qanastek/EMEA-V3 huggingface dataset:
If Dynastat is used with strong pain killers such as morphine the dose of Dynastat will be the same as explained above.
Jekk tieħu Dynastat flimkien ma ’ mediċini qawwija għall- kontra l- uġigħ, bħall- morfina, id- doża ta ’ Dynastat tkun kif inhi spjegata hawn fuq.
Children and adolescents under the age of 18 will not be given Dynastat.
Tfal u adoloxxenti ta ’ taħt it- 18 – il sena m’ għandhomx jingħataw Dynastat.
People aged 18 and over will be given the adult dose.
Pesuni li għandhom 18- il sena u aktar jingħataw id- doża li tingħata lill- adulti.
If you have any further questions on the use of this product ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Dynastat can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Dynastat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some people given Dynastat can have side effects.
Dynastat jista ’ jkollu effetti oħra għal xi ftit nies.
If you notice any of these, or any other effects of the injections not mentioned, tell a doctor or nurse, as some of these effects may be serious enough to require immediate medical attention.
Jekk tinduna bi kwalinkwe effetti oħra, jew xi effetti oħra li mhux imsemmija f’ dan il- fuljett, kellem lit- tabib tiegħek għax ftit minn dawn l- effetti jistgħu jkunu serji biżżejjed li jeħtieġu attenzjoni medika immedjata.
Stop taking Dynastat and tell your doctor immediately:
Tibqax tieħu Dynastat u għid lit- tabib tiegħek minnufih:
- if you develop a rash or ulceration in any part of your body (e. g. skin, mouth, eyes, face, lips or
- jekk tiżviluppa raxx jew ulċerazzjoni f’ xi parti ta ’ ġismek (eż. ġilda, ħalq, għajnejn, wiċċ,
tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause wheezing, difficulty breathing, or swallowing – this occurs rarely
xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, tax- xoffa jew ta ’ l- ilsien li tista ’ tikkawża tħarħir, diffikultà fit- teħid tan- nifs, jew diffikulta ’ meta tibla ’ - dan rarament jiġri
- if you have blistering or peeling of the skin – this occurs rarely
- jekk għandek bżieżaq fil- ġilda jew jekk il- ġilda tiegħek qegħda titqaxxar - dan rarament jiġri
- the onset of skin reactions can occur at any time but most often occur in the first month of
- il- bidu ta ’ reazzjonijiet tal- ġilda jista ’ jseħħu fi kwalunkwe mument iżda l- aktar li jseħħ ta ’ spiss
treatment; the reported rate of these events appears to be greater for valdecoxib as compared to other cox-2 inhibitors
huwa fl- ewwel xahar tat- trattament; ir- rata rrapportata ta ’ dawn l- avvenimenti tidher li hija ikbar għal valdecoxib meta mqabbla ma ’ inibituri oħra ta ’ cox- 2.
- if you have jaundice (your skin or the whites of your eyes appear yellow)
- jekk għandek is- suffejra (il- ġilda tiegħek jew l- abjad ta ’ għajnejk jidhru sofor)
if you have any signs of bleeding in the stomach or intestine, such as passing a black or blood- stained bowel movement or vomiting blood
- jekk għandek xi sinjal ta ’ fsada fl- istonku jew fl- intestini, bħal per eżempju tipporga iswed jew
83 More common effects These could affect between 1 and 10 in every 100 people Blood pressure may be made higher or lower You may get back pain Ankles, legs and feet may swell (fluid retention) You may feel numb You may get stomach ache, indigestion, bloating and wind Tests may show abnormal kidney function You may feel agitated or find it hard to sleep There is a risk of anaemia You may get a sore throat or difficulty breathing Your skin may be itchy You may pass less urine than usual Dry socket (inflammation and pain after a tooth extraction). > If any of these affects you, talk to your doctor or nurse.
87 Testijiet juru funzjoni anormali tal- kliewi Tħossok aġitat jew issibha diffiċli biex torqod Hemm riskju ta ’ anemija Ikollok griżmejk juġgħawk jew tbati biex tieħu n- nifs Ġilda tieklok Tgħaddi inqas urina mis- soltu Sokit xott (infjammazzjoni u uġigħ wara li taqla ’ sinna) Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib jew lin- ners tiegħek.
Uncommon effects These could affect less than 1 in every 100 people Worsening of high blood pressure Ulcers in the digestive system The heart may beat more slowly Blood tests may show abnormal liver function You may bruise easily (or have a low blood platelet count) Surgical wounds may become infected There is a risk of stroke. > If any of these affects you, talk to your doctor or nurse.
Effetti mhux komuni Dawn jistgħu jaffettwaw inqas minn 1 persuna f’ 100 Aggravar tal- pressjoni għolja Ulċeri fis- sistema diġestiva Il- qalb tħabbat iżjed bil- mod Testijiet tad- demm jistgħu juru anomaliji fil- funzjoni tal- fwied Titbenġel malajr (jew ikollok għadd baxx ta ’ plejtlets fid- demm) Feriti ta ’ operazzjoni jistgħu jinfettaw ruħhom Hemm riskju ta ’ puplesija Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib jew lil xi infermier/ a.
Rare Effects These could affect less than 1 in every 1000 people.
Effetti rari Dawn jistgħu jaffettwaw inqas minn 1 persuna f’ 1000.
Rash or ulceration in any part of your body (e. g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing Swelling, blistering or peeling of the skin Kidney failure and acute kidney failure Heart failure, heart attack Racing or irregularity of the heartbeat Breathlessness Hepatitis (inflamed liver) Abdominal pain Nausea (feeling sick) Vomiting
Insuffiċjenza tal- kliewi u insuffiċjenza akuta tal- kliewi.
> If any of these affects you, talk to your doctor or nurse.
Insuffiċjenza tal- qalb, attakk tal- qalb Taħbit tal- qalb mgħaġġel ħafna jew irregolari Qtugħ ta ’ nifs Epatite (fwied infjammat) Uġigħ addominali Nawsja (dardir) Rimettar Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib tiegħek jew lil xi infermier/ a.
