qanastek/EMEA-V3 huggingface dataset:
Antibody-mediated PRCA has been very rarely reported in patients after months to years of subcutaneous (injection under the skin) erythropoietin treatment.
PRCA medjata mill- antikorpi kienet irrappurtata b’ mod rari ħafna fil- pazjenti wara perjodu ta ’ minn xhur għal snin ta ’ kura minn taħt il- ġilda (injezzjoni taħt il- ġilda) bl- eritropoetin.
Your doctor can decide whether Abseamed is not working properly for you.
It- tabib tiegħek jista ’ jiddeċiedi jekk Abseamed hux qiegħed jaħdem sewwa għalik.
If you develop PRCA your Abseamed therapy will be discontinued and your doctor will decide how best to treat your anaemia.
Jekk tiżviluppa PRCA, it- terapija tiegħek b’ Abseamed ser titwaqqaf u t- tabib tiegħek ser jiddeċiedi kif l - aħjar li tiġi kkurata l- anemija tiegħek.
There is not much experience with subcutaneous use (injection into the skin) of Abseamed in kidney patients.
M’ hemmx wisq esperjenza bl- użu minn taħt il- ġilda (injezzjoni ġol- ġilda) ta ’ Abseamed f’ pazjenti b’ mard tal- kliewi.
Therefore, if you are being treated for anaemia associated with kidney disease, Abseamed has to be given by injection into a vein (intravenously).
Għalhekk, jekk inti qed tkun ikkurat/ a għal anemija assoċjata ma ’ mard tal- kliewi, Abseamed għandu jingħata permezz ta ’ injezzjoni ġo vina.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly
It- tabib tiegħek ser jiċċekkja l- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek b’ mod regolari
- to ensure that your haemoglobin does not exceed a certain level as high haemoglobin could put
- biex jiżgura li l- emoglobina tiegħek ma taqbiżx ċertu livell, għax livell għoli ta ’ emoglobina
you at risk of having a problem of the heart or the blood vessels and could increase risk of death
jista ’ jpoġġik f’ riskju li jkollok xi problema tal- qalb jew tal- vini jew arterji, u jista ’ jżid ir- riskju li tmut
- to minimise the risk of an increase in blood pressure.
- biex jitnaqqas ir- riskju ta ’ żieda fil- pressjoni tad- demm.
If an elevated or increasing serum potassium level is detected, your doctor may consider to discontinue the treatment with Abseamed until the potassium level has returned to the normal range.
Jekk jiġi osservat livell ta ’ potassju fis- serum għoli jew qiegħed jogħla, it- tabib tiegħek jista ’ jikkunsidra li jwaqqaf il- kura b’ Abseamed sakemm il - livell tal- potassju jkun reġa ’ lura għall- medda normali.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Abseamed.
Żieda fid- doża ta ’ mediċina partikulari li traqqaq id- demm (heparin) waqt l- emodijalisi ta ’ sikwit tkun meħtieġa matul il- kors tat- terapija b’ Abseamed.
Based on information available to date, treatment of anaemia with Abseamed in adult patients with chronic kidney failure (renal insufficiency) who do not yet require dialysis, does not accelerate the rate of progression of renal insufficiency.
Fuq il- bażi ta ’ l- informazzjoni disponibbli sa issa, il- kura ta ’ l- anemija b’ Abseamed f’ pazjenti adulti b’ insuffiċjenza tal- kliewi kronika (insuffiċjenza renali) li jkun għad m’ għandhomx bżonn dijalisi, ma żżidx ir- rata tal- progressjoni ta ’ l- insuffiċjenza renali.
The 2-3 week delay between epoetin alfa administration and the appearance of desired effects should be taken into account when assessing the efficacy of Abseamed.
Id- dewmien ta ’ 2- 3 ġimgħat bejn l- għoti ta ’ epoetin alfa u d- dehra ta ’ l- effetti mixtieqa għandu jiġi kkunsidrat meta tkun evalwata l- effikaċja ta ’ Abseamed.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly and adjust your dose of Abseamed accordingly to minimise the risk of blood clotting (thrombotic events).
It- tabib tiegħek ser jiċċekkja l- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek b’ mod regolari u jaġġusta d- doża tiegħek ta ’ Abseamed kif meħtieġ sabiex inaqqas ir- riskju ta ’ tagħqid tad - demm (episodji trombotiċi).
If you are a cancer patient you should be aware that Abseamed may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Jekk inti pazjent marid bil- kanċer, għandek tkun taf li Abseamed jista ’ jaġixxi bħala fattur tat- tkabbir taċ- ċelluli tad- demm u f’ xi ċirkustanzi jista ’ jkollu impatt negattiv fuq il- kanċer tiegħek.
If you are due to have major orthopaedic surgery, the cause of anaemia should be established and treated, if possible, before the start of Abseamed treatment.
Jekk wasalt biex tagħmel operazzjoni ortopedika maġġuri, il- kawża ta ’ l- anemija għandha tiġi stabbilita u kkurata, jekk jista ’ jkun, qabel il- bidu tal- kura b’ Abseamed.
Blood clots (thrombotic events) can be a
L- emboli (episodji trombotiċi) jistgħu jkunu ta ’ riskju.
Your doctor will weight this risk carefully against the benefits to be derived from treatment with epoetin alfa.
It- tabib tiegħek ser jevalwa sewwa dan ir- riskju kontra l- benefiċċji li jistgħu jinkisbu minn kura b’ epoetin alfa.
If your levels of the red blood pigment (haemoglobin) are too high you should not receive Abseamed, since you have an increased risk of blood clotting after the surgery.
Inti m’ għandekx tingħata Abseamed jekk il- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek ikunu għoljin iżżejjed, billi ser ikollok riskju akbar ta ’ tagħqid tad- demm wara l- operazzjoni.
