natgillin/translations-raw huggingface dataset:
NEW ORAL SYRINGE SET UP BEFORE FIRST DOSING: 1.
PRIPRAVA NOVE ORALNE BRIZGE PRED PRVIM ODMERJANJEM: 1.
Therefore the use of the product during pregnancy and lactation is not recommended.
Zato uporaba zdravila ni priporočljiva v obdobju brejosti in laktacije.
In summary, dexmedetomidine, by decreasing central noradrenergic and serotonergic neurotransmission, is effective in alleviating canine acute anxiety and fear associated with noise.
Skratka, deksmedetomidin z zmanjšanjem noradrenergične in serotoninergične nevrotransmisije v osrednjem živčevju učinkovito lajša s hrupom povezano akutno tesnobo in strah pri psih.
Place the oral syringe tip between the dog's cheek and gum and press the plunger until the ring-stop causes the plunger to stop.
Postavite konico oralne brizge med lice in dlesen psa ter pritiskajte bat, dokler ga zaporni obroček ne ustavi.
If the dose for the dog is more than 6 dots (1.5 ml), half of the dose should be administered to the oral mucosa on one side of the dog's mouth and the other half of the dose onto the other side.
Če je odmerek za psa večji kot 6 pik (1,5 ml), je treba dati polovico odmerka na ustno sluznico na eno stran in drugo polovico odmerka na drugo stran.
Hold the plunger with your left hand and unlock the green ring-stop by turning it towards you until it is able to slide freely.
Držite bat z levo roko in odklenite zeleni zaporni obroček tako, da ga zasukate proti sebi, dokler ne začne prosto drseti.
Pre-filled 3 ml HDPE oral syringes with graduations from 0.25 ml (1 dot) to 3 ml (12 dots).
Napolnjene 3 ml oralne brizge iz HDPE z ločilnimi oznakami od 0,25 ml (1 pika) do 3 ml (12 pik).
PHARMACEUTICAL FORM Oromucosal gel
FARMACEVTSKA OBLIKA Oralni gel
Pack sizes: single pack of 1 oral syringe and multipacks of 3 (3 packs of one), 5 (5 packs of one), 10 (10 packs of one) and 20 (20 packs of one).
Velikosti pakiranj: enojno pakiranje po 1 oralno brizgo ter skupna pakiranja po 3 (3 pakiranja po eno), 5 (5 pakiranj po eno), 10 (10 pakiranj po eno) in 20 (20 pakiranj po eno).
Text on the seals: Push
Besedilo na plombah: Pritisnite
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental ingestion or prolonged mucosal contact, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega zaužitja ali podaljšanjega stika s sluznico nemudoma poiščite zdravniško pomoč in mu pokažite navodilo za uporabo ali ovojnino.
Push to break white seal.
Pritisnite, da zlomite belo plombo.
New oral syringe set up before first dosing:
Priprava nove oralne brizge pred prvim odmerjanjem:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton (3 x 1, 5 x 1, 10 x 1 and 20 x 1 pre-filled syringes)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (3 x 1, 5 x 1, 10 x 1 in 20 x 1 napolnjena brizga)
Dexmedetomidine is a potent and selective alpha-2 adrenoceptor agonist that inhibits the release of noradrenaline (NA) from noradrenergic neurons, blocks the startle reflex and thus counteracts arousal.
Deksmedetomidin je močan in selektiven agonist adrenergičnih receptorjev alfa-2, ki zavira sproščanje noradrenalina (NA) iz noradrenergičnih nevronov, blokira odziv na preplah in tako preprečuje vzburjenje.
A slight decrease in body temperature may be observed.
Telesna temperatura se lahko nekoliko zniža.
Return the oral syringe to the outer carton immediately after each use for child safety and also in order to protect from light.
Takoj po vsaki uporabi vrnite brizgo v kartonsko škatlo zaradi varnosti otrok in za zaščito zdravila pred svetlobo.
Due to peripheral vasoconstriction, transient paleness of mucous membranes at the application site may be observed.
Zaradi periferne vazokonstrikcije se lahko na mestu dajanja pojavi prehodna bledica sluznic.
METHOD AND ROUTE(S) OF ADMINISTRATION For oromucosal use.
NAČIN IN POT(I) UPORABE Oralna uporaba.