HOW TO STORE DYNASTAT
KIF TAĦŻEN DYNASTAT
Keep out of the reach or sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
The product should not be used after the expiry date stated on the label.
Il- prodott m’ għandux jintuża wara d- data ta ’ skadenza li tidher fuq it- tikketta.
This medicinal product does not require any special storing conditions prior to reconstitution.
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni ta ’ ħażna speċjali qabel ir- rikostituzzjoni.
Your doctor will use Dynastat as soon as possible after it is mixed with solvent.
It- tabib tiegħek ser juża Dynastat mill- aktar fis wara li dan ta ’ l- aħħar jitħallat mas- solvent.
If there are particles in the injection solution or if either the powder or solution is discoloured, the solution will not be used.
Jekk tara xi frak fis- soluzzjoni għall- injezzjoni jew jekk it- trab jew is- soluzzjoni tilfu l- kulur tagħhom, is- soluzzjoni m’ għandiex tintuża.
84 6.
88 6.
What Dynastat contains
X’ fih Dynastat
- The active substance is parecoxib (as parecoxib sodium).
- Is- sustanza attiva hija parecoxib (bħala parecoxib sodium).
Each vial contains 20 mg parecoxib, as
Kull fjala fiha 20 mg parecoxib, bħala
21.18 mg parecoxib sodium.
21. 18 mg parecoxib sodium.
When reconstituted with 1 ml solvent, provides 20 mg/ ml of parecoxib.
Meta rikostitwit b’ 1 ml solvent, jipprovdi 20 mg/ ml ta ’ parecoxib.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.22 mEq of sodium per vial.
Meta rikostitwit f’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride, Dynastat ikun fih madwar 0. 22 mEq ta ’ sodiumf’ kull fjala.
Powder Disodium hydrogen phosphate Phosphoric acid and/ or sodium hydroxide (for pH adjustment).
Trab Disodium hydrogen phosphate Phosphoric acid u/ jew sodium hydroxide (għal aġġustament tal- pH).
What Dynastat looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
Dynastat is available as a white to off-white powder.
Dynastat huwa disponibbli bħala trab abjad għal offwajt.
The powder is contained in colourless glass vials (2 ml) with a laminated stopper, sealed with a yellow flip-off cap on the aluminium overseal.
It- trab jinżamm fi fjali tal- ħġieġ bla kulur (2 ml) b’ tapp laminat, issiġillat b’ għatu isfar li jitfetaħ b’ daqqa ta ’ saba ’ fuq it- tgeżwira fuq kollox ta ’ l- aluminju.
Marketing Authorisation Holder and Manufacturer
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Pfizer Limited, Sandwich, Kent CT13 9NJ United Kingdom Manufacturer:
Pfizer Limited, Sandwich, Kent CT13 9NJ Ir - Renju Unit Manifattur:
NPIL Pharmaceuticals (UK) Ltd, Morpeth, Northumberland NE613YA United Kingdom Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
NPIL Pharmaceuticals (UK) Ltd, Morpeth, Northumberland NE613YA Ir- Renju Unit Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belġjum
85 Ελλάδα Pfizer Hellas A. E.
89 Ελλάδα Pfizer Hellas A. E.
România Pfizer România S. R. L.
Români Pfizer România S. R. L.
This leaflet was last approved on {date} < ------------------------------------------------------------------------------------------------------------------
Dan il- fuljett kien approvat l- aħħar f ’: < ---------------------------------------------------------------------------------------------------------------------
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu.
86 The following information is intended for medical or healthcare professionals only
90 INFORMAZZJONI GĦAL- PROFESSJONISTA TAS- SAĦĦA
Administration is by intramuscular (IM) or intravenous (IV) injection.
Tingħata b’ injezzjoni fil- muskolu (IM) jew fil- vina (IV).
The IM injection is to be given slowly and deeply into the muscle and the IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
L- injezzjoni IM għandha tingħata bil- mod u fil- fond tal- muskolu u l- injezzjoni IV bolus tista tingħata malajr u direttament ġol- vina jew fit- tubu ta ’ l- IV eżistenti.
Reconstitution process Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Solventi għar- rikostituzzjoni Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra u għandu jiġi rikostitwit biss ma ’: • sodium chloride 9 mg/ ml (0. 9%) soluzzjoni • glucose 50 g/ l (5%) soluzzjoni għall- infużjoni • sodium chloride 4. 5 mg/ ml (0. 45%) u glucose 50 g/ l (5%) soluzzjoni għall- injezzjoni Mhux rrikkmandat l- użu tas- soluzzjoni għall- injezzjoni Ringer- Lactate jew glukosju 50g/ l (5%) fis - soluzzjoni għall- injezzjoni Ringer- Lactate għar- rikostituzzjoni minħabba li jikkawża preċipitazzjoni tal- parecoxib minn mas- soluzzjoni, Mhux irrikmandat l- użu ta ’ Ilma Sterili għall- injezzjoni għar- rikostituzzjoni minħabba li is- soluzzjoni ma tirriżultax isotonika Proċess ta ’ Rikostituzzjoni Uża teknika asettika biex tirrikostitwixxi parecoxib lajofilizzat (bħala parecoxib sodium).
20 mg vial:
20 mg fjala:
Remove the yellow flip-off cap to expose the central portion of the rubber stopper of the parecoxib 20 mg vial.
Neħħi l- kappa safra li tinfetaħ b’ subgħajk b’ mod li tikxef il- parti tan- nofs tat- tapp tal - gomma tal- fjala 20 mg parecoxib.
Withdraw with a sterile needle and syringe, 1 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 20 mg vial.
Iġbed permezz ta ’ labra sterili u siringa, 1ml ta ’ solvent xieraq u daħħal il- labra ġol- parti tan- nofs tat- tapp tal- gomma, b’ mod li s- solvent jiġi trasferit ġol- fjala ta ’ 20 mg parecoxib.
