qanastek/EMEA-V3 huggingface dataset:
Anti-OP-1 antibodies have the ability to neutralize the in vitro biological activity of at least BMP-6.
Anti- korpi Anti- OP- 1 għandhom il- ħila jinnewtralizzaw l- attività bijoliġikali in vitro ta ’ l- anqas ta ’ BMP- 6.
Therefore, upon re- administration of Osigraft, a risk of developing autoimmunity towards the endogenous BMP proteins may exit.
Mela, hekk kif jerġa ’ jingħata Osigraft, jista ’ jkun hemm riskju ta ’ l- iżvilupp ta ’ awtoimmunità għall - proteini endoġenużi BMP.
Pregnancy and breast-feeding Osigraft should not be used during pregnancy unless the benefits outweigh the risks to the foetus.
Tqala u treddigħ Osigraft m’ għandux jintuża matul it- tqala għajr meta l- benefiċċji huma akbar mir- riskji għall- fetu.
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Osigraft.
Nisa li jistgħu joħorġu tqal għandhom javżaw lill- professur tagħhom dwar il- possibilità tat- tqala qabel it- trattament bl- Osigraft.
Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.
Nisa li jistgħu joħorġu tqal għandhom jingħataw parir li għandhom jużaw kontraċettiv effettiv sa ta 'l- anqas 12- il xahar wara t- trattament.
Do not breast-feed your baby during Osigraft therapy.
Treddax lit- tarbija tiegħek waqt li tkun qed għaddejja bit- terapija Osigraft.
In animal studies, excretion of IgG class anti- OP-1 antibodies into milk has been shown.
Fi studji fuq bhejjem, kienet osservata t- tneħħija ta 'anti- korpi ta' anti- OP- 1 tal- klassi IgG fil- ħalib.
As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Osigraft therapy.
Peress li IgG jitneħħa fil - ħalib uman, u l- potenzjal għall- ħsara għat- tarbija mhux magħruf, in- nisa m’ għandhomx ireddgħu waqt li jkunu qed jirċievu t- terapija bil- Osigraft.
If you are nursing you should use Osigraft only if your treating physician considers the benefits outweigh the risks.
Jekk int qed tredda ’ int għandek tuża Osigraft biss jekk it - tabib kuranti tiegħek jemmen li l- benefiċċji huma akbar mir- riskji.
Driving and using machines Not relevant
Sewqan u tħaddim ta ’ magni M’ għandux x’ jaqsam.
Important information about some of the ingredients of Osigraft Do not use Osigraft if you have a known hypersensitivity to collagen.
Tagħrif importanti dwax xi wħud mis- sustanzi ta ’ Osigraft Tużax Osigraft jekk int għandek sensittività eċċessiva għall- kollaġen.
HOW TO USE OSIGRAFT
KIF GĦANDEK TUŻA OSIGRAFT
18 Treatment requires a single surgery.
19 It- trattament jinħtieġ operazzjoni waħda.
Depending on the size of the defect (gap of bone break), more than a single 1g unit of Osigraft may be required.
Għandu mnejn ikun hemm bżonn ta 'aktar minn kunjett ta ’ 1g ta ’ Osigraft dejjem jiddependi mill- kobor tad- difett (il- fetħa tal- ksur fl- għadma).
The maximum human dose should not exceed 2 vials (2g) since its effectiveness in the treatment on non-unions with gaps requiring higher doses has not been established.
Id- doża massima umana m’ għandhiex taqbeż 2 kunjetti (2 g) għax l- effikaċja tagħha fit- trattament fuq non- unjonijiet b’ fetħiet li għandhom bżonn dożi ogħla ma ġietx stabbilita.
Osigraft is administered by your doctor during your surgery.
Osigraft jingħata mit- tabib tiegħek matul l- operazzjoni tiegħek.
It is placed directly at the defect (injury) site in contact with the prepared bone surface.
Titpoġġa direttament fis- sit tad- difett (il- ferita) f’ kuntatt mal- wiċċ ippreparat tal- għadma.
The surrounding soft tissues (muscle and skin) are then closed around the implant.
It- tessuti rotob tal- madwar (muskolu u ġilda) imbagħad jingħalqu madwar l- impjant.
You will be asleep during this procedure.
Int ser tkun rieqed matul il- proċedura.
The following are directions for the use of Osigraft by your doctor.
Hawn taħt għandna struzzjonijiet għall- użu ta ’ Osigraft mit - tabib tiegħek.
Lift the plastic flip-top and remove the crimp from the vial.
Neħħi t- tapp tal- plastik li tifflippjah u neħħi l- krimp mill- kunjett.
Aligning your thumb with the internal gap of the stopper, pry up the edge of the stopper.
Allinja subgħajk l- kbir ma ’ l- ispazju ta ’ ġewwa tat- tapp, iftaħ bis- saħħa it- tarf tat- tapp.
Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of product.
Hekk kif jiġi eliminat il- vakum, neħħi t- tapp tal- kunjett waqt li tkun qed iżżomm l- kunjett dritt biex ma jkunx hemm ħela tal- prodott.
Do not insert a needle through the stopper.
Iddaħħalx labra ġot- tapp.
Puncture of the stopper with a needle may result in particles of stopper material contaminating Osigraft.
Jekk it- tapp jittaqqab b’ labra, il- frak tal- materjal tat- tapp għandhom mnejn jikkontaminaw l- Osigraft.
Reconstitute Osigraft with 2 to 3 ml of sterile 9 mg/ ml sodium chloride solution for injection (0.9% w/ v) prior to use.
Irrikonstitwixxi Osigraft qabel ma jintuża b’ minn 2 sa 3 ml ta ’ soluzzjoni sterili għall- injezzjoni ta ’ klorid tas- sodju ta ’ 9mg/ ml (0. 9% w/ v).
Once the implant is prepared it should be used immediately.
Hekk kif l- impjant ikun ippreparat dan għandu jintuża minnufih.
