qanastek/EMEA-V3 huggingface dataset:
Laboratory tests did not show an interaction between epoetin alfa and G-CSF or GM-CSF (G-CSF and GM-CSF are medicines to stimulate the immune-system e. g. when receiving a chemotherapy for cancer or in case of HIV).
It- testijiet tal- laboratorju ma wrew l- ebda interazzjoni bejn epoetin alfa u G- CSF jew GM- CSF (G - CSF u GM- CSF huma mediċini użati biex jistimulaw is- sistema immuni, eż. meta tirċievi kimoterapija għall- kanċer jew fil- każ ta ’ l- HIV).
Pregnancy and breast-feeding
Tqala u treddigħ
There is not much experience with Binocrit in pregnant women or women who are breast-feeding.
Hemm esperjenza limitata b’ Binocrit f’ nisa tqal jew f’ nisa li qegħdin ireddgħu.
Driving and using machines
Sewqan u tħaddim ta ’ magni
No effects on ability to drive or use machines have been observed.
Ma kienu osservati l- ebda effetti fuq il- ħila biex issuq jew tħaddem magni.
Important information about some of the ingredients of Binocrit
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Binocrit
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”
Dan il- prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f’ kull doża, jiġifieri essenzjalment “ ħieles mis- sodium ”.
HOW TO USE BINOCRIT
KIF GĦANDEK TUŻA BINOCRIT
Your doctor will conduct investigations, for example blood tests, to decide if it is necessary for you to have Binocrit.
It- tabib tiegħek ser jagħmel investigazzjonijiet, pereżempju testijiet tad- demm, biex jiddeċiedi jekk hux neċessarju għalik li tieħu Binocrit.
He/ she will work out the correct dose of Binocrit for you to use and how long the treatment should continue.
Huwa/ hija ser jaħdimlek id- doża korretta li għandek tieħu ta ’ Binocrit u kemm għandha ddum il- kura.
The dose you receive is based on your body weight in kilograms.
Id- doża li tingħata hija bbażata fuq il- piż tal- ġisem tiegħek f’ kilogrammi.
The Binocrit pre-filled syringe is ready for use.
Is- siringa mimlija għal- lest ta ’ Binocrit hija lesta biex tintuża.
Only solutions which are clear, colourless and free of visible particles may be injected.
Soluzzjonijiet li huma ċari, bla kulur u mingħajr frak viżibbli biss jistgħu jiġu injettati.
Binocrit is a sterile but unpreserved product and is for single use only.
Binocrit huwa prodott sterili iżda mhux ippreservat u jista ’ jintuża darba biss.
Binocrit should not be shaken.
201 Binocrit m’ għandux jitħawwad.
At the start of your therapy, Binocrit may be injected under the supervision of experienced medical staff.
Fil- bidu tat- terapija tiegħek, Binocrit jista ’ jkun injettat taħt is- superviżjoni ta ’ staff mediku b’ esperjenza.
Kidney patients
Pazjenti morda bil- kliewi
Binocrit is given by injection into a vein (intravenously).
Binocrit jingħata bħala injezzjoni ġo vina.
Do not give by injection under the skin (subcutaneously).
Tinjettax taħt il- ġilda (injezzjoni taħt il- ġilda).
191 Cancer patients or patients scheduled for major orthopaedic surgery
Pazjenti morda bil- kanċer jew pazjenti skedati għal operazzjoni ortopedika maġġuri
Binocrit is given by injection under the skin (subcutaneously).
Binocrit għandu jingħata b’ injezzjoni taħt il- ġilda (injezzjoni taħt il- ġilda).
Dosage
Dożaġġ
Adults receiving haemodialysis
Pazjenti adulti li jkunu qegħdin jirċievu l- emodijalisi
The usual starting dose is 50 International Units (IU) per kilogram bodyweight.
Id- doża inizjali tas- soltu hi 50 Unità Internazzjonali (IU) għal kull kilogram ta ’ piż tal- ġisem.
This is given three times a week by injection into a vein.
Din tingħata tliet darbiet fil- ġimgħa permezz ta ’ injezzjoni ġo vina.
Depending on how your anaemia responds to treatment, the dose may be adjusted approximately every four weeks until your condition is controlled.
Skond kif tirrispondi l- anemija tiegħek għall- kura, id- doża tista ’ tiġi aġġustata bejn wieħed u ieħor kull erba ’ ġimgħat sakemm il- kundizzjoni tiegħek tkun ikkontrollata.
Your doctor may order regular blood tests to see that this is being achieved and to ensure that your medicine is continuing to work properly and your haemoglobin does not exceed a certain level.
It- tabib tiegħek jista ’ jordna testijiet regolari tad- demm biex jiċċekkja li dan qiegħed jintlaħaq u biex jaċċerta li l- mediċina qed tkompli taħdem tajjeb u l- emoglobina tiegħek ma taqbiżx ċertu livell.
When your condition has been brought under control, you will receive regular doses of Binocrit.
Meta l- kundizzjoni tiegħek tinġieb taħt kontroll, inti għandek tirċievi dożi regolari ta ’ Binocrit.
The recommended weekly dose is between 75 and 300 IU per kilogram.
Id - doża rakkomandata ta ’ kull ġimgħa hija bejn 75 u 300 IU għal kull kilogramm.
