qanastek/EMEA-V3 huggingface dataset:
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct- acting and/ or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Peress li Zoledronic acid ma jiġix metabolizzat mill- bnedmin u s- sustanza nstabet li kellha ftit jew l- ebda ħila bħala impeditur ta ’ l- enzimi P450 li jaħdem b’ mod dirett u/ jew b’ mod irriversibli dipendenti fuq il - metaboliżmu, mhux probabbli li zoledronic acid jnaqqas it- tneħħija ta ’ sustanzi li jiġu metabolizzati permezz tas- sistemi ta ’ enzimi ta ’ cytochrome P450.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Zoledronic acid ma jintrabatx bil- qawwa mal - proteini tal- plażma (madwar 43- 55% jintrabat) u l- irbit huwa indipendenti mill- konċentrazzjoni.
Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Għaldaqstant, nuqqas ta ’ qbil minħabba qlugħ ta ’ mediċini li jintrabtu ħafna mal- proteini mhuwiex probabbli.
Special populations (see section 4.2) The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/ min (range 22 to 143 ml/ min) in the 64 patients studied.
Popolazzjonijiet speċjali (ara sezzjoni 4. 2) It- tneħħija renali ta ’ zoledronic acid kienet relatata mat- tneħħija tal- krejatinina, fejn it- tneħħija mill - kliewi kienet tirrapreżenta 75 ± 33% tat- tneħħija tal- krejatinina, li wriet medja ta ’ 84 ± 29 ml/ min (medda 22 sa 143 ml/ min) fil- 64 pazjent li kien studjat.
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50– 80 ml/ min) and moderate renal impairment down to a creatinine clearance of 35 ml/ min are not necessary.
11 nuqqas ta ’ akkumulu tal- mediċina b’ dożi multipli irrispettivament mill- funzjoni renali, jissuġġerixxu li tibdil fid- dożi ta ’ zoledronic acid f’ pazjenti li għandhom indeboliment renali ħafif (Clcr = 50- 80 ml/ min) u moderat sakemm it- tneħħija tal- krejatinina tinżel għal 35 ml/ min mhux neċessarju.
As only limited data are available in severe renal impairment (creatinine clearance < 30 ml/ min), no dosing recommendations are possible for this population.
Peress li tagħrif f’ każijiet ta ’ indeboliment renali sever (creatinine tneħħija < 30 ml/ min) huwa biss limitat, ma jistgħux isiru rakkomandazzjonijiet ta ’ dużaġġi f’ din il- popolazzjoni.
11 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Acute toxicity The highest non-lethal single intravenous dose was 10 mg/ kg body weight in mice and 0.6 mg/ kg in rats.
Tossiċità akuta L- ogħla doża minn ġol- vina li ma kkawżatx il- mewt kienet ta ’ 10 mg/ kg piż tal- ġisem fil- ġrieden u 0. 6 mg/ kg fil- firien.
In the single-dose dog infusion studies, 1.0 mg/ kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Fi studji b’ dożi mogħtija f’ darba minn ġol- vina fil- klieb, 1. 0 mg/ kg (6 darbiet l - esponiment terapewtiku rakkomandat fil- bniedem bażat fuq l- AUC) mogħtija fuq perijodu ta ’ 15- il minuta kienu tollerati sew mingħajr effetti renali.
Subchronic and chronic toxicity In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/ kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/ kg administered at 2– 3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Tossiċità sottokronika u kronika Fi studji b’ infużjoni fil- vini, l- ammont ta ’ zoledronic acid li jifilħu l- kliewi kienet stabilita fil- firien meta kienu mogħtija 0. 6 mg/ kg bħala infużjonijiet ta ’ 15- il minuta b’ intervalli ta ’ 3 ijiem, sitt darbiet b’ kollox (għal doża kumulattiva li kienet tikkorrispondi għall- livelli ta ’ AUC madwar 6 darbiet l - esponiment terapewtiku fil- bniedem), filwaqt li ħames infużjonijiet ta ’ 15- il minuta ta ’ 0. 25 mg/ kg mogħtija f’ intervalli ta ’ minn 2- 3 ġimgħat (doża kumulattiva li kienet tikkorrispondi għal 7 darbiet l - esponiment terapewtiku fil- bniedem) kienu tollerati sew fi klieb.
In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration:
Fi studji ta ’ bolus mogħti ġol- vina, id- dożi li kienu tollerati sew naqsu maż- żieda fit- tul ta ’ l- istudju:
0.2 and 0.02 mg/ kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/ kg and 0.005 mg/ kg in rats and dogs, respectively, when given for 52 weeks.
0. 2 u 0. 02 mg/ kg kuljum kienu tollerati sew għal 4 ġimgħat f’ firien u klieb, rispettivament iżda 0. 01 mg/ kg u 0. 005 mg/ kg biss f’ firien u klieb, rispettivament, meta jingħata għal 52 ġimgħa.
Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
Meta ngħataw dożi ripetuti għal tul ta’ żmien li laħqu esponimenti kumulattivi li qabżu biżżejjed l - ogħla esponiment intiż għall- bniedem wasslu għall- effetti tossikoloġiċi f’ organi oħrajn, inklużi l - passaġġ gastro- intestinali u l- fwied, u fil- post mnejn tingħata l- infużjoni ġol- vina.
