natgillin/translations-raw huggingface dataset:
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Vialmix operaterja opozori, če je frekvenca stresanja 5% ali več pod ciljno frekvenco.
It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Prav tako je programiran, da se izključi in odda vidno in slišno opozorilo, če frekvenca stresanja preseže ciljno frekvenco za 5% ali se zmanjša za 10% pod njo.
- The vial should be activated using the Vialmix.
- Z Vialmixom aktivirajte vialo.
Immediately after activation, Luminity appears as a
Takoj po aktiviranju je zdravilo Luminity videti kot mlečno bela
milky white dispersion.
disperzija.
- The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before
- Preden izvlečete disperzijo, zabodite v vialo sterilno injekcijsko iglo ali sterilno, nesilikonizirano
withdrawing the dispersion.
mini- konico, da bo viala odzračena.
- The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile
- Disperzijo morate izvleči iz viale z brizgo, ki ima nameščeno sterilno iglo številka 18 do 20 ali
needle or attached to a sterile non-siliconised mini-spike.
sterilno nesilikonizirano mini- konico.
- Luminity may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose
- Zdravilo Luminity lahko razredčite z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje ali
50 mg/ ml (5%) solution for injection.
s 50 mg/ ml (5%) raztopino glukoze za injiciranje.
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / Brussel Belgium
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Belgija
2.800 I-04010 Sermoneta (Latina) Italy
2. 800 I- 04010 Sermoneta (Latina) Italija
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren
Luminity 150 mikrolitrov/ ml raztopina za disperzijo za injiciranje ali infundiranje perflutren
Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μ m (approximately 150 μ l perflutren gas per ml).
En mililiter vsebuje največ 6, 4 x 109 perflutren vsebujočih lipidnih mikrosfer s povprečnim razponom premera od 1, 1 do 2, 5 μm (približno 150 μl plina perflutrena na mililiter).
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
1, 2- dipalmitoil- sn- glicero- 3- fosfatidilholin (DPPC), 1, 2- dipalmitoil- sn- glicero- 3 - fosfatidilna kislina, mononatrijeva sol (DPPA), N - (metoksipolietilenglikol 5000 karbamoil) - 1, 2 - dipalmitoil- sn- glicero- 3- fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol, voda za injekcije
1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
raztopina za disperzijo za injiciranje ali infundiranje 1 x 1, 5- ml viala z enim odmerkom 4 x 1, 5- ml viale z enim odmerkom
EXP After activation: use within 12 hours
Po aktiviranju: uporabite v 12 urah.
Store in a refrigerator After activation:
Shranjujte v hladilniku.
Do not store above 30°C
Po aktiviranju:
Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / BrusselBelgium
Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Belgija
EU/ 1/ 06/ 361/ 001 4 single-dose vials EU/ 1/ 06/ 361/ 002 1 single-dose vial
EU/ 1/ 06/ 361/ 001 4 viale z enim odmerkom EU/ 1/ 06/ 361/ 002 1 viala z enim odmerkom
As Luminity is only intended for administration by healthcare professionals no information will be included in Braille.
Luminity bodo aplicirali le zdravstveni delavci, zato podatki v Braillovi pisavi ne bodo vključeni.
Luminity 150 microlitres/ ml solution for dispersion for injection or infusion Perflutren Intravenous use
Luminity 150 mikrolitrov/ ml raztopina za disperzijo za injiciranje ali infundiranje perflutren intravenska uporaba
Read all of this leaflet carefully before you are given this medicine.
Preden dobite to zdravilo, natančno preberite navodilo!
What Luminity is and what it is used for 2.
Kaj je zdravilo Luminity in za kaj ga uporabljamo 2.
Before you are given Luminity 3.
Kaj morate vedeti, preden boste dobili zdravilo Luminity 3.
How Luminity is given 4.
Kako dajemo zdravilo Luminity 4.
How to store Luminity 6.
Shranjevanje zdravila Luminity 6.
WHAT LUMINITY IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LUMINITY IN ZA KAJ GA UPORABLJAMO
Luminity is an ultrasound contrast agent that contains tiny gas bubbles.
