qanastek/EMEA-V3 huggingface dataset:
The recovery of hypoglycaemia may be delayed because Optisulin has a long action.
L- irkuprar mill- ipogliċemija tista ’ ddum minħabba li Optisulin jibqa ’ jaħdem fit- tul.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Huwa rrakkomandat li tittestja l- livell tiegħek taz- zokkor fid- demm, immedjatament wara li tieħu l - glukosju biex tiċċekkja li tassew għandek l- ipogliċemija.
Optisulin 100 Units/ ml solution for injection in a cartridge Insulin glargine
Optisulin 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ Insulina glargine
The instructions for using the insulin pen are provided with your insulin pen.
L- istruzzjonijiet dwar l- użu tal - pinna ta ’ l- insulina huma ipprovduti mal- pinna tiegħek ta ’ l- insulina.
What Optisulin is and what it is used for 2.
X’ inhu Optisulin u għalxiex jintuża 8.
Before you use Optisulin 3.
Qabel ma tuża Optisulin 9.
How to use Optisulin 4.
Kif għandek tuża Optisulin 10.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu 11.
How to store Optisulin 6.
Kif taħżen Optisulin 12.
It is made by a biotechnology process.
Huwa magħmul permezz ta ’ proċess bijoteknoloġku rikombinanti.
BEFORE YOU USE OPTISULIN
QABEL TUŻA OPTISULIN
Take special care with Optisulin
Oqgħod attent/ a ħafna b’ Optisulin:
47 Travel
47 Safar Qabel tivvjaġġa kellem lit- tabib tiegħek.
Before travelling consult your doctor.
- id- disponibbiltà ta ’ l- insulina tiegħek fil- pajjiż li qiegħed iżżur,
You may need to talk about
- il- forniment ta ’ l- insulina, siringi eċċ,
- the availability of your insulin in the country you are visiting,
- il- ħażna korretta ta ’ l- insulina tiegħek waqt l- ivvjaġġar,
- supplies of insulin, syringes etc.,
- il- ħin ta ’ l- ikel u t- teħid ta ’ l- insulina waqt l- ivvjaġġar
- correct storage of your insulin while travelling,
- l- effetti possibbli fit- tibdil minn żona ta ’ ħin għal oħra differenti,
- timing of meals and insulin administration while travelling,
- il- possibbiltà ta ’ riskji ġodda għal saħħtek fil- pajjiż li tkun qiegħed iżżur
- the possible effects of changing to different time zones,
- x’ għandek tagħmel f’ sitwazzjonijiet ta ’ emerġenza meta ma tħossokx tajjeb jew timrad.
In the following situations, the management of your diabetes may require a lot of care: − If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia). − If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
- Jekk m’ intix qed tiekol biżżejjed, il- livell taz- zokkor fid- demm tiegħek jista ’ jinżel iżżejjed
Always tell people who are caring for you or treating you that you require insulin.
F’ kull każ, jista ’ jkun meħtieġ li taġġusta d- doża tiegħek ta ’ l- insulina biex tevita livelli taz- zokkor fid- demm li jkunu baxxi wisq jew għoljin.
Using other medicines
- il- mediċini l- oħra kollha użati għall- kura tad- dijabete,
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
- l- inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE) (użati għall- kura ta ’ ċerti -
In each case, it may be necessary to adjust your insulin dosage to avoid blood sugar levels that are either too low or too high.
kundizzjonijiet tal- qalb jew ta ’ pressjoni għolja fid- demm)
Be careful when you start or stop taking another medicine.
- disopyramide (użat għall- kura ta ’ ċerti kundizzjonijiet tal- qalb)
Tell your doctor or pharmacist if you are taking or have recently taken any other all medicines, including medicines obtained without a prescription.
Il- mediċini li jistgħu jgħollu l- livell taz- zokkor f’ demmek (ipergliċemija) jinkludu:
Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
- danazol (mediċina li taħdem fuq l- ovulazzjoni),
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: − all other medicines used to treat diabetes, − angiotensin converting enzyme (ACE) inhibitors, used to treat certain heart conditions or high blood pressure), − disopyramide (used to treat certain heart conditions), − fluoxetine (used to treat depression), − fibrates (used to lower high levels of blood lipids), − monoamine oxidase (MAO) inhibitors (used to treat depression), − pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever) − sulfonamide antibiotics.
- id- dijuretiċi (użati għall- kura ta ’ pressjoni għolja fid- demm jew iż- żamma eċċessiva ta ’
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: − corticosteroids (such as "cortisone"used to treat inflammation), − danazol (medicine acting on ovulation), − diazoxide (used to treat high blood pressure), − diuretics (used to treat high blood pressure or excessive fluid retention), − glucagon (pancreas hormone used to treat severe hypoglycaemia), − isoniazid (used to treat tuberculosis), − oestrogens and progestogens (such as in the contraceptive pill used for birth control), − phenothiazine derivatives (used to treat psychiatric disorders), − somatropin (growth hormone), − sympathomimetic medicines (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma), − thyroid hormones (used to treat thyroid gland disorders),
- somatropin (ormon tat- tkabbir),
Your blood sugar level may either rise or fall if you take: − beta-blockers, (used to treat high blood pressure), − clonidine (used to treat high blood pressure), − lithium salts (used to treat psychiatric disorders).
ormoni tat- tirojde (użati għall- kura ta ’ disturbi fil- glandola tat- tirojde), l- mediċini hekk imsejħa atipiċi kontra l- psikożi (bħal olanzapine u clozapine) l- inibituri ta ’ protease (użati għall- kura ta ’ l- HIV)
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
L- imblokkaturi tar- riċetturi beta, bħal mediċini oħra simpatolitiċi (bħal clonidine, guanethidine u reserpine) jistgħu jdgħajjfu jew jaħbu kompletament l- ewwel sintomi ta ’ twissija li jgħinuk tagħraf xi ipogliċemija.
