natgillin/translations-raw huggingface dataset:
Patients with hepatic impairment There is no pharmacokinetic data in patients with hepatic impairment.
Bolnice z jetrnim popuščanjem Za bolnice z jetrnim popuščanjem ni farmakokinetičnih podatkov.
5.3 Preclinical safety data
8 5. 3 Predklinični podatki o varnosti
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in karcinogenega potenciala ne kažejo posebnega tveganja za človeka.
Chronic oral administration of strontium ranelate at high doses in rodents induced bone and tooth abnormalities, mainly consisting of spontaneous fractures and delayed mineralisation.
Kronično peroralno dajanje stroncijevega ranelata v velikih odmerkih glodalcem je povzročilo nepravilnosti v kosteh in zobeh, predvsem spontane zlome in zapoznelo mineralizacijo.
These effects were reported at bone strontium levels 2-3 times higher than long-term clinical bone strontium levels and were reversible after cessation of treatment.
O tovrstnih učinkih so poročali pri vrednostih stroncija v kosteh, ki so bile 2 - do 3- krat večje od dolgoročnih kliničnih in so po prekinitvi zdravljenja izginili.
8 Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e. g. bent long bones and wavy ribs) in the offspring.
Študije razvojne toksičnosti pri podganah in zajcih so pokazale nepravilnosti v kosteh in zobeh (na primer ukrivljene dolge kosti in valovita rebra) pri potomstvu.
Aspartame (E951) Maltodextrin Mannitol (E421)
aspartam (E 951) maltodekstrin manitol (E 421)
Paper/ polyethylene/ aluminium/ polyethylene sachets.
Vrečke iz papirja/ polietilena/ aluminija/ polietilena.
Pack sizes Boxes containing 7, 14, 28, 56, 84 or 100 sachets.
Velikost pakiranja Škatle vsebujejo 7, 14, 28, 56, 84 ali 100 vrečk.
LES LABORATOIRES SERVIER 22, rue Garnier 92200 Neuilly-sur-Seine France
LES LABORATOIRES SERVIER 22, rue Garnier 92200 Neuilly- sur- Seine Francija
11 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France
Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy Francija
Outer carton
ŠKATLA
Each sachet contains 2 g strontium ranelate.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
7 sachets
zrnca za peroralno suspenzijo 7 vrečk
For oral use Read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
14 sachets
zrnca za peroralno suspenzijo 14 vrečk
28 sachets
zrnca za peroralno suspenzijo 28 vrečk
56 sachets [84 sachets] [100 sachets]
zrnca za peroralno suspenzijo 56 vrečk [84 vrečk] [100 vrečk]
EU/ 1/ 04/ 287/ 004 56 sachets EU/ 1/ 04/ 287/ 005/ 84 sachets EU/ 1/ 04/ 287/ 006 100 sachets
EU/ 1/ 04/ 287/ 004 56 vrečk EU/ 1/ 04/ 287/ 005 84 vrečk EU/ 1/ 04/ 287/ 006 100 vrečk
Sachet
VREČKA
Strontium ranelate.
POSTOPEK UPORABE
What OSSEOR is and what it is used for 2.
Kaj je zdravilo OSSEOR in za kaj ga uporabljamo 2.
Before you take OSSEOR 3.
Kaj morate vedeti, preden boste vzeli zdravilo OSSEOR 3.
How to take OSSEOR 4.
Kako jemati zdravilo OSSEOR 4.
How to store OSSEOR 6.
Shranjevanje zdravila OSSEOR 6.
WHAT OSSEOR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OSSEOR IN ZA KAJ GA UPORABLJAMO
OSSEOR is a non-hormonal medicine used to treat osteoporosis in postmenopausal women.
OSSEOR je nehormonsko zdravilo za zdravljenje osteoporoze pri ženskah v obdobju po menopavzi.
OSSEOR reduces the risk of fracture at the spine and at the hip.
