qanastek/EMEA-V3 huggingface dataset:
Protaphane Protaphane should not be disposed of via wastewater or household waste.
89 Protaphane m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
1 ml contains 100 IU of insulin human.
Protaphane huwa suspensjoni ta ’ insulina isophane (NPH) Millilitru fih 100 UI ta ’ insulina umana.
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper).
Dejjem i ekkja l- iskarto, inklu il- plan er (tapp) tal- gomma.
See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination.
Ara l- manwal tas- sistema tal- forniment tieg ek g al aktar struzzjonijiet Iddi infetta l- membrana tal- gomma b’ tajjara medi inali G al kull injezzjoni dejjem u a labra dida sabiex tevita l- kontaminazzjoni
In insulin infusion pumps If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk Penfill jew it- tag mir li jkun fih l- Penfill jitwaqqa ’, ji rilu l - sara jew jitg affe, hemm ir- riskju ta ’ tnixxija ta ’ l- insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Protaphane)
Do not refill Protaphane Penfill.
Timliex mill - did Protaphane Penfill.
If you are treated with Protaphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Protaphane Penfill u bi skarto Penfill ta ’ insulina o ra, g andek tu a ew sistemi ta ’ g oti ta ’ l- insulina, wa da g al kull tip ta ’ insulina.
Protaphane is for injection under the skin (subcutaneously).
Protaphane hu mag mul biex ikun injettat ta t il - ilda.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store Protaphane without the needle attached.
U a t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tieg ek u li huwa deskritt fil- manwal tas- sistema li biha ting ata l - insulina. omm il- labra ta t il - ilda tieg ek g al mill- anqas 6 sekondi biex ti gura li d- do a s i a tkun ing atat Wara kull injezzjoni a erta ru ek li tne i u tarmi l- labra u li ta en Protaphane ming ajr ma l- labra tkun imwa la.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Ti ux insulina jekk t oss li ejja ipo. omm fuqek pilloli tal- glukosju, elu, gallettini jew meraq tal- frott, fil- ka li jkollok b onnhom.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
G id lill- qraba, il - bieb u l- kollegi tieg ek li jekk tintilef minn sensik (i ossok a in), huma g andhom: idawruk fuq enbek u j ibu g ajnuna medika immedjatament.
They must not give you any food or drink as it could choke you.
M' g andhomx jag tuk ikel jew xorb, g ax tista ’ tifga.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Jekk ipogli emija severa ma tkunx ikkurata, din tista ’ tikkaw a sara fil- mo (temporanja jew permanenti) u anki l- mewt Jekk ikollok ipo li ieg lek tintilef minn sensik, jew afna ipos, kellem lit- tabib tieg ek.
Using glucagon
93 Kif tu a glucagon
Seek medical advice immediately: • if signs of allergy spread to other parts of the body, or • if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.
94 • jekk f’ daqqa wa da ma t ossokx tajjeb/ tajba u: tibda teg req; tibda t ossok imdardar/ imdardra (tirremetti); ikollok diffikultà biex tie u n- nifs; ikollok ta bit mg a el tal- qalb; t ossok stordut/ a; t ossok li ej xi ass a in.
Protaphane should not be disposed of via wastewater or household waste.
Protaphane m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
What to do in an emergency 5.
Din in- na a tal- fuljett:
Further information
1 X’ inhu Protaphane u g alxiex jintu a 2 Qabel ma tu a Protaphane 3 Kif g andek tu a Protaphane 4 X’ g andek tag mel f’ emer enza 5 Effetti sekondarji li jista ’ jkollu 6 Kif ta en Protaphane 7 Aktar tag rif
Protaphane is human insulin to treat diabetesProtaphane is a long-acting insulin.
Ji i f’ pinna mimlija g al- lest ta ’ 3 ml (li tissejja NovoLet - ara l- pa na ta ’ wara g al struzzjonijiet dettaljati).
