qanastek/EMEA-V3 huggingface dataset:
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jintbagħat • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifikazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jnaqqsu r- riskju. • Fi żmien 60 jum minn meta jintlaħaq passimportanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba tal- EMEA
154 ANNEX III
154 ANNESS III
156 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
156 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Epoetin alfa HEXAL 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 1000 IU/ 0. 5 ml IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Solution for injection in a pre-filled syringe.
Siringa 1 mimlija għal- lest ta ’ 0. 5 ml 6 siringi mimlija għal- lest ta ’ 0. 5 ml
Hexal AG, Industriestrasse 25, D-83607 Holzkirchen, Germany
Hexal AG, Industriestrasse 25, D- 83607 Holzkirchen, il- Ġermanja
Epoetin alfa HEXAL 1000 IU/ 0.5 ml
Epoetin alfa HEXAL 1000 IU/ 0. 5 ml
158 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
158 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
159 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
159 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 1000 IU/ 0.5 ml injection
Epoetin alfa HEXAL 1000 IU/ 0. 5 ml injezzjoni
160 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
160 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml
5.
162 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
162 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
163 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
163 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 2000 IU/ 1 ml injection
Epoetin alfa HEXAL 2000 IU/ 1 ml injezzjoni
164 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
164 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Solution for injection in a pre-filled syringe.
5.
Epoetin alfa HEXAL 3000 IU/ 0.3 ml
Epoetin alfa HEXAL 3000 IU/ 0. 3 ml
166 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
166 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
167 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
167 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 3000 IU/ 0.3 ml injection
Epoetin alfa HEXAL 3000 IU/ 0. 3 ml injezzjoni
168 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
168 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.4 ml 6 pre-filled syringes of 0.4 ml
5.
Epoetin alfa HEXAL 4000 IU/ 0.4 ml
Epoetin alfa HEXAL 4000 IU/ 0. 4 ml
170 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
170 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
171 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
171 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 4000 IU/ 0.4 ml injection
Epoetin alfa HEXAL 4000 IU/ 0. 4 ml injezzjoni
172 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
172 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Epoetin alfa HEXAL 5000 IU/ 0.5 ml
Epoetin alfa HEXAL 5000 IU/ 0. 5 ml
174 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
174 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
175 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
175 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 5000 IU/ 0.5 ml injection
Epoetin alfa HEXAL 5000 IU/ 0. 5 ml injezzjoni
176 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
176 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.6 ml 6 pre-filled syringes of 0.6 ml
5.
Epoetin alfa HEXAL 6000 IU/ 0.6 ml
Epoetin alfa HEXAL 6000 IU/ 0. 6 ml
178 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
178 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
179 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
179 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 6000 IU/ 0.6 ml injection
Epoetin alfa HEXAL 6000 IU/ 0. 6 ml injezzjoni
180 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
180 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.7 ml 6 pre-filled syringes of 0.7 ml
5.
Epoetin alfa HEXAL 7000 IU/ 0.7 ml
Epoetin alfa HEXAL 7000 IU/ 0. 7 ml
182 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
182 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
183 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
183 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 7000 IU/ 0.7 ml injection
Epoetin alfa HEXAL 7000 IU/ 0. 7 ml injezzjoni
184 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
184 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.8 ml 6 pre-filled syringes of 0.8 ml
5.
Epoetin alfa HEXAL 8000 IU/ 0.8 ml
Epoetin alfa HEXAL 8000 IU/ 0. 8 ml
186 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
186 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
187 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
187 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 8000 IU/ 0.8 ml injection
Epoetin alfa HEXAL 8000 IU/ 0. 8 ml injezzjoni
188 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
188 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 pre-filled syringe of 0.9 ml 6 pre-filled syringes of 0.9 ml
5.
Epoetin alfa HEXAL 9000 IU/ 0.9 ml
Epoetin alfa HEXAL 9000 IU/ 0. 9 ml
190 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
190 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
191 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
191 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 9000 IU/ 0.9 ml injection
Epoetin alfa HEXAL 9000 IU/ 0. 9 ml injezzjoni
192 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
192 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Epoetin alfa HEXAL 10 000 IU/ 1 ml
Epoetin alfa HEXAL 10, 000 IU/ 1 ml
194 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
194 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
195 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
195 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Epoetin alfa HEXAL 10 000 IU/ 1 ml injection
Epoetin alfa HEXAL 10, 000 IU/ 1 ml injezzjoni
197 PACKAGE LEAFLET:
197 FULJETT TA ’ TAGĦRIF:
Epoetin alfa HEXAL 10 000 IU/ 1 ml solution for injection in a pre-filled syringe Epoetin alfa
Epoetin alfa HEXAL 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin alfa
What Epoetin alfa HEXAL is and what it is used for 2.
X’ inhu Epoetin alfa HEXAL u għalxiex jintuża 2.
Before you use Epoetin alfa HEXAL 3.
Qabel ma tuża Epoetin alfa HEXAL 3.
How to use Epoetin alfa HEXAL 4.
Kif għandek tuża Epoetin alfa HEXAL 4.
How to store Epoetin alfa HEXAL 6.
Kif taħżen Epoetin alfa HEXAL 6.
WHAT EPOETIN ALFA HEXAL IS AND WHAT IT IS USED FOR
X’ INHU EPOETIN ALFA HEXAL U GĦALXIEX JINTUŻA
Epoetin alfa HEXAL contains a hormone called epoetin alfa, which stimulates the production of red blood cells.
Epoetin alfa HEXAL fih ormon imsejjaħ epoetin alfa, li jistimula l- produzzjoni taċ- ċelluli l- ħomor tad- demm.