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Jekk m’ intix ċert/ a jekkintix qed tieħu xi waħda minn dawn il- mediċini staqsi lit- tabib jew lill- ispiżjar tiegħek.
Your blood sugar levels may either rise or fall if you drink alcohol.
Il- livelli taz- zokkor fid- demm tiegħek jistgħu jogħlew jewjitbaxxew jekk tixrob l- alkoħol
Your insulin dosage may need to be changed during pregnancy and after giving birth.
Id- dożaġġ tiegħek ta ’ l - insulina għandu mnejn jeħtieġ li jinbidel waqt it- tqala u wara li twelled. Il- kontroll għaqli tad- dijabete tiegħek, u l- prevenzjoni ta ’ l- ipogliċemija, huma importanti għas- saħħa tat- tarbija tiegħek.
Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Jekk int qed tredda ’, għid lit- tabib tiegħek għax jista ’ jagħti l- każ li teħtieġ tibdiliet fid- dożi ta ’ l - insulina u d- dieta tiegħek.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
L- abbiltà tiegħek biex tikkonċentra u tirreaġixxi tista ’ tonqos jekk:
Driving and using machines
- għandek l- ipogliċemija (livell baxx ta ’ zokkor fid- demm)
Your ability to concentrate or react may be reduced if: − you have hypoglycaemia (low blood sugar levels) − you have hyperglycaemia (high blood sugar levels) − you have problems with your sight.
- għandek l- ipergliċemija (livell għoli ta ’ zokkor fid- demm)
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i. e. it is essentially ‘ sodium free’.
Għal kull doża dan il- prodott mediċinali fih inqas minn 1 mmol (23 mg) ta ’ sodium, i. e tista ’ tgħid li huwa ‘ nieqes minn sodium ’.
Dosage Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:
DożaġġSkond l- istil ta ’ ħajtek u r- riżultati tat- testijiet taz- zokkor (glukożju) fid- demm u l- użu preċedenti tiegħek ta ’ l- insulina, it- tabib tiegħek sejjer:
- tell you when you may need to inject a higher or lower dose of Optisulin.
- jgħidlek meta għandek bżonn tinjetta doża akbar jew iżgħar ta ’ Optisulin.
You need one injection of Optisulin every day, at the same time of the day.
Kemm il- darba jingħata Għandek bżonn ta ’ injezzjoni waħda ta ’ Optisulin kuljum, fl- istess ħin tal- ġurnata.
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Optisulin cartridges, and as recommended in the information provided by the device manufacturer.
L- iskartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- iskartoċċi ta ’ Optisulin u kif inhu rrakkomandat fit- tagħrif ipprovdut mal- pinna mill- manifattur.
Keep the cartridge at room temperature for 1 or 2 hours before inserting it in the pen.
Żomm l- iskartoċċ fit- temperatura ambjentali ta ’ ġewwa minn siegħa sa sagħtejn, qabel ma ddaħħlu fil - pinna.
Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it.
Użah biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah l- ilma, u m’ għandhiex xi frak jidher fiha.
Do not shake or mix it before use.
Tħawdux jew tħallthux qabel l- użu.
If you think you may have a problem with Optisulin, have it checked by your doctor or pharmacist.
Jekk taħseb li għandek problema b’ Optisulin, ħudu għand it- tabib jew l- ispiżjar tiegħekbiex jeżaminah.
Do not re-fill and re-use empty cartridges.
Terġax timla jew tuża l- iskartoċċi vojta.
Do not add any other insulin to the cartridge.
Iżżidx xi insulina oħra fl- iskartoċċ.
Mixing or diluting may change the action of Optisulin.
Jekk tħalltu jew tiddilwieh jista ’ jinbidel l- effett ta ’ Optisulin.
50 Problems with the insulin pen?
50 Problemi bil- pinna ta ’ l- insulina?
- If you have injected too much Optisulin, your blood sugar level may become too low
Jekk tuża aktar Optisulin milli suppost Jekk injettajt aktar Optisulin milli meħtieġ, il- livell taz- zokkor tiegħek fid- demm jista ’ jitbaxxa wisq (ipogliċemija).
In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Ġeneralment biex tevita l- ipogliċemija, għandek tiekol aktar u timmoniterja z- zokkor f’ demmek.
For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Għal aktar informazzjoni fuq il- kura ta ’ l - ipogliċemija ara l- kaxxa fit- tmiem ta ’ dan il- fuljett.
If you forget to use Optisulin
Jekk tinsatuża Optisulin
If you have missed a dose of Optisulin or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Jekk qbiżt doża ta ’ Optisulin jew jekk ma injettajtx biżżejjed insulina, il- livell taz- zokkor f’ demmek jista ’ jogħla wisq (ipergliċemija).
- Do not take a double dose to make up for a forgotten dose.
- Tieħux doża doppja biex tpatti għal dik li insejt.