The clinical relevance of these findings is unknown.
Ir- rilevanza klinika ta ’ dawn is- sejbiet mhix magħrufa.
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound’ s pharmacological antiresorptive activity.
L- aktar sejba frekwenti fi studji b’ dożi ripetuti kienet żieda fi sponġoża primarja fil- metafisis ta ’ l- għadam twil f’ annimali li kienu qed jikbru kważi fid- dożi kollha, sejba li rriflettiet l- attività farmakoloġika kontra r- risorbiment li għandha s- sustanza.
Reproduction toxicity Teratology studies were performed in two species, both via subcutaneous administration.
Tossiċità tar- riproduzzjoni Studji teratoloġiċi saru f’ żewġ speċi, it- tnejn permezz ta ’ għotja taħt il- ġilda.
Teratogenicity was observed in rats at doses ≥ 0.2 mg/ kg and was manifested by external, visceral and skeletal malformations.
Teratoġeniċità dehret f’ firien b’ dożi ≥ 0. 2 mg/ kg u ħarġet bħala malformazzjonijiet esterni, vixxerali u skeletriċi.
Dystocia was observed at the lowest dose (0.01 mg/ kg body weight) tested in rats.
Tbatija tal - ħlas kienet osservata bl- aktar doża baxxa (0. 01 mg/ kg piż tal- ġisem) eżaminata fil- firien.
No teratological or embryo/ foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/ kg due to decreased serum calcium levels.
Ma dehrux effetti teratoloġiċi jew fuq l- embriju/ fetu fil- fniek, għalkemm tossiċità fl- omm kienet qawwija b’ 0. 1 mg/ kg minħabba livelli baxxi ta ‘ calcium fis- serum.
Mutagenicity and carcinogenic potential Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Potenzjal ta ’ effett tossiku fuq il- ġeni u riskju ta ’ kanċer Zoledronic acid ma kellux effett tossiku fuq il- ġeni fit- testijiet dwar l- effett tossiku fuq il- ġeni li saru, u testijiet fuq ir- riskju ta ’ kanċer ma taw l- ebda ħjiel ta ’ potenzjal ta ’ riskju ta ’ kanċer.
Mannitol Sodium citrate Water for injections
Mannitol Sodium citrate Ilma għall- injezzjonijiet
Aclasta must not be allowed to come into contact with any calcium-containing solutions.
Aclasta m’ għandhiex titħalla tiġi f’ kuntatt ma ’ ebda soluzzjonijiet li fihom calcium.
Aclasta must not be mixed or given intravenously with any other medicinal products.
Aclasta m’ għandhiex titħallat jew tingħata minn ġol- vina ma ’ xi mediċini oħra.
6.3 Shelf life
12 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Unopened bottle:
Flixkun mhux miftuħ:
After opening:
Wara li jinfetaħ:
24 hours at 2°C - 8°C
24 siegħa f’ 2°C - 8°C
12 From a microbiological point of view, the product should be used immediately.
Mill- lat mikrobijoloġiku, il- prodott għandu jintuża mill- ewwel.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Jekk ma jintużax mill- ewwel, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ min qed jużah u normalment m’ għandhomx jaqbżu l- 24 siegħa f’ 2°C - 8°C
The unopened bottle does not require any special storage conditions.
Il- flixkun mhux miftuħ m’ għandhux bżonn ħażna speċjali.
100 ml transparent plastic (cycloolefinic polymer) bottle closed with a fluoro-polymer coated bromobutyl rubber stopper and an aluminium/ polypropylene cap with a flip component.
Flixkun ta ’ 100 ml tal- plastik trasparenti (polimeru cycloolefinic) magħluq b’ tapp tal- gomma bromobutyl miksi b’ flworo- polimeru u għatu ta ’ aluminium/ polypropylene b’ komponent li tiftħu b’ saba.
Aclasta is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.
Aclasta jinsab f’ pakketti li fihom flixkun wieħed bħala pakkett wieħed jew f’ pakketti multipli li jkun fihom 5 pakketti, kull wieħed ikun fih flixkun 1.
For single use only.
Biex jintuża darba biss.
Any unused solution should be discarded.
Kull soluzzjoni li ma tintużax għandha tintrema.
Only clear solution free from particles and discoloration should be used.
Għandha tintuża biss soluzzjoni ċara li ma jkunx fiha frak u tibdil fil- lewn.
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Jekk tkessaħha, ħalli s- soluzzjoni mkessħa tilħaq it- temperatura tal- kamra qabel tagħtiha.
Aseptic techniques must be followed during the preparation of the infusion.
Proċeduri asettiċi għandhom jintużaw waqt li tkun qed tiġi preparata l- infużjoni.
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release:
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
Medicinal product subject to restricted medical prescription.
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib.
