natgillin/translations-raw huggingface dataset:
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
Preden uporabite Protaphane se prepri ajte, da imate pravo vrsto insulina, za vsako injiciranje uporabite novo iglo, da prepre ite kontaminacijo.
In insulin infusion pumps If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Shranjevanje zdravila Protaphane); e po resuspendiranju ni enakomerno belo in motno.
Don’ t take any insulin if you feel a hypo coming on.
93 zaspanost;, nenavadno utrujenost in šibkost, živ nost ali tresenje; ob utek tesnobe; ob utek zmedenosti; težave s koncentracijo. e se pojavi kateri od teh znakov, zaužijte tablete glukoze ali prigrizek, ki vsebuje veliko sladkorja (bonbone, piškote, sadni sok), in nato po ivajte. e utite, da se pojavlja hipa, si ne dajajte insulina.
Side effects reported uncommonly (in less than 1 patient in 100)
94 Ob asno opisani neželeni u inki (manj kot 1 bolnik na 100)
After removing the NovoLet from the refrigerator it is recommended to let it reach room
Peresnika NovoLet, ki ga uporabljate, ga boste pravkar uporabili ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku!
95 temperature before resuspending the insulin as instructed for the first time use.
Potem ko Protaphane NovoLet vzamete iz hladilnika, je priporo ljivo pustiti NovoLet, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
Always keep the pen cap on your NovoLet when you’ re not using it in order to protect it from light.
95 Kadar peresnika NovoLet ne uporabljate, naj bo vedno pokrit s pokrov kom, da bo zaš iten pred svetlobo!
Not all packs may be marketed.
Izgled zdravila Protaphane in vsebina pakiranja Suspenzija za injiciranje je motna, bela, vodna suspenzija, opremljena v pakiranjih z 5 ali 10 vložkov po 3 ml (na trgu lahko ni vseh navedenih pakiranj).
96 Information on how to use Protaphane NovoLet
96 Navodilo za uporabo zdravila Protaphane NovoLet
Please read the following instructions carefully before using your Protaphane NovoLet.
Preden uporabite Protaphane NovoLet, natan no preberite to navodilo.
Protaphane NovoLet is a simple, compact pre-filled pen.
Protaphane NovoLet je preprost, kompakten, napolnjen injekcijski peresnik.
97 Getting started
97 Za etek
Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin.
Preverite nalepko in se prepri ajte, da vaš Protaphane NovoLet vsebuje pravo vrsto insulina.
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
Pred vsakim injiciranjem: • Preverite, da je v vložku vsaj še 12 enot insulina, kar zagotavlja enakomerno resuspendiranje. e je preostalo manj kot 12 enot, uporabite nov Protaphane NovoLet. • Peresnik premikajte gor in dol med položajema a in b ter nazaj (slika A), tako da se steklena kroglica premika z enega konca vložka na drugega.
The movement must always be repeated, until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Protaphane NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Premikanje je treba vedno ponavljati, dokler teko ina ni enakomerno bela in motna. • Po resuspendiranju brez odlašanja opravite vse ostale korake za injiciranje. • Dezinficirajte gumijasto membrano z medicinskim zložencem. • Za vsako injiciranje uporabite novo iglo, da prepre ite kontaminacijo. • Odstranite zaš itno nalepko z igle NovoFine. • Iglo naravnost in trdno privijte na Protaphane NovoLet (slika B). • Snemite veliki zunanji pokrov ek in notranji pokrov ek igle.
To avoid injection of air and ensure proper dosing: • Hold Protaphane NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Da boste prepre ili injiciranje zraka in zagotovili pravilno odmerjanje: • Držite Protaphane NovoLet tako, da je igla obrnjena navzgor. • S prstom nekajkrat narahlo potrkajte po vložku.
98
98 D C
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Protaphane NovoLet horizontally.