If you stop using Optisulin This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Dan jista ’ jwassal għal ipergliċemija severa (livell għoli ħafna ta ’ zokkor fid- demm) u ketoaċidożi (jogħla l- livell ta ’ aċtu fid- demm minħabba li l- ġisem qiegħed jimmetabolizza x- xaħam minflok iz - zokkor).
Do not stop Optisulin without speaking to a doctor, who will tell you what needs to be done.
Tieqafx tieħu Opitsulin mingħajr ma tkun tkellimt ma ’ tabib, li se jgħidlek x’ għandek tagħmel.
51 Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Effetti sekondarji rrapportati b’ mod komuni ħafna (jidhru f’ aktar minn pazjent 1 minn kull 10 pazjenti) • Ipogliċemija
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.
51 Ipogliċemija (livell baxx ta ’ zokkor fid- demm) tfisser li m’ hemmx biżżejjed zokkor fid- demm.
Rare reported side effect (experienced in more than 1 in 10,000 but less than 1 in 1,000 patients) • Severe allergic reactions to insulins Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.
Każijiet severi ta ’ reazzjonijiet ġeneraliżżati, inkluża r- reazzjoni anafilattika, tista ’ tkun fatali.
Paediatric patients In general, the side effects in patients of 18 years of age or less are similar to those seen in adults.
Ġeneralment, l- effetti sekondarji, f’ pazjenti taħt it- 18- il sena, huma l- istess bħal dawk li jiġru fl- adulti.
Do not use Optisulin after the expiry date which is stated on the carton and on the label of the cartridge.
Tużax Optisulin wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta ta ’ l- iskartoċċ.
52 Unopened cartridges Store in a refrigerator (2°C-8°C).
Aħżen fil- friġġ (2°Ċ- 8°Ċ).
In use cartridges Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Skartoċċi fl- użu (ġo pinna ta ’ l- insulina) jew li qegħdin jinġarru bħala sper, għandhom jinżammu għal mhux aktar minn 4 ġimgħat u f’ temperatura mhux iżjed minn 25°Ċ., ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The cartridge in use in the insulin pen must not be stored in a refrigerator.
L- iskartoċċ li qed intuża m’ għandux jinżamm fi friġġ.
Do not use it after this time period.
Tużahx wara dan il- perijodu ta ’ żmie
Only use Optisulin if the solution is clear, colourless and waterlike.
Uża Optisulin biss jekk is- soluzzjoni hija ċara, bla kulur u tixbah l- ilma.
- Other ingredients of Optisulin are: zinc chloride, m-cresol, glycerol, sodium hydroxide, hydrochloric
- Is- sustanzi l- oħra ta ’ Optisulin huma: zinc chloride, m- cresol, glycerol, sodium hydroxide,
acid and water for injections.
hydrochloric acid, u ilma għall- injezzjonijiet.
What Optisulin looks like and contents of the pack
Id- dehra ta ’ Optisulin u l- kontenuti tal- pakkett:
Optisulin 100 Units/ ml solution for injection in a cartridge is a clear and colourless solution.
Optisulin 100 Unità/ ml soluzzjoni għall- injezzjoni fi skartoċċ huwa soluzzjoni ċara u mingħajr kulur.
Optisulin comes in a special cartridge for use in an Insulin Pen such as OptiPen and other pens suitable for Optisulin cartridges.
Optisulin huwa fornut f’ skartoċċ speċjali għall- użu f’ pinna ta ’ l- insulina bħal OptiPen u pinen oħra adattati għall- iskartoċċi ta ’ Optisulin.
Each cartridge contains 3 ml solution (300 Units) and they are available in packs of 4, 5 and 10 cartridges.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni (300 Unità) u huwa disponibbli f’ pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi.
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
53 België/ Belgique/ Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
France sanofi-aventis France Tél:
France sanofi- aventis F rance Tél:
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
54 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
This leaflet was last approved on Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Dan il- fuljett kien approvat l- aħħar f ’
54 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
Warning symptoms of hyperglycaemia Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and, glucose and ketone bodies in urine.
Sintomi ta ’ twissija ta ’ ipergliċemija Għatx, tħoss il- bżonn miżjud biex tgħaddi l- awrina aktar spiss miss- soltu, għeja, ġilda xotta, ħmura tal- wiċċ, nuqqas ta ’ aptit, pressjoni baxxa tad- demm, il- qalb tħabbat mġħaġġel u glukosju u ketoni fl - awrina.
- you are recovering from an illness or fromfever,
- int qed tirkupra minn marda jew mid- deni,
55 Hypoglycaemia is also more likely to occur if
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
-In your brain Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Ezempji ta ’ sintomi li jindikaw livell baxx taz- zokkor fil- moħħ: uġigħ ta ’ ras, ġuħ kbir, dardir, remettar, għeja, ngħas, disturbi fl- irqad, nuqqas ta ’ kwiet, komportament aggressiv, nuqqas ta ’ attenzjoni, reazzjonijiet imfixklin, depressjoni, konfużjoni mentali, taħwid fid- diskors, (xi drabi it- telf komplet tad- diskors), indeboliment tal- vista, rogħda, paralisi, tnemnim (parasteżija), sensazzjoni mtarrxa u tnemnim fir- reġjun tal- ħalq, sturdament, inabbiltà li trażżan lilek innifsek, inabbiltà li tieħu ħsieb tiegħek innifsek, aċċessjonijiet u t- telf mis- sensi.