If you are taking cyclosporin (medicine to suppress your immune system) during therapy with Abseamed, your doctor may order special blood tests to measure cyclosporin levels.
Jekk qiegħed tieħu cyclosporin (mediċina biex trażżan is- sistema immuni tiegħek) matul it- terapija b’ Abseamed, it- tabib tiegħek jista ’ jordna testijiet speċjali tad- demm biex ikejjel il- livelli ta ’ cyclosporin.
There is not much experience with Abseamed in pregnant women or women who are breast-feeding.
Hemm esperjenza limitata b’ Abseamed f’ nisa tqal jew f’ nisa li qegħdin ireddgħu.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat - tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Important information about some of the ingredients of Abseamed
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Abseamed
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”
Dan il- prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f’ kull doża, jiġifieri essenzjalment “ ħieles mis- sodium.
HOW TO USE ABSEAMED
KIF GĦANDEK TUŻA ABSEAMED
Your doctor will conduct investigations, for example blood tests, to decide if it is necessary for you to have Abseamed.
It- tabib tiegħek ser jagħmel investigazzjonijiet, pereżempju testijiet tad- demm, biex jiddeċiedi jekk hux neċessarju għalik li tieħu Abseamed.
He/ she will work out the correct dose of Abseamed for you to use and how long the treatment should continue.
Huwa/ hija ser jaħdimlek id- doża korretta li għandek tieħu ta ’ Abseamed u kemm għandha ddum il- kura.
The Abseamed pre-filled syringe is ready for use.
201 Is- siringa mimlija għal- lest ta ’ Abseamed hija lesta biex tintuża.
Abseamed is a sterile but unpreserved product and is for single use only.
Abseamed huwa prodott sterili iżda mhux ippreservat u jista ’ jintuża darba biss.
Abseamed should not be shaken.
Abseamed m’ għandux jitħawwad.
At the start of your therapy, Abseamed may be injected under the supervision of experienced medical staff.
Fil- bidu tat- terapija tiegħek, Abseamed jista ’ jkun injettat taħt is- superviżjoni ta ’ staff mediku b’ esperjenza.
Abseamed is given by injection into a vein (intravenously).
Abseamed jingħata bħala injezzjoni ġo vina.
Do not give by injection under the skin (subcutaneously).
Tinjettax taħt il- ġilda( injezzjoni taħt il- ġilda).
Abseamed is given by injection under the skin (subcutaneously).
Abseamed għandu jingħata b’ injezzjoni taħt il- ġilda (injezzjoni taħt il- ġilda).
When your condition has been brought under control, you will receive regular doses of Abseamed.
Meta l- kundizzjoni tiegħek tinġieb taħt kontroll, inti għandek tirċievi dożi regolari ta ’ Abseamed.
Depending on how your anaemia responds, the dose may be adjusted until your condition is controlled.
Skond kif tirrispondi l- anemija tiegħek, id- doża tista ’ tiġi aġġustata sakemm il- kundizzjoni tiegħek tkun ikkontrollata u li l - emoglobina tiegħek ma taqbiżx ċertu livell.
Your doctor may order regular blood tests to see that this is being achieved and to ensure that your medicine is continuing to work properly and your haemoglobin does not exceed a certain level.
It- tabib tiegħek jista ’ jordna testijiet regolari tad- demm biex jara li dan qiegħed jintlaħaq u biex jiżgura li l- mediċina qed tkompli taħdem tajjeb.
When your condition has been brought under control, you will receive regular doses of Abseamed between 25 and 50 IU/ kg twice a week in two equal injections.
Meta l - kundizzjoni tiegħek tinġieb taħt kontroll, inti għandek tirċievi dożi regolari ta ’ Abseamed bejn 25 u 50 IU/ kg darbtejn fil- ġimgħa f’ żewġ injezzjonijiet ugwali.
After your condition has been brought under control, you will receive regular doses of Abseamed between 17 and 33 IU/ kg, three times a week.
Meta l- kundizzjoni tiegħek tkun ġiet ikkontrollata, inti ser tirċievi dożi regolari ta ’ Abseamed bejn 17 u 33 IU/ kg, tliet darbiet fil- ġimgħa.
Alternatively, Abseamed can be administered as an initial dose of 450 IU/ kg once a week by injection under the skin.
Inkella, Abseamed jista ’ jingħata bħala doża inizjali ta ’ 450 IU/ kg darba fil- ġimgħa b’ injezzjoni taħt il- ġilda.
Treatment with Abseamed should be continued until one month after the end of chemotherapy.
Il- kura b’ Abseamed għandha titkompla sa xahar wara t- tmiem tal- kimoterapija.
You will receive Abseamed during the 3 weeks before your surgery.
Inti ser tirċievi Abseamed matul it- 3 ġimgħat qabel l- operazzjoni tiegħek.
You will also take iron supplements before and during Abseamed treatment to increase the effectiveness of Abseamed.
Ser tieħu wkoll supplimenti tal- ħadid qabel u matul il- kura b’ Abseamed biex iżżid l- effettività ta ’ Abseamed.
It is important that levels of iron in your blood are normal throughout Abseamed treatment.
Huwa importanti li l- livelli ta ’ ferritin fid- demm tiegħek ikunu normali matul il- kors tal- kura b’ Abseamed.
Where appropriate you will receive oral doses of iron, ideally starting before the Abseamed treatment begins.
Meta jkun xieraq, inti ser tirċievi dożi orali ta ’ ħadid, li idealment jibdew qabel tibda l - kura b’ Abseamed.
Instructions for injecting Abseamed under the skin
Struzzjonijiet biex tinjetta Abseamed taħt il- ġilda
If you are a kidney patient Abseamed has to be given by injection into a vein.
Jekk inti pazjent/ a li tbati b’ mard tal- kliewi, Abseamed irid jingħata permezz ta ’ injezzjoni ġo vina.