Dissolve the powder completely using a gentle swirling motion and inspect the reconstituted product before use.
Dewweb it- trab kompletament billi dawwru u ifli l- prodott rikostitwit qabel ma tużah.
The reconstituted solution must not be used if discoloured or cloudy or if particulate matter is observed The entire contents of the vial should be withdrawn for a single administration.
Dak kollu li jkun hemm fil- fjala għandu jiġi miġbud sabiex jiġi amministrat f’ darba biss.
IV line solution compatibility Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection.
Kumpatibilita ’ ta ’ l- apparat ta ’ soluzzjoni IV Meta Dynastat jitħallat ma ’ mediċini oħra f’ soluzzjoni jista jirriżulta fi preċipitazzjoni, u għalhekk Dynastat ma għandux jitħallat ma ’ l- ebda mediċina oħra, kemm waqt rikostituzzjoni u kemm waqt injezzjoni.
In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility After reconstitution with acceptable solvents, Dynastat may only be injected into IV lines delivering: • sodium chloride 9 mg/ ml (0.9%) solution • glucose 50 g/ l (5%) solution for infusion • sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection • Ringer-Lactate solution for injection Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in this section, is not recommended as this may cause precipitation from solution.
Wara r- rikostituzzjoni b’ solventi xierqa, Dynastat jista ’ jiġi injettat biss IV jew IM jew ġo tubi ta ’ L - IV ta ’: • sodium chloride 9 mg/ ml (0. 9%) soluzzjoni • glucose 50 g/ l (5%) soluzzjoni għall- infużjoni • sodium chloride 4. 5 mg/ ml (0. 45%) u glucose 50 g/ l (5%) soluzzjoni għall- injezzjoni • soluzzjoni Ringer- Lactate għall- injezzjoni L- injezzjoni fit- tubu ta ’ l- IV li tagħti glukożju 50g/ l (5%) fis- soluzzjoni għall- injezzjoni Ringer - Lactate jew fluwidi IV oħra mhux mniżżla f’ din is- sezzjoni, mhix irrikmandata minħabba li din tista tikkawża preċipitazzjoni tas- soluzzjoni.
The solution is for single use only and must not be stored in a refrigerator or freezer.
Is- soluzzjoni hija għal użu ta ’ darba biss u m’ għandiex tinżamm fil- friġġ jew friża.
Information for the User
91 FULJETT TA ’ TAGĦRIF:
Dynastat 20 mg powder and solvent for solution for injection parecoxib (parecoxib sodium)
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Dynastat 20 mg trab u solvent għal soluzzjoni għal injezzjoni parecoxib (bħala parecoxib sodium)
- If you have further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Dynastat is and what it is used for 2.
X’ inhu Dynastat u għalxiex jintuża 2.
It is supplied in cartons containing 1, 3 or 5 vials that also contain 1, 3 or 5 glass ampoules of a solvent for dissolving the contents of the vials.
Dynastat jinstab f’ pakketti ta’ 1, 3 u 5 fjali li fihom anke 1, 3 u 5 ampulli tal- ħġieġ tas- solvent biex tiddissolvi l- kontenut tal- fjali.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet kollha jkunu għal skopijiet kummerċjali
- if you have established heart disease and / or cerebrovascular disease e. g. if you have had a heart
- jekk għandek jew kellek problemi biċ- ċirkolazzjoni tad- demm tiegħek (mard arterjali periferali)
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
- jekk fil- passat kellek xi ulċera, tisfija tad- demm jew perforazzjoni tal- passaġġ gastro- intestinali
- if you have or have had problems with your blood circulation (peripheral arterial disease) or if
- tużax Dynastat jekk fil- preżent għandek ulċera gastrika jew intestinali jew fsada gastrointestinali
Make sure your doctor knows, before you are given Dynastat If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
Tużax Dynastat jekk għandek mard serju fil- fwied
Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine.
It- tabib tiegħek jista ’ jnaqqas id- doża ta ’ Dynastat jew ta ’ mediċini oħra, jew jista ’ jkollok bżonn tieħu mediċina oħra.
It’ s especially important to mention:
Huwa importanti ferm għalik li ssemmi:
Acetylsalicylic acid or other anti-inflammatory drugs Fluconazole – used for fungal infections ACE inhibitors – used for high blood pressure and heart conditions Cyclosporin or Tacrolimus – used after transplants Warfarin – or other medicines used to prevent blood clots Lithium – used to treat depression Rifampicin – used for bacterial infections Antiarrhythmics – used to treat an irregular heartbeat Phenytoin or Carbamazepine – used for epilepsy Theophylline – used for asthma Methotrexate – used for rheumatoid arthritis and cancer Antidepressants – used to treat depression Neuroleptics – used to treat psychoses
Acetylsalicylic acid jew mediċini oħra kontra l- infjammazzjoni Fluconazole – użati biex jittrataw infezzjonijiet tal- fungi Inibituri ACE – użati għal pressjoni għolja u mard tal- qalb Cyclosporin jew Tacrolimus – użati wara trapjanti Warfarina – jew mediċini oħra wżati biex jimpedixxu emboli Lithium – użat kontra d- depressjoni Rifampicin – użat għal infezzjonjiet b’ batterji Antiarrhythmics – użati sabiex jittratta taħbit irregolari tal- qalb Phenytoin jew Carbamazepine – użat għall- epilepsija Theophylline – użat għall- ażma Methotrexate – għal l- artrite rewmatika u kanċer Anti- dipressanti – użati biex jittrattaw id- depressjoni Newrolettiċi – użati sabiex jittrattaw psikożi
Dynastat can be used in combination with low dose acetylsalicylic acid
Dynastat jista ’ jintuża f’ kombinazzjoni ma ’ doża baxxa ta ’ acetylsalicylic acid
89 Get advice from a doctor or pharmacist before taking any medicine if you’ re pregnant or breast- feeding.
Itlob għall- parir tat- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina jekk int tqila jew qed tredda ’.
Driving and using machines If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.