In case of overdose, the appropriate dose of atipamezole calculated in micrograms is 3 times (3X) the dose of administered dexmedetomidine hydrochloride in Sileo gel.
V primeru prevelikega odmerjanja je ustrezni odmerek atipamezola, izračunan v mikrogramih, 3-kratni (3x) uporabljeni odmerek deksmedetomidinijevega klorida v gelu Sileo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton (1 pre-filled syringe)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (1 napolnjena brizga)
Do not exceed the recommended dose.
Priporočeni odmerek se ne sme preseči.
If the gel is swallowed, it may not be effective.
V nasprotnem primeru morda ne bo učinkoval.
In case the gel is swallowed the dog can be given another dose if necessary 2 hours after the previous dose.
Če pes zdravilo pogoltne, lahko 2 uri po prejšnjem odmerku dobi še en odmerek, če ga potrebuje.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Pogostost neželenih učinkov je opredeljena z naslednjim dogovorom: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali med enim zdravljenjem), - pogosti (pojavijo se pri 1 od 10 živali od 100 živali), - občasni (pojavijo se pri 1 od 10 živali od 1.000 živali), - redki (pojavijo se pri 1 od 10 živali od 10.000 živali), - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
The effects of dexmedetomidine can be eliminated using a specific antidote, atipamezole (alpha-2 adrenoceptor antagonist).
Učinke deksmedetomidina je mogoče odpraviti s specifičnim antidotom, atipamezolom (antagonist adrenergičnih receptorjev alfa-2).
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made by the veterinary surgeon.
Pričakovano je, da bo uporaba drugih zaviralcev osrednjega živčnega sistema povečala učinke deksmedetomidina, zato mora veterinar ustrezno prilagoditi odmerek.
Pack sizes: single pack of 1 oral syringe and multipacks of 3 (3 packs of one oral syringe).
Velikosti pakiranj: enojno pakiranje z eno oralno brizgo in skupna pakiranja po 3 (3 pakiranja po eno oralno brizgo).
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
MOVE RING Move the ring-stop to the opposite end of the plunger.
PREMAKNITE OBROČEK Premaknite zaporni obroček na nasprotni konec bata.
Dexmedetomidine as an alpha-2 adrenoceptor agonist alters the levels of NA, serotonin (5-HT) and dopamine (DA) in the hippocampus and frontal cortex, indicating that such compounds affect also the regions of the brain involved in creating and maintaining complex anxieties.
Deksmedetomidin kot agonist adrenergičnih receptorjev alfa-2 spremeni ravni NA, serotonina (5-HT) in dopamina (DA) v hipokampusu in frontalnem korteksu, kar kaže, da take učinkovine vplivajo tudi na predele možganov, ki sodelujejo pri ustvarjanju in ohranjanju zapletene tesnobe.
Position the ring-stop so that the side nearest the barrel is in line with the graduation mark (black line), and the required number of dots shows between the ring-stop and the barrel.
NASTAVITE ODMEREK IN ZAKLENITE Premaknite zaporni obroček, tako da je stran, ki je najbližje cevi, poravnana z ločilno oznako (črna črta), ter da je med zapornim obročkom in cevjo prikazano zahtevano število pik.
Uncommon adverse reactions in clinical trials were anxiety, periorbital oedema, drowsiness and signs of gastroenteritis.
Občasni neželeni učinki v kliničnih preskušanjih so bili tesnoba, periorbitalni edem, zaspanost in znaki gastroenteritisa.
The oral syringe is fitted with a plunger, dosing ring and end cap (for sealing it).
Oralna brizga je opremljena z batom, odmernim obročkom in pokrovčkom (za zatesnitev).
Push to break yellow seal.
Pritisnite, da zlomite rumeno plombo.
Other commonly observed adverse events in clinical trials were sedation, emesis and urinary incontinence.
Drugi pogosto opaženi neželeni učinki v kliničnih preskušanjih so bili sedacija, bruhanje in urinska inkontinenca.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001 (1 x 3 ml oral syringe)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/181/001 (1 x 3 ml oralna brizga)
Uncommon reactions: - distress - swelling around the eyes - drowsiness - loose stools.
Občasni neželeni učinki: - čustvena stiska, - oteklina okoli oči, - zaspanost, - mehko blato.
In case of accidental ingestion or prolonged mucosal contact, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja ali podaljšanjega stika s sluznico se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Shelf life after first opening the oral syringe: 4 weeks.