Zdravilo Luminity je kontrastno sredstvo za ultrazvočne preiskave, ki vsebuje drobne plinske mehurčke.
It enhances the images seen with ultrasound and helps your doctor to get a clearer picture (scan) of your heart.
Zdravilo Luminity ojača ultrazvočni prikaz in zdravniku pomaga, da dobi jasnejše slike (posnetke) srca.
BEFORE YOU ARE GIVEN LUMINITY
KAJ MORATE VEDETI, PREDEN BOSTE DOBILI ZDRAVILO LUMINITY
Do not use Luminity
Ne uporabljajte zdravila Luminity
- if you are allergic (hypersensitive) to perflutren or any of the other ingredients of Luminity.
- če ste alergični (preobčutljivi) na perflutren ali katerokoli sestavino zdravila Luminity.
Luminity should not be used in children and adolescents as it has not been studied in these groups.
Zdravila Luminity se ne sme uporabljati pri otrocih in mladostnikih, ker v teh starostnih skupinah ni raziskano.
Take special care with Luminity
Bodite posebno pozorni pri uporabi zdravila Luminity
- if you have been told you have a heart shunt
- če so vam povedali, da imate srčni spoj (šant),
- if you have severe heart or lung diseases
- če imate hudo bolezen srca ali pljuč,
- if you have an artificial valve in your heart
- če imate umetno srčno zaklopko,
- if you have acute severe inflammation/ sepsis
- če imate hujše akutno vnetje/ sepso,
- if you have known hyperactive coagulation system/ or recurrent thromboembolism
- če je znano, da imate hiperaktivni koagulacijski sistem/ ali ponavljajočo se trombembolijo,
- if you have liver disease
- če imate bolezen jeter,
- if you have kidney disease
- če imate bolezen ledvic.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil
17 Pregnancy and breast-feeding Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
17 Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Driving and using machines The ability to drive and use machines is not affected.
Nosečnost in dojenje Preden dobite zdravilo Luminity, morate zdravniku ali farmacevtu povedati, če ste noseči ali če dojite, in se z njim posvetovati.
Important information about some of the ingredients of Luminity This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
Pomembne informacije o nekaterih sestavinah zdravila Luminity Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar dejansko pomeni, da je “ brez natrija ”.
HOW LUMINITY IS GIVEN
KAKO DAJEMO ZDRAVILO LUMINITY
Luminity is for intravenous use and the prepared dispersion is either diluted with sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection and given by infusion over a period of time (drip solution), or given undiluted as an intravenous injection (direct injection into the vein).
Pripravljeno disperzijo je treba razredčiti bodisi z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje ali s 50 mg/ ml (5%) raztopino glukoze za injiciranje in dati v infuziji, ki traja nekaj časa (kapalna raztopina), bodisi dati nerazredčeno v intravenski injekciji (neposredna injekcija v veno).
For heart ultrasound examination, the recommended dose is multiple intravenous injections of 0.1 to 0.4 ml of Luminity, followed by an intravenous injection of 3 to 5 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Za ultrazvočno preiskavo srca je priporočeni odmerek večkratno intravensko injiciranje od 0, 1 do 0, 4 ml zdravila Luminity, ki mu sledi intravensko injiciranje od 3 do 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje.
The maximum total dose is 1.6 ml.
Največji celotni odmerek je 1, 6 ml.
The product can also be given at a dose of 10 microlitre/ kg by intravenous injection followed by an intravenous injection of 10 ml sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection, depending on which ultrasound technique your doctor has chosen to use.
Zdravilo Luminity je mogoče uporabiti tudi v odmerku 10 mikrolitrov/ kg v intravenski injekciji, ki ji sledi intravenska injekcija 10 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje, odvisno od tega, za kakšen način ultrazvočne preiskave se odloči zdravnik.
In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
V nekaterih primerih se lahko zdravnik odloči, da bo za izvedbo ultrazvočne preiskave uporabil dve injekciji.
Your doctor may also choose to give Luminity via an intravenous infusion of 1.3 ml added to 50 ml of sodium chloride 9 mg/ ml (0.9%) or glucose 50 mg/ ml (5%) solution for injection.