Adults receiving peritoneal dialysis
Pazjenti adulti li jkunu qegħdin jirċievu dijalisi peritonali
The usual starting dose is 50 International Units (IU) per kilogram bodyweight.
Id- doża inizjali tas- soltu hi 50 Unità Internazzjonali (IU) għal kull kilogramm ta ’ piż tal- ġisem.
This is given twice a week by injection into a vein.
Din għandha tingħata darbtejn fil- ġimgħa permezz ta ’ injezzjoni ġo vina.
Depending on how your anaemia responds, the dose may be adjusted until your condition is controlled.
Skond kif tirrispondi l- anemija tiegħek, id- doża tista ’ tiġi aġġustata sakemm il- kundizzjoni tiegħek tkun ikkontrollata.
Your doctor may order regular blood tests to see that this is being achieved and to ensure that your medicine is continuing to work properly and your haemoglobin does not exceed a certain level.
It- tabib tiegħek jista ’ jordna testijiet regolari tad- demm biex jara li dan qiegħed jintlaħaq u biex jiżgura li l- mediċina qed tkompli taħdem tajjeb u li l- emoglobina tiegħek ma taqbiżx ċertu livell.
When your condition has been brought under control, you will receive regular doses of Binocrit between 25 and 50 IU/ kg twice a week in two equal injections.
Meta l- kundizzjoni tiegħek tinġieb taħt kontroll, inti għandek tirċievi dożi regolari ta ’ Binocrit bejn 25 u 50 IU/ kg darbtejn fil- ġimgħa f’ żewġ injezzjonijiet ugwali.
Adults with kidney disease not yet receiving dialysis
Pazjenti adulti b’ mard tal- kliewi li jkunu għadhom mhux qegħdin fuq id- dijalisi
The starting dose may be adjusted by your doctor approximately every 4 weeks until your condition is controlled.
Id- doża inizjali tista ’ tiġi aġġustata mit- tabib tiegħek bejn wieħed u ieħor kull 4 ġimgħat sakemm il- kundizzjoni tiegħek tkun ikkontrollata.
Your doctor may order regular blood tests to see that control is being achieved and to ensure that your haemoglobin does not exceed a certain level.
It- tabib tiegħek jista ’ jordna testijiet regolari tad- demm biex jara li dak il- kontroll qiegħed jintlaħaq u biex jiżgura li l- emoglobina tiegħek ma taqbiżx ċertu livell.
After your condition has been brought under control, you will receive regular doses of Binocrit between 17 and 33 IU/ kg, three times a week.
Meta l- kundizzjoni tiegħek tkun ġiet ikkontrollata, inti ser tirċievi dożi regolari ta ’ Binocrit bejn 17 u 33 IU/ kg, tliet darbiet fil- ġimgħa.
The dosage should not normally exceed 200 IU per kilogram, three times a week.
Id- dożaġġ normalment m’ għandux jaqbeż il- 200 IU għal kull kilogramma, tliet darbiet fil- ġimgħa.
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 biex jiżgura li l- mediċina tiegħek qed tkompli taħdem tajjeb.
Children receiving haemodialysis
Tfal li jirċievu l- emodijalisi
This is given three times a week, injected into a vein.
Din tingħata tliet darbiet fil- ġimgħa, b’ injezzjoni ġo vina.
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 u ieħor kull 4 ġimgħat sakemm il- kundizzjoni tkun ikkontrollata.
The doctor will order regular blood tests to see that this is being achieved and to ensure that the haemoglobin value does not exceed a certain level.
It- tabib tiegħek ser jordna testijiet regolari tad- demm biex jara li dan qiegħed jintlaħaq u biex jiżgura li l - emoglobina ma taqbiżx ċertu livell.
Cancer patients
202 Pazjenti morda bil- kanċer
The usual starting dose is 150 International Units (IU) per kilogram bodyweight.
Id- doża inizjali tas- soltu hi 150 Unità Internazzjonali (IU) għal kull kilogramm ta ’ piż tal- ġisem.
This is given 3 times a week by injection under the skin (subcutaneously).
Din tingħata 3 darbiet fil- ġimgħa b’ injezzjoni taħt il- ġilda (injezzjoni taħt il- ġilda).
Alternatively, Binocrit can be administered as an initial dose of 450 IU/ kg once a week by injection under the skin.
Inkella, Binocrit jista ’ jingħata bħala doża inizjali ta ’ 450 IU/ kg darba fil- ġimgħa b’ injezzjoni taħt il- ġilda.
The dose may be adjusted by your doctor depending on how your anaemia responds to treatment.
Id- doża tista ’ tiġi aġġustata mit- tabib tiegħek skond kif l- anemija tiegħek tirrispondi għall- kura.
Your doctor will check that your haemoglobin does not exceed a certain level.
It- tabib tiegħek ser jiċċekkja li l- emoglobina tiegħek ma taqbiżx ċertu livell.
Treatment with Binocrit should be continued until one month after the end of chemotherapy.
Il- kura b’ Binocrit għandha titkompla sa xahar wara t- tmiem tal- kimoterapija.
Use in adult patients in an autologous predonation programme
L- użu f’ pazjenti adulti fi programm ta ’ predonazzjoni awtologa.
The usual starting dose is 600 International Units (IU) per kilogram bodyweight.