Sewqan u tħaddim ta ’ magni Jekk l- injezzjoni tistordik jew tħeddlek, issuqx u m’ għandekx tħaddem magni sa ma tħossok aħjar.
HOW TO USE DYNASTAT
93 3 KIF TINGĦATA L- INJEZZJONI
Some people may be given lower doses:
Xi persuni jistgħu jingħataw dożi iżgħar:
People with liver problems People with severe kidney problems Patients over 65 who weigh less than 50 kg People taking fluconazole.
Persuni bi problemi fil- fwied Persuni li għandhom problemi serji fil- kliewi Persuni li għandhom ‘ l fuq minn 65 sena u li jiżnu inqas minn 50 kg Persuni li jkunu qegħdin jieħdu fluconazole
tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause wheezing, difficulty breathing, or swallowing – this occurs rarely
xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża tħarħir, diffikultà fit- teħid tan- nifs, jew diffikulta meta tibla ’ – dan rarament jiġri
- if you have blistering or peeling of the skin – this occurs rarely
- jekk għandek bżieżaq fil- ġilda jew jekk il- ġilda tiegħek qegħda titqaxxar – dan rarament jiġri
treatment; the reported rate of these events appears to be greater for valdecoxib as compared to other cox-2 inhibitors
huwa fl- ewwel xahar tat- trattament; ir- rata rrapportata ta ’ dawn l- avvenimenti tidher li hija ikbar għal valdecoxib meta mqabbla ma ’ inibituri cox- 2 oħra
- if you have jaundice (your skin or the whites of your eyes appear yellow)
- jekk għandek suffejra (il- ġilda tiegħek jew l- abjad ta ’ għajnejk jidhru sofor)
- if you have any signs of bleeding in the stomach or intestine, such as passing a black or blood-
- jekk għandek xi sinjal ta ’ fsada fl- istonku jew fl- intestini, billi per eżempju tipporga iswed jew
stained bowel movement or vomiting blood.
bid- demm jew tirremetti d- demm
90 More common effects These could affect between 1 and 10 in every 100 people Blood pressure may be made higher or lower You may get back pain Ankles, legs and feet may swell (fluid retention) You may feel numb You may get stomach ache, indigestion, bloating and wind Tests may show abnormal kidney function You may feel agitated or find it hard to sleep There is a risk of anaemia You may get a sore throat or difficulty breathing Your skin may be itchy You may pass less urine than usual.
Il- pressjoni tiżdied jew tonqos Jista ’ jkollok uġigħ f’ dahrek Għaksiet, riġlejn jew saqajn jintefħu (żamma ta ’ fluwidu) Ikollok tnemnim
Dry socket (inflammation and pain after a tooth extraction). > If any of these affects you, talk to your doctor or nurse.
94 Uġigħ fl- istonku, indiġistjoni, dijarrea, nawżea, imbulmar u gass Testijiet juru funzjoni anormali tal- kliewi Tħossok aġitat jew issibha diffiċli biex torqod Hemm riskju ta ’ anemija Ikollok griżmejk juġgħawk jew tbati biex tieħu n- nifs Ġilda tieklok Tgħaddi inqas urina mis- soltu Sokit xott (infjammazzjoni u uġigħ wara li taqla ’ sinna) Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib jew lin- ners tiegħek.
Rash or ulceration in any part of your body (e. g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing Swelling, blistering or peeling of the skin Kidney failure and acute kidney failure Heart failure, heart attack Racing or irregularity of the heartbeat Breathlessness Hepatitis (inflamed liver) Abdominal pain Nausea (feeling sick) Vomiting
Raxx jew ulċerazzjoni f’ xi parti ta ’ ġismek (eż. ġilda, ħalq, għajnejn, wiċċ, xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża diffikultà fit- teħid tan- nifs, jew tħarħir Insuffiċjenza tal- kliewi u insuffiċjenza akuta tal- kliewi.
> If any of these affects you, talk to your doctor or nurse.
Insuffiċjenza tal- qalb, attack tal- qalb Taħbit tal- qalb mgħaġġel ħafna jew irregolari Qtugħ ta ’ nifs Epatite (fwied infjammat) Uġigħ addominali Nawsja (dardir) Rimettar Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib tiegħek jew lil xi infermier/ a.
The product should not be used after the expiry date stated on the label.
Tużax Dynastat wara d- data ta ’ skadenza li tidher fuq it- tikketta.
This medicinal product does not require any special storing conditions prior to reconstitution.
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni ta ’ ħżin speċjali qabel rikostituzzjoni.
91 solution will not be used.
Jekk tara xi frak fis- soluzzjoni għall- injezzjoni jew jekk it- trab jew is- soluzzjoni tilfu l- kulur tagħhom, is- soluzzjoni m’ għandiex tintuża.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.22 mEq of sodium per vial.
Meta rikostitwit f’ soluzzjoni 9 mg/ ml (0. 9%) ta ’ sodium chloride, Dynastat fih madwar 0. 22 mEq ta ’ sodium kull fjala.
Solvent Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injections.
Ilma għal injezzjonijiet..
The powder is contained in colourless glass vials (2 ml) with a laminated stopper, sealed with a yellow flip-off cap on the aluminium overseal.
It- trab jinżamm fi fjali tal- ħġieġ bla kulur (2 ml) b’ tapp laminat, issiġillat b’ tapp isfar tat- tip flip- off fuq tgeżwira fuq kollox ta ’ l- aluminju.
The solvent is contained in colourless neutral glass ampoules (2 ml).
Is- solvent jinżamm f’ ampulli tal- ħġieġ bla kulur (2 ml).
