qanastek/EMEA-V3 huggingface dataset:
35 problems, your heart rate may be monitored.
Jekk għandek storja ta ’ problemi tal - qalb, ir- rata tal- qalb tiegħek ser tiġi sorveljata.
If any problems occur while you are having your infusion, the medical staff will be on hand to take any necessary action.
Jekk ikun hemm xi problemi waqt li tkun qed tieħu l - infużjoni, l- impjegati mediċi ser ikunu fil- viċin sabiex jieħdu kull azzjoni meħtieġa.
Side effects may occur while you are receiving Paxene or following treatment.
Jistgħu jinħassu effetti sekondarji waqt li tkun qed tirċivei Paxene jew wara l- kura.
During treatment, you should tell the medical staff if you feel unwell.
Waqt il- kura inti għandek tinforma lill- personal mediku jekk ma tħossokx f’ siktek.
If you feel unwell between courses or after your treatment has finished, tell your doctor or pharmacist as soon as you can.
Jekk tħossok ma tiflaħx bejn il - korsijiet jew wara li tkun spiċċajt il- kura, għarraf lit- tabib jew lill- ispiżjar tiegħek kemm jista ’ jkun malajr.
Possible side effects may include:
Effetti oħra possibli jistgħu jinkludu:
• Allergic reactions - this product contains polyoxyl castor oil.
• Reazzjonijiet allerġiċi - dan il- prodott fih polyoxyl castor oil.
This can cause an allergic reaction - you may become breathless or have trouble breathing, you may notice chest pain, flushing (red face and neck) and a speeding up of your heart, or your blood pressure may fall making you light-headed and sweaty.
Dan jista ’ jikkawża reazzjoni allerġika - jista ’ jinqatalek nifsek, jew ikollok problemi biex tieħu nifs, tista ’ tinnota uġigħ fis - sider, fwawar, (wiċċ u għonq isir ħamrani) u żjieda fit- taħbit tal- qalb, jew il- pressjoni tad- demm
You may notice wheals (localised swellings on your skin), or swelling of your lips and/or your tongue.
Inti tista tinnota li jkollok xi tbenġil (nefħat lokalizzati fuq il- ġilda tiegħek) jew nefħat fuq ix- xoftejn u/ jew fuq ilsienek.
If any of these symptoms occur, contact your doctor immediately. • Blood disorders temporary low white blood cell counts which may make you more likely to develop infections.
Jekk xi wieħed minn dawn is- sintomi jseħħu, ikkuntattja lit- tabib tiegħek minnufih. • Disturbi tad- demm – għadd baxx taċ- ċelluli l- bojod tad- demm temporanju li jagħmluk suxxettibbli għal infezzjoni.
Temporary low platelets counts which can cause unusual bleeding (for example nose bleeds) or unexplained bruising.
Għadd baxx ta’ plejtlets temporanju li jista ’ joħloq fsada mhux tas - soltu (per eżempju tinfaraġ) jew tbenġil mingħajr spjegazzjoni.
A temporary lowering of red blood cells (anaemia) may also occur.
Jista ’ jkun hemm tnaqqis temporanju fiċ- ċelluli l- ħomor (anemija) ukoll.
You may notice that you become tired and your skin tone becomes pale Very rarely, such changes in your blood can be permanent.
F’ każijiet rari ħafna dawn il- bidliet fid- demm jistgħu jkunu permanenti.
Leukaemia (an abnormal increase in the number of white cells in your blood) may also occur very rarely. • Heart problems - changes in normal heart rate and high/low blood pressure (you may begin to feel light-headed and faint and begin to sweat), thrombosis (blood clots) can occur.
Lewkimja (żjieda anormali fl- għadd taċ- ċelluli l- bojod fid- demm) tista ’ ukoll iseħħ f’ każijiet rari ħafna. • Disturbi fil- qalb – jistgħu iseħħu bidliet fir- rata normali tat- taħbit tal- qalb u pressjoni baxxa/ għolja (tista ’ tibda tħossok storduta u jħossok ħażin u tibda ’ tegħreq), u trombożi (emboli tad- demm).
Uncommonly, heart failure (which may cause difficulty breathing), cardiomyopathy (impairment of heart muscle, which may cause difficulty breathing or chest pain) or heart attack can occur.
Mhux komuni li jseħħu, insuffiċjenza tal- qalb (li jista ’ jikkawża diffikutà fit- teħid tan- nifs), kardjomajopatija (indeboliment tal- muskolu tal- qalb li jista ’ jikkawża diffikutà biex tieħu n- nifs jew uġigħ fis- sider) jew attakk tal- qalb.
If you experience any palpitation, breathlessness or chest pain, please contact your doctor immediately. • Gastrointestinal disorders - such as nausea, vomiting, abdominal pain, constipation, diarrhoea, indigestion (dyspepsia), discoloration of stool (melaena), dry mouth, sore mouth and tongue and loss of appetite (anorexia).
Jekk tħoss xi palpitazzjoni, tħossok b’ nifsek maqtugħ jew uġigħ fis- sider, jekk jogħġbok ikkuntattja lit- tabib tiegħek minnufih.. • Disturbi gastrointestinali – bħat- tqalligħ, rimettar, uġigħ fl- addome, stitikezza, dijarrea, indiġestjoni (dispepsja), bdil fil- kulur ta ’ l- ippurgar (melana), ħalq xott, uġigħ fil- ħalq u l- ilsien u tnaqqis fl- aptit (anoreksja).
Intestinal blockage (ileus), bowel perforation or inflammation (all of which usually cause abdominal pain), and abdominal swelling (ascites) may occur very rarely.
Sadd fl- imsaren (ileju), l- imsaren jittaqqbu jew jiffjammaw( li ġeneralment kollha jikkawżaw uġigħ addominali) u nefħa fl- addome (axxite) jistgħu jiġru f’ każijiet rari ħafna.
Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of a serious bowel inflammation (pseudomembranous colitis), or bloody watery diarrhoea may occur rarely.
Dijarrea b’ ilma tad - demm tista sseħħ b’ mod rari.
Severe, persistent abdominal pain radiating to the back with vomiting (acute pancreatitis) may occur rarely. • Respiratory disorders - shortness of breath (dyspnoea), bleeding from the nose (epistaxis), scarring of the lung and fluid around the lungs (pleural effusion) may occur.