Id- doża normali tal- bidu hi ta ’ 600 Unità Internazzjonali (IU) għal kull kilogramm ta ’ piż tal- ġisem.
This is given 2 times a week by injection into a vein.
Din tingħata darbtejn fil- ġimgħa permezz ta ’ injezzjoni ġo vina.
You will receive Binocrit during the 3 weeks before your surgery.
Inti ser tirċievi Binocrit matul it- 3 ġimgħat qabel l- operazzjoni tiegħek.
You will also take iron supplements before and during Binocrit treatment to increase the effectiveness of Binocrit.
Ser tieħu wkoll supplimenti tal- ħadid qabel u matul il- kura b’ Binocrit biex iżżid l- effettività ta ’ Binocrit.
192 Adult patients scheduled for orthopaedic surgery
Pazjenti adulti skedati għal operazzjoni ortopedika
The recommended dose of 600 International Units (IU) per kilogram bodyweight is given weekly for three weeks before surgery and on the day of surgery.
Id- doża rakkomandata ta ’ 600 Unità Internazzjonali (IU) għal kull kilogramm ta ’ piż tal- ġisem tingħata kull ġimgħa għal tliet ġimgħat qabel l- operazzjoni u fil- ġurnata ta ’ l- operazzjoni.
This is given by injection under the skin (subcutaneously).
Din tingħata b’ injezzjoni taħt il- ġilda (injezzjoni taħt il- ġilda).
In cases where there is a need to shorten the time for treatment before the operation is carried out, a dose of 300 IU/ kg is given on each of the next ten days before surgery, on the day of surgery and for four days immediately afterwards.
F’ każijiet fejn ikun meħtieġ li jitqassar iż- żmien tal- kura qabel ma ssir l- operazzjoni, tingħata doża ta ’ 300 IU/ kg kuljum f’ kull wieħed mill- għaxart ijiem li jmiss qabel l- operazzjoni, fil- jum ta ’ l - operazzjoni u għal erbat ijiem eżattament wara.
If blood tests in the period before the operation show your haemoglobin level to be too high, the treatment will be stopped.
Jekk it- testijiet tad- demm fil- perjodu ta ’ qabel l- operazzjoni juru li l- livell ta ’ l- emoglobina tiegħek hu għoli żżejjed, il- kura ser titwaqqaf.
It is important that levels of iron in your blood are normal throughout Binocrit treatment.
Huwa importanti li l- livelli ta ’ ferritin fid- demm tiegħek ikunu normali matul il- kors tal- kura b’ Binocrit.
Where appropriate you will receive oral doses of iron, ideally starting before the Binocrit treatment begins.
Meta jkun xieraq, inti ser tirċievi dożi orali ta ’ ħadid, li idealment jibdew qabel tibda l- kura b’ Binocrit.
Instructions for injecting Binocrit under the skin
Struzzjonijiet biex tinjetta Binocrit taħt il- ġilda
Please note:
Jekk jogħġbok innota:
If you are a kidney patient Binocrit has to be given by injection into a vein.
Jekk inti pazjent/ a li tbati b’ mard tal- kliewi, Binocrit irid jingħata permezz ta ’ injezzjoni ġo vina.
Do not give by injection under the skin (subcutaneously).
Tagħtix l- injezzjoni minn taħt il- ġilda.
The amount injected in any one place should not normally exceed one mililitre (1 ml).
L- ammont injettat fi kwalunkwe post, normalment m’ għandux jaqbeż millitru wieħed (1 ml).
The injections are given preferably in the thigh or the front part of the abdominal wall.
Preferibbilment, l- injezzjonijiet jingħataw fil- koxxa jew fil- parti ta ’ quddiem taż- żaqq.
At the start of your therapy, Binocrit may be injected by medical staff.
Fil- bidu tat- terapija tiegħek, Binocrit jista ’ jkun injettat minn staff mediku.
However, your doctor may decide that it is right for you to learn how to inject Binocrit under the skin yourself.
Madankollu, it- tabib tiegħek jista ’ jiddeċiedi li jkun tajjeb għalik li titgħallem kif tinjetta Binocrit taħt il- ġilda inti stess.
You will receive appropriate training for you to do this.
Inti ser tirċievi taħriġ adattat biex tagħmel dan.
Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Taħt l- ebda ċirkustanza m’ għandek tipprova tinjetta lilek innifsek jekk ma tkunx imħarreġ/ imħarrġa biex tagħmel hekk.
Wash your hands.
Aħsel idejk.
Remove one syringe from the pack and remove the protective cap from the injection needle.
Neħħi siringa waħda mill- pakkett u neħħi l- għatu protettiv minn fuq il- labra ta ’ l- injezzjoni.
Clean the skin at the injection site using an alcohol wipe.
Naddaf il- ġilda fis- sit ta ’ l- injezzjoni bl- użu ta ’ biċċa bl- alkoħol.
Insert the needle into the skin fold with a quick, firm action.
Daħħal il- labra ġot- tiwja tal- ġilda b’ azzjoni mgħaġġla u soda.
Inject the Binocrit solution.
Injetta s- soluzzjoni ta ’ Binocrit.
Ensure that you only inject the amount as instructed by your doctor or nurse.