• Ponovno namestite pokrov ek na peresnik, tako da je 0 na kazalniku odmerka (slika E). • Preverite, da je potisni gumb pritisnjen do konca. e ni, zasu ite pokrov ek, dokler ni potisni gumb povsem dol. • Držite Protaphane NovoLet vodoravno.
99 G
99 G
100 Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
100 Po vsakem injiciranju morate iglo odstraniti in zavre i, NovoLet pa shraniti brez nameš ene igle. V nasprotnem primeru lahko teko ina izteka, to pa lahko povzro i neto no odmerjanje.
Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Protaphane NovoLet povsem zaprite; 0 mora biti na kazalniku odmerka.
Dispose of your used Protaphane NovoLet carefully without the needle attached.
Odrabljen peresnik Protaphane NovoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
Your Protaphane NovoLet is designed to work accurately and safely.
Vaš Protaphane NovoLet je izdelan za natan no in varno delovanje.
Do not refill Protaphane NovoLet.
Peresnika Protaphane NovoLet se ne sme znova polniti.
You can clean the exterior of your Protaphane NovoLet by wiping it with a medicinal swab.
Zunanjost peresnika Protaphane NovoLet lahko o istite tako, da ga obrišete z medicinskim zložencem.
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Pri uporabi zdravila Protaphane bodite posebej pozorni: e imate težave z ledvicami, jetri, nadledvi no žlezo, hipofizo ali š itnico; e pijete alkohol: pazite na znake hipe in alkohola nikdar ne pijte na prazen želodec.; e ste telesno bolj dejavni kot ponavadi ali želite spremeniti svojo obi ajno prehrano; ste bolni: insulin uporabljajte še naprej; potujete v tujino: potovanje med razli nimi asovnimi pasovi lahko vpliva na potrebe po insulinu in na asovni razpored injekcij.
Talk to your 102 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
102 Posvetujte se z zdravnikom ali s farmacevtom, e jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi e ste ga dobili brez recepta.
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Shranjevanje zdravila Protaphane), e po resuspendiranju ni enakomerno belo in motno.
Don’ t take any insulin if you feel a hypo coming on.
103 zaspanost; nenavadno utrujenost in šibkost; živ nost ali tresenje; ob utek tesnobe; ob utek zmedenosti; težave s koncentracijo. e se pojavi kateri od teh znakov, zaužijte tablete glukoze ali prigrizek, ki vsebuje veliko sladkorja (bonbone, piškote, sadni sok), in nato po ivajte. e utite, da se pojavlja hipa, si ne dajajte insulina.
104 Side effects reported uncommonly (in less than 1 patient in 100)
104 Ob asno opisani neželeni u inki (manj kot 1 bolnik na 100)
After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Potem ko Protaphane InnoLet vzamete iz hladilnika, je priporo ljivo pustiti InnoLet, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
Always keep the pen cap on your InnoLet when you’ re not using it in order to protect it from light.
105 Kadar peresnika InnoLet ne uporabljate, naj bo vedno pokrit s pokrov kom, da bo zaš iten pred svetlobo!
105 Protaphane should not be disposed of via wastewater or household waste.
Zdravila Protaphane ne smete odvre i v odpadne vode ali med gospodinjske odpadke.
Not all packs may be marketed.
Izgled zdravila Protaphane in vsebina pakiranja Suspenzija za injiciranje je motna, bela, vodna suspenzija, opremljena v pakiranjih z 1, 5 ali 10 vložkov po 3 ml (na trgu lahko ni vseh navedenih pakiranj).
106 Information on how to use Protaphane InnoLet
106 Navodilo za uporabo zdravila Protaphane InnoLet
Please read the following instructions carefully before using your Protaphane InnoLet.
Preden uporabite Protaphane InnoLet, natan no preberite to navodilo.
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Protaphane InnoLet je preprost, kompakten napolnjen injekcijski peresnik, s katerim je mogo e injicirati odmerke od 1 do 50 enot v koraku po 1 enoto.