Pfizer Limited, Sandwich, Kent CT13 9NJ United Kingdom Manufacturer:
Pfizer Limited, Sandwich, Kent CT13 9NJ Renju Unit Manifattur:
NPIL Pharmaceuticals (UK) Ltd, Morpeth, Northumberland NE613YA United Kingdom Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
NPIL Pharmaceuticals (UK) Ltd, Morpeth, Northumberland NE613YA Renju Unit Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belġjum
92 Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055 51000
96 Deutschland Pfizer Pharma GmbH Tel: +49 (0) 30 550055 51000
1800 633 363 (toll free) +44 (0)1304 616161
1800 633 363( toll free) +44 (0) 1304 616161
This leaflet was last approved on {date} < ------------------------------------------------------------------------------------------------------------------
< ---------------------------------------------------------------------------------------------------------------------
93 The following information is intended for medical or healthcare professionals only
97 INFORMAZZJONI GĦAL- PROFESSJONISTA TAS- SAĦĦA
The reconstituted solution must not be used if discoloured or cloudy or if particulate matter is observed The entire contents of the vial should be withdrawn for a single administration.
F’ dawk il- pazjenti li l- istess apparat ta ’ IV jintuża għall- injezzjoni ta ’ mediċina oħra, l - apparat għandu jitlaħlaħ sew b’ soluzzjoni kompatibbli ma ’ Dynastat, kemm qabel u kemm wara l - injezzjoni ta ’ Dynastat.
IV line solution compatibility Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility After reconstitution with acceptable solvents, Dynastat may only be injected into IV lines delivering: • sodium chloride 9 mg/ ml (0.9%) solution • glucose 50 g/ l (5%) solution for infusion • sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection • Ringer-Lactate solution for injection Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in this section, is not recommended as this may cause precipitation from solution.
Wara r- rikostituzzjoni b’ solventi xierqa, Dynastat jista ’ jiġi injettat biss IV jew IM jew ġo tubi ta ’ L - IV ta ’: • sodium chloride 9 mg/ ml (0. 9%) soluzzjoni • glucose 50 g/ l (5%) soluzzjoni għall- infużjoni • sodium chloride 4. 5 mg/ ml (0. 45%) u glucose 50 g/ l (5%) soluzzjoni għall- injezzjoni • soluzzjoni Ringer- Lactate għall- injezzjoni L- injezzjoni fit- tubu ta ’ l- IV li tagħti glukożju 50g/ l (5%) fis- soluzzjoni għall- injezzjoni Ringer - Lactate jew fluwidi IV oħra mhux mniżżla f’ din is- sezzjoni, mhix irrikmandata minħabba li din tista tikkawża preċipitazzjoni tas- soluzzjoni.
Information for the User
98 FULJETT TA ’ TAGĦRIF:
Dynastat 40 mg powder for solution for injection parecoxib (as parecoxib sodium)
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Dynastat 40 mg trab għal soluzzjoni għall- injezzjoni parecoxib (bħala parecoxib sodium)
- If any of the side effects gets serious, or if you notice any side effects not listed in thois leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Dynastat is and what it’ s used for 2.
X’ inhu Dynastat u għalxiex jintuża 2.
- if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding
- jekk fil - preżent għandek ulċera gastrika jew intestinali jew fsada gastrointestinali
- if you have established heart disease and / or cerebrovascular disease e. g. if you have had a heart
- jekk għandek mard tal- qalb stabbilit u/ jew mard ċerebrovaskulari eż. jekk kellek attack tal- qalb,
95
- jekk fil- passat kellek xi ulċera, tisfija tad- demm jew perforazzjoni tal- passaġġ gastro- intestinali
Make sure your doctor knows, before you are given Dynastat … If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
Tużax Dynastat jekk għandek mard serju fil- fwied
Do not use Dynastat if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding If you are taking acetylsalicylic acid or other NSAIDs (e. g. ibuprofen) If you smoke If you have diabetes If you have angina, blood clots, raised blood pressure or raised cholesterol If you are taking anti-platelet therapies (e. g. acetylsalicylic acid) If you have fluid retention (oedema) If you have liver or kidney disease.
- jekk inti nieqes mill- ilma – dan jista jiġri jekk kellek dijarrea, kont qed tirremetti (peress li marid)
Do not use Dynastat if you have severe liver disease If you might be dehydrated – this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids If you have an infection as it may hide a fever (which is a sign of infection) If you use medicines to reduce blood clotting (e. g. warfarin) If you are a woman trying to become pregnant
Jekk qed tieħu mediċini biex tnaqqas it- tgħaqqid tad- demm (e. ż. warfarina)
Acetylsalicylic acid or other anti-inflammatory drugs Fluconazole – used for fungal infections ACE inhibitors – used for high blood pressure and heart conditions Cyclosporin or Tacrolimus – used after transplants Warfarin – or other medicines used to prevent blood clots Lithium – used to treat depression Rifampicin – used for bacterial infections Antiarrhythmics – used to treat an irregular heartbeat Phenytoin or Carbamazepine – used for epilepsy Theophylline – used for asthma Methotrexate – used for rheumatoid arthritis and cancer Antidepressants – used to treat depression Neuroleptics – used to treat psychoses.
Acetylsalicylic acid jew mediċini oħra kontra l- infjammazzjoni Fluconazole – użati biex jittrataw infezzjonijiet tal- fungi Inibituri ACE – użati għal pressjoni għolja u mard tal- qalb Cyclosporin jew Tacrolimus – użati wara trapjanti Warfarina – jew mediċini oħra wżati biex jimpedixxu emboli Lithium – użat kontra d- depressjoni Rifampicin – użat għal infezzjonjiet b’ batterji Antiarrhythmics – użati sabiex jittratta taħbit irregolari tal- qalb Phenytoin jew Carbamazepine – użat għall- epilepsija Theophylline – użat għall- ażma Methotrexate – għal l- artrite rewmatika u kanċer Anti- dipressanti – użati biex jittrattaw id- depressjoni Newrolettiċi – użati sabiex jittrattaw psikożi
Get advice from a doctor or pharmacist before taking any medicine if you’ re pregnant or breast- feeding.
Itlob għall- parir tat- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina jekk int tqila jew qed tredda ’.
96 Driving and using machines If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.
Sewqan u tħaddim ta ’ magni Jekk l- injezzjoni tistordik jew tħeddlek, issuqx u m’ għandekx tħaddem magni sa ma tħossok aħjar.