Aċċerta ruħek li tinjetta biss l- ammont li qallek it- tabib jew in- ners tiegħek.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Iġbed il- labra malajr u applika pressjoni fuq is- sit ta ’ l- injezzjoni b’ garza xotta u sterili.
Discard any remaining liquid.
Armi kwalunkwe likwidu li jibqa ’.
Only use each syringe for one injection.
Uża biss kull siringa għal injezzjoni waħda.
If you inject more Binocrit than you should
Jekk tinjetta aktar Binocrit milli suppost
You should inform the doctor immediately if you think too much Binocrit has been injected.
Inti għandek tinforma immedjatament lit- tabib tiegħek jekk taħseb li ġie injettat iżżejjed Binocrit.
If you forget to use Binocrit
Jekk tinsa tuża Binocrit
If you have missed an injection, or injected too little, talk to your doctor.
Jekk insejt tieħu injezzjoni, jew injettajt ftit wisq, kellem lit- tabib tiegħek.
Do not take a double dose to make up for a forgotten dose.
203 M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Like all medicines, Binocrit can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Binocrit 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 għal għarrieda li jixbah lill - emigranja, jew tħossok konfuż jew jagħtuk l- aċċessjonijiet, għid lit- tabib tiegħek immedjatament.
These may be the warning signs of a sudden rise in blood pressure which requires urgent treatment.
Dawn jistgħu jkunu sinjali ta ’ twissija ta ’ żieda f’ daqqa fil- pressjoni tad- demm li teħtieġ kura urġenti.
193 Other side effects:
Effetti sekondarji oħrajn:
- skin rash
- raxx tal- ġilda
- flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness,
- sintomi jixbhu lill- influwenza, bħal uġigħ ta ’ ras, uġigħ fil- ġogi, sensazzjoni ta ’ dgħjufija, għeja,
tiredness, dizziness.
sturdament.
These may be more common at the start of treatment.
Dawn jistgħu jkunu aktar komuni fil- bidu tal- kura.
- An increase in levels of blood platelets (thrombocytes) which are normally involved in the
- Jista ’ jkun hemm żieda fil- livelli tal- plejtlits fid- demm (tromboċiti) li normalment huma involuti
formation of a blood clot may occur.
fil- formazzjoni ta ’ embolu.
Your doctor will check on this.
It- tabib tiegħek ser jiċċekkja dwar dan.
- Thrombotic events (blood clotting) in blood vessels, such as disturbed blood perfusion of the
- Episodji trombotiċi (tagħqid tad- demm) fil- vini u l- arterji, bħal perfużjoni tad- demm imfixkla
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.
fil- qalb, attakk tal- qalb, emorraġiji ċerebrali, puplesija, disturb temporanju tal- perfużjoni tad - demm fil- moħħ, trombożi fonda fil- vini, trombożi arterjali, emboliżmu pulmonari, twessigħ 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- eritropoetins.
- Hypersensitivity reactions have been reported in rare cases, including swelling, mainly in the
- F’ każijiet rari kienu rrappurtati reazzjonijiet ta ’ sensittività eċċessiva, fosthom nefħiet, l- aktar
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.
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 tal- menopawsa u polz mgħaġġel.
- Pure red cell aplasia (PRCA) has been very rarely reported in patients after months to years of
- Aplasja taċ- ċelluli il- ħomor tad- demm pura kienet irrappurtata b’ mod rari ħafna f’ pazjenti wara
subcutaneous (injection under the skin) erythropoietin treatment.
perijodu ta ’ minn xhur sa snin ta ’ kura mogħtija minn taħt il- ġilda (injezzjoni taħt il- ġilda) bl - eritropoetins.
PRCA means the inability to produce enough red blood cells in the bone (see section “ Take special care with Binocrit”).
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’ Binocrit ”).
- raised blood pressure which may require treatment with medicinal products or adjustment of the
- Pressjoni għolja tad- demm li jista ’ jkollha bżonn ta ’ kura bi prodotti mediċinali jew
dosage of medicinal products you already take for high blood pressure.
aġġustament fid- doża ta ’ prodotti mediċinali li diġà tkun qiegħed tieħu għall- pressjoni għolja tad- demm.
Your doctor may monitor your blood pressure regularly while you are using Binocrit, particularly at the start of therapy.
It- tabib tiegħek jista ’ jimmonitorja l- pressjoni tad- demm tiegħek b’ mod regolari waqt li tkun qiegħed/ qiegħda tuża Binocrit, b’ mod partikulari fil- bidu tat- terapija.
- Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if
- Okklużjoni fejn l- arterja tikkonnettja mal- vina (trombożi fix- xant) tista ’ sseħħ speċjalment jekk
you have low blood pressure or if your arteriovenous fistula has complications.
ikollok pressjoni baxxa tad- demm jew jekk il- fistula bejn l- arterja u l- vina jkollha kumplikazzjonijiet.
Your doctor may check your shunt and prescribe a medicinal product to prevent thrombosis.
It- tabib tiegħek jista ’ jiċċekkja x- xant tiegħek u jordnalek prodott mediċinali biex tiġi evitata trombożi.
- blood clotting (thrombotic vascular events) (see section “ Take special care with Binocrit”).
- tagħqid tad- demm (episodji trombotiċi vaskulari) (ara s- sezzjoni “ Oqgħod attent ħafna
- increase of blood pressure.
- żieda fil- pressjoni tad- demm.