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Protaphane InnoLet je namenjen za uporabo z iglami NovoFine S, dolgimi 8 mm ali manj.
Check the label to make sure that your Protaphane InnoLet contains the correct type of insulin.
Preverite nalepko in se prepri ajte, da vaš Protaphane InnoLet vsebuje pravo vrsto insulina.
If there are less than 12 units left, use a new Protaphane InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Pred vsakim injiciranjem: • Preverite, da je v vložku vsaj še 12 enot insulina, kar zagotavlja enakomerno resuspendiranje. e je preostalo manj kot 12 enot, uporabite nov Protaphane InnoLet. • Peresnik premikajte gor in dol med položajema A in B ter nazaj, tako da se steklena kroglica premika z enega konca vložka na drugega (slika 1A).
107 1A
Premikanje je treba vedno ponavljati, dokler teko ina ni enakomerno bela in motna. • Po resuspendiranju brez odlašanja opravite vse ostale korake za injiciranje.
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Protaphane InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
• Dezinficirajte gumijasto membrano z medicinskim zložencem. • Za vsako injiciranje uporabite novo iglo, da prepre ite kontaminacijo. • Odstranite zaš itno nalepko z igle NovoFine S. • Iglo naravnost in trdno privijte na Protaphane InnoLet (slika 1B). •. Snemite veliki zunanji pokrov ek in notranji pokrov ek igle.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Protaphane InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C) • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Da boste prepre ili injiciranje zraka in zagotovili pravilno odmerjanje: • Nastavite 2 enoti tako, da izbirnik odmerka zasu ete v smeri urnega kazalca. • Podržite Protaphane InnoLet tako, da je igla obrnjena navzgor, in s prstom nekajkrat narahlo potrkajte po vložku, da se bodo zra ni mehur ki zbrali na vrhu vložka (slika 1C). • Z iglo obrnjeno navzgor pritisnite potisni gumb do konca in izbirnik odmerka se bo vrnil na ni lo.
If not, change the needle and repeat the procedure no more than 6 times.
108 • Na konici igle se mora pokazati kapljica insulina. e se ne, zamenjajte iglo in ponovite postopek, vendar ne ve kot 6 krat.
108 If a drop of insulin still does not appear, the device is defective and must not be used.
e se kapljica insulina še vedno ne pojavi, je peresnik pokvarjen in ga ne smete uporabiti.
You will hear clicks as the dose selector returns to zero • After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button • Remove the needle after each injection.
109 • Po injiciranju mora igla ostati pod kožo vsaj 6 sekund, da je zanesljivo injiciran celotni odmerek. • Pazite, da med injiciranjem ne boste ovirali izbirnika odmerka, kajti zagotoviti je treba, da se ta med pritiskom na potisni gumb neovirano vrne na ni lo. • Iglo po vsakem injiciranju odstranite.
Dispose of your used Protaphane InnoLet carefully without the needle attached.
Odrabljen peresnik Protaphane InnoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
110 PACKAGE LEAFLET:
110 Vzdrževanje
INFORMATION FOR THE USER
111 NAVODILO ZA UPORABO
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. – e imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Protaphane is often given in combination with fast-acting insulin products.
Protaphane se pogosto uporablja v kombinaciji s hitrodelujo imi insulinskimi insulini.
Talk to your 111 doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
112 Posvetujte se z zdravnikom ali s farmacevtom, e jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi e ste ga dobili brez recepta.
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Shranjevanje zdravila Protaphane); e po resuspendiranju ni enakomerno belo in motno.
112 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Opozorilni znaki hipe se lahko pojavijo nenadoma in lahko obsegajo: hladno znojenje; hladno in bledo kožo; glavobol; hitro bitje srca; ob utek slabosti; hudo lakoto; prehodne spremembe vida; zaspanost; nenavadno utrujenost in šibkost; živ nost ali tresenje; ob utek tesnobe; ob utek zmedenosti; težave s koncentracijo.