Rok uporabnosti po prvem odprtju oralne brizge: 4 tedne.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001-005 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/06/2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 10/06/2015
Hold the oral syringe so that you can see the dot markings on the oral syringe plunger.
Držite oralno brizgo tako, da boste lahko videli pike na njenem batu.
Instead, it must be placed onto the mucosa between the dog's cheek and gum of the dog.
Namesto tega ga je treba dati psu na sluznico med licem in dlesnijo.
The Sileo oral syringe delivers the product in small increments (0.25 ml).
Oralna brizga za zdravilo Sileo odmerja zdravilo v majhnih korakih (0,25 ml).
DOSE INTO CHEEK
ODMERITE V LICE
Dexmedetomidine hydrochloride 0.1 mg (equivalent to 0.09 mg dexmedetomidine).
Deksmedetomidinijev klorid 0,1 mg (kar ustreza 0,09 mg deksmedetomidina).
Shelf life after first opening the immediate packaging (removal of the cap): 4 weeks.
Rok uporabnosti po prvem odpiranju stične ovojnine (odstranitev pokrovčka): 4 tedne.
Push yellow seal and pull open
Pritisnite rumeno plombo in povlecite.
N-methylation, N-glucuronidation and oxidation in the imidazole ring have also been observed.
Opazili so tudi N-metilacijo, N-glukuronidacijo in oksidacijo imidazolovega obroča.
Hold the plunger with your right hand and lock the ring-stop by turning it away from you.
Držite bat z desno roko in zaklenite zaporni obroček tako, da ga zasukate stran od sebe.
DOSE SELECTION AND DOSING:
IZBIRA ODMERKA IN ODMERJANJE:
The dosing table provides the number of dots to be administered corresponding to the dog's bodyweight.
V preglednici za odmerjanje je prikazano število pik, ki jih je treba dati glede na telesno težo psa.
Advice to physicians:
Namenjeno zdravniku:
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Sileo is a translucent, green oromucosal gel containing 0.1 mg/ml dexmedetomidine hydrochloride (active substance), equivalent to 0.09 mg/ml dexmedetomidine.
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN Sileo je prosojen, zelen oralni gel, ki vsebuje 0,1 mg/ml deksmedetomidinijevega klorida (zdravilna učinkovina), kar ustreza 0,09 mg/ml deksmedetomidina.
Sileo contains dexmedetomidine (as the hydrochloride salt) as the active substance.
Zdravilo Sileo vsebuje zdravilno učinkovino deksmedetomidin (v obliki hidrokloridne soli).
Dexmedetomidine, the active ingredient of Sileo, is an alpha-2 adrenoceptor agonist.
Deksmedetomidin, zdravilna učinkovina v zdravilu Sileo, je agonist adrenergičnih receptorjev alfa-2.
The following dosing table provides the dose volume (in dots) to be administered for the corresponding bodyweight.
V naslednji preglednici za odmerjanje so na voljo velikosti odmerkov (v pikah), ki se uporabijo glede na telesno težo psa.
Instructions for dosing the gel:
NAVODILA ZA ODMERJANJE GELA:
HOLD PLUNGER
DRŽITE BAT
Return the oral syringe to the outer carton immediately after each use.
Po vsaki uporabi takoj vrnite oralno brizgo v škatlo.
Signs of sedation may occur when the dose is exceeded.
Po prevelikem odmerku lahko nastopijo znaki sedacije.
Hydroxypropylcellulose Sodium laurilsulfate Brilliant blue (E133) Tartrazine (E102)
Briljantno modro FCF (E133) Tartrazin (E102)
Your dog should not be given Sileo if it: - has severe liver, kidney or heart disease.
Pes ne sme dobiti zdravila Sileo, če: - ima hudo bolezen jeter, ledvic ali srca; - je preobčutljiv na zdravilno učinkovino ali katero koli pomožno snov; - je zaspan zaradi prejšnjega odmerka zdravila.
Common reactions: - paleness of the mucous membranes at the application site - tiredness (sedation) - vomiting - uncontrolled urination.
Pogosti neželeni učinki: - bledica sluznice na mestu uporabe, - utrujenost (sedacija), - bruhanje, - nenadzorovano uriniranje.
If the oromucosal gel is swallowed it will become less effective.
