natgillin/translations-raw huggingface dataset:
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
Nekateri bolniki z dolgo trajajočim diabetesom mellitusom tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z zdravilom Glustin in insulinom, so doživeli razvoj srčnega popuščanja.
50 In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
V kliničnih preskušanjih, v katerih so primerjali pioglitazon z drugimi peroralnimi antidiabetičnimi zdravili ali placebom (slepa tableta), so opazili večje število zlomov kosti pri ženskah (vendar ne pri
If you take more Glustin 15 mg tablets than you should:
Če ste vzeli večji odmerek tablet Glustin 15 mg, kot bi smeli:
If you forget to take Glustin 15 mg tablets:
Če ste pozabili vzeti tablete Glustin 15 mg:
Try to take Glustin 15 mg tablets daily as prescribed.
Poskušajte jemati tablete Glustin 15 mg vsak dan, kakor vam je predpisano.
Like all medicines, Glustin 15 mg tablets can have side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi tablete Glustin 15 mg neželene učinke.
The following side effects have been experienced by some patients taking Glustin 15 mg tablets:
Nekateri bolniki, ki so jemali tablete Glustin 15 mg, so izkusili naslednje neželene učinke, ki pa se ne pojavijo pri vseh bolnikih:
If you experience these
Če imate te simptome
symptoms for the first time or if they get worse tell your doctor as soon as possible.
prvič ali če se poslabšajo, povejte svojemu zdravniku kakor hitro je mogoče.
- a small reduction in red blood cell count.
- majhno znižanje števila rdečih krvničk
HOW TO STORE GLUSTIN
SHRANJEVANJE ZDRAVILA GLUSTIN
51 Medicines should not be disposed of via wastewater or household waste.
54 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The active substance is Glustin 15 mg tablets is pioglitazone.
Kaj vsebuje zdravilo Glustin Zdravilna učinkovina v tabletah Glustin 15 mg je pioglitazon.
Glustin 15 mg tablets are white to off-white, round, convex tablets marked 15 on one face, AD4 on the other..
Izgled zdravila Glustin in vsebina pakiranja Glustin 15 mg tablete so bele do umazano bele barve, okrogle, izbočene, z oznako 15 na eni strani in AD4 na drugi.
52 Ελλάδα Takeda Global Research and Development Centre (Europe) Ltd., Ηνω µένο Βασίλειο Τηλ: +44 (0)20 3116 8000
55 Ελλάδα Takeda Global Research and Development Centre (Europe) Ltd., Ηνωµένο Βασίλειο Τηλ: +44 (0) 20 3116 8000
53 PACKAGE LEAFLET
56 NAVODILO ZA UPORABO GLUSTIN 30 mg TABLETE
GLUSTIN 30 MG TABLETS (Pioglitazone (as hydrochloride))
pioglitazon (v obliki pioglitazonijevega klorida)
Glustin 30 mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Glustin 30 mg tablete so antidiabetično zdravilo za zdravljenje diabetesa mellitusa tipa 2 (od insulina neodvisnega diabetesa).
Glustin 30 mg tablets helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Glustin 30 mg tablete pomagajo nadzorovati raven sladkorja v krvi, če imate diabetes mellitus tipa 2, in sicer tako, da telesu pomagajo bolje izkoristiti insulin, ki ga izdela.
Glustin 30 mg tablets may be used on their own or in combination with metformin and/ or a sulphonylurea which are also oral anti-diabetic medicines.
Glustin 30 mg tablete lahko uporabljamo same ali skupaj z metforminom in/ ali sulfonilsečnino, ki sta tudi peroralni antidiabetični zdravili.
Glustin 30 mg tablets may also be used in combination with insulin.
Glustin 30 mg tablete se lahko uporabljajo tudi v kombinaciji z insulinom.
Do not take Glustin 30 mg tablets:
Ne jemljite tablet Glustin 30 mg:
30 mg tablets.
- Če ste preobčutljivi za (alergični na) pioglitazon ali katerokoli sestavino tablet Glustin 30 mg.
Take special care with Glustin 30 mg tablets:
Bodite posebno pozorni pri jemanju tablet Glustin 30 mg:
- If you have a special type of diabetic disease called macular oedema (swelling of the back of
- Če imate poseben tip diabetične očesne bolezni imenovane makularni edem (oteklina očesnega
the eye).
ozadja).