OSSEOR zmanjšuje tveganje za zlome v hrbtenici in kolku.
About osteoporosis Your body is constantly breaking down old bone and making new bone tissue.
O osteoporozi Telo neprestano razgrajuje staro kost in tvori novo kostno tkivo.
This is especially common in women after the menopause (change of life).
Zlasti pogosto se to dogaja pri ženskah v obdobju po menopavzi (sprememba življenja).
How OSSEOR works OSSEOR belongs to a group of medicines used to treat bone diseases.
Kako OSSEOR deluje OSSEOR spada v skupino zdravil za zdravljenje bolnikov z boleznimi kosti.
BEFORE YOU TAKE OSSEOR
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO OSSEOR
Do not take OSSEOR:
Ne jemljite zdravila OSSEOR:
- if you are allergic (hypersensitive) to strontium ranelate or any of the other ingredients of
- če ste alergični (preobčutljivi) na stroncijev ranelat ali katerokoli sestavino zdravila OSSEOR.
Before taking OSSEOR talk to your doctor:
Bodite posebno pozorni pri uporabi zdravila OSSEOR Pred jemanjem zdravila OSSEOR se pogovorite s svojim zdravnikom:
- if you have severe kidney disease.
- če imate hudo bolezen ledvic;
- if you are being treated or have been treated for blood clots.
- kadar se zdravite zaradi krvnih strdkov ali ste se zaradi njih zdravili v preteklosti;
- if you are confined to bed or if you are to undergo an operation.
- če ste priklenjeni na posteljo ali čakate na operacijo.
The risk of vein thrombosis
Tveganje venske tromboze (krvnih strdkov
(blood clots in the leg) may be increased in the event of lengthy immobilisation.
v nogah) se lahko poveča, če ste dlje časa negibljivi;
- OSSEOR is not intended for use in children and adolescents.
- OSSEOR ni namenjen otrokom in mladostnikom.
25 During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice.
25 in poiskati zdravniško pomoč.
If you have stopped treatment due to hypersensitivity reactions it should be permanent and you should not re-start therapy with OSSEOR.
Če ste prenehali z zdravljenjem zaradi preobčutljivostnih reakcij, naj bo prenehanje trajno in zdravljenja z zdravilom OSSEOR ne začnite ponovno.
If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.
Če jemljete zdravila, ki vsebujejo kalcij, je priporočljivo počakati najmanj 2 uri, preden boste vzeli OSSEOR.
You should stop taking OSSEOR if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Prenehajte jemati OSSEOR, če se zdravite s peroralnimi tetraciklini ali kinoloni (dve vrsti antibiotikov).
Taking OSSEOR with food and drink:
Jemanje zdravila OSSEOR skupaj s hrano in pijačo:
Therefore, OSSEOR should not be taken during pregnancy.
OSSEOR je namenjen le ženskam v obdobju po menopavzi in ga torej ne smete jemati med nosečnostjo.
If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
Če ga med nosečnostjo nehote zaužijete, takoj prenehajte z jemanjem in se posvetujte z zdravnikom.
OSSEOR is meant for use only in postmenopausal women.
OSSEOR je namenjen le ženskam v obdobju po menopavzi in ga torej ne smete jemati med dojenjem.
If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.
Če ga med dojenjem nehote zaužijete, takoj prenehajte z jemanjem in se posvetujte z zdravnikom.
OSSEOR is not known to affect your ability to drive or use machines.
Ni znano, da bi OSSEOR vplival na vašo sposobnost upravljanja vozil in strojev.
Important information about some of the ingredients of OSSEOR:
Pomembne informacije o nekaterih sestavinah zdravila OSSEOR:
OSSEOR contains aspartame.
OSSEOR vsebuje aspartam.
If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Če imate fenilketonurijo (redka dedna motnja presnove), se posvetujte z zdravnikom, preden boste začeli jemati to zdravilo.
