qanastek/EMEA-V3 huggingface dataset:
After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
168 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Il- konċentrazzjoni mmirata ta ’ l- emoglobina fi tnejn mill- istudji kienet > 13 g/ dl; fit - tliet studji li jibqa ’ din kienet 12- 14 g/ dl.
Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42% as compared with intravenous administration.
Fl- erba ’ studji kkontrollati bil- plaċebo il- proporzjon ta ’ periklu għas- sopravivenza globali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
Meta- analiżi bbażata fuq tagħrif tal- pazjent individwali, li nkludiet tagħrif mit- 12- il studju kliniku kkontrollat kollha, magħmula b’ NeoRecormon f’ pazjenti anemiċi bil- kanċer (n=2301), uriet estimu globali tal- punt tal- proporzjon ta ’ periklu għas- sopravivenza ta ’ 1. 13 favur il- kontrolli (95% CI 0. 87, 1. 46).
A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
F’ pazjenti b’ emoglobina fil- linja bażi ≤ 10 g/ dl (n=899), l- estimu tal- punt tal- proporzjon ta ’ periklu għas- sopravivenza kien 0. 98 (95% CI 0. 68 sa 1. 40).
PHARMACEUTICAL PARTICULARS
Żjieda fir- riskju relattiv ta ’ episodji tromboembolitiċi kienet osservata fil- popolazzjoni globali (RR 1. 62, 95% CI:
6.1 List of excipients
1. 13, 2. 31).
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Meta- analiżi tat- tagħrif tas- sopravivenza globali pproduċiet estimu tal- punt ta ’ proporzjon ta ’ periklu ta ’ 1. 08 favur il- kontrolli (95% CI:
6.2 Incompatibilities
0. 99, 1. 18; 42 prova u 8167 pazjent).
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
1. 35, 2. 06, 35 prova u 6769 pazjent) kienet osservata f’ pazjenti kkurati b’ eritropoetin rikombinanti umana.
6.3 Shelf life
F’ każijiet rari ħafna, ffurmaw antikorpi newtralizzanti kontra l- eritropoetin b’ aplasja pura taċ- ċelluli ħomor (PRCA) u anki mingħajrha waqt terapija b’ rHuEPO.
2 years.
5. 2 Tagħrif farmakokinetiku
164 6.4 Special precautions for storage
Riżultati jixxibħu nkisbu minn esperimenti fl- annimali f’ firien normali u uremiċi.
Store in a refrigerator (2°C – 8°C).
Il- half- life terminali hija ogħla minn dik wara amministrazzjoni minn ġol- vini, b’ medja ta ’ bejn 13 - 28 siegħa.
Keep the pre-filled syringe in the outer carton, in order to protect from light.
Il- biodisponibiltà ta ’ epoetin beta wara amministrazzjoni minn taħt il- ġilda hija bejn 23 u 42% meta mqabbel ma ’ amministrazzjoni minn ġol- vina.
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
6.5 Nature and contents of container
Studju dwar il- karċenoġeniċita` b’ eritropoetin omologu fil- ġrieden ma żvelax sinjali ta ’ potenzjal proliferattiv jew tumuroġeniku.
Pack sizes of 1 or 6 Not all pack sizes may be marketed.
TAGĦRIF FARMAĊEWTIKU
6.6 Special precautions for disposal and other handling
6. 1 Lista ta ’ sustanzi mhux attivi
Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate, Calcium chloride dihydrate, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine, Ilma għall- injezzjonijiet.
Remove the cap from the syringe.
6. 2 Inkompatibilitajiet
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Keep pressing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
4.
Sentejn
Clean the skin at the site of injection using an alcohol wipe.
6. 4 Prekawzjonijiet speċjali għall- ħażna
Form a skin fold by pinching the skin between thumb and forefinger.
Aħżen fi friġġ (2°C – 8°C).
Hold the syringe barrel near to the needle, and insert the needle into the skin fold with a quick, firm action.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perijodu wieħed ta ’ mhux aktar minn tlett ijiem
This medicinal product is for single use only.
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
MARKETING AUTHORISATION HOLDER
Daqsijiet tal- pakkett ta ’ 1 jew 6.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
MARKETING AUTHORISATION NUMBERS
2.
EU/ 1/ 97/ 031/ 037 - 038
Injetta s- soluzzjoni ta ’ NeoRecormon.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
16 July 2007
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
165 10.
8.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
EU/ 1/ 97/ 031/ 037 - 038
166 1.
9.