Epoetin alfa is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Epoetin alfa huwa prodott b’ teknoloġija ġenetika speċjalizzata u jaħdem eżatt bl- istess mod bħal l- ormon naturali eritropoetin.
Epoetin alfa HEXAL is used: for treating symptomatic anaemia associated with kidney disease (given by injection into a vein) in children and adults on dialysis in adults on peritoneal dialysis for treating severe symptomatic anaemia caused by kidney disease in adults not yet undergoing dialysis (given by injection into a vein) for treating anaemia and reducing the need for a blood transfusion in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the doctor in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous predonation) as an alternative to a blood transfusion in adult patients about to undergo major orthopaedic (bone) surgery where there is a potentially high risk from blood transfusion complications
Epoetin alfa HEXAL jintuża: biex tiġi kkurata anemija sintomatika assoċjata ma ’ mard tal- kliewi (mogħti permezz ta ’ injezzjoni ġo vina) fi tfal u adulti fuq id- dijalisi f’ adulti fuq dijalisi peritonali biex tiġi kkurata anemija sintomatika severa kkawżata minn mard tal- kliewi f’ persuni adulti li jkunu għadhom mhux qegħdin fuq id- dijalisi (mogħti permezz ta ’ injezzjoni ġo vina) biex tiġi kkurata anemija u titnaqqas il- ħtieġa għal trasfużjoni tad- demm f’ persuni adulti li jkunu qegħdin jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla, u f’ riskju ta ’ trasfużjoni kif evalwat mit- tabib f’ pazjenti li jkunu moderatament anemiċi li jkun ser ikollhom operazzjoni, u qabel din issir, jagħtu d - demm biex id- demm tagħhom stess ikun jista ’ jingħatalhom waqt jew wara l- operazzjoni (predonazzjoni awtologa)
BEFORE YOU USE EPOETIN ALFA HEXAL
QABEL MA TUŻA EPOETIN ALFA HEXAL
Do not use Epoetin alfa HEXAL:
Tużax Epoetin alfa HEXAL:
- if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of Epoetin alfa
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal epoetin alfa jew sustanzi oħra ta ’
Take special care with Epoetin alfa HEXAL:
Oqgħod attent ħafna b’ Epoetin alfa HEXAL:
In all patients treated with Epoetin alfa HEXAL blood pressure should be closely monitored and treated, if necessary.
Il- pressjoni tad- demm fil- pazjenti kollha kkurati b’ epoetin alfa HEXAL għandha tiġi mmonitorjata mill- qrib u kkurata, jekk ikun meħtieġ.
Epoetin alfa HEXAL should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Epoetin alfa HEXAL għandu jintuża b’ attenzjoni fil- preżenza ta ’ pressjoni għolja mhux ikkurata, ikkurata b’ mod inadegwat jew li ma tistax tiġi kkontrollata tajjeb.
If blood pressure cannot be controlled, Epoetin alfa HEXAL treatment should be discontinued.
Jekk il- pressjoni tad - demm ma tkunx tista ’ tiġi kkontrollata, il- kura b’ Epoetin alfa HEXAL għandha titwaqqaf.
Take special care with Epoetin alfa HEXAL if you have epilepsy or chronic liver disease.
Oqgħod attent ħafna b’ Epoetin alfa HEXAL jekk għandek epilessija jew mard kroniku tal- fwied.
There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Epoetin alfa HEXAL, which gradually regresses during the course of continued therapy.
Jista ’ jkun hemm żieda moderata dipendenti fuq id- doża fl- għadd ta ’ plejtlits fil- medda normali waqt kura b’ Epoetin alfa HEXAL, li gradwalment tmur lura matul il- kors tat- terapija kontinwa.
Your doctor may do regular blood tests to check your blood platelet count during the first 8 weeks of therapy.
It- tabib tiegħek jista ’ jagħmillek testijiet regolari tad- demm biex jiċċekkja l- għadd tal- plejtlits fid- demm tiegħek matul l- ewwel 8 ġimgħat tat- terapija.
All other causes of anaemia, e. g. iron deficiency, damage of red blood cells (haemolysis), blood loss, vitamin B12 or folate deficiency, should be taken into account and treated prior to initiating therapy with Epoetin alfa HEXAL.
Il- kawżi l- oħra kollha ta ’ anemija, eż. defiċjenza ta ’ ħadid, ħsara fiċ- ċelluli l- ħomor tad- demm (emodijalisi), telf ta ’ demm, defiċjenza ta ’ vitamina B12 jew ta ’ folate, għandhom jiġu kkunsidrati u kkurati qabel tinbeda t- terapija b’ Epoetin alfa HEXAL.
In order to ensure optimum response to Epoetin alfa HEXAL adequate iron stores should be ensured.
Sabiex jiġi assigurat l- aħjar respons għal Epoetin alfa HEXAL għandhom ikunu żgurati ħażniet adegwati ta ’ ħadid.
Your doctor may do blood tests to decide, if you need iron supplements.
It- tabib tiegħek jista ’ jagħmillek testijiet tad- demm biex jiddeċiedi jekk għandekx bżonn supplimenti ta ’ ferritin.
199 Kidney patients
199 ta ’ sturdament jew qtugħ ta ’ nifs.
There is not much experience with subcutaneous use (injection into the skin) of Epoetin alfa HEXAL in kidney patients.
M’ hemmx wisq esperjenza bl- użu minn taħt il- ġilda (injezzjoni ġol- ġilda) ta ’ Epoetin alfa HEXAL f’ pazjenti b’ mard tal- kliewi.
Therefore, if you are being treated for anaemia associated with kidney disease, Epoetin alfa HEXAL has to be given by injection into a vein (intravenously).
