natgillin/translations-raw huggingface dataset:
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • upper respiratory tract infection (infection of the nose, throat or trachea) • dizziness • other injection site reactions such as hard lump, tingling or numbness.
♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100, vendar več kot 1 od 1. 000 odmerkov cepiva): • okužba zgornjih dihal (okužba nosu, žrela in sapnika). • omotica. • druge reakcije na mestu injiciranja, kot so zatrdlina, zbadanje ali odrevenelost.
HOW TO STORE CERVARIX
SHRANJEVANJE CEPIVA CERVARIX
Do not use Cervarix after the expiry date which is stated on the carton.
Cepiva Cervarix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
45 Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Ask your pharmacist how to dispose of medicines no longer required.
O načinu odstranjevanja zdravil, ki jih ne potrebujete več, se posvetujte s farmacevtom.
What Cervarix contains
Kaj vsebuje cepivo Cervarix
- The active substances are:
- Zdravilne učinkovine so:
Human Papillomavirus1 type 16 L1 protein2,3,4 Human Papillomavirus1 type 18 L1 protein2,3,4 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing:
L1 protein2, 3, 4 genotipa 16 humanega virusa papiloma2, 3, 4 L1 protein2, 3, 4 genotipa 18 humanega virusa papiloma2, 3, 4 1 humani virus papiloma = HPV 2 z adjuvansom AS04, ki vsebuje:
0.5 milligrams Al3+ in total
L1 protein v obliki nekužnih virusu podobnih delcev (VLPs, “ virus- like particles ”), pridobljenih s tehnologijo rekombinantne DNA s pomočjo bakulovirusnega ekspresijskega sistema na osnovi Hi- 5 Rix4446 celic, pridobljenih iz žuželke Trichoplusia ni.
- The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
- Pomožne snovi so natrijev klorid (NaCl), natrijev dihidrogenfosfat dihidrat (NaH2PO4. 2 H2O) in
(NaH2PO4.2 H2O) and water for injections.
voda za injekcije.
Cervarix is available in vials for 1 dose (0.5 ml) in packs of 1, 10 and 100.
Cepivo Cervarix je na voljo v vialah za en odmerek (0. 5 ml), ki so pakirane po 1, 10 in 100.
Rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Belgija 49 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. ------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
INFORMATION FOR THE USER
51 NAVODILO ZA UPORABO
49 • has a severe infection with a high temperature.
52 na koncu tega navodila (glejte poglavje 6).
Cervarix is intended for females from 10 years of age onwards.
53 Cepivo Cervarix je namenjeno za cepljenje žensk, starejših od 10 let.
50 If necessary, the vaccination schedule can be more flexible.
Shemo cepljenja se po potrebi lahko tudi prilagodi.
51 Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Cervarix is available in vials for 2 doses (1 ml) in packs of 1, 10 and 100.
Cervarix je na voljo v vialah za 2 odmerka (1 ml) v pakiranjih po 1, 10 in 100.
GlaxoSmithKline Biologicals s. a.
55 GlaxoSmithKline Biologicals s. a.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
56 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. ------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred cepljenjem morate vsebino viale, preden jo pretresete in po tem, pregledati glede morebitnih tujkov in/ ali neobičajnega fizikalnega videza.
INFORMATION FOR THE USER
58 NAVODILO ZA UPORABO
- cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb),
- rak materničnega vratu (rak spodnjega dela maternice ali uterusa).
- pre cancerous cervical lesions (changes in cells of the cervix that have a risk of turning into
- predrakave spremembe na materničnem vratu (spremembe v celicah materničnega vratu iz
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • has a severe infection with a high temperature.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težave z dihanjem in otekanje obraza ali jezika. • če ima hudo okužbo z visoko telesno temperaturo.