(See Annex I:
(Ara Anness I:
Summary of Product Characteristics, section 4.2)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
The Marketing Authorisation Holder (MAH) 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.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq (MAH) għandu jiżgura 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: • Physician educational material • Patient information pack
Il- programm edukattiv fih dawn li ġejjin: • 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
15 • OTHER CONDITIONS
15 • KUNDIZZJONIJIET OĦRA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the version 3.0 dated 13 July 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Il- MAH għandhu jiżgura li s- sistema ta ’ farmakoviġilanza kif spjegat fil- verżjoni 3. 0 bid- data tat- 13 ta ’ Lulju 2007 ippreżentata f’ Module 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis - Suq, qiegħda fis- seħħ u qed tiffunzjona qabel ma ’ l- prodott ikun fis- suq u waqt li l- prodott ikun fis - suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 004 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju Il- MAH jintrabat li jagħmel l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali kif iddettaljat fil - Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 004 tal- Pjan għall- Immaniġġar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti ta ’ l- RMP bi qbil mal- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- linji gwida tal- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jiġi sottomess flimkien mar- Rapport Perjodiku Aġġornat ta ’ Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma dan, għandu jiġi sottomess RMP aġġornat • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- iSpeċifikazzjonijiet ta ’ Sigurtà, il - Pjan ta ’ Farmakoviġilanza jew l- attivitajiet tat- tnaqqis tar- riskju kurrenti • Fi żmien 60 ġurnata minn meta tintlaħaq ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis tar - riskju) • Meta dan jiġi mitlub mill- EMEA
16 ANNEX III
16 ANNESS III
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
FOLDING BOX (WITH BLUE BOX) AND BOTTLE LABEL FOR UNIT PACK
KAXXA LI TINTLEWA (BIL- KAXXA ĊELESTI) U TIKKETTA TAL- FLIXKUN GĦALL - PAKKETT WIEĦED
Aclasta 5 mg solution for infusion Zoledronic acid
Aclasta 5 mg soluzzjoni għall- infużjoni Zoledronic acid
1 bottle contains 5 mg zoledronic acid (anhydrous).
Flixkun 1 fih 5 mg zoledronic acid (anhydrous).
Mannitol, sodium citrate and water for injections.
Mannitol, sodium citrate u ilma għall- injezzjonijiet.
PHARMACEUTICAL FORM AND CONTENTS
GĦAMLA FARMAĊEWTIKA U KONTENUTI
1 bottle – 100 ml
Flixkun 1 – 100 ml
Intravenous use.
Użu għal ġol- vini.
EXP After opening:
JIS Wara li jinfetaħ:
24 hours at 2°C - 8°C.
24 siegħa f’ 2°C - 8°C.
Justification for not including braille accepted.
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata.
20 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT INTERMEDJU
FOLDING BOX (WITH BLUE BOX) AND BOTTLE LABEL FOR INTERMEDIATE PACK
KAXXA LI TINTLEWA (BIL- KAXXA ĊELESTI) U TIKKETTA TAL- FLIXKUN GĦALL - PAKKETT INTERMEDJU
1 bottle - 100 ml Component of a multi-pack comprising 5 bottles, each bottle of 100 ml.
Flixkun 1 – 100 ml Jagħmel parti minn pakkett multiplu li jkun fih 5 ifliexken, kull flixkun ta ’ 100 ml.
22 PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TA ’ BARRA TAL- PAKKETT MULTIPLU (INKLUŻA L- KAXXA Ċ- ĊELESTI)
Multi-pack comprising 5 bottles, each bottle of 100 ml.
Pakkett multiplu li jkun fih 5 fliexken, kull flixkun ta ’ 100 ml.
25 PACKAGE LEAFLET:
25 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you are given this medicine.
Aqra sew dan il- fuljett kollu qabel tingħata din il- mediċina.
You may need to read it again.
Jista ’ jkollok bżonn terġa taqrah.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar jew ners tiegħek.
please tell your doctor, pharmacist or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- ispiżjar jew ners tiegħek.
What Aclasta is and what it is used for 2.
X’ inhi Aclasta u għalxiex tintuża 2.
Before you are given Aclasta 3.
Qabel ma tingħata Aclasta 3.
How Aclasta is given 4.
Kif tingħata Aclasta 4.
How to store Aclasta 6.
Kif taħżen Aclasta 6.
WHAT ACLASTA IS AND WHAT IT IS USED FOR
X’ INHI ACLASTA U GĦALXIEX TINTUŻA
Aclasta is given as a single infusion into a vein by a doctor or nurse.
Aclasta jingħata bħala infużjoni waħda ġol vina minn tabib jew ners.
It belongs to a group of medicines called bisphosphonates and is used to treat osteoporosis in post-menopausal women, osteoporosis in men and Paget’ s disease of the bone.
Tagħmel parti minn grupp ta ’ mediċini li jissejħu bisphosphonates u tintuża biex tikkura l- osteoporożi f’ nisa ta ’ wara l- menopawsa, l- osteoporożi fl- irġiel u l- marda ta ’ Paget ta ’ l- għadam.
Osteoporosis Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men.
Osteoporożi Osteoporożi hija marda fejn l- għadam jirqaq u jiddgħajjef u hija komuni f’ nisa wara l- menopawsa, iżda tista ’ sseħħ ukoll fl- irġiel.