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk g andek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - tirojde Jekk qed tixrob l- alko ol: oqg od attent/ a g as- sinjali ta ’ xi ipo u qatt m' g andek tixrob l - alko ol fuq stonku vojt Jekk tag mel e er izzju fi iku aktar mis- soltu jew jekk trid tibdel id- dieta normali tieg ek Jekk inti marid/ a: kompli u l- insulina tieg ek
92 Using other medicines
Meta tu a medi ini ohra
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
G al kull injezzjoni dejjem u a labra dida sabiex tevita l- kontaminazzjoni
In insulin infusion pumps If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk in- NovoLet titwaqqa ’, ti rilha l - sara jew titg affe, hemm ir- riskju li jkun hemm xi telf ta ’ insulina Jekk ma jkunx in a en kif suppost jekk kien iffri at (ara 6 Kif ta en Protaphane)
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Ti ux insulina jekk t oss li ejja ipo. omm fuqek pilloli tal- glukosju, elu, gallettini jew meraq tal - frott, fil- ka li jkollok b onnhom.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away.
G id lill- qraba, il - bieb u l- kollegi tieg ek li jekk i ossok a in (tintilef minn sensik), huma g andhom: idawruk fuq enbek u j ibu g ajnuna medika immedjatament.
If you get any of these signs. test your blood sugar level and test your urine for ketones if you can.
Jekk ikollok xi wie ed minn dawn is- sinjali: i ekkja l- livell taz- zokkor fid- demm tieg ek u jekk tista ’ i ekkja l- awrina tieg ek g all- ketoni.
95 temperature before resuspending the insulin as instructed for the first time use.
Wara li tkun ri t in- NovoLet mill- fri, huwa rakkomandat li t alliha til aq it- temperatura ambjentali tal- kamra qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni, kif istruwit/ a meta ti i biex tu aha g all- ewwel darba.
96 Information on how to use Protaphane NovoLet
101 Informazzjoni dwar kif tu a Protaphane NovoLet
Please read the following instructions carefully before using your Protaphane NovoLet.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a l- Protaphane NovoLet tieg ek.
Protaphane NovoLet is a simple, compact pre-filled pen.
Protaphane NovoLet hi pinna mimlija g al- lest sempli i u kumpatta.
Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin.
I ekkja t- tikketta biex ti gura li l- Protaphane NovoLet tieg ek ikun fiha t- tip korrett ta ’ insulina.
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
Jekk ikun baqa ’ anqas minn 12- il unità, u a Protaphane NovoLet did. aqlaq il- pinna ’ l fuq u ’ l isfel bejn il- po izzjonijiet a u b u lura (stampa A), biex b’ hekk il - • bo a tal - ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto g al mill- anqas 20 darba.
The movement must always be repeated, until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Protaphane NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment g andu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi Wara li tkun er ajt g amilt is- suspensjoni, wettaq l- istadji kollha ta ’ l- injezzjoni li ejjin • bla dewmien Iddi infetta l- membrana tal- gomma b’ tajjara b’ di infettant • Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni • Ne i s- si ill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Protaphane NovoLet (stampa B) • •
To avoid injection of air and ensure proper dosing: • Hold Protaphane NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u ti gura do a korrett: omm Protaphane NovoLet bil- labra tipponta ’ l fuq • B’ sebg ek tektek l- iskarto bil- mod g al xi ftit drabi.
98
103 D C
C
Kif tissettja d- do a
D
• •
Setting the dose
Er a 'I ekkja
• Put the cap back on the pen, with 0 next to the dosage indicator (picture E) • Check that the push-button is fully down.
Jekk dan ma jkunx il- ka,
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Protaphane NovoLet horizontally.
dawwar l- g atu sakemm il- buttuna ta ’ l- injezzjoni tkun mag fusa kollha ’ l isfel •
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
li te tie • Dawwar l- g atu fid- direzzjoni tal- vle a (stampa F) biex tissettja d- do a korretta.
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
• Jekk tkun issettjajt id- do a a in, sempli iment dawwar l- g atu ’ l quddiem jew lura sakemm tissettja n- numru korrett ta 'unitajiet.
Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Ag laq kompletament l- Protaphane NovoLet tieg ek bi - 0 biswit l- indikatur tad- do a.
Dispose of your used Protaphane NovoLet carefully without the needle attached.
Armi l- Protaphane NovoLet u ata tieg ek b’ attenzjoni ming ajr ma l- labra tkun imwa la.
Your Protaphane NovoLet is designed to work accurately and safely.
L- Protaphane NovoLet tieg ek hi mag mula biex ta dem bi pre i joni u bla periklu.
Do not refill Protaphane NovoLet.
Timliex mill - did Protaphane NovoLet.