55 Take special care with Cervarix You should tell the doctor if the person to be vaccinated: • has a bleeding problem or bruises easily. • has any disease which reduces her resistance to infection such as HIV infection
Bodite posebno pozorni pri uporabi cepiva Cervarix Obvestite svojega zdravnika, če ima oseba, ki bo cepljena: • težave s krvavitvami ali hitrim pojavom modric. • katerokoli bolezen, ki zmanjšuje odpornost proti okužbam, npr okužbo z virusom HIV.
Cervarix is intended for females from 10 years of age onwards.
60 Cepivo Cervarix je namenjeno za cepljenje žensk, starejših od 10 let.
56 When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete 3-dose vaccination course.
Po cepljenju s prvim odmerkom cepiva Cervarix priporočamo, da se tudi cepljenje s preostalima dvema odmerkoma opravi s cepivom Cervarix (in ne z drugim cepivom proti HPV).
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain • itching, red skin rash, hives (urticaria) • joint pain • fever (≥38°C)
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od 100 odmerkov cepiva): • prebavni simptomi, vključno s siljenjem na bruhanje, bruhanjem, drisko in bolečinami v trebuhu. • srbenje, rdeč kožni izpuščaj, koprivnica (urtikarija). • bolečine v sklepih. • zvišana telesna temperatura (≥ 38 °C).
57 Medicines should not be disposed of via wastewater or household waste.
Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
3-O-desacyl-4’- monophosphoryl lipid A (MPL)3 3
3- O- desacil- 4 ’ - monofosforil lipid A (MPL) 3 3 adsorbiran na hidratirani aluminijev hidroksid (Al( OH) 3) 4
Cervarix is available in pre-filled syringes with or without needles in packs of 1 and 10.
Cepivo Cervarix je na voljo v napolnjenih injekcijskih brizgah z injekcijskimi iglami ali brez v pakiranjih po 1 in 10.
Rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 62 B- 1330 Rixensart, Belgija
Sími: +354-530 3700
63 Sími: +354- 530 3700
The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred cepljenjem morate vsebino napolnjene injekcijske brizge, preden jo pretresete in po tem, pregledati glede morebitnih tujkov in/ ali neobičajnega fizikalnega videza.
Cetrotide is a powder and solvent to be made up in a solution for injection.
Zdravilo Cetrotide je prašek in vehikel za pripravo raztopine za injiciranje.
Cetrotide contains the active substance cetrorelix, either 0.25 mg or 3 mg per vial.
Zdravilo Cetrotide vsebuje zdravilno učinkovino cetroreliks, in sicer 0, 25 mg ali 3 mg na vialo.
What is Cetrotide used for?
Za kaj se uporablja zdravilo Cetrotide?
Cetrotide is given to women having fertility treatment whose ovaries are being stimulated to produce more eggs (ovarian stimulation).
Zdravilo Cetrotide se daje ženskam, zdravljenim zaradi težav s plodnostjo, katerih jajčnike spodbujajo, da tvorijo več jajčec (ovarijska stimulacija).
It is used to prevent premature ovulation (early release of eggs from the ovary, before induction of the ovulation).
Zdravilo se uporablja za preprečevanje prezgodnje ovulacije (zgodnje sprostitve jajčec iz jajčnikov, pred sprožitvijo ovulacije).
Cetrotide can only be obtained with a prescription.
Zdravilo Cetrotide se dobi samo na recept.
Cetrotide 0.25 mg is given daily, either in the morning or in the evening, starting on day 5 or 6 of ovarian stimulation, until the day of planned ovulation induction.
0, 25 mg zdravila Cetrotide se daje dnevno, zjutraj ali zvečer, začenši s petim ali šestim dnem spodbujanja jajčnikov, do dneva načrtovane sprožitve ovulacije.
Cetrotide 3 mg is given as a single dose on day 7.
3 mg zdravila Cetrotide se da v obliki enega odmerka na sedmi dan.
This can be followed by daily injections of Cetrotide 0.25 mg if Cetrotide treatment is still needed more than 4 days later.
Temu lahko sledi dajanje dnevnih injekcij po 0, 25 mg zdravila Cetrotide, v primeru, da je zdravljenje z zdravilom Cetrotide potrebno še več kot 4 dni.