Taking Glustin 30 mg tablets with food and drink:
Jemanje tablet Glustin 30 mg skupaj s hrano in pijačo:
Important information about some of the ingredients of Glustin 30 mg tablets:
Pomembne informacije o nekaterih sestavinah zdravila Glustin 30 mg tablete:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glustin 30 mg tablets.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, pokličite svojega zdravnika preden vzamete Glustin 30 mg tablete.
You can usually continue to take other medicines whilst you are being treated with Glustin 30 mg tablets.
Običajno lahko med zdravljenjem s tabletami Glustin 30 mg nadaljujete z jemanjem drugih zdravil.
If you have the impression that the effect of Glustin 30 mg tablets is too weak, talk to your doctor.
Če menite, da je učinek tablet Glustin 30 mg prešibak, se posvetujte z zdravnikom.
Glustin 30 mg tablets can be taken with or without food.
Tablete Glustin 30 mg lahko vzamete s hrano ali brez nje.
When Glustin 30 mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Če boste jemali tablete Glustin 30 mg skupaj z drugimi zdravili za zdravljenje diabetesa (kot so insulin, klorpropamid, glibenklamid, gliklazid, tolbutamid), vam bo zdravnik povedal, ali morate jemati nižje odmerke teh zdravil.
If you are following a diabetic diet, you should continue with this while you are taking Glustin 30 mg tablets.
Če ste na diabetični dieti, jo med jemanjem tablet Glustin 30 mg nadaljujte.
55 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
Nekateri bolniki z dolgo trajajočim diabetesom mellitusom tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z Glustin in insulinom, so doživeli razvoj srčnega popuščanja.
In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
58 V kliničnih preskušanjih, v katerih so primerjali pioglitazon z drugimi peroralnimi antidiabetičnimi zdravili ali placebom (slepa tableta), so opazili večje število zlomov kosti pri ženskah (vendar ne pri moških), ki so jemale pioglitazon.
If you take more Glustin 30 mg tablets than you should:
Če ste vzeli večji odmerek tablet Glustin 30 mg, kot bi smeli:
If you forget to take Glustin 30 mg tablets:
Če ste pozabili vzeti tablete Glustin 30 mg:
Try to take Glustin 30 mg tablets daily as prescribed.
Poskušajte jemati tablete Glustin 30 mg vsak dan, kakor vam je predpisano.
Like all medicines, Glustin 30 mg tablets can have side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi tablete Glustin 30 mg neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following side effects have been experienced by some patients taking Glustin 30 mg tablets:
Nekateri bolniki, ki so jemali tablete Glustin 30 mg, so izkusili naslednje neželene učinke:
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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 GLUSTIN
SHRANJEVANJE TABLET GLUSTIN 30 mg
56 This medicinal product does not require any special storage precautions.
Za shranjevanje zdravila niso potrebna posebna navodila.
Medicines should not be disposed of via wastewater or household waste.
59 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The active substance in Glustin 30 mg tablets is pioglitazone.
Kaj vsebuje zdravilo Glustin Zdravilna učinkovina v tabletah Glustin 30 mg je pioglitazon.
Glustin 30 mg tablets are white to off white, round, flat tablets marked 30 on one face, AD4 on the other..
Izgled zdravila Glustin in vsebina pakiranja Glustin 30 mg tablete so bele do umazano bele barve, okrogle, ploščate, z oznako 30 na eni strani in AD4 na drugi.
Takeda Global Research and Development Centre (Europe) Ltd., 61 Aldwych, London, WC2B 4AE, United Kingdom.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London, WC2B 4AE, Velika Britanija.
Ελλάδα Takeda Global Research and Development Centre (Europe) Ltd., Ηνω µένο Βασίλειο Τηλ: +44 (0)20 3116 8000
60 Ελλάδα Takeda Global Research and Development Centre (Europe) Ltd., Ηνωµένο Βασίλειο Τηλ: +44 (0) 20 3116 8000
58 PACKAGE LEAFLET
61 NAVODILO ZA UPORABO GLUSTIN 45 mg TABLETE
GLUSTIN 45 MG TABLETS (Pioglitazone (as hydrochloride))
pioglitazon (v obliki pioglitazonijevega klorida)
Glustin 45 mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Glustin 45 mg tablete so antidiabetično zdravilo za zdravljenje diabetesa mellitusa tipa 2 (od insulina neodvisnega diabetesa).