You can clean the exterior of your Protaphane NovoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf il- parti ta ’ barra ta ’ l- Protaphane NovoLet tieg ek billi timsa a b’ tajjara b’ di infettant.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 UI/ ml suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Talk to your 102 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg ed tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- InnoLet titwaqqa ’, ji rilha l - sara jew titg affe, hemm ir- riskju li jkun hemm xi telf ta ’ insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Protaphane)
103 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistg u ji u g al g arrieda u jistg u jinkludu: g araq kiesa; ilda kies a u pallida; u ig ta ’ ras; ta bit mg a el tal- qalb; t ossok imqalla ’; t oss u kbir; tibdil temporanju fil- vista; ng as; g eja u debbulizza mhux tas- soltu; nervo ità jew rog da; t ossok ansju / a; t ossok konfu / a; diffikultà biex tikkon entra.
105 Protaphane should not be disposed of via wastewater or household waste.
Protaphane m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
106 Information on how to use Protaphane InnoLet
111 Informazzjoni dwar kif tu a Protaphane InnoLet
Please read the following instructions carefully before using your Protaphane InnoLet.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a l- Protaphane InnoLet tieg ek.
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Protaphane InnoLet hija pinna mimlija g al- lest sempli i u kumpatta li kapa i tag ti minn 1 sa 50 unità f’ inkrementi ta ’ unità 1.
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Protaphane InnoLet hi mag mula biex tintu a ma ’ labar NovoFine S ta '8 mm jew iqsar.
Take off the pen cap (as shown by the arrow).
I ekkja t- tikketta biex ti gura li l- Protaphane InnoLet tieg ek ikun fiha t- tip korrett ta ’ insulina Ne i t- tapp tal- pinna (kif muri bil- vle a).
If there are less than 12 units left, use a new Protaphane InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Jekk ikun baqa ’ inqas minn 12- il unità, u a Protaphane InnoLet dida aqlaq il- pinna ’ l fuq u ’ l isfel bejn il- po izzjonijiet A u B u lura biex b’ hekk il- bo a tal - • ie ti aqlaq minn tarf g all- ie or ta ’ l- iskarto (stampa 1A) g al mill- anqas 20 darba.
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Protaphane InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
Iddi infetta l- membrana tal- gomma b’ tajjara b’ di infettant • Dejjem u a labra dida g al kull injezzjoni sabiex tevita l- kontaminazzjoni • Ne i s- si ill protettiv minn fuq labra NovoFine S • Invita l- labra bi dritt u b' mod issikkat fuq Protaphane InnoLet (stampa 1B) • •
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Protaphane InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C) • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Biex tevita l- injezzjoni ta ’ l- arja u ti gura do a korrett: • Isselezzjona 2 unitajiet billi ddawwar is- selettur tad- do a lejn il- lemin omm l- Protaphane InnoLet bil- labra tipponta ’ l fuq u b’ sebg ek tektek bil- mod l - • iskarto g al xi ftit drabi, biex jekk ikun hemm xi b ie aq ta ’ l- arja dawn jin abru fin- na a ta ’ fuq ta ’ l- iskarto (stampa (stampa 1C) • Filwaqt li omm il- labra ’ l fuq, ag fas il- buttuna ta ’ l- injezzjoni u s- selettur tad- do a jirritorna fuq i - ero • Qatra insulina g andha tidher fil- ponta tal- labra.
108 If a drop of insulin still does not appear, the device is defective and must not be used.
113 Jekk il- qatra ta' l- insulina tibqa ’ ma titfa ax, l- apparat hu difettu u m’ g andux jintu a.
Dispose of your used Protaphane InnoLet carefully without the needle attached.
Armi l- Protaphane InnoLet u ata tieg ek bl- attenzjoni ming ajr ma ’ l- labra tkun imwa la.
Your Protaphane InnoLet is designed to work accurately and safely.
L- Protaphane InnoLet tieg ek hi mag mula biex ta dem bi pre i joni u bla periklu.
Do not refill Protaphane InnoLet.
Timliex mill - did Protaphane InnoLet.
You can clean your Protaphane InnoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf l- Protaphane InnoLet tieg ek billi timsa a b’ tajjara b’ di infettant.