HOW TO TAKE OSSEOR
KAKO JEMATI ZDRAVILO OSSEOR
Always take OSSEOR exactly as your doctor has told you.
Pri jemanju zdravila OSSEOR vedno natančno upoštevajte zdravnikova navodila.
It is recommended that you take OSSEOR at bedtime.
Priporočljivo je, da OSSEOR jemljete pred spanjem.
OSSEOR can interact with milk and milk products, so it is important that you mix OSSEOR only with water to be sure it works properly.
OSSEOR lahko medsebojno deluje z mlekom in mlečnimi izdelki, zato je za pravilno delovanje pomembno, da OSSEOR mešate le z vodo.
26 Empty the granules from the sachet into a glass;
26 Zrnca stresite iz vrečke v kozarec.
If for some reason you do not drink the medicine straight away, make sure you stir it again before drinking.
Če iz kakršnegakoli vzroka zdravila ne popijete takoj, ga morate pred pitjem ponovno premešati.
Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
Zdravnik vam lahko poleg zdravila OSSEOR svetuje pripravke kalcija in vitamina D.
Do not take calcium supplements at bedtime, at the same time as OSSEOR.
Ne jemljite kalcijevih pripravkov pred spanjem hkrati z zdravilom OSSEOR.
If you take more OSSEOR than you should:
Če ste vzeli večji odmerek zdravila OSSEOR, kot bi smeli:
Like all medicines, OSSEOR can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo OSSEOR neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
During clinical trials, the most common side effects were nausea, diarrhoea, headache and skin irritation.
V kliničnih študijah so bili najpogostejši neželeni učinki slabost, diareja, glavobol in vzdražena koža.
Other events less commonly reported included blood clots, fainting fit, memory troubles and, in rare cases, seizures.
Drugi dogodki, o katerih so poročali redkeje, zajemajo krvne strdke, omedlevico, težave s spominom in pri redkih bolnikih napade.
The following side effects have also been reported by patients taking OSSEOR: vomiting, abdominal pain, oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/ or joint pain, muscle cramps, hypersensitivity syndromes (allergic reactions including rash and fever), itching, hives, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling confused.
Neželeni učinki, o katerih so pri bolnicah, ki so prejemale zdravilo OSSEOR, tudi poročali, so: bruhanje, bolečine v trebuhu, razdraženje ust (kot so ustne razjede ali vnetje dlesni), bolečine v kosteh, mišicah in/ ali sklepih, mišični krči, preobčutljivostni sindromi (alergijske reakcije, vključno s kožnim izpuščajem in zvišano telesno temperaturo), srbenje, koprivnica, angioedem (kot so zatekel obraz, jezik ali grlo, težave pri dihanju ali požiranju), otekanje okončin, občutek zmedenosti.
In some cases very serious hypersensitivity reactions have been reported.
V nekaterih primerih so poročali o zelo hudih preobčutljivostnih reakcijah.
Therefore you should immediately stop taking OSSEOR and see your doctor if you experience symptoms of angioedema or hypersensitivity syndrome.
Zato morate zdravilo OSSEOR prenehati jemati in takoj obiskati svojega zdravnika, če opazite znake angioedema ali preobčutljivostnega sindroma.
If you have stopped treatment due to hypersensitivity syndrome, it should be permanent and you should not re-start therapy with OSSEOR.
Če ste prenehali z zdravljenjem zaradi preobčutljivostnega sindroma, naj bo prenehanje trajno in zdravljenja z zdravilom OSSEOR ne začnite ponovno.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
27 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE OSSEOR
SHRANJEVANJE ZDRAVILA OSSEOR
Do not use after the expiry date which is stated on the box and the sachet.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in vrečki.
What OSSEOR contains
Kaj vsebuje zdravilo OSSEOR
- The active substance is strontium ranelate.
- Zdravilna učinkovina je stroncijev ranelat.
- The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
- Pomožne snovi so aspartam (E 951), maltodekstrin, manitol (E 421).