HOW TO USE DYNASTAT
100 3 KIF TINGĦATA L- INJEZZJONI
People with liver problems People with severe kidney problems Patients over 65 who weigh less than 50 kg People taking fluconazole.
Persuni bi problemi fil- fwied Persuni bi problemi serju fil- kliewi Persuni li għandhom ‘ l fuq minn 65 sena u li jiżnu inqas minn 50 kg Persuni li jkunu qegħdin jieħdu fluconazole
tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause wheezing, difficulty breathing, or swallowing – this occurs rarely
xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża tħarħir, diffikultà fit- teħid tan- nifs, jew diffikulta 'meta tibla ’ - dan rarament jiġri
- if you have blistering or peeling of the skin - this occurs rarely
- jekk għandek bżieżaq fil- ġilda jew jekk il- ġilda tiegħek qegħda titqaxxar – dan rarament jiġri
stained bowel movement or vomiting blood
bid- demm jew tirremetti d- demm
97 More common effects These could affect between 1 and 10 in every 100 people Blood pressure may be made higher or lower You may get back pain Ankles, legs and feet may swell (fluid retention) You may feel numb You may get stomach ache, indigestion, bloating and wind Tests may show abnormal kidney function You may feel agitated or find it hard to sleep There is a risk of anaemia You may get a sore throat or difficulty breathing Your skin may be itchy You may pass less urine than usual.
Il- pressjoni tiżdied jew tonqos Jista ’ jkollok uġigħ f’ dahrek Għaksiet, riġlejn jew saqajn jintefħu (żamma ta ’ fluwidu) Ikollok tnemnim Uġigħ fl- istonku, indiġistjoni, dijarrea, nawżea, imbulmar u gass Testijiet juru funzjoni anormali tal- kliewi
Dry socket (inflammation and pain after a tooth extraction) > If any of these affects you, talk to your doctor or nurse.
101 Tħossok aġitat jew issibha diffiċli biex torqod Hemm riskju ta ’ anemija Ikollok griżmejk juġgħawk jew tbati biex tieħu n- nifs Ġilda tieklok Tgħaddi inqas urina mis- soltu Sokit xott (infjammazzjoni u uġigħ wara li taqla ’ sinna) Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib jew lin- ners tiegħek.
Uncommon effects These could affect less than 1 in every 100 people Worsening of high blood pressure Ulcers in the digestive system The heart may beat more slowly Blood tests may show abnormal liver function You may bruise easily (or have a low blood platelet count) vSurgical wounds may become infected There is a risk of stroke. > If any of these affects you, talk to your doctor or nurse.
Effetti mhux komuni Dawn jistgħu jaffettwaw inqas minn 1 persuna f’ 100 Aggravar tal- pressjoni għolja Ulċeri fis- sistema diġestiva Il- qalb tħabbat iżjed bil- mod Testijiet tad- demm jistgħu juru anomaliji fil- funzjoni tal- fwied Titbenġel malajr (jew ikollok għadd baxx ta ’ plejtlets fid- demm) Feriti ta ’ operazzjoni jistgħu jinfettaw ruħhom Hemm riskju ta ’ puplesija Jekk xi wieħed minn dawn jaffettwak, kellem lit- tabib jew lil xi infermier/ a.
Rash or ulceration in any part of your body (e. g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing Swelling, blistering or peeling of the skin Kidney failure and acute kidney failure Heart failure, heart attack Racing or irregularity of the heartbeat Breathlessness Hepatitis (inflamed liver) Abdominal pain Nausea (feeling sick) Vomiting.
Raxx jew ulċerazzjoni f’ xi parti ta ’ ġismek (eż. ġilda, ħalq, għajnejn, wiċċ, xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża diffikultà fit- teħid tan- nifs, jew tħarħir Insuffiċjenza tal- kliewi u insuffiċjenza akuta tal- kliewi.
Each vial contains 40 mg parecoxib, as
Kull fjala fiha 40 mg parecoxib, bħala
42.36 mg parecoxib sodium.
42. 36 mg parecoxib sodium.
When reconstituted with 2 ml solvent, provides 20 mg/ ml of parecoxib.
Meta rikostitwit b’ 2 ml solvent, jipprovdi 20 mg/ ml ta ’ parecoxib.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial.
Meta rikostitwit f’ soluzzjoni 9 mg/ ml (0. 9%) ta ’ sodium chloride, Dynastat fih madwar 0. 44 mEq ta ’ sodium kull fjala.
The powder is contained in colourless glass vials (5 ml) with a laminated stopper, sealed with a purple flip-off cap on the aluminium overseal.
It- trab jinżamm fi fjali tal- ħġieġ bla kulur (5 ml) b’ tapp laminat, issiġillat b’ tapp vjola tat- tip flip- off fuq tgeżwira fuq kollox ta ’ l- aluminju.
99 Ελλάδα Pfizer Hellas A. E.
103 Ελλάδα Pfizer Hellas A. E.
< ------------------------------------------------------------------------------------------------------------------
Dan il- fuljett kien approvat l- aħħar f ’: < ---------------------------------------------------------------------------------------------------------------------
100 The following information is intended for medical or healthcare professionals only
104 INFORMAZZJONI GĦAL- PROFESSJONISTA TAS- SAĦĦA
40 mg vial:
20 mg fjala:
Remove the purple flip-off cap to expose the central portion of the rubber stopper of the parecoxib 40 mg vial.
Neħħi l- kappa safra li tinfetaħ b’ subgħajk b’ mod li tikxef il- parti tan- nofs tat- tapp tal - gomma tal- fjala 20 mg parecoxib.
Withdraw with a sterile needle and syringe, 2 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 40 mg vial.
Iġbed permezz ta ’ labra sterili u siringa, 1ml ta ’ solvent xieraq u daħħal il- labra ġol- parti tan- nofs tat- tapp tal- gomma, b’ mod li s- solvent jiġi trasferit ġol- fjala ta ’ 20 mg parecoxib.