Talk to your 111 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg ed tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk il- FlexPen titwaqqa ’, ji rilha l - sara jew titg affe, hemm ir- riskju li jkun hemm xi telf ta ’ insulina Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Protaphane)
112 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Is- sinjali ta ’ twissija ta ’ ipo jistg u ji u g al g arrieda u jistg u jinkludu: g araq kiesa; ilda kies a u pallida; u ig ta ’ ras; ta bit mg a el tal- qalb; t ossok imqalla ’; t oss u kbir; tibdil temporanju fil- vista; ng as; g eja u debbulizza mhux tas- soltu; nervo ità jew rog da; t ossok ansju / a; t ossok konfu / a; diffikultà biex tikkon entra.
113 Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b 'mod mhux komuni (f’ inqas minn pazjent 1 minn kull 100)
Do not use Protaphane the expiry date which is stated on the label and the carton.
Tu ax Protaphane wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
114 Protaphane should not be disposed of via wastewater or household waste.
Protaphane m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
Now turn over for information on how to use your FlexPen.
120 Issa aqleb g al informazzjoni dwar kif tu a il- FlexPen tieg ek.
115 Introduction
121 Introduzzjoni
Please read the following instructions carefully before using your Protaphane FlexPen.
bok aqra sew l- istruzzjonijiet li ejjin qabel ma tu a l- Protophane FlexPen tieg ek.
Protaphane FlexPen Pen cap
Protaphane FlexPen G atu tal- pinna
Preparing your Protaphane FlexPen
Kif tipprepara l- Protophane FlexPen tieg ek
116 Pull off the pen cap.
Ne i l- g atu tal- pinna.
C
123 C
G Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
124 G omm il- FlexPen tieg ek bil- labra tipponta ’ l fuq u b’ sebg ek tektek bil- mod l- iskarto g al xi ftit drabi, biex jekk ikun hemm xi b ie aq ta ’ l- arja dawn jin abru fin- na a ta ’ fuq ta ’ l- iskarto
The dose selector returns to 0.
Is- selettur tad- do a jirritorna fuq i - ero
119 I
125 I
120 Dispose of it carefully and put the pen cap back on.
126 Oqg od attent kif tarmiha u er a ’ po i lura l- g atu tal- pinna
121
127
What is PROTELOS?
X’ inhu PROTELOS?
PROTELOS is a medicine containing the active substance strontium ranelate.
PROTELOS hu mediċina li fiha s- sustanza attiva strontium ranelate.
What is PROTELOS used for?
Għal x' hiex jintuża PROTELOS?
PROTELOS is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
PROTELOS 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 PROTELOS used?
Kif jintuża PROTELOS?
PROTELOS is taken as one sachet once a day.
PROTELOS Jittieħed qartas wieħed ta ’ kuljum.
PROTELOS should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
PROTELOS għandu jittieħed ta ’ l- anqas sagħtejn wara li jittieħed xi ikel, ħalib, prodotti tal- ħalib jew supplimenti tal- kalċju, preferibbilmnet f’ ħin l- irqad.
PROTELOS is intended for long-term use.
PROTELOS hu intenzjonat għal użu fit- tul.
How does PROTELOS work?
Kif jaħdem PROTELOS?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Fin- nisa, l- osteoporożi hija aktar komuni wara l- menopawża, meta l- livelli ta 'l- ormon tan- nisa, l - estroġenu, jaqgħu.
The active substance in PROTELOS, strontium ranelate, acts on the bone structure.
Is- sustanza attiva fi PROTELOS, 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 PROTELOS been studied?
Kif ġie studjat PROTELOS?
PROTELOS has been studied in almost 7,000 postmenopausal elderly women in two large studies.
PROTELOS ġie studjat f’ żewġ studji kbar 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 PROTELOS were compared with those of placebo (a dummy treatment).
L- istudji qabblu l- effetti ta 'PROTELOS ma' dawk ta '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 kisra periferali ġdida minħabba l- osteoporożi (fi kwalunkwe post apparti mis- sinsla tad- dahar) fit- tieni studju.
(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 PROTELOS 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 Liema benefiċċju wera PROTELOS waqt l- istudji li ġew mwettqa?
In the first study, PROTELOS 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 PROTELOS 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 PROTELOS jiżviluppaw kisra vertebrali ġdida, meta mqabbla ma ’ 33% ta ’ dawk is- 723 li ħadu l- plaċebo.
Overall, he results of the second study taken alone were insufficient to demonstrate a benefit of PROTELOS in preventing peripheral fractures.