Oralni gel bo manj učinkovit, če ga žival pogoltne.
Therefore feeding the dog or giving it treats within 15 minutes after administration of the gel should be avoided.
Zato psa ne hranite in mu ne dajajte priboljškov 15 minut po tem, ko ste mu dali zdravilo.
Replace cap after use.
Po uporabi namestite pokrovček.
BACK TO PACKAGE
VRNITE V OVOJNINO
In case of eye or oromucosal contact, rinse abundantly with fresh water.
Ob stiku z očmi ali ustno sluznico sperite z obilico vode.
Uterine contractions and decreased foetal blood pressure may occur after systemic exposure to dexmedetomidine.
Po sistemski izpostavljenosti deksmedetomidinu se lahko pojavita krčenje maternice in znižanje krvnega tlaka pri plodu.
SPECIAL STORAGE CONDITIONS Replace cap after use.
POSEBNA NAVODILA ZA SHRANJEVANJE Po uporabi namestite pokrovček.
WEAR GLOVES
NOSITE ROKAVICE
EXPIRY DATE EXP: {month/year} Once opened use within 4 weeks.
Po odprtju porabite v 4 tednih.
Reduced heart rate may be seen after administration of higher than recommended doses of Sileo gel.
Po dajanju odmerka gela Sileo, ki je večji od priporočenega, se lahko upočasni srčni utrip.
Keep the package out of sight and reach of children at all times.
Ovojnina naj bo vedno nedosegljiva otrokom.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Dexmedetomidine hydrochloride 0.1 mg/ml
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Deksmedetomidinijev klorid 0,1 mg/ml
STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml: Dexmedetomidine hydrochloride 0.1 mg
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI 1 ml: deksmedetomidinijev klorid 0,1 mg
ROUTE(S) OF ADMINISTRATION Oromucosal use.
POT(I) UPORABE ZDRAVILA Oralna uporaba.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Oral syringe
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Wear impermeable disposable gloves when handling the veterinary medicinal product.
Med ravnanjem z veterinarskim zdravilom nosite neprepustne rokavice za enkratno uporabo.
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pričakovano je, da bo uporaba drugih zaviralcev osrednjega živčnega sistema povečala učinke deksmedetomidina, zato je treba ustrezno prilagoditi odmerek.
Higher than recommended doses of Sileo gel may also induce a number of other alpha-2 adrenoceptor mediated effects, which include mydriasis, depression of motor and secretory functions of the gastrointestinal tract, temporary AV-blocks, diuresis and hyperglycaemia.
Med njimi so midriaza, depresija motoričnih in sekretornih funkcij prebavil, začasni AV-bloki, diureza in hiperglikemija.
Sileo is administered onto the oral mucosa between the dog's cheek and gum.
Zdravilo Sileo se daje na ustno sluznico med licem in dlesnijo psa.
Translucent, green gel.
Prosojen, zelen gel.
Wear impermeable disposable gloves when handling the veterinary medicinal product and handling the oral syringe.
Pri ravnanju z zdravilom za uporabo v veterinarski medicini in oralno brizgo nosite neprepustne rokavice za enkratno uporabo.
PACKAGE LEAFLET FOR: Sileo 0.1 mg/ml oromucosal gel for dogs
NAVODILO ZA UPORABO Sileo 0,1 mg/ml oralni gel za pse
LOCK
ZAKLENITE
NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sileo 0,1 mg/ml oralni gel za pse deksmedetomidinijev klorid
NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel dexmedetomidine HCl
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sileo 0,1 mg/ml oralni gel deksmedetomidinijev klorid
NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sileo 0,1 mg/ml oralni gel za pse
Interaction with other medicinal products and other forms of interaction: Inform your veterinary surgeon if your dog is using other medicines.
Obvestite svojega veterinarja, če vaš pes dobiva druga zdravila.
Before dosing make sure that the ringstop is locked.
Zaklenite zaporni obroček tako, da ga zasukate stran od sebe. Pred odmerjanjem se prepričajte, da je zaporni obroček zaklenjen.
NOT SWALLOWED
NI ZAUŽITJA
No measurable concentrations were found after gastro-intestinal gavage of dexmedetomidine to dogs.