- you have recently changed from an animal insulin to a human insulin such as Optisulin,
- dan l- aħħar biddilt minn tip ta ’ insulina ġejja mill- annimali għal dik tat- tip umana bħal -
56 Tell your relatives, friends and close colleagues the following:
Għid lill- qrabatek, ħbiebek u l- kollegi qrib tiegħek b’ dan li ġej:
What is Optruma?
X' inhu Optruma?
Optruma is a medicine containing the active substance raloxifene hydrochloride.
Optruma huwa mediċina li fiha s- sustanza attiva raloxifene kloridrat (hydrochloride).
What is Optruma used for?
Għal xiex jintuża Optruma?
Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Optruma jintuża għat- trattament u l- prevenzjoni tal- osteoporożi (marda li tagħmel l- għadam fraġli) f' nisa li għaddew mill- menopawża.
Optruma has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Intwera li Optruma jnaqqas b' mod sinifikanti l- ksur vertebrali (tas - sinsla tad- dahar), iżda mhux il- ksur fil- ġenbejn.
How is Optruma used?
Kif jintuża Optruma?
The recommended dose for adults and the elderly is one tablet taken once a day, with or without food.
Id- doża rakkomandata għall- adulti u għall- anzjani hija ta 'pillola waħda kuljum, fuq stonku vojt jew le.
Optruma is intended for long-term use.
Optruma huwa maħsub għal użu fit- tul.
How does Optruma work?
Kif jaħdem Optruma?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta l- għadam ġdid ma jiġġenerax ruħu biżżejjed biex jissostitwixxi l- għadam li jitfarrak naturalment.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Gradwalment, l- għadam jinsilet u jsir aktar fraġli, u għalhekk ikun aktar faċli li jinkiser.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
L- osteoporożi hija aktar komuni fin- nisa li għaddew mill- menopawża minħabba t- tnaqqis tal - livelli tal- estroġeni: l- estroġenu jnaqqas it- tkissir tal- għadam u jagħmel l- għadam inqas suxxettibbli għall- ksur.
The active substance in Optruma, raloxifene, is a selective oestrogen receptor modulator (SERM).
Is- sustanza attiva f' Optruma, raloxifene, hija modulatur selettiv tar- riċettur tal- estroġenu (SERM).
Raloxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Raloxifene jaġixxi bħala 'agonista' tar- riċettur tal- estroġenu (sustanza li tistimula r- riċettur għal estroġenu) f' xi tessuti fil- ġisem.
How has Optruma been studied?
Kif ġie studjat Optruma?
Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies.
Optruma ġie studjat fit- trattament u fil- prevenzjoni tal- osteoporożi f' erba 'studji prinċipali.
Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or placebo (a dummy treatment) for two years.
Tliet studji eżaminaw il- prevenzjoni tal- osteoporożi f' 1, 764 mara ttrattati b' Optruma jew bil- plaċebo (trattament finta) għal sentejn.
What benefit has Optruma shown during the studies?
Ir- raba 'studju qabbel l- effetti ta' Optruma ma 'dawn ta' plaċebo fit- trattament tal- osteoporożi f' 7, 705 nisa fuq erba 'snin.
Optruma was more effective than placebo in preventing and treating osteoporosis.
Optruma rriżulta aktar effikaċi mill- plaċebo fil- prevenzjoni u fit- trattament tal- osteoporożi.
In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Fil- prevenzjoni tal- osteoporożi, in- nisa ttrattati b' Optruma kellhom żieda fid- densità tal- għadam fil - ġenbejn jew fis- sinsla tad- dahar ta '1. 6% fuq sentejn, u dawk ittrattati bil- plaċebo kellhom tnaqqis ta' 0. 8%.
When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Meta użat fit- trattament tal- osteoporożi, Optruma rriżulta aktar effikaċi mill- plaċebo fit- tnaqqis tan - numru ta 'ksur vertebrali.
Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Fuq erba 'snin, meta mqabbel mal- plaċebo, Optruma naqqas in- numru ta' ksur vertebrali ġodda b' 46% f' nisa li jbatu mill- osteoporożi u bi 32% f' nisa li jbatu mill- osteoporożi u ksur eżistenti.
There was no effect of Optruma on hip fractures.
Ma kien hemm ebda effett ta 'Optruma fuq ksur tal- ġenbejn.
What is the risk associated with Optruma?
X' inhu r- riskju assoċjat ma 'Optruma?
The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
L- aktar effetti sekondarji komuni ma 'Optruma (li jidhru f' aktar minn pazjent 1 minn kull 100) huma t - twessigħ tal- arterji u tal- vini (vasodilation) (fwawar) u sintomi simili għal dawk tal- influwenza.
For the full list of side effects reported with Optruma, see the Package Leaflet.
Għal - lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Optruma, ara l- Fuljett ta' Tagħrif.
Optruma should not be used in women who: • could become pregnant; • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs); • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Optruma ma għandux jintuża minn nisa li: • jistgħu jinqabdu tqal; • għandhom jew kellhom disturbi fl- għaqid tad- demm, inkluż trombożi tal- vini fil- fond u emboliżmu pulmonari (ċappa demm fil- pulmun); • għandhom marda fil- fwied, marda serja fil- kliewi, fsada mingħajr raġuni mill- ġuf jew kanċer tal - endometriju (kanċer tal- inforra tal- ġuf).
Optruma should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.
Optruma ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal raloxifene jew għal xi sustanza oħra tiegħu.
Why has Optruma been approved?
Għaliex ġie approvat Optruma?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Optruma wera l - effikaċja tiegħu fil- prevenzjoni u fit- trattament tal- osteoporożi, u ma kellu ebda effett fuq is- sider jew fuq il- ġuf.