Globalment, ir- riżultati tat- tieni studju meħud waħdu ma kinux biżżejjed biex juru xi benefiċċju ta ’ PROTELOS 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 PROTELOS.
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 ’ PROTELOS.
When looking at results of the two studies taken together, fewer women in the PROTELOS group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with PROTELOS compared with 389 out of 3,256 for placebo).
Meta ġew analizzati r- riżultati taż- żewġ studji flimkien, inqas nisa mill- grupp ta ’ PROTELOS żviluppaw kisriet periferali ta ’ l- osteoporożi fi kwalunkwe sit (inkluża l- għadma tal- ġenb) milli mill - grupp tal- plaċebo (331 mit- 3, 295 bi PROTELOS 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 PROTELOS?
X’ inhu r- riskju assoċjat ma ’ PROTELOS?
The most common side effects with PROTELOS (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 ’ PROTELOS (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 PROTELOS, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati bi PROTELOS, ara l- Fuljett ta' Tagħrif.
PROTELOS should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
PROTELOS m' għandux jintuża minn persuni li jkunu allerġiċi għal strontium ranelate jew għal xi sustanza oħra tiegħu.
Why has PROTELOS been approved?
Għaliex ġie approvat PROTELOS?
The Committee for Medicinal Products for Human Use (CHMP) decided that PROTELOS’ 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 PROTELOS 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 PROTELOS be given marketing authorisation.
Il- Kumitat irrakkomanda li PROTELOS tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about PROTELOS:
Informazzjoni oħra dwar PROTELOS:
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for PROTELOS on 21 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal PROTELOS valida fl- Unjoni Ewropea kollha lil LES LABORATORIES SERVIER għal PROTELOS fil- 21 ta ’ Settembru 2004.
The full EPAR for PROTELOS is available here.
. L- EPAR sħiħ dwar PROTELOS jista ’ jinstab hawnhekk.
PROTELOS 2 g granules for oral suspension
PROTELOS 2 g granijiet għal suspensjoni orali
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
L- assorbiment ta ’ strontium ranelate jonqos bl - ikel, bil- ħalib u prodotti derivati mill- ħalib u għalhekk, PROTELOS għandu jingħata bejn ikla u oħra.
Given the slow absorption, PROTELOS 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, PROTELOS għandu jingħata qabel ir- raqda ta ’ bil- lejl, prefiribilment mill- inqas sagħtejn wara l- ikel (ara sezzjonijiet 4. 5 u 5. 2).
Use in children and adolescents PROTELOS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Użu fit- tfal u adoloxxenti PROTELOS 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, PROTELOS 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, PROTELOS mhux rakkomandat f’ pazjenti b’ clearance tal- krejatinina ta ’ inqas minn 30ml/ min (ara sezzjoni 5. 2).
Continuation of treatment with PROTELOS in patients developing severe renal impairment should be considered on an individual basis.
Il - kontinwazzjoni tat- trattament bil PROTELOS f’ pazjenti li jiżviluppaw indeboliment renali severi għandu jiġi meqjus fuq bażi individwali.
PROTELOS should be used with caution in patients at increased risk of VTE, including patients with a past history of VTE.
PROTELOS għandu jintuża b’ attenzjoni f’ pazjenti b’ riskju miżjud ta ’ trombo- emboliżmu tal- vina (VTE), inklużi pazjenti bi storja passata ta ’ VTE.
PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
PROTELOS għandu sors ta ’ phenylalanine, li tista tkun ta ’ ħsara f’ nies bil- fenilketonuria.
Treatment with PROTELOS should be discontinued in case of serious allergic reaction.
Il- kura bi PROTELOS 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 PROTELOS (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 ’ PROTELOS (ara sezzjoni 4. 8).
Time to onset was usually around 3-6 weeks and the outcome in most cases favourable upon discontinuation of PROTELOS 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 PROTELOS u nbdiet il- kura bil- kortikosterojd.
Patients should be informed to stop PROTELOS immediately and permanently when a rash occurs and to seek medical advice.
Il- pazjenti għandhom jiġu mgħarfa biex iwaqqfu PROTELOS 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 PROTELOS.
Il- pazjenti li jkunu waqfu l- kura minħabba reazzjonijiet ta ’ sensittività eċċessiva m ’ għandhomx jerġgħu jibdew kura b’ PROTELOS.
Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Għalhekk, PROTELOS għandu jittieħed preferibbilment mill- inqas sagħtejn ’ l bogħod minn dawn il- prodotti (ara sezzjoni 5. 2).
An in vivo clinical interaction study showed that the administration of aluminium and magnesium hydroxides either two hours before or together with strontium ranelate caused a slight decrease in the absorption of strontium ranelate (20-25% AUC decrease), while absorption was almost unaffected
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.
It is therefore preferable to take antacids at least two hours after PROTELOS.
Għalhekk, prefiribilment l- mediċini kontra l- aċidu fl- istonku għandhom jittieħdu ta ’ mill - inqas sagħtejn wara PROTELOS.
However, when this dosing regimen is impractical due to the recommended administration of PROTELOS at bedtime, concomitant intake remains acceptable.
Madankollu, meta dan ir- reġim ta’ dosaġġ ma jkunx prattikabbli, peress li huwa rakkomandat li PROTELOS jittieħed f’ ħin l- irqad, jibqa ’ aċċettabli li wieħed jieħu PROTELOS flimkien mal- mediċini kontra l- aċidu fl- istonku.
As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Bħala prekawzjoni, il- kura bi PROTELOS 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 PROTELOS 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 ’ PROTELOS ma ’ jaqblux flimkien jew iżidu b’ mod rilevanti l- livell ta ’ strontium fid- demm fil- popolazzjoni indikata.
PROTELOS is only intended for use in postmenopausal women.
PROTELOS huwa intenzjonat għall- użu fin- nisa wara l- menopawsa biss.
If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
Jekk PROTELOS jintuża mingħajr ħsieb waqt it- tqala, il- kura għandha titwaqqaf.
PROTELOS has been studied in clinical trials involving nearly 8,000 participants.
PROTELOS ġie studjat fi studji kliniċi li kien fihom kważi 8, 000 parteċipant.
4 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.
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 over 5 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).
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.
Disturbi gastro- intestinali Frekwenza mhux mgħrufa: remettar, uġigħ addominali, irritazzjoni fil- mukuża tal- ħalq inkluża stomatiti u/ jew ulċera tal- ħalq Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Frekwenza mhux mgħrufa: reazzjonijiet ta ’ sensittività eċċessiva fil- ġilda inkluż raxx, prurite, urtikarja, anġjoedema, is- sindromu Stevens- Johnson.
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).
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 magħrufa: oedema periferali Disturbi psikjatriċi Frekwenza mhux magħrufa: stat ta 'konfuzjoni
5 5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
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.
Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with PROTELOS 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 PROTELOS 2 g/ jum.
This should be taken into account when interpreting BMD changes during treatment with PROTELOS.
Dan it- tagħrif għandu jiġi ikkonsidrat meta tiġi interpretata l- bidla fil- BMD waqt il- kura bi PROTELOS.
In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS 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 PROTELOS, il- medja mkejla ta ’ BMD mil- bażi żdiedet bi PROTELOS 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.
The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies:
Il- programm ta ’ studju fuq PROTELOS kontra l- ksur kien jikkonsisti minn żewġ studji fażi III ikkontrollati bi plaċebo:
6 PROTELOS reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
PROTELOS naqqas ir- riskju relattiv ta ’ ksur ġdid fis- sinsla b’ 41% tul tlett snin fl- istudju SOTI (tabella 1).
Similar benefits were demonstrated in women with multiple fractures at baseline.
Benefiċċji simili ntwerew f’ nisa bi ksur multiptipliku fil- linja bażi.
PROTELOS also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
PROTELOS wera wkoll tnaqqis fin- numru ta ’ pazjenti b’ telf ta ’ tul tal - ġisem ta ’ mill- inqas 1 cm meta mqabbel ma ’ plaċebo.
Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo.
Stima tal- kwalità tal- ħajja bbażata fuq l- iskala speċifika QUALIOST kif ukoll fuq il- punteġġ tal- perċezzjoni tas- Saħħa Ġenerali ta ’ l- iskala ġenerali SF- 36 indikat benefiċju bi PROTELOS, meta mqabbel ma ’ plaċebo.
Efficacy of PROTELOS to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline.