101 PACKAGE LEAFLET:
105 FULJETT TA ’ TAGĦRIF:
Information for the User
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Dynastat 40 mg powder and solvent for solution for injection parecoxib (as parecoxib sodium)
Dynastat 40 mg trab u solvent għal soluzzjoni għal injezzjoni parecoxib (bħala parecoxib sodium)
It is supplied in cartons containing 1, 3 or 5 vials that also contain 1, 3 or 5 glass ampoules of a solvent for dissolving the contents of the vials.
Dynastat jinstab f’ pakketti ta’ 1, 3 u 5 fjali li fihom anke 1, 3 u 5 ampulli tas- solvent għad- dissoluzjoni tal- kontenut tal- fjali.
Do not take Dynastat
Tużax Dynastat
- if you have or have had problems with your blood circulation (peripheral arterial disease) or if
- jekk għandek jew kellek problemi biċ- ċirkolazzjoni tad- demm tiegħek (mard arterjali periferali)
you have had surgery on the arteries of your legs.
jew jekk kellek kirurġija fuq l- arterji ta ’ saqajk
If any of these applies to you, you will not be given the injection.
- jekk tbati minn anġina emboli, pressjoni għolja jew livell għoli ta ’ kolesterol
Rifampicin – used for bacterial infections Antiarrhythmics – used to treat an irregular heartbeat Phenytoin or Carbamazepine – used for epilepsy Theophylline – used for asthma Methotrexate – used for rheumatoid arthritis and cancer Antidepressants – used to treat depression Neuroleptics – used to treat psychoses.
Acetylsalicylic acid jew mediċini oħra kontra l- infjammazzjoni Fluconazole – użati biex jittrataw infezzjonijiet tal- fungi Inibituri ACE – użati għal pressjoni għolja u mard tal- qalb Cyclosporin jew Tacrolimus – użati wara trapjanti Warfarina – jew mediċini oħra wżati biex jimpedixxu emboli Lithium – użat kontra d- depressjoni Rifampicin – użat għal infezzjonjiet b’ batterji Antiarrhythmics – użati sabiex jittratta taħbit irregolari tal- qalb Phenytoin jew Carbamazepine – użat għall- epilepsija Theophylline – użat għall- ażma Methotrexate – għal l- artrite rewmatika u kanċer Anti- dipressanti – użati biex jittrattaw id- depressjoni Newrolettiċi – użati sabiex jittrattaw psikożi
Pregnancy and breast-feeding women If you are pregnant, tell your doctor, as Dynastat may not be right for you.
- Jekk int tqila, għid lit- tabib tiegħek, għax Dynastat jista ’ ma jkunx tajjeb għalik.
103 Get advice from a doctor or pharmacist before taking any medicine if you ’ re pregnant or breast- feeding.
Itlob għall- parir tat- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina jekk int tqila jew qed tredda ’.
HOW TO USE DYNASTAT
107 3 KIF TINGĦATA L- INJEZZJONI
People with liver problems People with severe kidney problems Patients over 65 who weigh less than 50 kg People taking fluconazole.
Persuni bi problemi fil- fwied Persuni bi problemi serji fil- kliewi Persuni li għandhom ‘ l fuq minn 65 sena u li jiżnu inqas minn 50 kg Persuni li jkunu qegħdin jieħdu fluconazole
tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause wheezing, difficulty breathing, or swallowing – this occurs rarely
xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża tħarħir, diffikultà fit- teħid tan- nifs, jew diffikulta ’ meta tibla ’ - dan rarament jiġri
104 More common effects These could affect between 1 and 10 in every 100 people Blood pressure may be made higher or lower You may get back pain Ankles, legs and feet may swell (fluid retention) You may feel numb You may get stomach ache, indigestion, bloating and wind Tests may show abnormal kidney function You may feel agitated or find it hard to sleep There is a risk of anaemia You may get a sore throat or difficulty breathing Your skin may be itchy You may pass less urine than usual.
Il- pressjoni tiżdied jew tonqos Jista ’ jkollok uġigħ f’ dahrek Għaksiet, riġlejn jew saqajn jintefħu (żamma ta ’ fluwidu) Ikollok tnemnim Uġigħ fl- istonku, indiġistjoni, dijarrea, nawżea, imbulmar u gass Testijiet juru funzjoni anormali tal- kliewi
Dry socket (inflammation and pain after a tooth extraction) > If any of these affects you, talk to your doctor or nurse.
108 Tħossok aġitat jew issibha diffiċli biex torqod Hemm riskju ta ’ anemija Ikollok griżmejk juġgħawk jew tbati biex tieħu n- nifs Ġilda tieklok Tgħaddi inqas urina mis- soltu Sokit xott (infjammazzjoni u uġigħ wara li taqla ’ sinna)
Rash or ulceration in any part of your body (e. g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing Swelling, blistering or peeling of the skin Kidney failure and acute kidney failure Heart failure, heart attack Racing or irregularity of the heartbeat Breathlessness Hepatitis (inflamed liver) Abdominal pain Nausea (feeling sick) Vomiting
Raxx jew ulċerazzjoni f’ xi parti ta ’ ġismek (eż. ġilda, ħalq, għajnejn, wiċċ, xofftejn jew ilsien), jew tiżviluppa xi sinjal ieħor ta ’ reazzjoni allerġika bħal raxx tal- ġilda, nefħa tal- wiċċ, xoffa jew ilsien li tista ’ tikkawża diffikultà fit- teħid tan- nifs, jew tħarħir Insuffiċjenza tal- kliewi u insuffiċjenza akuta tal- kliewi.
This medicinal product does not require any special storing conditions prior to reconstitution..
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni ta ’ ħżin speċjali qabel rikostituzzjoni.
105 solution will not be used.
Jekk tara xi frak fis- soluzzjoni għall- injezzjoni jew jekk it- trab jew is- soluzzjoni tilfu l- kulur tagħhom, is- soluzzjoni m’ għandiex tintuża.
