qanastek/EMEA-V3 huggingface dataset:
• Patients with moderate and severe renal and hepatic impairment.
• Pazjenti b’ indeboliment moderat u sever tas- sistemi tal- kliewi u tal- fwied.
4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition.
Għandha tingħata attenzjoni speċjali lin- nisa b’ sinjali u sintomi ta ’ kundizzjonijiet allerġiċi attivi jew passat magħruf ta ’ predispożizzjoni allerġika.
Treatment with Cetrotide is not advised in women with severe allergic conditions.
It- trattament b’ Cetrotide mhux rakkomandat li jintuża f’ nisa b’ kundizzjonijiet allerġiċi severi.
During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur.
Matul jew wara l- istimulazzjoni ta ’ l- ovarji, jista ’ jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l - ovarji.
This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins.
Dan l- avveniment għandu jkun kunsidrat bħala riskju intrinsiku tal- proċedura ta ’ stimulazzjoni bil- gonadotropini.
An ovarian hyperstimulation syndrome should be treated symptomatically, e. g. with rest, intravenous electrolytes/ colloids and heparin therapy.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji għandu jkun trattat b’ mod sintomatiku; eż. bil - mistrieħ, billi jingħataw l- elektroliti/ kollojdi ġol- vini u terapija bl- eparina.
Luteal phase support should be given according to the reproductive medical centre´s practice.
L- appoġġ għall- fażi luteali għandu jingħata skond il- prattika taċ- ċentru mediku tar- riproduttività.
There is limited experience up to now with the administration of Cetrotide 0.25 mg during a repeated ovarian stimulation procedure.
S’ issa l- esperjenza fir- rigward ta ’ l- għoti ta ’ Cetrotide 0. 25 mg matul il- proċedura ta ’ stimulazzjoni ta ’ l- ovarji ripetuta hi limitata.
Therefore Cetrotide 0.25 mg should be used in repeated cycles only after a careful risk/ benefit evaluation.
Għalhekk Cetrotide 0. 25 mg għandu jintuża biss f’ ċiklu ripetut wara evalwazzjoni akkurata ta ’ riskji/ benefiċċji.
In vitro investigations have shown that interactions are unlikely with medications that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way.
Investigazzjonijiet in vitro wrew li mhux probabbli li jkun hemm interazzjonijiet ma ’ mediċini li huma metabolizzati biċ- ċitokrom P450 jew glukurinizzati jew konjugati b’ xi mod ieħor.
However, interactions with commonly used medicinal products, including products that may induce histamine release in susceptible individuals, may occur.
Madankollu, il - possibilità ta ’ interazzjonijiet ma ’ prodotti mediċinali wżati ta ’ spiss, incluż prodotti li jistgħu jistimulaw it- terħir ta’ l- istamina, fin- nisa li huma suspetabili, jista jseħħ.
Cetrotide 0.25 mg is not intended to be used during pregnancy and lactation (see section 4.3).
(ara sezzjoni 4. 3)
Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy.
Studji fuq annimali indikaw li cetrorelix jeżerċita influwenza fuq il- fertilità, kapaċità riproduttiva u tqala skond kemm tkun qawwija d- doża li tingħata.
No teratogenic effects occurred when the drug was administered during the sensitive phase of gestation.
L- ebda effett teratoġeniku ma seħħ meta d- droga ttieħdet matul il- fażi sensittiva tal- ġestazzjoni.
3 4.7 Effects on ability to drive and use machines
3 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Due to its pharmacological profile cetrorelix is unlikely to impair the patient’ s ability to drive or to operate machinery.
Minħabba l- profil farmakoloġiku tiegħu cetrorelix mhux suppost li jkollu effett fuq il- ħila tal- pazjent biex isuq jew iħaddem xi makkinarju.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Għal kull grupp, l’ effetti mhux mixtieqa huma irrapresentati mill- iktar serji sa ’ l- inqas serji.
Immune system disorders
Disturbi fis- sistema immuni
Rare (≥ 1/ 10,000, < 1/ 1,000)
Rari (≥1/ 10, 000, < 1/ 1, 000)
Rare cases of hypersensitivity reactions including pseudo- allergic/ anaphylactoid reactions have also been reported
Kazijiet rari ta reazzjonijiet li jindikaw sensittività eċċessiva, incluz reazzjonijiet psewdo - allerġiċi / anafillatttiċi, kienu rrapurtati.
Nervous system disorders Gastrointestinal disorders Reproductive system and breast disorders
Disturbi fis- sistema riproduttiva
Uncommon (≥ 1/ 1,000, < 1/ 100) Uncommon (≥ 1/ 1,000, < 1/ 100) Common (≥ 1/ 100, < 1/ 10)
Komuni (≥1/ 100 sa < 1/ 10)
Headache Nausea Mild to moderate ovarian hyperstimulation syndrome (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see section 4.4).
Kazijiet tas- sindromu ta ’
Uncommon (≥ 1/ 1,000, < 1/ 100)
Mhux komuni (≥1/ 1, 000 sa < 1/ 100)
Severe ovarian hyperstimulation syndrome (WHO grade III)
Kazijiet severi tas - sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (WHO gradi III).
General disorders and administration site conditions
Disturbi ġenerali u
Common (≥ 1/ 100, < 1/ 10)
Komuni (≥1/ 100 sa < 1/ 10)
Local reactions at the injection site (e. g. erythema, swelling and pruritus) have been reported.
reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (eż. eritema, infieħ u ħakk tal- ġilda).
Usually they were transient in nature and mild intensity.
Ġeneralment dawn kienu ta ’ natura qasira u ta ’ intensità moderata..
The frequency as reported in clinical trials was 9.4% following multiple injections of 0.25 mg cetrorelix.
Il - frekwenza li kienet irrapurtata f’ eżamijiet kliniċi kienet ta ’ 9. 4% wara injezzjonijiet multipli ta ’ 0. 25 mg cetrorelix.
Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Teħid ta ’ doża eċċessiva mill- bnedmin tista ’ twassal biex jittawwal il- perjodu ta ’ żmien ta ’ l- azzjoni iżda mhux suppost li jkun hemm effetti tossiċi akuti.
