qanastek/EMEA-V3 huggingface dataset:
These may be the warning signs of a sudden rise in blood pressure, which requires urgent treatment.
Dawn jistgħu jkunu sinjali ta ’ twissija ta ’ pressjoni għolja f’ daqqa waħda, li jkollhom bżonn trattament urġenti.
There may be a rise in the level of platelets (cells that help blood clotting) during treatment with this medicine.
Jista ’ ikun hemm żieda fil- livell tal- plejtlits (ċelluli li jgħinu d- demm jgħaqad) waqt it- trattamant b’ din il- mediċina.
This should improve during the course of the treatment.
Dan għandu jitjieb waqt iż- żmen tat- trattament.
It is recommended that the platelet count is regularly checked during the first 8 weeks of therapy.
Huwa rrakomandat li l- għadd tal- plejtlits jiġi investigat spiss matul l- ewwel 8 ġimgħat ta ’ terapija.
Remember to tell your doctor that you are receiving Retacrit if you have to visit the hospital or family doctor for any treatmentincluding a blood test, as Retacrit may affect the results.
Ftakar biex tgħid lit- tabib tiegħek li qed tieħu Retacrit jekk ikollok bżonn iżżur l- isptar jew it- tabib tal - familja għal xi trattament, jew il- klinika għall- eżami tad- demm, peress li Retacrit jista ’ jaffettwa ir - riżultati.
Kidney disease patients There is no experience with subcutaneous use (injection into the skin) of Retacrit in kidney patients.
Pazjenti bil- mard tal- kliewi M’ hemmx wisq esperjenza fl- użu ta ’ taħt il- ġilda (injezzjoni taħt il- ġilda) ta ’ Retacrit fil- pazjenti tal - kliewi.
Therefore, if you are being treated for anaemia associated with kidney disease, Retacrit has to be given by injection into a vein (intravenously).
Għalhekk, jekk qiegħed tiġi ttrattat għal anemija assoċjata mal- mard tal- kliewi, Retacrit għandu jingħata f’ vina (ġol- vina).
Pure Red Cell Aplasia (PRCA) has been reported very rarely after months to years of subcutaneous treatment with other products containing erythropoietins and may not be ruled out with Retacrit.
Il- PRCA
PRCA means the inability to produce enough red blood cells in the bone marrow.
196 iffisser in- nuqqas ta ’ abilità li tipproduċi biżżejjed ċelluli ħomor fil- mudullun.
If this occurs it can result in severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
Jekk jiġri dan, dan jista ’ jwassal għal anemija severa, li s- sintomi tagħha huma għejja mhux tas- soltu, tħossok stordut jew bla nifs.
185 PRCA may be caused by the production to antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
Il- PRCA tista ’ tiġi kkaważata minn produzzjoni ta ’ antikorpi kontra il- prodott ta ’ l - eritropojetin u, wara,, għall- eritropojetin tiegħek stess.
You should discuss this information with your doctor.
Għandek tiddiskuti dan it- tagħrif mat- tabib tiegħek.
If PRCA, a very rare condition, occurs, the Retacrit therapy will be stopped and your doctor will determine the best course of action to treat the anaemia.
Jekk il- PRCA – kundizzjoni rari - tiġri, it- terapija b’ Retacrit titwaqqaf u t- tabib tiegħek jidditermina l- aħjar mod ta ’ trattament għall- anemija.
Although this complication is very rare, you should be aware that if you develop it, you would need to have regular blood transfusions, possibly lifelong, to treat your anaemia and the Retacrit therapy would have to be discontinued.
Għalkemm din il- kumplikazzjoni hija rari, għandek tkun taf li jekk tiżviluppaha, ikollok bżonn trasfużjonijiet tad - demm regolari, forsi għal kumplament ta ’ ħajtek, għat- trattament tal- anemija tiegħek u t- trattament b’ Retacrit jkun irid jitwaqqaf.
Tell your doctor immediately if you suddenly feel very tired or dizzy or suffer from shortness of breath.
Għarraf lit- tabib tiegħek mill- ewwel jekk f’ daqqa waħda tħossok għajjien ħafna jew stordut jew ikollok qtugħ ta ’ nifs.
Your doctor can decide whether Retacrit is not working properly for you and will end the treatment, if necessary.
It- tabib tiegħek jista ’ jiddeċiedi jekk Retacrit hux qed jaħdem tajjeb għalik u jwaqqaf it- trattament, jekk hemm bżonn.
Chronic renal failure patients on erythropoietin should have their haemoglobin (the part of a red blood cell that carries oxygen) levels measured on a regular basis until a stable level is achieved, and periodically thereafter to minimise the risk of an increase in blood pressure.
Pazjenti b’ insuffiċjenza renali kronika fuq l- eritropojetin għandu jkollhom il- livelli tal- emoglobina tagħhom (dik il- parti taċ- ċellula ħamra li ġġor l- ossiġinu) mkejla fuq bażi regolari sakemm jintlaħaq livell stabbli, imbagħad kultant żmien wara, biex jitnaqqas ir- riskju ta ’ zieda fil- pressjoni tad- demm.
If you are a patient with chronic kidney disease, your doctor will check that your haemoglobin does not exceed a certain level as high haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of death.
Jekk int pazjent b’ mard tal- kliewi kroniku, it- tabib tiegħek ser jiċċekkja jekk l- emoglobina tiegħek hiex qed taqbeż ċertu livell peress li emoglobina għolja tista ’ tpoġġik f’ riskju ta ’ problemi tal- qalb jew tal- vażi tad- demm u żżid ir- riskju ta ’ mewt.
Increases in blood potassium have happened in isolated cases.
