natgillin/translations-raw huggingface dataset:
However, interactions with commonly used medicinal products, including products that may induce histamine release in susceptible individuals, may occur.
Vendar pa se lahko pojavijo interakcije s pogosto uporabljanimi zdravili, vključno s tistimi, ki pri občutljivih posameznikih lahko sprožijo sproščanje histamina.
Cetrotide 0.25 mg is not intended to be used during pregnancy and lactation (see section 4.3).
Cetrotide 0, 25 mg ni namenjen za uporabo v času nosečnosti in dojenja (glejte poglavje 4. 3).
No teratogenic effects occurred when the drug was administered during the sensitive phase of gestation.
Pri uporabi zdravila med občutljivo fazo gestacije se niso pojavili teratogeni učinki.
3 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Due to its pharmacological profile cetrorelix is unlikely to impair the patient’ s ability to drive or to operate machinery.
Zaradi njegovega farmakološkega profila, je malo verjetno, da bi cetroreliks vplival na bolničino sposobnost vožnje ali upravljanja s stroji.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
3 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Rare (≥ 1/ 10,000, < 1/ 1,000)
Redki (≥1/ 10. 000, < 1/ 1. 000)
Rare cases of hypersensitivity reactions including pseudo- allergic/ anaphylactoid reactions have also been reported
V redkih primerih so poročali tudi o preobčutljivostnih reakcijah, vključno z psevdoalergijskimi/ anafilaktoidnimi reakcijami.
Nervous system disorders Gastrointestinal disorders Reproductive system and breast disorders
Občasni (≥1/ 1. 000, < 1/ 100)
Uncommon (≥ 1/ 1,000, < 1/ 100) Uncommon (≥ 1/ 1,000, < 1/ 100) Common (≥ 1/ 100, < 1/ 10)
Občasni (≥1/ 1. 000, < 1/ 100)
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).
Motnje reprodukcije in dojk
Uncommon (≥ 1/ 1,000, < 1/ 100)
Pogosti (≥1/ 100, < 1/ 10) Občasni (≥1/ 1. 000, < 1/ 100)
Severe ovarian hyperstimulation syndrome (WHO grade III)
Hud sindrom ovarijske hiperstimulacije (III. stopnje po WHO)
Common (≥ 1/ 100, < 1/ 10)
Pogosti (≥1/ 100, < 1/ 10)
Local reactions at the injection site (e. g. erythema, swelling and pruritus) have been reported.
mestu injiciranja (npr. eritem, oteklina in srbenje).
Usually they were transient in nature and mild intensity.
Običajno so bile reakcije prehodne in blage.
The frequency as reported in clinical trials was 9.4% following multiple injections of 0.25 mg cetrorelix.
Pogostnost, o kateri so poročali v kliničnih študijah, je bila 9, 4% po večkratnih injekcijah 0, 25 mg cetroreliksa.
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.
V študijah akutne toksičnosti z glodalci so opazili nespecifične toksične znake po intraperitonealni aplikaciji cetroreliksa v odmerkih, ki so bili 200- krat večji od farmakološko učinkovitega odmerka po subkutani uporabi.
LHRH-Antagonist, ATC code:
5. 1 Farmakodinamične lastnosti
4 Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland.
Cetroreliks zavira izločanje LH in FSH iz hipofize v odvisnosti od odmerka.
Following a single dose of 3 mg of cetrorelix a duration of action of at least 4 days has been evaluated.
Po enkratnem odmerku 3 mg cetroreliksa, je bilo trajanje delovanja ovrednoteno na najmanj 4 dni.
On day 4 the suppression was approximately 70%.
Četrti dan je bila supresija približno 70%.
At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
Učinek cetroreliksa se vzdržuje z injiciranjem odmerka 0, 25 mg, vsakih 24 ur.
5.2 Pharmacokinetic properties
4 5. 2 Farmakokinetične lastnosti
The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Absolutna biološka uporabnost cetroreliksa po subkutani uporabi je približno 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.
Celotni plazemski in ledvični očistek sta 1, 2 ml x min- 1 x kg- 1 oziroma 0, 1 ml x min- 1 x kg- 1.
The volume of distribution (Vd, area) is 1.1 l x kg-1.
Volumen porazdelitve (Vd, area) je 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.
Povprečen končni razpolovni čas po intravenski in subkutani uporabi je približno 12 ur oziroma 30 ur, kar dokazuje učinek procesa absorbcije na mestu injiciranja.
