natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials
EU/1/11/703/002 - 4 viale za enkratno uporabo
The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year.
Incidenca osteonekroze čeljustnice, korigirana za bolnik-leta, je bila prvo leto zdravljenja 0,2 % in drugo leto
Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer
Rezultati učinkovitosti pri bolnikih z napredovanimi malignomi, ki so zajeli kosti
• shortness of breath,
• kratka sapa,
A higher incidence of hypocalcaemia among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials.
V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost hipokalciemije med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
XGEVA is not recommended for use if you are pregnant.
Če ste noseči, uporaba zdravila XGEVA ni priporočljiva.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletna bolečina1
XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.
Pri odraslih in pri mladostnikih, pri katerih se je kostna rast končala, se zdravilo XGEVA uporablja tudi za zdravljenje gigantocelularnega kostnega tumorja, ki ga ni mogoče zdraviti z operacijo, ali če operacija ni najboljša možnost.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis.
Pri bolnikih, ki so dobivali zdravilo XGEVA in so imeli hudo okvaro ledvic ali so bili na dializi, so opažali tudi spremljajoče zvišanje paratiroidnega hormona.
Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving XGEVA.
Ko boste zdravilo XGEVA prenehali jemati, vas bo vaš zdravnik spremljal glede pojava znakov in simptomov visokih ravni kalcija.
Drug hypersensitivity1
Bolezni imunskega sistema redki preobčutljivost na zdravilo1
- The active substance is denosumab.
Zdravilo XGEVA vsebuje denosumab.
Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
6.1 Seznam pomožnih snovi ledocet* natrijev hidroksid (za prilagoditev pH)* sorbitol (E420) polisorbat 20 voda za injekcije * acetatni pufer nastane z mešanjem ocetne kisline z natrijevim hidroksidom
In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but can occur later.
V obdobju trženja zdravila so poročali o hudi simptomatski hipokalciemiji (vključno s smrtnimi primeri) (glejte poglavje 4.8).
1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4
2 Glejte poglavje Druge posebne skupine bolnikov.
GENERAL CLASSIFICATION FOR SUPPLY
Opozorila glede pomožnih snovi
A higher incidence of ONJ among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials.
V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost osteonekroze čeljustnice med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
Osteonecrosis of the jaw1
pogosti osteonekroza čeljustnice1
42 months
42 mesecev
Date of last renewal: 10/06/2015
Datum zadnjega podaljšanja: 10/06/2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 08/07/2005
ATC vet code: QI05AB03
Oznaka ATC-vet: QI05AB03
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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 določena po naslednjem dogovoru: - zelo pogosto (pri več kot 1 živali od 10 živali stranski učinki v času zdravljenja) - pogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - nepogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 1.000 živali) - redko (pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redko (pri manj kot 1 živali na 10.000 živali, vključno s posameznimi primeri)
PACKAGE SIZE 10 x 1 dose
VELIKOST PAKIRANJA 10 x 1 odmerek
62.5 µg For the full list of excipients, see section 6.1
62,5 µg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne učinke ali druge učinke, ki niso navedeni v tem navodilu, obvestite svojega veterinarja.
A third vaccination with Equilis Te should be repeated at least four weeks later.
Tretje cepljenje z Equilisom Te moramo ponoviti najmanj štiri tedne pozneje.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Zdravilna učinkovina je učinkovina biološkega izvora, namenjena za vzbujanje aktivne imunosti, in ni zajeta v Uredbi (ES) 470/2009.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tetanus toxoid 40 Lf/ml
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Toksoid tetanusa 40 Lf/ml
In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
V zelo redkih primerih lokalna reakcija presega 5 cm in lahko traja dlje kot 2 dni.
ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo pred uporabo ogrejte na sobno temperaturo.
Store in a refrigerator (2°C -8°C).
Shranjujte v hladilniku (2°C -8 °C).
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2°C -8 °C)
Vaccination schedule: Primary vaccination course
Shema cepljenja: Osnovno cepljenje
Administer 1 ml of vaccine intramuscularly.
Vbrizgajte 1 ml cepiva intramuskularno.