Għalhekk, jekk inti qed tkun ikkurat/ a għal anemija assoċjata ma ’ mard tal- kliewi, Epoetin alfa HEXAL għandu jingħata permezz ta ’ injezzjoni ġo vina.
If an elevated or increasing serum potassium level is detected, your doctor may consider to discontinue the treatment with Epoetin alfa HEXAL until the potassium level has returned to the normal range.
Jekk jiġi osservat livell ta ’ potassju fis- serum għoli jew qiegħed jogħla, it- tabib tiegħek jista ’ jikkunsidra li jwaqqaf il- kura b’ Epoetin alfa HEXAL sakemm il- livell tal- potassju jkun reġa ’ lura għall- medda normali.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Epoetin alfa HEXAL.
Żieda fid- doża ta ’ mediċina partikulari li traqqaq id- demm (heparin) waqt l- emodijalisi ta ’ sikwit tkun meħtieġa matul il- kors tat- terapija b’ Epoetin alfa HEXAL.
Based on information available to date, treatment of anaemia with Epoetin alfa HEXAL in adult patients with chronic kidney failure (renal insufficiency) who do not yet require dialysis, does not accelerate the rate of progression of renal insufficiency.
Fuq il- bażi ta ’ l- informazzjoni disponibbli sa issa, il- kura ta ’ l- anemija b’ Epoetin alfa HEXAL f’ pazjenti adulti b’ insuffiċjenza tal- kliewi kronika (insuffiċjenza renali) li jkun għad m’ għandhomx bżonn dijalisi, ma żżidx ir- rata tal- progressjoni ta ’ l- insuffiċjenza renali.
The 2-3 week delay between epoetin alfa administration and the appearance of desired effects should be taken into account when assessing the efficacy of Epoetin alfa HEXAL.
Id- dewmien ta ’ 2- 3 ġimgħat bejn l- għoti ta ’ epoetin alfa u d- dehra ta ’ l- effetti mixtieqa għandu jiġi kkunsidrat meta tkun evalwata l- effikaċja ta ’ Epoetin alfa HEXAL.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly and adjust your dose of Epoetin alfa HEXAL accordingly to minimise the risk of blood clotting (thrombotic events).
It- tabib tiegħek ser jiċċekkja l- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek b’ mod regolari u jaġġusta d- doża tiegħek ta ’ Epoetin alfa HEXAL kif meħtieġ sabiex inaqqas ir- riskju ta ’ tagħqid tad- demm (episodji trombotiċi).
If you are a cancer patient you should be aware that Epoetin alfa HEXAL may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Jekk inti pazjent marid bil- kanċer, għandek tkun taf li Epoetin alfa HEXAL jista ’ jaġixxi bħala fattur tat- tkabbir taċ- ċelluli tad- demm u f’ xi ċirkustanzi jista ’ jkollu impatt negattiv fuq il- kanċer tiegħek.
Depending on your individual situation a blood transfusion may be preferable.
Skond is- sitwazzjoni individwali tiegħek, trasfużjoni tad- demm tista ’ tkun preferibbli.
If you are due to have major orthopaedic surgery, the cause of anaemia should be established and treated, if possible, before the start of Epoetin alfa HEXAL treatment.
Jekk wasalt biex tagħmel operazzjoni ortopedika maġġuri, il- kawża ta ’ l- anemija għandha tiġi stabbilita u kkurata, jekk jista ’ jkun, qabel il- bidu tal- kura b’ Epoetin alf HEXAL.
Blood clots (thrombotic events)
L- emboli (episodji trombotiċi) jistgħu jkunu ta ’ riskju.
If your levels of the red blood pigment (haemoglobin) are too high you should not receive Epoetin alfa HEXAL, since you have an increased risk of blood clotting after the surgery.
Inti m’ għandekx tingħata Epoetin alfa HEXAL jekk il- livelli tal- pigment aħmar fid- demm (emoglobina) tiegħek ikunu għoljin iżżejjed, billi ser ikollok riskju akbar ta ’ tagħqid tad- demm wara l - operazzjoni.
If you are taking cyclosporin (medicine to suppress your immune system) during therapy with Epoetin alfa HEXAL, your doctor may order special blood tests to measure cyclosporin levels.
Jekk qiegħed tieħu cyclosporin (mediċina biex trażżan is- sistema immuni tiegħek) matul it- terapija b’ Epoetin alfa HEXAL, it- tabib tiegħek jista ’ jordna testijiet speċjali tad- demm biex ikejjel il- livelli ta ’ cyclosporin.
There is not much experience with Epoetin alfa HEXAL in pregnant women or women who are breast-feeding.
Hemm esperjenza limitata b’ Epoetin alfa HEXAL f’ nisa tqal jew f’ nisa li qegħdin ireddgħu.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il - parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Important information about some of the ingredients of Epoetin alfa HEXAL
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Epoetin alfa HEXAL
HOW TO USE EPOETIN ALFA HEXAL
KIF GĦANDEK TUŻA EPOETIN ALFA HEXAL
Your doctor will conduct investigations, for example blood tests, to decide if it is necessary for you to have Epoetin alfa HEXAL.
It- tabib tiegħek ser jagħmel investigazzjonijiet, pereżempju testijiet tad- demm, biex jiddeċiedi jekk hux neċessarju għalik li tieħu Epoetin alfa HEXAL.
He/ she will work out the correct dose of Epoetin alfa HEXAL for you to use and how long the treatment should continue.
Huwa/ hija ser jaħdimlek id- doża korretta li għandek tieħu ta ’ Epoetin alfa HEXAL u kemm għandha ddum il- kura.
The Epoetin alfa HEXAL pre-filled syringe is ready for use.