The subcutaneous administration of single doses (0.25 mg to 3 mg cetrorelix) and also daily dosing over 14 days show linear kinetics.
Subkutana uporaba enkratnih odmerkov (0, 25 mg do 3 mg cetroreliksa) in tudi dnevno odmerjanje daljše od 14 dni kaže linearno kinetiko.
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.
Prav tako ni bilo znakov z zdravilom povezanega lokalnega draženja ali inkompatibilnosti pri psih, po intravenski, intraarterialni in paravenski injekciji cetroreliksa v odmerkih, ki so izrazito presegali namen klinične uporabe pri človeku.
Water for Injections
voda za injekcije
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
5 6.3 Shelf life
6. 3 Rok uporabnosti
Keep the vial(s) in the outer carton in order to protect from light.
Vialo( e) shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Packs with 1 or 7 Type I glass vials each containing 55.7 mg powder for solution for injection sealed with a rubber stopper.
Škatla z 1 ali 7 vialami iz stekla tipa I, vsaka vsebuje 55, 7 mg praška za raztopino za injiciranje, neprodušno zaprtega z gumijastim zamaškom.
Additionally for each vial the packs contain:
5 Dodatno vsebuje škatla za vsako vialo še:
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.
1 napolnjeno injekcijsko brizgo (vložek iz stekla tipa I, zaprt z gumijastim zamaškom) z 1 ml vehikla za parenteralno uporabo 1 injekcijsko iglo (20 G) 1 subkutano injekcijsko iglo (27 G) 2 alkoholni blazinici.
Cetrotide 0.25 mg should only be reconstituted with the solvent provided, using a gentle, swirling motion.
Cetrotide 0, 25 mg smete rekonstituirati samo s priloženim vehiklom, z rahlim vrtinčenjem.
This ensures a delivery to the patient of a dose of at least 0.23 mg cetrorelix.
To zagotavlja, da bolnica prejme najmanj 0, 23 mg cetroreliksa.
The injection site should be varied daily.
Mesto injiciranja se mora dnevno spreminjati.
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall London E14 9TP Velika Britanija
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
13 April 1999 Date of last renewal:
13. april 1999 Datum zadnjega podaljšanja dovoljenja za promet:
15 April 2004
15. april 2004
Cetrotide 3 mg powder and solvent for solution for injection
Cetrotide 3 mg prašek in vehikel za raztopino za injiciranje
3.12 - 3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix.
3, 12 – 3, 24 mg cetroreliksijevega acetata, kar ustreza 3 mg cetroreliksa.
After reconstitution with the solvent provided, the concentration of cetrorelix is 1 mg/ ml.
Po rekonstituciji s priloženim vehiklom, je koncentracija cetroreliksa 1 mg/ ml.
164.40 mg mannitol.
164, 40 mg manitola.
Powder and solvent for solution for injection
Prašek in vehikel za raztopino za injiciranje Videz praška: bele liofilizirane pelete Videz vehikla: bistra brezbarvna raztopina
In clinical trials Cetrotide 3 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.
V kliničnih študijah so Cetrotide 3 mg uporabljali s humanim menopavznim gonadotropinom (HMG), vendar pa omejene izkušnje z rekombinantnim FSH kažejo podobno učinkovitost.
Cetrotide 3 mg should only be prescribed by a specialist experienced in this field.
Cetrotide 3 mg sme predpisovati samo specialist z izkušnjami na tem področju.
Cetrotide 3 mg is for subcutaneous injection into the lower abdominal wall.
Cetrotide 3 mg je namenjen za subkutano injiciranje v spodnji del trebušne stene.
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.
Prvo dajanje Cetrotide se mora izvesti pod nadzorom zdravnika in v pogojih, kjer je takojšnje zdravljenje možnih psevdo- alergijskih reakcij takoj na voljo.
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.
Vsebino 1 viale (3 mg cetroreliksa) je treba injicirati 7. dan ovarijske stimulacije (približno 132 do 144 ur po začetku ovarijske stimulacije) z urinskimi ali rekombinantnimi gonadotropini.
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.
Po prvi uporabi je priporočljivo, da bolnica ostane pod zdravniškim nadzorom še 30 minut, da se prepričamo, da nima alergijske/ psevdoalergijske reakcije na injekcijo.
Facilities for the treatment of such reactions should be immediately available.
Oprema za zdravljenje takšnih reakcij mora biti takoj na voljo.
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.