At the start of your therapy, Abseamed may be injected by medical staff.
Fil- bidu tat- terapija tiegħek, Abseamed jista ’ jkun injettat minn staff mediku.
However, your doctor may decide that it is right for you to learn how to inject Abseamed under the skin yourself.
Madankollu, it- tabib tiegħek jista ’ jiddeċiedi li jkun tajjeb għalik li titgħallem kif tinjetta Abseamed taħt il- ġilda inti stess.
Inject the Abseamed solution.
Injetta s- soluzzjoni ta ’ Abseamed.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Iġbed il- labra malajr u applika pressjoni fuq is- sit ta ’ l- injezzjoni b’ garża xotta u sterili.
If you inject more Abseamed than you should
Jekk tinjetta aktar Abseamed milli suppost
You should inform the doctor immediately if you think too much Abseamed has been injected.
Inti għandek tinforma immedjatament lit- tabib tiegħek jekk taħseb li ġie injettat iżżejjed Abseamed.
If you forget to use Abseamed
Jekk tinsa tuża Abseamed
Like all medicines, Abseamed can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Abseamed jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
- Pure red cell aplasia (PRCA) has been very rarely reported in patients after months to years of
- Aplasja taċ- ċelluli l- ħomor tad- demm pura kienet irrappurtata b’ mod rari ħafna f’ pazjenti wara
subcutaneous (injection under the skin) erythropoietin treatment.
perjodu ta ’ minn xhur sa snin ta ’ kura mogħtija minn taħt il- ġilda (injezzjoni taħt il- ġilda) bl - eritropoetins.
PRCA means the inability to produce enough red blood cells in the bone (see section “ Take special care with Abseamed”).
PRCA tfisser in- nuqqas ta ’ kapaċità li l- ġisem tiegħek jipproduċi biżżejjed ċelluli l- ħomor tad- demm fl- għadam (ara s- sezzjoni “ Oqgħod attent ħafna b’ Abseamed ”).
Your doctor may monitor your blood pressure regularly while you are using Abseamed, particularly at the start of therapy.
It- tabib tiegħek jista ’ jimmonitorja l- pressjoni tad- demm tiegħek b’ mod regolari waqt li tkun qiegħed/ qiegħda tuża Abseamed, b’ mod partikulari fil- bidu tat- terapija.
- Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if
- Okklużjoni fejn arterja tikkonnettja mal- vina (trombożi fix- xant) tista ’ sseħħ speċjalment jekk
- blood clotting (thrombotic vascular events) (see section “ Take special care with Abseamed”).
- tagħqid tad- demm (episodji trombotiċi vaskulari) (ara s- sezzjoni “ Oqgħod attent ħafna
with underlying cardiovascular disease: after donating blood repeatedly vascular and thrombotic events (blood clotting) can occur independently of treatment with Abseamed.
b’ mard kardjovaskulari diġà eżistenti; wara li jagħtu d- demm ripetutament, avvenimenti vaskulari u trombotiċi (emboli tad- demm) jistgħu jseħħu indipendentement mill- kura b’ Abseamed.
Treatment with Abseamed may be associated with an increased risk of blood clotting after the surgery (postoperative thrombotic/ vascular disorders) if your levels of the red blood pigment are too high.
Il- kura b’ Abseamed tista ’ tkun assoċjata ma ’ riskju akbar ta ’ tagħqid tad- demm wara l- operazzjoni (disturbi trombotiċi/ vaskulari wara l- operazzjoni) jekk il- livelli tal- pigment aħmar fid- demm tiegħek ikunu għoljin iżżejjed.
HOW TO STORE ABSEAMED
KIF TAĦŻEN ABSEAMED
- You may take Abseamed out of the refrigerator and keep it at room temperature (up to 25°C) for
- Tista ’ toħroġ Abseamed mill- friġġ u żżommu f’ temperatura tal- kamra (sa 25°C) għal mhux
no longer than 3 days.
aktar minn 3 ijiem.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Ġaladarba s- siringa tkun tneħħiet mill- friġġ u laħqet it- temperatura tal - kamra (sa 25°C) din trid tintuża fi żmien 3 ijiem jew tintrema.
What Abseamed contains
X’ fih Abseamed
195 What Abseamed looks like and contents of the pack
Id- Dehra ta ’ Abseamed u l- kontenuti tal- pakkett
Abseamed is presented as a clear, colourless solution for injection in a pre-filled syringe.
Abseamed hu ppreżentat bħala soluzzjoni għall- injezzjoni ċara u bla kulur f’ siringa mimlija għal- lest.
Abseamed 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (1000 IU) of solution.
Abseamed 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (1000 IU) ta ’ soluzzjoni.
Abseamed 2000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (2000 IU) of solution.
Abseamed 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (2000 IU) ta ’ soluzzjoni.
Abseamed 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe The syringes contain 0.3 ml (3000 IU) of solution.
Abseamed 3000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 3 ml (3000 IU) ta ’ soluzzjoni.
Abseamed 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe The syringes contain 0.4 ml (4000 IU) of solution.
Abseamed 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 4 ml (4000 IU) ta ’ soluzzjoni.
Abseamed 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (5000 IU) of solution.
Abseamed 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (5000 IU) ta ’ soluzzjoni.
Abseamed 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe The syringes contain 0.6 ml (6000 IU) of solution.
Abseamed 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 6 ml (6000 IU) ta ’ soluzzjoni.
Abseamed 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe The syringes contain 0.7 ml (7000 IU) of solution.
Abseamed 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 7 ml (7000 IU) ta ’ soluzzjoni.
Abseamed 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe The syringes contain 0.8 ml (8000 IU) of solution.
Abseamed 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 8 ml (8000 IU) ta ’ soluzzjoni.
Abseamed 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe The syringes contain 0.9 ml (9000 IU) of solution.
Abseamed 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 9 ml (9000 IU) ta ’ soluzzjoni.