Po dajanju deksmedetomidina psom s sondo za hranjenje niso ugotovili merljivih koncentracij zdravila.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE, ODGOVOREN ZA SPROŠČANJE SERIJE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
FI-02200 Espoo FINLAND Tel.: +358 10 4261
FINSKA Tel.: +358 10 4261
The Sileo oral syringe is capable of delivering the product in 0.25 ml increments.
Z oralno brizgo za zdravilo Sileo se lahko zdravilo odmerja v korakih po 0,25 ml. Vsak korak označuje ena pika na batu.
EU/2/11/136/001 TruScient 0.66 mg Kit for implant
EU/2/11/136/001 TruScient 0,66 mg Komplet za implantacijo
1 vial + 1 vial + 2 sterile matrices syringes needles
1 viala + 1 viala + 2 sterilni matrica + 3 brizge + 3 brizge
Kit
Komplet
Packaging Content (Concentration)
Ovojnina Vsebina Velikost pakiranja
Withdrawal period
Periostalna uporaba
Janumet is taken twice a day.
Zdravilo Janumet se jemlje dvakrat na dan.
It is used in addition to diet and exercise in the following ways:
Uporablja se kot dodatek k dieti in telesni vadbi na naslednje načine:
Metformin has been available in the EU since the 1950s.
V EU je na voljo od petdesetih let prejšnjega stoletja.
Other information about Janumet
Druge informacije o zdravilu Janumet
The European Commission granted a marketing authorisation valid throughout the EU for Janumet on 16 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Janumet, veljavno po vsej Evropski uniji, odobrila dne 16. julija 2008.
The full EPAR for Janumet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Janumet je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The maximum dose of sitagliptin is 100 mg a day.
Najvišji dovoljeni odmerek sitagliptina je 100 mg na dan.
Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Sitagliptin je zaviralec dipeptidil-peptidaze-4 (DPP-4).
There was no difference in this effect between the patients also taking metformin and those not taking it.
Nobenih razlik ni bilo opaziti med bolniki, ki so jemali tudi metformin, in med tistimi, ki ga niso.
What benefit has Janumet shown during the studies?
Kakšne koristi je zdravilo Janumet izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Janumet.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Janumet.
For more information about treatment with Janumet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Janumet preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Janumet sitagliptin / metformin hydrochloride
Janumet sitagliptin/metforminijev klorid
It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding.
Prav tako se ne sme uporabljati pri bolnikih, ki prekomerno uživajo alkohol ali so alkoholiki, ali pri doječih ženskah.
Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007, and as Tesavel since 2008.
V Evropski uniji je od leta 2007 odobren pod imenoma Januvia in Xelevia, od leta 2008 pa pod imenom Tesavel.
The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Janumet (opažen pri 1 do 10 bolnikih od 100) je navzeja (slabost).
The strength of tablet to use depends on the dose of the other antidiabetes medicines that the patient was taking before.
Jakost tablete, ki jo je treba uporabiti, je odvisna od odmerkov drugih zdravil za zdravljenje sladkorne bolezni, ki jih je bolnik jemal prej.
• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
• pri bolnikih, ki že jemljejo kombinacijo sitagliptina in metformina v obliki ločenih tablet;
The results of three further studies were used to support the use of Janumet.
V podporo uporabi zdravila Janumet so bili uporabljeni rezultati treh nadaljnjih študij.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Janumet.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Janumet, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).
Na voljo je v obliki tablet (50 mg sitagliptina/850 mg metforminijevega klorida in 50 mg sitaglipina/1 000 mg metforminijevega klorida).
The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide.
Učinkovitost dodajanja sitagliptina k metforminu je bila podobna kot pri dodajanju glipizida.
It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Prav tako se ne sme uporabljati pri bolnikih, ki imajo diabetično ketoacidozo, predkomo (nevarno stanje, ki se lahko pojavi pri sladkorni bolezni), težave z ledvicami in jetri, obolenja, ki lahko prizadenejo ledvice, ali obolenja, ki povzročajo zmanjšano oskrbo tkiv s kisikom, kot so srčno popuščanje, težave s pljuči ali nedavni srčni napad.
CHMP decided that Janumet's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Janumet večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This study also compared the effects of adding sitagliptin or placebo.
V tej študiji so proučevali tudi učinek dodajanja sitagliptina ali placeba.
What is the risk associated with Janumet?
Kakšna tveganja so povezana z zdravilom Janumet?