201 Is- siringa mimlija għal- lest ta ’ Epoetin alfa HEXAL hija lesta biex tintuża.
Epoetin alfa HEXAL is a sterile but unpreserved product and is for single use only.
Epoetin alfa HEXAL huwa prodott sterili iżda mhux ippreservat u jista ’ jintuża darba biss.
Epoetin alfa HEXAL should not be shaken.
Epoetin alfa HEXAL m’ għandux jitħawwad.
At the start of your therapy, Epoetin alfa HEXAL may be injected under the supervision of experienced medical staff.
Fil- bidu tat- terapija tiegħek, Epoetin alfa HEXAL jista ’ jkun injettat taħt is- superviżjoni ta ’ staff mediku b’ esperjenza.
201 Kidney patients
Pazjenti morda bil- kliewi
Epoetin alfa HEXAL is given by injection into a vein (intravenously).
Epoetin alfa HEXAL jingħata bħala injezzjoni ġo vina.
Cancer patients or patients scheduled for major orthopaedic surgery
Pazjenti morda bil- kanċer jew pazjenti skedati għal operazzjoni ortopedika maġġuri
Epoetin alfa HEXAL is given by injection under the skin (subcutaneously).
Epoetin alfa HEXAL għandu jingħata b’ injezzjoni taħt il- ġilda (injezzjoni taħt il- ġilda).
When your condition has been brought under control, you will receive regular doses of Epoetin alfa HEXAL.
Meta l- kundizzjoni tiegħek tinġieb taħt kontroll, inti għandek tirċievi dożi regolari ta ’ Epoetin alfa HEXAL.
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.
When your condition has been brought under control, you will receive regular doses of Epoetin alfa HEXAL 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 ’ Epoetin alfa HEXAL bejn 25 u 50 IU/ kg darbtejn fil- ġimgħa f’ żewġ injezzjonijiet ugwali.
After your condition has been brought under control, you will receive regular doses of Epoetin alfa HEXAL between 17 and 33 IU/ kg, three times a week.
Meta l- kundizzjoni tiegħek tkun ġiet ikkontrollata, inti ser tirċievi dożi regolari ta ’ Epoetin alfa HEXAL 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.
Alternatively, Epoetin alfa HEXAL can be administered as an initial dose of 450 IU/ kg once a week by injection under the skin.
Inkella, Epoetin alfa HEXAL 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.
Treatment with Epoetin alfa HEXAL should be continued until one month after the end of chemotherapy.
Il- kura b’ Epoetin alfa HEXAL għandha titkompla sa xahar wara t- tmiem tal- kimoterapija.
202 Use in adult patients in an autologous predonation programme
L- użu f’ pazjenti adulti fi programm ta ’ predonazzjoni awtologa.
You will receive Epoetin alfa HEXAL during the 3 weeks before your surgery.
Inti ser tirċievi Epoetin alfa HEXAL matul it- 3 ġimgħat qabel l- operazzjoni tiegħek.
You will also take iron supplements before and during Epoetin alfa HEXAL treatment to increase the effectiveness of Epoetin alfa HEXAL.
Ser tieħu wkoll supplimenti tal- ħadid qabel u matul il - kura b’ Epoetin alfa HEXAL biex iżżid l- effettività ta ’ Epoetin alfa HEXAL.
Adult patients scheduled for orthopaedic surgery
Pazjenti adulti skedati għal operazzjoni ortopedika
It is important that levels of iron in your blood are normal throughout Epoetin alfa HEXAL treatment.
Huwa importanti li l- livelli ta ’ ferritin fid- demm tiegħek ikunu normali matul il- kors tal- kura b’ Epoetin alfa HEXAL.
Where appropriate you will receive oral doses of iron, ideally starting before the Epoetin alfa HEXAL treatment begins.
Meta jkun xieraq, inti ser tirċievi dożi orali ta ’ ħadid, li idealment jibdew qabel tibda l- kura b’ Epoetin alfa HEXAL.
Instructions for injecting Epoetin alfa HEXAL under the skin
Struzzjonijiet biex tinjetta Epoetin alfa HEXAL taħt il- ġilda
If you are a kidney patient Epoetin alfa HEXAL has to be given by injection into a vein.
Jekk inti pazjent/ a li tbati b’ mard tal- kliewi, Epoetin alfa HEXAL irid jingħata permezz ta ’ injezzjoni ġo vina.
At the start of your therapy, Epoetin alfa HEXAL may be injected by medical staff.
Fil- bidu tat- terapija tiegħek, Epoetin alfa HEXAL jista ’ jkun injettat minn staff mediku.
However, your doctor may decide that it is right for you to learn how to inject Epoetin alfa HEXAL under the skin yourself.
Madankollu, it- tabib tiegħek jista ’ jiddeċiedi li jkun tajjeb għalik li titgħallem kif tinjetta Epoetin alfa HEXAL taħt il- ġilda inti stess.
Insert the needle into the skin fold with a quick, firm action.
Ifforma tiwja fil- ġilda billi toqros il- ġilda bejn is- saba ’ l- kbir u s- saba ’ l- werrej.
Inject the Epoetin alfa HEXAL solution.
Daħħal il- labra ġot- tiwja tal- ġilda b’ azzjoni mgħaġġla u soda.
If you inject more Epoetin alfa HEXAL than you should
Jekk tinjetta aktar Epoetin alfa HEXAL milli suppost
You should inform the doctor immediately if you think too much Epoetin alfa HEXAL has been injected.
Inti għandek tinforma immedjatament lit- tabib tiegħek jekk taħseb li ġie injettat iżżejjed Epoetin alfa HEXAL.
If you forget to use Epoetin alfa HEXAL
203 Jekk tinsa tuża Epoetin alfa HEXAL
Like all medicines, Epoetin alfa HEXAL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Epoetin alfa HEXAL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
203 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.