In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
Fi studji dwar effett tossiku akut fuq annimali gerriema kienu osservati sintomi tossiċi mhux speċifiċi wara l- amministrazzjoni ġol- peritonew ta ’ dożi ta ’ cetrorelix ta ’ 200 darba aktar mid- doża farmakoloġikalment effettiva wara l- amministrazzjoni għal taħt il- ġilda.
Pharmacotherapeutic group:
Grupp farmakoterapewtiku:
LHRH-Antagonist, ATC code:
LHRH- Antagonista, kodiċi ATC:
Cetrorelix is a luteinising hormone releasing hormone (LHRH) antagonist.
Cetrorelix hu antagonist ta ’ l- ormon li jistimula l- produzzjoni ta ’ l- ormon ta ’ lutejinazzazzjoni (LHRH).
LHRH binds to membrane receptors on pituitary cells.
L- LHRH jingħaqqad mar- riċetturi fil- membrana ta ’ ċelloli pitwitarji.
Cetrorelix competes with the binding of endogenous LHRH to these receptors.
Cetrorelix jikkompeti ma ’ l- għaqda ta ’ LHRH endoġeni għal dawn ir- riċetturi.
Due to this mode of action, cetrorelix controls the secretion of gonadotropins (LH and FSH).
Minħabba dan il- mod t’ azzjoni, cetrorelix jikkontrolla t- tnixxija tal- gonadotropini (LH u FSH).
4 Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland.
Cetrorelix tinibixxi t- tnixxija ta ’ LH u FSH mill- glandola pitwitarja skond id- doza li tingħata.
The onset of suppression is virtually immediate and is maintained by continuous treatment, without initial stimulatory effect.
Il- bidu tas- suppressjoni jsir mill- ewwel u jinżamm b’ trattament kontinwu, mingħajr effett stimulatorju fil - bidu.
In females, cetrorelix delays the LH surge and consequently ovulation.
Fin- nisa, cetrorelix jtawwal il- livell għoli ta ’ LH u għalhekk ta ’ l- ovulazzjoni.
In women undergoing ovarian stimulation the duration of action of cetrorelix is dose dependent.
F’ nisa li jkunu għaddejjin minn stimulazzjoni ta ’ l- ovarji, il- perjodu ta ’ azzjoni ta ’ cetrorelix hu dipendenti mid- doża.
Following a single dose of 3 mg of cetrorelix a duration of action of at least 4 days has been evaluated.
Wara doża waħda ta ’ 3mg cetrorelix, kien hemm perjodu ta ’ azzjoni ta ’ mill- inqas erbat ijiem.
On day 4 the suppression was approximately 70%.
Fir- 4 ġurnata, is- supressjoni kienet bejn wieħed u ieħor ta ’ 70%.
At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
B’ doża ta ’ 0. 25 mg kull injezzjoni, injezzjonijiet ripetuti kull 24 siegħa jżommu l- effett ta ’ cetrorelix.
In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Fl- annimali kif ukoll fil- bnedmin, l- effetti ormonali antagonistiċi ta ’ cetrorelix kienu kompletament riversibbli wara t- tmiem tal- kura.
The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Il- mod assolut ta ’ kif jinfirex fil- ġisem cetrorelix wara teħid għal taħt il- ġilda hi ta ’ madwar 85%.
The total plasma clearance and the renal clearance are 1.2 ml x min-1 x kg-1 and 0.1 ml x min-1 x kg-1, respectively.
It- tneħħija għal- kollox mill- plasma u t- tneħħija mill- kliewi hi ta ’ 1. 2 ml x min- 1 x kg- 1 u0. 1 ml x min - 1 x kg- 1, rispettivament.
The volume of distribution (Vd, area) is 1.1 l x kg-1.
Il- volum fejn jinfirex (Vd, area) hu ta ’ 1. 1 l x kg- 1.
The mean terminal half-lives following intravenous and subcutaneous administration are about 12 h and 30 h, respectively, demonstrating the effect of absorption processes at the injection site.
Il- medja tal- ħin fl- aħħar biex l- ammont jinżel bin- nofs wara amministrazzjoni ġol- vini u għal taħt il- ġilda huma ta ’ madwar 12- il siegħa u 30- il siegħa, rispettivament, li juri l- effett tal- proċessi ta ’ assorbiment fis- sit ta ’ l- injezzjoni.
The subcutaneous administration of single doses (0.25 mg to 3 mg cetrorelix) and also daily dosing over 14 days show linear kinetics.
L- amministrazzjoni għal taħt il- ġilda ta ’ doża waħda (0. 25 mg sa 3 mg cetrorelix) u ta ’ doża kuljum għal 14- il ġurnata turi kinetiċi linejari.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni mhux kliniku juri li ma hemx periklu għal- bnedmin ibbasat fuq studji convenzjonali tas- sigurta farmakoloġika, tosiċita minħabba dosa rrepetuta, ġenotossiċita ’, potenzjal li jikawza il - kankru, tossiku għal riproduzzjoni.
No target organ toxicity could be observed from acute, subacute and chronic toxicity studies in rats and dogs following subcutaneous administration of cetrorelix.
L- ebda effett tossiku fl- organi li fuqhom jaħdem cetrorelix ma kien osservat minn studji dwar effett tossiku akut, bejn akut u kroniku, u kroniku f ’ ġrieden u klieb wara amministrazzjoni għal taħt il - ġilda ta ’ cetrorelix.
No signs of drug-related local irritation or incompatibility were noted in dogs after intravenous, intra-arterial and paravenous injection when cetrorelix was administered in doses clearly above the intended clinical use in man.
L- ebda sinjali ta ’ irritazzjoni lokali jew inkompatibilità marbuta mad- droga ma kienu osservati fil- klieb wara injezzjoni ġol- vini, ġol- arterji jew paraveni meta cetrorelix kien ingħata f’ doża li b’ mod ċar kienet aktar minn dik intenzjonata għall- użu kliniku fuq il- persuni.
Cetrorelix showed no mutagenic or clastogenic potential in gene and chromosome mutation assays.
Cetrorelix ma wera l- ebda potenzjal mutaġeniku jew klastoġeniku f’ analiżi tal- ġeni u ta ’ mutazzjoni ta ’ kromożomi.