Če rast folikla ne dovoljuje indukcije ovulacije 5. dan po injekciji Cetrotide 3 mg, se mora dodatno uporabljati 0, 25 mg cetroreliksa (Cetrotide 0, 25 mg) enkrat dnevno, s pričetkom 96 ur po injekciji Cetrotide 3 mg, vse do dneva indukcije ovulacije.
4.3 Contraindications
7 4. 3 Kontraindikacije
• Hypersensitivity to the active substance or any structural analogue of GnRH, extrinsic peptide hormones or to any of the excipients.
• Preobčutljivost za zdravilno učinkovino ali katerikoli strukturni analog GnRH, eksogene peptidne hormone ali katerokoli pomožno snov.
• Pregnancy, and lactation.
• Nosečnost in dojenje.
There is limited experience up to now with the administration of Cetrotide 3 mg during a repeated ovarian stimulation procedure.
Do danes imamo le omejene izkušnje z uporabo Cetrotide 3 mg pri ponovljenem postopku ovarijske stimulacije.
Therefore Cetrotide 3 mg should be used in repeated cycles only after a careful risk/ benefit evaluation.
Zato smemo Cetrotide 3 mg uporabiti v večkratnih ciklusih samo po natančni oceni razmerja tveganja/ koristi.
Cetrotide 3 mg is not intended to be used during pregnancy and lactation (see section 4.3).
Cetrotide 3 mg ni namenjen za uporabo v času nosečnosti in dojenja (glejte poglavje 4. 3).
No teratogenic effects occurred when the drug was administered during the sensitive phase of gestation.
Pri uporabi zdravila med občutljivo fazo gestacije, se niso pojavili teratogeni učinki.
Due to its pharmacological profile cetrorelix is unlikely to impair the patient’ s ability to drive or to operate machinery.
Zaradi njegovega farmakološkega profila je malo verjetno, da bi cetroreliks vplival na bolničino sposobnost vožnje ali upravljanja s stroji.
9 4.8 Undesirable effects
4. 8 Neželeni učinki
Immune system disorders
8 Bolezni imunskega sistema
Rare (≥ 1/ 10,000, < 1/ 1,000)
Redki (> 1/ 10. 000, < 1/ 1. 000)
The frequency as reported in clinical trials was 8.0%.
Pogostnost, o kateri so poročali v kliničnih študijah, je bila 8, 0%.
The onset of suppression is virtually immediate and is maintained by continuous treatment, without initial stimulatory effect.
Supresija je takojšnja in se s vzdržuje s stalnim zdravljenjem, brez začetnega stimulativnega učinka.
10 In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Po končanem zdravljenju so bili, tako pri živalih kot pri človeku, antagonistični hormonski učinki cetroreliksa popolnoma reverzibilni.
5.2 Pharmacokinetic properties
9 5. 2 Farmakokinetične lastnosti
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.
Celotni plazemski in ledvični očistek sta 1. 2 ml x min- 1 x kg- 1 oziroma 0, 1 ml x min- 1 x kg- 1.
The volume of distribution (Vd, area) is 1.1 l x kg-1.
Volumen porazdelitve (Vd, area) je 1, 1 l / x kg- 1.
5.3 Preclinical safety data
5. 3 Predklinični podatki
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.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Mannitol
Prašek:
Solvent:
manitol
Keep the vial in the outer carton in order to protect from light.
Vialo (e) shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
11 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Pack with 1 Type I glass vial containing 167.7 mg powder for solution for injection sealed with a rubber stopper.
Škatla z 1 vialo iz stekla tipa I, ki vsebuje 167, 7 mg praška za raztopino za injiciranje, neprodušno zaprtega z gumijastim zamaškom.
Additionally the pack contains:
Dodatno vsebuje škatla še:
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.
10 1 napolnjeno injekcijsko brizgo (vložek iz stekla tipa I, zaprt z gumijastim zamaškom) s 3 ml vehikla za parenteralno uporabo 1 injekcijsko iglo (20 G) 1 subkutano injekcijsko iglo (27 G) 2 alkoholni blazinici.
Cetrotide 3 mg should only be reconstituted with the solvent provided, using a gentle, swirling motion.
Cetrotide 3 mg smete rekonstituirati samo s priloženim vehiklom, z rahlim vrtinčenjem.
This ensures a delivery to the patient of a dose of at least 2.82 mg cetrorelix.
To zagotavlja, da bolnica prejme najmanj 2, 82 mg cetroreliksa.