Other side effects:
Effetti sekondarji oħrajn:
PRCA means the inability to produce enough red blood cells in the bone (see section “ Take special care with Epoetin alfa HEXAL”).
PRCA tfisser in- nuqqas ta ’ kapaċità li l- ġisem tiegħek jipproduċi biżżejjed ċelluli l- ħomor tad- demm fl- għadam (ara s- sezzjoni “ Oqgħod attent ħafna b’ Epoetin alfa HEXAL ”).
Your doctor may monitor your blood pressure regularly while you are using Epoetin alfa HEXAL, 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 Epoetin alfa HEXAL, b’ mod partikulari fil- bidu tat- terapija.
- blood clotting (thrombotic vascular events) (see section “ Take special care with Epoetin alfa
- tagħqid tad- demm (episodji trombotiċi vaskulari) (ara s- sezzjoni “ Oqgħod attent ħafna
HEXAL ”).
b’ Epoetin alfa HEXAL ”).
Patients donating their own blood before surgery
204 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 Epoetin alfa HEXAL.
b’ mard kardjovaskulari diġà eżistenti; wara li jagħtu d- demm ripetutament, avvenimenti vaskulari u trombotiċi (emboli tad- demm) jistgħu jseħħu indipendentement mill- kura b’ Epoetin alfa HEXAL.
Treatment with Epoetin alfa HEXAL 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’ Epoetin alfa HEXAL 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.
HOW TO STORE EPOETIN ALFA HEXAL
KIF TAĦŻEN EPOETIN ALFA HEXAL
- You may take Epoetin alfa HEXAL out of the refrigerator and keep it at room temperature (up
- Tista ’ toħroġ Epoetin alfa HEXAL mill- friġġ u żżommu f’ temperatura tal- kamra (sa 25°C) għal
to 25°C) for no longer than 3 days.
mhux aktar minn 3 ijiem.
What Epoetin alfa HEXAL contains
X’ fih Epoetin alfa HEXAL
205
205 Epoetin alfa HEXAL 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest: siringa waħda mimlija għal- lest ta ’ 0. 6 ml soluzzjoni għall- injezzjoni fiha 6000 unità internazzjonali (IU) li jikkorrispondu għal 50. 4 mikrogrammi ta ’ epoetin alfa Epoetin alfa HEXAL 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest: siringa waħda mimlija għal- lest ta ’ 0. 7 ml soluzzjoni għall- injezzjoni fiha 7000 unità internazzjonali (IU) li jikkorrispondu għal 58. 8 mikrogrammi ta ’ epoetin alfa Epoetin alfa HEXAL 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest: siringa waħda mimlija għal- lest ta ’ 0. 8 ml soluzzjoni għall- injezzjoni fiha 8000 unità internazzjonali (IU) li jikkorrispondu għal 67. 2 mikrogrammi ta ’ epoetin alfa Epoetin alfa HEXAL 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest: siringa waħda mimlija għal- lest ta ’ 0. 9 ml soluzzjoni għall- injezzjoni fiha 9000 unità internazzjonali (IU) li jikkorrispondu għal 75. 6 mikrogrammi ta ’ epoetin alfa Epoetin alfa HEXAL 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest: siringa waħda mimlija għal- lest ta ’ 1 ml soluzzjoni għall- injezzjoni fiha 10, 000 unità internazzjonali (IU) li jikkorrispondu għal 84. 0 mikrogrammi ta ’ epoetin alfa
What Epoetin alfa HEXAL looks like and contents of the pack
Id- Dehra ta ’ Epoetin alfa HEXAL u l- kontenuti tal- pakkett
Epoetin alfa HEXAL is presented as a clear, colourless solution for injection in a pre-filled syringe.
Epoetin alfa HEXAL hu ppreżentat bħala soluzzjoni għall- injezzjoni ċara u bla kulur f’ siringa mimlija għal- lest.
Syringes are embossed with graduation rings and the filling volume is indicated by a stick-on label in order to enable partial use if required.
Is- siringi huma mnaqqxa bi ċrieki ggradati u l- volum tal - mili hu indikat permezz ta ’ tikketta li teħel biex tippermetti l- użu parzjali jekk ikun meħtieġ.
Epoetin alfa HEXAL 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (1000 IU) of solution.
Epoetin alfa HEXAL 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (1000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 2000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (2000 IU) of solution.
Epoetin alfa HEXAL 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (2000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe The syringes contain 0.3 ml (3000 IU) of solution.
Epoetin alfa HEXAL 3000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 3 ml (3000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe The syringes contain 0.4 ml (4000 IU) of solution.
Epoetin alfa HEXAL 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 4 ml (4000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (5000 IU) of solution.
Epoetin alfa HEXAL 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 5 ml (5000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe The syringes contain 0.6 ml (6000 IU) of solution.
Epoetin alfa HEXAL 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 6 ml (6000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe The syringes contain 0.7 ml (7000 IU) of solution.
Epoetin alfa HEXAL 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 7 ml (7000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe The syringes contain 0.8 ml (8000 IU) of solution.
Epoetin alfa HEXAL 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 8 ml (8000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe The syringes contain 0.9 ml (9000 IU) of solution.
Epoetin alfa HEXAL 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 0. 9 ml (9000 IU) ta ’ soluzzjoni.
Epoetin alfa HEXAL 10 000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (10 000 IU) of solution.
Epoetin alfa HEXAL 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Is- siringi fihom 1 ml (10, 000 IU) ta ’ soluzzjoni.
Marketing Authorisation Holder and Manufacturer
206 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
206 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT PUBBLIKU TA ’ VALUTAZZJONI EWROPEW (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubbliku ta ’ Valutazzjoni Ewropew (EPAR).