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
To vzbuja pasivno zaščito pred tetanusom,ki traja najmanj 21 dni po sočasnem dajanju.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE NAVEDBA SMISELNA
Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Na mestu dajanja se lahko pojavi bolečina, ki ima lahko za posledico začasno funkcionalno nelagodje (otrdelost).
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljona spletni strani Evropske agencije za zdravila (European Medicines Agency, http:/ema.europa.eu).
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
NAČIN IN POT(I) UPORABE Intramuskularna uporaba
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
Kadar je povečana ogroženost zaradi okužbe ali premajhnega vnosa kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
24 months after the first revaccination
24 mesecev po prvi revakcinaciji
Special precautions for use in animals: Only healthy animals should be vaccinated.
Posebni previdnostni ukrepi za uporabo pri živalih Cepimo samo zdrave živali.
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles.
V tem primeru lahko damo prvi odmerek (C1) cepiva sočasno z ustreznim profilaktičnim odmerkom Tetanus-Seruma na drugo mesto in z različnimi brizgami in iglami.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
V4
C4
Special warnings for each target species:
Posebna opozorila za vsako živalsko vrsto
Purified Saponin
Prečiščeni saponin
potency test
preskusu potentnosti Dodatki
Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Po en odmerek (1 ml) intramuskularno po naslednji shemi: • Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje.
The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus.
Cepivo lahko uporabljamo hkrati s Tetanus-Serumom za zdravljenje poškodovanih konj, ki niso bili cepljeni proti tetanusu.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
A clear opalescent suspension.
Bistra opalescentna suspenzija
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Pharmacotherapeutic group: Inactivated bacterial vaccine.
Za vzbujanje aktivne imunosti proti tetanusu Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo
V3
C3
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila za uporabo v veterinarski mediini ne smete uporabljati po datumu izteka roka uporabnosti,
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur.
flokulacijski ekvivalenti; ustreza ≥ 30 i.e./ml seruma budre v Ph. Eur.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet.
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da lahko cepivo dajemo isti dan, toda ne pomešano z Intervetovim Tetanus-Serumom.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
V zelo redkih primerih se lahko za 1 dan, izjemoma za do 3 dni pojavi vročina, ki jo včasih spremlja letargija in inapetenca.
1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
1 ml suspenzije v napolnjeni brizgi iz stekla tipa I, v kateri je bat z nastavkom iz halogenobutila in je zaprta z zamaškom iz halogenobutilne gume.
1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
1 ml suspenzije v viali, steklo tipa I, zaprti z zamaškom iz halogenobutilne gume in zatesnjeni z aluminijasto zaporko.
PACKAGE LEAFLET FOR Equilis Te suspension for injection for horses
Equilis Te, suspenzija za injiciranje za konje
2 weeks after the primary vaccination course
2 tedna po osnovnem cepljenju
Incompatibilities: Do not mix with any other veterinary medicinal product.
6.2 Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Vsak odmerku po 1 ml vsebuje:
17 months after the primary vaccination course
17 mesecev po osnovnem cepljenju
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days.
Neostro omejena trda ali mehka oteklina (s premerom največ 5 cm) se lahko pojavi na mestu dajanja, ki mine v 2 dneh.
Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
Sočasna uporaba Equilisa Te in Intervetovega Tetanus-Seruma lahko zmanjša aktivno imunost proti tetanusu v primerjavi s konji, cepljenimi z Equilisom Te, ki niso prejeli seruma z antitoksinom tetanusa.
Cardboard box with 10 glass vials.
Škatla z 10 steklenimi vialami.
Suspension for injection.
FARMACEVTSKA OBLIKA Suspenzija za injiciranje.
Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
INDIKACIJA(E) Aktivna imunizacija konj po šestem mesecu starosti proti tetanusu za preprečevanje umrljivosti
Onset of immunity:
Razvoj imunosti:
Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v poglavju 4.6, razen blage depresivnosti na dan cepljenja.
Phosphatidylcholine
holesterol, fosfatidil holin
EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec(leto}
Equilis Te [a clear pictogram of a horse]
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Equilis Te [jasen piktogram konja]
Name and address of the manufacturers of the biological active substance GSK Vaccines GmbH
Ime in naslov izdelovalcev biološke zdravilne učinkovine
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Cardboard box with 10 pre-filled syringes with needles.