Cetrotide is given by subcutaneous (under the skin) injection into the lower abdominal (tummy) wall.
Zdravilo Cetrotide se daje s subkutano injekcijo (pod kožo) v spodnji del trebušne stene.
Because of the risk of allergic reaction, the first injection should be supervised by a doctor, and the patient looked after for 30 minutes.
Zaradi tveganj za nastanek preobčutljivostnih reakcij mora prvo injiciranje nadzorovati zdravnik, bolnica pa mora ostati pod nadzorom še 30 minut po injiciranju.
The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate an allergic reaction and what to do if this happens.
Nadaljnje injekcije si lahko daje tudi bolnica sama, vendar le, če je seznanjena z znaki in simptomi, ki utegnejo nakazovati preobčutljivostno reakcijo, in ustreznim ukrepanjem v takem primeru.
The active substance in Cetrotide, cetrorelix, blocks the effects of a natural hormone, called luteinising hormone releasing hormone (LHRH).
Zdravilna učinkovina zdravila Cetrotide, cetroreliks, zavira učinke naravnega hormona, imenovanega luteinizirajoči hormon sproščajočega hormona (LHRH).
LHRH controls the secretion of another hormone, called luteinising hormone (LH), which causes the release of eggs (ovulation) during the menstrual cycle.
LHRH uravnava izločanje drugega hormona, imenovanega luteinizirajoči hormon (LH), ki povzroči sproščanje jajčec (ovulacijo) med menstrualnim ciklom.
During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more eggs.
Med zdravljenjem težav s plodnostjo se običajno uporablja spodbujanje jajčnikov z namenom, da jajčniki tvorijo več jajčec.
A few days later, a hormone such as hCG (human Chorionic Gonadotropin) is given to trigger ovulation, and the eggs are then harvested and used in techniques such as in-vitro fertilisation.
Zatem se jajčeca odvzamejo in uporabijo v postopkih kot je npr. zunajtelesna oploditev.
Cetrotide, by blocking the effect of LHRH, stops the production of LH, and therefore prevents premature ovulation, the release by the ovaries of eggs that may be immature and not suitable for fertilisation.
S tem, ko blokira učinek LHRH, zdravilo Cetrotide zaustavi tvorjenje LH in potemtakem prepreči prezgodnjo ovulacijo, to je sprostitev jajčec, ki bi lahko bila nezrela in neprimerna za oploditev, iz jajčnikov.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Cetrotide been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Cetrotide raziskano?
The effectiveness of Cetrotide as a treatment to prevent premature ovulation was studied in three studies involving 814 women.
Učinkovitost zdravila Cetrotide pri preprečevanju prezgodnje ovulacije je bila raziskana v okviru treh raziskav, v katerih je sodelovalo 814 žensk.
Cetrotide was compared with buserelin nasal spray and triptorelin depot injection (both are medicines that also act on the secretion of LH, but via a different mechanism: they stimulate the production of LHRH to such an extent that the body stops making LH).
Zdravilo Cetrotide so primerjali z buserelinom v obliki pršila za nos in triptorelinom v obliki depo injekcije (obe zdravili prav tako vplivata na izločanje LH, vendar preko drugačnega mehanizma: spodbujata tvorjenje LHRH v tolikšni meri, da telo preneha tvoriti LH).
What benefit has Cetrotide shown during the studies?
Kakšne koristi je zdravilo Cetrotide izkazalo med raziskavami?
Cetrotide was as effective as the comparator treatments in preventing a surge (sudden increase) in the production of luteinising hormone.
Zdravljenje z zdravilom Cetrotide je bilo pri preprečevanju nenadnega porasta tvorbe luteinizirajočega hormona enako učinkovito kot zdravljenje s primerjalnima učinkovinama.
Once the assisted– reproduction procedure was completed, 23% of patients who received Cetrotide achieved pregnancy, against 32% in the comparator group.