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (10 000 IU) of solution.
Abseamed 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (10, 000 IU) ta ’ soluzzjoni.
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn Germany
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D- 58638 Iserlohn Il- Ġermanja
Κύπρος Medice Arzneimittel GmbH & Co.
207 Κύπρος Medice Arzneimittel GmbH & Co.
197 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
EPAR summary for the public
Sommarju ta ’ l- EPAR għall- pubbliku
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.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Aclasta?
X’ inhu Alcasta?
Aclasta is a solution for infusion (drip into a vein) containing the active substance zoledronic acid (5 mg/ 100 ml).
Aclasta hu soluzzjoni għall- infużjoni (dripp fil- vina) li fih is- sustanza attiva zoledronic acid (5 mg/ 100 ml).
What is Aclasta used for?
Għal xiex jintuża Alcasta?
Aclasta is used for the treatment of the following diseases: • osteoporosis (a disease that makes bones fragile), both in women who have been through the menopause and in men.
Aclasta jintuża għat- trattament ta ’ dawn il- mardiet: • osteoporożi (marda li tagħmel l- għadam fraġli) kemm f’ nisa li jkunu għaddew mill- menopawża u kemm fl- irġiel.
It is used in patients who are at risk of fracture (bone breaks), including patients who have recently broken their hip in a minor trauma, such as a fall; • Paget’ s disease of the bone, a disease where the normal process of bone growth is changed.
Dan jituża f’ pazjenti li jkunu f’ riskju ta ’ ksur (tal- għadam), inklużi pazjenti li riċentement ikunu kisru xi għadma tal- ġenbejn fi trawma minuri bħal waqgħa; • Il- marda ta ’ Paget fl- għadam, marda fejn jinbidel il- proċess normali li bih jikbru l- għadam.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib.
How is Aclasta used?
Kif jintuża Alcasta?
Aclasta is given as a 100 ml infusion, lasting at least 15 minutes.
Aclasta jingħata bħala infużjoni ta ’ 100 ml, li ddum ta ’ l- anqas 15- il minuta.
This can be repeated once a year in patients being treated for osteoporosis.
Din tista ’ tiġi ripetuta darba f’ sena f’ pazjenti li jkunu qed jiġu ttrattati għall- osteoporożi.
Patients who have broken their hip should receive Aclasta at least two weeks after the operation to repair the fracture.
Pazjenti li jkunu kisru xi għadma tal- ġenbejn għandhom jieħdu Alacasta minn ta ’ l- inqas ġimgħatejn wara l- operazzjoni sabiex ifejqu l - ksur.
For Paget’ s disease, only one infusion of Aclasta is given.
Għall- marda ta ’ Paget, tingħata biss infużjoni waħda ta ’ Aclasta.
The effect of the infusion lasts for a year or more.
L- effett ta ’ l- infużjoni idum sa sena jew iktar.
Patients must have adequate fluids before and after treatment.
Il- pazjenti jrid ikolhom fluwidi adegwati qabel u wara t- trattament.
Adequate supplements of vitamin D and calcium are also recommended for all patients receiving Aclasta.
Hu rakkomandat li jingħataw ukoll supplimenti tal- vitamina D u tal- kalċju għal pazjenti kollha li jkunu qed jieħdu Aclasta.
In addition, patients with Paget’ s disease should take at least 500 mg calcium twice a day for at least 10 days following treatment, and patients who have broken their hip should receive a large dose of vitamin D (50,000 to 125,000 international units) by mouth or by injection into a muscle before their first infusion.
Barra minn hekk, pazjenti bil- marda ta ’ Paget għandhom jieħdu minn ta ’ l- anqas 500 mg kalċju darbtejn kuljum għal ta ’ l- anqas għaxart ijiem wara t- trattament u l- pazjenti li jkunu kisru xi għadma tal- ġenbejn għandhom jieħdu doża kbira ta ’ vitamina D (50, 000 sa 125 000 unitajiet internazzjonali) jew bil- ħalq jew b’ injezzjoni f’ muskolu qabel l- ewwel infużjoni tagħhom.
Using paracetamol or ibuprofen (anti-inflammation medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, flu-like symptoms, joint pain and headache in the three days following the infusion.
L- użu ta ’ paracetamol jew ibuprofen (mediċini anti- infjammatorji) ftit wara Aclasta jista ’ jnaqqas is- sintomi bħad- deni, uġigħ fil- muskolu, sintomi bħal ta ’ l- influwenza u uġigħ ta ’ ras fit- tlett ijiem wara l- infużjoni.
Aclasta is not recommended for use in patients who have severe problems with their kidneys.
Aclasta mhux rakkomandat għall- użu f’ pazjenti li jkollhom problemi severi fil- kliewi.
In the treatment of Paget’ s disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.
Fit- trattament tal- marda ta ’ Paget ta ’ l - għadam, Aclasta għandu jintuża biss minn tabib li jkollu esperjenza fit- trattament tal- marda.
How does Aclasta work?
Għal xiex jintuża Alcasta?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta ma jikbirx biżżejjed għadam ġdid biex jieħu post l- għadam li jitkisser b’ mod naturali.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Fin -
Reproduction is authorised provided the source is acknowledged. fall.
©European Medicines Agnecy, 2008, Reproduction is authorised provided the source is acknowledged nisa, l- osteoporożi hi iktar komuni wara l- menopawża, meta l- livelli ormoni feminili jitbaxxew.
In Paget’ s disease the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Fil - marda ta ’ Paget l- għadam jinkiser iktar malajr, u meta jerġa ’ jikber, ikun iktar dgħajjef min- normal.
The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Is- sustanza attiva f’ Aclasta, zoledronic acid, hu bisphosphonate.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Iwaqqaf l- azzjoni ta ’ l- osteoklasts, iċ - ċelloli li għandhom x’ jaqsmu mat- tkissir tat- tessut tal- għadam.