Škatla z 10 napolnjenimi brizgami z iglami.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Intervet International BV
EU/2/05/055/001 EU/2/05/055/002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/055/001-002
Emil-von-Behring-Str. 76 35 041 Marburg Germany
GSK Vaccines GmbH Emil-von-Behring-Str. 76
Phosphate buffer Chloride buffer
Laktoza, fosfatni pufer, kloridni pufer, sledi formaldehida,
Lot {number}
(otrdelost).
Cardboard box with 10 pre-filled syringes with needles
Škatla z 10 vialami Škatla z 10 napolnjenimi brizgami z iglami
MARKETING AUTHORISATION NUMBER(S)
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1 ml vial and 1 ml pre-filled syringe
OVOJNINAH Viala z 1 ml in napolnjena brizga
125 µg Phosphatidylcholine 62.5 µg
62,5 µg
Pack size blister (PVC/alu) 90 x 1 tablets (unit dose)
90 x 1 filmsko obložena tableta (posamezni odmerek)
This summary was last updated in 03-2010.
Povzetek je bil nazadnje posodobljen 03-2010.
The European Commission granted a marketing authorisation valid throughout the EU for Avandamet to SmithKline Beecham Ltd. on 20 October 2003.
Evropska komisija je dovoljenje za promet z zdravilom Avandamet, veljavno po vsej Evropski uniji, odobrila družbi SmithKline Beecham Ltd. dne 20. oktobra 2003.
What benefit has Avandamet shown during the studies?
Kakšne koristi je zdravilo Avandamet izkazalo med študijami?
After five years, the marketing authorisation was
Po petih letih je bilo dovoljenje za promet z zdravilom podaljšano za nadaljnjih pet let.
For more information about treatment with Avandamet, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Avandamet preberite navodilo za uporabo (ki je prav tako del EPAR).
It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, diseases that could affect the oxygen supply to the tissues (such as lung or heart problems, a recent heart attack or shock), problems with their liver or kidneys, acute alcohol intoxication (excessive alcohol consumption), alcoholism, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Uporabljati ga ne smejo bolniki s srčnim popuščanjem (nezmožnostjo srca, da poganja dovolj krvi po telesu), „akutnim koronarnim sindromom“, kot so nestabilna angina pektoris (huda vrsta bolečine v prsih, katere jakost se naglo spreminja) ali določene oblike srčnega napada, boleznimi, ki bi lahko vplivale na oskrbo tkiv s kisikom (kot so pljučne ali srčne bolezni, nedavni srčni napad ali šok), težavami z jetri in ledvicami, hudo zastrupitvijo z alkoholom (pretirano pitje alkohola), alkoholiki ali bolniki z zapleti sladkorne bolezni (diabetično ketoacidozo ali diabetično komo).
What is the risk associated with Avandamet?
Kakšna tveganja so povezana z zdravilom Avandamet?
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
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Avandamet.
This document is a summary of the European Public Assessment Report (EPAR) for Avandamet.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Avandamet.
The doses of Avandamet may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Odmerke zdravila Avandamet bo morda treba prilagoditi, kadar ga uporabljamo z nekaterimi drugimi zdravili, na primer gemfibrozilom ali rifampicinom.
• metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
• metformin pa učinkuje predvsem tako, da zavira nastajanje glukoze in zmanjšuje njeno absorpcijo v črevesju.
The most common side effect with Avandamet (seen in more than 1 patient in 10) is gastrointestinal symptoms (such as feeling sick, vomiting, diarrhoea, stomach ache and loss of appetite).
Najpogostejši neželeni učinki zdravila Avandamet (opaženi pri več kot 1 bolniku od 10) so gastrointestinalni simptomi (kot so slabost, bruhanje, driska, bolečina v trebuhu in izguba teka).
The studies of Avandia taken with metformin as separate tablets were used to support the use of Avandamet.
Študije zdravila Avandia, uporabljenega skupaj z metforminom v obliki ločenih tablet, so bile uporabljene v podporo uporabi zdravila Avandamet.
Avandamet contains two active substances, which have different modes of action:
Zdravilo Avandamet vsebuje dve zdravilni učinkovini, ki imata različen način delovanja:
Taking Avandamet with or just after food may reduce any stomach problems caused by metformin.