Zdravnik se lahko tudi odloči, da da zdravilo Luminity v intravenski infuziji, in sicer 1, 3 ml v 50 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 50 mg/ ml (5%) raztopine glukoze za injiciranje.
Your doctor will decide on the speed at which the infusion should be given.
Zdravnik bo določil, kako hitro mora teči infuzija.
If you are given more Luminity than you should It is not known what the effect of an overdose is.
Če ste dobili večji odmerek zdravila Luminity, kot bi smeli Učinki prevelikega odmerjanja niso znani.
Like all medicines, Luminity can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Luminity neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common side effects (greater than 1 patient out of 100, less than 1 patient out of 10) Headache, flushing.
Pogosti neželeni učinki (pri več kot 1 od 100, vendar manj kot 1 od 10 bolnikov) Glavobol, zardevanje.
Uncommon side effects (greater than 1 patient out of 1,000, less than 1 patient out of 100) Dizziness, altered taste, reduced blood pressure, difficulty in breathing, throat irritation, abdominal pain, diarrhoea, nausea (feeling sick), vomiting, itching, increased sweating, back pain, chest pain, fatigue, feeling hot and pain at the site of injection.
Občasni neželeni učinki (pri več kot 1 od 1. 000, vendar manj kot 1 od 100 bolnikov) Omotica, spremenjen okus, znižan krvni tlak, težko dihanje, draženje žrela, bolečine v trebuhu, driska, navzea (siljenje na bruhanje), bruhanje, srbenje, močnejše znojenje, bolečine v hrbtu, bolečine v prsih, utrujenost, občutek vročine in bolečina na mestu injiciranja.
Rare side effects (greater than 1 patient out of 10,000, less than 1 patient out of 1,000) Numbness, tingling and or burning sensation, altered heart rate, palpitations (you feel your heart beats harder or in an irregular way), feeling faint, increased blood pressure, peripheral coldness, breathing problems, cough, dry throat, difficulty in swallowing, rash, redness of the skin, joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness and abnormal electrocardiogram.
Redki neželeni učinki (pri več kot 1 od 10. 000, vendar manj kot 1 od 1. 000 bolnikov) Otrplost, mravljinčenje ali pekoč občutek, spremenjen srčni utrip, palpitacije (občutek močnejšega ali nerednega bitja srca), omedlevica, zvišan krvni tlak, hlad obrobnih predelov telesa, težave z dihanjem,
18 Some patients may experience allergic type reactions such as swelling of the face.
Pri nekaterih bolnikih se lahko pojavijo alergijske reakcije, npr. otekanje obraza.
There is however a risk that these allergic type reactions become severe and may include anaphylactic shock.
Te alergijske reakcije lahko postanejo resne in lahko vključujejo tudi anafilaktični šok.
In addition, some patients may experience convulsions, which may be associated with these allergic reactions.
Razen tega se pri nekaterih bolnikih lahko pojavijo tudi krči, ki so lahko povezani s temi alergijskimi reakcijami.
HOW TO STORE LUMINITY
SHRANJEVANJE ZDRAVILA LUMINITY
Do not use Luminity after the expiry date which is stated on the carton and label.
Zdravila Luminity ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki.
Before activation, store in a refrigerator (2°C - 8°C).
Pred aktiviranjem shranjujte v hladilniku (2 °C - 8 °C).
After activation, do not store above 30°C.
Po aktiviranju shranjujte pri temperaturi do 30 °C.
The dispersion should be given to you within 12 hours of activation.
Disperzijo morate dobiti v 12 urah po aktiviranju.
What Luminity contains
Kaj vsebuje zdravilo Luminity
The active substance is perflutren.
Zdravilna učinkovina je perflutren.
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
En mililiter vsebuje največ 6, 4 x 109 lipidnih mehurčkov, ki vsebujejo perflutren; povprečni razpon njihovega premera je od 1, 1 do 2, 5 mikrometra.