Uġigħ fl- addome li hu persistenti u serju li jiġi minn wara b’ rimettar (pankrejatite akuta) jista ’ jseħħ ukoll. • Disturbi respiratorji – jista ’ jkun hemm qtugħ ta ’ nifs (dispneja), u l- imnieħer jinfaraġ (epistassi), cikatrici fil- pulmun u l- fluwidu madwar il- pulmuni (nixxiegħa mill- plewre).
Very rarely inflammation of the lungs (pneumonitis) in patients receiving radiotherapy and/or gemcitabine (another cancer drug), cough and pneumonia and narrowing of the blood vessels in the lungs which may cause shortness of breathe (pulmonary hypertension) may occur. • Metabolism and nutrition disorders - excessive loss of water from the body (dehydration), weight gain and weight loss.
F’ każijiet rari ħafna jista ’ jkun hemm infjammazzjoni tal- pulmuni (pnewmonite) f’ pazjenti fuq radjuterapija u/ jew gemcitabine (mediċina oħra għal kanċer) sogħla u pnewmonja u tidjieq tal - vażi tad- demm fil- pulmuni li jistgħu jikkġunaw qtugħ ta ’ nifs (pressjoni pulmonari għolja). • Disturbi marbuta mal- metaboliżmu u n- nutrizzjon: telf eċċessiv ta ’ ilma mill- ġisem (diżidrazzjoni) żieda fil- piż jew telf ta ’ piż.
Abnormal electrolytes (e.g. low blood sodium or magnesium) and high blood sugar may occur very rarely during combination with platinum-containing therapy. • Eye and ear disorders - dry eyes, impaired vision (amblyopia) and ringing in the ears (tinnitus), hearing loss and unsteadiness (vertigo).
F’ każijiet rari ħafna, jista ’ jkun hemm, elettroliti anormali (p. e. livell baxx ta ’ sodju u magnesju fid- demm) u zokkor għoli fid- demm meta jingħata f’ terapija konġunta li jkun fiha l- platinu. • Disturbi fl- għajnejn u widnejn - għajnejn xotti, vista mċajpra, (amblijopija) u tisfir fil- widnejn (tinnitu) telf ta’ smiegħ u żbilanċ (vertigo).
Rarely or very rarely minor weakness of the arms or legs and intestinal paralysis, and epileptic fits can occur.
Jista ’ jkun hemm episodji rari ħafna ta ’ disturbi viżwali oħrajn f’ pazjenti li jkunu rċevew dożi ogħla minn dawk rakkomandati. • Disturbi tal- muskoli u tal- ġogi - uġigħ fil- ġogi, muskolu u għadam, bugħawwiġijiet u dgħjufija anormali ta ’ ċertu muskoli (majastenja). • Disturbi fin- nervituri - tirżiħ u textix tal- ġilda tiegħek (li ġiet riżolta f’ madwar 40 sa 60% tal - pazjenti), għejja, stordament, nervożità, depressjoni, ħsibijiet anormali, nuqqas ta ’ rqad, mobilità mnaqqsa (ipokinesja), perċezzjoni sensorjali mnaqqsa (ipestesija), problemi bil- pass, togħma mibdula u uġigħ ta ras.
36 • Skin disorders - such as dry skin, rash, itching (pruritus), abnormal reddening, flaking, and thickening of the skin (exfoliative dermatitis), acne, hair loss, discoloured nails or nail bed and detachment of the nail plate from the nail bed (onycholysis).
F’ episodji rari jew rari ħafna jista ’ jkun hemm dgħjufija tad - dirgħajn jew ir- riġlejn, paraliżi ta ’ l- imsaren u attakki epilettiċi • Disturbi fil- ġilda - bħal ġilda xotta, raxx, ħakk, ħmura anormali, sfoll, il- ġilda tiħxien (il- ġilda taqa qxur qxur), akne, telf ta ’ xagħar, tibdil fil- kulur tad- dwiefer u tal- bażi tad- diefer u d- difer jinqala minn mal- bażi (onikolisi).
You should avoid exposing your hands and feet excessively to sunlight during the therapy.
M’ għandekx tesponi idejk u saqajk għad- dawl tax- xemx waqt it- terapija.
Very rarely, wheals (localised swelling of the skin), a symmetrical red raised rash usually on the limbs (erythema multiforme), skin peeling and fever (toxic epidermal necrolysis) or a widespread blistering rash causing ulcers of the skin, mouth and genital area and fever (Stevens-Johnson syndrome) may occur. • Liver and renal disorders - increase of bilirubin (jaundice) and liver enzymes such as alkaline phosphatase and AST (SGOT), and painful urination (dysuria).
F’ każijiet rari ħafna jista ’ jkun hemm episodji ta ’ ħsara fil- fwied u insuffiċjenza epatika.
Very rarely, liver damage and liver failure can occur. • Infections - you may experience chills, fever, flu syndrome, viral infections such as herpes simplex, inflammation of the throat (pharyngitis), inflammation of the mucous membranes of the nose (rhinitis) and fungal infection in the mouth (oral candidiasis). • Other disorders - swelling due to accumulation of fluid in body tissues (oedema), feeling and being sick (malaise), weakness (asthenia), pain (especially back pain and chest pain). • Irritation around the injection site - swelling, redness, soreness and discoloured skin.
37 • Infezzjonijiet - tista tħoss sirdat, deni, sindromu ta ’ l- influwenza, infezzjonijiet virali bħal herpes simplex, infjammazzjoni tal- griżmejn (farinġite), infjammazzjoni tal- membrani mukużi u l- imnieħer (rinite) u infezzjoni fungali fil- ħalq (kandidajażi orali). • Disturbi oħrajn - tinfih minħabba l- ġbir ta ’ fluwidu fit- tessut tal- ġisem (edema), tħossok u tkun marid (telqa), dgħjufija (astenija), uġigħ (speċjalment uġigħ tad- dahar u uġigħ fis- sider). • Irritazzjoni madwar il- lok ta ’ l- injezzjoni - nefħa, ħmurija, uġigħ u tibdil fil- kulur tal- ġilda.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
STORING PAXENE
KIF TAĦŻEN PAXENE
Your concentrate for solution for infusion will be kept in the pharmacy and they will prepare it, ready to be given by the doctor or nurse.