Jemanje zdravila Avandamet sočasno s hrano ali neposredno po obroku lahko ublaži želodčne težave, ki jih povzroča metformin.
It is available as tablets (yellow: 1 mg rosiglitazone and 500 mg metformin hydrochloride, and 2 mg rosiglitazone and 1,000 mg metformin hydrochloride; pale pink: 2 mg rosiglitazone and 500 mg metformin hydrochloride; pink: 4 mg rosiglitazone and 1,000 mg metformin
Na voljo je v obliki tablet (rumenih: 1 mg rosiglitazona in 500 mg metforminijevega klorida in 2 mg rosiglitazona in 1000 mg metforminijevega klorida; bledo rožnatih: 2 mg rosiglitazona in 500 mg metforminijevega klorida, rožnatih: 4 mg rosiglitazona in 1000 mg metforminijevega klorida).
Avandamet is used in patients who have type 2 diabetes, particularly those who are overweight.
Zdravilo Avandamet se uporablja pri bolnikih, ki imajo sladkorno bolezen tipa 2, še zlasti pri bolnikih s čezmerno telesno maso.
Avandamet should not be used in people who may be hypersensitive (allergic) to rosiglitazone, metformin or any of the other ingredients.
Zdravila Avandamet ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rosiglitazon, metformin ali katero koli drugo sestavino zdravila.
Rosiglitazone has been authorised in the European Union (EU) as Avandia since 2000, to be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Rosiglitazon je v Evropski uniji (EU) odobren od leta 2000 pod imenom Avandia za uporabo skupaj z metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče doseči zadovoljivega nadzora.
Avandamet is a medicine that contains two active substances, rosiglitazone and metformin hydrochloride.
Avandamet je zdravilo, ki vsebuje dve zdravilni učinkovini, rosiglitazon in metforminijev klorid.
rosiglitazone and metformin hydrochloride
Avandamet rosiglitazon in metforminijev klorid
It is given in two divided doses, either as two 1-mg/500-mg tablets or one
Daje se v obliki dveh ločenih odmerkov, bodisi kot dve tableti 1 mg/500 mg bodisi kot ena tableta 2 mg/1000 mg.
The recommended starting dose of Avandamet is 4 mg rosiglitazone and 2,000 mg metformin hydrochloride a day.
Priporočeni začetni odmerek zdravila Avandament je 4 mg rosiglitazona in 2000 mg metforminijevega klorida na dan.
The rosiglitazone dose may need to be increased to 8 mg a day after eight weeks if better blood glucose control is needed, but this should be done with caution in patients who are also taking a sulphonylurea, due to the risk of fluid retention.
Če je potrebno močnejše uravnavanje koncentracije glukoze v krvi, se lahko ta odmerek po osmih tednih poveča na 8 mg rosiglitazona na dan, vendar pa je pri bolnikih, ki hkrati jemljejo tudi sulfonilsečnino, potrebna previdnost zaradi tveganja za zastajanje tekočine.
The CHMP decided that Avandamet's benefits are greater than its risks and recommended that it be
CHMP je zaključil, da so koristi zdravila Avandamet večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Another study was also carried out comparing the effects of adding either rosiglitazone or placebo (a dummy treatment) to metformin.
Izvedena je bila tudi druga študija, v okviru katere so primerjali učinke dodajanja rosiglitazona ali placeba (zdravila brez zdravilne učinkovine) metforminu.
In triple therapy, one study looked at the effect of adding rosiglitazone to a sulphonylurea (glibenclamide) and metformin in 1,202 patients whose blood glucose was not being controlled
V eni študiji zdravljenja s tremi zdravili hkrati so proučevali učinek dodajanja rosiglitazona sulfonilsečnini (glibenklamidu) in metforminu pri 1202 bolnikih, pri katerih glukoza v krvi ni bila zadostno uravnana.
For the full list of all side effects reported with Avandamet, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Avandamet, glejte navodilo za uporabo.
If the patient is already using triple therapy, then Avandamet is given to provide the same doses of rosiglitazone and metformin as before.
Če je pri bolniku že bilo uvedeno zdravljenje s tremi zdravili hkrati, se Avandamet predpiše tako, da zagotavlja enake odmerke rosiglitazona in metformina, kot jih je bolnik prejemal dotlej.