Don’ t take any insulin if you feel a hypo coming on.
113 e se pojavi kateri od teh znakov, zaužijte tablete glukoze ali prigrizek, ki vsebuje veliko sladkorja (bonbone, piškote, sadni sok), in nato po ivajte. e utite, da se pojavlja hipa, si ne dajajte insulina.
113 Side effects reported uncommonly (in less than 1 patient in 100)
Ob asno opisani neželeni u inki (manj kot 1 bolnik na 100)
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
114 Spremembe na mestu injiciranja (lipodistrofija). e insulin prepogosto injicirate na isto mesto, se lahko podkožno maš evje na tem mestu skr i (lipoatrofija) ali zadebeli (lipohipertrofija).
Do not use Protaphane the expiry date which is stated on the label and the carton.
Zdravila Protaphane ne uporabljajte po preteku roka uporabnosti, ozna enega na nalepki in škatlici.
After removing the FlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
Potem ko Protaphane FlexPen vzamete iz hladilnika, je priporo ljivo pustiti FlexPen, da doseže sobno temperaturo, preden insulin resuspendirate po navodilu za prvo uporabo.
Protaphane must be protected from excessive heat and sunlight.
115 Protaphane je treba zaš ititi pred ezmerno toploto in son no svetlobo.
114 Protaphane should not be disposed of via wastewater or household waste.
Zdravila Protaphane ne smete odvre i v odpadne vode ali med gospodinjske odpadke.
Not all packs may be marketed.
Izgled zdravila Protaphane in vsebina pakiranja Suspenzija za injiciranje je motna, bela, vodna suspenzija, opremljena v pakiranjih z 1, 5 ali 10 prednapolnjenih peresnikov po 3 ml (na trgu lahko ni vseh navedenih pakiranj).
115 Introduction
116 Uvod
Please read the following instructions carefully before using your Protaphane FlexPen.
Preden uporabite Protaphane FlexPen, natan no preberite ta navodila
Protaphane FlexPen Pen cap
Protaphane FlexPen pokrov ek peresnika
Preparing your Protaphane FlexPen
Priprava peresnika Protaphane FlexPen
116 Pull off the pen cap.
117 Snemite pokrov ek peresnika.
H Keeping the needle upwards, press the push-button all the way in.
H Z iglo obrnjeno navzgor pritisnite potisni gumb do konca.
• Always remove the needle after each injection and store your FlexPen without the needle attached.
Pazljivo jo zavrzite in na peresnik znova namestite njegov pokrov ek.
What is PROTELOS?
Kaj je zdravilo PROTELOS?
PROTELOS is a medicine containing the active substance strontium ranelate.
PROTELOS je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
What is PROTELOS used for?
Za kaj se zdravilo PROTELOS uporablja?
PROTELOS is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
Zdravilo PROTELOS se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, in sicer za zmanjšanje tveganja za zlome vretenc (hrbtenice) in kolka.
How is PROTELOS used?
Kako se zdravilo PROTELOS uporablja?
PROTELOS is taken as one sachet once a day.
Zdravilo PROTELOS se jemlje v odmerku ene vrečke enkrat dnevno.
PROTELOS should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Zdravilo PROTELOS je treba jemati najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
PROTELOS is intended for long-term use.
Zdravilo PROTELOS je namenjeno dolgoročnemu zdravljenju.
How does PROTELOS work?
Kako zdravilo PROTELOS deluje?
The active substance in PROTELOS, strontium ranelate, acts on the bone structure.
Zdravilna učinkovina v zdravilu PROTELOS, stroncijev ranelat, učinkuje na strukturo kosti.
Once in the gut, strontium ranelate releases strontium, which is similar to calcium and, like calcium, is absorbed into the bone.
Ko stroncijev ranelat prispe v črevesje, začne sproščati stroncij, ki je podoben kalciju in se tako kot kalcij absorbira v kost.