Żidietfil- potassju fid- demm ġraw f’ każijiet iżolati.
In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake.
F’ pazjenti b ’ insuffiċjenza renali kronika, korrezzjoni għall- anemija tista ’ twassal għal żieda fl- aptit, t- teħid tal- potassju u proteini.
If you are receiving dialysis treatment when you begin treatment with Retacrit, your dialysis regimen may need to be adjusted to maintain urea, creatinine and potassium levels in the desired range.
Jekk qed tirċievi trattament ta ’ dijalisi meta tibda t- trattament b’ Retacrit, ir- reġim ta- dijalisi tiegħek jista ’ jkollu bżonn li jiġi aġġustat sabiex jinżammu l- livelli tal- ureja, il- kreatinina u l- potassju f’ livelli mixtieqa.
Your doctor will decide this.
Dan jiġi deċiż mit- tabib tiegħek.
Serum electrolytes (substances in your blood) should be monitored in chronic renal failure patients.
L- elettroliti fis- serum (sustanzi f’ demmek) għandhom jiġu osservati f’ pazjenti b ’ insuffiċjenza renali kronika.
If an elevated (or rising) serum potassium level is detected, your doctor may consider to stop the treatment with Retacrit until the level is back to normal.
Jekk il- livell ta ’ potassju fis- serum għola (jew qed jogħla) jiġi osservat imbagħad kunsiderazzjoni għandha tingħata sabiex jingħataRetacrit sakemm il- livell jiġi lura għan- normal.
An increase in the dose of a particular blood-thinning medicine (heparin) during haemodialysis is often needed during the course of therapy with Retacrit to minimize the risk of blood clotting.
Spiss ikun hemm bżonn żieda fid- doża ta ’ mediċina partikulari li traqqaq id- demm (l- eparina) matul l - emodijalisi matul il- kors tat- terapija b’ Retacrit sabiex jitnaqqas ir- riskju li d- demm jagħqad.
Blockage of the dialysis system is possible if heparinisation is not optimum.
Huwa possibbli li s- sistema tad- dijalisi tinstadd jekk l- eparizzazzjoni mhux ottimali.
Cancer patients Cancer patients are more likely to suffer from blood clots if receiving erythropoietin medicines, like Retacrit (see section 4).
Il- pazjenti tal- kanċer l- pazjenti tal- kanċer iżjed għandhom lok li jbatu mid- demm li jgħaqad jekk ikunu qegħdin jirċievu l - mediċini bl- eritropojetin, bħal Retacrit (ara sezzjoni 4).
Therefore, you should discuss the benefits of Retacrit with your doctor, particularly if you are obese or have a history of blood clots/blood clotting disorders.
Għalhekk, għandek tidisskuti l- benifiċċji ta ’ Retacrit mat- tabib tiegħek, partikolarment jekk int oħxon jew jekk fil- passat kellek problemi biex jgħaqad id- demm/ mard biex jgħaqad id- demm.
Cancer patients on erythropoietin should have haemoglobin (the part of a red blood cell that carries oxygen) levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Il- pazjenti tal- kanċer li huma fuq l- eritropojetin għandu jkollhom il- livelli tal- emoglobina (dik il- parti taċ- ċellula ħamra li ġġor l- ossiġinu) mkejla fuq bażi regolari sakemm il- livell stabbli jintlaħaq, u perjodkament wara.
If you are a cancer patient, you should be aware that Retacrit, may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Jekk int pazjent tal- kanċer, għandek tkun konxju li Retacrit jista ’ jaġixxi bħala fattur ta’ żvilupp għaċ - ċellula tad- demm u f’ xi ċirkostanzi jista ’ jkollu impatt negattiv fuq il- kanċer tiegħek.
Depending on your individual situation a blood transfusion may be preferable.
Skont is - sitwazzjoni individwali tiegħek, jista ’ jkun li trasfużjoni tad- demm tkun ippreferuta.
Please discuss this with your doctor.
Jekk jogħġbok iddisskuti dan mat- tabib tiegħek.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jew l- ispiżjar jekk intix tieħu jew ħadt dan l- aħħar mediċini oħra, li jinkludu mediċini li hadt mingħajr riċetta.
In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure ciclosporin levels while you are taking Retacrit.
Partikolarment, jekk qed tieħu mediċina li fiha s- sustanza attiva ciclosporin sabiex trażżan is- sistema immunitarja tiegħek wara trapjant tal- kliewi, it- tabib tiegħek jista ’ jordna eżamijiet speċjali tad- demm
Iron supplements and other blood stimulants may increase the effectiveness of Retacrit.
Is- supplimenti tal- ħadid u stimulanti oħra tad- demm jistgħu jgħollu l- effikaċja ta ’ Retacrit.
Your doctor will decide if it is right for you to take them.
It- tabib tiegħek jiddeċiedi jekk tistax teħodhom.
186 Pregnancy and breast-feeding
Tqala u Treddigħ
Tell your doctor if you are pregnant or think you may be pregnant or are breast-feeding.
Għid lit- tabib tiegħek jekk inti tqila jew taħseb li tista ’ tkun tqila jew li qed tredda ’.
If you are pregnant or breast-feeding, Retacrit should be used only if the potential benefit outweighs the potential risk to the foetus.
Jekk int tqila jew qed tredda ’, Retacrit għandu jintuża biss jekk il- benefiċċju potenzjali huwa akbar mir- riskju għall- fetu.
Ask your doctor for advice before taking any medicine.
Staqsi lit- tabib tiegħek qabel ma tieħu xi mediċina.
Retacrit has no or negligible effect on the ability to drive and use machines.