At the menopause, a woman’ s ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Fil- menopawsa, l- ovarji tal- mara jieqfu jipproduċu l- ormon femminili estroġenu, li jgħin biex iżomm l- għadam b’ saħħtu.
Following the menopause bone loss occurs, bones become weaker and break more easily.
Wara l- menopawsa jseħħ telf ta ’ l- għadam, l - għadam jiddgħajjef u jinqasam aktar malajr.
Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Ħafna pazjenti b’ osteoporosi ma jkollhomx sintomi iżda xorta jkollhom riskju li jaqsmu l- għadam għaliex l- osteoporożi tkun dgħajjfet l- għadam tagħhom.
Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
It - tnaqqis fil- livelli ta ’ l- ormoni tas- sess, l- aktar l- estroġeni maqluba mill- androġeni, ukoll għandhom sehem fit- tnaqqis iżjed gradwali ta ’ l- għadam osservat fl- irġiel.
In both women and men, Aclasta strengthens the bone and therefore makes it less likely to break.
Kemm fin- nisa kif ukoll fl- irġiel, Aclasta ssaħħaħ l- għadam u għalhekk tgħamilhom anqas faċli li jinqasmu.
Because Aclasta works for a long time, you will not need another dose of Aclasta for a year.
Peress li Aclasta jaħdem għal żmien twil, ma jkollokx bżonn doża oħra ta ’ Aclasta għal sena.
Paget’ s disease of the bone It is normal that old bone is removed and is replaced with new bone material.
Il- Marda ta ’ Paget ta ’ l- għadam Hija ħaga normali li l- għadam jitneħħa u jinbidel b’ materjal ta ’ l- għadam ġdid.
This process is called remodelling.
Dan il- proċess jissejjaħ rimudellar.
In Paget’ s disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Fil- marda ta ’ Paget, il- bini mill- ġdid ta ’ l- għadam huwa mgħaġġel wisq u għadam ġdid jifforma b’ mod mhux ordinat, li jgħamlu aktar dgħajjef min- normali.
If the disease is not treated, bones may become deformed and painful, and may break.
Jekk il- marda ma tkunx kurata, l- għadam jista ’ jisfigura ruħu u jibda jweġġa, u jista ’ jinqasam.
Aclasta works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Aclasta jaħdem billi jreġġa lura għan- normal il- proċess ta ’ rimudellar ta ’ l- għadam, jiżgura l- formazzjoni ta ’ għadam normali, b’ hekk jagħti lura s- saħħa lill - għadam.
BEFORE YOU ARE GIVEN ACLASTA
QABEL MA TINGĦATA ACLASTA
Follow all instructions given to you by your doctor carefully before you are given Aclasta.
Segwi bir- reqqa l- istruzzjonijiet kollha li jkun tak it- tabib tiegħek qabel tingħata Aclasta.
You should not be given Aclasta
M’ għandekx tingħata Aclasta
- if you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates or any of the other
- jekk tbati minn allerġija (sensittività eċċessiva) għal zoledronic acid, bisphosphonates oħrajn
ingredients of Aclasta.
jew sustanzi oħra ta ’ Aclasta.
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
- jekk għandek ipokalċimja (din tfisser li l- livelli ta ’ calcium fid- demm tiegħek baxxi wisq).
- if you are breast-feeding.
- Jekk ħriġt tqila jew bi ħsiebek toħroġ tqila.
26 Take special care with Aclasta Tell your doctor before you are given Aclasta:
26
- if you are being treated with Zometa, which contains the same active substance as Aclasta.
- jekk qed tingħata kura b’ Zometa, li fih l- istess sustanza attiva bħal Aclasta.
- if you have a kidney problem, or used to have one.
- jekk għandek problema fil- kliewi jew xi darba kellek problema fil- kliewi.
- if you are unable to take daily calcium supplements.
- jekk ma tistax tieħu calcium kuljum bħala suppliment.
- if you have had some or all of the parathyroid glands in your neck surgically removed.
- jekk kellek xi glandoli tal- paratirojde f’ għonqok imneħħija parzjalment jew għall- kollox
- if you have had sections of your intestine removed.
- jekk kellek xi partijiet mill- imsaren imneħħija.
- if you had or have pain, swelling or numbness of the jaw or a loosening of the tooth.
- jekk kellek jew għandek uġigħ, nefħa, tnemnim tax- xedaq jew għandek xi sinna qed tiċċaqlaq.
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Aclasta.
Jekk qed tieħu kura għas- snien jew se tagħmel operazzjoni tas- snien, għid lid- dentist tiegħek li qiegħed tingħata kura b’ Aclasta.
Aclasta is not recommended for anyone under 18 years of age.
Aclasta mhux rakkomandat għall- ebda persuna taħt it- 18- il sena.
The use of Aclasta in children and adolescents has not been studied.
L- użu ta ’ Aclasta fi tfal u adolexxenti ma kienx studjat.
Taking other medicines Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib, lill- ispiżjar jew lin- ners tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
It is especially important for your doctor to know if you are taking any medicines known to be harmful to your kidneys.