The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl- sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Pomožne snovi so 1, 2- dipalmitoil- sn- glicero- 3- fosfatidilholin (DPPC), 1, 2- dipalmitoil- sn- glicero- 3 - fosfatidilna kislina, mononatrijeva sol (DPPA), N - (metoksipolietilenglikol 5000 karbamoil) - 1, 2 - dipalmitoil- sn- glicero- 3- fosfatidiletanolamin, mononatrijeva sol (MPEG5000 DPPE), natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, propilenglikol, glicerol in voda za injekcije.
Luminity is a solution for dispersion for injection or infusion and is available in a pack containing one or four single-use 1.5 ml vials.
Na voljo je v pakiranjih, ki vsebujejo eno in štiri 1, 5- ml viale za enkratno uporabo.
Before activating the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid.
Pred aktiviranjem vsebine viale je zdravilo Luminity brezbarvna, enakomerno bistra do prosojna tekočina.
After activation, the product appears as a milky white liquid.
Po aktiviranju ima videz mlečno bele disperzije.
Marketing Authorisation Holder Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B-1170 Bruxelles / Brussel Belgium
19 Imetnik dovoljenja za promet Bristol- Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 / Terhulpsesteenweg 185 B- 1170 Bruxelles / Brussel Belgija
19 04010 Sermoneta (LT) Italy
Via del Murillo Km 2, 800 04010 Sermoneta (LT) Italija
Tel: + 353 (1 800) 749 749
20 Ireland BRISTOL- MYERS SQUIBB PHARMACEUTICALS LTD Tel: + 353 (1 800) 749 749
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu.
Immediately after activation, Luminity appears as a
Takoj po aktiviranju je zdravilo Luminity videti kot mlečno
milky white dispersion.
bela disperzija.
Luveris is a powder and solvent for solution for injection.
Zdravilo Luveris je prašek in vehikel za raztopino za injiciranje.
Luveris contains the active substance lutropin alfa.
Zdravilo Luveris vsebuje zdravilno učinkovino lutropin alfa.
Luveris is a fertility treatment.
Zdravilo Luveris je namenjeno zdravljenju težav s plodnostjo.
It is used with another type of hormone (follicle stimulating hormone, FSH) to stimulate the development of eggs in the ovaries of women with severe deficiency for luteinising hormone (LH) and FSH.
Uporablja se skupaj z drugo vrsto hormona (folikle stimulirajočim hormonom, FSH) za spodbujanje razvoja jajčec v jajčnikih pri ženskah s hudim pomanjkanjem luteinizirajočega hormona (LH) in FSH.
Luveris can only be obtained with a prescription.
Zdravilo Luveris se dobi samo na recept.
Luveris is given daily, together with FSH, and the patient ’ s response to treatment is monitored to check how the egg development in the ovary is progressing.
Zdravilo Luveris se daje dnevno, skupaj s FSH, pri čemer se spremlja odziv bolnice na zdravljenje, da bi tako nadzorovali, kako napreduje razvoj jajčeca v jajčniku.
Doses are adjusted according to the response, and treatment may continue for up to 5 weeks.
Odmerki se prilagajajo v odvisnosti od odziva, pri čemer lahko zdravljenje traja do 5 tednov.
Luveris powder is mixed with the solvent provided just before use, to make up a solution.
Pred uporabo se prašek Luveris zmeša s priloženim vehiklom v raztopino.
This solution can be mixed with a FSH preparation in the same syringe.
To raztopino je mogoče zmešati s preparatom FSH v isti brizgi.
It is given by subcutaneous injection (under the skin).
Zdravilo se daje s subkutano injekcijo (pod kožo).
The patient or their partner may carry out the subcutaneous injection once they have been trained by the doctor and provided that they have access to expert advice.
Subkutano injekcijo si lahko daje bolnica sama ali ji jo da njen partner, pod pogojem, da jo/ ga je zdravnik ustrezno usposobil in da imata dostop do strokovnega nasveta.
The active substance in Luveris, lutropin alfa, is a copy of the natural luteinising hormone (LH).
Učinkovina zdravila Luveris, lutropin alfa, je kopija naravnega luteinizirajočega hormona (LH).
In the body, LH causes the release of eggs (ovulation) during the menstrual cycle.
V telesu povzroči LH sproščanje jajčec (ovulacijo) med menstrualnim ciklom.