Retacrit għandu ftit jew l- ebda effett fuq il- kapacità tas- sewqan jew it- tħaddim tal- magni.
Important information about some of the ingredients of Retacrit
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Retacrit
This medicine contains phenylalanine and may be harmful for people with phenylketonuria.
Tista ’ tkun ta ’ ħsara għan- nies bil- fenilketonurja.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodju (23 mg) f’ kull doża, i. e. essenzjalment ‘ bla sodju ’.
HOW TO USE RETACRIT
KIF GĦANDEK TUŻA RETACRIT
Retacrit therapy is usually started under medical supervision.
It- terapija b’ Retacrit normalmment tibda taħt superviżjoni medika.
The injections can then be given by a doctor, trained nurse or other health care professional.
L- injezzjonijiet b’ Retacrit jistgħu imbagħad jingħataw minn tabib, infermiera mħarrġa jew professjonist ieħor.
In case Retacrit is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Jekk Retacrit jiġi injettat taħt il- ġilda, tista ’ tinjetta lilek nnifsek bis- soluzzjoni la darba jkunu wrewk kif.
Always use Retacrit exactly as your doctor has told you.
Dejjem għandek tuża Retacrit skond il- parir eżatt tat- tabib.
Dosage information
Tagħrif dwar dożaġġ
The dose you receive is based on your body weight in kilograms.
Id- doża li tirċievi hija bbażata fuq it- piż ta ’ ġismek f’ kilogrammi.
Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Retacrit.
It- tabib tiegħek jagħmel l- investigazzjonijiet, per eżempju, testijiet tad- demm, biex jgħinuh jiddeċiedi jekk ikun hemmx bżonn li int tieħi Retacrit.
He/she will work out the correct dose of Retacrit for you to use, how long the treatment should continue and by what route the medicine will be given.
Hu/ Hi jaħdmu d- doża ta ’ Retacrit li suppost int għandek tuża, kemm idum it- trattament u b’ liema mod il- prodott mediċinali għandu jingħata.
These decisions will be influenced by what is causing your anaemia.
Dawn id - deċiżjonijiet ikunu influwenzati minn dak li qiegħed jikkawża l- anemija tiegħek.
Use in adult patients receiving haemodialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl (6.2 - 7.5 mmol/l).
L- użu f’ pazjenti adulti li qegħdin jirċievu l- emodijalisi It- tabib tiegħek ser iżomm il- konċentrazzjoni tal- emoglobina bejn 10 u 12 g/ dl (6. 2 - 7. 5 mmol/ l)
Retacrit may be given during the dialysis session or after you have received a dialysis session.
Retacrit jista ’ jingħata waqt is- sessjoni tad- dijalisi jew wara li tkun irċevejt sessjoni tad- dijalisi.
The usual starting dose of Retacrit is 50 IU/kg (International Units per kilogram).
Id- doża normali tal- bidu hija 50 IU/ kg (Units Intenazzjonali kull kilogramma).
This is given 3 times a week by injection into a vein (intravenous injection over 1-2 minutes).
Din tingħata 3 darbiet fil- ġimgħa b’ injezzjoni fil- vina (għal 1- 2 minuti).
Depending on how your anaemia responds to treatment, the dose may be adjusted approximately every 4 weeks until your condition is controlled.
Skond kif tirrispondi l- anemija tiegħek għat- trattament, id- doża tista ’ tiġi aġġustata bejn wieħed u ieħor kull 4 ġimgħat sakemm il- kundizzjoni tiegħek hija kkontrollata.
The dose you receive should not normally exceed 200 IU/kg 3 times a week, and should be given by injection into a vein or a tube that goes into a vein.
Id- doża li tirċievi m’ għandiex taqbeż normalment il- 200 IU/ kg 3 darbiet fil- ġimgħa, u għandha tingħata b’ injezzjoni fil- vina jew permezz ta ’ tubu li jidħol f’ vina.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
It- tabib tiegħek ser jordna testijiet regolari tad- demm sabiex jassigura li l- mediċina tiegħek qiegħda
When your condition has been brought under control, you will receive regular doses of Retacrit, 2 or 3 times a week.
Meta l- kundizzjoni tiegħek tkun ġiet ikkontrollata, int tirċievi dożi regolari ta ’ Retacrit, 2 jew 3 darbiet fil- ġimgħa.
These doses may not be as high as those received initially.
Dawn id- dożi mhux bil- fors ikunu għoljin daqs dawk li tkun irċevejt fil- bidu.
Use in children and adolescents up to 18 years receiving haemodialysis In children the doctor will maintain the haemoglobin concentration between 9.5 and 11 g/dl
Użu fit- tfal u l- adolexxednti (≤18) li qegħdin jirċievu l- emodijalisi Fit- tfal, it- tabib ser iżomm il- konċentrazzjoni tal- emoglobina bejn 9. 5 u 11 g/ dl
Retacrit should be given after the patient has received a dialysis session.
Retacrit għandu jingħata wara li l- pazjent irċieva s- sessjoni ta ’ dijalisi.
187 The dose for children and adolescents is based on body weight in kilograms.
Id- doża għat- tfal u l- adolexxenti hija bbażata fuq it- piż tal- ġisem f’ kilogrammi.
The usual starting dose is 50 IU/kg.
Id- doża normali tal - bidu hija ta ’ 50 IU kull kilogramma.
This is given three times a week, injected into a vein (over 1-2 minutes).
Din tingħata tliet darbiet fil- ġimgħa, injettata f’ vina (għal 1- 2 minuti).
Depending on how the anaemia responds, the dose may be adjusted approximately every 4 weeks until the condition is controlled.