Il- konċentrat tiegħek għal soluzzjoni għall- infużjoni ser tinżamm fl- ispiżerija u ser jippreparawha bil - lest biex imbagħad kemm tingħata mit- tabib jew infermier.
It must be kept out of the sight and reach of children.
Għandha tinżamm fejn ma tintlaħaqx u ma tidhirx mit- tfal.
The concentrate for solution for infusion will be kept below 25 °C in the outer carton.
Il- konċentrat għal soluzzjoni għall- infużjoni m’ għandiex tinħażen f’ temperatura ′ l fuq minn 25°C fil - kartuna ta ’ barra.
The concentrate for solution for infusion will not be used after the “use by” date that can be found on the vial label and outer carton.
Il- konċentrat għal soluzzjoni għall- infużjoni mhux ser jintuża wara d- data “ uża sa ” li tista ’ tkun indikata fuq it- tikketta tal- fjala u l- kartuna ta ’ barra.
Česká republika IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
Danmark IVAX Scandinavia AB Tlf.: +46 850666300
Deutschland Mayne Pharma (Deutschland) GmbH D-85540 Haar Tel: +49 89 43 77 770
Mayne Pharma (Deutschland) GmbH Tel: + 32 2 332 0315 D- 85540 Haar Tel: + 49 89 43 77 770
România IVAX Pharmaceuticals s.r.o Tel: +420 553 641 111
Portugal France Mayne Pharma (Portugal) Lda Mayne Pharma (France) SAS Tel: + 351 21 485 7430 Tel: + 33 1 41 11 28 50
Κύπρος Norton Healthcare Ltd t/a IVAX Pharmaceuticals UK Тηλ.: +44 8705 02 03 04
UK Тηλ.: +44 8705 02 03 04
Sverige Mayne Pharma (Nordic) AB, Sverige Tel: + 46 8 672 85 00
39 Tel: + 46 8 672 85 00
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {date}
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa:
Further instructions for preparation for infusion
Aktar struzzjoniiet dwar il- preparament ta ’ l- infużjoni
Recommendations for handling
Rakkomandazzjonijiet għal maniġġjar
Paxene is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Paxene huwa aġent nejoplastiku u, bħal fil- każ ta ’ komposti tossiċi potenzjali oħrajn, trid tingħata attenzjoni fil- maniġġjar ta ’ Paxene.
The use of gloves, goggles and protective clothing is recommended.
L- użu ta ’ ingwanti, gogils u ilbies protettiv huwa rakkomandat.
If Paxene solution comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
Jekk it- taħlita likwida ta ’ Paxene tiġi f’ kuntatt mal- ġilda, aħsel minnufih il- ġilda b’ sapun u ilma.
If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water.
Jekk Paxene jiġi f’ kuntatt mal- membrani mukużi, il- membrani għandhom jiġu mlaħalħa sew b’ ilma.
Pregnant staff should not handle Paxene.
Impjegati nisa li huma tqal m’ għandhomx imissu Paxene.
Preparation of the infusion solution
Preparazzjoni tat- taħlita likwida għall- infużjoni
Paxene must be diluted under aseptic conditions prior to infusion.
Paxene għandu jiġi mgħammed taħt kundizzjonijiet asettiċi qabel l- infużjoni.
Paxene should be diluted in 0.9% w/v sodium chloride solution for infusion, 5% glucose solution for infusion, or 5% glucose in Ringer’s solution to a final concentration of 0.3 to 1.2 mg/ml.
Paxene irid jiġi dilwit b’ 0. 9% w/ v soluzzjoni ta ’ klorur tas- sodju għal infużjoni, 5% soluzzjoni ta ’ glukożju għal infużjoni, jew 5% glukożju għal soluzzjoni ta ’ Ringer għal konċentrazzjoni finali ta ’ 0. 3 sa 1. 2 mg/ ml.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours when stored below 25 °C.
Wara li jkun dilwit, l- istabbiltà kimika u fiżika fil- boroż ta ’ infużjoni tal- polypropylene waqt l- użu nstabet li ddum għal mill- anqas 24 siegħa f’ temperatura anqas minn 25°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih il- ħinijiet ta ’ ħażna u kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ l- utent u m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, kemm- il darba it- tgħammid ikun sar f’ kundizzjonijiet ikkontrollati u asettikament validati.
Chemical and physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 ºC.
Instab li l- stabbiltà kimika, fiżika u mikrobika ta ’ prodott mhux użat u mhux dilwit li jifdal fil- fjala intwera li jdum sa 28 ġurnata meta maħżun ftemperatura ta ’ inqas minn 25°C.
Other in-use storage times and conditions are the responsibility of the user.
Żminijiet u kundizzjonijiet oħra ta ’ ħażna waqt l- użu huma r- responsabilità ta ’ l- utent.
39 Levels of the extractable plasticiser DEHP [di-(2-ethylhexyl)phthalate] increase with time and concentration when dilutions are prepared in PVC containers.
Livelli ta ’ plastiżer li jlissi ta ’ DEHP [di - (2- ethylhexyl) phthalate] jiżdid mal- ħin u konċentrazzjoni meta t- tgħammid isir f’ reċipjenti tal- PVC.
Consequently, the use of plasticised PVC containers and administration sets is not recommended.
Sussegwentement, l- użu ta ’ PVC plstiċizzat għal reċipjenti u settijiet ta ’ amministrazzjoni m’ huwiex rakkomandat.
Paxene solutions should be prepared and stored in glass, polypropylene, or polyolefin containers.
40 Soluzzjonijiet ta ’ Paxene għandhom jiġi ppreparati u maħżuna f’ reċipjenti tal- ħġieġ, polypropylene jew polyolefin.
Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Paxene għandu jiġi mogħti f’ filtru fil- pajp b’ membrana mikroporuża li mhiex akbar minn 0. 22 µm.
Use of filter devices which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
L - użu ta ’ tagħmir li jiffiltra bħal dak li jinkorpora dħul u ħruġ qasir ta ’ pajpijiet miksija bil- PVC ma rriżultatx f’ lissi sinifikanti ta ’ DEHP.
Handling and disposal
Maniġġjar u rimi
Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Proċeduri għal maniġġjar xierqa u rimi ta ’ prodotti mediċinali li huma ċitotossiċi għandha tiġi segwita.