Therefore your haemoglobin-levels and your blood pressure should
Għalhekk il- livelli ta ’ l- emoglobina tiegħek u l- pressjoni tad -
be controlled.
demm tiegħek għandhom jiġi kkontrollati.
Patients donating their own blood before surgery
Pazjenti li jagħtu d- demm tagħhom stess qabel l- operazzjoni
with underlying cardiovascular disease: after donating blood repeatedly vascular and thrombotic events (blood clotting) can occur independently of treatment with Binocrit.
b’ mard kardjovaskulari diġà eżistenti; wara li jagħtu d- demm ripetutament, avvenimenti vaskulari u trombotiċi (emboli tad- demm) jistgħu jseħħu indipendentement mill- kura b’ Binocrit.
Therefore your doctor may prescribe a medicinal product for volume replacement (infusion).
Għalhekk it- tabib tiegħek jista ’ jagħtik riċetta għal prodott mediċinali għas- sostituzzjoni tal- volum (infużjoni).
Patients scheduled for orthopaedic surgery
204 Pazjenti skedati għal operazzjoni ortopedika
Treatment with Binocrit may be associated with an increased risk of blood clotting after the surgery (postoperative thrombotic/ vascular disorders) if your levels of the red blood pigment are too high.
Il- kura b’ Binocrit tista ’ tkun assoċjata ma ’ riskju akbar ta ’ tagħqid tad- demm wara l- operazzjoni (disturbi trombotiċi/ vaskulari wara l- operazzjoni) jekk il- livelli tal- pigment aħmar fid- demm tiegħek ikunu għoljin iżżejjed.
If any of the side effects gets 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 BINOCRIT
KIF TAĦŻEN BINOCRIT
- Keep out of the reach and sight of children.
- Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
- Do not use this medicine after the expiry date which is stated on the label and carton after
Id -
The expiry date refers to the last day of that month.
data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
- Keep the pre-filled syringe in the outer carton in order to protect from light.
- Żomm s- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
- Do not freeze.
- Tagħmlux fil- friża.
- Store and transport refrigerated (2°C - 8°C).
- Żommu fi friġġ waqt il- ħażna u l- ġarr (2°C – 8°C).
- You may take Binocrit out of the refrigerator and keep it at room temperature (up to 25°C) for
- Tista ’ toħroġ Binocrit mill- friġġ u żżommu f’ temperatura tal- kamra (sa 25°C) għal mhux aktar
no longer than 3 days.
minn 3 ijiem.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Ġaladarba s- siringa tkun tneħħiet mill- friġġ u laħqet it- temperatura tal- kamra (sa 25°C) din trid tintuża fi żmien 3 ijiem jew tintrema.
Do not use this medicine
Tużax din il- mediċina
- if the solution is cloudy or there are particles in it.
- jekk is- soluzzjoni tkun imdardra jew ikun hemm frak fiha.
- if the solution has been accidently frozen.
- jekk is- soluzzjoni tkun ġiet iffriżata bi żball.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
FURTHER INFORMATION
AKTAR TAGHRIF
What Binocrit contains
X’ fih Binocrit
- The active substance is epoetin alfa.
- Is- sustanza attiva hi epoetin alfa.
- The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate
- Is- sustanzi l- oħra huma sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate,
dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
sodium chloride, glycine, polysorbate 80, hydrochloric acid (għal aġġustament tal- pH), sodium hydroxide (għal aġġustament tal- pH), u ilma għall- injezzjonijiet.
195 What Binocrit looks like and contents of the pack
Id- Dehra ta ’ Binocrit u l- kontenuti tal- pakkett
Binocrit is presented as a clear, colourless solution for injection in a pre-filled syringe.
Binocrit hu ppreżentat bħala soluzzjoni għall- injezzjoni ċara u bla kulur f’ siringa mimlija għal- lest.
The syringes are sealed in a blister.
Is- siringi huma ssiġillati f’ folja.
Binocrit 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (1000 IU) of solution.
Binocrit 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (1000 IU) ta ’ soluzzjoni.
Binocrit 2000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (2000 IU) of solution.
Binocrit 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (2000 IU) ta ’ soluzzjoni.
Binocrit 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe The syringes contain 0.3 ml (3000 IU) of solution.
Binocrit 3000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 3 ml (3000 IU) ta ’ soluzzjoni.
Binocrit 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe The syringes contain 0.4 ml (4000 IU) of solution.
Binocrit 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 4 ml (4000 IU) ta ’ soluzzjoni.
Binocrit 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (5000 IU) of solution.
Binocrit 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (5000 IU) ta ’ soluzzjoni.
Binocrit 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe The syringes contain 0.6 ml (6000 IU) of solution.
Binocrit 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 6 ml (6000 IU) ta ’ soluzzjoni.
Binocrit 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe The syringes contain 0.7 ml (7000 IU) of solution.
Binocrit 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 7 ml (7000 IU) ta ’ soluzzjoni.
Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe The syringes contain 0.8 ml (8000 IU) of solution.
Binocrit 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 8 ml (8000 IU) ta ’ soluzzjoni.
Binocrit 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe The syringes contain 0.9 ml (9000 IU) of solution.
Binocrit 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 9 ml (9000 IU) ta ’ soluzzjoni.
Binocrit 10 000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (10 000 IU) of solution.