Huwa speċjalment importanti għat- tabib tiegħek li jkun jaf jekk hux qed tieħu xi mediċini li jistgħu jkunu ta ’ ħsara għall- kliewi tiegħek.
Using Aclasta with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Aclasta, as directed by your doctor.
Meta tuża Aclasta ma ’ l- ikel u max- xorb Aċċerta ruħek li tixrob fluwidi biżżejjed (mill- anqas tazza jew tnejn) qabel u wara l- kura b’ Aclasta, kif spjegat mit- tabib tiegħek.
This will help to prevent dehydration.
Dan jgħin biex tevita li jkun hemm deidrazzjoni.
You may eat normally on the day you are treated with Aclasta.
Tista ’ tiekol b’ mod normali fil- jum meta tkun qed tiġi kkurat b’ Aclasta.
Elderly patients (age 65 years and over) Aclasta can be given to older patients.
Pazjenti anzjani (65 sena u iktar) Aclasta jista ’ jingħata lill- pazjenti anzjani
Pregnancy and breast-feeding You should not be given Aclasta if you are pregnant or plan to become pregnant.
Tqala u treddigħ M’ għandekx tingħata Aclasta jekk ħriġt tqila jew bi ħsiebek toħroġ tqila.
You should not be given Aclasta if you are breast-feeding.
M’ għandekx tingħata Aclasta jekk qed tredda.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Itlob il- parir tat- tabib l- ispiżjar, jew ners tiegħek qabel tieħu xi mediċina.
Driving and using machines Aclasta has no known effects on the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Aclasta m’ għandux effetti magħrufa fuq il- ħila ta ’ sewqan jew tħaddim ta ’ magni.
HOW ACLASTA IS GIVEN
KIF TINGĦATA ACLASTA
Osteoporosis The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse.
Osteoporożi Id- doża li ssoltu tingħata hija 5 mg, li tingħatalek bħala infużjoni waħda ġol- vina mit- tabib jew ners tiegħek.
The infusion will take at least 15 minutes.
L- infużjoni tieħu mill- anqas 15- il minuta.
In case you recently broke your hip, it is recommended that Aclasta is administered two or more weeks after your hip repair surgery.
F’ każ li riċentement kellek ksur f’ ġenbejk, huwa rakkomandat li Aclasta jingħata ġimgħatejn jew aktar wara li tkun għamilt operazzjoni ħabba ksur tal- ġenbejn.
Follow carefully all instructions given to you by your doctor or nurse.
Segwi sew l- istruzzjonijiet kollha li jingħatawlek mit- tabib jew ners tiegħek.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Huwa importanti li tieħu calcium u vitamina D bħala suppliment (per eżempju pilloli) kif spjegat mit - tabib tiegħek.
For osteoporosis, Aclasta works for one year and you will need the next dose after one year.
Għall- osteoporożi, Aclasta jaħdem għal sena u jkollok bżonn id- doża li jmiss wara sena.
27 Paget’ s disease The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
27 Il- Marda ta ’ Paget Id- doża li ssoltu tingħata hija 5 mg, li tingħatalek bħala infużjoni waħda ġol- vina mit- tabib jew ners tiegħek.
As Aclasta works for a long time, you may not need another dose of Aclasta for a year or longer.
Peress li Aclasta iddum taħdem fit- tul, jista ’ jkun li ma jkollokx bżonn doża oħra ta ’ Aclasta għal sena jew aktar.
Follow carefully all instructions given to you by your doctor or nurse.
Segwi bir- reqqa l- istruzzjonijiet kollha li jkunu tawk it- tabib jew ners tiegħek.
Your doctor may advise you to take calcium and vitamin D supplements (e. g. tablets) for at least the first ten days after being given Aclasta.
Jista ’ jkun li t- tabib tiegħek itik parir tieħu calcium jew supplimenti ta ’ vitamina D (eż pilloli) għal mill- anqas l- ewwel għaxart ijiem wara li tkun ingħatajt Aclasta.
It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Huwa importanti li ssegwi dan il- parir bir- reqqa sabiex il- calcium fid- demm ma jaqax baxx wisq fil- perijodu ta ’ wara l- infużjoni.
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
It- tabib tiegħek ser jinfurmak dwar is- sintomi assoċjati ma ’ ipokalċimja.
For Paget’ s disease Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
Għal marda ta ’ Paget Aclasta jista ’ jaħdem għal aktar minn sena, u t- tabib tiegħek ser jgħidlek jekk ikollokx bżonn kura oħra.
If a dose of Aclasta is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Jekk taqbeż doża ta ’ Aclasta Għamel kuntatt mat- tabib tiegħek jew l- isptar kemm jista ’ jkun malajr sabiex terġa ’ tagħmel l - appuntament mill- ġdid.
Your doctor will advise you and decide how long you should be treated with Aclasta.
Qabel twaqqaf it- terapija b’ Aclasta Jekk qed tikkonsidra li twaqqaf il- kura b’ Aclasta, jekk jogħġbok mur għall- appuntament tiegħek li jmiss u ddiskuti dan mat- tabib tiegħek, It- tabib tiegħek jagħtik parir u jiddeċiedi kemm għandek iddum tiġi kkurat b’ Aclasta.