NAME OF THE MEDICINAL PRODUCT
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
NeoRecormon 30,000 IU solution for injection in pre-filled syringe
16 ta ’ Lulju 2007
QUALITATIVE AND QUANTITATIVE COMPOSITION
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
One pre-filled syringe with 0.6 ml solution for injection contains 30,000 international units (IU) corresponding to 250 micrograms epoetin beta* (recombinant human erythropoietin).
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
One ml solution for injection contains 50,000 IU epoetin beta.
ISEM TAL- PRODOTT MEDIĊINALI
* produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology
NeoRecormon 30, 000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Excipients:
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Phenylalanine (up to 0.3 mg/ syringe) Sodium (less than 1 mmol/ syringe)
Siringa waħda mimlija għal- lest b’ 0. 6 ml soluzzjoni għall- injezzjoni li fiha 30, 000 unità internazzjonali (IU) li jikkorrespondu għal 250 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
For a full list of excipients, see section 6.1.
* prodott minn ċelluli tal- Ovarju tal- Ħamster Ċiniż (CHO) permezz ta ’ teknoloġija rikombinanti tad - DNA.
PHARMACEUTICAL FORM
Sustanzi mhux attivi:
Colourless, clear to slightly opalescent solution.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
CLINICAL PARTICULARS
GĦAMLA FARMAĊEWTIKA
4.1 Therapeutic indications
Soluzzjoni għall- injezzjoni.
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and
- Kura sintomatika ta ’ anemija assoċjata ma ’ insuffiċjenza kronika tal- kliewi (CRF) f’ pazjenti
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
172 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
167 haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
NeoRecormon għandu jingħata minn taħt il- ġilda jew minn ġol- vini sabiex iżid l- emoglobina sa mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
173 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
168 Prevention of anaemia of prematurity:
Prevenzjoni ta ’ anemija ta ’ prematurità:
Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia.
174 Il- pazjenti għandhom jiġu sorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ NeoRecormon biex jiġi pprovdut kontoll adegwat tas- sintomi ta ’ l- anemija.
169 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Id- dożaġġ għandu jkun iddeterminat għal kull pazjent individwali mill- iskwadra kirurġika bħala funzjoni ta ’ l- ammont meħtieġ ta ’ demm mogħti minn qabel u r- riserva ta ’ ċelluli ħomor endoġeni:
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
Riserva ta ’ ċelluli ħomor endoġeni = volum tad- demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad- demm [ml] = 41 [ml/ kg] × piż tal- ġisem [kg] + 1200 [ml] Irġiel: volum tad- demm [ml] = 44 [ml/ kg] × piż tal- ġisem [kg] + 1600 [ml] (piż tal- ġisem ≥ 45 kg)
The indication for treatment with NeoRecormon and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserve according to the following graphs.
L- indikazzjoni għall- kura b’ NeoRecormon, u jekk jingħata, id- doża waħdanija għandha tiġi determinata mill- ammont meħtieġ ta ’ demm mogħti minn qabel u r- riserva ta ’ ċelluli ħomor endoġeni skond dawn il- graffs
Female patients
Pazjenti Nisa
Male patients
Pazjenti Rġiel
Required amount of pre-donated blood [units]
Ammont meħtieġ ta ’ demm mogħti Minn qabel [unitajiet]
Required amount of pre-donated blood [units]
Ammont meħtieġ ta ’ demm mogħti minn qabel [unitajiet]
Endogenous red cell reserve [ml]
TÜ
Endogenous red cell reserve [ml]
/ k
The single dose thus determined is administered twice weekly over 4 weeks.
g
4.3 Contraindications
6 Ü / kg
Poorly controlled hypertension.
Ü
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
s.
170 4.4 Special warnings and precautions for use
Ü /
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
T
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines.
rm
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
/ k
The indication for treatment with NeoRecormon of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
g
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Tg
In chronic renal failure patients an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
n
In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with NeoRecormon, especially after intravenous administration.
g:
It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
8 Ü/ k
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
eo
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
R
In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly.
/ kg
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
: 8
171
1 oR
- shortened time to tumour progression in patients with advanced head and neck cancer receiving
e
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
N
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
i. v
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l),
i. v
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
:
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Ü
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
ed
There may be an increase in blood pressure which can be treated with drugs.
Üs
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
e
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
0T ttie
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with NeoRecormon as a result of the increased packed cell volume.
T
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
N
Serum potassium and phosphate levels should be monitored regularly during therapy with NeoRecormon.
00 / kg
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
d
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/ dl [6.83 mmol/ l]) should donate;
00 / kg d 0
- special care should be taken with patients below 50 kg weight;
i
12% of the patient's estimated blood
4 TÜ ie e
volume.