Pedea 5 mg/ ml solution for injection
Pedea 5 mg/ ml soluzzjoni għall- injezzjoni
Each ml contains 5 mg ibuprofen.
Kull ml fih 5 mg ibuprofen.
Each 2 ml ampoule contains 10 mg ibuprofen.
Kull ampulla ta ’ 2 ml fiha 10 mg ibuprofen.
For excipients, see section 6.1.
Għal sustanzi mhux attivi, ara sezzjoni 6. 1.
Clear, colourless to slightly yellow solution.
Soluzzjoni ċara, mingħajr kulur jew li tagħti daqsxejn fl- isfar.
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Trattament ta ’ patent ductus arteriosus sinifikament emadinamika fi trabi li jitwieldu qabel iż- żmien li għnadhom inqas minn 34 ġimgħa ta ’ żmien ta ’ ġestazzjoni.
For intravenous use only.
Użu għal ġol- vina biss.
Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Trattament b’ Pedea għandu jsir biss fit- taqsima tal- kura intensiva tat- trabi li għadhom kif twieldu, taħt is- superviżjoni ta ’ neonatoloġista b’ esperjenza.
A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
Kors ta ’ terapija jfisser tliet dożi ġol- vina ta ’ Pedea mogħtija f’ intervalli ta ’ 24 siegħa.
The ibuprofen dose is adjusted to the body weight as follows:
Id- doża ta ’ ibuprofen hija mibdula skond il- piż tal- ġisem kif ġej:
- 1st injection:
- 1el injezzjoni:
- 2nd and 3rd injections:
- 2ni u 3et injezzjoni:
If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.
Kemm- il darba d- ductus arteriosus ma jagħlaqx fi żmien 48 siegħa mill- aħħar injezzjoni, jew jekk jerġa ’ jinfetaħ, jista ’ jingħata t- tieni kors ta ’ 3 dożi kif indikat hawn fuq.
If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
Jekk il- kondizzjoni ma tinbidilx wara t- tieni kors ta ’ terapija, jista ’ jkun hemm bżonn ta ’ operazzjoni għall- kondizzjoni ta ’ ductus arteriosus.
Method of administration:
Metodu ta ’ kif għandu jingħata:
Pedea should be administered as a short infusion over 15 minutes, preferably undiluted.
Pedea għandha tingħata bħala infużjoni qasira fuq 15- il minuta, preferibbilment mhux dilwita.
If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection.
Jekk ikun hemm bżonn, il- volum ta ’ l- injezzjoni jista ’ jiġi mibdul jew b’ soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml ta ’ (0. 9%) sodium chloride jew soluzzjoni għall- injezzjoni ta ’ 50 mg/ ml (5%) glukożju.
Any unused portion of the solution should be discarded.
Kull fdal tas- soluzzjoni li ma tiġix użata għandha tintrema.
The total volume of solution injected should take into account the total daily fluid volume administered.
Għandu jitqies il- volum ta ’ fluwidu kollu li jingħata kuljum fil- volum kollu ta ’ soluzzjoni injettatat.
If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.
Jekk iseħħu anurja jew oligurja li tidher wara l- ewwel jew it- tieni doża, id- doża li jmiss m’ għandhiex tingħata sakemm l- ammont ta ’ awrina jerġa ’ jiġi għal- livelli normali.
Pedea is contraindicated in neonates with:
Pedea hija kontra- indikata fi trabi tat- twelid b ’:
- life-threatening infection;
- infezzjoni li tista ’ tkun fatali;
- active bleeding, especially intracranial or gastrointestinal haemorrhage;
- fsada attiva, speċjalment intrakranjali jew emorraġġija gastro- intestinali;
- thrombocytopenia or coagulation defects;
- tromboċitopenja jew problemi ta ’ koagulazzjoni;
- congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory
- mard tal- qalb konġenitali li fih il- patency ta ’ ductus arteriosus huwa meħtieġ għall- ċirkolazzjoni
pulmonary or systemic blood flow (e. g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta);
tad- demm pulmonari jew sistemiku sodisfaċenti (eż. atreżja pulmonari, tetraloġija serja ta ’ Fallot, kowarktazzjoni serja ta ’ l- aorta);
- known or suspected necrotising enterocolitis;
- enterokolite nekrotika magħrufa jew suspettata;
- hypersensitivity to ibuprofen or to any of the excipients.
- sensittività eċċessiva għal ibuprofen jew għal xi sustanzi mhux attivi.
Before administration of Pedea an adequate echocardiographic examination should be performed in order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary hypertension and ductal-dependent congenital heart disease.
Għandu jsir eżami ekokardjografiku xieraq sabiex tiġi tinstab il- patent ductus arteriosus emodinamikament sinifikanti u sabiex tiġi eskluża pressjoni pulmonari għolja u mard tal- qalb konġenitali li hu dipendenti mit- tubu qabel l- għoti ta ’ Pedea.
Since prophylactic use in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased pulmonary and renal adverse events, Pedea should not be used prophylactically (see sections 4.8 and 5.1).
Pedea m’ għandhiex tintuża b’ mod profilattiku, billi l- użu profilattiku tagħha fl- ewwel 3 ijiem ta ’ ħajja (li jibdew fl- ewwel 6 sigħat mit- twelid) fi trabi li jkunu għadhom kif twieldu qabel iż- żmien u li għandhom anqas minn 28 ġimgħa ta ’ ġestazzjoni kien assoċjat ma ’ żieda fil- każijiet avversi pulmonari u renali (ara sezzjonijiet 4. 8 u 5. 1) B’ mod partikolari, ipoksemja serja u pressjoni pulmonari għolja kienu rapportati fi 3 trabi fi żmien siegħa mill- ewwel infużjoni.
In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy.
Dan kien ikkurat fi żmien tletin minuta b’ teħid bin- nifs ta ’ nitric oxide.
Since ibuprofen was shown in vitro to displace bilirubin from its binding site to albumin, the risk of bilirubin encephalopathy in premature newborn infants may be increased (see section 5.2).
Billi ntwera li ibuprofen in vitro li jneħħi bilirubin mill- post ta ’ twaħħil ma ’ albumin, hemm riskju akbar fi trabi li twieldu qabel iż- żmien ta ’ enċefelopatija ta ’ bilirubin (ara sezzjoni 5. 2).