Skond kif tirrispondi l- anemija, id- doża tista ’ tiġi aġġustata bejn wieħed kull 4 ġimgħat sakemm il - kundizzjoni hija kontrollata.
Your doctor will order regular blood tests to see that this is being achieved.
It- tabib tiegħek ser jordna testijiet regolari tad- demm sabiex jara li dan qiegħed jintlaħaq.
Use in adult patients receiving peritoneal dialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl.
L- użu fl- adulti li qegħdin jirċievu d- dijalisi peritonjali It- tabib tiegħek ser iżomm il- konċentrazzjoni tal- emoglobina bejn 10 u 12 g/ dl
The usual starting dose is 50 IU/kg.
Id- doża normali tal- bidu hija ta ’ 50 IU/ kg.
This is given twice a week by injection into a vein or a tube that goes into a vein.
Din tingħata darbtejn fil- ġimgħa b’ injezzjoni f’ vina jew tubu li jidħol f’ vina.
Depending on how your anaemia responds, the dose may be adjusted approximately every 4 weeks until your condition is controlled.
Skond kif tirrejaġixxi l- anemija tiegħek, id- doża tista tkun aġġustata bejn wieħed u ieħor kull 4 ġimgħat sakemm tiġi ikkontrollata il- kundizzjoni tiegħek.
The total weekly dose that you receive should not normally exceed 200 IU/kg and should be given by injection into a vein or a tube that goes into a vein.
Id- doża totali ta ’ ġimgħa li tirċievi m’ għandiex taqbeż normalment il- 200 IU/ kg u għandħa tingħata b’ injezzjoni f’ vina jew tubu li jidħol ġo vina.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
It- tabib tiegħek ser jordna testijiet regolari tad- demm sabiex jassigura li l- mediċina tiegħek qiegħda tkompli taħdem tajjeb.
The usual starting dose is 50 IU/kg.
L- użu f’ pazjenti adulti b’ mard fil- kliewi imma li m’ humiex jirċievu d- dijalisi Id- doża normali tal- bidu hija ta ’ 50 IU/ kg.
This is given 3 times a week by injection into a vein or a tube that goes into a vein.
Din tingħata 3 darbiet fil- ġimgħa b’ injezzjoni f’ vina jew tubu li jidħol f’ vina.
The starting dose may be adjusted by your doctor until your condition is controlled.
Id- doża tal- bidu tista ’ tiġi aġġustata mit- tabib tiegħek sakemm il- kundizzjoni tiegħek hija kkontrollata.
After your condition has been brought under control, you will receive regular doses of Retacrit, 3 times a week.
Wara li l- kundizzjoni tiegħek tkun ġiet taħt kontroll, int tierċievi dożi regolari ta ’ Retacrit, 3 darbiet fil- ġimgħa.
The dosage should not normally exceed 200 IU/kg, 3 times a week and should be given by injection into a vein or a tube that goes into a vein.
Id- doża m’ għandiex normalment taqbeż il- 200 IU/ kg, 3 darbiet fil- ġimgħa u għandha tingħata b’ injezzjoni f’ vina jew tubu li jidħol ġo vina.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
It- tabib tiegħek ser jordna testijiet regolari tad- demm sabiex jassigura li l- mediċina tiegħek qiegħda tkompli taħdem kif suppost.
Use in adult patients receiving chemotherapy Your doctor may initiate treatment with Retacrit if your haemoglobin level is 10 g/dl or less.
L- użu fil- pazjenti adulti li qegħdin jirċievu l- kimoterapija It- tabib tiegħek jista ’ jibda t- trattament b’ Retacrit jekk il- livell tal- emoglobina hu ta ’ 10 g/ dl jew inqas.
After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dl
Wara li tinbeda t- terapija, it- tabib tiegħek ser iżomm il- livell tal- emoglobina tiegħek bejn 10 u 12 g/ dl.
The usual starting dose is 150 IU/kg.
Id- doża normali tal- bidu hija ta ’ 150 IU/ kg.
This is given 3 times a week by injection under the skin.
Din tingħata 3 darbiet fil- ġimgħa b’ injezzjoni taħt il- ġilda.
Alternatively, your doctor may recommend a starting dose of 450 IU/kg once a week.
Jew inkella, it- tabib tiegħek jista ’ jirrakomanda doża tal- bidu ta ’ 450 IU/ kg darba fil- ġimgħa.
The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Retacrit until 1 month after the end of chemotherapy.
Id- doża tal- bidu tista ’ tiġi aġġustata mit- tabib tiegħek skond kif tirrisspondi l- anemija tiegħek għat- trattament; normalment int ser tierċievi Retacrit sa xahar wara t- tmiem tal- kimoterapija.
Use in adult patients in an autologous predonation programme The usual starting dose is 600 IU/kg.
L- użu f’ pazjenti adulti f’ programm ta ’ predonazzjoni awto- anologu Id- doża normali tal- bidu hija ta ’ 600 IU/ kg.
This is given 2 times a week by injection into a vein.
Din tingħata darbtejn fil- ġimgħa b’ injezzjoni f’ vina.
You will receive Retacrit during the 3 weeks before your surgery.
Int ser tieċievi Retacrit matul it- 3 ġimgħat qabel il- kirurġija tiegħek.
You will also take iron supplements before and during Retacrit treatment to increase the effectiveness of Retacrit.
Int ser tieħu wkoll supplimenti tal - ħadid qabel u waqt it- trattament b’ Retacrit sabiex iżżid l- effikaċija ta ’ Retacrit.
Information on administration
199 Informazzjoni ta ’ kif jingħata
The pre-filled syringe is ready for use.
Is- siringa mimlija minn qabel b’ Retacrit hija lesta biex tintuża.