What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension. OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Izgled zdravila OSSEOR in vsebina pakiranja OSSEOR je na voljo v vrečkah, ki vsebujejo rumena zrnca za peroralno suspenzijo Škatle zdravila OSSEOR vsebujejo 7, 14, 28, 56, 84 ali 100 vrečk.
Marketing Authorisation Holder Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine France
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 22, rue Garnier 92200 Neuilly- sur- Seine Francija
Manufacturer Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France
Izdelovalec Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy Francija
This leaflet was last approved in {date}
{datum}
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacijo podlagi za priporočia CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Ovitrelle is a powder and solvent to be made up into a solution for injection.
Zdravilo Ovitrelle je prašek in vehikel za pripravo raztopine za injiciranje.
It is also available as a solution in a pre-filled syringe.
Na voljo je tudi kot raztopina v predhodno napolnjeni brizgi.
Ovitrelle contains the active substance choriogonadotropin alfa.
Zdravilo Ovitrelle vsebuje zdravilno učinkovino horiogonadotropin alfa.
Ovitrelle is used to treat women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of eggs by the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy.
Zdravilo Ovitrelle se uporablja pri ženskah, ki so že prejemale zdravljenje za stimulacijo jajčnikov, za sprožitev ovulacije (sprostitve jajčec iz jajčnikov) in za razvoj posebne strukture na jajčniku (rumeno telesce), kar pomaga pri zanositvi.
It can be used in women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation), and in women who are anovulatory (do not produce eggs) or oligo-ovulatory (rarely produce eggs).
Lahko se uporablja pri ženskah, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je npr. oploditev in vitro), in pri ženskah brez ovulacije (ne tvorijo jajčec) ali z oligoovulacijo (redko tvorijo jajčeca).
Ovitrelle can only be obtained with a prescription.
Zdravilo Ovitrelle se dobi samo na recept.
Treatment with Ovitrelle should be carried out by a doctor who has experience in the treatment of fertility problems.
Zdravljenje z zdravilom Ovitrelle mora izvajati zdravnik z izkušnjami pri zdravljenju težav s plodnostjo.
Ovitrelle is given subcutaneously (under the skin).
Zdravilo Ovitrelle se daje s subkutano injekcijo (pod kožo).
The powder should be mixed with the solvent provided just before use.
Neposredno pred uporabo se prašek zmeša s priloženim vehiklom.
One vial of Ovitrelle (250 micrograms) is given 24 to 48 hours after the ovaries have produced follicle(s) that are mature enough (eggs ready for ovulation).
Eno vialo zdravila Ovitrelle (250 mikrogramov) se injicira 24 do 48 ur potem, ko so jajčniki proizvedli dovolj zrele folikle (jajčeca, pripravljena za ovulacijo).
In women undergoing fertility treatment, this is generally 24 to 48 hours after stopping the prior treatment for ovarian stimulation (such as a follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG) preparation).
Pri ženskah, ki se zdravijo zaradi težav s plodnostjo, se to običajno zgodi 24 do 48 ur potem, ko je bilo končano predhodno zdravljenje za stimulacijo jajčnikov (npr. s pripravkom, ki vsebuje folikle stimulirajoči hormon (FSH) ali humani menopavzni gonadotropin (hMG)).
The active substance in Ovitrelle, choriogonadotropin alfa, is a copy of the natural hormone human chorionic gonadotropin (hCG), also known as the ‘ pregnancy’ hormone, In the body, hCG is present during pregnancy, where it helps maintaining the corpus luteum, and consequently maintaining pregnancy.
Zdravilna učinkovina horiogonadotropin alfa v zdravilu Ovitrelle je posnetek naravnega humanega horionskega gonadotropina (hCG), znanega tudi pod imenom » nosečnostni « hormon.
In fertility treatments, hCG is used because it is similar to luteinising hormone (LH), the hormone that triggers ovulation during the menstrual cycle.