How has PROTELOS been studied?
Kako je bilo zdravilo PROTELOS raziskano?
PROTELOS has been studied in almost 7,000 postmenopausal elderly women in two large studies.
Zdravilo PROTELOS o preučevali v dveh obsežnih študijah, ki so vključevale skoraj 7. 000 starejših žensk po menopavzi.
In both studies, the effects of PROTELOS were compared with those of placebo (a dummy treatment).
V obeh študijah so učinke zdravila PROTELOS primerjali z učinki placeba (zdravila brez zdravilne učinkovine).
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has PROTELOS 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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo PROTELOS izkazalo med raziskavami?
In the first study, PROTELOS was more effective than placebo in reducing the risk of new vertebral fractures.
V prvi študiji je bilo zdravilo PROTELOS pri zmanjševanju tveganja za nove zlome vretenc učinkovitejše od placeba.
The risk was reduced by 41% over three years, with 21% of the 719 women who took PROTELOS developing a new vertebral fracture, compared with 33% of those 723 who took placebo.
Tveganje se je v treh letih zmanjšalo za 41%, pri čemer je do novega vretenčnega zloma prišlo pri 21% od 719 žensk, ki so jemale zdravilo PROTELOS, medtem ko je pri ženskah, ki so jemale placebo, do novega vretenčnega zloma prišlo pri 33% od 723 žensk.
Overall, he results of the second study taken alone were insufficient to demonstrate a benefit of PROTELOS in preventing peripheral fractures.
Gledano v celoti, rezultati druge študije niso zadostno dokazali koristnosti zdravila PROTELOS pri preprečevanju perifernih zlomov.
When looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of hip fractures with PROTELOS.
Če pa gledamo zgolj rezultate, dobljene pri ženskah, starih 74 let ali več, ki so imele posebno šibki stegnenici, je mogoče ugotoviti, da je zdravilo PROTELOS zmanjšalo tveganje za zlom kolka.
When looking at results of the two studies taken together, fewer women in the PROTELOS group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with PROTELOS compared with 389 out of 3,256 for placebo).
Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da je do perifernih osteoporotičnih zlomov na katerem koli mestu (vključno s kolkom) prišlo pri manj ženskah iz skupine, ki je jemala zdravilo PROTELOS kot pri tistih iz skupine, ki je jemala placebo (331 izmed 3. 295 v skupini, ki je jemala zdravilo PROTELOS, v primerjavi s 389 izmed 3. 256 v skupini, ki je jemala placebo).
What is the risk associated with PROTELOS?
Kakšna tveganja so povezana z zdravilom PROTELOS?
The most common side effects with PROTELOS (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), diarrhoea, loose stools, dermatitis (skin reactions) and eczema (flaky skin rash).
Najpogostejši neželeni učinki zdravila PROTELOS (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, navzeja (slabost), driska, redko blato, dermatitis (kožne reakcije) in ekcemi (luskasti kožni izpuščaji).
For the full list of all side effects reported with PROTELOS, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PROTELOS, glejte Navodilo za uporabo.
PROTELOS should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
Zdravila PROTELOS se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) stroncijev ranelat ali katerokoli drugo sestavino zdravila.
Why has PROTELOS been approved?
Zakaj je bilo zdravilo PROTELOS odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that PROTELOS’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila PROTELOS pri zdravljenju in preprečevanju osteoporoze po menopavzi z namenom zmanjšanja tveganja zlomov vretenc in kolka večje od z njim povezanih tveganj.
The Committee recommended that PROTELOS be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo PROTELOS odobri dovoljenje za promet.
Other information about PROTELOS:
Druge informacije o zdravilu PROTELOS:
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for PROTELOS on 21 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom PROTELOS, veljavno po vsej Evropski uniji, odobrila družbi LES LABORATOIRES SERVIER dne 21. septembra 2004.