Luveris is used together with FSH (another hormone that stimulates ovulation).
Zdravilo Luveris se uporablja skupaj s FSH (drugim hormonom, ki stimulira ovulacijo).
The active ingredient of Luveris, lutropin alfa, is produced by a method known as ‘ recombinant DNA technology’.
Učinkovina zdravila Luveris, lutropin alfa, se proizvaja po metodi, imenovani » rekombinantna tehnologija DNK «.
It is made by a cell that has received a gene (DNA), which makes it able to produce human LH.
Proizvaja ga celica, ki je prejela gen (DNK), ki ji omogoča tvorjenje humanega LH.
Luveris has been studied in two studies in a total of 81 patients, where the effect of different doses of Luveris was studied.
Zdravilo Luveris so raziskovali v okviru dveh raziskav z 81 bolnicami, pri čemer so preučevali učinek različnih odmerkov zdravila Luveris.
Because the number of patients with the condition is low, Luveris was not compared to any other medicine.
Ker je bilo število bolnic s tem stanjem majhno, zdravila Luveris niso primerjali z drugimi zdravili.
Luveris was used together with follitropin alfa – a follicle stimulating hormone preparation.
Zdravilo Luveris je bilo uporabljeno skupaj s folitropinom alfa – pripravkom folikle stimulirajočega hormona.
The main measure of effectiveness was the ovulation rate per menstrual cycle.
Glavno merilo učinkovitosti je bila stopnja ovulacije na menstrualni cikel.
(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 What benefit has Luveris shown during the studies?
(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 Kakšne koristi je zdravilo Luveris izkazalo med raziskavami?
In these studies, about two thirds of the women who received 75 International Units (IU) of Luveris with follitropin alfa produced functional follicles (these are eggs in the ovaries that are ready for ovulation).
V teh raziskavah sta približno dve tretjini žensk, ki so prejele 75 internacionalnih enot (i. e.) zdravila Luveris s folitropinom alfa, proizvedlo funkcionalne folikle (to so jajčeca v jajčnikih, ki so pripravljena na ovulacijo).
The higher doses were no more effective than the 75 IU dose, which is why this dose was selected for marketing.
Večji odmerki niso bili bolj učinkoviti od 75 i. e., kar je razlog za izbiro tega odmerka za tržno ponudbo.
The most common side effects (seen in between 1 and 10 patients in 100) are reactions at the injection site, headache, somnolence (sleepiness), nausea (feeling sick), abdominal (tummy) pain, pelvic (lower abdominal) pain, ovarian hyperstimulation syndrome (e. g. feeling sick, weight gain, diarrhoea), ovarian cyst, and breast pain.
Najpogostejši neželeni stranski učinki (opaženi pri 1 do 10 bolnicah izmed 100) so reakcije na mestu injiciranja, glavobol, zaspanost, slabost, bolečina v trebuhu, bolečine v medenici, sindrom ovarijske hiperstimulacije (t. j. slabost, povečanje telesne mase, driska), ovarijska cista in bolečine v dojkah.
Ovarian hyperstimulation syndrome occurs when the ovaries over- respond to treatment, especially when medicines to trigger ovulation have been used.
Sindrom ovarijske hiperstimulacije nastopi, kadar se jajčniki preveč odzovejo na zdravljenje, še posebej, če so uporabljena zdravila za sprožitev ovulacije.
For the full list of all side effects reported with Luveris, see the Package Leaflet.
Celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Luveris, najdete v Navodilih za uporabo.
Luveris should not be used in people who may be hypersensitive (allergic) to LH or FSH or any of the other ingredients, and in women who have tumours of the pituitary gland, hypothalamus, breast, uterus, or ovary.
Zdravila Luveris se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi (alergični) na LH ali FSH ali katero drugo sestavino tega zdravila, ter pri ženskah, ki imajo tumor hipofize, hipotalamusa, dojke, maternice ali jajčnikov.
It should also not be used when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or vaginal bleeding.
Ravno tako se ne sme uporabljati v primeru povečanja jajčnikov ali ciste, ki ni nastala zaradi policistične bolezni jajčnikov, ter v primeru vaginalne krvavitve.