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall London E 14 9TP Velika Britanija
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( ŠTEVILKE) DOVOLJENJA( DOVOLJENJ) ZA PROMET
12 ANNEX II
11 DODATEK II
MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
13 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Baxter Oncology GmbH Kantstraße 2 D-33790 Halle Germany
Baxter Oncology GmbH Kantstraβe 2 D- 33790 Halle Nemčija
Not applicable
13 DODATEK III
LABELLING
15 PODATKI NA ZUNANJI OVOJNINI
Cetrotide 0.25 mg, powder and solvent for solution for injection. cetrorelix
Cetrotide 0, 25 mg prašek in vehikel za raztopino za injiciranje cetroreliks
1 vial with 55.7 mg powder contains:
1 viala s 55, 7 mg praška vsebuje:
0.26 – 0.27 mg cetrorelix acetate equivalent to 0.25 mg cetrorelix.
0, 26 – 0, 27 mg cetroreliksijevega acetata, kar ustreza 0, 25 mg cetroreliksa.
Mannitol.
Pomožne snovi: manitol.
1 pre-filled syringe with solvent contains:
1 napolnjena injekcijska brizga z vehiklom vsebuje:
1 ml water for injections.
1 ml vode za injekcije.
1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
1 injekcijsko iglo (20 G) 1 subkutano injekcijsko iglo (27 G) 2 alkoholni blazinici
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
17 PODATKI NA ZUNANJI OVOJNINI
BOX OF 7 VIAL AND 7 PRE-FILLED SYRINGE
ŠKATLA S 7 VIALAMI IN 7 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
LIST OF EXCIPIENTS
POMOŽNIH SNOVI
7 injection needle (20 gauge) 7 hypodermic injection needle (27 gauge) 14 alcohol swabs.
7 injekcijskih igel (20 G) 7 subkutanih injekcijskih igel (27 G) 14 alkoholnih blazinic
Do not store above 25 °C.
18 Shranjujte pri temperaturi do 25°C.
SolventBatch:
Serija vehikla:
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CETROTIDE 0.25 MG VIAL LABEL
CETROTIDE 0, 25 MG NALEPKA NA VIALI
Cetrotide 0.25 mg powder for solution for injection cetrorelix Subcutaneous use.
Cetrotide 0, 25 mg prašek za raztopino za injiciranje cetroreliks Za subkutano uporabo.
55.7 mg/ vial
55, 7 mg/ vialo
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Water for Injections Solvent for use with Cetrotide 0.25 mg
Voda za injekcije Vehikel za uporabo s Cetrotide 0, 25 mg
1 ml/ pre-filled syringe
1 ml/ v napolnjeni injekcijski brizgi
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI
Cetrotide 3 mg, powder and solvent for solution for injection. cetrorelix
Cetrotide 3 mg prašek in vehikel za raztopino za injiciranje cetroreliks
1 vial with 167.7 mg powder contains:
1 viala z 167, 7 mg praška vsebuje:
3.12 – 3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix.
3, 12 – 3, 24 mg cetroreliksijevega acetata, kar ustreza 3 mg cetroreliksa.
3 ml water for injections.
3 ml vode za injekcije.
OTHER SPECIAL WARNING(S), IF NECESSARY
POSEBNA OPOZORILA, ČE SO POTREBNA
Batch Solvent Batch
Serija Serija vehikla:
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CETROTIDE 3 MG VIAL LABEL
CETROTIDE 3 MG NALEPKA NA VIALI
Cetrotide 3 mg powder for solution for injection cetrorelix Subcutaneous use.
Cetrotide 3 mg prašek za raztopino za injiciranje cetroreliks Za subkutano uporabo.
167.7 mg/ vial
167, 7 mg/ vialo
Water for Injections Solvent for use with Cetrotide 3 mg
Voda za injekcije Vehikel za uporabo s Cetrotide 3 mg
3 ml/ pre-filled syringe
3 ml/ v napolnjeni injekcijski brizgi
PACKAGE LEAFLET
26 NAVODILO ZA UPORABO
Cetrotide 0.25mg powder and solvent for solution for injection
Cetrotide 0, 25 mg prašek in vehikel za raztopino za injiciranje cetroreliksijev acetat
if their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni podobne vašim.
What Cetrotide is and what it is used for 2.
Kaj je zdravilo Cetrotide in za kaj ga uporabljamo 2.
Before you use Cetrotide 3.
Kaj morate vedeti, preden boste uporabili zdravilo Cetrotide 3.
How to use Cetrotide 4.
Kako uporabljati zdravilo Cetrotide 4.