Each syringe should be used for a single injection only.
Kull siringa għandha tintuża għal injezzjoni waħda biss.
Retacrit must not be shaken or mixed with any other liquid.
L- injezzjoni ta ’ Retacrit m’ għandiex titħawwad jew titħallat ma ’ xi likwidu ieħor.
If Retacrit is injected under the skin for anaemia not associated with kidney disease the amount injected in any one place should not exceed 1 ml.
Jekk Retacrit huwa injettat taħt il- ġilda għall- anemija mhix assoċjata mal- mard tal- kliewi l- ammont injettat f’ post wieħed m’ għandux ikun ta ’ izjed minn 1 ml.
Always follow these instructions when using Retacrit:
Dejjem segwi dawn l- isruzzjonijiet meta tuża Retacrit:
Take one sealed syringe blister and leave it to stand for a few minutes until it reaches room temperature prior to using it.
Ħu pakkett b’ siringa issiġillat u ħallih għal ftit minuti sakemm jilħaq it- temperatura tal- kamra qabel ma tużah.
This usually takes between 15 and 30 minutes.
Dan normalment jieħu bejn 15 u 30 minuta.
Remove the syringe from the blister and check that the solution is clear, colourless and practically free from visible particles.
Neħħi s- siringa mill- pakkett u ara li l- soluzzjoni hija ċara, bla kulur u prattikament bla partiċelli viżibbli.
Remove the protective cap from the injection needle and expel air from the syringe and injection needle by holding the syringe vertically and gently pressing the plunger upwards.
Neħħi t- tapp protettiv mil- labra tas- siringa u neħħi l- arja mis- siringa u l- labra billi żżomm is - siringa dritta u bil mod il- mod tagħfas it- tapp ‘ il- fuq.
Inject the solution as you have been shown by your doctor.
Injetta s- soluzzjoni kif uriek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek tara mat- tabib jew mall- ispiżjar tiegħek jekk m’ intix ċerta.
• the blister sealing is broken or the blister is damaged in any way • the liquid is coloured or you can see particles floating in it • any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister • you know or think it may have been accidentally frozen
Tużax Retacrit jekk: • Is- siġġill tal- pakkett hu mkisser jew is- siġġill għandu xi ħsara • il- likwidu huwa kkulurit jew tista ’ tara partiċelli jgħumu fil- wiċċ • kwalunke likwidu ħareġ mis- siringa mimlija minn qabel jew kondensazzjoni hija viżibbli mill - pakkett issiġġillat • taf jew taħseb li seta ’ ġie iffriżat bi żball
Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection) Once your condition is controlled you will receive regular doses of Retacrit.
Bdil minn injezzjoni f’ vina għal injezzjoni taħt il- ġilda La darba l- kundizzjoni tiegħek hija kkontrollata int tirċievi dożi regolari ta ’ Retacrit.
If your anaemia is not associated with kidney disease, your doctor may decide that it is better for you to receive Retacrit by injection under the skin (subcutaneous) rather than into a vein (intravenous).
Jekk l- anemija mhix assocjata mal- mard tal- kliewi, it- tabib tiegħek jista ’ jiddeċiedi li huwa aħjar għalik li tirċievi Retacrit bl- injezzjoni taħt il- ġilda minflok fil- vina.
The dose should remain the same while the change is being made.
Id- doża għandha tibqa l- istess waqt li l- bidla qiegħda sseħħ.
Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.
Wara, t- tabib tiegħek jista ’ jordna t - testijiet tad- demm biex jara jekk hemmx bżonn xi aġġustament fid- doża.
Injecting Retacrit under the skin yourself for anaemia not associated with kidney disease At the start of your therapy, Retacrit is injected by medical or nursing staff.
L- Injezzjoni ta ’ Retacrit taħt il- ġilda minnek stess għall- anemija mhix assocjata mal- mard tal- kliewi Fil- bidu tat- terapija tiegħek, Retacrit jista ’ jiġi injettat min staff mediku jew infermiera.
However, your doctor may decide that it is right for you to learn how to inject Retacrit under the skin (subcutaneously) yourself.
Iżda, t- tabib tiegħek jista ’ jiddeċiedi li huwa tajjeb li titgħallem int stess kif tinjetta Retacrit taħt il- ġilda.
You will receive appropriate training to enable you to do this.
Int ser tirċievi taħriġ xieraq għalik biex tagħmel dan.
Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Taħt l- ebda ċirkostanzi m’ għandek tinjetta lilek inniffsek jekk ma ġejtx imħarreġ biex tagħmel dan.
If you use more Retacrit than you should
Jekk tuża ’ aktar Retacrit milli suppost
Retacrit has a wide safety margin and side effects due to an overdose of using Retacrit are unlikely.
Retacrit għandu marġini wiesa ’ ta ’ sigurtà u effetti sekondarji minħabba doża żejda mill- użu ta ’ Retacrit huma remoti.
You should inform the doctor or nurse immediately if you think too much Retacrit has been injected.
Għandek tinforma lit- tabib jew l- infermiera mil- ewwel jekk taħseb li wisq Retacrit ġie injettat.
If you forget to use Retacrit
Jekk tinsa tuża Retacrit
Do not use a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal xi doża li tkun insejt tieħu.
If you stop using Retacrit Do not to stop the treatment without consultation of your doctor.
Qatt m’ għandek twaqqaf it- trattament mingħajr ma tikkonsulta lit- tabib tiegħek.
If you have any further questions on the use of this product, ask your doctor.
Jekk għandek xi mistoqsijiet oħra dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib tiegħek.
Like all medicines, Retacrit can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Retacrit jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience headaches, particularly sudden, stabbing migraine-like headaches or feel confused or have fits, tell your doctor immediately.