2 ux j
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/ benefit assessment for homologous transfusions.
a
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
g
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/ syringe as an excipient.
M
172 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Riserva ta ’ ċelluli ħomor endoġeni [ml]
4.5 Interaction with other medicinal products and other forms of interaction
Riserva ta ’ ċelluli ħomor endoġeni [ml]
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Id- doża waħdanija ddeterminata b’ dan il- mod tingħata darbtejn fil- ġimgħa fuq medda ta ’ 4 ġimgħat.
Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
L- ogħla doża m’ għandhiex tkun iktar minn 1600 IU/ kg piż tal- ġisem kull ġimgħa għall - amministrazzjoni ġol- vini jew 1200 IU/ kg kull ġimgħa għall- amministrazzjoni minn taħt il- ġilda.
4.6 Pregnancy and lactation
175 4. 3 Kontra- indikazzjonijiet
For epoetin beta no clinical data on exposed pregnancies are available.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Caution should be exercised when prescribing to pregnant women.
Meta ikun qed jingħata għall - “ kura biex jiżdied id- demm li jagħmel il- pazjent innifsu ”: infart mijokardjali jew puplesija fix- xahar ta ’ qabel it- trattament, angina pectoris mhux stabbli, riskju akbar ta ’ deep venous thrombosis bħal storja ta ’ mard tromboemboliku fil- vini.
4.7 Effects on ability to drive and use machines
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
NeoRecormon has no influence on the ability to drive and use machines.
Wieħed għandu jiżgura li m’ hemmx defiċjenza ta ’ folic acid u vitamina B12 għax dawn inaqqsu l- effikaċja ta ’ NeoRecormon.
4.8 Undesirable effects
Biex tkun żgurata l- formazzjoni effettiva taċ- ċelluli tad- demm ħomor, għandu jkun evalwat l- istat tal - ħadid għal kull pazjent qabel u waqt il- kura, u jista ’ jkun hemm bżonn ta ’ terapija supplimentari bil - ħadid li għandha tingħata skond il- linji gwida tat- terapija.
Based on results from clinical trials including 1725 patients approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.
Togħbija severa ta ’ aluminju minħabba kura ta ’ insuffiċjenza tal- kliewi tista ’ tnaqqas l- effikaċja ta ’ NeoRecormon.
- Anaemic patients with chronic renal failure
L- indikazzjoni għall- kura b’ NeoRecormon ta ’ pazjenti nefrosklerotiċi li għadhom ma bdewx id- dijalisi, għandha tiġi ddefinita ndividwalment, għax l- possibiltà ta ’ aċċelerazzjoni ta ’ progressjoni ta ’ insuffiċjenza renali ma tistax titwarrab b’ ċertezza.
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4).
Aplasja pura taċ- ċelloli ħomor ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ terapija b’ eritropoetin, inkluż NeoRecormon.
Hypertensive crisis with encephalopathy-like symptoms (e. g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Dawn l- antikorpi ntwerew li jirreaġixxu mal- proteini eritopoetiċi kollha, u pazjenti ssuspettati jew ikkonfermati li għandhom antikorpi newtralizzanti kontra l- eritropoetin m’ għandhomx jinqalbu għal NeoRecormon (ara sezzjoni 4. 8).
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e. g. stenoses, aneurisms), see section 4.4.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi, speċjalment f’ każijiet ta ’ żjieda f’ daqqa fil- PCV, jista ’ jkun hemm żjieda fil- pressjoni tad- demm jew pressjoni għolja ġa eżistenti tista ’ tmur għal agħar.
In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4).
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati b’ prodotti mediċinali.
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Speċjalment fil- bidu tat- terapija, hija rakkomandata sorveljanza regolari tal- pressjoni tad- demm, inkluż bejn dijalisi u ieħor.
In isolated cases, neutralising anti erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
Tista ’ sseħħ kriżi ipertensiva b’ sintomi jixbħu lil enċefalopatija li tinħtieġ attenzjoni mmedjata ta ’ tabib u kura medika intensiva.
In case anti-erythropoietin antibody- mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4).
Għandha tingħata attenzjoni speċjali lill- uġigħ ta ’ ras li jagħti f’ daqqa, itektek u jixbaħ lill- emikranja, għax jista ’ jkun sinjal possibbli ta ’ twissija.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Din tonqos tul il- kors tat- terapija.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Huwa rakkomandat li l- għadd ta ’ plejtlits ikun issorveljat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
System Organ Class
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u ta ’ episodji kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
Adverse Drug Reaction
176 Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwiti lill- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied ’ il fuq mil- livell neċessarju għall- kontroll ta ’ sintomi ta ’ l - anemija u biex tiġi evitata trasfużjoni tad- demm.