When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Meta jkun rikonstitwit, Osigraft għandu l- konsistenza ta ’ ramel imxarrab, li jiffaċilita l- impjantazzjoni u tpoġġija fis- sit tad- difetti ta 'l- għadma.
Any unused Osigraft should be disposed together with surgical waste in accordance with local requirements.
Kwalunkwe Osigraft mhux użat flimkien ma skart kirurġiku għandhom jintremew skond il- kondizzjonijiet lokali.
Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone so that Osigraft is in direct contact with bleeding bone and viable osseous tissue.
Neħħi t- tessuti fibrużi, nekrużi jew sklerotiċi u neħħi kif suppost il- kopertura ħoxna ta 'barra tal - għadma biex l- Osigraft ikun f' kuntatt dirett mal- għadma li qed joħroġ id- demm minnha u mat - tessut osseu vijabbli.
Provide adequate haemostasis to ensure that material is not dislodged from the surgical site.
Ipprovdi emostasi adegwata biex tkun ċert li l- materjal ma jinqalax mis- sit kirurġiku.
Where practical, surgical manipulations to the site should be completed prior to product implantation.
Il- manipulazzjonijiet kirurġiċi għas- sit għandhom jintemmu qabel l- impjantazzjoni tal- prodott, meta dan ikun prattiku.
The amount of Osigraft used should approximate the size of the bone defect.
L- ammont ta ’ Osigraft użat għandu jkun bejn wieħed u ieħor daqs id - daqs tad- difett tal- għadma.
Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
Neħħi l- fluwidu żejjed jekk dan hu neċessarju billi tiġbed bl- arja ħdejn is- sit ta 'l- impjant jew billi tuxxuga bl- attenzjoni l- post permezz ta' sponża sterili.
After closure of the soft tissues around the defect, irrigate field, if necessary to remove any product, which may have become dislodged during soft tissue closure.
Wara l- għeluq tat- tessuti rotob madwar id- difett, aħsel bl- ilma l- post, jekk hemm bżonn neħħi kwalunkwe prodott, li għandu mnejn inqala 'matul l- għeluq tat- tessut artab.
Like all medicines, Osigraft can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Osigraft jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Administration of Osigraft requires surgery.
L- għoti ta ’ l- Osigraft jinħtieġ operazzjoni.
Adverse events following such surgery and not specifically associated with the product may include wound infection, osteomyelitis (infection of the bone), complications of mechanical support (such as the metal rod or plate used for stabilisation), bleeding at the wound site, failure of the wound to heal, nausea, fever and pain.
Episodji avversi wara tali operazzjoni u mhux speċifikament assoċjati mal- prodott għandhom mnejn jinkludu infezzjoni tal- ferita, ostejomijeliti (infezzjoni tal- għadma), komplikazzjonijiet ta ’ l- appoġġ mekkaniku (bħal ngħidu aħna virga tal- metal jew plejt użat għall- istabilizzazzjoni), ħruġ tad- demm fis- sit tal- ferita, il- ferita ma tfiqx, tqallih, deni u uġigħ.
The incidence of these events in clinical studies was > 10%.
L- inċidenza ta ’ dawn l- episodji fi studji kliniċi kienu > 10%.
However, there were no differences in the incidence of these adverse events compared with patients who received bone autograft (transplanted bone) instead of Osigraft, except in the case of osteomyelitis (infection of the bone) for which the incidence of osteomyelitis was statistically higher in the autograft group.
Imma, kien hemm differenzi fl - inċidenza ta ’ dawn l- episodji avversi a paragun ma 'pazjenti li ngħataw awtotrapjant (għadma trapjantata) minflok Osigraft barra mill- każ ta' ostejomijeliti (infezzjoni tal- għadma) li għaliha l - inċidenza ta 'ostejomijeliti kienet statistikament ogħla fil- grupp ta ’ l- awtotrapjant.
In clinical studies, the following undesirable effects have been reported as related to Osigraft discoloration of the wound site, erythema (redness of the skin), tenderness, and swelling over the implant site, and heterotopic ossification / myositis ossificans (bone formation outside of the fracture area).
Fi studji kliniċi, l- effetti mhux mixtieqa li ġejjin kienu rrapportati bħala li għandhom x' jaqsmu ma 'Osigraft, telf ta' kulur fis- sit tal- ferita, eritema (ħmur tal- ġilda), dak li jkun iweġġa ’ malajr, u nefħa fuq is- sit ta ’ l- impjant, u ossifikazzjoni eterotopika / mijosite ossifikanti (formazzjoni tal- għadma barra ż - żona tal- frattura).
None of these events were classified as serious.
L- ebda waħda minn dawn l- episodji mhuma meqjusa bħala serji.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.
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 tiegħek.
HOW TO STORE OSIGRAFT
KIF TAĦŻEN OSIGRAFT
Store in a refrigerator at (2°C - 8°C) Keep the blister pack in the outer carton
Aħżen fil- friġġ (2°C - 8°C) Żomm il- pakkett ta ’ l- istrixxi fil- kartuna ta ’ barra.
Any unused product or waste material should be disposed of in accordance with local requirements
Kull prodott li ma jkunx intuża jew skart għandu jintrema kif jitolbu l- liġijiet lokali.
Do not use after the expiry date which is stated on the label.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta.
What Osigraft contains The active substance is eptotermin alfa (3.3 mg in 1 g of powder), produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
X’ fih Osigraft Is- sustanza attiva hi eptotermin alfa (3. 3 mg f’ 1g ta ’ trab), ipproduċut bit- teknoloġija rikombinanti tad - DNA fiċ- ċelluli ta 'l- Ovarju tal- Ħamster Ċiniż (CHO).
The other ingredient is vacuum dried bovine collagen, (1 g of powder in a vial).
L- ingredjent l- ieħor hu kollaġen bovine imnixxef f' vakuum (1 g ta 'trab f' kunjett).
What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber colored glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.
Id- dehra ta ’ Osigraft u d- daqs tal- pakkett Osigraft jingħata bħala trab bejn abjad u off- white ippakkjat f’ kunjett tal- ħġieġ tal- kulur ambra (daqs ta ’ pakkett 1) fil– pakkett ta ’ l- istrixxa, li jikkonsisti fi trej tal- plastik u għatu, f’ kartuna.