This leads to less bone loss in osteoporosis and less disease activity in Paget’ s disease.
Dan iwassal għal inqas telf ta ’ għadam fl- osteoporożi u inqas attività tal- marda fil- marda ta ’ Paget.
How has Aclasta been studied?
Kif ġie studjat Alcasta?
Because the active substance in Aclasta is the same as the active substance in Zometa, some of the data presented for Zometa were taken into account when assessing Aclasta.
Billi s- sustanza attiva ta ’ Aclasta hija l- istess bħas- sustanza attiva f’ Zometa, xi ftit mid- dejta ppreżentata għal Zometa ġiet ikkunsidrata waqt il- valutazzjoni ta ’ Aclasta.
For the treatment of osteoporosis, the effects of Aclasta given once a year have been compared with those of placebo (a dummy treatment) in two main studies.
Għat- trattament ta ’ l- osteoporożi, l- effetti ta ’ Aclasta mogħti darba fis- sena tqabblu ma ’ dawk ta ’ plaċebo (trattament finta) f’ żewġ studji prinċipali.
The first involved almost 8,000 elderly women with osteoporosis, looking at the number of spine and hip fractures over three years.
L- ewwel studju ħares lejn in- numru ta ’ ksur fis - sinsla u fil- ġenbejn fuq perjodu ta ’ tliet snin u kien jinkludi kważi 8, 000 mara anzjana bl- osteoporożi.
The second involved 2,127 men and women with osteoporosis who were aged over 50 years and had recently broken their hip, and looked at the number of fractures over up to five years.
It- tieni studju kien jinkludi 2, 127 raġel u mara bl- osteoporożi li kellhom iktar minn 50 sena u li kienu reċentement kisru l- għadma tal- ġenbejn, dan l- istudju ħares lejn in- numru ta ’ ksur sa ħames snin żmien.
In both studies, the patients were allowed to take other medicines for osteoporosis, but not other bisphosphonates.
Fiż- żewġ studji, il- pazjenti tħallew jieħdu mediċini oħra għall- osteoporożi, iżda mhux għall - bisfosfonati.
In Paget’ s disease, Aclasta has been studied in a total of 357 patients in two studies, where it was compared with risedronate (another bisphosphonate) over six months.
Fil- marda ta ’ Paget, Aclasta ġie studjat fuq total ta ’ 357 pazjent f’ żewġ studji fejn ġie mqabbel ma ’ risedronate (bisfosfonat ieħor) fuq perjodu ta ’ sitt xhur.
The main measure of effectiveness was whether blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returned to normal or fell by at least 75% of the way back to normal levels.
Il- kelj ewlieni ta ’ l- effikaċja kien dak li jara jekk il- livelli tad- demm fis- serum alkaline phosphatase (enżim involut fit- tkissir ta ’ l - għadam) jirritornawx għan- normal jew jekk jinżlux b’ minn ta ’ l- inqas 75% lura għal livelli normali.
What benefit has Aclasta shown during the studies?
X’ inhu l- benefiċċju ta ’ Alcasta li ntwera f’ dan l- istudju?
In osteoporosis, Aclasta was more effective than placebo at reducing the number of fractures.
Fl- osteoporożi, Aclasta kien iktar effettiv mill- plaċebo fit- tnaqqis tan- numru ta ’ ksur.
In the study of elderly women, the risk of spine fractures was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years, compared with those taking placebo.
Fl- istudju tan - nisa anzjani, ir- riskju ta ’ ksur fis- sinsla tad- dahar tnaqqas b’ 70% fil- pazjenti li kienu qed jieħdu Aclasta (mingħajr mediċini oħra għall- osteoporożi) fuq tul ta ’ tliet snin, meta mqabbel ma ’ dawk li kienu qed jieħdu l- plaċebo..
There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
Kien hemm tnaqqis fir- riskju ta ’ 41% fil- ksur tal- ġenbejn, meta tqabblu n - nisa kollha li kienu qed jieħdu Aclasta (ma ’ jew mingħajr mediċini oħra ta ’ l- osteoporożi) ma ’ dawk li ngħataw il- plaċebo.
In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with 13% of the patients receiving placebo (139 out of 1,062).
Fl- istudju ta ’ l- irġiel u n- nisa li kienu kisru ġenbithom, 9% tal- pazjenti li rċevew Aclasta kellhom ksur (92 minn 1, 065), mqabbla mat- 13% tal- pazjenti li rċevew plaċebo (139 minn 1, 062).
This represents a 35% reduction in the risk of fracture in patients receiving Aclasta.
Dan juri 35% tnaqqis ta ’ riskju ta ’ ksur fil- pazjenti li jkunu ħadu Aclasta.
In Paget’ s disease, Aclasta was more effective than risedronate.
Fil- marda ta ’ Paget, Aclasta kien iktar effikaċi minn risedronate.
After six months, the proportion of patients who had responded to treatment was 95% in one study and 97% in the other, compared with 75% and 73% of the patients who received risedronate.
Wara sitt xhur, il- proporzjon ta ’ pazjenti li kienu rrispondew għat- trattament kien 95% fi studju wieħed u 97% fl- ieħor, mqabbel ma ’ 75% u 73% tal- pazjenti li rċevew risedronate.
What is the risk associated with Aclasta?
X’ inhu r- riskju assoċjat ma ’ Alcasta?
Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions.
L- iktar effetti sekondarji komuni ma ’ Aclasta għandhom it- tendenza li jseħħu fl- ewwel tlett ijiem wara l- infużjoni, u jsiru inqas komuni ma ’ infużjonijiet ripetuti.
The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever.
L- iktar effetti sekondarji komuni ma ’ Aclasta (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma d- deni.
For the full list of all side effects reported with Aclasta, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rappurtati ma ’ Aclasta, ara l- Fuljett ta ’ Tagħrif.