Med nosečnostjo je hCG prisoten v telesu, kjer ohranja rumeno telesce in posledično nosečnost.
The choriogonadotropin alfa in Ovitrelle is produced by a method known as ‘ recombinant DNA technology’.
Pri zdravljenju težav s plodnostjo se hCG uporablja zato, ker je podoben luteinizirajočemu hormonu (LH), ki sproža ovulacijo med menstrualnim ciklusom.
It is made by a cell that has received a gene (DNA), which makes it able to produce human chorionic gonadotropin.
Horiogonadotropin alfa v zdravilu Ovitrelle se proizvaja po metodi, imenovani » tehnologija rekombinantne DNK «: proizvaja ga celica, ki je prejela gen (DNK), ki ji omogoča tvorjenje humanega horionskega gonadotropina.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Ovitrelle was measured by looking at how many eggs could be released.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©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 Ovitrelle raziskano?
Ovitrelle was compared to the natural hCG hormone that had been extracted from urine.
Zdravilo Ovitrelle so primerjali z naravnim hormonom hCG, pridobljenim iz urina.
One study has also been carried out in women who cannot ovulate.
Ena raziskava je bila opravljena tudi pri ženskah, ki niso imele ovulacije.
What benefit has Ovitrelle shown during the studies?
Kakšne koristi je zdravilo Ovitrelle izkazalo med raziskavami?
Ovitrelle was as effective as urinary hCG in producing ovulation, and the 250 micrograms dose of Ovitrelle was as effective as the 500 micrograms dose.
250 mikrogramski odmerek zdravila Ovitrelle je bil enako učinkovit kot 500 mikrogramski.
In anovulatory women, ovulation was seen in 91.9% of women treated with Ovitrelle.
Pri 91, 9% žensk brez ovulacije, ki so se zdravile z zdravilom Ovitrelle, je prišlo do ovulacije.
The most common side effects (seen in between 1 and 10 patients in 100) are a reaction or pain at the injection site, headache, tiredness, vomiting, nausea (feeling sick), abdominal (tummy) pain, and ovarian hyperstimulation syndrome (e. g. feeling sick, weight gain, diarrhoea).
Najpogostejši neželeni stranski učinki (opaženi pri 1 do 10 bolnicah izmed 100) so reakcije ali bolečina na mestu injiciranja, glavobol, utrujenost, bruhanje, slabost, bolečina v trebuhu in sindrom hiperstimulacije jajčnikov (t. j. slabost, pridobivanje telesne teže, driska).
Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment, especially when medicines to trigger ovulation have been used.
Sindrom hiperstimulacije jajčnikov nastopi, kadar se jajčniki preveč odzovejo na zdravljenje, še posebej, če so uporabljena zdravila za sprožitev ovulacije.
Ovitrelle should not be used in people who may be hypersensitive (allergic) to choriogonadotropin alfa or any of the other ingredients, or in patients with tumours of the hypothalamus and pituitary gland, ovary, uterus or breast.
Zdravila Ovitrelle ne smejo jemati osebe, ki utegenejo biti preobčutljive (alergične) na horiogonadotropin alfa ali katero drugo sestavino tega zdravila oz. bolniki, ki imajo tumorje hipotalamusa, hipofize, jajčnikov, maternice ali dojke.
It should not be used when a response cannot be obtained (such as in ovarian failure).
Ne sme se uporabljati kadar terapevtskega odziva ni mogoče doseči (npr. pri insuficienci jajčnikov).
It should not be used in women when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or unexplained vaginal bleeding, or who have had an ectopic pregnancy in the previous 3 months.
Ravno tako se ne sme uporabljati v primeru povečanja jajčnikov ali ciste, ki ni posledica policistične bolezni jajčnikov, kakor tudi ne v primeru nepojasnjene krvavitve iz nožnice ali pri ženskah, ki so imele v zadnjih 3 mesecih zunajmaternično nosečnost.