Marketing Authorisation Holder and Manufacturer Howmedica International S. de R.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Howmedica International S. de R.
Division of Stryker Corporation Raheen Business Park Limerick Ireland
Taqsima ta ’ Stryker Corporation Raheen Business Park
21
21 Limerick Irlanda
What is OSSEOR?
X’ inhu OSSEOR?
OSSEOR is a medicine containing the active substance strontium ranelate.
OSSEOR hu mediċina li fiha s- sustanza attiva strontium ranelate.
It is available as 2-g sachets containing yellow granules, which are made up into an oral suspension.
Tiġi fi qratas taż- żewġ grammi li jkun fihom granuli sofor, li jinħallu biex jiffurmaw sospensjoni orali.
What is OSSEOR used for?
Għal xiex jintuża OSSEOR?
OSSEOR is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
OSSEOR jintuża fit- trattament ta ’ l- osteoporożi (marda li ddgħajjef l- għadam) f’ nisa li jkunu għaddew mill- menopawża biex inaqqas ir- riskji ta ’ ksur fis- sinsla tad- dahar u fl- għadma tal- ġenb.
How is OSSEOR used?
Kif jintuża OSSEOR?
OSSEOR is taken as one sachet once a day.
Jittieħed qartas wieħed ta ’ OSSEOR kuljum.
The contents of the sachet are made up into a suspension in a glass of water and drunk just after being prepared.
Il- kontenut tal- qartas jitħallat ma ’ tazza ilma u jifforma sospensjoni li tinxtorob mill- ewwel.
OSSEOR should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
OSSEOR għandu jittieħed ta ’ l- anqas sagħtejn wara li jittieħed xi ikel, ħalib, prodotti tal- ħalib jew supplimenti tal- kalċju, preferibbilmnet f’ ħin l- irqad.
OSSEOR is intended for long-term use.
OSSEOR għandu jintuża fit- tul.
Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.
Il- pazjenti għandhom jirċievu supplimenti tal- kalċju jew tal- vitamina D jekk ma jkunux qed jieħdu biżżejjed mid- dieta.
How does OSSEOR work?
Kif jaħdem OSSEOR?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta ma jkunx hemm biżżejjed għadam ġdid biex jissostitwixxi l- għadam li jitkisser b’ mod naturali.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Gradwalment, l- għadam isir irqiq u fraġli, u jkun hemm probabilità ikbar li jinkiser (ikun hemm ksur fih).
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
L- osteoporożi hija iktar komuni fin- nisa wara l- menopawża, meta jonqos il- livell ta ’ l- ormon femminili oestrogen.
The active substance in OSSEOR, strontium ranelate, acts on the bone structure.
Is- sustanza attiva f’ OSSEOR, strontium ranelate, taġixxi fuq l- istruttura tal- għadam.
Once in the gut, strontium ranelate releases strontium, which is similar to calcium and, like calcium, is absorbed into the bone.
Ladarba jkun fl- imsaren, strontium ranelate jillibera l- istronzju, li jixbah lill- kalċju u, bħall- kalċju, jiġi assorbit mill- għadam.
The mechanism of action of strontium is not fully understood but it stimulates bone formation and reduces bone breakdown.
Il- mekkaniżmu ta ’ l- azzjoni ta ’ l- istronzju għadu mhux magħruf għal kollox iżda jistumula l- formazzjoni tal- għadam u jnaqqas il- ksur tal - għadam.
How has OSSEOR been studied?
Kif ġie studjat OSSEOR?
OSSEOR has been studied in almost 7,000 postmenopausal elderly women in two large studies.
OSSEOR ġie studjat fi kważi 7, 000 mara anzjana li għaddew mill- menopawża.
Nearly a quarter of the patients were over 80 years of age.
Kważi kwart mill - pazjenti kellhom ’ il fuq minn 80 sena.
The first study included 1,649 women with osteoporosis who already had vertebral fractures and the second included over 5,000 women whose osteoporosis affected the hip region in the thighbone.
Fl- ewwel studju ħadu sehem 1, 649 mara bl- osteoporożi li kienu diġà sofrew minn ksur fis- sinsla tad- dahar u fit- tieni wieħed ħadu sehem iktar minn 5, 000 mara li l - osteoporożi tagħhom kienet affettwat ir- reġjun ta ’ l- ingroppa fil- koxxa.
In both studies, the effects of OSSEOR were compared with those of placebo (a dummy treatment).
Fiż- żewġ studji, l- effetti ta ’ OSSEOR tqabblu ma ’ dawk tal- plaċebo (trattament finta).
The main measure of effectiveness was the proportion of patients who, over three years, developed a new vertebral (spine) fracture in the first study, or a new osteoporosis peripheral fracture (at any site other than the spine) in the second study.
Il- mezz ewlieni tal- kejl ta ’ l- effettività kien il- proporzjon ta ’ pazjenti li, f’ perjodu ta ’ tliet snin, kellhom kisra ġdida fis- sinsla fl- ewwel studju, jew
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has OSSEOR shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged kisra periferali ġdida minħabba l- osteoporożi (fi kwalunkwe post apparti mis- sinsla tad- dahar) fit- tieni studju.
In the first study, OSSEOR was more effective than placebo in reducing the risk of new vertebral fractures.
Fl- ewwel studju, OSSEOR kien iktar effettiv mill- plaċebo fit- tnaqqis tar- riskju għal ksur vertebrali ġdid.
The risk was reduced by 41% over three years, with 21% of the 719 women who took OSSEOR developing a new vertebral fracture, compared with 33% of those 723 who took placebo.
Ir- riskju tnaqqas b’ iktar minn 41% matul tliet snin, b’ 21% tas- 719- il mara li ħadu OSSEOR jiżviluppaw kisra vertebrali ġdida, meta mqabbla ma ’ 33% ta ’ dawk is- 723 li ħadu l- plaċebo.
Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of OSSEOR in preventing peripheral fractures.
Globalment, ir- riżultati tat- tieni studju meħud waħdu ma kinux biżżejjed biex juru xi benefiċċju ta ’ OSSEOR fil- prevenzjoni ta ’ kisriet periferali.
When looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of hip fractures with OSSEOR.
Meta ġew analizzati biss ir- riżultati ta ’ nisa ta ’ 74 sena jew iktar bl- għadam tal- koxxa partikolarment dgħajjef, ir- riżultati ssuġġerew li kien hemm tnaqqis tar - riskju ta ’ ksur fl- għadma tal- ġenb ma ’ l- għoti ta ’ OSSEOR.
When looking at results of the two studies taken together, fewer women in the OSSEOR group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with OSSEOR compared with 389 out of 3,256 for placebo).
Meta ġew analizzati r- riżultati taż- żewġ studji flimkien, inqas nisa mill- grupp ta ’ OSSEOR żviluppaw kisriet periferali ta ’ l- osteoporożi fi kwalunkwe sit (inkluża l- għadma tal- ġenb) milli mill- grupp tal - plaċebo (331 mit- 3, 295 b’ OSSEOR meta mqabbla ma ’ 389 minn 3, 256 għall- plaċebo).
This showed that the risk of fracture is reduced.
Dan wera li r - riskju ta ’ ksur tnaqqas.
What is the risk associated with OSSEOR?
X’ inhu r- riskju assoċjat ma ’ OSSEOR?
The most common side effects with OSSEOR (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), diarrhoea, loose stools, dermatitis (skin reactions) and eczema (flaky skin rash).
L- iktar effetti sekondarji komuni ma ’ OSSEOR (li deher f’ bejn pazjent wieħed u għaxra minn kull mija) huma l- uġigħ ta ’ ras, id- dardir, id- dijarea, ippurgar merħi, dermatite (reazzjonijiet fil- ġilda) u ekżema (raxx u tqaxxir fil- ġilda).
For the full list of all side effects reported with OSSEOR, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ OSSEOR, ara l- Fuljett ta ’ Tagħrif.
OSSEOR should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
OSSEOR m’ għandux jintuża minn persuni allerġiċi għal strontium ranelate jew għal kwalunkwe sustanzi minn tiegħu.
Why has OSSEOR been approved?
Għaliex ġie approvat OSSEOR been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that OSSEOR’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li OSSEOR għandu iktar benefiċċji milli riskji għat- trattament ta ’ l- osteoporożi ta ’ wara l- menopawża biex inaqqas ir - riskju ta ’ ksur vertebrali jew fl- ingroppa.
The Committee recommended that OSSEOR be given marketing authorisation.
Il- Kumitat irrakkomanda li OSSEOR jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about OSSEOR:
Tagħrif ieħor dwar OSSEOR:
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for OSSEOR on 21 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal OSSEOR valida fl- Unjoni Ewropea kollha lil LES LABORATORIES SERVIER fil- 21 ta ’ Settembru 2004.
The full EPAR for OSSEOR is available here.
L- EPAR sħiħ għal OSSEOR huwa disponibbli minn hawnhekk.
EU number
Daqs tal- pakkett Numru ta ’ l- EU
Granules for oral suspension
suspensjoni orali Granijiet għal
sachet (paper/ PE/ alu)
Qratas (tal- karti/ PE/ alu)
14 sachets
14 qratas
28 sachets
28 qratas
56 sachets
56 qratas
Granules for oral suspension
suspensjoni orali
84 sachets
84 qratas
Granules for oral suspension
Granijiet għal suspensjoni orali
100 sachets
100 qratas
OSSEOR 2 g granules for oral suspension
OSSEOR 2 g granijiet għal suspensjoni orali
Each sachet contains 2 g of strontium ranelate.
Kull qartas fih 2 g strontium ranelate.
Excipient: also contains 20 mg of aspartame (E951).
Fih ukoll 20 mg aspartame (E951)
Granules for oral suspension Yellow granules
Granijiet għal suspensjoni orali Granijiet sofor
Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures (see section 5.1).
Kura ta ’ osteoporożi ta ’ wara l- menopawsa biex tnaqqas ir- riskju ta ’ ksur ta ’ l- għadam fis- sinsla tad- dahar u fl- għadam tal- ġenb (ara sezzjoni 5. 1).
The recommended daily dose is one 2 g sachet once daily by oral administration.
Id- doża rakkomandata ta ’ kuljum hija ta ’ qartas wieħed ta ’ 2 g darba kuljum mill- ħalq.
Due to the nature of the treated disease, strontium ranelate is intended for long-term use.
Minħabba n- natura ta ’ din il- marda, strontium ranelate huwa intenzjonat biex jittieħed fit- tul.
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals.
L- assorbiment ta ’ strontium ranelate jonqos bl - ikel, bil- ħalib u prodotti derivati mill- ħalib u għalhekk, OSSEOR għandu jingħata bejn ikla u oħra.
Given the slow absorption, OSSEOR should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Minħabba li jiġi assorbit bil- mod, OSSEOR għandu jingħata qabel ir- raqda ta ’ bil- lejl, prefiribilment mill- inqas sagħtejn wara l- ikel (ara sezzjonijiet 4. 5 u 5. 2).
The granules in the sachets must be taken as a suspension in a glass of water.
Il- granijiet ta ’ ġol- qratas għandhom jittieħdu bħala suspensjoni f’ tazza ilma.
Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
Għalkemm studji waqt l- użu wrew li strontium ranelate huwa stabbli f’ suspensjoni għal 24 siegħa wara li tiġi ippreparata, is - suspensjoni għandha tinxtorob immedjatament wara li tkun preparata.
Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.
Pazjenti li qiegħdin fuq il- kura ta ’ strontium ranelate għandhom jirċievu supplimenti tal- vitamina D u calcium jekk neqsin minnhom fid- dieta li jsegwu.
Use in the elderly The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis.