L- effikaċja ta ’ PROTELOS biex inaqqas ir- riskju tal- ksur ġdid tas- sinsla kien ikkonfermat fl- istudju TROPOS, li jinkludi l- pazjenti bl- osteoporożi mingħajr ksur fraġli fil- bidu ta ’ l- istudju.
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs.
F’ pazjenti ’ l fuq minn 80 sena meta daħlu fl- istudju, analiżi miġbura flimkien ta ’ l- istudji SOTI u TROPOS uriet li PROTELOS naqqas ir- riskju relattiv li wieħed isofri minn ksur ġdid tas- sinsla b’ 32% fuq 3 snin (inċidenza ta ’ 19. 1% bi strontium ranelate vs.
12.0% with placebo).
F’ analiżi a- posteriori ta ’ pazjenti mill- istudji SOTI u TROPOS miġbura flimkien b’ bażi lumbari ta ’ l - ispina u/ jew ta ’ l- għonq tal- femur BMD fil- wisa ’ osteopenika u mingħajr ksur prevelanti iżda b’ mill - inqas fattur ta ’ riskju addizjonali għal ksur (N = 176), PROTELOS naqqas ir- riskju li jkun hemm l- ewwel ksur tas- sinsla b’ 72% tul 3 snin (inċidenza ta ’ ksur tas- sinsla 3. 6% bi strontium ranelate vs. 12. 0% bi plaċebo).
In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
F’ dan il- grupp, tul 3 snin ta ’ kura, PROTELOS naqqas ir- riskju ta ’ ksur tal- ġenb b’ 36% relattivament mal- grupp bi plaċebo.
The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during long-term exposure in postmenopausal osteoporotic women including elderly women.
Il- farmakokinetika ta ’ strontium u ranelic acid ġew studjati f’ żagħżagħ irġiel b’ saħħithom u nisa wara l- menopawsa b’ saħħithom, kif ukoll waqt espożizzjoni fit- tul f’ nisa wara l- menopawsa bl- osteoporożi, li jinkludu nisa anzjani.
Absorption The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Assorbiment Il- biodisponibiltà assoluta ta ’ strontium hija ta ’ madwar 25% (bejn 19% u 27%) wara doża mill- ħalq ta ’ 2 g strontium ranelate.
Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of PROTELOS.
Minħabba l- assorbiment relattivament bil- mod ta ’ strontium it- teħid ta ’ l- ikel u calcium għandu jiġi evitat kemm qabel kif ukoll wara l- għoti ta ’ PROTELOS.
The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
It- twaħħil ta ’ strontium mal- protejini tal- plażma tad- demm uman huwa baxx (25%) u strontium għandu affinità kbira għat - tessuti ta ’ l- għadam.
8 Patients with hepatic impairment There is no pharmacokinetic data in patients with hepatic impairment.
Pazjenti b’ indeboliment fil- fwied Mhemmx tagħrif farmakokinetiku f’ pazjenti b’ indeboliment fil- fwied.
Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e. g. bent long bones and wavy ribs) in the offspring.
Studji tossici fuq l- iżvilupp f’ firien u fil- fniek irriżultaw f’ abnormalitajiet fl- għadam u fis- snien (p. e. tgħawwiġ fl- għadam it- twil u kustilji mxenglin) fil- wild.
PROTELOS 2 g granules for oral suspension Strontium ranelate
PROTELOS 2 g granijiet għal suspensjoni orali Strontium ranelate
EU/ 1/ 04/ 288/ 004 56 sachets EU/ 1/ 04/ 288/ 005 84 sachets EU/ 1/ 04/ 288/ 006 100 sachets
EU/ 1/ 04/ 288/ 004 56 qratas EU/ 1/ 04/ 288/ 005 84 qratas EU/ 1/ 04/ 288/ 006 100 qratas
PROTELOS 2 g granules for oral suspension.
PROTELOS 2 g granijiet għal suspensjoni orali.
What PROTELOS is and what it is used for 2.
X’ inhu PROTELOS u għalxiex jintuża 2.
Before you take PROTELOS 3.
Qabel ma tieħu PROTELOS 3.
How to take PROTELOS 4.
Kif għandek tieħu PROTELOS 4.
How to store PROTELOS 6.
Kif taħżen PROTELOS 6.
WHAT PROTELOS IS AND WHAT IT IS USED FOR
X’ INHU PROTELOS U GĦALXIEX JINTUŻA
PROTELOS is a non-hormonal medicine used to treat osteoporosis in postmenopausal women.
