natgillin/translations-raw huggingface dataset:
An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered (see vial content table below).
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 µg romiplostima (glejte tabelo Vsebina viale spodaj).
- The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
- Druge sestavine zdravila so manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
In a randomised placebo-controlled trial in MDS adult subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo.
V randomiziranem, s placebom kontroliranem preskušanju pri odraslih bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
An additional overfill is included in each vial to ensure that 500 micrograms of romiplostim can be delivered.
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 mikrogramov romiplostima.
• Do dispose of any left-over Nplate in proper waste container.
• Zavrzite morebitni preostanek zdravila Nplate v ustrezen vsebnik za odpadke.
= 500 mcg in 1.00 mL 500 mcg/mL
= 500 µg v 1,00 ml 500 µg/ml
Solvent for Nplate Water for injections
Vehikel za zdravilo Nplate voda za injekcije
Vial containing 500 micrograms of romiplostim.
Ena viala vsebuje 500 mikrogramov romiplostima.
Romiplostim serum levels appear inversely related to platelet counts.
Koncentracija romiplostima v serumu je obratno sorazmerna številu trombocitov.
Withdraw all of the medicinal product solution into the administration syringe.
Izvlecite vso raztopino zdravila v brizgo za injiciranje.
The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/or discolouration are observed.
Pred uporabo morate raztopino pregledati in se prepričati, da ne vsebuje delcev in ni obarvana.
• When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
• Ko je brizga prazna, iglo izvlecite iz kože.
Nplate 250 micrograms powder for solution for injection
Nplate 250 mikrogramov prašek za raztopino za injiciranje
How to store Nplate
Shranjevanje zdravila Nplate
c Number of weeks with platelet response is defined as number of weeks with platelet counts ≥ 50 x 109/L during study weeks 2-25.
Prehodni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 109/l, ugotovljeno 4- ali večkrat od 2. do 25. tedna, a brez trajnega odziva.
An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered.
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 mikrogramov romiplostima.
In a randomised placebo-controlled trial in MDS subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo.
V randomiziranem, s placebom kontroliranem preskušanju pri bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
Portal vein thrombosis Increase in transaminase
Bolezni jeter, žolčnika in žolčevodov tromboza portalne vene zvišanje transaminaz
Vial containing 250 micrograms of romiplostim.
Ena viala vsebuje 250 mikrogramov romiplostima.
Eye disorder Eye pruritus Lacrimation increased Papilloedema Visual disturbances
Očesne bolezni konjunktivalna krvavitev motnja akomodacije slepota očesne težave srbenje oči močnejše solzenje papiledem motnje vida
Upper respiratory tract infection
Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta gastroenteritis gripa lokalizirana okužba nazofaringitis
EU/1/08/497/005 - 1 pack EU/1/08/497/006 - 4 pack
EU/1/08/497/005 - 1 pakiranje EU/1/08/497/006 - 4 pakiranja
1 mL Luer-lock tip syringe x1
1 sterilno 1 ml brizgo z nastavkom Luer 1 sterilno varnostno iglo
After dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25ºC when the diluted product was held in a disposable syringe, or 4 hours in a refrigerator (2ºC - 8ºC) when the diluted product was held in the original vial.
Če je redčeno zdravilo shranjeno v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 4 ure v hladilniku (2 °C do 8 °C).
Aplastic anaemia Bone marrow failure Leucocytosis Splenomegaly Thrombocythaemia Platelet count increased
Bolezni krvi in limfatičnega sistema motnja kostnega mozga* trombocitopenija* anemija aplastična anemija odpoved kostnega mozga levkocitoza splenomegalija trombocitemija povečano število trombocitov nenormalno število trombocitov
The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 31.7% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Prevalenca sočasne uporabe zdravil za ITP je kazala trend zmanjševanja v času preskušanja; od 31,7 % (1. do 12. teden) do < 20,0 % (13. do 240. teden) in nato 0 % od tedna 240 do konca preskušanja.
Do not over tighten.
Ne privijte preveč.
• Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
• Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije, s čimer dobimo 0,25 ml uporabne količine.
Nplate 125 micrograms powder for solution for injection romiplostim
Nplate 125 mikrogramov prašek za raztopino za injiciranje romiplostim
Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, tako nastane 0,5 ml uporabne količine.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina***
No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects.
Pri nobenem od teh 3 bolnikov niso zabeležili kliničnih posledic zvišanega števila trombocitov.
