natgillin/translations-raw huggingface dataset:
IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Zdravilo Somavert je pri vseh testiranih odmerkih zmanjšalo ravni IGF-I, ki so bile ob koncu študije (12. teden) normalne pri 38,5 %, 75 % oziroma 82 % bolnikov, zdravljenih z 10, 15 oziroma 20 mg zdravila na dan v primerjavi z 9,7 % bolnikov, zdravljenih s placebom.
The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Najpogostejši neželeni učinki zdravila Somavert (opaženi pri več kot 1 bolniku od 10) so bili glavobol, driska in bolečine v sklepih.
As for all medicines, data on the use of Somavert are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Somavert stalno spremljajo.
The patient or caregiver can inject Somavert after being trained by a doctor or a nurse.
Bolnik ali negovalec lahko zdravilo injicirata sama, potem ko sta ju za to usposobila zdravnik ali medicinska sestra.
Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Zdravilo Somavert so v okviru 12-tedenske študije proučili pri 112 bolnikih z akromegalijo.
Other information about Somavert
Druge informacije o zdravilu Somavert
Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Somavert, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Somavert upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Somavert and why it is authorised in the EU
Pregled zdravila Somavert in zakaj je odobreno v EU
What benefits of Somavert have been shown in studies?
Kakšne koristi je zdravilo Somavert izkazalo v študijah?
Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood.
Pred začetkom zdravljenja in med zdravljenjem z zdravilom Somavert je treba pri bolniku opraviti meritve ravni jetrnih encimov v krvi.
Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Nato so prejeli 10, 15 ali 20 mg zdravila Somavert na dan ali placebo.
Why is Somavert authorised in the EU?
Zakaj je bilo zdravilo Somavert odobreno v EU?
For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Somavert glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Somavert?
Kakšna tveganja so povezana z zdravilom Somavert?
Somavert contains the active substance pegvisomant.
Zdravilo Somavert vsebuje učinkovino pegvisomant.
Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Bolniki so prejeli začetni 80-miligramski odmerek zdravila Somavert ali placebo (zdravilo brez zdravilne učinkovine).
Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Uporablja se pri bolnikih, ki se niso dobro odzvali na kirurški poseg in/ali obsevanje ali na zdravljenje z analogi somatostatina (druge vrste zdravila, ki se uporablja za zdravljenje akromegalije).
The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
zdravilu Somavert, pegvisomant, je zelo podobna človeškemu rastnemu hormonu, vendar je zasnovana tako, da zavira receptorje, na katere se ta hormon običajno veže.
What is Somavert and what is it used for?
Kaj je zdravilo Somavert in za kaj se uporablja?
Following this, Somavert is given as an injection of 10 mg once a day.
Zatem se zdravilo Somavert v odmerku 10 mg enkrat dnevno injicira pod kožo.
Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Zdravilo Somavert je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje pod kožo.
Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly.
Predpisovanje in izdaja zdravila Somavert je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem akromegalije.
For the full list of side effects and restrictions with Somavert, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Somavert glejte navodilo za uporabo.
IGF-I is regulated by human growth hormone and causes growth in the body.
Rastni faktor IGF-I, ki povzroča rast v telesu, uravnava človeški rastni hormon.
In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),
Prekomerna proizvodnja rastnega hormona pri odraslih povzroča akromegalijo s prekomerno rastjo kosti, otekanjem mehkega tkiva (npr. dlani in stopal), boleznimi srca in drugimi motnjami.
Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Somavert je zdravilo, ki se uporablja za zdravljenje bolnikov z akromegalijo (redko hormonsko motnjo, ki se običajno pojavlja pri odraslih srednjih let, povzroči pa jo hipofiza, ki izloča preveč rastnega hormona).
By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
S tem zdravilo preprečuje delovanje rastnega hormona in posledično tudi nezaželeno rast ter druge motnje, opažene pri akromegaliji.
How is Somavert used?
Kako se zdravilo Somavert uporablja?
Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Akromegalija se razvije, če hipofiza, tj. žleza na možganskem dnu, izloča preveč rastnega hormona, običajno zaradi benignega (nerakastega) tumorja.
How does Somavert work?
Kako zdravilo Somavert deluje?
2nd injection: after 3 weeks.
2. injekcija: po 3 tednih.
1st injection: from 1.5 months of age.
1. injekcija: od 1,5 meseca starosti.
a) the administration of the product to animals will interfere with the implementation of national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
The level of efficacy for other species may differ from that observed in sheep.
Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri ovcah.
*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
* Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
Off-white or pink liquid.
Umazano bela ali roza tekočina.
Duration of immunity: 12 months after completion of the primary vaccination scheme.
Trajanje imunosti: 12 mesecev po koncu primarne sheme cepljenja.
Date of last renewal: 07/01/2016
Datum podaljšanja dovoljenja za promet: 07/01/2016
Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Za vsak program ponovnega cepljenja se je potrebno dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem lokalno epidemiološko situacijo.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU glede nadzora nad boleznijo modrikastega jezika.