Jekk ikollok uġigħ ta ’ ras, b’ mod partikulari uġigħ ta ’ ras qawwi għall- għarrieda li jixbah lill - emigranja, jew tħossok konfuż jew jagħtuk l- aċċessjonijiet, għid lit- tabib tiegħek immedjatament.
189 – skin rash – flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, tiredness, dizziness.
- Sintomi jixbħu lill- influwenza, bħal uġigħ ta ’ ras, uġigħ fil- ġogi, sensazzjoni ta ’ dgħjufija,
These may be more common at the start of treatment. – An increase in levels of blood platelets (thrombocytes) which are normally involved in the formation of a blood clot may occur.
It- tabib tiegħek ser jiċċekkja dwar dan.
Your doctor will check on this. – Vascular and thrombotic events (blood clotting) in blood vessels, such as disturbed blood perfusion of the heart, heart attack, cerebral haemorrhages, stroke, temporary disturbance of blood perfusion in the brain, deep vein thrombosis, arterial thrombosis, pulmonary embolism, dilatation of the wall of a blood vessel (aneurysm), retinal thrombosis, and blood clot in an artificial kidney have been reported in patients receiving erythropoietin treatment. – Hypersensitivity reactions have been reported in rare cases, including swelling, mainly in the region of the eyelids and the lips (Quincke's oedema) and shock-like allergic reactions with symptoms of tingling, reddening, itching, hot flush and accelerated pulse. – Pure red cell aplasia (PRCA) has been very rarely reported in patients after months to years of subcutaneous (injection under the skin) erythropoietin treatment.
fil- qalb, attakk tal- qalb, emorraġiji ċerebrali, puplesija, disturb temporanju tal- perfużjoni tad - demm fil- moħħ, trombożi fonda fil- vini, trombożi arterjali, emboliżmu pulmonari, twessiegħ tal- ħajt ta ’ vina jew arterja (anewriżma), trombożi fir- retina, u embolu f’ kilwa artifiċjali ġew irrappurtati f’ pazjenti li kienu qegħdin jirċievu kura bl- erythropoietins.
PRCA means the inability to produce enough red blood cells in the bone (see section “Take special care with Retacrit”).
- F’ każijiet rari kienu rrappurtati reazzjonijiet ta ’ sensittività eċċessiva, fosthom nefħa, l- aktar
Kidney patients – raised blood pressure which may require treatment with medicinal products or adjustment of the dosage of medicinal products you already take for high blood pressure.
fiż- żona ta ’ tebqet il- għajn u tax- xufftejn (edema ta ’ Quincke) u reazzjonijiet allerġiċi li jixbhu lil xokk b’ sintomi ta ’ tnemnim, ħmura, ħakk, fawra u polz mgħaġġel.
Your doctor may monitor your blood pressure regularly while you are using Retacrit, particularly at the start of therapy. – Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if you have low blood pressure or if your arteriovenous fistula has complications.
PRCA tfisser in- nuqqas ta ’ kapaċità li l- ġisem tiegħek jipproduċi biżżejjed ċelluli ħomor tad- demm fl- għadam (ara s- sezzjoni “ Oqgħod attent ħafna b’ Retacrit ”).
Your doctor may check your shunt and prescribe a medicinal product to prevent thrombosis.
- Pressjoni għolja tad- demm li jista ’ jkollha bżonn ta ’ kura bi prodotti mediċinali jew
Cancer patients – blood clotting (thrombotic vascular events) (see section “Take special care with Retacrit”). – increase of blood pressure.
- Okklużjoni fejn l- arterja tikkonnettja mal- vina (trombożi fix- xant) tista ’ sseħħ, speċjalment jekk
Therefore your haemoglobin-levels and your blood pressure should be controlled.
Għalhekk il- livelli tal- emoglobina tiegħek u l- pressjoni tad- demm
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE RETACRIT
KIF TAĦŻEN RETACRIT
Keep out of the reach and sight of children.
201 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Retacrit after the expiry date which is stated on the label and the carton.
Tużax Retacrit wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa wara “ JIS ”.
The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Is- siringa tista ’ titneħħa mill- friġġ u tista ’ titħalla f’ temperatura tal- kamra għal perjodu wieħed ta ’ mhux aktar minn 3 ijiem (iżda mhux f’ aktar minn 25°C).
Ask your pharmacist about how to dispose of medicines that are no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall protezzjoni ta ’ l- ambjent.
What Retacrit contains
X’ fih Retacrit
190 – The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Is- sustanza attiva hi l- epoetin zeta (magħmul permezz tat- teknoloġija tar- rikombinant DNA fil - – linja taċ- ċellula fil- CHO).
Retacrit 1000 IU/0.3ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 3 ml soluzzjoni għall- injezzjoni fiha 1000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 2000 IU/0.6ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 2000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni fiha 2000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 3000 IU/0.9ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 9 ml soluzzjoni għall- injezzjoni fiha 3000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 4000 IU/0.4ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 4 ml soluzzjoni għall- injezzjoni fiha 4000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 5000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni fiha 5000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 6000 IU/0.6ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni fiha 6000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 8000 IU/0.8ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8000 international units (IU) epoetin zeta (recombinant human erythropoietin).
202 internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 10000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 10000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni fiha 10000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 20000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni fiha 20000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 30000 IU/0.75ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 75 ml soluzzjoni għall- injezzjoni fiha 30000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Retacrit 40000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 40000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Retacrit 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni fiha 40000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
191 The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Is- sustanzi l- oħra huma disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (għal aġġustament tal- pH), hydrochloric acid (għal aġġustament tal- pH).