If you have any questions on the use of this product, ask your doctor, pharmacist or nurse.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib, lill- ispiżjar jew lin- ners tiegħek.
Like all medicines, Aclasta can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aclasta jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most cases, no specific treatment is required.
Fil- parti l- kbira tal- każijiet, ma jkunx hemm bżonn ta ’ l- ebda kura speċifika.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Effetti sekondarji relatati ma ’ l- ewwel infużjoni huma komuni ħafna (jseħħu f’ aktar minn 30% tal - pazjenti) iżda huma anqas komuni fl- infużjonijiet li jsiru wara.
The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Aclasta.
Il- parti l- kbira ta ’ l- effetti sekondarji, bħal deni u dehxiet, uġigħ fil- muskoli jew ġogi, u uġigħ ta ’ ras, jseħħu fl- ewwel tlett ijiem wara d- doża ta ’ Aclasta.
The symptoms are usually mild to moderate and go away within three days.
Is- sintomi s- soltu jkunu ħfief jew moderati u jmorru fi żmien tlett ijiem.
Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects.
It- tabib tiegħek jista ’ jirrakkomandalek mediċina ħafifa li ttaffi l- uġigħ bħal ibuprofen jew paracetamol biex tnaqqas dawn l- effetti sekondarji.
The chance of experiencing these side effects decreases with subsequent doses of Aclasta.
Il- probabbilità li tħoss dawn l- effetti sekondarji tonqos bid- dożi ta ’ Aclasta sussegwenti.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for post- menopausal osteoporosis.
Ritmu irrregolari tal- qalb (fibrillazzjoni atrijali) dehret f’ pazjenti li kienu qed jirċievu Aclasta għal ostejoporosi ta ’ wara l- menopawsa.
It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Bħalissa mhux ċar jekk huwiex Aclasta li jikkawża dan ir- ritmu irregolari tal- qalb iżda għandek tirrappurta lit- tabib tiegħek jekk tħoss sintomi bħal dawn wara li tkun irċevejt Aclasta.
Very common side effects (affecting 10 or more in every 100 patients):
Effetti sekondarji komuni ħafna (jeffettwaw 10 f’ kull 100 pazjent):
Fever
Deni.
Common side effects (affecting less than 10 in every 100 patients):
Effetti sekondarji komuni (jeffettwaw anqas minn 10 f’ kull 100 pazjent):
Fever and chills, headache, feeling sick, pain in your muscles, pain in your bones and/ or joints, tiredness, weakness, dizziness, vomiting, pain in your back, arms or legs.
Deni u dehxiet, uġigħ ta ’ ras, tħossok ma tiflaħx, uġigħ fil- muskoli tiegħek, uġigħ f’ għadmek u/ jew fil - ġogi tiegħek, għeja dgħjufija, sturdament, rimettar, uġigħ f’ darek, dirgħajk jew riġlejk.
In patients with Paget’ s disease: symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth.
F’ pazjenti bil- marda ta ’ Paget: sintomi minħabba li l- calcium fid- demm ikun baxx, bħal spażmi fil - muskoli, jew tnemnim, jew sensazzjoni ta ’ tingiż l- aktar mad- dawra tal- ħalq.
Uncommon side effects (affecting less than 1 in every 100 patients):
28 Effetti sekondarji mhux komuni (jeffettwaw anqas minn 1 f’ kull 100 pazjent):
Flu, sleeplessness, tiredness, feeling of pins and needles or tingling sensation, drowsiness, tremor, temporary loss of consciousness, taste disturbance, diarrhoea, indigestion, abdominal pain, dry mouth, inflammation of oesophagus, toothache, joint pain, joint swelling, stiffness, eating disorder, redness, itching and pain in the eyes, chest pain, increased blood pressure, flushing, shortness of breath, rash,
Influwenza, ngħas, għeja, tnemnim jew sensazzjoni ta ’ tingiż, ngħas, tregħid, telf mis- sensi temporanju, disturbi fit- togħma, dijarea, indiġestjoni, uġigħ fl- addome, ħalq xott, infjammazzjoni ta ’ l - esofagu, uġigħ fis- snien, uġigħ fil- ġogi, nefħa fil- ġogi, ebusija, disturbi biex tiekol, ħmura, ħakk u uġigħ fl- għajnejn, uġigħ fis- sider, żieda fil- pressjoni tad- demm, fwawar, qtugħ ta ’ nifs, raxx, għaraq, ħakk, ħmura tal- ġilda, għamil frekwenti ta ’ l- awrina, żidiet mumentanji tal- krejatinina fis- serum, nefħa tat- tessuti u għatx.
Rare side effects (affecting less than 1 in every 1,000 patients):
Effetti sekondarji rari (jeffettwaw anqas minn 1 f’ kull 1, 000 pazjent):
Painful red eye.
Għajn ħamra miġugħa.
Skin reactions such as redness, swelling and/ or pain at the infusion site may occur.
Reazzjonijiet tal- ġilda bħall- ħmura, nefħa u/ jew uġigħ fil- post ta ’ l- infużjoni jistgħu jseħħu.