Possible side effects 5 How to store Cetrotide 6.
Shranjevanje zdravila Cetrotide 6.
WHAT CETROTIDE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CETROTIDE IN ZA KAJ GA UPORABLJAMO
Cetrotide 0.25 mg inhibits the effects of a natural hormone, called luteinising hormone releasing hormone (LHRH).
Cetrotide 0, 25 mg zavira učinke naravnega hormona, ki se imenuje luteinizirajoči hormon sproščajoči hormon (LHRH).
LHRH regulates the secretion of another hormone, called luteinising hormone (LH), which induces ovulation during the menstrual cycle.
LHRH uravnava izločanje drugega hormona, imenovanega luteinizirajoči hormon (LH), ki inducira ovulacijo med menstrualnim ciklusom.
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 zavira prezgodnjo ovulacijo, ki je nezaželena med hormonskim zdravljenjem za stimulacijo jajčnikov, saj so samo zrele jajčne celice primerne za oploditev.
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 se uporablja za preprečevanje prezgodnje ovulacije v času kontrolirane stimulacije jajčnikov, ki ji sledijo vsrkanje oocitov in tehnike asistirane reprodukcije.
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.
V kliničnih študijah so Cetrotide 0, 25 mg uporabljali skupaj s humanim menopavznim gonadotropinom (HMG), vendar pa omejene izkušnje z rekombinantnim folikle stimulirajočim hormonom (FSH) kažejo podobno učinkovitost.
HMG and FSH are hormones promoting egg maturation.
HMG in FSH sta hormona, ki pospešujeta dozorevanje jajčeca.
BEFORE YOU USE CETROTIDE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO CETROTIDE
Do not use Cetrotide
Ne uporabljajte zdravila 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.
• če ste alergični na (preobčutljivi za) cetroreliksijev acetat, eksogene peptidne hormone (zdravila, podobna Cetrotide 0, 25 mg) ali katerokoli sestavino zdravila Cetrotide • če ste noseči ali dojite • če ste že v menopavzi • če imate zmerno ali hudo ledvično ali jetrno bolezen.
Take special care with Cetrotide
Bodite posebno pozorni pri uporabi zdravila Cetrotide
Special care should be taken in women with an active allergic condition or a known history of allergy.
Posebna pozornost je potrebna pri ženskah, ki imajo aktivno alergijsko stanje ali potrjeno alergijo v preteklosti.
Since treatment with Cetrotide is not advised in women with severe allergic conditions it is important that you inform your doctor of any allergies.
Zdravljenje s Cetrotidom se odsvetuje ženskam s hudimi alergijskimi stanji, zato je pomembno, da obvestite svojega zdravnika o kakršnihkoli alergijah.
28 During or following hormonal stimulation of the ovaries an ovarian hyperstimulation syndrome can occur.
27 Med ali po hormonski stimulaciji jajčnikov se lahko pojavi sindrom hiperstimulacije jajčnikov.
This event is related to the stimulation procedure with gonadotropins (hormones promoting egg maturation).
Ta dogodek je povezan s postopkom stimulacije z gonadotropini (hormoni, ki pospešujejo dozorevanje jajčeca).
For symptoms and suitable measures please refer to the Patient Information Leaflet of the gonadotropin-containing medicine prescribed for you.
Vse o simptomih in ustreznih ukrepih preberite v navodilu za uporabo za zdravilo z gonadotropinom, ki vam je bilo predpisano.
Luteal phase support (a measure to support the onset of pregnancy) should be given according to the reproductive medical centre´s practice.
Podpora lutealne faze (ukrep za podporo začetka nosečnosti) mora potekati v skladu z ustaljeno prakso zdravstvenega centra za reprodukcijo.
There is limited experience up to now with the administration of Cetrotide 0.25 mg during a repeated ovarian stimulation procedure.
Sedanje izkušnje z uporabo Cetrotida 0, 25 mg pri ponovljenem postopku stimulacije jajčnikov so omejene.
Therefore you should use Cetrotide 0.25 mg in repeated cycles only after a careful risk/ benefit evaluation by your doctor.
Zato smete Cetrotide 0, 25 mg v ponavljajočih ciklusih uporabljati samo, če tako presodi vaš zdravnik po natančni oceni razmerja tveganja/ koristi.
Experimental investigations have shown that interactions are unlikely with medications that are metabolised in the liver.
Eksperimentalne raziskave so pokazale, da so interakcije z zdravili, ki se presnavljajo v jetrih, le malo verjetne.