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Pri tej kategoriji živali cepivo uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja in/ali v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrikastega jezika (BTV).
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABEZDRAVILA
High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
20 ml, 100 ml ali 240 ml-viale iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko, ki vsebujejo 10, 50 ali 120 odmerkov cepiva.
Vaccination may be followed in most animals by a local reaction at the injection site.
Po cepljenju se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Preprinted carton box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml
PODATKI NA ZUNANJI OVOJNINI Vnaprej tiskana kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
SPECIAL STORAGE CONDITIONS Store and transport refrigerated .
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
Shelf life after first opening the immediate packaging: use immediately after broaching.
Rok uporabnosti po prvem odpiranju stične ovojnine: Načeto uporabite takoj.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera do primera.
Each dose of 2 ml of vaccine contains:
Vsak odmerek (2 ml) cepiva vsebuje:
Pregnancy: Can be used during pregnancy.
Brejost: Lahko se uporablja v obdobju brejosti.
The safety and the efficacy of the vaccine have not been established in breeding males.
Varnost in učinkovitost cepiva pri plemenskih samcih nista bili ugotovljeni.
To stimulate active immunity against Bluetongue virus, serotypes 1 and 8 in sheep.
Za stimulacijo aktivne imunosti proti virusu modrega jezika, serotipa 1 in 8, pri ovcah.
Primary vaccination: Administer one dose of 2 ml according to the following vaccination scheme:
Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja:
Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Po dajanju dvojnega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
No data are available on safety in lactating animals.
Podatkov glede varnosti pri živalih v laktaciji ni.
PACKAGE LEAFLET: Zulvac 1+8 Ovis suspension for injection for sheep
NAVODILO ZA UPORABO Zulvac 1+8 Ovis suspenzija za injiciranje za ovce
These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Te reakcije so v večini primerov v obliki splošne otekline na mestu injiciranja (ne traja več kot 9 dni) ali kot otipljivi noduli (subkutani granulomi, ki lahko trajajo tudi več kot 63 dni).
These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).
Te reakcije so v večini primerov v obliki splošne otekline na mestu injiciranja (ne traja več kot 7 dni) ali kot otipljivi noduli (subkutani granulomi, ki lahko trajajo tudi več kot 48 dni).
4.2 Indications for use, specifying the target species Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija ovac, starejših od 1,5 meseca, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotipa 1 in 8.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/03/2011.
Datum pridobitve dovoljenja za promet: 14/03/2011
Adjuvants: Aluminium hydroxide
aluminijev hidroksid
A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination.
Do 24 ur po cepljenju se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 1,2 °C.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Disodium hydrogen phosphate dodecahydrate Sodium chloride
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid saponin tiomersal kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid voda za injekcije
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
*(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT-PCR, kar kaže, da virusni genom ni prisoten) Nastop imunosti: 21 dni po osnovnem programu cepljenja.
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Do 24 ur po dajanju dvojnega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °C.
Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8.
INDIKACIJA(E) Aktivna imunizacija ovac, starejših od 1,5 meseca, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotipa 1 in 8.
Pack sizes:
Pakiranja:
The entire content of the bottle should be used immediately after broaching and during the same procedure.
Takoj po odpiranju porabite naenkrat celotno vsebino stekleničke.
1 bottle of 120 doses (240 ml).
1 viala s 120 odmerki (240 ml).
1 bottle of 10 doses (20 ml).
1 viala z 10 odmerki (20 ml).
Aluminium hydroxide Saponin
aluminijev hidroksid, saponin, tiomersal.
SPAIN
Girona ŠPANIJA
Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 RP* ≥ 1 inaktiviran virus bolezni modrikastega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1
1 bottle of 50 doses (100 ml).
1 viala s 50 odmerki (100 ml).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml and 240 ml
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na viali 100 ml in 240 ml
Pack of 1 bottle of 10 doses (20 ml).
Velikost pakiranja: Pakiranje z 1 vialo z 10 odmerki (20 ml).
MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/001-003
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/120/001-003
MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/120/001
4.9 Amounts to be administered and administration route
4.9 Odmerjanje in pot uporabe Subkutana uporaba.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/120/002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/120/002
Pharmacotherapeutic group: Inactivated viral vaccines for sheep, Bluetongue virus.
Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.Oznaka ATC vet: QI04AA02
Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
V odmerku 2 ml: inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 inaktiviran virus bolezni modrikastega jezika, serotip 8, sev BTV-8/BEL2006/02
Special precautions for use in animals: Only use in healthy animals.
Posebni previdnostni ukrepi za uporabo pri živalih:
QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Vsak odmerek (2 ml) vsebuje:
Date of first authorisation: 17 October 2003 Date of latest renewal: 17 October 2008
Datum prve odobritve: 17. oktober 2003 Datum zadnjega podaljšanja: 17. oktober 2008
Therefore, do not take Stalevo and iron supplements at the same time.