Binocrit 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (10, 000 IU) ta ’ soluzzjoni.
Pack size of 1 or 6 pre-filled syringe(s).
Daqs tal- pakkett ta ’ 1 jew 6 siringa/ i mimlija għal- lest.
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
10 A-6250 Kundl Austria
10 A- 6250 Kundl L- Awstrija
Manufacturer
206 Manifattur
Hexal AG Industriestraße 25 D-83607 Holzkirchen Germany
Hexal AG Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
EPAR summary for the public
Sommarju ta 'l- EPAR għall- pubbliku
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jaslu għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Biograstim?
X’ inhu Biograstim?
Biograstim is a solution for injection or for infusion (drip into a vein).
Biograstim hu konċentrat li jiġi mdewweb biex jingħata b’ infużjoni (drip fil- vina).
It contains the active substance filgrastim.
Fih is- sustanza attiva filgrastim.
Biograstim is a ‘ biosimilar’ medicine.
Biograstim hija mediċina ‘ bijosimili ’.
This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Biograstim huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl- Unjoni Ewropea (UE) u li tinkludi fiha l- istess sustanza attiva (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Biograstim is Neupogen.
Il- mediċina ta ’ referenza għal Biograstim hija Neupogen.
For more information on biosimilar medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċini bijosimili, ara d- dokument ta ’ ‘ mistoqsija u tweġiba ’ hawn.
What is Biograstim used for?
Għal xiex jintuża Biograstim?
Biograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Biograstim huwa wżat sabiex jistimula l- produzzjoni ta ’ ċelloli bojod fid- demm fis- sitwazzjonijiet li ġejjin: • Inaqqas iż- żmien ta ’ newtropenija (livelli baxxi ta ’ newtrofili, tip ta ’ ċellola bajda tad- demm) u l - każ li jkun hemm newtropenija febbrili (newtropenija fil- fwied) f’ pazjenti li jirċievu l - kemoterapija (trattament tal- kanċer) li huwa ċitotossiku (joqtol iċ- ċelloli); • Inaqqas iż- żmien ta ’ newtropenija f’ pazjenti li għaddejjin bi trattament li jkisser iċ- ċelloli tal - mudullum qabel ma ’ l- mudullum jiġi trapjantat (bħal f’ xi pazjenti bil- lewkimja) jekk ikunu f’ riskju ta ’ newtropenija severa fuq żmien twil; • Iżid il- livelli ta ’ newtrofili u jnaqqas ir- riskju ta ’ infezzjonijiet f’ pazjenti bin- newtropenija li għandhom storja ta ’ infezzjonijiet severi u repetuti; • Jittratta newtropenija persistenti f’ pazjenti bil- vajrus uman ta ’ l- immunodefiċjenza fi stat avvanzat [HIV]). Biograstim jista ’ jintuża wkoll f’ pazjenti li ser jagħtu ċ- ċelloli staminali tad- demm għal trapjant, sabiex dan jgħin fir- rilaxx taċ- ċelloli mill- mudullum.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib.
How is Biograstim used?
Kif jintuża Biograstim?
Biograstim is given by injection under the skin or infusion into a vein.
Biograstim jingħata b’ injezzjoni taħt il- ġilda jew infużjoni fil- vina.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient’ s body weight and the response to treatment.
Il- mod ta ’ kif jingħata, id- doża u ż- żmien tat- trattament jiddependu fuq ir- raġuni ta ’ l- użu, il- massa korporja tal- pazjent u r- rispons għat- trattament.
Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Biograstim normalment jingħata f’ ċentru ta ’ trattament speċjalizzat, minkejja li pazjenti li jirċievuh b’ injezzjoni taħt il- ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
For more information, see the Package Leaflet.
Għal iktar tagħrif, ara l- Fuljett ta 'Tagħrif..
How does Biograstim work?
Kif jaħdem Biograstim?
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Is- sustanza attiva f’ Biograstim, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal- kolownja granuloċijto (G- CSF).
Filgrastim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Filgrastim huwa prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: hija magħmula minn batterju li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi filgrastim.
The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Il- fattur sostituttiv jaġixxi bl- istess mod trapjantabbli u jaħdem bl- istess mod bħal prodott b’ mod naturali G- CSF billi jinkoraġġixxi l- mudullum sabiex jipproduċi aktar ċelloli bojod tad- demm.
How has Biograstim been studied?
Kif ġie studjat Biograstim?
Biograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Biograstim ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Neupogen.
Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Biograstim ġie kumparat ma ’ Neupogen u ma ’ placebo (trattament fint) fi studju prinċipali li kien jinvolvi 348 pazjent bil- kanċer tas- sider.
The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.
L- istudju ħares lejn żmien ta ’ newtropenija severa matul l - ewwel ċiklu ta ’ kemoterapija ċitotossika tal- pazjenti.
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’ s lymphoma.
Sabiex tiġi studjata s- sigurtà ta ’ Biograstim, saru żewġ studju oħrajn fuq pazjenti bil- kanċer tal - pulmun u limfoma non- Hodgkin.
What benefit has Biograstim shown during the studies?
X' benefiċċju wera Biograstim matul l- istudji mwettqa?
Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Trattament bir- Biograstim u n- Neupogen ġab tnaqqis simili fiż- żmien ta ’ newtropenija severa.