Użu fl- anzjani L- effikaċja u s- sigurtà ta ’ strontium ranelate ġew stabbiliti f’ firxa wiesa ’ ta ’ etajiet ta ’ nisa wara l- menopawsa bl- osteoporożi (sa 100 sena meta daħlu fl- istudju).
No dosage adjustment is required in relation to age.
Ma hemmx bżonn l- ebda tibdil fid- doża minħabba l- età.
Use in renal impairment No dosage adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/ min creatinine clearance) (see section 5.2).
Użu fl- indeboliment renali Ma hemm bżonn l- ebda tibdil fid- doża f’ pazjenti b’ indeboliment renali minn ftit sa moderat (30- 70 ml/ min ta ’ clearance tal- krejatinina) (ara sezzjoni 5. 2).
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/ min) (see sections 4.4 and 5.2).
Strontium ranelate mhux rakkomandat f’ pazjenti b’ indeboliment renali severi (clearance tal- krejatinina taħt it- 30 ml/ min) (ara sezzjonijiet 4. 4 u 5. 2).
2 Use in hepatic impairment As strontium ranelate is not metabolised, no dosage adjustment is required in patients with hepatic impairment.
2 Użu fl- indeboliment tal- fwied Minħabba li strontium ranelate ma jiġix metaboliżżat, m’ hemmx bżonn titbiddel id- doża f’ pazjenti b’ indeboliment tal- fwied.
Use in children and adolescents OSSEOR is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Użu fit- tfal u adoloxxenti OSSEOR mhux irrakkomandat għall- użu fit- tfal u adoloxxenti peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, OSSEOR is not recommended in patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Fin- nuqqas ta ’ tagħrif dwar is- sigurtà fl- għadam f’ pazjenti b’ indeboliment renali severi fuq kura bi strontium ranelate, OSSEOR mhux rakkomandat f’ pazjenti b’ clearance tal- krejatinina ta ’ inqas minn 30ml/ min (ara sezzjoni 5. 2).
In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
Skond il- prattika tajba tal- mediċina, evalwazzjoni minn żmien għal żmien tal- funzjoni renali huwa rakkomandat f’ pazjenti b’ indeboliment kroniku renali.
Continuation of treatment with OSSEOR in patients developing severe renal impairment should be considered on an individual basis.
Il- kontinwazzjoni tat - trattament bil OSSEOR f’ pazjenti li jiżviluppaw indeboliment renali severi għandu jiġi meqjus fuq bażi individwali.
In phase III placebo-controlled studies, strontium ranelate treatment was associated with an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism (see section 4.8).
Fi studju kliniċi ta ’ fażi III kontrollati bil- plaċebo, il- kura bi strontium ranelate kienet assoċjata ma ’ żieda fl- inċidenza annwali ta ’ trombo- emboliżmu tal- vina (VTE), inkluż emboliżmu fil- pulmun (ara sezzjoni 4. 8).
The cause of this finding is unknown.
Mhux magħruf il- kawża ta ’ dan il- fatt.
OSSEOR should be used with caution in patients at increased risk of VTE, including patients with a past history of VTE.
OSSEOR għandu jintuża b’ attenzjoni f’ pazjenti b’ riskju miżjud ta ’ trombo- emboliżmu tal- vina (VTE), inklużi pazjenti bi storja passata ta ’ VTE.
When treating patients at risk, or developing risk of VTE, particular attention should be given to possible signs and symptoms of VTE and adequate preventive measures taken.
Meta jiġu trattati pazjenti b’ riskju, jew li jistgħu jiżviluppaw riskju ta ’ VTE, attenzjoni partikolari għandha tingħata għal possibiltà ta ’ sinjali u sintomi ta ’ VTE u għandhom jittieħdu mezzi adekwati ta ’ prevenzjoni.
Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations.
Strontium ifixkel il- metodi kolorimetriċi biex titkejjel il- konċentrazzjoni ta ’ calcium fid- demm u fl- awrina.
Therefore, in medical practice, inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry methods should be used to ensure an accurate assessment of blood and urinary calcium concentrations.
Għalhekk, fil- prattika medika, għandu jintuża l- ispektrometrija ta ’ l- emissjoni atomika tal- plasma inductively coupled jew l- ispektrometrija ta ’ l- assorbiment atomika biex wieħed ikejjel b’ mod tajjeb il- konċentrazzjoni ta ’ calcium fid- demm u fl- awrina.
OSSEOR contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
OSSEOR għandu sors ta ’ phenylalanine, li tista tkun ta ’ ħsara f’ nies bil- fenilketonuria.
Treatment with OSSEOR should be discontinued in case of serious allergic reaction.
Il- kura bi OSSEOR għandha titwaqqaf f’ każ ta ’ reazzjoni allerġika serja.
Cases of severe hypersensitivity syndromes, including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS), sometimes fatal, have been reported with the use of OSSEOR (see section 4.8).
Każi ta ’ sindromi ta ’ sensittività eċċessiva severa, li jinkludu partikolarment, raxx tal- mediċina b’ eosinofilja u sintomi sistematiċi (DRESS), xi drabi fatali, ġew irraportati bl’ użu ta ’ OSSEOR (ara sezzjoni 4. 8).
The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (e. g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease).
Is- sindromu DRESS huwa kkaraterizzat b’ raxx, deni, eosinofilja, u involviment sistemiku (p. e. adenopatija, epatite, nefropatija interstitjali, u mard tal- pulmun interstitjali).
Time to onset was usually around 3-6 weeks and the outcome in most cases favourable upon discontinuation of OSSEOR and after initiation of corticosteroid therapy.
Iż- żmien sakemm tfaċċa is- sindromu kien ġeneralment ta ’ madwar 3- 6 ġimgħat u r- riżultat ta ’ ħafna mill - każijiet kien tajjeb wara li twaqqaf OSSEOR u nbdiet il- kura bil- kortikosterojd.
Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.
Il- fejqan jista ’ jkun bil- mod u s- sindromu ġie rraportat li reġa ’ tfaċċa f’ xi każi wara li twaqqfet il- kura bil- kortikosterojd.