Po zaključku postopka oploditve z biomedicinsko pomočjo je zanosilo 23% bolnic, ki so prejemale zdravilo Cetrotide, v primerjavi z 32% v primerjalni skupini.
This suggests a higher pregnancy rate for the comparators.
To nakazuje višjo stopnjo nosečnosti za primerjalni učinkovini.
Mild and short lasting reactions may occur at the injection site, e. g. reddening, itching, and swelling.
Lahko se pojavijo blažje in kratkotrajne reakcije na mestu injiciranja, kot so pordela koža, srbenje in otekanje.
Nausea and headache are also possible side effects.
Možna stranska učinka sta tudi slabost in glavobol.
For the full list of all side effects reported with Cetrotide, please see the Package Leaflet.
Celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Cetrotide, najdete v Navodilih za uporabo.
Cetrotide should not be used in people who may be hypersensitive (allergic) to cetrorelix or any of the other ingredients, in women who are pregnant or breast-feeding, in postmenopausal women or in patients with moderate or severe kidney or liver disease.
Zdravila Cetrotide ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na cetroreliks ali katero drugo sestavino tega zdravila, nosečnice in doječe matere, ženske po menopavzi ali bolnice z zmerno ali hudo boleznijo ledvic ali jeter.
For the full list of restrictions, see the Package Leaflet.
Celoten seznam omejitev najdete v Navodilih za uporabo.
The Committee for Medicinal products for Human Use (CHMP) concluded that Cetrotide in a safe and effective alternative to existing treatments to prevent premature ovulation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da predstavlja zdravilo Cetrotide varno in učinkovito alternativo obstoječim zdravilom za preprečevanje prezgodnje ovulacije.
They decided that Cetrotide’ s benefits are greater than its risks in this indication, and they recommended that Cetrotide be given marketing authorisation.
Zato je priporočil, da se za zdravilo Cetrotide podeli dovoljenje za promet.
Other information about Cetrotide:
Druge informacije o zdravilu Cetrotide:
The European Commission granted a marketing authorisation valid throughout the European Union, for Cetrotide to Serono Europe Limited on 13 April 1999.
Evropska komisija je dovoljenje za promet z zdravilom Cetrotide, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Limited dne 13. aprila 1999.
The marketing authorisation was renewed on 13 April 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano 13. aprila 2004.
The full EPAR for Cetrotide is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cetrotide je na voljo tukaj.
This summary was last updated in 04-2006.
Ta povzetek je bil nazadnje posodobljen aprila 2006.
Invented Name
farmacevtska oblika
Strength
pot uporabe
Pharmaceutical form Route of administration Packaging
ovojnina
Content (concentration)
vsebina (koncentracija) velikost pakiranja
Cetrotide
0, 25 mg
0.25 mg
Subkutana uporaba
Powder and solvent for Subcutaneous use Powder: vial (glass) solution for injection Solvent: pre-filled syringe (glass)
prašek: viala (steklo); vehikel: napolnjena injekcijska brizga (steklo)
0.25 mg Solvent:
0, 25 mg; vehikel:
Powder and solvent for Subcutaneous use solution for injection
Prašek in vehikel za raztopino za injiciranje
Powder: vial (glass) Solvent: pre-filled syringe (glass)
prašek: viala (steklo); vehikel: napolnjena injekcijska brizga (steklo)
3 mg Solvent:
3 mg; vehikel:
Cetrotide 0.25 mg powder and solvent for solution for injection
Cetrotide 0, 25 mg prašek in vehikel za raztopino za injiciranje
1 vial contains:
1 viala 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.
After reconstitution with the solvent provided, the concentration of cetrorelix is 0.25 mg/ ml.
Po rekonstituciji s priloženim vehiklom, je koncentracija cetroreliksa 0, 25 mg/ ml.
54.80 mg mannitol.
54, 80 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
The pH of the reconstituted solution is 4.0 – 6.0
pH rekonstituirane raztopine je 4, 0 do 6, 0.