Incidence
Fi trabi prematuri, jista ’ jkun hemm żjieda żgħira fl- għadd ta ’ plejtlits, partikolarment sa 12- 14- il ġurnata ta ’ ħajja, għalhekk il- plejtlits għandhom jiġu sorveljati regolarment.
Vascular disorders
Fi studji kliniċi kkontrollati, l- użu ta ’ NeoRecormon u sustanzi oħra li jistimolaw l- eritropoesi wrew:
Hypertensive crisis Hypertension
- ħin imqassar sal- progressjoni tat- tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed
Uncommon (> 0.1% ,< 1%) Common (> 1% ,< 10%)
jirċievu terapija ta ’ radjazzjoni meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 mmol/ l),
Nervous system disorders Blood and the lymphatic system disorders
- sopravivenza globali mqassra u żjieda fl- imwiet attribwiti lill- progressjoni tal- marda wara 4
Headache Shunt thrombosis Thrombocytosis
xhur f’ pazjenti b’ kanċer metastatiku tas- sider li qed jirċievu kimoterapija meta mogħti biex tintlaħaq emoglobina ta ’ 12- 14 g/ dl (7. 5- 8. 7 mmol/ l),
Common (> 1% ,< 10%) Rare (> 0.01% ,< 0.1%) Very rare (< 0.01%)
- żjieda fir- riskju ta ’ mewt meta mogħti biex tintlaħaq emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l)
173
ESAs mhumiex indikati għall- użu f’ din il- popolazzjoni ta ’ pazjenti.
- Patients with cancer
Fatturi li għandhom jiġu kkunsidrati f’ din il- valutazzjoni għandhom jinkludu t- tip ta ’ tumur u l- istadju tiegħu; il- grad ta ’ l- anemija; it- tul mistenni tal- ħajja; l- ambjent li fih qed jiġi kkurat il- pazjent; u l- preferenza tal- pazjent (ara sezzjoni 5. 1)
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
Għalhekk huwa rrakkomandat li tiġi sorveljata l- pressjoni tad- demm, speċjalment fil- fażi tal- bidu tal- kura f’ pazjenti bil- kanċer.
In some patients, a fall in serum iron parameters is observed (see section 4.4).
L- għadd ta ’ plejtlits u l- livell ta ’ emoglobina ukoll għandhom jiġu sorveljati f’ intervalli regolari f’ pazjenti bil- kanċer.
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
Għalhekk huwa rakkomandat li f’ dawn il- pazjenti l- għadd ta ’ plejtlits jiġi determinat mill- inqas darba fil- ġimgħa.
In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
Jekk ikun hemm żjieda ikbar minn 150 x 109/ l jew jekk il- plejtlits jiżdiedu iktar mill- limitu normali, il- kura b’ NeoRecormon għandha titwaqqaf.
Vascular disorders Blood and the lymphatic system disorders
177 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
Hypertension Thromboembolic event
Biex NeoRecormon jintuża fuq pazjenti li jkunu fi programm fejn jingħataw id- demm tagħhom stess, għandhom jiġu kkunsidrati l- linji gwida uffiċjali dwar il- prinċipji tad- donazzjoni tad- demm, partikolarment: jistgħu jagħtu d- demm biss pazjenti b’ PCV ≥ 33% (emoglobina ≥ 11 g/ dl [6. 83 mmol/ l];
Common (> 1% ,< 10%) Common (> 1% ,< 10%)
-
Nervous system disorders
- kura speċjali trid tingħata lil pazjenti li jiżnu inqas minn 50 kg;
Headache
- il- volum meħud f’ darba m’ għandux jaqbeż bejn wieħed u ieħor it- 12% ta ’ dak li hu stmat li hu
Common (> 1%, < 10%)
il- volum tad- demm tal- pazjent.
- Patients in an autologous blood predonation programme
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li joħolqu periklu ta ’ mewt.
Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
NeoRecormon jista ’ jkun fih sa 0. 3 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
However, a causal relationship with treatment with NeoRecormon could not be established.
Għalhekk, dan għandu jkun ikkunsidrat f’ każ ta ’ pazjenti li jbatu minn forom severi ta ’ phenylketonuria.
In placebo controlled trials temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4).
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
Nervous system disorders
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Headache
NeoRecormon m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Common (> 1%, < 10%)
4. 8 Effetti mhux mixtieqa
- Premature infants
Skond ir- riżultati miksubin minn provi kliniċi li nkludew 1725 pazjent, madwar 8% tal- pazjenti kkurati b’ NeoRecormon huma mistennija li jkollhom esperjenza ta ’ reazzjonijiet avversi.