Patients should be informed to stop OSSEOR immediately and permanently when a rash occurs and to seek medical advice.
Il- pazjenti għandhom jiġu mgħarfa biex iwaqqfu OSSEOR immedjatament u għal dejjem meta jkun hemm raxx u biex ifittxu parir mediku.
Patients who have stopped treatment due to hypersensitivity reactions should not re-start therapy with OSSEOR.
Il- pazjenti li jkunu waqfu l- kura minħabba reazzjonijiet ta ’ sensittività eċċessiva m ’ għandhomx jerġgħu jibdew kura b’ OSSEOR.
Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%.
L- ikel, il- ħalib u derivattivi tal- ħalib, u mediċini li fihom calcium jistgħu jnaqqsu l- biodisponibiltà ta ’ strontium ranelate bejn wieħed u ieħor 60% - 70%.
Therefore, administration of OSSEOR and such products should be separated by at least two hours (see section 5.2).
Għalhekk, OSSEOR għandu jittieħed preferibbilment mill- inqas sagħtejn ’ l bogħod minn dawn il- prodotti (ara sezzjoni 5. 2).
It is therefore preferable to take
3 Studji kliniċi in vivo dwar prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott urew li t- teħid ta ’ aluminium u magnesium hydroxides sagħtejn qabel jew flimkien ma ’ strontium ranelate wasslu għal tnaqqis żgħir fl- assorbiment ta ’ strontium ranelate (tnaqqis ta ’ 20- 25% AUC), fil- waqt li l- assorbiment kważi ma ġie mfixkel xejn meta l- mediċina kontra l- aċidu fl- istonku ngħatat sagħtejn wara strontium ranelate.
3 antacids at least two hours after OSSEOR.
Għalhekk, prefiribilment l- mediċini kontra l- aċidu fl- istonku għandhom jittieħdu ta ’ mill - inqas sagħtejn wara OSSEOR.
However, when this dosing regimen is impractical due to the recommended administration of OSSEOR at bedtime, concomitant intake remains acceptable.
Madankollu, meta dan ir- reġim ta’ dosaġġ ma jkunx prattikabbli, peress li huwa rakkomandat li OSSEOR jittieħed f’ ħin l- irqad, jibqa ’ aċċettabli li wieħed jieħu OSSEOR flimkien mal- mediċini kontra l- aċidu fl- istonku.
As divalent cations can form complexes with oral tetracycline and quinolone antibiotics at the gastro- intestinal level and thereby reduce their absorption, simultaneous administration of strontium ranelate with these medicinal products is not recommended.
Minħabba li l- ketajins b’ valenza doppja jistgħu jiffurmaw kumplessi ma ’ l- antibiotiċi tetracycline u quinolone mill- ħalq fil- livell gastro- intestinali, u b’ hekk jitnaqqas l- assorbiment, m’ huwiex rakkomandat li strontium ranelate jingħata ma ’ dawn il- mediċini.
As a precautionary measure, OSSEOR treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Bħala prekawzjoni, il- kura bi OSSEOR għandha titwaqqaf waqt il- kura bl- antibiotiċi, tetracycline jew quinolone mill- ħalq.
No interaction was observed with oral supplementation of vitamin D.
Ma jidhirx li s- supplimenti bil- Vitamina D li tittieħed mill- ħalq ma jaqblux ma dan il- prodott.
No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with OSSEOR in the target population were found during clinical trials.
Fi studji kliniċi, ma hemm l- evidenza ta ’ żieda tal- livell tas- strontium fid- demm li għandha x’ taqsam li mediċini li wieħed jistenna li jingħataw ta ’ spiss ma ’ OSSEOR ma ’ jaqblux flimkien jew iżidu b’ mod rilevanti l- livell ta ’ strontium fid- demm fil- popolazzjoni indikata.
These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
Dawn il- mediċini jinkludu: mediċini anti- inflammatorji mhux sterojdi (inkluż acetylsalicylic acid), anilides (bħal paracetamol), mediċini li jimblukkaw ir- riċetturi H2 u l- pompa protonika, diuretiċi, digoxin u glycosidi tal- qalb, nitrati organiċi u mediċini oħra li jwessgħu l- vini f’ mard tal- qalb, imblokkaturi tal- kanal ta ’ calcium, imblokkaturi beta, mediċini li jimpedixxu l- ACE, mediċini li jaħdmu kontra l- angiotensin II, mediċini li jgħinu selettivament il- beta- 2 adrenoriċetturi, antikoagulanti mill- ħalq, mediċini li jimpedixxu t- twaħħil tal- plejtlits, statins, fibrates u derivattivi tal- benzodiazepines.
OSSEOR is only intended for use in postmenopausal women.
OSSEOR huwa intenzjonat għall- użu fin- nisa wara l- menopawsa biss.
No clinical data on exposed pregnancies are available for strontium ranelate.
Għall- strontium ranelate m ’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3).
F’ dożi għolja, studji fl- annimali wrew effetti reversibbli fuq l- għadam tal- feti tal- firien u l- fniek waqt it- tqala (ara sezzjoni 5. 3).
If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Jekk OSSEOR jintuża mingħajr ħsieb waqt it- tqala, il- kura għandha titwaqqaf.
Strontium is excreted in milk.
Strontium jitneħħa fil- ħalib.
Strontium ranelate should not be given to nursing women.
Strontium ranelate m’ għandux jingħata fin- nisa li qed ireddgħu.
Strontium ranelate has no or negligible influence on the ability to drive and use machines.
Strontium ranelate m’ għandu l- ebda jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddem magni.
OSSEOR has been studied in clinical trials involving nearly 8,000 participants.
OSSEOR ġie studjat fi studji kliniċi li kien fihom kważi 8, 000 parteċipant.
Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/ day (n=3,352) or placebo (n=3,317) in phase III studies.
Is- sigurtà fit- tul ġiet studjata f’ nisa wara l- menopawsa bl- osteoporożi li ngħataw kura sa 60 xahar bi strontium ranelate 2 g/ jum (n = 3, 352) jew plaċebo (n = 3, 317) fi studji fażi III.
Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age.
L- età medja meta ddaħħlu fl- istudju kienet ta ’ 75 sena u 23% tal- pazjenti kellhom età li tvarja bejn it- 80 u 100 sena.
Overall incidence rates for adverse events with strontium ranelate did not differ from placebo and adverse events were usually mild and transient.
Ir- rata globali ta ’ l- effetti mhux mixtieqa bi strontium ranelate ma kienetx differenti minn dik fil- grupp tal- plaċebo u effetti mhux mixtieqa s- soltu kienu ħfief u ma jdumux fit- tul.
The most common adverse events consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
L- iżjed effetti mhux mixtieqa komuni kienu dardir u dijarea, li s- soltu ġew irrappurtati fil- bidu tal- kura mingħajr ma kien hemm l- ebda differenza bejn il- gruppi wara.
Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively).
Twaqqif tal- kura kien l- iżjed minħabba dardir (1. 3% u 2. 2% fil- gruppi plaċebo u strontium ranelate rispettivament).
Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); very rare (< 1/10 ,000).
Reazzjonijiet avversi, definiti bħala avventimenti avversi kkonsidrati ta ’ l- inqas possibli attribwiti għall- kura bi strontium ranelate f’ fażi III huma dawn li ġejjin bl- użu ta ’ din il- konvenzjoni (frekwenza versus plaċebo): komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1, 000, < 1/ 100); rari (> 1, 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Nervous system disorders Common: headache (3.3% vs.
4 Disturbi fis- sistema nervuża Komuni: uġigħ ta ’ ras (3. 3% vs.
Gastrointestinal disorders Common: nausea (7.1% vs.
Disturbi gastro- intestinali Komuni: dardir (7. 1% vs.
4.6%), diarrhoea (7.0% vs.
4. 6%), dijarrea (7. 0% vs.
5.0%), loose stools (1.0% vs.
5. 0%), ippurgar maħlul (1. 0% vs.
Skin and subcutaneous tissue disorders Common: dermatitis (2.3% vs.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni: dermatite (2. 3% vs.
2.0%), eczema (1.8% vs.
2. 0%), ekżema (1. 8% vs.
1.4%)
1. 4%)
4 There were no differences in the nature of adverse events between treatment groups regardless of whether patients were aged below or above 80 at inclusion.
Ma kienx hemm differenza fin- natura ta ’ l- avvenimenti avversi bejn gruppi li rċevew il- kura indipendentament jekk il- pazjenti kellom inqas jew aktar minn 80 sena meta ġew inklużi fl- istudju.
In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
Fi studji fażi III l- inċidenza annwali ta ’ trombo- emboliżmu tal- vina (VTE) osservati tul 5 snin kien bejn wieħed u ieħor 0. 7% b’ riskju relattiv ta ’ 1. 4 (95% CI = [1. 0; 2. 0]) f’ pazjenti trattati b’ strontium ranelate kif imqabblin ma ’ plaċebo (ara sezzjoni 4. 4).
In phase III studies, over 5 years, nervous system disorders were reported with higher frequency in patients treated with strontium ranelate, compared with placebo: disturbances in consciousness (2.6% vs.
Fi studji Fażi III, tul 5 snin, mard tas- sistema nervuża kien irraportat bi frekwenza għola f’ pazjenti trattati bi strontium ranelate, mqabbla ma ’ plaċebo: mard tal- konxju (2. 6% vs.
2.1%), memory loss (2.5% vs.
2. 1%), telf ta ’ memorja (2. 5% vs.
2.0%) and seizures (0.4% vs.
2. 0%) u puplesija (0. 4% vs.
0.1%).
0. 1%).
Laboratory test findings Transient emergent increases (> 3 times the upper limit of the normal range) in creatine kinase (CK) activity (musculo-skeletal fraction) were reported in 1.4% and 0.6% of the strontium ranelate and placebo groups respectively.
Tagħrif minn studji fil- laboratorju Żieda emergenti (> 3 darbiet l- ogħla livell tal- wisa normali) li ma damitx fit- tul fl- attività ta ’ creatinine kinase (CK) (parti muskolu- skeletali) kienet irrappurtata fi 1. 4% u 0. 6% tal- gruppi strontium ranelate u plaċebo rispettivament.
In most cases, these values spontaneously reverted to normal without change in treatment.
Fil- parti il- kbira tal- kura, dawn il- livelli reġgħu marru għan- normal spontanjament mingħajr ma nbidlet il- kura.
The following events have been reported in post-marketing experience:
Dawn il- każi ġew irraportati b’ esperjenza wara li l- mediċina tpoġġiet fis- suq:
Gastrointestinal disorders Frequency unknown: vomiting, abdominal pain, oral mucosal irritation including stomatitis and/ or mouth ulceration Skin and subcutaneous tissue disorders Frequency unknown: hypersensitivity skin reactions including rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome. Cases of severe hypersensitivity syndromes including drug rash with eosinophilia and systemic symptoms (DRESS) (see section 4.4).
Każi ta ’ sindromi b’ sensittività eċċessiva severa inkluż raxx bil- mediċina b’ eosinofilja u s- sintomi sistemiċi (DRESS) (ara sezzjoni 4. 4).
Musculoskeletal and connective tissue disorders Frequency unknown: musculoskeletal pain including muscle spasm, myalgia, bone pain, arthralgia and pain in extremity.
Disturbi musko- skeletrali u tal- connective tissue Frekwenza mhux mgħrufa: uġigħ muskoskeletrali li jinkludu tigbid fil- muskoli, majalgja, ugigħ fl - għadam, artralġja u uġigħ fit- trufijiet ta ’ l- idejn u s- saqajn.
General disorders and administration site conditions Frequency unknown: peripheral oedema Psychiatric disorders Frequency unknown: confusional state
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Frekwenza mhux mgħrufa: oedema periferali Disturbi psikjatriċi Frekwenza mhux mgħrufa: stat ta 'konfuzjoni
Good tolerance was shown in a clinical study investigating the repeated administration of 4 g strontium ranelate per day over 25 days in healthy postmenopausal women.