The Committee decided that Optruma’ s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Il- Kumitat iddeċieda li l- benefiċċji ta 'Optruma huma ikbar mir- riskji tiegħu għat- trattament u l - prevenzjoni tal- osteoporożi f' nisa li jkunu għaddew mill- menopawża.
The Committee recommended that Optruma be given marketing authorisation.
Il- Kumitat irrakkomanda li Optruma jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Optruma:
Informazzjoni oħra dwar Optruma:
The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B. V. on 5 August 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal Optruma lil Eli Lilly Nederland B. V. fil- 5 ta 'Awwissu 1998.
The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 5 ta 'Awwissu 2003 u fil- 5 ta' Awwissu 2008.
The full EPAR for Optruma is available here.
L- EPAR sħiħ għal Optruma jista 'jiġi kkonsultat hawn.
blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). bottle (HDPE)
folja (PVC/ PE/ PCTFE) folja (PVC/ PE/ PCTFE) folja (PVC/ PE/ PCTFE) flixkun (HDPE)
14 tablets 28 tablets 84 tablets 100 tablets
14- il pillola 28 pillola 84 pillola 100 pillola
OPTRUMA 60 mg film coated tablets
OPTRUMA 60 mg pilloli miksija b’ rita
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Kull pillola miksija b’ rita fiha 60 mg raloxifene hydrochloride, ekwivalenti g al 56 mg ta ’ raloxifene ba i libera.
Excipient: each tablet contains lactose (149.40 mg)
Sustanza mhux attiva: kull pillola fiha lactose (149. 40 mg)
Elliptically shaped, white tablets imprinted with the code ’ 4165’.
Pilloli bojod ovali bil- kodi i ‘ 4165 ’ stampat fuqhom.
OPTRUMA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
4. 1 Indikazzjonijiet terapewti i
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Intwera tnaqqis sinifikanti fl- in idenza ta ’ ksur tal- vertebri, i da mhux ksur ta ’ l- g adam tal - enbejn.
When determining the choice of OPTRUMA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Meta wie ed jag el bejn OPTRUMA u terapiji o ra, inklu l- estro enu, g al mara li qieg da fil - menopawsa, fuq ba i individwali jridu jitqiesu s- sintomi tal- menopawsa, l- effetti fuq it- tessuti ta ’ l - utru u s- sider, ir- riskji u l- benefi ji kardjovaskulari (ara sezzjoni 5. 1).
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals.
Id- do a rrakkomandata hija pillola wa da kuljum, me uda oralment, li tista ’ tittie ed fi kwalunkwe in tal - urnata ming ajr rigward g all- ikel.
No dose adjustment is necessary for the elderly.
M’ hemmx b onn ta ’ tibdil fid- do a g all- anzjani.
Due to the nature of this disease process, OPTRUMA is intended for long term use.
Min abba n- natura tal- pro ess naturali tal- marda, OPTRUMA hija intenzjonata biex tittie ed g al mien twil.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
eneralment huwa rrakkomandat li n- nisa li g andhom livelli baxxi tal- calcium u l- vitamina D fid - dieta, g andhom jing ataw supplimenti ta ’ dawn.
Use in renal impairment:
L- u u f’ indeboliment renali:
OPTRUMA should not be used in patients with severe renal impairment (see section 4.3).
OPTRUMA m’ g andhiex tintu a f’ pazjenti b’ indeboliment renali sever (ara sezzjoni 4. 3).
In patients with moderate and mild renal impairment, OPTRUMA should be used with caution.
F’ pazjenti b’ indeboliment renali moderat u afif, OPTRUMA g andha tintu a b’ kawtela.
Use in hepatic impairment:
L- u u f’ indeboliment epatiku:
OPTRUMA should not be used in patients with hepatic impairment (see section 4.3).
OPTRUMA m’ g andhiex tintu a f’ indeboliment epatiku (ara sezzjoni 4. 3).
Hypersensitivity to the active substance or to any of the excipients.
Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi.
Must not be used in women with child bearing potential.
M’ g andiex tintu a fin- nisa li g ad jistg u jo or u tqal.
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Passat mediku jew kundizzjoni pre enti ta ’ avvenimenti tromboemboli i fil- vini (VTE), li jinkludu t - trombo i tal- vini fondi, emoboli mu pulmonari u trombo i tal- vina tar- retina.
2 Hepatic impairment including cholestasis.
2 Indeboliment epatiku inklu a kolesta i.
Unexplained uterine bleeding.
Tnixxija ta ’ demm mill- utru ming ajr ma tkun mag rufa l- kaw a.
OPTRUMA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
OPTRUMA m’ g andhiex tintu a meta jkun hemm sinjali jew sintomi ta ’ kan er ta ’ l- endometriju g aliex is- sigurtà f’ dan il- grupp ta ’ pazjenti ma ietx studjata bi ejjed.
Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy.
Raloxifene huwa asso jat ma ’ riskju mi jud ta ’ avvenimenti tromboemboliti i fil- vini, li huwa simili g al dak irrappurtat li hu asso jat ma ’ l- u u kurrenti tat- terapija bl- ormoni, b ala sostitut.
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Il- bilan bejn ir- riskji u l- benefi iji g andu jitqies f’ pazjenti li huma f’ riskju ta ’ avvenimenti tromboemboliti i fil- vini, hi x’ inhi l- kaw a.