Romiplostim
angioedem
Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration - a syringe with graduations of 0.01 mL should be used.
Posebno pozornost je treba nameniti temu, da iz viale potegnete ustrezno količino zdravila Nplate za subkutano dajanje.
• Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
• Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, s čimer dobimo 0,5 ml uporabne količine.
EU/1/08/497/007 - 1 pack EU/1/08/497/008 - 4 pack
EU/1/08/497/007 - 1 pakiranje EU/1/08/497/008 - 4 pakiranja
Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije; tako nastane 0,25 ml uporabne količine.
After dissolving, a deliverable amount of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Po raztapljanju vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
Remove 1 mL administration syringe from package.
Vzemite 1 ml brizgo za injiciranje zdravila iz njenega pakiranja.
Attach the 1 mL syringe to vial adapter of reconstituted solution by twisting the syringe tip onto the vial adapter until you feel a slight resistance.
Namestite 1 ml brizgo na nastavek za vialo pripravljene raztopine, tako da konico brizge zasučete v nastavek za vialo, dokler ne začutite rahlega upora.
Rhinorrhoea Dry throat Dyspnoea Nasal congestion Painful respiration
pljučna embolija* kašelj rinoreja suho žrelo dispneja zamašenost nosu bolečine pri dihanju
Turn clockwise to lock into Luer lock tip.
Zavrtite v smeri urinega kazalca, da boste iglo namestili na konico nastavka Luer.
After dissolving, a deliverable amount of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Po raztapljanju vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
After dissolving, a deliverable amount of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Po raztapljanju vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
• joint pain (arthralgia);
• bolečine v sklepih (artralgija),
Prepare new syringe for injection Step 6.
Odpnite brizgo za injiciranje z nastavka za vialo.
Injection site reaction Peripheral swelling***
Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta rinitis***
• upper abdominal pain;
• bolečina v zgornjem delu trebuha,
• Check and remove all air bubbles in the syringe.
• Preverite, ali so v brizgi zračni mehurčki, in jih odstranite.
Platelet counts should be assessed weekly until a stable platelet count
Število trombocitov je treba kontrolirati vsak teden, dokler ni doseženo stabilno število trombocitov (≥ 50 x 10
Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Nplate 250 micrograms powder for solution for injection romiplostim
Nplate 250 mikrogramov prašek za raztopino za injiciranje romiplostim
• itchy, runny or blocked nose (rhinitis);
• srbeč in zamašen nos, izcedek iz nosu (rinitis),
Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL.
Nplate 500 mikrogramov prašek za raztopino za injiciranje Zdravilo Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1,2 ml sterilne vode za injekcije, tako nastane 1 ml uporabne količine.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 25ºC in disposable syringes, or 4 hours in a refrigerator (2ºC - 8ºC) in the original vials, protected from light.
Čas običajno ne sme presegati 4 ure pri 25 °C za brizgo za enkratno uporabo ali 4 ure v hladilniku (2 °C do 8 °C) za originalno vialo, zaščiteno pred svetlobo.
Nplate 500 micrograms powder for solution for injection romiplostim
Nplate 500 mikrogramov prašek za raztopino za injiciranje romiplostim
Decreased appetite Dehydration Gout
Presnovne in prehranske motnje neprenašanje alkohola anoreksija zmanjšanje teka dehidracija protin
1 vial of powder for solution for injection.
prašek za raztopino za injiciranje 1 viala
• tiredness (fatigue);
• srbeč izpuščaj (urtikarija).
Reproductive system and breast disorders
Vpliv na sposobnost razmnoževanja
Headache
Krvavitve
Nplate is not recommended for use if you are breast-feeding.
Če dojite, uporaba zdravila Nplate ni priporočljiva.
After reconstitution, a deliverable volume of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Po pripravi vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
Set up materials for an injection
1. korak: Priprava materiala za injiciranje
An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered.
Vsaka viala vsebuje presežek, ki zagotavlja, da je mogoče iz nje dobiti 125 µg romiplostima.
After reconstitution, a deliverable volume of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Po pripravi vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
500 mcg
Za komplet 500 μg
Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 10
V študijah, kontroliranih s placebom, je romiplostim po prvih 4 tednih študije med 6-mesečnim zdravljenjem ohranil število trombocitov ≥ 50 x 109/l pri 50 % do 70 % bolnikov.
Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Prašek: manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Powder: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Prašek: manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Nplate 125 µg powder for injection romiplostim
Nplate 125 µg prašek za injiciranje romiplostim s.c.
After reconstitution, a deliverable volume of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Po pripravi vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
Upper abdominal pain***
Bolezni prebavil bolečina v zgornjem delu trebuha***
Nplate 500 micrograms powder and solvent for solution for injection romiplostim
Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
Attach vial adapter to Nplate vial by peeling off paper backing from vial adapter, keeping the vial adapter in its packaging.
Namestite nastavek za vialo na vialo zdravila Nplate tako, da odstranite papirnato prelepko z nastavka za vialo.
Nplate 250 micrograms powder and solvent for solution for injection
Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje
Nplate 250 micrograms powder and solvent for solution for injection romiplostim
Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Prenehanje zdravljenja z romiplostimom ob uporabi antikoagulantov ali antiagregacijskih zdravil povečuje tveganje za krvavitve.
Nplate 250 µg powder for injection romiplostim
Nplate 250 µg prašek za injiciranje romiplostim s.c.
Nplate 500 µg powder for injection romiplostim
Nplate 500 µg prašek za injiciranje romiplostim s.c.
9/L at study entry.
9/l od 2. do 25. tedna študije.
Lacrimation increased Papilloedema Visual disturbances
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
Nplate 500 micrograms powder and solvent for solution for injection
Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje:
Plunger rod for pre-filled sterile water syringe x1 Pre-filled sterile water syringe x1
1 vialo praška za raztopino za injiciranje 1 napolnjeno injekcijsko brizgo, ki vsebuje 1,2 ml vehikla 1 držalo bata za napolnjeno injekcijsko brizgo 1 sterilen nastavek za vialo
• contusion;
• zaprtje,
• Keeping the vial on the table, attach water-filled syringe to vial adapter by holding the side of the vial adapter with one hand and twisting the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance.
To naredite tako, da z eno roko držite stranski del nastavka za vialo, z drugo roko pa sučete konico brizge v smeri urnega kazalca v nastavek, dokler ne začutite rahlega upora.
Injection site haemorrhage Chest pain Irritability Malaise Face oedema Feeling hot Feeling jittery
krvavitev na mestu injiciranja bolečine v prsih razdražljivost splošno slabo počutje edem obraza občutek vročine občutek živčnosti
Prepare new syringe for injection
5. korak: Priprava nove brizge za injiciranje
ZIMULTI is taken as one tablet once a day, before breakfast.
Zdravilo ZIMULTI se jemlje kot ena tableta enkrat dnevno pred zajtrkom.
The European Commission granted a marketing authorisation valid throughout the European Union for ZIMULTI to sanofi-aventis on 19 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom ZIMULTI, veljavno po vsej Evropski uniji, odobrila družbi sanofi-aventis dne 19. junija 2006.
The receptors are also found in adipocytes (fat tissue).
Receptorji se nahajajo tudi v adipocitih (maščobnem tkivu).
The studies in smoking cessation did not show consistent results, and the effect of ZIMULTI in this area was difficult to estimate.
Študije v zvezi s prenehanjem kajenja niso pokazale konsistentnih rezultatov, učinek zdravila ZIMULTI na tem področju pa je bilo težko oceniti.
Which measures are being taken to ensure the safe use of ZIMULTI?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila ZIMULTI?
Other information about ZIMULTI:
Druge informacije o zdravilu ZIMULTI:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije,, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
The company will use specific databases to monitor the side effects, especially those linked to the nervous system.
Specifične zbirke podatkov bo podjetje uporabilo za spremljanje neželenih učinkov, zlasti tistih, povezanih z živčnim sistemom.
The medicine also reduced the risk of regaining weight.
Zdravilo je tudi zmanjšalo tveganje za ponovno povečanje telesne mase.
The medicine should not be used in patients who have severe problems with their liver or their kidneys.
Zdravila ne smejo jemati bolniki, ki imajo hude težave z jetri ali ledvicami.
The effects of ZIMULTI were first tested in experimental models before being studied in humans.
Učinki zdravila ZIMULTI so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The patients should also follow a reduced calorie diet and increase their level of physical activity.
Poleg tega morajo bolniki slediti dieti z zmanjšano vsebnostjo kalorij in povečati fizično aktivnost.
The company decided to withdraw its application for smoking cessation.