What Retacrit looks like and contents of the pack
Id- Dehra ta ’ Retacrit u l- kontenuti tal- pakkett:
Retacrit is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Jintela f’ siringi ċari tal- ħġieġ b’ labra fissa għall- injezzjoni.
The pre-filled syringes contain between 0.3 and 1.0 ml solution, depending on the content of epoetin zeta (see “What Retacrit contains”).
Is- siringi mimlija minn qabel fihom bejn 0. 3 u 1. 0 ml ta ’ soluzzjoni, skond il- kontenut ta ’ l- epoetin zeta (ara “ X’ fih Retacrit ”).
One pack contains 1, 4 or 6 pre-filled syringes
Pakkett wieħed għandu 1 jew 4 jew 6 siringi mimlija minn qabel.
Latvija Berren Medical, c/o Axellus SIA Tel: + 371 721 1629
Latvija Berren Medical, c/ o Axellus SIA
United Kingdom Hospira UK Limited Tel: + 44 (0) 1926 820820
United Kingdom Hospira UK Limited
What is Revasc?
X’ inhu Revasc?
Revasc is a powder and solvent in a vial, which is made up into a solution for injection.
Revasc huwa trab u solvent f’ kunjett, li jsir soluzzjoni għall- injezzjoni.
Revasc contains the active substance desirudin.
Revasc fih is- sustanza attiva desirudin.
What is Revasc used for?
Għal x’ hiex jintuża Revasc?
Revasc is used in adult patients to prevent blood clotting after hip or knee replacement surgery.
Revasc jintuża f’ pazjenti adulti biex jostakola l- tagħqid tad- demm wara kirurġija biex jinbidel il- ġenb jew tinbidel l- irkoppa.
Revasc is intended for short-term use.
Revasc huwa intenzjonat għal użu fuq żmien qasir.
How is Revasc used?
Kif jintuża Revasc?
Revasc is intended to be given subcutaneously (under the skin), preferably in the abdomen (the tummy).
Revasc huwa intenzjonat biex jingħata taħt il- ġilda, preferibbilment fl- addome (iż- żaqq).
A doctor who has experience in coagulation (clotting) disorders should start treatment with Revasc.
Tabib li għandu esperjenza f’ disturbi tal- koagulazzjoni (tagħqid tad- demm) għandu jibda trattament b’ Revasc.
The recommended dose of Revasc is 15 mg twice daily.
Id- doża irrakkomandata ta ’ Revasc hija 15 mg darbtejn kuljum.
The first injection should be started 5 to 15 minutes before surgery but after any anaesthesia.
L- ewwel injezzjoni għandha tinbeda 5 sa 15- il minuta qabel il- kirurġija iżda wara kull anesteżija.
Revasc is then given twice daily for 9 and up to a maximum of 12 days, or until the patient is able to walk, whichever occurs first.
Imbagħad Revasc għandu jingħata darbtejn kuljum għal 9 t’ ijiem u sa massimu ta ’ 12- il jum, jew sakemm il- pazjent ikun kapaċi jimxi, skond liema sseħħ l- ewwel.
In patients who have liver or kidney problems, the doctor will monitor blood clotting to see if the dosages may need to be adjusted.
F’ pazjenti li għandhom problemi bil- fwied u bil- kliewi, t- tabib jissorvelja t - tagħqid tad- demm biex jara jekk ikunx meħtieġ li d- dożaġġi jiġu aġġustati.
How does Revasc work?
Kif jaħdem Revasc?
Blood clotting can be a problem when blood flow is disturbed in any way.
It- tagħqid tad- demm jista ’ jkun problema meta t- tnixxija tad- demm tkun disturbata b’ xi mod.
Revasc is an anticoagulant; it prevents the blood from coagulating (clotting).
Revasc huwa antikoagulant; huwa ma jħallix id- demm jikkoagula (jagħqad).
Desirudin, the active substance in Revasc, is nearly identical to hirudin, the anticoagulant substance produced by leeches.
Desirudin, is- sustanza attiva f’ Revasc, hija kważi identika għal hirudin, is- sustanza antikoagulanti prodotta mis- sangisugi.
Desirudin is produced by a method known as ’ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce the substance.
Desirudin huwa magħmul b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: huwa magħmul minn ħmira li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi s- sustanza.
It specifically blocks one of the substances involved in the clotting process, thrombin.
Huwa speċifikament jimblokka waħda mis- sustanzi involuta fil- proċess tat- tagħqid tad- demm, thrombin.
Thrombin is central to the complete process of blood clotting.
Thrombin huwa fundamentali biex itemm il- proċess tat- tgħaqid tad- demm.
By using Revasc during and after hip or knee surgery, the risk of a blood clot forming in the blood vessels of the legs (deep vein thrombosis) is greatly reduced.
Bl- użu ta ’ Revasc waqt u wara kirurgija tal- ġenb jew l- irkoppa, ir- riskju li tifforma ċappa demm fil- vini u l- arterji tad- demm tar - riġlejn (trombożi tal- vini l- fondi) huwa ferm imnaqqas.
How has Revasc been studied?
Kif ġie studjat Revasc?
The effectiveness of Revasc as an anticoagulant has been studied in four studies involving 1,621 patients who received Revasc.
L- effikaċja ta ’ Revasc bħala antikoagulant ġiet studjata f’ erba ’ studji li involvew 1, 621 pazjent li rċevew Revasc.
Revasc was compared with unfractionated heparin or enoxaparin (other anticoagulants).
Revasc tqabbel ma ’ l- eparina mhux frazzjonata jew enoxaparin (antikoagulanti oħra).