Powder:
Trap:
Water for Injections
Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Dan il prodott medicinali ma ’ jistgħax jitħallat ma ’ prodotti medicinali ohra, ħlief dawk imsemmija fis- sezzjoni 6. 6.
5 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
The solution should be used immediately after preparation.
It- taħlita għandha tintuża immedjatament wara l- preparazzjoni.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali ghall- ħażna
Do not store above 25 °C.
Taħżinx f’ temperatura ‘ l fuq minn 25 °C.
Keep the vial(s) in the outer carton in order to protect from light.
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
Packs with 1 or 7 Type I glass vials each containing 55.7 mg powder for solution for injection sealed with a rubber stopper.
Pakketti b’ 1 jew 7 fjali tal- ħġieġ ta ’ Tip I b’ kull wieħed fih 55. 7mg trab biex jinħall f’ likwidu għall - injezzjoni u ssiġġillat b’ tapp tal- lasktu.
Additionally for each vial the packs contain:
Barra minn dan, għal kull fjala, il- pakketti fihom:
1 pre-filled syringe (Type I glass cartridge closed with rubber stoppers) with 1 ml solvent for parenteral use 1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
Siringa waħda mimlija lesta (Cartridge tal- ħġieġ tat- Tip I ssiġillati b’ tappijiet tal- lasktu) b’ 1 ml solvent għall- użu parenterali Labra waħda għall- injezzjoni (20 gauge) Labra waħda għall- injezzjonijiet ipodermiċi (27 gauge) Żewġ ċraret bl- alkoħol
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- prodott jistghu jigu mholljien fis- suq.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet għall- użu u maniġġar u għar- rimi
Cetrotide 0.25 mg should only be reconstituted with the solvent provided, using a gentle, swirling motion.
Cetrotide 0. 25 mg għandu jitħallat biss bis- solvent provdut, u mħawwad bil- mod b’ mod ċirkulari.
Vigorous shaking with bubble formation should be avoided.
Taħlit bis- saħħa li jwassal għall- ħolqien ta ’ bżieżaq għandu jiġi evitat.
Do not use if the solution contains particles or if the solution is not clear.
Is- soluzzjoni mħallta m’ għandix tigi wżata jekk fiha xi frak jew mhix ċara.
Withdraw the entire contents of the vial.
Neħħi l- kontenut kollhu tal- fjala.
This ensures a delivery to the patient of a dose of at least 0.23 mg cetrorelix.
Dan jassigura li l- pazjent jingħata doża ta ’ mill- anqas 0. 23 mg cetrorelix.
The solution should be used immediately after reconstitution.
It- taħlita għandha tintuża mill- ewwel hekk kif tiġi mħallta.
The injection site should be varied daily.
Il- parti tal- ġisem fejn tingħata l- injezzjoni għandha tinbidel kuljum.
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall Londra E14 9TP Renju Unit
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L- AWTORIZZAZZJONI
13 April 1999 Date of last renewal:
13 ta ’ April 1999 Data ta ’ l- ahhar irrinnovament:
15 April 2004
15 ta ’ April 2004
Cetrotide 3 mg powder and solvent for solution for injection
Cetrotide 3 mg trab u solvent għal soluzzjoni għall- injezzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITTATIVA U KWANTITTATIVA
3.12 - 3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix.
3. 12 – 3. 24 mg cetrorelix acetate ekwivalenti għall- 3 mg cetrorelix.
After reconstitution with the solvent provided, the concentration of cetrorelix is 1 mg/ ml.
Wara t- taħlita mas- solvent provdut, il- konċentrazzjoni ta ’ cetrorelix hi ta ’ 1 mg/ ml.
Excipients:
Għal sustanzi mhux attivi:
164.40 mg mannitol.
164. 40 mg mannitol
For a full list of excipients, see section 6.1.
Għal lista kompluta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għall- injezzjoni.
In clinical trials Cetrotide 3 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.
F’ eżamijiet kliniċi Cetrotide 3 mg intuża mal- gonadotropin uman tal- menopawża (HMG), iżda l - esperjenza limitata mal- FSH rikombinanti tissuġġerixxi effiċjenza simili.
Cetrotide 3 mg should only be prescribed by a specialist experienced in this field.
Cetrotide 3 mg għandu jiġi preskritt biss minn speċjalista espert f’ dan il- qasam.
Cetrotide 3 mg is for subcutaneous injection into the lower abdominal wall.
Cetrotide 3 mg jingħata permezz ta ’ injezzjoni għal taħt il- ġilda fil- parti t’ isfel tal- membrana ta - addome.
The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where treatment of possible pseudo-allergic reactions is immediately available.
L- ewwel amministrazzjoni ta ’ Cetrotide għandha sseħħ taħt is- superviżjoni ta ’ tabib u taħt kundizzjonijiet fejn il- kura għal reazzjonijiet psewdo- allerġiċi li jistgħu jinqalgħu jkunu disponibbli immedjatament.
The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
Dawn l- injezzjonijiet li jingħataw wara jistgħu jittieħdu mill- pazjent stess sakemm dan jingħata għarfien tas- sinjali u sintomi li jistgħu jindikaw sensittività eċċessiva, bil- konsegwenzi ta ’ din it- tip ta ’ reazzjoni u l- bżonn ta ’ intervent mediku immedjat.
The contents of 1 vial (3 mg cetrorelix) are to be administered on day 7 of ovarian stimulation (approximately 132 to 144 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins.
Il- kontenut ta ’ fjala (3 mg cetrorelix) għandu jittieħed fis- 7 ġurnata ta ’ stimulazzjoni ta ’ l- ovarji (madwar 132 sa 144 siegħa wara l- bidu ta ’ stimulazzjoni ta ’ l- ovarji) b’ gonadotropini urinarji jew rikombinanti.
Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/ pseudo-allergic reaction reaction to the injection.
Wara li jittieħed għall- ewwel darba, hu suġġerit li l- pazjent jinżamm taħt osservazzjoni medika għal 30 minuta biex ikun assigurat li m’ hemm l- ebda reazzjoni allerġika/ psewdo- allerġika għall- injezzjoni.
Facilities for the treatment of such reactions should be immediately available.