OPTRUMA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
OPTRUMA g andha titwaqqaf fl- eventwalità ta ’ marda jew kundizzjoni li omm g al perijodu twil l- individwa immobilizzata.
Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
Il- waqfien irid isir mill- aktar fis f’ ka ta ’ mard, jew minn 3 ijiem qabel ma jse l- immobilizzar.
Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
It- terapija m’ g andhiex ter a ’ tinbeda sakemm il - kundizzjoni tal- bidu tkun g addiet u l- pazjenta tkun mobbli g al kollox.
In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Fi studju kliniku li sar fin- nisa wara l- menopaw a u li huwa dokumentat li jbatu minn mard tal- qalb koronarju jew li qeg din f’ riskju og la li jkollhom xi problemi koronarji, raloxifene meta mqabbel ma ’ pla ebo, ma kellu ebda effett fuq l- in idenza ta ’ attakk ta ’ qalb, ta ’ b onn li tid ol l- isptar min abba sindromu koronarju akut, ta ’ mortalità in enerali li tinkludi l- imwiet kardjovaskulari kollu jew ta ’ attakk ta ’ puplesija.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Madankollu, kien hemm ieda fl- imwiet min abba attakki ta ’ puplesija fin- nisa li ew mg otija raloxifene.
This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
L- in idenza fil- mortalità min abba attakki ta ’ puplesija kienet ta ’ 1. 5 minn kull 1000 mara kull sena g al dawk fuq pla ebo kontra 2. 2 minn kull 1000 mara kull sena g al dawk fuq raloxifene. Trid i omm dawn ir- ri ultati f’ mo ok meta tordna raloxifene g al nisa wara l- menopaw a u li g andhom passat mediku ta ’ attakk ta ’ puplesija jew xi fatturi sinifikanti o ra ta ’ riskju g al attakki ta ’ puplesija b al attakk iskemiku tran itorju jew fibbrillazzjoni atrijali
Any uterine bleeding during OPTRUMA therapy is unexpected and should be fully investigated by a specialist.
Kwalunkwe tnixxija ta ’ demm mill- utru, waqt it- terapija b’ OPTRUMA mhux mistennija u din g andha ti i investigata sew minn spe jalista.
The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
L- aktar ew kundizzjonijiet dijanjostikati ta ’ spiss waqt il- kura b’ raloxifene, asso jati mat- tnixxija ta ’ demm mill- utru, kienu l- atrofija ta ’ l- endometriju u l- qarnit beninju ta ’ l- endometriju.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Fin- nisa wara l - menopawsa li ng ataw kura b’ raloxifene g al 4 snin, il- qarnit beninju ta ’ l- endometriju kien irrapportat f’ 0. 9% meta mqabbel ma ’ 0. 3% fin- nisa li r evew trattament bil- pla ebo.
Raloxifene is metabolised primarily in the liver.
Raloxifene ji i metaboli at primarjament fil- fwied.
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Do a wa da ta ’ raloxifene li ng atat lill- pazjenti li g andhom irro i u indeboliment moderat tal- fwied (Klassi A Child- Pugh) wasslet g all - kon entrazzjonijiet ta ’ raloxifene fil- pla ma li kienu madwar 2. 5 drabi akbar minn dawk li ma kellhomx dawn il- kundizzjonijiet.
The increase correlated with total bilirubin concentrations.
Din i - ieda kienet korrelata mal- livelli totali tal- kon entrazzjoni tal- bilirubin.
Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of OPTRUMA is not recommended in this patient population.
Sakemm is- sigurtà u l- effika ja ji u evalwati aktar f’ pazjenti b’ insuffi jenza tal- fwied, l - u u ta ’ Optruma mhux irrakkomandat f’ dan il- grupp ta ’ pazjenti.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Il- livelli tal- bilirubin fis- serum, gamma- glutamyl transferase, alkaline phosphatase, ALT u AST g andhom ikunu immoniterjati mill - qrib waqt il- kura jekk jinstabu livelli g oljin.
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/ l), raloxifene may be associated with a marked increase in serum triglycerides.
Informazzjoni klinika limitata tissu erixxi, li f’ pazjenti b’ passat mediku ta ’ ipertrigli eridimja (> 5. 6 mmol/ l), dovuti g all- estro enu orali, raloxifene jista ’ jkun asso jat ma ’ ieda qawwija fil - livelli tat- trigli eridi fis- serum.
Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
Il- pazjenti li g andhom dan il- passat mediku, je tie u li l- livelli tat - trigli eridi fis- serum ji u immoniterjati meta jkunu qeg din jie du raloxifene.
The safety of OPTRUMA in patients with breast cancer has not been adequately studied.
Is- sigurtà ta ’ OPTRUMA f’ pazjenti li g andhom kan er tas- sider g adha ma ietx studjata bi ejjed.
No data are available on the concomitant use of OPTRUMA and agents used in the treatment of early or advanced breast cancer.
M’ hemmx informazzjoni disponibbli dwar l- u u ta ’ OPTRUMA flimkien ma ’ sustanzi w ati fil- kura tal- kan er tas- sider, kemm fil- fa i bikrija jew f’ dik avvanzata.
Therefore, OPTRUMA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
G alhekk, OPTRUMA g andha tintu a g all- kura ta ’ l- osteoporo i u l- prevenzjoni tag ha, wara li l- kura g all- kan er tas- sider, inklu a t- terapija mi juda, tkun tlestiet.