(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 problems) and the rate of deep vein thrombosis (the formation of a blood clot in one of the deep veins of the body, usually in the leg).
(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 Il- miżuri ewlenin kienu r- rata totali ta ’ reazzjonijiet trombotiċi (ċapep tad- demm li jikkaġunaw problemi) u r- rata ta ’ trombożi tal- vini l- fondi (il- formazzjoni ta ’ ċappa demm f’ waħda mill- vini l - fondi tal- ġisem, ġeneralment fir- riġel).
What benefit has Revasc shown during the studies?
X’ benefiċċju wera Revasc waqt l- istudji?
The studies showed that desirudin was more effective than both comparator medicines in the prevention of deep vein thrombosis after hip replacement surgery.
L- istudji wrew li desirudin kien aktar effettiv miż- żewġ mediċini li ġie kkumparat magħhom (comparator medicines) fil- prevenzjoni ta ’ trombożi tal- vini l- fondi wara kirurġija ta ’ sostituzzjoni tal - ġenb.
What is the risk associated with Revasc?
X’ inhu r- riskju assoċjat ma ’ Revasc?
The most common side effects with Revasc (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), nausea (feeling sick), wound secretion (oozing of fluid from wounds), hypotension (low blood pressure), deep thrombophlebitis (inflammation of deep veins that can be caused by a blood clot), fever, injection site mass (lumps at the site of injection), haematomas (collections of blood), oedema (swelling) in legs, and non-fatal allergic reactions.
L- aktar effetti sekondarji komuni b’ Revasc (li dehru f’ madwar 1 u 10 pazjenti minn kull100) huma anemija (għadd baxx taċ- ċelloli ħomor tad- demm), nawżja (dardir), tnixxija mill- ferita (tnixxija ta ’ fluwidu mill- feriti), pressjoni baxxa, tromboflebite fonda (infjammazzjoni ta ’ vini fondi li tista ’ tkun ikkaġunata minn ċappa demm), deni, massa fis- sit ta ’ l- infezzjoni (għoqiedi fis- sit ta ’ l- infezzjoni), ematomi (kollezzjonijiet ta ’ demm), edima (nefħa) fir- riġlejn, u reazzjonijiet allerġiċi mhux fatali.
As with other anticoagulants, a common side effect of Revasc is bleeding.
Bħal b’ antikoagulanti oħra, effett sekondarju ta ’ Revasc huwa l- emorraġija.
Some patients can have an allergic shock when they receive Revasc again, and doctors should be very careful when re-exposing a patient to the medicine or to another hirudin analogue.
Xi pazjenti jista ’ jkollhom xokk allerġiku meta jerġgħu jirċievu Revasc, u t- tobba għandhom joqogħdu attenti ħafna meta jesponu pazjent għall- mediċina jew għal analogu hirudin ieħor mill- ġdid.
For the full description of all side effects reported with Revasc, see the Package Leaflet.
Għal deskrizzjoni sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Revasc, ara l- Fuljett ta ’ Tagħrif.
Revasc should not be used in people who may be hypersensitive (allergic) to desirudin or any of the other ingredients, who are pregnant, who have had recent bleeding, who have severe high blood pressure or severe liver or kidney problems, or who have a heart infection.
Revasc m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal desirudin jew għal xi sustanzi oħra tiegħu, li jkunu tqal, li reċentament kellhom emorraġija, li għandhom pressjoni għolja serja jew problemi serji tal- fwied jew tal- kliewi, jew li jkollhom infezzjoni tal- qalb.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijet, ara l- Fuljett ta ’ Tagħrif.
Why has Revasc been approved?
Għaliex ġie approvat Revasc?
The Committee for Medicinal products for Human Use (CHMP) decided that Revasc’ s benefits are greater than its risks to prevent deep vein thrombosis in patients undergoing hip or knee replacement.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Revasc huma akbar mir- riskji tiegħu biex jimpedixxi trombożi fil- vini fondi f’ pazjenti li tkun qed issirilhom sostituzzjoni tal- ġenb jew ta ’ l- irkoppa.
The Committee recommended that Revasc be given marketing authorisation.
Il- Kumitat irrakkomanda li Revasc jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Revasc:
Tagħrif ieħor dwar Revasc:
The European Commission granted a marketing authorisation valid throughout the European Union for Revasc to Canyon Pharmaceuticals Limited on 9 July 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Revasc lil Canyon Pharmaceuticals Limited fid- 9 ta ’ Lulju 1997.
The marketing authorisation was renewed on 9 July 2002 and on 9 July 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fid- 9 ta ’ Lulju 2002 u fid- 9 ta ’ Lulju 2007.
The full EPAR for Revasc can be found here.
L- EPAR sħiħ għal Revasc jista ’ jinkiseb minn hawn.
Fill volume (concentration)
(konċentrazzjoni)
Powder: vial (glass) Solvent: ampoule (glass)
Kunjett (ħġieġ)
15 mg Solvent:
15 mg
0.5 ml (15 mg/ 0.5 ml)
0. 5 ml (15 mg / 0. 5 ml)
2 vials + 2 ampoules
2 ampulli
10 vials + 10 ampoules
10 ampulli
Revasc 15mg/ 0.5ml powder and solvent for solution for injection
Revasc 15 mg / 0. 5 ml trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 15 mg desirudin.
Kull kunjett fih 15 mg ta ’ desirudin.
After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml
Wara r- rikostituzzjoni, kunjett wieħed fih 15 mg ** ta ’ desirudin * f’ kull 0. 5 ml.
Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
Desirudin jikkonsisti f’ katina waħda polipeptida magħmula minn residwi ta ’ 65 amminoaċidi u tliet rabtiet ta ’ disulphide.