Il- faċilitajiet għat- trattament ta ’ dawn ir- reazzjonijiet għandhom ikunu disponibbli immedjatament.
8 If the follicle growth does not allow ovulation induction on the fifth day after injection of Cetrotide 3 mg, additionally 0.25 mg cetrorelix (Cetrotide 0.25 mg) should be administered once daily beginning 96 hours after the injection of Cetrotide 3 mg until the day of ovulation induction.
8 Jekk it- tkabbir tal- follikuli ma jippermettix induzzjoni ta ’ l- ovulazzjoni fil- ħames ġurnata wara l - injezzjoni ta ’ Cetrotide 3 mg, 0. 25 mg cetrorelix (Cetrotide 0. 25 mg) għandu jingħata wkoll darba kuljum 96 siegħa wara l- injezzjoni ta ’ Cetrotide 3 mg sal- ġurnata ta ’ l- induzzjoni ta ’ l- ovulazzjoni.
For instructions on preparation, see section 6.6.
Għall- istruzzjonijiet dwar l- użu u l- immaniġġar, ara sezzjoni 6. 6.
• Hypersensitivity to the active substance or any structural analogue of GnRH, extrinsic peptide hormones or to any of the excipients.
• Sensittività eċċessiva għal cetrorelix acetate jew analogi strutturali tal- GnRH, ormoni estrinsiċi tal- peptide jew għal mannitol.
• Pregnancy, and lactation.
• Tqala u waqt li qed tredda ’.
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition.
Għandha tingħata attenzjoni speċjali ma ’ nisa b’ sinjali u sintomi ta ’ kundizzjonijiet allerġiċi attivi jew passat magħruf ta ’ predispożizzjoni allerġika.
Treatment with Cetrotide is not advised in women with severe allergic conditions.
It- trattament b’ Cetrotide mhux rakkomandat li jintuża minn nisa b’ kundizzjonijiet allerġiċi severi.
An ovarian hyperstimulation syndrome should be treated symptomatically, e. g. with rest, intravenous electrolytes/ colloids and heparin therapy.
Is- sindromu ta’ stimulazzjoni eċċessiva ta ’ l- ovarji għandu jkun trattat b’ mod sintomatiku; eż. bil - mistrieħ, billi jingħataw elektroliti/ kollojdi fil- vini u terapija bl- eparina.
Luteal phase support should be given according to the reproductive medical centre´s practice.
L- appoġġ għal fażi luteali għandu jingħata skond il- prattika taċ- ċentru mediku tar- riproduttivita.
There is limited experience up to now with the administration of Cetrotide 3 mg during a repeated ovarian stimulation procedure.
S’ issa l- esperjenza hi limitata fir- rigward ta ’ l- għoti ta ’ Cetrotide 3 mg matul il- proċedura ta ’ stimulazzjoni ta ’ l- ovarji ripetuta.
Therefore Cetrotide 3 mg should be used in repeated cycles only after a careful risk/ benefit evaluation.
Għalhekk Cetrotide 3 mg għandu jintuża biss f’ ċiklu ripetut wara evalwazzjoni akkurata ta ’ riskji/ benefiċċji.
However, interactions with commonly used medicinal products, including products that may induce histamine release in susceptible individuals, may occur.
Madankollu, il - possibilità ta ’ interazzjonijiet ma ’ prodotti mediċinali wżati ta ’ spiss, incluż prodotti li jistgħu jistimulaw it- terħir ta ’ l- istamina, fin- nisa li huma suxxettibbli, jista jseħħ.
Cetrotide 3 mg is not intended to be used during pregnancy and lactation (see section 4.3).
Cetrotide 3 mg mhux intenzjonat għall- użu waqt it- tqala u waqt li qed trdda ’. (ara sezzjoni 4. 3)
4.7 Effects on ability to drive and use machines
9 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Due to its pharmacological profile cetrorelix is unlikely to impair the patient’ s ability to drive or to operate machinery.
4. 8 Effetti mhux mixtieqa Għal kull grupp, l’ effetti mhux mixtieqa huma irrapresentati f’ ordni ta ’ l- izjed sa ’ l- inqas serjieta.
9 4.8 Undesirable effects
Disturbi fis- sistema immuni
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Kazijiet rari ta reazzjonijiet li jindikaw sensittività eċċessiva, incluz reazzjonijiet psewdo - allerġiċi / anafillatttiċi, kienu rrapurtati.
Immune system disorders
Disturbi fis- sistema nervuża
Rare (≥ 1/ 10,000, < 1/ 1,000)
Mhux komuni (≥1/ 1, 000 sa < 1/ 100)
Rare cases of hypersensitivity reactions including pseudo- allergic/ anaphylactoid reactions have also been reported
Mhux komuni (≥1/ 1, 000 sa < 1/ 100)
The frequency as reported in clinical trials was 8.0%.
Il - frekwenza li kienet irrapurtata f’ eżamijiet kliniċi kienet ta ’ 8. 0%.
In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
Fi studji dwar effett tossiku akut fuq annimali gerriema kienu osservati sintomi tossiċi mhux speċifiċi wara l- amministrazzjoni ġol- peritonew ta ’ dożi ta ’ cetorelix ta ’ 200 darba aktar mid- doża farmakoloġikalment effettiva wara l- amministrazzjoni għal taħt il- ġilda.
Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland.
Cetrorelix tinibixxi t- tnixxija ta ’ LH u FSH mill- glandola pitwitarja skond id- doża li tingħata.
Following a single dose of 3 mg of cetrorelix a duration of action of at least 4 days has been evaluated.
Wara doża waħda ta ’ 3mg cetrorelix, kien hemm perjodu ta ’ azzjoni ta ’ mill - inqas erbat ijiem.
At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
B’ doża ta ’ 0. 25mg kull injezzjoni, injezzjonijiet ripetuti kull 24 siegħa jżommu l- effett ta ’ cetrorelix.
10 In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Fl- annimali kif ukoll fil- bnedmin, l- effetti ormonali antagonistiċi ta ’ cetrorelix kienu kompletament riversibbli wara t- tmiem tal- kura.
The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Il- mod assolut ta ’ kif jinfirex fil- ġisem ta ’ cetrorelix wara teħid għal taħt il- ġilda hu ta ’ madwar 85%.