Zato ne jemljite zdravila Stalevo in železovih dodatkov sočasno.
Experience with Stalevo in patients under 18 years is limited.
Izkušnje z zdravilom Stalevo pri bolnikih, starih manj kot 18 let, so omejene.
Therefore, the use of Stalevo in children or adolescents is not recommended.
Zato se uporaba zdravila Stalevo pri otrocih ali mladostnikih ne priporoča.
You should be aware that Stalevo may make these reactions worse.
Zavedati se morate, da lahko zdravilo Stalevo te reakcije še poslabša.
Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.
Zdravnik lahko izvede nekaj rednih laboratorijskih preiskav med dolgoročnim zdravljenjem z zdravilom Stalevo.
Stalevo with food and drink
Zdravilo Stalevo skupaj s hrano in pijačo
Paediatric population: The safety and efficacy of Stalevo in children aged below 18 years have not been established.
Pediatrična populacija: Varnost in učinkovitost zdravila Stalevo pri otrocih starih do 18 let nista bili dokazani.
What Stalevo is and what it is used for
Kaj je zdravilo Stalevo in za kaj ga uporabljamo
The starting dose of Stalevo should provide either the same amount of levodopa or slightly (5-10%) more.
Začetni odmerek zdravila Stalevo naj zagotavlja enako ali nekoliko (5-10 %) večjo količino levodope.
Stalevo should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Zdravila Stalevo ne smete uporabljati pri nosečnicah, razen če koristi za mater ne odtehtajo morebitnega tveganja za plod.
However, caution should be exercised when these medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).
Vseeno pa je potrebna previdnost, kadar se ta zdravila uporabljajo sočasno z zdravilom Stalevo (glejte poglavji 4.3 in 4.4).
For some patients, Stalevo may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Pri nekaterih bolnikih se zdravilo Stalevo ne absorbira tako dobro, če ga jemljejo med obrokom ali kmalu po obroku proteinsko bogate hrane (npr. meso, ribe, mlečni izdelki, semena in oreški).
- All patients treated with Stalevo should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour.
- Vse bolnike, ki se zdravijo z zdravilom Stalevo, je treba skrbno spremljati, če bi prišlo do psihičnih sprememb, depresije s samomorilnimi nagnjenji ter drugih resnih oblik antisocialnega vedenja.
What you need to know before you take Stalevo
Kaj morate vedeti, preden boste vzeli zdravilo Stalevo
However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 1126%].
Vendar pa v raziskavi interakcij pri zdravih prostovoljcih entakapon ni povzročil spremembe plazemskih koncentracij S-varfarina, med tem, ko so se vrednosti AUC R-varfarina povečale v povprečju za 18 % [CI90 11-26 %].
Other medicines and Stalevo
Druga zdravila in zdravilo Stalevo
Daily ON time with and without entacapone was recorded in home-diaries by patients.
Dnevni interval učinkovanja zdravila z ali brez entakapona so bolniki beležili v domači dnevnik.
If you must undergo surgery, please tell your doctor that you are using Stalevo.
Če morate na operacijo, povejte svojemu zdravniku, da jemljete zdravilo Stalevo.
Detailed information on this medicinal product is available on the website of European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
Do not take Stalevo if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Ne uporabljajte zdravila Stalevo, če jemljete nekatera zdravila za zdravljenje depresije (kombinacija selektivnih zaviralcev MAO-A in MAO-B ali neselektivnih zaviralcev MAO).
In the pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
V raziskavah farmakokinetike zdravila Stalevo je biološka uporabnost levodope pri ženskah večja kot pri moških predvsem zaradi razlike v telesni masi, medtem ko pri karbidopi in entakaponu razlike med spoloma ni bilo.
Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy.
Zdravilo Stalevo lahko zniža vaš krvni tlak, zaradi česar se boste počutili vrtoglavi in omotični.
If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately.
Če ste po naključju vzeli več tablet zdravila Stalevo, kot bi smeli, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
Stalevo may have a major influence on the ability to drive and use machines.
Zdravilo Stalevo ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Therefore Stalevo should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Zato je potrebna previdnost pri dajanju zdravila Stalevo bolnikom, ki jemljejo druga zdravila, ki lahko povzročajo ortostatsko hipotenzijo.
- Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
- Zdravilo Stalevo vsebuje saharozo, zato bolniki z redkimi prirojenimi motnjami, kot so intoleranca za fruktozo, malabsorpcija glukoze-galaktoze ali pomanjkanje saharaze-izomaltaze, ne smejo jemati tega zdravila.
It may therefore be necessary, particularly in patients with dyskinesia, to reduce levodopa dose by 10-30% within the first days to first weeks after initiating Stalevo treatment.
Zato bo morda potrebno v prvih dneh oziroma prvih tednih po uvedbi zdravljenja z zdravilom Stalevo, zlasti pri bolnikih z diskinezijo zmanjšati odmerek levodope za 10-30 %.