A fall in serum ferritin values
- Pazjenti anemiċi b’ insuffiċjenza kronika tal- kliewi
is very common (> 10%) (see
Tista ’ sseħħ ukoll kriżi ipertensiva b’ sintomi bħal ta ’ enċefalopatija (e. ż. uġigħ ta ’ ras u konfużjoni, problemi ta ’ koordinazzjoni – bħal problemi biex wieħed jitkellem jew diffikultà fil- mixi – sa anki attakki ta ’ epilessija tonokloniċi) f’ pazjenti ndividwali li ssoltu jkollhom pressjoni normali jew baxxa (ara sezzjoni 4. 4).
section 4.4).
Barra minn hekk, f’ każijiet iżolati, kienu osservati żiediet temporanji fil- livelli ta ’ potassju u fosfat fis- serum (ara sezzjoni 4. 4).
Rarely (≥ 1/ 10.000 to ≤ 1/ 1.000), epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
F’ każijiet iżolati kienet irrappurata aplasja pura taċ- ċelloli ħomor (PRCA) ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, f’ assoċjazzjoni ma ’ terapija b’ NeoRecormon.
In very rare cases (≤ 1/ 10.000), epoetin beta treatment- related anaphylactoid reactions have been reported.
F’ każ ta ’ dijanjosi ta ’ PRCA ikkawżata minn antikorpi kontra l- eritropoetin, it- terapija b’ NeoRecormon għandha titwaqqaf u l- pazjenti għandhom jinqalbu għal fuq proteina eritropoetika oħra (ara sezzjoni 4. 4).
However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
L- inċidenza ta ’ effetti mhux mixtieqa fi provi kliniċi, kkunsidrati bħala relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
In very rare cases (≤ 1/ 10.000), particularly when starting treatment, epoetin beta treatment-related flu- like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/ or bone pain have been reported.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Sistema tal- Klassifika tal - Organi
The therapeutic margin of NeoRecormon is very wide.
Kriżi ipertensiva
Even at very high serum levels no symptoms of poisoning have been observed.
Mhux komuni (> 0. 1%, < 1%)
174 5.
Pressjoni għolja
PHARMACOLOGICAL PROPERTIES
Komuni (> 1%, < 10%)
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors.
Disturbi tad- demm u tas - sistema limfatika
It acts as a mitosis stimulating factor and differentiation hormone.
Shunt thrombosis Tromboċitożi
After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Rari (> 0. 01%, < 0. 1%) Rari ħafna (< 0. 01%)
Cytotoxic actions of epoetin beta on bone marrow or on human skin cells were not detected.
- Pazjenti bil- kanċer
After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Uġigħ ta ’ ras u pressjoni għolja li tista ’ tiġi kkontrollata b’ mediċini, relatati ma ’ kura b’ epoetin beta, huma komuni (> 1%, < 10%) (ara sezzjoni 4. 4).
Erythropoietin is a growth factor that primarily stimulates red cell production.
F’ xi pazjenti, huwa osservat tnaqqis fil- parametri ta ’ ħadid fis- serum (ara sezzjoni 4. 4).
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Studji kliniċi urew frekwenza ogħla ta ’ avvenimenti trombo- embolitiċi f’ pazjenti bil- kanċer ikkurati b’ NeoRecormon meta mqabbla ma ’ dawk il- kontrolli mhux ikkurati jew ma ’ plaċebo.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
F’ pazjenti kkurati b’ NeoRecormon, din l- inċidenza hija ta ’ 7% meta mqabbla ma ’ 4% fil- kontrolli; din mhix assoċjata ma ’ żjieda fil- mortalità b’ kawża trombo- embolitika meta mqabbla mal- kontrolli.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
In patients with baseline haemoglobin ≤ 10 g/ dl (n=899), the hazard ratio point estimate for survival was 0.98 (95% CI 0.68 to 1.40).
Sistema tal- Klassifika tal - Organi
An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95% CI:
Reazzjoni Avversa tal- Mediċina
1.13, 2.31).
Inċidenża
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Disturbi vaskulari Disturbi tad- demm u tas - sistema limfatika
0.99, 1.18; 42 trials and 8167 patients).
Pressjoni għolja Avveniment trombo - embolitiku
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Komuni (> 1%, < 10%) Komuni (> 1%, < 10%)
175 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Disturbi fis- sistema nervuża
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia (PRCA) occurred during rHuEPO therapy.
Uġigħ ta ’ ras
5.2 Pharmacokinetic properties
Komuni (> 1%, < 10%)
Analogous results have been found in animal experiments in uraemic and normal rats.
- Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu
After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu kienu rrappurtati li juru frekwenza ta ’ avvenimenti trombo- embolitiċi kemmxejn akbar.
The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Madankollu, ma tistax tiġi stabbilita relazzjoni kawżali ma ’ kura b’ NeoRecormon.
Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42% as compared with intravenous administration.
Fi provi kliniċi kontrollati bil- plaċebo, defiċjenza temporanja ta ’ ħadid deheret aktar f’ pazjenti kkurati b’ NeoRecormon meta mqabbla mal- gruppi ta ’ kontroll (ara sezzjoni 4. 4).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
179 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
PHARMACEUTICAL PARTICULARS
Sistema tal- klassifika tal - organi
6.1 List of excipients
Reazzjoni Avversa tal- Mediċina
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Inċidenza
6.2 Incompatibilities
Disturbi fis- sistema nervuża
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Uġigħ ta ’ ras
6.3 Shelf life
Komuni (> 1%, < 10%)
2 years.
- Trabi prematuri
176 6.4 Special precautions for storage
Tnaqqis fil- valuri ta ’ ferritin fis- serum huwa komuni ħafna (> 10%) (ara sezzjoni 4. 4).
Store in a refrigerator (2°C – 8°C).
- Indikazzjonijiet kollha
Keep the pre-filled syringe in the outer carton, in order to protect from light.
Rarament (≥1/ 10. 000 to ≤1/ 1. 000), reazzjonijiet tal- ġilda relatati ma ’ kura b’ epoetin beta, bħal raxx, ħakk, urtikarja jew reazzjonijiet fis- sit ta ’ l- injezzjoni jistgħu jiġru.
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Madankollu, fi studji kliniċi ikkontrollati ma nstabet l- ebda żjieda fl- inċidenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva.
6.5 Nature and contents of container
4. 9 Doża eċċessiva
0.6 ml of solution in pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber) with a needle 27G1/ 2.
Il- marġni terapewtiku ta ’ NeoRecormon huwa wiesa ’ ħafna.
Pack sizes of 1 or 4 Not all pack sizes may be marketed.
Lanqas f’ livelli għoljin ħafna fis- serum ma dehru sintomi ta ’ avvelenament.
6.6 Special precautions for disposal and other handling
TAGĦRIF FARMAKOLOĠIKU
1.
5. 1 Tagħrif farmakodinamiku
Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles.
Kategorija farmakoterapewtika: anti- anemiku, Kodiċi ATC:
2.
B03XA
3.
Epoetin beta huwa identiku fl- amino acids u l- karboidrati tiegħu, għall- eritropoetin li kien iżolat mill - urina ta ’ pazjenti anemiċi.
Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
Eritropoetin hu glikoproteina li tistimola l- formazzjoni ta ’ ċelluli ħomor tad- demm mill- proġenituri tagħhom.
Keep pressing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
Jaħdem bħala fattur li jistimola l- mitożi u bħala ormon ta ’ divrenzjar.
Hold the syringe barrel near to the needle, and insert the needle into the skin fold with a quick, firm action.
L- effikaċja bijoloġika ta ’ epoetin beta kienet murija wara li ngħatat minn taħt il- ġilda u minn ġol- vini lil diversi annimali in vivo li ntużaw bħala mudell (firien normali u uremiċi, ġrieden poliċitemiċi, klieb).
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Wara l- amministrazzjoni ta ’ epoetin beta, in- numru ta ’ eritroċiti, il- valuri tal- Hb u l- għadd ta ’ retikuloċiti żdiedu, flimkien mar- rata ta ’ inkorporazzjoni ta ’ 59Fe.
This medicinal product is for single use only.
Investigazzjonijiet f’ kulturi ta ’ ċelluli tal- mudullun uman urew li epoetin beta jistimula l- formazzjoni ta ’ ċelluli tad- demm ħomor imma ma jaffettwax il- formazzjoni tal- lewkoċiti.
Any unused product or waste material should be disposed of in accordance with local requirements.
Ma kienux osservati azzjonijiet ċitotossiċi ta ’ epoetin beta fuq mudullun jew fuq ċelluli tal- ġilda umana.
MARKETING AUTHORISATION HOLDER
Wara amministrazzjoni ta ’ doża waħda ta ’ epoetin beta ma kienux osservati effetti fuq l- imġieba jew fil- mod ta ’ ċaqliq ta ’ ġrieden u fil- funzjonijiet ċirkulatorji u respiratorji tal- klieb.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Eritropoetin huwa fattur tat- tkabbir li primarjament jistimola l- produzzjoni ta ’ ċelluli ħomor.