Kien hemm tolleranza tajba fi studju kliniku fejn ġiet studjata l- għoti ripetut ta ’ 4 g strontium ranelate kull ġurnata fuq firxa ta ’ 25 jum f’ nisa b’ saħħithom wara l- menopawsa.
Single administration of doses up to 11 g in healthy young male volunteers did not cause any particular symptoms.
Doża waħda ta ’ livell sa 11 g f’ żagħżagħ voluntieri rġiel b’ saħħithom ma kkawżat l- ebda sintomi partikolari.
Following episodes of overdoses during clinical trials (up to 4 g/ day for a maximal duration of 147 days), no clinically relevant events were observed.
Wara doża eċċessiva waqt studji kliniċi (sa 4 g/ jum għal tul massimu ta ’ 147 jum), ma kienu osservati l- ebda avvenimenti klinikament relevanti.
Administration of milk or antacids may be helpful to reduce the absorption of the active substance.
Jekk jittieħed il- ħalib jew mediċina ta ’ kontra l- aċidu fl- istonku, dan jista ’ jgħin biex titnaqqas l- assorbiment tal- mediċina.
In the event of substantial overdose, vomiting may be considered to remove unabsorbed active substance.
Jekk tittieħed doża eċċessiva ħafna, wieħed jista ’ jikkawża remettar biex titneħħa l- mediċina li ma ġietx assorbita.
Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation ATC code:
Kodiċi ATC:
In vitro, strontium ranelate:
In vitro, strontium ranelate:
- increases bone formation in bone tissue culture as well as osteoblast precursor replication and
- jżid il- formazzjoni ta ’ l- għadam fil- kultivazzjoni tat- tessuti ta ’ l- għadam kif ukoll iżid
collagen synthesis in bone cell culture;
ir- replikazzjoni tal- prekursuri ta ’ l- osteoblasti u s- sinteżi tal- kollaġen fil- kultivazzjoni taċ- ċelluli ta ’ l- għadam;
- reduces bone resorption by decreasing osteoclast differentiation and resorbing activity.
- inaqqas ir- ri- assorbiment ta ’ l- għadam billi jnaqqas l- iżvilupp ta ’ l- osteoklasti u l- attività tagħhom
5 This results in a rebalance of bone turnover in favour of bone formation.
Dan jikkawża bilanċ ġdid tat- tibdil ta ’ l- għadam favur il- formazzjoni ta ’ l- għadam.
The activity of strontium ranelate was studied in various non-clinical models.
L- attività ta’ strontium ranelate ġiet studjata f’ numru ta ’ mudelli mhux kliniċi.
In particular, in intact rats, strontium ranelate increases trabecular bone mass, trabeculae number and thickness; this results in an improvement of bone strength.
Partikolarment, f’ firien intatti, strontium ranelate jżid il- massa ta ’ l- għadam trabekulari, in- numru u l- ħxuna tat- trabekuli; dan jirriżulta f’ titjib fil- qawwa ta ’ l- għadam.
In bone tissue of treated animals and humans, strontium is mainly adsorbed onto the crystal surface and only slightly substitutes for calcium in the apatite crystal of newly formed bone.
Fit- tessuti ta ’ l- għadam ta ’ l- annimali u tal- bnedmin, strontium huwa fil- biċċa l- kbira assorbit fuq il - wiċċ tal- kristall u biss bi ftit jissostitwixxi l- calcium fil- kristall apatit ta ’ l- għadma iffurmata ġdida.
Strontium ranelate does not modify the bone crystal characteristics.
Strontium ranelate ma jibdilx il- karatterstiċi tal- kristall ta’ għadam.
In iliac crest bone biopsies obtained after up to 60 months of treatment with strontium ranelate 2 g/ day in phase III trials, no deleterious effects on bone quality or mineralisation were observed.
F’ biopsiji tal- krest ta ’ l- ilju meħuda wara sa 60 xahar ta ’ kura bi strontium ranelate 2 g/ jum fi provi fażi III, l- ebda effetti ħżiena ma ġew osservati kemm fuq il- kwalità ta ’ l- għadam kif ukoll fuq il- mineralizzazzjoni.
The combined effects of strontium distribution in bone (see section 5.2) and increased X-ray absorption of strontium as compared to calcium, leads to an amplification of bone mineral density (BMD) measurement by dual-photon X-ray absorptiometry (DXA).
L- effetti kombinanti tad- distribuzzjoni ta ’ strontium fl- għadam (ara sezzjoni 5. 2) u ż- żieda fl - assorbiment tal- X- ray bi strontium kif imqabbel ma ’ calcium, iwasslu għal amplifikazzjoni fid- densità minerali ta ’ l- għadam (BMD) kif imkejla permezz ta ’ assorbimetrika tal- X- ray dual- photon (DXA).
Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with OSSEOR 2 g/ day.
Tagħrif disponibbli juri li dawn il- fatturi isarrfu għal bejn wieħed u ieħor 50% tal- bidla fil- BMD mkejla tul 3 snin tal- kura bi OSSEOR 2 g/ jum.
This should be taken into account when interpreting BMD changes during treatment with OSSEOR.
Dan it- tagħrif għandu jiġi ikkonsidrat meta tiġi interpretata l- bidla fil- BMD waqt il- kura bi OSSEOR.
In phase III studies, which demonstrated the anti-fracture efficacy of OSSEOR treatment, measured mean BMD increased from baseline with OSSEOR by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Fi studji fażi III, li wrew l- effett kontra l- ksur bil- kura bi OSSEOR, il- medja mkejla ta ’ BMD mil- bażi żdiedet bi OSSEOR bejn wieħed u ieħor b’ 4% kull sena fil- lumbari ta ’ l- ispina tad- dahar u b’ 2% kull sena fl- għonq tal- femur, u tilħaq 13% sa 15% u 5% sa 6% rispettivament wara 3 snin skond l- istudju.