Aclasta should not be used in people who may be hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Aclasta m’ għandux jintuża minn persuni allerġiċi għal zoledronic acid, għal bisphosphonates oħra jew għal sustanzi oħra.
Aclasta should not be used in patients with hypocalcaemia (low blood calcium levels) or in pregnant or breast-feeding women.
Aclasta m’ għandux jintuża f’ pazjenti b’ ipokalċemija (livelli baxxi ta ’ kalċju) jew f’ nisa tqal jew li jkunu qed ireddgħu.
As with all bisphosphonates, patients taking Aclasta may also be at risk of kidney problems, reactions at the site of infusion and osteonecrosis (death of bone tissue) in the jaw.
Bħal fil- bisphosphonates kollha, il- pazjenti li jkunu qed jieħdu Aclasta jista ’ jkollhom ukoll riskju ta ’ problemi bil- kliewi, reazzjonijiet fis- sit ta ’ l- infużjoni u osteonekrożi (mewt ta ’ tessut ta ’ l- għadam) fix- xedaq.
Why has Aclasta been approved?
Għaliex ġie approvat Alcasta?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aclasta’ s benefits are greater than its risks for the treatment of osteoporosis in post-menopausal women and in men, at increased risk of fracture including those with a recent low-trauma hip fracture, and of Paget’ s disease of the bone.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Aclasta huma ikbar mir- riskji tiegħu għat- trattament ta ’ l- osteoporożi f’ nisa li jkunu għaddew mill - menopawża u fl- irġiel li jkollhom riskju ikbar ta ’ ksur inklużi dawk bi trawma reċenti ta ’ ksur fil - ġenbejn, u tal- marda ta ’ Paget ta ’ l- għadam.
The Committee recommended that Aclasta be given marketing authorisation.
Il- Kumitat irrakkomanda li Aclasta jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Aclasta?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Aclasta?
The company that makes Aclasta will provide educational packs for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used, and similar packs for patients, which explain the medicine’ s side effects and when they should contact their doctor.
Il- kumpanija li tagħmel Aclasta se tipprovdi pakketti edukattivi għal tobba li jippreskrivu Aclasta għall- osteoporożi, li jfakkruhom kif għandha tintuża l- mediċina, u pakketti simili għal pazjenti, li jispjegaw l- effetti sekondarji u meta jkollhom jikkuntattjaw lit- tabib tagħhom.
2/ 3 The full EPAR for Aclasta is available here.
2/ 3 Tagħrif ieħor dwar Aclasta:
This summary was last updated in 09-2008.
L- EPAR sħiħ għal Aclasta jista ’ jiġi kkonsultat hawnhekk.
Invented name
Isem inventat
Pharmaceutical Form
Għamla Farmaċewtika
Packaging
Il- Pakkett
Solution for infusion
Soluzzjoni għall - infużjoni
Intravenous use
Użu għal ġol- vini
bottle (plastic)
flixkun (plastik)
1 bottle
flixkun 1
5 x 1 bottle (unit pack)
5 x flixkun 1 (pakkett b’ wieħed)
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI KUNDIZZJONIJIET JEW RESTRIZZJONJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR • PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States shall ensure that the educational programme implemented for the authorised indication of treatment of post-menopausal osteoporosis, is extended to the potential prescribers concerned by the new indication: treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
L- Istati Membri se jiżguraw li l- programm edukattiv li jiġi fis- seħħ għall- indikazzjoni awtorizzata tal- kura ta ’ osteoporożi ta ’ wara l- menopawża, jiġi estiż għat- tobba li jistgħu jordnawh rigward l- indikazzjoni l- ġdida: kura ta ’ osteoporożi ta ’ wara l- menopawża fin- nisa u f’ irġiel li ġhandhom riskju akbar ta ’ ksur, inklużi dawk li kellhom ksur tal- ġenbejn b’ daqqa ħafifa.
The educational programme contains the following:
Il- programm edukattiv fih dawn li ġejjin:
• Physician educational material • Patient information pack
• Materjal edukattiv għat- tobba • Pakkett ta ’ informazzjoni għall- pazjent
The physician educational material should contain the following key elements: • The Summary of Product Characteristics • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Recommendation not to use Aclasta in patients with creatinine clearance < 35 ml/ min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. o Need for appropriate physical activity, non-smoking and healthy diet • Patient information pack
Il- materjal edukattiv għat- tobba għandu jkun fih dawn il- punti essenzjali li ġejjin: • Is- Sommarju tal- Karattereristiċi tal- Prodott • Biljett biex ifakkar b’ dawn il- messaġġi essenzjali: o Il- bżonn li titkejjel il- kreatinna fis- serum qabel trattament b’ Aclasta o Ir- rakkomandazzjoni biex Aclasta ma tintużax f’ pazjenti bi tneħħija tal- kreatinina ta ’ < 35 ml/ min o Il- kontra- indikazzjoni f’ nisa tqal u li qed ireddgħu minħabba li jista ’ jkun teratoġeniku o Il- bżonn li tiżgura l- idratazzjoni xierqa tal- pazjent o Il- bżonn li l- infużjoni ta ’ Aclasta tingħata bil- mod fuq perjodu ta ’ mhux anqas minn 15- il minuta o Il- frekwenza tad- doża li tingħata darba f’ sena o Li ammonti xierqa ta ’ calcium u vitamina D huma rakkomandati li jittieħedu meta tingħata Aclasta o Il- bżonn ta ’ attività fiżika xierqa, li ma tpejjipx u dieta tajba għas- saħħa. • Pakkett ta ’ informazzjoni għall- pazjent
The patient information pack should be provided and contain the following key messages: • Package leaflet • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non- smoking and healthy diet • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Il- pakkett ta ’ informazzjoni għall- pazjent għandu jingħata u għandu jkun fih il- messaġġi essenzjali li ġejjin: • Fuljett ta ’ tagħrif • Il- kontra- indikazzjoni f’ nisa tqal u li qed ireddgħu • Il- bżonn ta ’ supplimentazzjoni xierqa bil- calcium u l- vitamina D, attività fiżika xierqa, li ma tpejjipx u dieta tajba għas- saħħa • Is- sinjali u s- sintomi essenzjali ta ’ każijiet avversi serji • Meta għandek tfittex għajnuna mingħand persuni fil- qasam mediku
Aclasta 5 mg solution for infusion
Aclasta 5 mg soluzzjoni għall- infużjoni
Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.