The total plasma clearance and the renal clearance are 1.2 ml x min-1 x kg-1 and 0.1 ml x min-1 x kg-1, respectively.
It- tneħħija għall- kollox mill- plasma u t- tneħħija mill- kliewi huma ta ’ 1. 2 ml x min- 1 x kg- 1 u0. 1 ml x min- 1 x kg- 1, rispettivament.
The mean terminal half-lives following intravenous and subcutaneous administration are about 12 h and 30 h, respectively, demonstrating the effect of absorption processes at the injection site.
Il- medja tal- ħin fl- aħħar biex l- ammont jinżel bin- nofs wara amministrazzjoni ġol- vini u għal taħt il- ġilda huma ta ’ madwar 12 - il siegħa u 30- il siegħa, rispettivament, li juri l- effett tal- proċessi ta ’ assorbiment fis- sit ta ’ l- injezzjoni.
Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni mhux kliniku juri li ma hemx periklu għal- bnedmin ibbasat fuq studji convenzjonali tas- sigurta farmakoloġika, tosiċita minħabba dosa rrepetuta, ġenotossiċita ’, potenzjal li jikawza il - kankru, tossiku għal riproduzzjoni
No target organ toxicity could be observed from acute, subacute and chronic toxicity studies in rats and dogs following subcutaneous administration of cetrorelix.
L- ebda effett tossiku fl- organi li fuqhom jaħdem cetrorelix ma kien osservat minn studji dwar effett tossiku akut, bejn akut u kroniku, u kroniku fuq ġrieden u klieb wara amministrazzjoni għal taħt il - ġilda ta ’ cetrorelix.
6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi Trap:
Water for injections
Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott medicinali ma ’ jistgħax jitħallat ma ’ prodotti medicinali ohra, ħlief dawk imsemmija fis- sezzjoni 6. 6.
2 years.
Sentejn
Keep the vial in the outer carton in order to protect from light.
Żomm il- kontenitur fil- kartuna ta ’ barra, sabiex tipproteġi mid- dawl.
11 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih.
Pack with 1 Type I glass vial containing 167.7 mg powder for solution for injection sealed with a rubber stopper.
Pakketti b’ fjala waħda tal- ħġieġ ta ’ Tip I b’ kull wieħed fih 167. 7mg trab biex jinħall f’ likwidu għall - injezzjoni u ssiġillat b’ tapp tal- lasktu.
Additionally the pack contains:
Barra minn dan, għal kull fjala, il- pakketti fihom:
1 pre-filled syringe (Type I glass cartridge closed with rubber stoppers) with 3 ml solvent for parenteral use 1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
Siringa waħda mimlija lesta (Cartridge tal- ħġieġ tat- Tip I ssiġillata b’ tappijiet tal- lasktu) b’ 3 ml solvent għall- użu parenterali Labra waħda għall- injezzjoni (20 gauge) Labra waħda għall- injezzjonijiet ipodermiċi (27 gauge) Żewġ ċraret bl- alkoħol
6.6 Special precautions for disposal and other handling
6. 6 Tagħrif għall- użu u maniġġar u għar- rimi
Cetrotide 3 mg should only be reconstituted with the solvent provided, using a gentle, swirling motion.
Cetrotide 3 mg għandu jitħallat biss bis- solvent provdut, u jiġi mħawwad bil- mod b’ mod ċirkulari.
Do not use if the solution contains particles or if the solution is not clear.
Is- soluzzjoni mħallta m’ għandix tiġi wżata jekk fiha xi frak jew mhix ċara.
This ensures a delivery to the patient of a dose of at least 2.82 mg cetrorelix.
Dan jassigura li l- pazjent jingħata doża ta ’ mill- anqas 2. 82 mg cetrorelix.
13 April 1999 Date of last renewal:
13 ta ’ April 1999 Data ta ’ l- aħħar irrinnovament:
12 ANNEX II
13 ANNEX II
MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT B.
13 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
14 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabli għall- ħruġ tal- lott
B CONDITIONS OF THE MARKETING AUTHORISATION
B KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Not applicable
Mhux applikabbli
15 A.
15 ANNESS III
BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
KAXXA TA ’ FJALA WAĦDA U SIRINGA WAĦDA MIMLIJA LESTA
1 vial with 55.7 mg powder contains:
Fjala waħda b’ 55. 7 mg trab jinkludi:
0.26 – 0.27 mg cetrorelix acetate equivalent to 0.25 mg cetrorelix.
0. 26 – 0. 27 mg cetrorelix acetate ekwivalenti għal 0. 25 mg cetrorelix.
1 pre-filled syringe with solvent contains:
Siringa waħda mimlija lesta bis- solvent tinkludi:
1 ml water for injections.
1 ml ilma għall- injezzjonijiet.
1 pre-filled syringe with solvent for parenteral use.
Fjala waħda bit- trab għal soluzzjoni għall- injezzjoni 1 siringa mimlija lesta bis- solvent għall- użu parenterali.
Additionally, the pack contains:
Barra minn dan, għal kull fjala, il- pakketti fihom:
1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
Labra waħda għall- injezzjoni (20 gauge) Labra waħda għall- injezzjonijiet ipodermiċi (27 gauge) Żewġ ċraret bl- alkoħol
Read the package leaflet before use
Aqra ’ il- fuljett ta ’ tagħrif qabel l- użu.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
Do not store above 25 °C.
Taħżinx f’ temperatura ‘ l fuq minn 25°C.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
Solvent Batch:
Lott tas- Solvent:
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib..
INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BREJL
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 7 VIAL AND 7 PRE-FILLED SYRINGE
KAXXA TA ’ 7 FJALI U 7 SIRINGI MIMLIJIN LESTI
1 vial with 55.7 mg powder contains:
Fjala wahda b’ 55. 7 mg trab jinkludi:
7 pre-filled syringes with solvent for parenteral use.
7 fjali ta 'trab għal soluzzjoni għall- injezzjoni 7 siringi mimlijin lesti bis- solvent għall- użu parenterali.
Additionally, the pack contains:
Barra minn dan, il- pakkett fih:
7 injection needle (20 gauge) 7 hypodermic injection needle (27 gauge) 14 alcohol swabs.