PROTELOS huwa mediċina li ma fihx ormoni li tintuża biex jikkura l- osteoporożi f’ nisa wara l- menopawsa.
PROTELOS reduces the risk of fracture at the spine and at the hip.
PROTELOS inaqqas ir- riskju ta ’ ksur ta ’ l- għadam fis- sinsla tad- dahar u fil- ġenb.
However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists
Madankollu, l- osteoporożi tista żżidlek iċ- ċans li jkollok ksur (jinqassmu l- għadam), speċjalment ta ’ l- ispina, il- ġnub u l- polz.
How PROTELOS works PROTELOS belongs to a group of medicines used to treat bone diseases.
Kif jaħdem PROTELOS PROTELOS jappartjeni għall- grupp ta ’ mediċini li jintużaw għall- kura ta’ mard fl- għadam.
PROTELOS works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
PROTELOS jaħdem billi jnaqqas il- ksur fl- għadam u jistimula l- bini ta ’ l- għadam mill- ġdid u għalhekk inaqqas ir- riskju ta ’ ksur.
BEFORE YOU TAKE PROTELOS
QABEL MA TIEĦU PROTELOS
Do not take PROTELOS:
Tieħux PROTELOS
Before taking PROTELOS talk to your doctor:
Oqgħod attent ħafna bi PROTELOS Qabel tieħu PROTELOS kellem lit- tabib tiegħek:
- if you are being treated or have been treated for blood clots.
- jekk int qiegħed tieħu kura jew qatt ħadt kura għall- emboli fid- demm.
- PROTELOS is not intended for use in children and adolescents.
- PROTELOS mhux indikat għall- użu fit- tfal u fl- addoloxxenti.
25 During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking PROTELOS and seek medical advice.
25 Waqt il- kura, jekk ikollok xi reazzjoni allerġika (bħal nefħa fil- wiċċ, ilsien jew fil- gerżuma, diffikultà biex tieħu in- nifs jew biex tibla ’, raxx) għandek tieqaf immedjatament milli tieħu PROTELOS u għandek tfittex parir mediku.
If you have stopped treatment due to hypersensitivity reactions it should be permanent and you should not re-start therapy with PROTELOS.
Jekk tkun waqqaft il- kura minħabba reazzjonijiet ta ’ sensittività eċċessiva din għandha tkun permanenti u m’ għandekx terga ’ tibda kura b’ PROTELOS.
If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
Jekk qed tieħu mediċini li fihom calcium, għandek tħalli ta ’ mill- inqas sagħtejn qabel ma tieħu PROTELOS.
If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Jekk tieħu mediċini kontra l- aċidu fl- istonku (mediċini biex itaffu l- ħruq fl- istonku) għandek toħodhom mill- inqas 2 sigħat wara PROTELOS.
If this is not possible, it is acceptable to take the two medicines at the same time.
Jekk dan mhux possibli, huwa aċċettabli li - tieħu ż - żewġ mediċini fl- istess ħin.
You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Għandek tieqaf mill tieħu PROTELOS jekk ikollok bżonn tieħu tetracyclines jew quinolones mil- ħalq (żewġ tipi ta ’ antibiotiċi).
You can take PROTELOS again when you have finished taking these antibiotics.
Tista terġa tibda tieħu PROTELOS meta tispiċċa tieħu dawn l- antibiotiċi.
Taking PROTELOS with food and drink:
Meta tieħu PROTELOS ma ’ l- ikel u max- xorb:
It is recommended that you take PROTELOS in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
Huwa rakkomandat li tieħu PROTELOS bejn l- ikel, prefibbilment qabel ir- raqda ta ’ bil- lejl mill- inqas sagħtejn wara l- ikel, il- ħalib jew prodotti magħmulin mill- ħalib u supplimenti ta ’ calcium.
PROTELOS is meant for use only in postmenopausal women.
PROTELOS huwa magħmul biss għall- użu f’ nisa wara l- menopawsa.
Therefore, PROTELOS should not be taken during pregnancy.
Għalhekk, PROTELOS m’ għandux jittieħed waqt it- tqala.
If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
Jekk tieħdu biż- żball waqt it- tqala, għandek tieqaf tieħdu mill- ewwel u tfittex il- parir tat- tabib tiegħek.