Therefore, ibuprofen should not be used in infants with marked unconjugated hyperbilirubinaemia.
Għalhekk, ibuprofen m’ għandux jintuża fi trabi li għandhom iperbilirubinimja mhux konjugata.
As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection.
Bħala mediċina anti- infjammatorja mhux sterojde (NSAID), ibuprofen jista ’ jgħatti s- sinjali u sintomi normali ta ’ infezzjoni.
Pedea must therefore be used cautiously in the presence of an infection.
Pedea għandha għalhekk tintuża b’ attenzjoni fil- preżenza ta ’ infezzjoni.
Pedea should be administered carefully to avoid extravasation and potential resultant irritation to tissues.
Pedea għandha tingħata b’ attenzjoni biex tevita l- ekstravażazzjoni u l- irritazzjoni potenzjali fit- tessuti.
As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of bleeding.
Billi ibuprofen jista ’ jimpedixxi l- aggregazzjoni ta ’ plejtlets, trabi li jkunu twieldu qabel iż- żmien għandhom jiġu sorveljati għal sinjali ta ’ fsada.
As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels is recommended during co-administration with ibuprofen.
Billi ibuprofen jista ’ jnaqqas it- tneħħija ta ’ aminoglycosides, huwa rakkomandat li jkun hemm sorveljanza stretta tal- livelli tagħhom fis- serum waqt l- għoti flimkien ma ibuprofen.
Careful monitoring of both renal and gastrointestinal function is recommended.
Monitoraġġ b’ attenzjoni tal- funzjoni renali u gastro- intestinali huwa rakkomandat.
In preterm newborn infants less than 27 weeks of gestational age, the closure rate of the ductus arteriosus was shown to be low at the recommended dose regimen (see section 5.1).
Fi trabi tat- twelid li twieldu qabel iż- żmien u li għandhom anqas minn 27 ġimgħa ta ’ ġestazzjoni, ir - rata ta ’ għeluq tad- ductus arteriosus intwera li hu inqas bil- kors tad- doża rakkomandata (ara sezzjoni 5. 1).
As a NSAID, ibuprofen may interact with the following medicinal products:
Bħala NSAID, jista ’ jkun hemm interazzjoni bejn ibuprofen u l- prodotti mediċinali li ġejjin:
- diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of
- dijuretiċi: ibuprofen jista ’ jnaqqas l- effett ta ’ dijuretiċi; dijuretiċi jistgħu jżidu r- riskju ta ’
nephrotoxicity of NSAIDs in dehydrated patients.
nefrotossiċità ta ’ NSAIDs f’ pazjenti deidratati.
- anticoagulants: ibuprofen may increase the effect of anticoagulants and enhance the risk of
- sustanzi li jaħdmu kontra l- koagulazzjoni: ibuprofen jista ’ jżid l- effett ta ’ sustanzi li jaħdmu kontra
bleeding.
l- koagulazzjoni u jżid ir- riskju ta ’ fsada.
- corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding.
- kortikosterojdi: ibuprofen jista ’ jżid ir- riskju ta ’ fsada gastro- intestinali.
- nitric oxide: since both medicinal products inhibit platelet function, their combination may in
- Nitric oxide: billi ż- żewġ prodotti mediċinali jimpedixxu l- funzjoni tal- plejtlets, il- kombinazzjoni
theory increase the risk of bleeding.
tagħhom tista ’ b’ mod teoriku iżid ir- riskju ta ’ fsada.
- other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the
- NSAIDs oħrajn: l- użu flimkien ta ’ aktar minn NSAID wieħed għandu jiġi evitat minħabba r- riskju
increased risk of adverse reactions.
ogħla ta ’ reazzjonijiet avversi.
- aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their co-
- aminoglycosides: imbilli ibuprofen jista ’ jnaqqas ir- rata ta ’ tneħħija ta ’ aminoglycosides, l- għoti
administration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).
flimkien tagħhom jista jżid r- riskju ta ’ nefrotossiċità u ototossiċità (ara sezzjoni 4. 4).
3 4.6 Pregnancy and lactation
3 Mhux rilevanti
Not relevant
Mhux rilevanti
Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea.
Tagħrif huwa attwalment disponibbli fuq madwar 1, 000 tarbija mwielda qabel iż- żmien kemm mill - litteratura dwar ibuprofen u kemm minn provi kliniċi b’ Pedea.
Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen.
Il- kawżalità ta ’ każijiet avversi rrapportati fi trabi mwielda qabel iż- żmien huwa diffiċli biex jiġi analizzat billi jista ’ jkun relatat ma ’ konsegwenzi emodinamiċi tal- patent ductus arteriosus kif ukoll l- effetti diretti ta ’ ibuprofen.
Reported adverse events are listed below, by system organ class and by frequency.
Każijiet avversi rrapportati huma elenkati hawn isfel, skond il- kategorija tas- sistema tal - klassifikazzjoni ta ’ l- organi u skond il- frekwenza.
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Il- frekwenzi huma mfissra bħala: komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10) u mhux komuni (> 1/ 1, 000, < 1/ 100).
Blood and lymphatic system disorders Nervous system disorders
Disturbi tad- demm u tas- sistema limfatika Disturbi tas- sistema nervuża
Thrombocytopenia, Neutropenia Common:
Tromboċitopenja, Newtropenja Komuni:
Intraventricular haemorrhage, Periventricular leukomalacia
Emorraġġija intraventrikulari, Lewkomalaċja periventrikulari
Bronchopulmonary dysplasia Common:
Displażja bronkopulmonari Komuni:
Pulmonary haemorrhage Uncommon:
Emorraġġija pulmonari Mhux komuni:
Hypoxemia
Ipoksimja
Necrotizing enterocolitis, Intestinal perforation Uncommon:
Enterokolite nekrotika, Perforazzjoni fl - imsaren Mhux komuni:
Gastrointestinal haemorrhage
Emorraġġija gastro- intestinali
Renal and urinary disorders
Disturbi renali u tas- sistema urinarja
Oliguria, Fluid retention, Haematuria Uncommon:
Oligurja, Żamma ta ’ fluwidu, Ematurja Mhux komuni:
Acute renal failure
Insuffiċjenza renali akuta
Blood creatinine increased, Blood sodium decreased
Żieda ta ’ krejatinina fid- demm, tnaqqis ta ’ sodium fid- demm
In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/ 81 (16%) for indomethacin versus 23/ 94 (24%) for ibuprofen.