7 Labar għall- injezzjoni (20 gauge) 7 Labar għall- injezzjonijiet ipodermiċi (27 gauge) 14 ċraret bl- alkoħol
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD - DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL - KUMMERĊ
SolventBatch:
Lott tas- Solvent:
cetrotide 0.25mg
cetrotide 0. 25mg
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CETROTIDE 0.25 MG VIAL LABEL
TIKKETTA TAL- FJALA CETROTIDE 0. 25 MG
Cetrotide 0.25 mg powder for solution for injection cetrorelix Subcutaneous use.
Cetrotide 0. 25 mg trab għal soluzzjoni għall- injezzjoni Cetrorelix Użu għal taħt il- ġilda
Batch
Lott:
55.7 mg/ vial
55. 7 mg/ fjala
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOLVENT PRE-FILLED SYRINGE LABEL
TIKKETTA TAS- SIRINGA MIMLIJA LESTA BIS- SOLVENT
Water for Injections Solvent for use with Cetrotide 0.25 mg
Ilma għall- injezzjonijiet Solvent għall- użu ma ’ Cetrotide 0. 25 mg
METHOD OF ADMINISTRATION
METODU TA’ KIF GĦANDU JINGĦATA
1 ml/ pre-filled syringe
1 ml/ siringa mimlija lesta
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
KAXXA TA ’ FJALA WAĦDA U SIRINGA MIMLIJA LESTA
1 vial with 167.7 mg powder contains:
Fjala waħda b’ 167. 7 mg trab jinkludi:
3.12 – 3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix.
3. 12 – 3. 24 mg cetrorelix acetate ekwivalenti għal 3 mg cetrorelix.
3 ml water for injections.
3 ml ilma għall- injezzjonijiet.
1 pre-filled syringe with solvent for parenteral use.
Fjala waħda bit- trab għal soluzzjoni għall- injezzjoni Siringa waħda mimlija lesta bis- solvent għall- użu parenterali.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD_ DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Sid l- awtorizzazzjoni għall- kummerċ:
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall LondraE14 9TP Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Batch Solvent Batch
Lott tas- Solvent:
INSTRUCTIONS ON USE
STUZZJONIJIET DWAR L- UŻU
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CETROTIDE 3 MG VIAL LABEL
TIKKETTA TAL- FJALA CETROTIDE 3 MG
Cetrotide 3 mg powder for solution for injection cetrorelix Subcutaneous use.
Cetrorelix
167.7 mg/ vial
167. 7 mg/ fjala
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Water for Injections Solvent for use with Cetrotide 3 mg
Ilma għall- injezzjonijiet Solvent għall- użu ma ’ Cetrotide 3 mg
3 ml/ pre-filled syringe
3 ml/ siringa mimlija lesta
Cetrotide 0.25mg powder and solvent for solution for injection
Cetrotide 0. 25mg trab u solvent għal soluzzjoni għall- injezzjoni
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il- fuljett kollu qabel ma tibda tuża din il- mediċina.
It may harm them, even
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
What Cetrotide is and what it is used for 2.
X’ inhu Cetrotide u għalxiex jintuża 2.
Before you use Cetrotide 3.
Qabel ma tuża Cetrotide 3.
How to use Cetrotide 4.
Kif għandek tuża Cetrotide 4.
Possible side effects 5 How to store Cetrotide 6.
Kif taħżen Cetrotide 6.
WHAT CETROTIDE IS AND WHAT IT IS USED FOR
X’ INHU CETROTIDE U GĦALXIEX JINTUŻA
Cetrotide 0.25 mg inhibits the effects of a natural hormone, called luteinising hormone releasing hormone (LHRH).
Cetrotide 0. 25 mg iwaqqaf l- effetti ta ’ ormon naturali, magħruf bħala ormon li jistimula l- produzzjoni ta ’ l- ormon ta ’ lutejinazzjoni (LHRH).
LHRH regulates the secretion of another hormone, called luteinising hormone (LH), which induces ovulation during the menstrual cycle.
L- LHRH jirregola t- tnixxija ta ’ ormon ieħor, magħruf bħala ormon ta ’ lutejinazzjoni (LH), li jinduċi l- ovulazzjoni matul iċ- ċiklu mestrwali.
Cetrotide 0.25 mg inhibits premature ovulation which is undesirable during hormone treatment for ovarian stimulation as only mature egg cells are suitable for fertilisation.
Cetrotide 0. 25 mg iwaqqaf l- ovulazzjoni prematura li mhiex mixtieqa matul it- trattament ta ’ stimulazzjoni ta ’ l- ovarji bl - ormoni minħabba li ċelloli tal- bajd matur biss huma tajbin għall- fertilizzazzjoni.
Therapeutic indications
Indikazzjonijiet terapewtiċi
Cetrotide 0.25 mg is used to prevent premature ovulation during a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Cetrotide 0. 25 mg jintuża fil- prevenzjoni ta ’ ovulazzjoni prematura f’ pazjenti li għaddejjin minn stimulazzjoni kontrollata ta ’ l- ovarji, segwita minn ġbir ta ’ l- ooċit u minn teknika ta ’ riproduzzjoni assistita.
In clinical trials Cetrotide 0.25 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle stimulating hormone (FSH) suggested similar efficacy.
F’ eżamijiet kliniċi Cetrotide 0. 25 mg ġiet użata mal- gonadotropina umana tal- menopawża (HMG), iżda l- esperjenza limitata mal- FSH rikombinanti tissuġġerixxi effiċjenza simili.
HMG and FSH are hormones promoting egg maturation.
HMG u FSH huma ormoni li jippromwovu l- maturazzjoni tal- bajd.
BEFORE YOU USE CETROTIDE
QABEL MA TUŻA CETROTIDE
Do not use Cetrotide
Tużax Cetrotide:
• if you are allergic (hypersensitive) to cetrorelix acetate, exogenous peptide hormones (medicines similar to Cetrotide 0.25 mg) or any of the other ingredients. • if you are pregnant or breast-feeding • if you have already reached your menopause • if you have a moderate or severe kidney or liver disease.