As safety information regarding co-administration of raloxifene with systemic oestrogens is limited such use is not recommended
3 Peress li l- informazzjoni dwar is- sigurtà fl- u u fl- istess mien ta ’ raloxifene u estro eni sistemi i hi limitata, dan l- u u mhux irrakkomandat.
3 OPTRUMA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
OPTRUMA mhix effettiva biex tnaqqas il- va odilatazzjoni (fwawar) u sintomi o ra tal- menopawsa asso jati ma ’ defi jenza ta ’ l- estro enu.
Optruma contains lactose.
Optruma fih lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza g al galactose, ta ’ difett fil - Lapp lactase jew ta ’ nuqqas fl- assorbiment ta ’ glucose- galactose m’ g andhomx jie du din il- medi ina.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti medi inali o ra li ma jaqblux ma dan il- prodott u affarijiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott.
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
It- te id konkomittanti ta ’ calcium carbonate jew ta ’ aluminium u magnesium hydroxide li jinstabu fil - medi ini kontra l- a idu ta ’ l- istonku, ma jaffetwax l- espo izzjoni sistemika ta ’ raloxifene.
Co-administration of raloxifene and warfarin does not alter the pharmacokinetics of either compound.
It- te id ta ’ raloxifene flimkien ma ’ warfarin ma jbiddilx il- farmakokineti i ta ’ l- ebda wa da minn dawn is- sustanzi.
However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored.
Madankollu, tnaqqis moderat fil - in tal- protrombina kien osservat, u jekk raloxifene jing ata flimkien ma ’ warfarin jew ma xi derivattivi o ra tal- coumarin, il - in tal- protrombina jrid ikun immoniterjat.
Effects on prothrombin time may develop over several weeks if OPTRUMA treatment is started in patients who are already on coumarin anticoagulant therapy.
L- effetti fuq il - in tal- protrombina jistg u ji viluppaw tul diversi img at, jekk il- kura b’ EVSITA tinbeda f’ pazjenti li di a qeg din fuq it- terapija antikoagulanti bil- coumarin.
Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
Raloxifene m’ g andhux effett fuq il - farmakokinetika ta ’ methylprednisolone meta jing ata b ala do a wa da.
Raloxifene does not affect the steady-state AUC of digoxin.
Raloxifene m’ g andux effett fuq l- AUC fi stat stabbli ta ’ digoxin.
The Cmax of digoxin increased by less than 5%.
Is- Cmax ta ’ digoxin diedet b’ inqas minn 5%.
The influence of concomitant medication on raloxifene plasma concentrations was evaluated in the prevention and treatment trials.
L- effett ta ’ medi ini li jittie du flimkien fuq il- kon entrazzjonijiet ta ’ raloxifene fil- pla ma kienu evalwati fi provi ta ’ prevenzjoni u kura.
Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Prodotti medi inali li jing ataw spiss inkludew paracetamol, is- sustanzi kontra l- infjammazzjoni li mhumiex sterojdi (b al acethylsalicylic acid, ibuprofen u naproxen), l- antibijoti i orali, l- antagonisti H1, l- antagonisti H2, u l- benzodija epini.
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Ma kienx hemm effetti klinikament rilevanti bl- u u konkomittanti ta ’ dawn is- sustanzi fuq il- kon entrazzjonijiet ta ’ raloxifene fil- pla ma.
Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
L- u u konkomittanti tas- sustanzi va inali ta ’ l- estro enu t alla fil- programm tal- prova klinika, jekk dan kien ne essarju biex jittratta s- sintomi ta ’ l- atrofija va inali.
Compared to placebo there was no increased use in OPTRUMA treated patients.
Meta mqabbel mal- pla ebo ma kienx hemm ieda fl- u u fil- pazjenti li kienu ittrattati b’ OPTRUMA.
Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Raloxifene m’ g andhux jing ata flimkien ma ’ cholestyramine (jew xi re ini o ra tat- tip li jibdlu l - enajins), li jnaqqas b’ mod sinifikanti l- assorbiment u - iklu enteroepatiku ta ’ raloxifene.
Peak concentrations of raloxifene are reduced with co-administration with ampicillin.
l- og la livelli ta ’ raloxifene jitnaqqsu meta jing ata flimkien ma ’ ampicillin.
However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
Madankollu, peress li l - ammont enerali ta ’ raloxifene li ji i assorbit u r- rata tat- tne ija tieg u ma ji ux effetwati, raloxifene jista ’ jing ata flimkien ma’ ampicillin.
Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Raloxifene j id moderatament il- kon entrazzjonijiet tal- globulini li jaqbdu ma ’ l- ormoni, inklu i l - glubulini li jaqbdu ma ’ l- ormoni sesswali sterojdi (SHBG), il- globulina li taqbad ma ’ l- ormon thyroxine (TBG) u l- globulina li taqbad mal- kortikosterojdi (CBG), b ’ idiet korrispondenti fil - kon entrazzjonijiet totali ta ’ l- ormoni.
These changes do not affect concentrations of free hormones.
Dawn il- bidliet ma jeffetwawx il- kon entrazzjonijiet ta ’ l - ormoni liberi, ji ifieri mhux marbuta.
4.6 Pregnancy and lactation
4. 6 Tqala u Treddig
OPTRUMA is only for use in postmenopausal women.
OPTRUMA g andha tintu a biss fin- nisa wara l- menopawsa.
OPTRUMA must not be taken by women of child bearing potential.