Kull flixkun b’ 100 ml ta ’ soluzzjoni fih 5 mg zoledronic acid anhydrous, li jikkorrispondi għal 5. 330 mg zoledronic acid monohydrate.
One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
Ml wieħed ta ’ soluzzjoni fih 0. 05 mg zoledronic acid anhydrous li jikkorrispondi għal 0. 0533 mg zoledronic acid monohydrate.
Solution for infusion
Soluzzjoni għall- infużjoni
Clear and colourless solution.
Soluzzjoni ċara u bla kulur.
Treatment of osteoporosis • in post-menopausal women • in men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Għall- kura ta ’ osteoporożi • f’ nisa wara l- menopawsa • f’ irġiel li jkollhom riskju akbar ta ’ ksur, inklużi dawk li riċenti kellhom ksur tal- ġenbejn bi trawma żgħira.
Treatment of Paget’ s disease of the bone.
Għall- kura tal- marda ta ’ Paget ta ’ l- għadam.
For the treatment of post-menopausal osteoporosis and osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
Għall- kura ta ’ l- osteoporożi ta ’ wara l- menopawsa u ta ’ l- osteoporożi fl- irġiel, id- doża rakkomandata hija infużjoni waħda minn ġol- vini ta ’ 5 mg Aclasta li tingħata darba f’ sena.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1).
F’ pazjenti bi ksur fil- ġenbejn bi trawma żgħira, huwa rakkomandat li l- infużjoni ta ’ Aclasta tingħata ġimagħtejn jew aktar wara li jissewwa l- ksur fil- ġenbejn (ara sezzjoni 5. 1).
For the treatment of Paget’ s disease, Aclasta should be prescribed only by physicians with experience in treatment of Paget’ s disease of the bone.
Għall- kura tal- marda ta ’ Paget, Aclasta għandha tinkiteb biss minn tobba li għandhom l- esperjenza fil - kura tal- marda ta ’ Paget ta ’ l- għadam.
The recommended dose is a single intravenous infusion of 5 mg Aclasta.
Id- doża rakkomandata hija ta ’ infużjoni waħda fil- vini ta ’ 5 mg Aclasta.
Retreatment of Paget’ s disease: specific retreatment data are not available.
Kura mill- ġdid tal- marda ta ’ Paget: m’ hemmx dejta speċifiku dwar il- kura mill- ġdid.
After a single treatment with Aclasta in Paget’ s disease, an extended remission period is observed in responding patients (see section 5.1).
Wara kura waħda b’ Aclasta fil- marda ta ’ Paget, jidher perijodu twil mingħajr il- marda f’ pazjenti li jkollhom rispons (ara sezzjoni 5. 1).
Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Aclasta (5 mg f’ 100 ml soluzzjoni lesta- biex- tintuża) tingħata minn pajp ta’ l infużjoni ventat u b’ rata ta ’ infużjoni fissa.
The infusion time must not be less than 15 minutes.
Il- ħin ta ’ l- infużjoni m’ għandux ikun anqas minn 15- il minuta.
For information on the infusion of Aclasta, see section 6.6.
Għal aktar tagħrif dwar l- infużjoni ta ’ Aclasta, ara sezzjoni 6. 6.
Patients must be appropriately hydrated prior to administration of Aclasta.
Il- pazjenti għandhom ikunu idratati kif jixraq qabel jingħataw Aclasta.
This is especially important for the elderly and for patients receiving diuretic therapy.
Dan huwa importanti b’ mod partikolari fl- anzjani u għall- pazjenti li qed jingħataw terapija dijuretika.
2 Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Huwa rakkomandat li meta tingħata Aclasta, magħha jingħataw ukoll ammonti xierqa ta ’ calcium u vitamina D.
In addition, in patients with Paget’ s disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).
Minbarra hekk, f’ pazjenti li jsofru mill- marda ta ’ Paget, huwa rakkomandat ħafna li jkun 2 żgurat li jittieħed suppliment ta ’ calcium li jikkorrispondi għal mill- anqas 500 mg calcium bħala element, darbtejn kuljum għal mill- anqas 10- ijiem wara li tingħata Aclasta (ara sezzjoni 4. 4).
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
F’ pazjenti bi ksur fil- ġenbejn bi trawma żgħira, hija rakkomandata doża ta ’ tagħbija ta ’ 50, 000 sa 125, 000 IU vitamina D mogħtija mill- ħalq jew permezz ta ’ injezzjoni għal ġol- muskolu qabel ma tingħata l- ewwel infużjoni ta ’ Aclasta.
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
L- inċidenza ta ’ sintomi ta ’ wara d- doża li jseħħu fi żmien tlett ijiem wara li tingħata Aclasta jistgħu jitnaqqsu meta jingħataw paracetamol jew ibuprofen ftit wara li tingħata Aclasta.
Patients with renal impairment (see section 4.4) Use of Aclasta in patients with creatinine clearance < 35 ml/ min is not recommended due to limited clinical experience in this population.
Pazjenti b’ indeboliment renali (ara sezzjoni 4. 4) L- użu ta ’ Aclasta f’ pazjenti b’ tneħħija tal- krejatinina < 35 ml/ min mhuwiex rakkomandat minħabba li l- esperjenza klinika f’ din il- popolazzjoni hija limitata.