• jekk int allerġiku (sensittività eċċessiva) għal cetrorelix acetate, ormoni esoġeni tal- peptide (mediċini simili għal Cetrotide 0. 25 mg) jew xi ingredienti oħra • jekk int tqila jew qed tredda ’ • jekk diġà wasalt fil- menopawża • jekk għandek mard moderat jew serju fil- kliewi jew fil- fwied.
Take special care with Cetrotide
29 Oqgħod attent ħafna b’ Cetrotide:
Special care should be taken in women with an active allergic condition or a known history of allergy.
Għandha tingħata attenzjoni speċjali f’ każi ta ’ nisa b’ kundizzjoni allerġika attiva jew passat magħruf ta ’ allerġiji.
Since treatment with Cetrotide is not advised in women with severe allergic conditions it is important that you inform your doctor of any allergies.
Minħabba li t- trattament b’ Cetrotide mhux suġġerit li jintuża fuq nisa b’ kundizzjonijiet allerġiċi qawwija hu importanti li tinforma lit- tabib tiegħek b’ xi allerġiji li għandek.
28 During or following hormonal stimulation of the ovaries an ovarian hyperstimulation syndrome can occur.
Matul jew wara l- istimulazzjoni ormonali ta ’ l- ovarji jista ’ jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji.
This event is related to the stimulation procedure with gonadotropins (hormones promoting egg maturation).
Dan l- avveniment hu marbut mal- proċedura ta ’ stimulazzjoni bil- gonadotropini (ormoni li jippromwovu l- maturazzjoni tal- bajd).
For symptoms and suitable measures please refer to the Patient Information Leaflet of the gonadotropin-containing medicine prescribed for you.
Għas- sintomi u miżuri xierqa jekk jogħġbok irreferi għall- Pakkett ta ’ Informazzjoni għall- Pazjent tal- mediċina li fiha l- gonadotropina li ġiet mogħtija lilek b’ riċetta tat- tabib.
Luteal phase support (a measure to support the onset of pregnancy) should be given according to the reproductive medical centre´s practice.
L- appoġġ għall- fażi lutejali (miżura ta ’ appoġġ fil- bidu tat- tqala) għandu jingħata skond il- prattika taċ - ċentru mediku tar- riproduzzjoni.
There is limited experience up to now with the administration of Cetrotide 0.25 mg during a repeated ovarian stimulation procedure.
Hemm esperjenza limitata s’ issa fl- ingħatar ta ’ Cetrotide 0. 25 mg matul proċedura ta ’ stimulazzjoni ta ’ l- ovarji ripetuta.
Therefore you should use Cetrotide 0.25 mg in repeated cycles only after a careful risk/ benefit evaluation by your doctor.
Għalhekk għandek tuża Cetrotide 0. 25 mg f’ ċikli ripetuti biss wara evalwazzjoni dettaljata ta ’ riski/ benefiċċji mit- tabib tiegħek.
Using other medicines
Użu ta ’ mediċini oħra:
Experimental investigations have shown that interactions are unlikely with medications that are metabolised in the liver.
Investigazzjonijiet sperimentali wrew li mhux suppost li jkun hemm interazzjonijiet ma ’ medikamenti li huma metabolizzati fil- fwied.
However, the possibility of interactions with commonly used medicinal products cannot entirely be excluded.
Madankollu, il- possibilità ta ’ interazzjonijiet ma ’ prodotti mediċinali wżati ta ’ spiss ma tistax tiġi eskluża kompletament.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċina oħra, anki mhux bir- riċetta.
Pregnancy and breast-feeding:
Tqala u jekk qed tredda:
You should not use Cetrotide 0.25 mg if you are already pregnant, or suspect that you might be pregnant, or if you are breast-feeding.
M’ għandekx tuża Cetrotide 0. 25 mg jekk int diġà tqila, jew għandek suspett li tista ’ tkun tqila, jew jekk qed tredda ’.
HOW TO USE CETROTIDE
KIF JINTUŻA CETROTIDE
Always use cetrotide exactly as your doctor has told you.
Dejjem uża Cetrotide eżatt kif jghidlek it- tabib.
You should check with your doctor if you are not sure.
Cċekkja mat- tabib jekk mintiex ċerta.
The following statements apply to Cetrotide 0.25 mg unless otherwise prescribed by your doctor.
L- informazzjoni segwenti tapplika għal Cetrotide 0. 25 mg sakemm ma jkunx ordnat mod ieħor mit- tabib tiegħek.
Please observe these instructions for use, otherwise you will not fully benefit from Cetrotide 0.25 mg.
Jekk jogħġbok osserva dawn l- istruzzjonijiet għall- użu, inkella ma tkunx tista ’ tibbenefika bis- sħiħ minn Cetrotide 0. 25 mg.
The contents of one vial (0.25 mg Cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening.
Il- kontenut kollu ta ’ fjala waħda (0. 25 mg Cetrorelix) għandu jingħata darba kuljum, kull 24 siegħa, jew filgħodu jew filgħaxija.
Administration in the morning:
Kif tingħata l- injezzjoni filgħodu:
Treatment with Cetrotide 0.25 mg should begin on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
It- trattament b’ Cetrotide 0. 25 mg għandu jibda fil- 5 jew 6 ġurnata ta ’ l- istimulazzjoni ta ’ l- ovarji (madwar 96 sa 120 siegħa wara l- bidu ta ’ l- istimulazzjoni ta ’ l- ovarji) permezz ta ’ gonadotropini urinarji jew rikombinanti u kontinwament matul il- perjodu ta ’ trattament b’ gonadotropini inkluża l- ġurnata li fiha jkun hemm l- induzzjoni ta ’ l- ovulazzjoni.
Treatment with Cetrotide 0.25 mg should begin on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
It- trattament b’ Cetrotide 0. 25 mg għandu jibda fil- 5 ġurnata ta ’ l - istimulazzjoni ta ’ l- ovarji (madwar 96 sa 108 siegħa wara l- bidu ta ’ l- istimulazzjoni ta ’ l- ovarji) permezz ta ’ gonadotropini urinarji jew rikombinanti u kontinwament matul il- perjodu ta ’ trattament b’ gonadotropini sal- lejl ta ’ qabel il- ġurnata li fiha jkun hemm l- induzzjoni ta ’ l- ovulazzjoni.