Fi prova kurattiva klinika li kienet tinvolvi 175 tarbija mwielda qabel iż- żmien b’ inqas minn 35 ġimgħa ta ’ ġestazzjoni, l- inċidenza ta ’ displażja bronkopulmonari fis- 36 ġimgħa ta ’ età ta ’ wara l - konċepiment kienet ta ’ 13/ 81 (16%) għal indomethacin kontra 23/ 94 (24%) għal ibuprofen.
In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age.
Fi prova klinika fejn Pedea ġiet mogħtija b’ mod profilattiku fl- ewwel 6 sigħat ta ’ ħajja, irriżulta li fi 3 trabi li kellhom inqas minn 28 ġimgħa ta ’ ġestazzjoni kien hemm ipoksimja serja u pressjoni pulmonari għolja.
This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide.
Dan kien ikkurat fi żmien tletin minuta b’ teħid bin- nifs ta ’ nitric oxide.
No case of overdose has been reported with intravenous ibuprofen in preterm newborn infants.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat b’ ibuprofen mogħti ġol- vina lil trabi mwielda qabel iż- żmien.
CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Madankollu, doża eċċessiva ġiet deskritta fi trabi u tfal li ġew mogħtija ibuprofen b’ mod orali: ġew osservati depressjoni tas- CNS, aċċessjonijiet, disturbi gastro- intestinali, bradikardja, pressjoni baxxa, apneja, funzjoni tal- kliewi anormali u ematurja.
Massive overdose (up to more than 1000 mg/ kg) has been reported to induce coma, metabolic acidosis, and transient renal failure.
Kien raportat li doża eċċessiva massiva (sa aktar minn 1000 mg/ kg) twassal għal koma, aċidożi metabolika u insuffiċjenza renali għal żmien qasir.
All patients recovered with conventional treatment.
Il- pazjenti kollha rkupraw bi trattament konvenzjonali.
Only one recorded death has been published: after an overdose of 469 mg/ kg, a 16-month old child developed an apnoeic episode with seizures and a fatal aspiration pneumonia.
Kien hemm biss mewta waħda li ġiet ippubblikata: wara doża eċċessiva ta ’ 469 mg/ kg, wild ta ’ 16- il xahar żvillupa episodju apnejaku b’ aċċessjonijiet u pulmonite ta ’ aspirazzjoni fatali.
The management of ibuprofen overdose is primarily supportive.
Doża eċċessiva b’ ibuprofen għandha tkun maniġġata prinċipalment b’ kura ta ’ support.
Pharmacotherapeutic group: other cardiac preparations, ATC code:
Kategorija farmakoterapewtika: mediċini kardijaċi oħrajn, Kodiċi ATC:
Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Ibuprofen huwa NSAID li għandu attività anti- infjammatorja, analġeżika u kontra d- deni.
Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers.
Ibuprofen hija taħlita raċemika ta ’ enantjomers S( +) u R (-).
In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity.
Studji in vivo u in vitro jindikaw li l- iżomer S( +) huwa responsabbli għall- attività klinika.
Ibuprofen is a non selective inhibitor of cyclo- oxygenase, leading to reduced synthesis of prostaglandins.
Ibuprofen huwa impeditur mhux selettiv ta ’ cyclo- oxygenase, li jwassal biex inaqqas is- sintesi ta ’ prostaglandins.
Since prostaglandins are involved in the persistence of the ductus arteriosus after birth, this effect is believed to be the main mechanism of action of ibuprofen in this indication.
Billi prostaglandins huma involuti fil- persistenza tad- ductus arteriosus wara t- twelid, dan l- effett huwa maħsub li huwa l- mekkaniżmu ewlieni ta ’ l- azzjoni ta ’ ibuprofen f’ din l- indikazzjoni.
In a dose-response study of Pedea in 40 preterm newborn infants, the ductus arteriosus closure rate associated to the 10-5-5 mg/ kg dose regimen was 75% (6/ 8) in neonates of 27-29 weeks’ gestation and 33% (2/ 6) in neonates of 24-26 weeks ’ gestation.
Fi studju għal respons għal Pedea f’ 40 tarbija mwielda qabel iż- żmien, ir- rata ta ’ għeluq tad- ductus arteriosus li hu assoċjat mal- kors tad- doża ta’ 10- 5- 5 mg/ kg kienet ta ’ 75% (6/ 8) fi trabi għadhom jitwieldu wara 27- 29- il ġimgħa ġestazzjoni u 33% (2/ 6) fi trabi għadhom jitwieldu wara 24- 26- il ġimgħa ta ’ ġestazzjoni.
Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary haemorrhage, as compared to curative use.
L- użu profilattiku ta ’ Pedea, meta mqabbel ma ’ l- użu kurattiv, fl- ewwel 3 ijiem ta ’ ħajja (li jibdew minn 6 sigħat mit- twelid) fi trabi li twieldu qabel iż- żmien b’ inqas minn 28 ġimgħa ta ’ ġestazzjoni, kien assoċjat ma ’ inċidenza ogħla ta ’ insuffiċjenza renali u każijiet pulmonari avversi bħal ipoxja, pressjoni pulmonari għolja u emorraġġija pulmonari.
Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Minn naħa l- oħra, kien hemm inċidenza mnaqqsa ta ’ emorraġġija intraventrikulari ta ’ grad III- IV fi trabi għadhom jitwieldu u ta ’ interventi kirurġiċi għall- irbit assoċjati ma ’ l- użu profilattiku ta ’ Pedea.
Although a great variability is observed in the premature population, peak plasma concentrations are measured around 35-40 mg/ l after the initial loading dose of 10 mg/ kg as well as after the last maintenance dose, whatever gestational and postnatal age.
Minkejja l- varjabilità kbira li hija osservata fil- popolazzjoni prematura, l- ogħla konċentrazzjonijiet fil - plażma huma mkejla madwar 35- 40 mg/ l wara d- doża għolja tal- bidu ta ’ 10mg/ kg, kif ukoll wara l - aħħar doża ta ’ manteniment, tkun xi tkun l- età ta ’ ġestazzjoni jew wara t- twelid.