Bisphosphonates (the group of substances Aclasta belongs to) may cause swelling, redness, pain and itching of the eyes or eye sensitivity to light.
Bisphosphonates (Aclasta jaqa ’ fil- grupp ta ’ dawn is- sustanzi) jistgħu jikkawżaw nefħa, ħmura, uġigħ u ħakk fl- għajnejn jew sensittività ta ’ l- għajnejn għad- dawl.
Persistent pain and/ or non-healing sores of the mouth or jaw have been reported primarily in patients treated with bisphosphonates for other illnesses.
Uġigħ persistenti u/ jew ġrieħi li ma jfiequx tal- ħalq jew xedaq kienu rappurtati l- aktar f’ pazjenti kurati b’ bisphosphonates għall- mard ieħor.
If you experience these symptoms, tell your doctor or dentist.
Jekk tħoss dawn is- sintomi, għid lit- tabib jew dentist tiegħek.
Allergic reactions have been reported including rare cases of difficulty breathing, hives and angioedema (such as swollen face, tongue or throat).
Reazzjonijiet allerġiċi kienu rrappurtati inklużi każijiet rari ta ’ tbatija biex tieħu n- nifs, ħorriqija u anġjoedema (bħal wiċċ, ilsien jew grieżem minfuħin).
There have been isolated reports of very serious allergic reactions.
Kien hemm rapporti iżolati ta ’ reazzjonijiet allerġiċi serji.
If you notice any of these side effects, tell your doctor.
Jekk tinnota xi wieħed minn dawn l- effetti sekondarji, għid lit- tabib tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
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, lill- ispiżjar jew ners tiegħek.
HOW TO STORE ACLASTA
KIF TAĦŻEN ACLASTA
Your doctor, pharmacist or nurse knows how to store Aclasta properly.
It- tabib, spiżjar jew ners tiegħek jafu kif jaħżnu Aclasta b’ mod xieraq.
- Keep Aclasta out of the reach and sight of children.
- Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
- Do not use Aclasta after the expiry date which is stated on the carton and bottle.
- Tużax Aclasta wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- flixkun.
- The unopened bottle does not require any special storage conditions.
- Il- flixkun mhux miftuħ m’ għandhux bżonn ħażna speċjali.
- After opening the bottle, the product should be used immediately in order to avoid microbial
- Wara li tiftaħ il- flixkun, il- prodott għandu jintuża mill- ewwel sabiex tiġi evitata l -
contamination.
kontaminazzjoni b’ mikrobi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C.
Jekk ma jintużax mill- ewwel, iż- żmien ta ’ ħażna waqt l- użu u l - kundizzjonijiet tal- ħażna huma r- responsabbilità ta ’ min qed jużah u normalment ma jkunux aktar minn 24 seigħa f’ temperatura bejn 2°C – 8°C.
Allow the refrigerated solution to reach room temperature before administration.
Ħalli s- soluzzjoni mkessħa tilħaq it - temperatura tal- kamra qabel tagħtiha.
What Aclasta contains
X’ fiha Aclasta
- The active substance is zoledronic acid.
- Is- sustanza attiva hi zoledronic acid.
Each bottle with 100 ml of solution contains 5 mg
Kull flixkun b’ 100 ml ta ’ soluzzjoni fih 5 mg zoledronic
zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.
acid anhydrous, li jikkorrispondi għal 5. 330 mg zoledronic acid monohydrate.
One ml solution contains 0.05 mg zoledronic acid anhydrous corresponding to 0.05330 mg zoledronic acid monohydrate.
Millilitru wieħed ta ’ soluzzjoni fih 0. 05 mg zoledronic acid anhydrous li jikkorrispondi għal 0. 05330 mg zoledronic acid monohydrate.
- The other ingredients are mannitol, sodium citrate and water for injections.
- Is- sustanzi l- oħra huma mannitol, sodium citrate u ilma għall- injezzjonijiet.
What Aclasta looks like and contents of the pack Aclasta is a clear and colourless solution.
Id- Dehra ta ’ Aclasta u l- kontenuti tal- pakkett Aclasta hija soluzzjoni ċara mingħajr kulur.
It comes in 100 ml plastic bottles as a ready-to-use solution for infusion.
Tiġi fi fliexken tal- plastik ta ’ 100 ml bħala soluzzjoni għall- infużjoni lesta biex tintuża.
It is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.
Tiġi f’ pakketti li jkun fihom flixkun wieħed bħala pakkett b’ wieħed jew f’ paketti multipli li jkun fihom 5 pakketti, kull wieħed ikun fih flixkun 1.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il - pakketti kollha jkunu għal skop kummerċjali.
29 Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
29 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Manifattur Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved in {date}
Dan il- fuljett kien approvat l- aħħar f ’
31 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
31 TAGĦRIF GĦALL- PROFESSJONIST FIL- QASAM TAS- SAĦĦA
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
The dose of 5 mg of zoledronic acid must be administered over at least 15 minutes.
Id- doża ta ’ 5 mg ta ’ zoledronic acid għandha tingħata fuq mill- anqas 15- il minuta.
Aclasta is not recommended for patients with severe renal impairment (creatinine clearance < 35 ml/ min) due to lack of adequate clinical experience in this population.
