
Jekk tintuża il- pillola, id- doża hija ta ’ pillola waħda fix- xahar.
The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water.
Il- pillola dejjem għandha tittieħed wara sawma ta ’ lejl sħiħ, siegħa qabel l- ikel jew ix- xorb, ħlief l- ilma, u ma ’ tazza mimlija ilma naturali.
The patient must not lie down for one hour after taking the tablet.
Il- pazjent m’ għandux jimtedd sa siegħa wara li jieħu l- pillola.
The dose by injection is 3 mg once every three months.
Id- doża f’ injezzjoni hija ta ’ 3 mg darba kull tliet xhur.
Patients taking Bondenza should also take vitamin D and calcium supplements if they do not get enough from their diet.
Il- pazjenti li jieħdu Bondenza għandhom jieħdu wkoll supplimenti ta 'kalċju u ta' vitamina D jekk ma jkunux qegħdin jieħdu biżżejjed mid- dieta tagħhom.
Bondenza is not recommended for patients who have severe kidney problems.
Bondenza mhuwiex irrakkomandat għal pazjenti bi problemi severi fil- kliewi.
How does Bondenza work?
Kif jaħdem Bondenza?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta l- għadam ġdid ma jiġġenerax ruħu biżżejjed biex jissostitwixxi l- għadam li jitfarrak b’ mod naturali.
Gradually, the bones become thin and fragile, and more likely to break.
Bil- mod l- għadam jinsilet u jsir aktar fraġli, u għalhekk ikun aktar faċli li jinkiser.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Fin- nisa, l- osteoporożi hija aktar komuni wara l- menopawża, meta jaqgħu l- livelli tal- ormon tan- nisa, l- estroġenu.
The active substance in Bondenza, ibandronic acid, is a bisphosphonate.
Is- sustanza attiva f’ Bondenza, aċidu ibandroniku huwa bisfosfonat.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Huwa jwaqqaf l- azzjoni tal- osteoklasti, iċ- ċelluli involuti fit- tfarrik tat- tessut tal- għadam.
This leads to less bone loss.
Dan iwassal għal inqas telf ta ’ għadam.
How has Bondenza been studied?
Kif ġie studjat Bondenza?
Bondenza was studied in three main studies involving women with osteoporosis.
Bondenza ġie studjat fi tliet studji ewlenin li kienu jinvolvu nisa bl- osteoporożi.
The first study compared Bondenza 2.5 mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
L- ewwel studju qabbel pilloli ta ’ Bondenza 2. 5 mg, li ttieħdu darba kuljum, ma ’ plaċebo (trattament finta) fi kważi
The other two studies compared the 150 mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5 mg once-daily tablets.
Iż- żewġ studji l- oħra qabblu l- pilloli ta ’ 150 mg li jittieħdu darba fix- xahar (1, 609 pazjenti) u l - injezzjonijiet (1, 395 pazjent) ma ’ pilloli ta ’ 2. 5 mg li jittieħdu kuljum.
The studies looked at the change in the density of the bones in the spine and the hip over two years.
L- istudji eżaminaw il- bidla fid - densità tal- għadam fis- sinsla tad- dahar u l- ġenbejn fuq tul ta ’ żmien ta ’ sentejn.
Note that the 2.5 mg once-daily tablets used in the studies are no longer authorised.
Għandu jitqies li l- pilloli ta ’ 2. 5 mg li jittieħdu kuljum użati fl- istudji m’ għadhomx awtorizzati.
What benefit has Bondenza shown during the studies?
Liema benefiċċju wera Bondenza waqt l- istudji mwettqa?
In the first study, daily treatment with Bondenza 2.5 mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Fl- ewwel studju, it- trattament kuljum b’ pilloli ta ’ Bondenza 2. 5 mg naqqas ir- riskju ta ’ ksur ġdid fis - sinsla tad- dahar b’ 62% meta mqabbel mal- plaċebo.
The other two studies showed that the 150 mg monthly tablets and the injections were more effective than the 2.5 mg once-daily tablets at increasing bone density in the spine and the hip.
Iż- żewġ studji l- oħra wrew li l- pilloli 150 mg ta ’ darba fix- xahar u l- injezzjonijiet kienu iktar effikaċi mill- pilloli 2. 5 mg ta ’ kuljum fiż- żieda tad- densità tal- għadam fis- sinsla tad- dahar u l- ġenbejn.
Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Matul sentejn, id- densità tal- għadam fis- sinsla tad- dahar żdiedet b’ 7% bil- pilloli ta ’ kull xahar u b’ 6% bl - injezzjonijiet, meta mqabbla ma ’ 5% bil- pilloli ta ’ kuljum.
In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Fil- ġenbejn, id- densità tal- għadam żdiedet b’ 4% bil- pilloli ta ’ kull xahar u b’ 3% bl- injezzjonijiet, meta mqabbla ma ’ 2% bil- pilloli ta ’ kuljum.
What is the risk associated with Bondenza?
X’ inhu r- riskju assoċjat ma ’ Bondenza?
The most common side effects with Bondenza tablets (seen in between 1 and 10 patients in 100) are gastritis (inflammation of the stomach), diarrhoea, abdominal pain (stomach ache), dyspepsia (indigestion), nausea (feeling sick), influenza-like illness, fatigue (tiredness), musculoskeletal pain (pain in the muscles and bones), arthralgia (joint pain), myalgia (muscle pain) and musculoskeletal stiffness.
L- effetti sekondarji l- iktar komuni bil- pilloli Bondenza (li dehru f’ bejn pazjent wieħed sa għaxra minn kull 100) huma gastrite (infjammazzjoni tal- istonku), dijarrea, uġigħ addominali (uġigħ fl- istonku), dispepsija (indiġestjoni), nawżea (dardir), mard li jixbah l- influwenza, għeja, uġigħ muskoluskeletriku (uġigħ fil- muskoli u l- għadam), artralġija (uġigħ fil- ġogi), mijalġija (uġigħ fil- muskoli) u ebusija mukoluskeletriku.
With the injection, constipation, headache and back pain are also seen in between 1 and 10 patients in 100.
Bl- injezzjoni, jidhru wkoll stitikezza, uġigħ ta ’ ras u fid- dahar f’ bejn pazjent wieħed sa 10 pazjenti minn kull 100.
For the full list of all side effects reported with Bondenza, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Bondenza, ara l- Fuljett ta ’ Tagħrif.
Bondenza should not be used in people who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
Bondenza m’ għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għall- aċidu ibandroniku jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have hypocalcaemia (low blood calcium levels).
M’ għandux jintuża f’ pazjenti li jbatu minn ipokalċemija (livelli baxxi ta ’ kalċju fid- demm).
Bondenza treatment may be linked to osteonecrosis of the jaw (collapse of bone tissue in the jaw).
It- trattament b’ Bondenza jista ’ jkun marbut mal- osteonekrożi tax- xedaq (meta jaqa t- tessut tal- għadam fix- xedaq).
Care is needed in patients who receive the medicine and are having dental treatment.
Hija meħtieġa attenzjoni għal pazjenti li jingħataw il- mediċina u li jkunu għaddejjin minn trattament dentali.
Why has Bondenza been approved?
Għaliex ġie approvat Bondenza?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bondenza’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Bondenza għandu aktar benefiċċji milli riskji għat- trattament ta 'l- osteoporożi f' nisa wara l- menopawża f' riskju miżjud ta' ksur.
The Committee recommended that Bondenza be given marketing authorisation.
Il- Kumitat irrakkomanda li Bondenza jingħata awtorizzazzjoni għat- tqegħid fis- suq.