MARKETING AUTHORISATION NUMBERS
Riċetturi għall- eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ diversi ċelluli tat- tumur.
EU/ 1/ 97/ 031/ 045 - 046
180 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Fi tnejn mill- istudji ħadu sehem pazjenti li kienu qed jiġu kkurati b’ kimoterapija.
16 July 1997 Date of the last renewal:
Żjieda fir- riskju relattiv ta ’ episodji tromboembolitiċi kienet osservata fil- popolazzjoni globali (RR 1. 62, 95% CI:
16 July 2007
1. 13, 2. 31).
DATE OF REVISION OF THE TEXT
0. 99, 1. 18; 42 prova u 8167 pazjent).
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Żjieda fir- riskju relattiv ta ’ episodji tromboembolitiċi (RR 1. 67, 95% CI:
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
1. 35, 2. 06, 35 prova u 6769 pazjent) kienet osservata f’ pazjenti kkurati b’ eritropoetin rikombinanti umana.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Għalhekk hemm evidenza konsistenti biex tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lill- pazjenti b’ kanċer li huma kkurati b’ eritropoetin rikombinanti umana.
Name and address of the manufacturer(s) of the biological active substance(s)
F’ każijiet rari ħafna, ffurmaw antikorpi newtralizzanti kontra l- eritropoetin b’ aplasja pura taċ- ċelluli ħomor (PRCA) u anki mingħajrha waqt terapija b’ rHuEPO.
Roche Diagnostics GmbH Nonnenwald 2 D-82377 Penzberg Germany
5. 2 Tagħrif farmakokinetiku
Name and address of the manufacturer(s) responsible for batch release
Riżultati jixxibħu nkisbu minn esperimenti fl- annimali f’ firien normali u uremiċi.
Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Il- half- life terminali hija ogħla minn dik wara amministrazzjoni minn ġol- vini, b’ medja ta ’ bejn 13 - 28 siegħa.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Il- biodisponibiltà ta ’ epoetin beta wara amministrazzjoni minn taħt il- ġilda hija bejn 23 u 42% meta mqabbel ma ’ amministrazzjoni minn ġol- vina.
Medicinal product subject to restricted medical prescription (See Annex I:
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Studju dwar il- karċenoġeniċita` b’ eritropoetin omologu fil- ġrieden ma żvelax sinjali ta ’ potenzjal proliferattiv jew tumuroġeniku.
Not applicable.
TAGĦRIF FARMAĊEWTIKU
• OTHER CONDITIONS
6. 1 Lista ta ’ sustanzi mhux attivi
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate, Calcium chloride dihydrate, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine, Ilma għall- injezzjonijiet.
180 ANNEX III
6. 2 Inkompatibilitajiet
LABELLING AND PACKAGE LEAFLET
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
LABELLING
Sentejn
182 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
6. 4 Prekawzjonijiet speċjali għall- ħażna
OUTER CARTON
Aħżen fi friġġ (2°C – 8°C).
NAME OF THE MEDICINAL PRODUCT
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
NeoRecormon Multidose 50,000 IU Lyophilisate and solvent for solution for injection (5000 IU/ ml) Epoetin beta
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perijodu wieħed ta ’ mhux aktar minn tlett ijiem
STATEMENT OF ACTIVE SUBSTANCE(S)
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
1 vial contains 50,000 IU epoetin beta.
Daqsijiet tal- pakkett ta ’ 1 jew 4.
LIST OF EXCIPIENTS
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
1 vial contains:
1.
Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
3.
1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections).
Żomm is- siringa wieqfa u mbotta il- planġer ’ il fuq biex titneħħa l- arja mis- siringa u il- labra.
Medicinal product contains phenylalanine and sodium and solvent contains benzyl alcohol, see leaflet for further information.
Ibqa ’ mbotta il- planġer sakemm ikun hemm NeoRecormon fis- siringa daqs kemm għandu jingħata.
PHARMACEUTICAL FORM AND CONTENTS
Injetta s- soluzzjoni ta ’ NeoRecormon.
Lyophilisate and solvent for solution for injection 1 vial with lyophilisate (50,000 IU) for solution for injection, 1 ampoule with preserved solvent (10 ml), 1 reconstitution and withdrawal device, 1 disposable syringe (10 ml), 1 needle 21G2
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
METHOD AND ROUTE(S) OF ADMINISTRATION
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Read the package leaflet before use.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 3AY, Ir- Renju Unit
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Keep out of the reach and sight of children
EU/ 1/ 97/ 031/ 045 - 046
OTHER SPECIAL WARNING(S), IF NECESSARY
Data ta ’ l- ewwel awtorizzazzjoni:
EXPIRY DATE
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
EXP The reconstituted solution is stable for 1 month if stored at 2°C – 8°C (in a refrigerator)
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
183 9.