Glustin 45 mg tablets helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Glustin 45 mg tablete pomagajo nadzorovati raven sladkorja v krvi, če imate diabetes mellitus tipa 2, in sicer tako, da telesu pomagajo bolje izkoristiti insulin, ki ga izdela.
Glustin 45 mg tablets may be used on their own or in combination with metformin and/ or a sulphonylurea which are also oral anti-diabetic medicines.
Glustin 45 mg tablete lahko uporabljamo same ali skupaj z metforminom ali sulfonilsečnino, ki sta tudi peroralni antidiabetični zdravili.
Glustin 45 mg tablets may also be used in combination with insulin.
Glustin 45 mg tablete se lahko uporabljajo tudi v kombinaciji z insulinom.
Do not take Glustin 45 mg tablets:
Ne jemljite tablet Glustin 45 mg:
45 mg tablets.
- Če ste preobčutljivi za (alergični na) pioglitazon ali katerokoli sestavino tablet Glustin 45 mg.
Take special care with Glustin 45 mg tablets:
Bodite posebno pozorni pri jemanju tablet Glustin 45 mg:
Taking Glustin 45 mg tablets with food and drink:
Jemanje tablet Glustin 45 mg skupaj s hrano in pijačo:
Important information about some of the ingredients of Glustin 45 mg tablets:
Pomembne informacije o nekaterih sestavinah zdravila Glustin 45 mg tablete:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glustin 45 mg tablets.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, pokličite svojega zdravnika preden vzamete Glustin 45 mg tablete.
You can usually continue to take other medicines whilst you are being treated with Glustin 45 mg tablets.
Običajno lahko med zdravljenjem s tabletami Glustin 45 mg nadaljujete z jemanjem drugih zdravil.
If you have the impression that the effect of Glustin 45 mg tablets is too weak, talk to your doctor.
Če menite, da je učinek tablet Glustin 45 mg prešibak, se posvetujte z zdravnikom.
Glustin 45 mg tablets can be taken with or without food.
Tablete Glustin 45 mg lahko vzamete s hrano ali brez nje.
When Glustin 45 mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Če boste jemali tablete Glustin 45 mg skupaj z drugimi zdravili za zdravljenje diabetesa (kot so insulin, klorpropamid, glibenklamid, gliklazid, tolbutamid), vam bo zdravnik povedal, ali morate jemati nižje odmerke teh zdravil.
If you are following a diabetic diet, you should continue with this while you are taking Glustin 45 mg tablets.
Če ste na diabetični dieti, jo med jemanjem tablet Glustin 45 mg nadaljujte.
60 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
Nekateri bolniki z dolgo trajajočim diabetesom mellitusom tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z Glustin in insulinom, so doživeli razvoj srčnega popuščanja.
If you take more Glustin 45 mg tablets than you should:
63 Če ste vzeli večji odmerek tablet Glustin 45 mg, kot bi smeli:
If you forget to take Glustin 45 mg tablets:
Če ste pozabili vzeti tablete Glustin 45 mg:
Try to take Glustin 45 mg tablets daily as prescribed.
Poskušajte jemati tablete Glustin 45 mg vsak dan, kakor vam je predpisano.
Like all medicines, Glustin 45 mg tablets can have side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi tablete Glustin 45 mg neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The following side effects have been experienced by some patients taking Glustin 45 mg tablets:
Nekateri bolniki, ki so jemali tablete Glustin 45 mg, so izkusili naslednje neželene učinke:
HOW TO STORE GLUSTIN
SHRANJEVANJE TABLET GLUSTIN 45 mg
61 Do not use after the expiry date stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
The active substance in Glustin 45 mg tablets is pioglitazone.
Kaj vsebuje zdravilo Glustin Zdravilna učinkovina v tabletah Glustin 45 mg je pioglitazon.
Glustin 45 mg tablets are white to off white, round, flat tablets marked 45 on one face, AD4 on the other..
Izgled zdravila Glustin in vsebina pakiranja Glustin 45 mg tablete so bele do umazano bele barve, okrogle, ploščate, z oznako 45 na eni strani in AD4 na drugi.