Residual concentrations are around 10- 15 mg/ l 24 hours after the last dose of 5 mg/ kg.
Konċentrazzjonijiet residwi huma ta ’ madwar 10- 15 mg/ l 24 siegħa wara l- aħħar doża ta’ 5 mg/ kg.
Plasma concentrations of the S-enantiomer are much higher than those of the R-enantiomer, which reflects a rapid chiral inversion of the R- to the S-form in a proportion similar to adults (about 60%).
Konċentrazzjonijiet fil- plażma ta ’ l- enantjomer S huma aktar ogħla minn dawk ta ’ enantjomer R, li jirrifletti inverżjoni kirali mgħaġġla mill- għamla R għall- għamla S fi proporzjon bħal ta ’ l- adulti (madwar 60%).
The apparent volume of distribution is on average 200 ml/ kg (62 to 350 according to various studies).
Il- volum apparenti ta ’ distribuzzjoni huwa f’ medja ta ’ 200 ml/ kg (62 sa 350 skond l- istudji varji).
The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes.
Il - volum ċentrali ta ’ distribuzzjoni jista ’ jiddependi fuq l- istat tad- ductus u t- tnaqqis kif id- ductus ikun qed jagħlaq.
Elimination rate is markedly lower than in older children and adults, with an elimination half-life estimated at approximately 30 hours (16– 43).
Ir- rata ta ’ eliminazzjoni hija mnaqqsa sew fi tfal akbar u adulti, b’ half- life ta ’ eliminazzjoni stmata f’ madwar 30 siegħa (16– 43).
The clearance of both enantiomers increases with gestational age, at least in the range of 24 to 28 weeks.
It- tneħħija taż- żewġ enantjomers jiżdied skond l- età ta ’ ġestazzjoni, ta ’ l - anqas fil- firxa ta ’ 24 sa 28 ġimgħa.
In vitro studies suggest that, similarly to other NSAIDs, ibuprofen is highly bound to plasma albumin, although this seems to be significantly lower (95%) compared with adult plasma (99%).
Studji in vitro jissuġerixxu li, bħal fil- każ ta ’ mediċini NSAIDs oħrajn, ibuprofen jingħaqad sew ma ’ l - albumina fil- plażma, għalkemm dan jidher li huwa sinifikament inqas (95%) meta mqabbel ma ’ plażma ta ’ l- adulti (99%).
Ibuprofen competes with bilirubin for albumin binding in newborn infant serum and, as a consequence, the free fraction of bilirubin may be increased at high ibuprofen concentrations.
Ibuprofen jikkompeti ma ’ bilirubin għall- irbit ma ’ l- albumina fis- serum ta ’ trabi għadhom jitwieldu u, bħala konsegwenza, il- frazzjoni ħielsa ta ’ bilirubin tista ’ tiżdied b’ konċentrazzjonijiet għolja ta ’ ibuprofen.
In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha.
Fi trabi mwielda qabel iż- żmien, ibuprofen naqqas b’ mod sinifikanti l- konċentrazzjonijiet ta ’ prostaglandins u l- metaboliti tagħhom fil- plażma, b’ mod partikolari PGE2 u 6- keto- PGF- 1- alpha.
Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Livelli mnaqqsa inżammu sa 72 siegħa fi trabi li għadhom jitwieldu li ħadu 3 dożi ta ’ ibuprofen, filwaqt li żjidiet oħra ġew osservati fit- 72 siegħa wara doża waħda ta ’ ibuprofen.
5.3 Preclinical safety data
5 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.
M’ hemm l- ebda tagħrif ta ’ qabel l- użu kliniku li hu kkunsidrat rilevanti għas- sigurtà klinika barra t - tagħrif li jinsab f’ sezzjonijiet oħra ta ’ dawn il- Karatteristiċi tal- Prodott fil- Qosor.
With the exception of an acute toxicity study, no further studies have been carried out in juvenile animals with Pedea.
Bl- eċċezzjoni ta ’ studju dwar tossiċità akuta, l- ebda studju ieħor ma twettaq fuq annimali ta ’ età żgħira b’ Pedea.
Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Trometamol, Sodium chloride, Sodium hydroxide (biex jirregola l- pH), Hydrochloric acid 25% (biex jirregola l- pH), ilma għall- injezzjonijiet.
Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics.
Is- soluzzjoni Pedea m’ għandhiex tiġi f’ kuntatt ma ’ xi soluzzjoni aċiduża bħal antibijotiċi jew dijuretiċi.
A rinse of the infusion line must be performed between each product administration (see section 6.6).
Kull darba qabel ma jingħata il- prodott il- pajp ta ’ l- infużjoni irid jiġi mlaħlaħ (ara sezzjoni 6. 6).
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali
Colourless type 1 glass ampoule.
Ampulla tal- ħġieġ ta ’ bla kulur ta ’ tip I.
Pedea is supplied in packs of 4 x 2 ml ampoules.
Pedea ssibu f’ pakketti ta ’ 4 ampulli x 2 ml.
6.6 Instructions for use and handling
6. 6 Struzzjonijiet għall- użu u maniġġar
As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Bħal fil- każ ta ’ kull prodott parenterali, l- ampulli ta ’ Pedea għandhom jiġu miflija għal xi frak u għall - integrità tal- kontenitur qabel ma jintużaw.
Ampoules are intended for single use only, any unused portions must be discarded.
L- ampulli huma intiżi biex jintużaw darba biss u kull fdal tal- prodott li ma jiġix użat għandu jintrema.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution.
Chlorhexidene m’ għandux jintuża biex jidiżinfetta l- għonq ta ’ l- ampulla billi hu mhuwiex kompatibbli mas- soluzzjoni ta ’ Pedea.
Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
Għalhekk, għal asepsi ta ’ l- ampulla qabel l- użu, huwa rakkomandat l- użu ta ’ ethanol 60% jew isopropyl alcohol 70%.
When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.
Meta l- għonq ta ’ l- ampulla jiġi ddiżinfettat b’ antisettiku, sabiex tiġi evitata kull interazzjoni mas - soluzzjoni ta ’ Pedea, l- ampulla trid tkun nixfet kompletament qabel ma tinfetaħ.