During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Matul l- ewwel 21 jum ta ’ ċiklu kemoterapewtiku, pazjenti trattati b’ kemm Biograstim jew Neupogen kellhom newtropenija severa għal medja ta ’ 1. 1 jum, kumparat ma ’ 3. 8 jum f’ dak li jirċievu placebo.
Therefore, the effectiveness of Biograstim was shown to be equivalent to that of Neupogen.
Għalhekk, l- effikaċja ta ’ Biograstim ġiet murija bħala ekwivalenti għal dik ta ’ Neupogen.
What is the risk associated with Biograstim?
X’ inhu r- riskju assoċjat ma ’ Biograstim?
The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
X' inhu r- riskju assoċjat ma 'Biograstim (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu uġiegħ muskoloskeletali (uġigħ fil- muskoli u fl- għadam).
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for.
Effetti sekondarji oħrajn jistgħu jidhru f’ aktar minn pazjent minn għaxra skond il- kondizzjoni li Biograstim jkun użat għaliha.
For the full list of all side effects reported with Biograstim, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Biograstim, ara l- Fuljett ta ’ Tagħrif.
Biograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Biograstim m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Biograstim been approved?
Għaliex ġie approvat Biograstim?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet ta ’ l- Unjoni Ewropea, Biograstim wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Neupogen.
Therefore, the CHMP’ s view was that, as for Neupogen, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal Neupogen, il- benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Biograstim be given marketing authorisation.
Il- Kumitat irrakkomanda li Biograstim jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Biograstim:
Tagħrif ieħor dwar Biograstim:
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Biograstim lil CT Arzneimittel GmbH fil- 15 ta 'Settembru 2008.
The full EPAR for Biograstim can be found here.
L- EPAR sħiħ għal Biograstim jista ’ jinstab hawnhekk.
This summary was last updated in 09-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
Pharmaceutical Form Solution for injection or infusion
Soluzzjoni għall- injezzjoni jew infużjoni
Route of Administration Subcutaneous or intravenous use
Użu għal taħt il- ġilda u għal ġol- vini
Packaging pre-filled syringe (glass)
siringa mimlija għal- lest (ħġieġ)
Package size 1 pre-filled syringe
1 siringa mimlija għal - lest
Solution for injection or infusion
Soluzzjoni għall- injezzjoni jew infużjoni
Subcutaneous or intravenous use
Użu għal taħt il- ġilda u għal ġol- vini
pre-filled syringe (glass)
siringa mimlija 0. 5 ml għal- lest (ħġieġ)
5 pre-filled syringes
5 siringi mimlijin għal - lest
2 x 5 pre-filled syringes
2 x 5 siringi mimlijin għal - lest
10 pre-filled syringes
10 siringi mimlijin għal - lest
pre-filled syringe (glass)
siringa mimlija 0. 8 ml għal- lest (ħġieġ)
1 pre-filled syringe
1 siringa mimlija għal - lest
Biograstim 30 MIU/ 0.5 ml solution for injection or infusion
Biograstim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni
Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Kull ml ta ’ soluzzjoni għall- injezzjoni jew infużjoni fiha 60 miljun international units [MIU] (600 µg) ta ’ filgrastim.
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 ml solution for injection or infusion.
Kull siringa mimlija għal- lest fiha 30 MIU (300 µg) filgrastim f’ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni.
Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Filgrastim (recombinant methionyl human granulocyte- colony stimulating factor) huwa magħmul minn Escherichia coli K802 b ’ teknoloġija rikombinanti- DNA.
Excipient:
Sustanza mhux attiva:
Each ml of solution contains 50 mg of sorbitol.
Kull ml ta ’ soluzzjoni fiha 50 mg sorbitol.
Clear, colourless solution.
Soluzzjoni ċara u mingħajr kulur.
Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Biograstim huwa indikat għat- tnaqqis fid- dewmien ta ’ newtropenja u fl- inċidenza ta ’ newtropenja bid - deni f’ pazjenti kkurati b’ kimoterapija ċitotossika stabbilita kontra malinni (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat- tnaqqis fid- dewmien ta ’ newtropenja f’ pazjenti, taħt kura majeloablativa u segwita bit- trapjant tal- mudullun, li huma meqjusa li għandhom riskju għola ta ’ newtropenja qawwija u mdewma.
The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Is- sigurtà u l- effikaċja ta ’ filgrastim huma simili fl - adulti u fit- tfal li qed jirċievu kimoterapija ċitotossika.
Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Biograstim huwa indikat għall- mobilizzazzjoni taċ- ċelluli proġenitriċi tad- demm periferali( PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
F’ pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl- Għadd Assolut ta ’ Newtrofili (ANC) ta ’ 0. 5 x 109/ l, u storja ta ’ infezzjonijiet qawwija jew li jirkadu, it- terapija fit- tul b’ Biograstim huwa indikat biex jiżdied l- għadd ta ’ newtrofili u sabiex l- inċidenza u t- tul ta ’ ġrajjiet avversi relatati ma ’ infezzjonijiet jonqsu.
Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Biograstim huwa indikat għal kura ta ’ newtropenja persistenti (ANC ta ’ 1. 0 x 109/ l jew inqas) f’ pazjenti b’ infezzjoni avvanzata ta ’ l- HIV, sabiex jitnaqqas ir- riskju ta ’ infezzjonijiet batteriċi, dan meta għażliet oħra għall- immaniġġjar ta ’ newtropenja ma jkunux addattati.