Ovitrelle should also not be used in patients with active thrombo-embolic (clotting) disorders.
Zdravila Ovitrelle se prav tako ne sme uporabljati pri bolnicah z aktivnimi tromboemboličnimi motnjami (strdki).
The Committee for Medicinal products for Human Use (CHMP) decided that Ovitrelle’ s benefits are greater than its risks for women who need to ovulate before fertility treatment and in women who are anovulatory or oligo-ovulatory.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ovitrelle pri zdravljenju žensk, pri katerih je potrebno spodbuditi ovulacijo pred zdravljenjem neplodnosti ter pri ženskah brez ovulacije ali z oligoovulacijo, večje od z njim povezanih tveganj.
They recommended that Ovitrelle be given marketing authorisation.
Zato je priporočil, da se za zdravilo Ovitrelle podeli dovoljenje za promet.
Other information about Ovitrelle:
Druge informacije o zdravilu Ovitrelle:
The European Commission granted a marketing authorisation valid throughout the European Union, for Ovitrelle to Serono Europe Limited on 2 February 2001.
Evropska komisija je dovoljenje za promet z zdravilom Ovitrelle, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Limited dne 2. februarja 2001.
The marketing authorisation was renewed on 2 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 2. februarja 2006.
The full EPAR for Ovitrelle is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ovitrelle je na voljo tukaj.
EU/ 1/ 00/ 165/ 001
Številka EU EU/ 1/ 00/ 165/ 001
Ovitrelle
Zaščiteno ime Ovitrelle
250 micrograms
Jakost 250 mikrogramov
Powder: vial (glass) Solvent: ampoule (glass)
Ovojnina prašek: viala (steklo); vehikel: ampula (steklo)
Powder:
Vsebina prašek:
250 micrograms Solvent:
250 µg; vehikel:
1 vial + 1 ampoule
Velikost pakiranja 1 viala + 1 ampula
Powder: vial (glass) Solvent: ampoule (glass)
prašek: viala (steklo); vehikel: ampula (steklo)
2 vials + 2 ampoules
2 viali+ 2 ampuli
10 vials + 10 ampoules
10 vial+ 10 ampul
Powder: vial (glass) Solvent: vial (glass)
prašek: viala (steklo); vehikel: ampula (steklo)
2 vials + 2 vials
2 viali+ 2 viali
10 vials + 10 vials
10 vial+ 10 vial
250 micrograms/ Solution for injection 0.5 ml
250 mikrogramov / 0, 5 ml
Pre-filled syringe (glass)
napolnjena injekcijska brizga (steklo)
Ovitrelle 250 micrograms powder and solvent for solution for injection
Ovitrelle 250 mikrogramov prašek in vehikel za raztopino za injiciranje.
To ensure delivery of a 250 microgram dose, each vial contains 285 micrograms of choriogonadotropin alfa.
Za zagotovitev 250 mikrogramskega odmerka vsebuje vsaka viala 285 mikrogramov horiogonadotropina alfa.
Choriogonadotropin alfa is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Horiogonadotropin alfa je pridobljen s tehnologijo rekombinantne DNA iz celic jajčnika kitajskega hrčka.
A dose of 250 micrograms is equivalent to approximately 6500 IU.
Odmerek 250 mikrogramov ustreza približno 6. 500 i. e.
30 mg sucrose
30 mg saharoze.
Appearance of the powder:
Videz praška: bele do belkaste pelete.
White to off-white pellet Appearance of the solvent:
Videz vehikla: bistra brezbarvna raztopina.
The pH of the reconstituted solution is 6.5 – 7.5
pH rekonstituirane raztopine je 6, 5 – 7, 5.
Ovitrelle is indicated in the treatment of:
Ovitrelle je indiciran za zdravljenje:
Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Žensk, ki so v postopku sprožitve superovulacije pred postopki asistirane reprodukcije, kot je npr. in vitro oploditev (IVF):