The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Il- volum meħtieġ li għandu jingħata t- tarbija għandu jiġi stabbilit skond il- piż tal- ġisem u għandu jingħata bħala injezzjoni ta ’ infużjoni qasira ġol- vina fuq 15- il minuta, preferibbilment mhux dilwita.
Use only sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution to adjust injection volume.
Uża biss 9 mg/ ml (0. 9%) sodium chloride soluzzjoni għall- injezzjoni jew soluzzjoni ta ’ 50 mg/ ml (5%) glukożju sabiex tagħmel il- volum meħtieġ ta ’ injezzjoni.
The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
6 Il- volum totali ta ’ soluzzjoni injettata fi trabi mwielda qabel iż- żmien irid jiġi kkunsidrat fil- kuntest tal- volum ta ’ fluwidu totali mogħti kuljum.
A maximal volume of 80 ml/ kg/ day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/ kg birthweight/ day) up to a maximal volume of 180 ml/ kg birthweight/ day.
Volum massimu ta ’ 80 ml/ kg/ jum fl- ewwel jum ta ’ ħajja għandu ġeneralment jiġi rispettat; dan għandu jiżdid b’ mod progressiv fil- ġimgħa jew ġimgħatejn ta ’ wara (madwar 20 ml/ kg piż ta ’ twelid / jum) sa volum massimu ta ’ 180 ml/ kg piż ta ’ twelid / jum.
Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%), solution for injection.
Qabel u wara l- għoti ta ’ Pedea, sabiex jiġi evitat kull kuntatt ma ’ soluzzjoni aċiduża l- pajp ta ’ infużjoni għandu jiġi mlaħlaħ għal madwar 15- il minuta b’ 1. 5 sa 2 ml jew ta ’ 9mg/ ml (0. 9%) sodium chloride jew 50 mg/ ml (5%) glukożju, bħala soluzzjoni għall- injezzjoni.
6 After first opening of an ampoule, any unused portions must be discarded.
Wara li tiftaħ l- ampulla l- ewwel darba, kull fdal tal- prodott li ma jiġix użat għandu jintrema.
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense - France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris La Défense - Franza
29 July 2004
29 ta ’ Lulju 2004
8 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
8 A SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Orphan Europe S. A. R. L., Immeuble “ Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux, France
Orphan Europe SARL, Immeuble “ Le Wilson “ 70 avenue du Général de Gaulle F- 92800 Puteaux, Franza.
Summary of Product Characteristics, 4.2).
Karatteristiċi tal- Prodott fil - Qosor, 4. 2)
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Pedea 5 mg/ ml solution for injection Ibuprofen
Pedea 5 mg/ ml soluzzjoni għall- injezzjoni Ibuprofen
Each ml contains 5 mg ibuprofen Each 2 ml ampoule contains 10 mg ibuprofen
Kull ml fih 5 mg ibuprofen Kull ampulla ta ’ 2 ml fiha 10 mg ibuprofen
Excipients: trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Sustanzi mhux attivi: trometamol, sodium chloride, sodium hydroxide (biex jirregola l- pH), hydrochloric acid 25% (biex jirregola l- pH), ilma għall- injezzjonijiet.
4 x 2 ml ampoules
4 ampulli x 2 ml
Intravenous use as short infusion Read the package leaflet before use From a microbiological point of view, the product should be used immediately
Użu għal ġol- vina bħala infużjoni qasira Aqra l- fuljett ta ’ tagħrif qabel ma tużah Mill- lat mikrobijoloġiku, il- prodott għandu jintuża minnufih
After first opening of an ampoule any unused portions must be discarded.
Wara l- ftuħ ta ’ l- ampulla għall- ewwel darba, kull fdal tal- prodott li ma jiġix użat għandu jintrema.
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris La Défense- France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris La Défense - Franza
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
GLASS AMPOULE TEXT (white label stuck on the ampoule)
KITBA FUQ L- AMPULLA TAL- ĦĠIEĠ (tikketta bajda mwaħħla fuq l- ampulla)
Pedea 5 mg/ ml solution for injection Ibuprofen IV use
Pedea 5 mg/ ml soluzzjoni għall- injezzjoni Ibuprofen Użu IV
See leaflet
Ara l- fuljett
COMPANY NAME
ISEM TAL- KUMPANIJA
15 PACKAGE LEAFLET
15 FULJETT TA ’ TAGĦRIF
Read all of this leaflet carefully before this medicine is administered to your baby.
Aqra dan il- fuljett kollu b’ attenzjoni qabel din il- mediċina tingħata lit- tarbija tiegħek.
It may
- Din il- mediċina ġiet mogħtija għall- użu tat- tarbija tiegħek u m’ għandekx tagħtiha lil persuni
harm them, even if their symptoms are the same as your baby ’ s.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tat- tarbija tiegħek.
What Pedea is and what it is used for 2.
X’ inhi Pedea u għalxiex tintuża 2.
Before Pedea is administered to your baby 3.
Qabel ma Pedea tiġi mogħtija lit- tarbija tiegħek 3.
How Pedea is used 4.
Kif tintuża Pedea 4.
Storing Pedea 6.
Kif taħżen Pedea 6.
- The active substance is ibuprofen.
- Is- sustanza attiva hija ibuprofen.
Each 2 ml ampoule
Kull ampulla ta ’ 2 ml fiha 10 mg
contains 10 mg ibuprofen.
ibuprofen.
- The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment),
- Is- sustanzi l- oħra huma trometamol, sodium chloride, sodium hydroxide (biex jirregola l- pH),
hydrochloric acid 25% (for pH adjustment) and water for injections.
hyfrochloric acid 25% (biex jirregola l- pH) u ilma għall- injezzjonijiet.
Marketing authorisation holder and Manufacturer:
Sid l- Awtorizzazzjoni għall- Kummerċ u Manifattur:
WHAT PEDEA IS AND WHAT IT IS USED FOR
X’ INHI PEDEA U GĦALXIEX TINTUŻA
Pedea is a solution for injection available in cartons of four 2 ml ampoules.
Pedea hija soluzzjoni għall- injezzjoni disponibbli f’ kartun ta ’ erba ’ ampulli ta ’ 2 ml.
While a baby is inside its mother’ s womb it does not need to use its lungs.
Meta tarbija tkun fil- ġuf ta ’ l- omm, m’ għandhiex bżonn tuża l- pulmun tagħha.