4 OPTRUMA m’ g andhiex tittie ed min- nisa li jistg u jo or u tqal.
Raloxifene may cause foetal harm when administered to a pregnant woman.
Raloxifene jista ’ jikkaw a sara lill- fetu jekk jing ata lill- mara tqila.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Jekk dan il- prodott medi inali jintu a bi ball waqt it- tqala, jew il- pazjenta to ro tqila waqt li qed tie du, il- pazjenta trid tkun informata bil- potenzjal tal - sara lill - fetu (ara sezzjoni 5. 3).
4 It is not known whether raloxifene is excreted in human milk.
Mhux mag ruf jekk raloxifene jo ro x fil - alib tas- sider.
Its clinical use, therefore, cannot be recommended in breast-feeding women.
G alhekk, l- u u kliniku tieg u ma jistax ikun irrakkomandat fin- nisa li qeg din ireddg u.
OPTRUMA may affect the development of the baby.
OPTRUMA tista ’ teffetwa l- i vilupp tat- tarbija.
Raloxifene has no known influence on the ability to drive and use machines.
Ma jidhirx li Raloxifene g andu xi effett fuq il - ila biex issuq u t addem magni
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactionswere recorded.
Fi studji ta ’ kura u prevenzjoni ta ’ l- osteoporo i u li nvolvew ’ l fuq minn 13, 000 mara wara l - menopaw a, ir- reazzjonijiet avversi kollha ew imni lin.
The duration of treatment in these studies ranged from 6 to 60 months.
It- tul ta - mien tal- kura f’ dawn l- istudji varja minn 6 sa 60 xahar.
The majority of adverse reactions have not usually required cessation of therapy.
Il- ma oranza tar- reazzjonijiet avversi normalment ma rrikjedux il- waqfien tat- terapija.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 OPTRUMA treated patients and 11.1% of 584 placebo-treated patients.
F’ pazjenti fejn OPTRUMA ntu at g all- prevenzjoni, kien hemm b onn li titwaqqaf it- terapija min abba xi reazzjoni avversa f’ 10. 7% ta ’ 581 pazjenta fuq OPTRUMA u 11. 1% ta ’ 584 pazjenta fuq il- pla ebo.
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8% of 2,557 OPTRUMA treated patients and 11.1% of 2,576 placebo treated patients.
F’ dawk il- pazjenti li kienu qeg din jie du OPTRUMA b ala kura, kien hemm b onn li titwaqqaf it- terapija min abba kwalunkwe avveniment kliniku avvers, f’ 12. 8% ta ’ 2, 557 pazjenta li kienu ittrattati b’ OPTRUMA u 11. 1% ta ’ 2, 576 pazjenta ittrattati bil- pla ebo.
The following convention has been used for the classification of the adverse reactions: very common (1/ 10), common (1/ 100 to < 1/ 10), uncommon (1/ 1,000 to < 1/ 100), rare (1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi asso jati ma ’ l- u u ta ’ raloxifene fil- provi klini i ta ’ l- osteoporo i huma mog tija fil- qosor fit- tabella ta ’ hawn ta t. iet u ata s- sistema li ejja b ala klassifikazzjoni tar - reazzjonijiet avversi: komuni afna (1/ 10), komuni (1/ 100, < 1/ 10), mhux komuni (> 1/ 1, 000, < 1/ 100), rari (> 1/ 10, 000, < 1/ 1, 000), rari afna (< 1/ 10, 000)
Vascular disorders Very common):
Disturbi vaskulari Komuni afna:
Vasodilation (hot flushes) Uncommon:
Va odilatazzjoni (fwawar) Mhux komuni:
Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis Superficial vein thrombophlebitis Musculoskeletal and connective tissue disorders Common:
Avvenimenti tromboemboli i fil- vini, inklu a t- trombo i tal- vini fondi, l- emboli mu pulmonari, it- trombo i tal- vina tar- retina, it- tromboflebite tal- vini superfi jali Disturbi muskolu- skeletali u tat- tessut Konnettiv Komuni:
Leg cramps General disorders and administration site conditions Very common:
Bug awwie ijiet tar- ri lejn Disturbi enerali u kondizzjonijiet ta ’ sit mnejn jing ata Komuni afna:
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in OPTRUMA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% OPTRUMA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for OPTRUMA and 7.1% placebo).
Meta mqabbel mal- pla ebo, l- okkorrenza tal- va odilatazzjoni (il- fwawar) kienet moderatament aktar komuni fil- pazjenti fuq OPTRUMA (il- provi klini i g al- prevenzjoni ta ’ l- osteoporo i; minn 2 sa 8 snin wara l- menopawsa, 24. 3% bl- OPTRUMA u 18. 2% bil- pla ebo, il- provi klini i g all- kura ta ’ l - osteoporo i, età medja ta ’ 66, 10. 6% bl- OPTRUMA u 7. 1% bil- pla ebo).
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Din ir- reazzjoni avversa kienet l- aktar komuni fl- ewwel 6 xhur tal- kura, u f’ ka ijiet rari okkorra de novo wara dan i - mien.
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
Fi studju ta ’ 10, 101 mara wara l- menopaw a u li huwa dokumentat li g andhom mard tal- qalb koronarju jew li qeg din f’ riskju og la li jkollhom xi problemi koronarji (RUTH), l- okkorrenza tal - va odilatazzjoni (il- fwawar) kienet ta ’ 7. 8% f’ pazjenti kkurati b’ raloxifene u ta ’ 4. 7% f’ pazjenti kkurati bi pla ebo.