Podjetje se je odločilo, da umakne vlogo za uporabo zdravila pri prenehanju kajenja.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Bolniki, pri katerih se pojavi depresija, se morajo pogovoriti z zdravnikom, zdravljenje pa bo morda porebno prekiniti.
The active substance in ZIMULTI, rimonabant, is a cannabinoid receptor antagonist.
Zdravilna učinkovina v zdravilu ZIMULTI, rimonabant, je antagonist kanabinoidnih receptorjev.
• who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m²,
• so debeli (z zelo prekomerno telesno maso) s indeksom telesne mase (BMI) večjim ali enakim 30 kg/m², ali
After one year, all patients who received ZIMULTI lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Po enem letu se je pri bolnikih, ki so prejemali zdravilo ZIMULTI telesna masa zmanjšala bolj kot pri tistih, ki so prejemali placebo: povprečno so izgubili 4,9 kg več kot s placebom, razen v študiji z diabetičnimi bolniki, kjer je bila razlika v zmanjšanju telesne mase 3,9 kg.
Therefore, ZIMULTI is not recommended as an aid for smoking cessation
Zdravilo ZIMULTI torej kot pomoč pri prenehanju kajenja ni priporočeno.
Caution should be used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Pri sočasnem jemanju zdravila ZIMULTI in nekaterih drugih zdravil, kot so ketokonazol ali itrakonazol (zdravili proti glivicam), ritonavir (ki se uporablja pri okužbi s HIV), telitromicin ali klaritromicin (antibiotika) je potrebna previdnost.
What benefit has ZIMULTI shown during the studies?
Kakšne koristi je zdravilo ZIMULTI izkazalo med raziskavami?
The company that makes ZIMULTI will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
Podjetje, ki izdeluje zdravilo ZIMULTI bo pripravilo program z izobraževalnim gradivom za bolnike zdravnike, s katerim bo zagotovilo, da se zdravilo uporablja pri bolnikih, ki ga potrebujejo zaradi zdravja in ne iz kozmetičnih razlogov, ter bo nadzorovalo njegovo uporabo.
ZIMULTI is a medicine containing the active substance rimonabant.
ZIMULTI so zdravilo, ki vsebuje zdravilno učinkovino rimonabant.
What is the risk associated with ZIMULTI?
Kakšna tveganja so povezana z zdravilom ZIMULTI?
It is available as white, teardropshaped tablets.
Na voljo je v obliki tablet bele barve, ki imajo obliko solze.
Why has ZIMULTI been approved?
Zakaj je bilo zdravilo ZIMULTI odobreno?
©EMEA 2007
Zdravilo nima veā dovoljenja za promet©EMEA 2007
ZIMULTI should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
Zdravila ZIMULTI ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rimonabant ali katero koli drugo sestavino zdravila ter ženske, ki dojijo.
The Committee recommended that ZIMULTI be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom ZIMULTI.
The Committee decided that ZIMULTI's benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Odločil je da so koristi zdravila ZIMULTI večje od z njim povezanih tveganj, kadar se uporablja kot dodatek k dieti in telesni dejavnosti pri zdravljenju debelih bolnikov in bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja kot so diabetes tipa 2 ali dispidemija.
The Committee for Medicinal products for Human Use (CHMP) concluded that ZIMULTI had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo ZIMULTI izkazalo učinkovitost pri zmanjšanju telesne mase pri debelih bolnikih in bolnikih s čezmerno telesno maso, pri katerih obstajajo dodatni dejavniki tveganja.
During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Neželeni učinki zdravila ZIMULTI, ki so bili med študijami najpogosteje opaženi (pri več kot 1 od 10 bolnikov), so navzeja (občutek slabosti) in okužbe zgornjih dihal.
ZIMULTI is used together with diet and exercise to treat adult patients:
Zdravilo ZIMULTI se kot dodatek k dieti in telesni dejavnosti uporablja za zdravljenje odraslih bolnikov, ki:
The studies compared the effect of ZIMULTI with that of a placebo (a dummy treatment) on weight loss over one to two years.
V študijah so primerjali učinek zdravila ZIMULTI z učinkom placeba (zdravila brez zdravilne učinkovine) na zmanjšanje telesne mase v enem do dveh let.
Four studies of ZIMULTI in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Zdravilo ZIMULTI je bilo raziskano v štirih študijah, v katerih je sodelovalo skoraj 7000 debelih bolnikov in bolnikov s čezmerno telesno maso, katerih teža je bila na začetku študij povprečno med 94 in 104 kg.