Special requirements
Ħtiġijiet speċjali
Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Il- kura b’ filgrastim għandha tingħata biss b’ kollaborazzjoni ma ’ ċentru ta ’ onkoloġija b’ esperjenza fil- kura bil- fattur uman li jistimola l- kolonji ta ’ granuloċiti (G- CSF) u ematoloġija u fejn jinstabu l- meżżi dijanjostiċi kollha meħtieġa.
The mobilisation and apheresis procedures should be performed in
Il- mobilizzazzjoni u l- proċeduri afereżi għandhom isiru flimkien
2 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
2 ma 'ċentru ta ’ l- onkoloġija u ematoloġija b’ esperjenza xierqa f’ dan il- qasam u fejn il- monitoraġġ taċ- ċelluli proġenitriċi ematopojetiċi jista ’ jsir korrettament.
Established cytotoxic chemotherapy
Kimoterapija ċitotossika stabbilita
The recommended dose of filgrastim is 0.5 MIU (5 μ g)/ kg/ day.
Id- doża rakkomandata ta ’ filgrastim hija 0. 5 MIU (5 μg) / kg/ jum.
The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy.
L- ewwel doża ta ’ filgrastim trid tingħata mhux inqas minn 24 siegħa wara l- kimoterapija ċitotossika.
Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/ ml (5%) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
Filgrastim jista ’ jiġi injettat ta ’ kuljum taħt il- ġilda jew jista ’ jiġi dilwit f’ soluzzjoni ta ’ glucose 50 mg/ ml (5%) u jingħata ta ’ kuljum bħala infużjoni ġol- vina fuq medda ta ’ 30 minuta (ara sezzjoni 6. 6 għall- istruzzjonijiet fuq id- dilwit).
The subcutaneous route is preferred in most cases.
L- amministrazzjoni taħt il- ġilda hija preferita fil- maġġoranza tal- każi.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Evidenza ġejja minn studju fuq l- amministrazzjoni ta ’ doża waħda turi li l- amministrazzjoni ġol- vina tista ’ tirriżulta f’ effett inqas fit- tul.
The clinical relevance of this finding to multiple dose administration is not clear.
Mhijiex ċara jekk din is- sejba għandha xi rilevanza klinika għall- amministrazzjoni ta ’ dożi ripetuti.
The choice of route should depend on the individual clinical circumstance.
L- għażla ta ’ minn fejn tingħata d- doża trid tkun ibbażata fuq iċ- cirkustanzi kliniċi ta ’ l- individwu.
In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μ g)/ m2/ day (4.0 to 8.4 μ g/ kg/ day) was used.
Fi studji kliniċi randomised, intużat doża ta ’ 23 MIU (230 μg) / m2/ jum (4. 0 sa 8. 4 μg/ kg/ jum) li ġiet amministrata taħt il- ġilda.
Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
L- amministrazzjoni ta ’ kuljum ta ’ filgrastim trid titkompla sakemm in- nadir mistenni jkun għadda u l- għadd ta ’ newtrofili jkun reġa ’ lura għan- normal.
Following established chemotherapy for solid tumours, lymphomas and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Wara kimoterapija stabbilita għal tumuri solidi, limfoma u lewkimja fis- sistema limfatika, huwa mistenni li l- kura tista ’ ddum sa 14- il ġurnata biex dawn il- kriterji jintlaħqu.
Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Wara l- kura tal- bidu u dik ikkonsolidata għal lewkimja majelojde akuta, it- terapija tista ’ ddum sostanzjalment iktar (sa 38 ġurnata) jiddependi fuq it- tip, doża u skeda tal- kimoterapija ċitotossika li tintuża.
In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of filgrastim therapy.
F’ pazjenti kkurati b’ kimoterapija ċitotossika, żjieda reversibbli fl- għadd ta ’ newtrofili tipikament tiġi osservata minn l- ewwel sat- tieni ġurnata ta ’ kura b’ filgrastim.
However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Madankollu, sabiex ikun hemm rispons terapewtiku fit- tul, il- kura b’ filgrastim m’ għandiex titwaqqaf qabel in- nadir mistenni jkun għadda u l- għadd ta ’ newtrofili jkun reġa ’ lura għan- normal.
Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
Waqfien prematur mill- kura b’ filgrastim qabel ma ’ jkun intlaħaq in- nadir mistenni mhuwiex rakkomandat.
In patients treated with myeloablative therapy followed by bone marrow transplantation
F’ pazjenti li rċievu kura majeloablativa segwit bit- trapjant tal- mudullun
The recommended starting dose of filgrastim is 1.0 MIU (10 μ g)/ kg/ day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μ g)/ kg/ day given by continuous 24 hour subcutaneous infusion.
Id- doża tal- bidu rakkomandata ta ’ filgrastim hija 1. 0 MIU (10 μg) / kg/ jum mogħtija bħala infużjoni ġol- vina fuq medda ta ’ 30 minuta jew 24 siegħa jew inkella 1. 0 MIU (10 μg) / kg/ jum mogħtija bħala infużjoni kontinwa taħt il- ġilda fuq medda ta ’ 24 siegħa.