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.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Erbitux?
X’ inhu Erbitux?
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Erbitux huwa soluzzjoni għall- infużjoni (dripp fil- vina) li fih is- sustanza attiva cetuximab.
What is Erbitux used for?
Għal xiex jintuża Erbitux?
Erbitux is used to treat the following types of cancer: • metastatic cancer of the colon or rectum (lower intestine or large bowel). ‘ Metastatic ’ means that the cancer has spread to other parts of the body.
Erbitux jintuża għat- trattament ta ’ dawn it- tipi ta ’ kanċer: • kanċer metastatiku tal- kolon u tar- rektum (il- musrana l- għamja). ‘ Metastatiku ’ tfisser li l- kanċer ikun infirex lejn partijiet oħra tal- ġisem.
Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain a ‘ wild-type’ (non-mutated) gene called ‘ KRAS’.
Erbitux jintuża f’ pazjenti fejn iċ- ċelloli tat- tumur ikollhom proteina fuq is- superfiċje magħrufa bħala reċetturi tal- fattur tat- tkabbir epidermiku (epidermal growth factor receptor, EGFR) u fihom ġene tat- tip selvaġġ (mhux mutat) li jismu ‘ KRAS ’.
This gene stimulates tumour growth when it is mutated in tumour cells.
Dan il- ġene jistimula t- tkabbir tat- tumur waqt il- mutazzjoni tiegħu f’ ċelloli tat- tumur.
Erbitux is used together with other anticancer medicines, or on its own when previous cancer treatment containing oxaliplatin and irinotecan has failed and the patient cannot receive irinotecan; • ‘ squamous cell’ cancers of the head and neck.
Erbitux jintuża flimkien ma ’ mediċini oħrajn ta ’ kontra l- kanċer, jew waħdu meta t- trattament preċedenti ta ’ kontra l- kanċer li jkun fih oxaliplatin u irinotecan ma jkunx irnexxa jew meta l - pazjent ma jkunx jista ’ jieħu irinotecan; • kanċer tat- tip ‘ squamous cell ’ tar- ras u tal- għonq.
These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx (voice box).
Dawn it- tipi ta ’ kanċer jolqtu ċ- ċelloli tal- kisi tal- ħalq jew il- gerżuma, jew l- organi bħal- larinġi (li jipproduċu l- leħen).
In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (radiation therapy).
Fil- kanċer lokalment avvanzat (meta t- tumur ikun kiber iżda għadu ma nfirixx), Erbitux jingħata f’ kombinazzjoni mar- radjoterapija (terapija ta ’ radjazzjoni).
The medicine can only be obtained with a prescription.
Meta l- kanċer ikun reċidiv (meta jerġa ’ lura wara trattament preċedenti) jew metastatiku, Erbitux jintuża ma ’ kombinazzjoni ta ’ mediċini kontra l- kanċer abbażi tal- platinu (fosthom mediċini bħal cisplatin jew carboplatin) Il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib.
How is Erbitux used?
Kif jintuża Erbitux?
Erbitux should only be given by doctors who have experience in the use of anticancer medicines.
Erbitux għandu jingħata minn tobba b’ esperjenza fl- użu tal- mediċini ta ’ kontra l- kanċer.
Before receiving Erbitux for the first time, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction.
Qabel ma jingħata Erbitux għall- ewwel darba, il- pazjent għandu jingħata antistamina u kortikosterojde biex jipprevjenu reazzjoni allerġika.
This is also recommended for all subsequent infusions.
Dan huwa rakkomandat ukoll għall- infużjonijiet sussegwenti kollha.
Erbitux is given once a week.
Erbitux jingħata darba kull ġimgħa.
The first infusion is given at a dose of 400 mg per square metre body surface area (calculated using the patient’ s height and weight) over two hours.
L- ewwel infużjoni tingħata b’ doża ta ’ 400 mg għal kull metru kwadru tal- erja tas- superfiċje tal- ġisem (ikkalkulata skont it- tul u l- piż tal- pazjent) u ddum tingħata sagħtejn.
The following infusions are 250 mg/ m2 given over one hour.
L- infużjonijiet ta ’ wara jingħataw b’ doża ta ’ 250 mg/ m2 fuq perjodu ta ’ siegħa.
When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds.
Meta jintuża waħdu jew ma ’ mediċini oħra kontra l- kanċer, Erbitux jitkompla sakemm jibqa ’ jirrispondi l- pazjent.
When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.
Meta jintuża mar- radjoterapija, Erbitux jinbeda ġimgħa qabel ma tibda r- radjoterapija u jitkompla sakemm tintemm ir- radjoterapija.
How does Erbitux work?
Kif jaħdem Erbitux?
The active substance in Erbitux, cetuximab, is a monoclonal antibody.
Is- sustanza attiva f’ Erbitux, cetuximab, huwa antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li jkun ġie ddisinjat biex jagħraf u jeħel ma ’ struttura speċifika (magħrufa bħala antiġene) li tinstab fuq ċerti ċelloli fil- ġisem.
Cetuximab has been designed to bind to EGFR, which can be found on the surface of certain tumour cells.
Cetuximab ġie maħsub biex jeħel ma ’ EGFR, li jista ’ jinstab fuq is- superfiċje ta ’ ċerti ċelloli tat- tumuri.
As a result of this binding, the tumour cell can no longer receive the messages needed for growth, progression and spread.
Minħabba din l- għaqda, iċ- ċelloli tat- tumuri ma jkunux jistgħu jibqgħu jirċievu l- messaġġi meħtieġa biex jikbru, javvanzaw u jinfirxu.