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/ min.
M’ hemmx bżonn tibdil fid- doża f’ pazjenti b’ tneħħija tal- krejatinina ≥ 35 ml/ min.
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Pazjenti b’ indeboliment tal- fwied M’ hemmx bżonn tibdil fid- doża (ara sezzjoni 5. 2).
Elderly patients (≥ 65 years) No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Pazjenti anzjani (≥ 65 sena) M’ hemmx bżonn tibdil fid- doża peress li l- bijodisponibilità, distribuzzjoni u eliminazzjoni kienu simili f’ pazjenti anzjani u f’ pazjenti iżgħar.
Children and adolescents Aclasta is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Tfal u adolexxenti Aclasta mhux irrakkomandat għall- użu fit- tfal u adolexxenti ta ’ taħt it- 18- il sena minħabba li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi jew għal xi bisphosphonates.
Aclasta is contraindicated for patients with hypocalcaemia (see section 4.4).
Aclasta hija kontra- indikata f’ pazjenti f’ ipokalċimja (ara sezzjoni 4. 4).
Aclasta is contraindicated during pregnancy and in breast-feeding women (see section 4.6).
Aclasta hija kontra- indikata f’ nisa waqt it- tqala u t- treddigħ (ara sezzjoni 4. 6).
The dose of 5 mg zoledronic acid must be administered over at least 15 minutes.
Id- doża ta ’ 5 mg zoledronic acid għandha tingħata fuq perijodu ta ’ mill- anqas 15- il minuta.
Aclasta is not recommended in patients with severe renal impairment (creatinine clearance < 35 ml/ min) due to limited clinical experience in this population.
Aclasta mhijiex rakkomandata f’ pazjenti li għandhom indeboliment renali sever (tneħħija tal - krejatinina < 35 ml/ min) minnħabba tagħrif kliniku limitat f’ din il- popolazzjoni.
Patients should have their serum creatinine level measured before receiving Aclasta.
Il- pazjenti għandu jkollhom il- livelli tal- krejatinina fis- serum imkejla qabel ma ’ jingħataw Aclasta.
Patients must be appropriately hydrated prior to administration of Aclasta.
Il- pazjenti għandhom ikunu idratati sew qabel jingħataw Aclasta.
This is especially important in the elderly and for patients receiving diuretic therapy.
Dan huwa importanti b’ mod partikolari fl- anzjani u f’ pazjenti li qed jingħataw terapija dijuretika.
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration), see section 4.5.
L- attenzjoni hija indikata meta Aclasta tingħata flimkien ma ’ mediċini li jista ’ jkollhom impatt sinifikanti fuq il- funzjoni renali (eż. aminoglycosides jew dijuretiċi li jistgħu jikkawżaw deidrazzjoni), ara sezzjoni 4. 5.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta (see section 4.3).
Pazjenti li jkollhom ipokalċimja minn qabel, għandhom ikunu kurati b’ ammonti xierqa ta ’ calcium u vitamina D qabel ma tinbeda t- terapija b’ Aclasta (ara sezzjoni 4. 3).
Other disturbances of mineral metabolism must also be effectively treated (e. g. diminished parathyroid reserve, intestinal calcium malabsorption).
Disturbi oħrajn fil- metaboliżmu tal- minerali għandhom ikunu kurati wkoll b’ mod effettiv (eż. tnaqqis fir- riżerva tal- paratirojde, malassorbiment tal- calcium mill- imsaren).
Physicians should consider clinical monitoring for these patients.
It- tobba għandhom iqiesu l- monitoraġġ kliniku għal dawn il- pazjenti.
3 Elevated bone turnover is a characteristic of Paget’ s disease of the bone.
Tibdil għoli fl- għadam huwa karatteristika tal- marda ta ’ Paget ta ’ l- għadam.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Aclasta (see section 4.8).
Minħabba li zoledronic acid jibda jaħdem malajr fuq dan it- tibdil ta ’ l- għadam, ipokalċimja tal- mument, kultant sintomatika,
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Huwa rakkomandat li meta tingħata Aclasta, magħha jingħataw ukoll ammonti xierqa ta ’ calcium u vitamina D.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.2).
Minbarra hekk, f’ pazjenti li jsofru mill- marda ta ’ Paget, huwa rakkomandat ħafna li jkun żgurat li jittieħed suppliment ta ’ calcium li jikkorrispondi għal mill- anqas 500 mg calcium bħala element, darbtejn kuljum għal mill- anqas 10- ijiem wara li tingħata Aclasta (ara sezzjoni 4. 2).
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Il - pazjenti għandhom jiġu informati dwar is- sintomi ta ’ ipokalċimja u jingħataw monitoraġġ kliniku xieraq waqt il- perijodu ta ’ riskju.
Measurement of serum calcium before infusion of Aclasta is recommended for patients with Paget´s disease.
Huwa rakkomandat li f’ pazjenti li jsofru mill- marda ta ’ Paget, jitkejjel il- calcium fis- serum qabel l- infużjoni ta ’ Aclasta.
Severe and occasionally incapacitating bone, joint and/ or muscle pain have been infrequently reported in patients taking bisphosphonates, including Aclasta.
Uġigħ sever u li kultant jinkapaċita fl- għadam, il- ġogi u/ jew il- muskoli kien irrappurtat b’ mod mhux frekwenti f’ pazjenti fuq bisphosphonates, inkluża Aclasta.
Aclasta contains the same active substance found in Zometa (zoledronic acid), used for oncology indications, and a patient being treated with Zometa should not be treated with Aclasta.
Aclasta fih l- istess sustanza attiva li hemm f’ Zometa (zoledronic acid), li jintuża fl- indikazzjonijiet ta ’ l- onkoloġija, u pazjent li jkun qed jingħata kura b’ Zometa m’ għandux jingħata kura b’ Aclasta.