Solvent Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injections.
Solvent Sodium chloride Hydrochloric acid jew sodium hydroxide (għal aġġustament tal- pH).
107 The following information is intended for medical or healthcare professionals only
111 INFORMAZZJONI GĦAL- PROFESSJONISTA TAS- SAĦĦA
EPAR summary for the public
t za Sommarju ta ’ l- EPAR għall- pubbliku
It explains how
riz Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR).
is the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji
or If you need more information about your medical condition or your treatment, read the Package
to mwettqa, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
th Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
aw Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
au of the EPAR).
x du
er What is Dynepo?
X’ inhu Dynepo?
Dynepo is a solution for injection in pre-filled syringe.
Dynepo huwa soluzzjoni għall- injezzjoni ġo siringa mimlija bil- lest.
It is available in strengths from 2,000 IU/ ml to ng 20,000 IU/ ml.
Huwa jiġi f ’ qawwiet li jvarjaw minn 2, 000 IU/ ml sa 20, 000 IU/ ml.
Dynepo contains the active ingredient epoetin delta. lo
Dynepo fih is- sustanza attiva epoetin delta. ’ g Għalxiex jintuża Dynepo?
Dynepo is used to treat anaemia (fewer than normal red blood cells in the blood) in adult patients with no
Dynepo jintuża biex jittratta l- anemija (anqas ċelloli ħomor fid- demm minn normal) f’ pazjenti adulti li im
chronic renal failure (long-term kidney disease).
jbagħtu minn problema kronika fil- kliewi (mard tal- kliewi mifruxa fuq tul ta ’ żmien).
It may be used in patients on dialysis (a blood clearance technique) or not on dialysis.
Jista ’ jintuża f’ pazjenti li jkunu fuq dijaliżi (teknika għat- tisfija artifiċjali tad- demm) jew f’ pazjenti li mhumiex fuq dijaliżi. il
The medicine can only be obtained with a prescription. ct du
Il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta tat- tabib. al
How is Dynepo used?
Kif jintuża Dynepo? in
A doctor who has experience in the care of renal failure patients should start any treatment with Dynepo.
Tabib li għandu esperjenza fil- kura ta ’ pazjenti li jbagħtu minn ħsara serja fil- kliewi jista ’ jibda kull tip ta ’ trattament b’ Dynepo.
Dynepo can be given intravenously (injection into a vein) or subcutaneously (injection under ro
Dynepo jista ’ jingħata ġol- vina (injezzjoni ġol- vina) jew taħt il- ġilda iċ
the skin).
(injezzjoni taħt il- ġilda).
The starting doses are 50 IU/ kg three times a week if given intravenously, and twice a week lp
Id- dożi tal- bidu huma 50 IU/ kg tlett darbiet fil- ġimgħa jekk mogħtija ġol - ed
if given subcutaneously.
vina, jew darbtejn fil- ġimgħa jekk mogħti taħt il- ġilda.
Doses are adjusted depending on the response. a
Id- dożi jistgħu jiġu aġġustati skond ir- riżultat.
How does Dynepo work?
Kif jaħdem Dynepo? m
Epoetin delta, the active ingredient of Dynepo, is a copy of the human hormone, produced by a ic
Ormon imsejjaħ erythropoietin jistimula l- produzzjoni ta ’ ċelloli ħomor tad- demm mill- mudullun, Epoetin delta, is- sustanza attiva ta ’ Dynepo, hija kopja ta ’ l- ormon uman, magħmula permezz ta ’ t
method known as ‘ genetic engineering’: the enzyme is made by a cell in which the gene (the code) for the enzyme is activated so that the cell makes more of the enzyme and it can then be extracted and ed
metodu magħruf bħala ‘ inġinerija ġenetika ’: l- enżima hija magħmula minn ċellola, li fiha, il- ġene (il - ot
In patients with long-term kidney failure, a cause of their anaemia can be a lack of erythropoietin.
kodiċi) għall- enzima huwa attivat sabiex iċ- ċellola tipproduċi aktar minn din l- enżima biex umbagħad tkun tista ’ tiġi estratta u wżata f’ Dynepo.
Dynepo works by stimulating production of red blood cells in the same way as M
F’ pazjenti li jbagħtu minn ħsara serjra fil- kliewi mifruxa fuq od
erythropoietin.
Pr
How has Dynepo been studied?
Kif ġie studjat Dynepo?
The effectiveness of Dynepo to treat anaemia has been studied in a total of 1308 patients with chronic renal failure, including two main clinical studies.
L- effettività ta ’ Dynepo biex jittratta anemija ġiet studjata fuq total ta ’ 1308 pażjenti bi problemi kroniċi fil- kliewi, inklużi żewġ studji kliniċi prinċipali.
In one of these, Dynepo given intravenously was compared with epoetin alfa (a similar type of drug).
F’ wieħed minn dawn, Dynepo mogħti ġol- vina tqabbel ma ’ epoetin alfa (mediċina simili).
In the other study, three different dosing schedules of subcutaneous Dynepo were compared.
Fl- istudju l- ieħor, tqabblu tliet skedi ta ’ dożi differenti ta ’ Dynepo mogħti taħt il- ġilda.
The main measure of effectiveness in the clinical studies was whether Dynepo increased haemoglobin levels (the protein found in red blood cells that carries oxygen around the body).
Il- miżura ewlenija ta ’ l- effettività fl- istudji kliniċi kienet jekk Dynepo jżidx il- livelli ta ’ l- emoglobina (il- proteina li tinsab fiċ- ċelloli ħomor tad- demm li ġġorr l- ossiġenu madwar il- ġisem).
(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 Dynepo 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 X’ benefiċċju wera Dynepo waqt l- istudji?
Dynepo was as effective as epoetin alfa at increasing haemoglobin levels in patients.
Dynepo kien effettiv daqs epoetin alfa biex iżid il- livelli ta ’ emoglobina fil- pazjenti.