Between 79 and 89% of colorectal cancers and more than 90% of squamous cell cancers of the head and neck have EGFR on the cell surface.
Bejn 79 u 89% tal- kanċers kolorettali u ‘ l fuq minn 90% tal- kanċers tat- tip ‘ squamous cell ’ fir- ras u fl- għonq ikollhom l- EGFR fuq is- superfiċje taċ- ċellola.
How has Erbitux been studied?
Kif ġie studjat Erbitux?
For metastatic cancer of the colon or rectum, Erbitux was studied in five main studies: • two studies involved 1,535 patients who had not received chemotherapy before, looking at the effects of adding Erbitux to a treatment combination containing either irinotecan or oxaliplatin; • three studies involved 2,199 patients whose disease had got worse while they were on previous treatment including irinotecan, oxaliplatin or both, or who could not receive these medicines.
Għall- kanċer metastatiku tal- kolon jew tar- rektum, Erbitux ġie studjat f’ ħames studji ewlenin: • żewġ studji li involvew 1, 535 pazjent li ma kinux ingħataw kemjoterapija qabel, eżaminaw l - effikaċja taż- żieda ta ’ Erbitux ma ’ trattament ta ’ kombinazzjoni li fih irinotecan jew oxaliplatin; • tliet studji involvew 2, 199 pazjent li l- marda tagħhom kienet marret għall- agħar waqt li kienu qed jingħataw trattament preċedenti li kienet tikkonsisti f’ irinotecan, oxaliplatin jew it- tnejn, jew li ma setgħux jingħataw dawn il- mediċini.
All of the studies looked at the length of time before the patient’ s cancer started to get worse or how long the patients survived.
Għall- kanċers fir- ras u fl- għonq, Erbitux ġie eżaminat f’ żewġ studji ewlenin: • l- ewwel studju involva 424 pazjent b’ kanċer lokalment avvanzat u eżamina l- effetti taż- żieda ta ’ Erbitux mar- radjoterapija; • it- tieni studju involva 442 pazjent b’ kanċer reċidiv jew metastatiku u eżamina l- effetti taż- żieda ta ’ Erbitux ma ’ kombinazzjoni ta ’ mediċini kontra l- kanċer abbażi tal- platinu; L- istudji kollha eżaminaw it- tul taż- żmien qabel ma l- kanċer tal- pazjent mar għall- agħar jew it- tul tal - perjodu ta ’ sopravivenza tal- pazjenti.
What benefit has Erbitux shown during the studies?
X’ inhu l- benefiċċju li wera Erbitux f’ dawn l- istudji?
In the studies of cancer of the colon or rectum, it took longer until the disease got worse in the patients with wild-type KRAS in their tumours when they received Erbitux: • in patients who had not received chemotherapy before, it took longer for the disease to get worse when they received Erbitux in addition to chemotherapy than when they did not add Erbitux.
Fl- istudji tal- kanċer tal- kolon u tar- rektum, għadda iktar żmien qabel mal- marda marret għall- agħar f’ pazjenti bi KRAS tat- tip selvaġġ meta ngħataw Erbitux: • fil- pazjenti li ma kinux ingħataw kemjoterapija qabel, għadda aktar żmien qabel ma l- marda marret għall- agħar meta ngħataw Erbitux flimkien mal- kemjoterapija milli meta Erbitux ma kienx miżjud.
This included chemotherapy including irinotecan (9.9 months compared with 8.7 months, on average) and including oxaliplatin (7.7 months compared with 7.2 months, on average) in patients who did not receive Erbitux. • the first study in patients who had taken chemotherapy before did not look at KRAS mutations.
Dan inkluda l- kemjoterapija flimkien ma ’ irinotecan (medja ta ’ 9. 9 xhur meta mqabbla ma ’ 8. 7 xhur) u ma ’ oxaliplatin (medja ta ’ 7. 7 xhur meta mqabbla ma ’ 7. 2 xhur) f’ pazjenti mhux ittrattati b’ Erbitux. • l- ewwel studju f’ pazjenti li kienu ttrattati bil- kemjoterapija qabel ma eżaminawx il- mutazzjonijiet KRAS.
In the other two studies, it took longer for the disease to get worse among patients with wild-type KRAS when Erbitux was added to their treatment.
Fiż- żewġ studji l- oħra, għadda aktar żmien biex il- marda tmur għall- agħar fost il- pazjenti bi KRAS tat- tip selvaġġ biż- żieda ta ’ Erbitux mat- trattament tagħhom.
In patients who had failed both oxaliplatin and irinotecan treatment, it took an average of 3.6 months with Erbitux and 1.9 months in those receiving best supportive care alone (the treatment of symptoms but not the cancer itself).
Fil- pazjenti li fallew kemm it- trattament b’ oxaliplatin kif ukoll dak b’ irinotecan, għaddiet medja ta ’ 3. 6 xhur b’ Erbitux u 1. 9 xhur f’ dawk ittrattati l- aqwa kura ta ’ appoġġ waħedha (it- trattament tas- sintomi iżda mhux il - kanċer stess).
In patients who had failed oxaliplatin treatment, it took an average of 4.0 months with Erbitux plus irinotecan and 2.6 months in those receiving irinotecan alone.
Fil- pazjenti li fallew it- trattament b’ oxaliplatin, għaddiet medja ta ’ 4. 0 xhur b’ Erbitux flimkien ma ’ irinotecan u 2. 6 xhur f’ dawk ittrattati b’ irinotecan biss.
In locally advanced head and neck cancers, it took longer for the disease to get worse when Erbitux was added to radiotherapy (24.4 months compared with 14.9 months).