España Takeda Farmacéutica España, S. A.
65 España Takeda Farmacéutica España, S. A.
What is GONAL-f?
Kaj je zdravilo GONAL- f?
GONAL-f is available either as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection.
Zdravilo GONAL- f je na voljo bodisi v obliki raztopine za injiciranje v napolnjenem peresu bodisi v obliki praška in vehikla, iz katerih se pripravi raztopina za injiciranje.
GONAL-f contains the active substance follitropin alfa.
Zdravilo GONAL- f vsebuje zdravilno učinkovino folitropin alfa.
What is GONAL-f used for?
Za kaj se zdravilo GONAL- f uporablja?
GONAL-f is used to treat women in the following cases: • Women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation). • Women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Zdravilo GONAL- f se uporablja za zdravljenje v naslednjih primerih: • Ženske z anovulacijo (ne nastajajo jajčeca) in ženske, ki se niso odzvale na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja ovulacijo). • Ženske, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je in vitro oploditev).
GONAL-f is administered to stimulate the ovaries to produce more than one egg at the time. • Women with severe hormone deficiency for luteinising hormone (LH) and follicle stimulating hormone (FSH).
Zdravilo GONAL- f se daje za spodbujanje jajčnikov k izdelavi več kot enega jajčeca naenkrat. • Ženske s hudo pomanjkljivostjo luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH).
GONAL-f is administered together with a LH preparation to stimulate egg maturation in the ovaries.
Zdravilo GONAL- f se daje skupaj s pripravkom LH za spodbujanje zorenja jajčec v jajčnikih.
GONAL-f can also be used together with human Chorionic Gonadotrophin (hCG) to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Zdravilo GONAL- f se lahko uporabi tudi sočasno s človeškim horionskim gonadotropinom (hCG) za spodbujanje nastajanja sperme pri moških, ki imajo hipogonadotropni hipogonadizem (redka bolezen pomanjkljivosti hormonov).
GONAL-f can only be obtained with a prescription.
Zdravilo GONAL- f se dobi samo na recept.
How is GONAL-f used?
Kako se zdravilo GONAL- f uporablja?
Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems.
Zdravljenje z zdravilom GONAL- f mora izvajati zdravnik, ki ima izkušnje pri zdravljenju težav s plodnostjo.
GONAL-f is given subcutaneously (under the skin).
Zdravilo GONAL- f se daje subkutano (pod kožo).
If using the powder, it should be mixed with the solvent provided just before use, and the contents of more than one vial of powder can be dissolved in one vial of solvent if needed.
Vsebina ene ali več vial praška se lahko zmeša v eni viali vehikla, če je treba.
The patient or their partner may carry out subcutaneous injection of GONAL-f if they have been properly instructed.
Podkožno injiciranje zdravila GONAL- f lahko po ustreznih navodilih opravljata bolnica/ bolnik ali partner/ partnerka.
The dosage and frequency of administration of GONAL-f depend on its use (see above) and the patient ’ s response to treatment.
Odmerjanje in pogostnost uporabe zdravila GONAL- f sta odvisna od namena (glejte zgornje besedilo) in terapevtski odziv bolnika.
For a full description of the dosages, please see the Package Leaflet.
Celoten opis odmerjanja najdete v Navodilih za uporabo.
How does GONAL-f work?
Kako zdravilo GONAL- f deluje?
The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH (follicle stimulating hormone).
Zdravilna učinkovina zdravila GONAL- f, folitropin alfa, je kopija naravnega hormona FSH (folikle stimulirajočega hormona).
In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs and in men, it stimulates the production of sperm by the testicles.
V telesu FSH uravnava funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških spodbuja nastajanje sperme v modih.
Previously, the FSH used as a medicine was extracted from urine.
V preteklosti so v medicini uporabljali FSH, ki je bil izločen iz urina.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Folitropin alfa v zdravilu GONAL- f je izdelan z metodo, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 GONAL-f 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 imenovano „ tehnologija rekombinantne DNA “.
The effectiveness of GONAL-f has been studied as part of an assisted reproductive procedure in 470 patients, and in 222 women who could not ovulate.
Učinkovitost zdravila GONAL- f je bila preučena kot del postopka asistirane reprodukcije pri 470 bolnicah in 222 ženskah, ki niso bile zmožne ovulacije.