Aclasta mhix rakkomandata f’ pazjenti b’ indeboliment sever tal- kliewi (tneħħija ta ’ krejatinina < 35 ml/ min) minħabba nuqqas ta ’ esperjenza klinika xierqa f’ din il- popolazzjoni.
Patients should have their serum creatinine level measured before receiving Aclasta.
Il- pazjenti għandu jkollhom il- livell tal - krejatinina fis- serum imkejjel qabel ma jingħataw Aclasta.
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.
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.
Patients must be appropriately hydrated prior to and following administration of Aclasta; this is especially important for patients receiving diuretic therapy.
Qabel u wara li jingħataw Aclasta, il- pazjenti għandhom ikunu idratati sew; dan huwa l- aktar importanti f’ dawk il- pazjenti li jkunu qed jirċievu terapija b’ dijuretiċi.
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).
Għandu jkun hemm attenzjoni meta Aclasta tingħata flimkien ma ’ prodotti mediċinali li jista ’ jkollhom impatt qawwi fuq il- funzjoni renali (eż aminoglycosides jew dijuretiċi li jistgħu jikkawżaw deidrazzjoni).
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta.
Jekk ikun hemm ipokalċimja minn qabel trid tiġi ikkurata b’ calcium u vitamina D qabel ma tinbeda t- terapija b’ Aclasta.
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 jiġu ikkurati wkoll b’ mod effettiv (eż. tnaqqis fir- riserva tal - paratirojde, malassorbiment tal- calcium mill- imsaren).
Physicians should consider clinical monitoring for these patients.
It- tobba għandhom iqiesu monitoraġġ kliniku f’ dawn il- pazjenti.
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.
Minħabba li l- effett ta ’ Zoledronic acid jibda malajr, ipokalċimja tal- mument, kultant b’ sintomi, tista ’ tiżviluppa u normalment tilħaq il- quċċata fl- ewwel 10 ijiem wara infużjoni b’ Aclasta.
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.
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.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Il- pazjenti għandhom ikunu infurmati dwar is - sintomi ta ’ ipokalċimja u jirċievu monitoraġġ kliniku xieraq waqt il- perijodu ta ’ riskju.
How to prepare and administer Aclasta
Kif tipprepara u tagħti Aclasta
- Aclasta 5 mg solution for infusion is ready for use.
- Is- soluzzjoni għall- infużjoni ta ’ Aclasta 5 mg hija lesta għall- użu.
For single use only.
Biex tintuża darba biss.
Any unused solution should be discarded.
Kwalunkwe soluzzjoni li ma tintużax għandha tintrema.
Only clear solution free from particles and discoloration should be used.
Għandha tintuża biss soluzzjoni ċara li ma jkunx fiha frak jew tibdil fil- kulur.
Aclasta must not be mixed or given intravenously with any other medication and must be given through a separate vented infusion line at a constant infusion rate.
Aclasta m’ għandhiex titħallat jew tingħata minn ġol- vina ma ’ xi mediċini oħra u għandha tingħata minn pajp ta’ l infużjoni ventat b’ rata fissa.
The infusion time must not be less than 15 minutes.
Il- ħin ta ’ l - infużjoni m’ għandux ikun anqas minn 15- il minuta.
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Jekk tinżamm fil- friġġ, ħalli s- soluzzjoni mkessħa tilħaq it- temperatura tal - kamra qabel tingħata.
Aseptic techniques must be followed during preparation of the infusion.
Waqt il- preparazzjoni tas- soluzzjoni għandhom jintużaw proċeduri asettiċi.
The infusion must be conducted according to standard medical practice.
L - infużjoni għandha ssir skond prattika medika standard.
How to store Aclasta
Kif taħżen Aclasta
- Keep Aclasta out of the reach and sight of children.
- Żomm Aclasta fejn ma tintlaħaqx u ma tidhirx mit- tfal.
- Do not use Aclasta after the expiry date which is stated on the carton and bottle.
- Tużax Aclasta wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- flixkun
- After opening the bottle, the product should be used immediately in order to avoid microbial
- Wara li jinfetaħ il- flixkun, il- prodott għandu jintuża kollu mill- ewwel sabiex tevita kontaminzzjoni
contamination.
b’ mikrobi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Jekk ma jintużax mill- ewwel, il- ħin tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l - użu huma responsabbiltà ta ’ min jużah u normalment ma jkunux itwal minn 24 siegħa f’ 2°C - 8°C.
Allow the refrigerated solution to reach room temperature before administration.
Ħalli s- soluzzjoni mkessħa tilħaq it- temperatura tal- kamra qabel tagħtiha.
d European Medicines Agency
at izz European Medicines Agency
ise EMEA/ H/ C/ 666
tor EMEA/ H/ C/ 666
or EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TAL- VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
ACOMPLIA
aw ACOMPLIA
uth EPAR summary for the public
Sommarju ta ’ l- EPAR għall- pubbliku
ra This document is a summary of the European Public Assessment Report (EPAR).
ux Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropew (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 għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta '
What is ACOMPLIA?
ad Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR). għ X’ inhi ACOMPLIA?