Fil- kanċers fir- ras u fl- għonq lokalment avvanzati, għadda aktar żmien sa ma l- marda marret għall - agħar meta żdied Erbitux mar- radjoterapija (medja ta ’ 24. 4 xhur, meta mqabbla ma ’ 14. 9 xhur).
In recurrent or metastatic head and neck cancer, survival was longer when Erbitux was added to a platinum-based anticancer medicine combination (10.1 months compared with 7.4 months).
Fil - kanċer fir- ras u fil- għonq reċidiv jew metastatiku, il- perjodu ta ’ sopravivenza rriżulta itwal meta żdied Erbitux ma ’ kombinazzjoni ta ’ mediċini kontra l- kanċer abbażi tal- platinu (10. 1 xhur meta mqabbla ma ’ 7. 4 xhur).
What is the risk associated with Erbitux?
X’ inhu r- riskju assoċjat ma ’ Erbitux?
The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), reactions linked to the infusion (such as fever, chills, dizziness and difficulty breathing), mucositis (inflammation of the lining of the mouth) and raised levels of some liver enzymes.
L- effetti sekondarji l- aktar komuni b’ Erbitux (li dehru f’ iktar minn pazjenti 1 minn kull 10) huma r - reazzjonijiet tal- ġilda bħal raxx, ipomanjeżjemija (livell baxx ta ’ manjeżju fid- demm), reazzjonijiet marbuta mal- infużjoni (bħal deni, tertir, sturdament u tbatija fit- teħid tan- nifs), mukożite (infjammazzjoni fil- kisja tal- ħalq) u livelli għoljin tal- enzimi tal- fwied.
Skin reactions are seen in more than 80% of patients.
Dehru reazzjonijiet tal- ġilda f’ iktar minn 80% tal- pazjenti.
For the full list of all side effects reported with Erbitux, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati ma ’ Erbitux, ara l- Fuljett ta ’ Tagħrif.
Erbitux should not be used in people who are very hypersensitive (allergic) to cetuximab.
Erbitux m’ għandux jintuża f’ persuni ipersensittivi (allerġiċi) ħafna għal cetuximab.
Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given.
2/ 3 Erbitux jista ’ jkun assoċjat ma ’ reazzjonijiet severi waqt l- infużjoni, u għalhekk il- pazjenti jkollhom jiġu sorveljati bir- reqqa sakemm jingħataw il- mediċina.
Why has Erbitux been approved?
Għaliex ġie approvat Erbitux?
The Committee for Medicinal Products for Human Use (CHMP) decided that Erbitux’ s benefits are greater than its risks for the treatment of patients with EGFR-expressing, KRAS wild-type metastatic
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Erbitux huma ogħla mir- riskji tiegħu fit- trattament ta ’ pazjenti b’ kanċers tal- kolon u tar- rektum metastatiku KRAS ta ’ tip selvaġġ li jesprimi karatteristiċi EGFR, u pazjenti b’ kanċer squamous cell fir- ras u fl- għonq.
The Committee recommended that Erbitux be given marketing authorisation.
Il- Kumitat irrakkomanda wkoll li Erbitux jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Erbitux:
Informazzjoni oħra dwar Erbitux:
The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux to Merck KGaA on 29 June 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Erbitux lil Merck KGaA fid- 29 ta ’ Ġunju 2004.
The full EPAR for Erbitux can be found here.
L- EPAR sħiħ għal Erbitux jista ’ jiġi kkonsultat hawn.
This summary was last updated in 12-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Erbitux 2 mg/ ml solution for infusion
Erbitux 2 mg/ ml soluzzjoni għall- infużjoni
Each ml of solution for infusion contains 2 mg cetuximab.
Kull 1 ml ta ’ soluzzjoni għall- infużjoni fih 2 mg ta ’ cetuximab.
Each vial contains 50 ml.
Kull kunjett fih 50 ml.
Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/ 0) by recombinant DNA technology.
Cetuximab hu antikorp kimeriku monoklonali IgG1 prodott f’ razza ta ’ ċelluli mammiferi (Sp2/ 0) minn teknoloġija DNA rikombinanti.
Solution for infusion.
Soluzzjoni għall- infużjoni.
Erbitux 2 mg/ ml is a colourless solution that may contain product-related whitish and amorphous visible particles.
Erbitux 2 mg/ ml hu soluzzjoni bla kulur li jista ’ jkun fiha frak viżibbli tal- prodott li huma bojod u bla sura.
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer • in combination with chemotherapy • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Erbitux hu indikat għall- kura ta ’ pazjenti b’ kanċer metastatiku tal- kolon u tar- rektum b’ espressjoni tar- riċettur tal- fattur tat- tkabbir epidermali (EGFR), ġene KRAS wild- type • flimkien mal- kimoterapija • bħala mediċina waħidha f’ pazjenti li ma rnexxewx bit- terapija bbażata fuq oxaliplatin u irinotecan, u li huma intolleranti għal irinotecan.
Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck • in combination with radiation therapy for locally advanced disease • in combination with platinum-based chemotherapy for recurrent and/ or metastatic disease.
Erbitux hu indikat għall- kura tal- pazjenti b' kanċer taċ- ċelluli skwamużi fir- ras u fl- għonq • flimkien ma ’ terapija bir- raġġi għal mard li jkun infirex lokalment • flimkien ma 'kimoterapija bbażata fuq il- platinum għal mard rikorrenti u/ jew metastatiku.
Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Erbitux għandu jingħata biss taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu ta ’ prodotti mediċinali antineoplastiċi.
Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion.
Monitoraġġ mill- qrib hu meħtieġ matul l- infużjoni u għal mill- inqas siegħa wara li tispiċċa l- infużjoni.
Availability of resuscitation equipment must be ensured.
Wieħed irid ikun ċert li jkun hemm mezzi tar- risuxitazzjoni.