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
4. 1 Terapevtske indikacije
In clinical trials Cetrotide 0.25 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.
V kliničnih študijah so Cetrotide 0, 25 mg uporabljali s humanim menopavznim gonadotropinom (HMG), vendar pa omejene izkušnje z rekombinantnim FSH kažejo podobno učinkovitost.
Cetrotide 0.25 mg should only be prescribed by a specialist experienced in this field.
Cetrotide 0, 25 mg sme predpisovati samo specialist z izkušnjami na tem področju.
Cetrotide 0.25 mg is for subcutaneous injection into the lower abdominal wall.
Cetrotide 0, 25 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 psevdoalergijskih reakcij takoj na voljo.
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.
Nadaljne injekcije si lahko bolnica daje sama, če je seznanjena z znaki in simptomi, ki lahko kažejo na preobčutljivostno reakcijo, posledicami takšne reakcije in potrebo po takojšnjem zdravniškem ukrepanju.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening.
Vsebino 1 viale (0, 25 mg cetroreliksa) je treba injicirati enkrat na dan, v 24 urnih razmakih, bodisi zjutraj ali zvečer.
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 to the injection.
Oprema za zdravljenje takšnih reakcij mora biti takoj na voljo.
Facilities for the treatment of such reactions should be immediately available.
Zdravljenje s Cetrotide 0, 25 mg moramo pričeti na 5. ali 6. dan ovarijske stimulacije (približno 96 do 120 ur po začetku ovarijske stimulacije) z urinskimi ali rekombinatnimi gonadotropini in ga nadaljujemo ves čas zdravljenja z gonadotropini, vključno z dnevom indukcije ovulacije.
2 Administration in the morning:
2 Uporaba zvečer:
Treatment with Cetrotide 0.25 mg should commence 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.
Zdravljenje s Cetrotide 0, 25 mg moramo pričeti na 5. dan ovarijske stimulacije (približno 96 do 108 ur po začetku ovarijske stimulacije) z urinskimi ali rekombinatnimi gonadotropini in ga nadaljujemo ves čas zdravljenja z gonadotropini, vse do večera pred dnevom indukcije ovulacije.
For instructions on preparation, see section 6.6.
Za navodila za pripravo glejte poglavje 6. 6.
• Hypersensitivity to the active substance or any structural analogues 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.
• Postmenopausal women.
• Ženske po menopavzi.
• Patients with moderate and severe renal and hepatic impairment.
• Bolnice z zmerno in hudo ledvično in jetrno okvaro.
Treatment with Cetrotide is not advised in women with severe allergic conditions.
Zdravljenje s Cetrotide se odsvetuje ženskam s hudimi alergijskimi stanji.
During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur.
Med ali po ovarijski stimulaciji se lahko pojavi sindrom ovarijske hiperstimulacije.
This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins.
Ta dogodek moramo upoštevati kot intrinzično tveganje postopka stimulacije z gonadotropini.
An ovarian hyperstimulation syndrome should be treated symptomatically, e. g. with rest, intravenous electrolytes/ colloids and heparin therapy.
Sindrom ovarijske hiperstimulacije moramo zdraviti simptomatsko, npr. s počitkom, intravenskimi elektroliti/ koloidi in heparinsko terapijo.
There is limited experience up to now with the administration of Cetrotide 0.25 mg during a repeated ovarian stimulation procedure.
Do danes imamo le omejene izkušnje z uporabo Cetrotide 0, 25 mg pri ponovljenem postopku ovarijske stimulacije.
Therefore Cetrotide 0.25 mg should be used in repeated cycles only after a careful risk/ benefit evaluation.
Zato smemo Cetrotide 0, 25 mg uporabiti v večkratnih ciklusih samo po natančni oceni razmerja tveganja/ koristi.
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.
Raziskave in vitro so pokazale, da so interakcije z zdravili, ki se presnavljajo s citokromom P450, glukuronidirajo ali konjugirajo na kakšen drug način, le malo verjetne.