Route of administration
30 Kif għandu jingħata Cetrotide?
Cetrotide is intended for subcutaneous use, that means given by injection just under the skin.
Cetrotide għandu jingħata b’ injezzjoni taħt il- ġilda.
It is for single use only.
Huwa għal - użu singlu.
The first injection of Cetrotide should be supervised by your doctor.
L- ewwel injezzjoni ta ’ Cetrotide għandha ssir taħt is- superviżjoni tat- tabib tiegħek.
You can carry out the following injections yourself as long as you have been made aware by your doctor of the symptoms that may indicate allergy, the consequences of such a reaction and the need for immediate treatment.
Int tista ’ tieħu dawn l- injezzjonijiet waħdek sakemm it- tabib tiegħek jkun infurmak bis- sintomi li jistgħu jindikaw allerġija, il- konsegwenzi ta ’ rejazzjoni tali u l- bżonn għall- kura immedjata.
29 Cetrotide 0.25 mg is for injection under the skin of the lower abdominal wall, preferably around the navel.
Cetrotide 0. 25 mg għandu jingħata b’ injezzjoni taħt il- ġilda fil- parti t’ isfel tal- membrana ta ’ l - addome, preferibilment madwar iż- żokra.
To minimise local irritation, please select a different injection site each day.
Biex titnaqqas l- irritazzjoni lokali, jekk jogħġbok agħżel parti tal- ġisem differenti għall- injezzjoni kuljum.
Dissolve Cetrotide 0.25 mg powder only with the water contained in the pre-filled syringe.
Ħoll it- trab ta ’ Cetrotide 0. 25 mg biss bl- ilma li jinstab fis- siringa mimlija lesta.
Do not use a Cetrotide 0.25 mg solution if it contains particles or if it is not clear.
Tużax it- taħlita ta ’ Cetrotide 0. 25 mg jekk fiha xi frak jew mhix ċara.
Before you administer Cetrotide yourself, please read the following instructions carefully
Qabel ma tieħu Cetrotide waħdek, jekk jogħġbok aqra l- istruzzjonijiet li ġejjin b’ attenzjoni:
It is important that your hands and all items you use are as clean as possible.
Hu importanti li idejk u l- oġġetti kollha li tuża jkunu nodfa kemm jista ’ jkun.
Lay out on a clean surface everything you need (one vial, one pre-filled syringe, one injection needle with a yellow mark, one injection needle with a grey mark and two alcohol swabs).
Poġġi kull ma għandek bżonn fuq wiċċ nadif (fjala waħda, siringa mimlija lesta, labra għall - injezzjoni b’ marka safra, labra għall- injezzjoni b’ labra griża u żewġ ċraret ta ’ l- alkoħol).
Flip off the plastic cover of the vial.
Neħħi l- għatu tal- plastik tal- fjala.
Wipe the aluminium ring and the rubber stopper with an alcohol swab.
Imsaħ iċ- ċirku ta ’ l- aluminju u t- tapp tal- lasktu biċ- ċarruta ta ’ l- alkoħol.
Take the injection needle with the yellow mark and remove the wrapping.
Aqbad il- labra għall- injezzjoni bil- marka safra u iftaħha.
Take the pre-filled syringe and remove the cover.
Aqbad is- siringa mimlija lesta u neħħilha l- għatu.
Put the needle on the syringe and remove the cover of the needle.
Poġġi l- labra fuq is- siringa u neħħi l- għatu tal- labra.
Push the needle through the centre of the rubber stopper of the vial.
Ibbotta l- labra miċ- ċentru tat- tapp tal- lasktu tal- fjala.
Inject the water into the vial by slowly pushing the plunger of the syringe.
Injetta l- ilma fil- fjala billi tibbota bil- mod il- parti ta ’ wara tas- siringa.
Leave the syringe on the vial.
Ħalli s- siringa fuq il- fjala.
Gently agitate the vial until the solution is clear and without residue.
Ċaqlaq il- fjala bil- mod sakemm it- taħlita hi ċara u mingħajr fdalijiet.
Avoid forming bubbles during dissolution.
Evita l- formazzjoni ta ’ bżieżaq waqt li tkun qed tħallat.
Draw the whole contents of the vial into the syringe.
Iġbed il- kontenut kollu tal- fjala fis- siringa.
If solution is left in the vial, invert the vial, pull back the needle until the opening of the needle is just inside the stopper.
Jekk it- taħlita titħalla fil- fjala, aqleb il- fjala, iġbed il - labra lura sakemm il- ftuħ tal- labra jkun eżatt fit- tapp.
If you look from the side through the gap in the stopper, you can control the movement of the needle and the liquid.
Jekk tħares mill- ġenb mill- ispazju tat - toqba tat- tapp, tkun tista ’ tikkontrolla ċ- ċaqliq tal- labra u tal- likwidu.
It is important to withdraw the entire contents of the vial.
Hu importanti li tiġbed il - kontenut kollu tal- fjala.
Detach the syringe from the needle and lay down the syringe.
Aqla s- siringa minn mal- labra u itlaq is- siringa.
Take the injection needle with the grey mark and remove its wrapping.
Aqbad il- labra ta ’ l- injezzjoni bil- marka l- griża u iftagħha.
Invert the syringe and push the plunger until all air bubbles have been expelled.
Aqleb is- siringa u ibbota l- parti ta ’ wara tas- siringa sakemm il- bżieżaq ta ’ l- arja jkunu tneħħew kollha.
Do not touch the needle or allow the needle to touch any surface.
Tmissx il- labra u tħallix il- labra tmiss ma ’ l- ebda wiċċ.
Choose an injection site at the lower abdominal wall, preferably around the navel.
Agħżel il- post ta’ injezzjoni fil- parti t’ isfel tal- membrana ta ’ l- addome, preferibilment madwar iż- żokra.
Take the second alcohol swab and clean the skin at the injection site.
Aqbad it- tieni ċarruta ta ’ l- alkoħol u naddaf il- ġilda fil- post fejn ħa tingħata l - injezzjoni.
Hold the syringe in one hand.
Żomm is- siringa f’ id waħda.