In these studies, GONAL-f was compared to human FSH that had been extracted from urine.
V teh raziskavah so zdravilo GONAL- f primerjali s FSH, ki je bil izločen iz urina.
GONAL-f has also been studied in 38 women with severe LH/ FSH deficiency and in 19 men with hypogonadotrophic hypogonadism.
Zdravilo GONAL- f so preučili tudi pri 38 ženskah s hudo pomanjkljivostjo LH/ FSH in 19 moških s hipogonadotropnim hipogonadizmom.
Because of the rarity of the conditions, these two studies were uncontrolled (GONAL-f was not compared to another treatment).
Zaradi redkosti tega stanja sta bili ti dve raziskavi nekontrolirani (zdravila GONAL- f niso primerjali z drugim zdravljenjem).
What benefit has GONAL-f shown during the studies?
Kakšne koristi je zdravilo GONAL- f izkazalo med raziskavami?
GONAL-f was as effective as the comparator to stimulate ovaries during assisted reproductive procedures.
Zdravilo GONAL- f je bilo pri spodbujanju jajčnikov med postopki asistirane reprodukcije enako učinkovito kot primerjano zdravilo.
In women who could not ovulate, GONAL-f produced ovulation in 84% of women compared with 91% for the Comparator.
Pri ženskah, ki niso zmožne ovulacije, je zdravilo GONAL- f izzvalo ovulacijo pri 84% ženskah, primerjano zdravilo pa pri 91% ženskah.
It was also effective in triggering egg development in women with severe LF/ FSH deficiency.
Zdravilo GONAL- f je bilo tudi učinkovito za sprožitev nastajanja jajčec pri ženskah s hudo pomanjkljivostjo LH/ FSH.
In the study in men GONAL-f was effective in stimulating sperm production:
V raziskavi pri moških je bilo zdravilo GONAL- f učinkovito pri spodbujanju nastajanja sperme:
63% of patients achieved sperm counts above 1.5 million/ ml.
63% bolnikov je doseglo koncentracijo spermijev nad 1, 5 milijona/ ml.
The studies in women with severe LH/ FSH deficiency and in men with hypogonadotrophic hypogonadism had low numbers of patients but were acceptable because these are rare conditions.
V raziskave pri ženskah s hudo pomanjkljivostjo LH/ FSH in moških s hipogonadotropnim hipogonadizmom je bilo vključeno majhno število bolnikov, vendar so bile raziskave sprejemljive zaradi redkosti teh bolezni.
What is the risk associated with GONAL-f?
Kakšna tveganja so povezana z zdravilom GONAL- f?
The most common side effects (seen in more than 1 patient in 10) are ovarian cysts, local reactions at the site of the injection (pain, redness, bruising, swelling and/ or irritation), and headache.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili ovarijske ciste, lokalne reakcije na mestu injiciranja (bolečina, pordelost, modrica, oteklina in/ ali razdraženost kože) in glavobol.
For the full list of all side effects reported with GONAL-f, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila GONAL- f, najdete v Navodilih za uporabo.
Sometimes, the ovaries can over-respond to treatment, especially when hCG has been used (ovarian hyperstimulation syndrome), and both doctors and patients must be aware of this possibility.
Na to možnost morajo biti pozorni zdravniki in bolnice.
GONAL-f must not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients, or in patients with tumours of the pituitary gland, hypothalamus, breast, uterus, or ovary.
Zdravilo GONAL- f ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) folitropin alfa, FSH ali katerokoli drugo sestavino zdravila, in bolniki s tumorji hipofize, hipotalamusa, dojk, maternice ali jajčnikov.
It should not be used when an effective response cannot be obtained (such as in patients with primary ovarian or testicular failure).
Zdravilo se ne sme uporabiti, kadar ni mogoče doseči učinkovitega odziva (npr. pri bolnicah s primarno odpovedjo jajčnikov ali bolnikih z odpovedjo mod).
In women, it must not be used when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or vaginal bleeding.
Pri ženskah se zdravilo ne sme uporabiti, če imajo povečanje jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni ali nožnične krvavitve.
Why has GONAL-f been approved?
Zakaj je bilo zdravilo GONAL- f odobreno?