183 ANNESS II
Store in a refrigerator Keep the container in the outer carton, in order to protect from light.
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
11.
184 A.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Roche Diagnostics GmbH Nonnenwald 2 D- 82377 Penzberg Il- Ġermanja
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim Il- Ġermanja
MARKETING AUTHORISATION NUMBER(S)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
EU/ 1/ 97/ 031/ 019
185 ANNESS III
13.
186 A.
BATCH NUMBER
PAKKETT TA 'BARRA
Lot
1.
GENERAL CLASSIFICATION FOR SUPPLY
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
Medicinal product subject to medical prescription
Kunjett fih 50, 000 IU epoetin beta.
INSTRUCTIONS ON USE
LISTA TA ’ SUSTANZI MHUX ATTIVI
(on the cover inside) Handling steps See package insert
Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, u L - Phenylalanine.
184 Labelling of the stand NeoRecormon Multidose 50,000 IU 5000 IU/ ml Store at +2°C to +8°C Always follow aseptic techniques.
Ampulla fiha solvent (benzyl alcohol u benzalkonium chloride f’ ilma għall- injezzjonijiet).
Use disposable sterile syringes and needles for each dose 5000 IU/ ml 500 IU 1000 IU 1500 IU 2000 IU 2500 IU 3000 IU 3500 IU 4000 IU 4500 IU 5000 IU 0.1 ml
Il- prodott mediċinali fih phenylalanine u sodju u s- solvent fih benzyl alcohol, ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
0.2 ml
4.
0.3 ml
5.
0.4 ml
6.
0.5 ml
7.
0.6 ml 0.7 ml 0.8 ml 0.9 ml 1.0 ml
DATA TA ’ META JISKADI
INFORMATION IN BRAILLE
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
185 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Aħżen fi friġġ Żomm il- kontenitur fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl
LABELS/ VIAL
10.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
NeoRecormon Multidose 50,000 IU Lyophilisate for injection (5000 IU/ ml) IV/ SC use
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
METHOD OF ADMINISTRATION
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Read the package leaflet before use.
EU/ 1/ 97/ 031/ 019
EXP
Lott
Reconst.
14.
EXP
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
⏐ ⏐ ⏐ ⏐ ⏐ ⏐ ⏐ ⏐ ⏐
Prodott mediċinali jingħata bir- riċetta tat- tabib
⏐ ⏐
15.
Once opened, the reconstituted solution may be stored for maximum of one month at 2°C - 8°C.
(fuq il- qoxra ġewwa) Gwida għall- immaniġġjar Ara l- fuljett ta ’ tagħrif
4.
0. 2 ml
BATCH NUMBER
0. 3 ml
Lot
0. 4 ml
5.
0. 5 ml
5000 IU/1 ml
0. 6 ml
OTHER
INFORMAZZJONI BIL- BRAILLE
186 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
190 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABELS/AMPOULE
TIKKETTI/ KUNJETT
10 ml solvent for NeoRecormon Multidose 50,000 IU (water for injection, benzyl alcohol, benzalkonium chloride)
NeoRecormon Multidose 50, 000 IU Lajofiliżat għall- injezzjoni (5000 IU/ ml) Użu IV/ SC
4.
Rikost.
BATCH NUMBER
⏐ ⏐ ⏐
Lot
⏐
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
⏐ ⏐ ⏐ ⏐ ⏐ ⏐
6.
⏐
187 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Wara li jinfetaħ, is- soluzzjoni rikostitwita tista ’ tinħażen għal massimu ta ’ xahar f’ 2°C - 8°C.
OUTER CARTON
NUMRU TAL- LOTT
NAME OF THE MEDICINAL PRODUCT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
NeoRecormon Multidose 100,000 IU Lyophilisate and solvent for solution for injection (20,000 IU/ml) Epoetin beta
5000 IU/ 1 ml
STATEMENT OF ACTIVE SUBSTANCE(S)
OĦRAJN
1 vial contains 100,000 IU epoetin beta.
191 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LIST OF EXCIPIENTS
TIKKETTI/ AMPULLA
1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections).
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
Medicinal product contains phenylalanine and sodium and solvent contains benzyl alcohol, see leaflet for further information.
10 ml solvent għal NeoRecormon Multidose 50, 000 IU (ilma għall- injezzjoni, benzyl alcohol, benzalkonium chloride)
PHARMACEUTICAL FORM AND CONTENTS
METODU TA ’ KIF GĦANDU JINGĦATA