natgillin/translations-raw huggingface dataset:
EU/2/99/014/001 (3 pipettes) EU/2/99/014/012 (15 pipettes)
EU/2/99/014/005 (120 mg - 3 merilne kapalke) EU/2/99/014/010 (120 mg - 6 merilnih kapalk)
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC UČINKOVINE IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
12% w/v solution selamectin 360 mg
12% w/v raztopina selamektin 360 mg
Flea treatment and prevention (cats and dogs)
Zdravljenje in preprečevanje infestacije z bolhami (mačke in psi)
Remove the Stronghold pipette from its protective package.
Merilno kapalko z zdravilom Stronghold vzamemo iz zaščitnega ovoja
12% w/v solution selamectin 30 mg
12% w/v raztopina selamektin 30 mg
INDICATION(S) Cats and dogs: Treatment and prevention of flea infestations caused by Ctenocephalides spp.
▪ Zdravljenje in preprečevanje infestacij z bolhami, ki jih povzročajo vrste Ctenocephalides spp.
6% w/v solution selamectin 60 mg
6% w/v raztopina selamektin 60 mg
selamectin 15 mg
NAVEDBA UČINKOVIN(E) selamektin 15 mg
Excipients:
Kako nanesti:
12% w/v solution selamectin 60 mg
12% w/v raztopina selamektin 60 mg
Treatment of roundworm infections (cats and dogs)
Preprečevanje obolenja pri okužbi z Dirofilario immitis (mačke in psi)
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age.
Z mesečnim tretiranjem brejih in doječih živali močno zmanjšamo populacijo bolh, obenem pa zaščitimo leglo z mladički pred infestacijo z bolhami do njihovega sedmega tedna starosti.
Dogs weighing 40.1-60.0 kg.
Psi s telesno maso 40, 1-60,0 kg.
Treatment of biting lice (cats and dogs)
Zdravljenje infestacij z ušmi (mačke in psi)
Stronghold 15 mg spot-on for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on for dogs 2.6-5.0 kg Stronghold 45 mg spot-on for cats 2.6-7.5 kg Stronghold 60 mg spot-on for cats 7.6-10.0 kg Stronghold 60 mg spot-on for dogs 5.1-10.0 kg Stronghold 120 mg spot-on for dogs 10.1-20.0 kg Stronghold 240 mg spot-on for dogs 20.1-40.0 kg Stronghold 360 mg spot-on for dogs 40.1-60.0 kg selamectin
Stronghold 15 mg kožni nanos za mačke in pse ≤ 2,5 kg Stronghold 30 mg kožni nanos za pse 2,6−5,0 kg Stronghold 45 mg kožni nanos za mačke 2,6−7,5 kg Stronghold 60 mg kožni nanos za mačke 7,6−10,0 kg Stronghold 60 mg kožni nanos za pse 5,1−10,0 kg Stronghold 120 mg kožni nanos za pse 10,1−20,0 kg Stronghold 240 mg kožni nanos za pse 20,1−40,0 kg Stronghold 360 mg kožni nanos za pse 40,1−60,0 kg selamektin
Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
CILJNE ŽIVALSKE VRSTE Mačke s telesno maso 2,6-7,5 kg.
Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Stronghold 30 mg kožni nanos, raztopina za pse 2,6−5,0 kg Stronghold 60 mg kožni nanos, raztopina za pse 5,1−10,0 kg Stronghold 120 mg kožni nanos, raztopina za pse 10,1−20,0 kg Stronghold 240 mg kožni nanos, raztopina za pse 20,1−40,0 kg Stronghold 360 mg kožni nanos, raztopina za pse 40,1−60,0 kg selamektin
Administered volume (nominal pipette size, ml)
NAVODILO ZA UPORABO Stronghold kožni nanos, raztopina
Prevention of heartworm disease (cats and dogs)
Zdravljenje infestacij z ušmi (psi in mačke)
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Special warnings for each target species: Animals may be bathed 2 hours after treatment without loss of efficacy.
Drugi previdnostni ukrepi Zdravljene živali se najmanj dve uri po zdravljenju ne smejo kopati v tekočih vodah.
Cats and dogs weighing 2.5 kg or less (Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg)
Stronghold 15 mg kožni nanos, raztopina za mačke in pse < 2,5 kg Stronghold 30 mg kožni nanos, raztopina za pse 2,6-5,0 kg Stronghold 45 mg kožni nanos, raztopina za mačke 2,6-7,5 kg Stronghold 60 mg kožni nanos, raztopina za mačke 7,6-10,0 kg Stronghold 30 mg kožni nanos, raztopina za pse 5,1-10,0 kg Stronghold 120 mg kožni nanos, raztopina za pse 10,1-20,0 kg Stronghold 240 mg kožni nanos, raztopina za pse 20,1-40,0 kg Stronghold 360 mg kožni nanos, raztopina za pse 40,1-60 kg
The European Commission granted a marketing authorisation valid throughout the European Union for Zostavax on 19 May 2006.
Evropska komisija je dovoljenje za promet z zdravilom Zostavax, veljavno po vsej Evropski uniji, izdala 19. maja 2006.
The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
Študija je bila izvedena po metodi dvojno slepega preskušanja, kar pomeni, da nista ne zdravnik ne bolnik vedela, katero zdravljenje je bolnik prejel.
What measures are being taken to ensure the safe and effective use of Zostavax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zostavax?
The full EPAR for Zostavax is available 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 Zostavax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It must also not be used in patients with active untreated tuberculosis or in pregnant women.
Ne sme se uporabljati niti pri bolnikih z aktivno, nezdravljeno tuberkulozo, ali pri nosečnicah.
Most of these side effects were mild.
Večina neželenih učinkov je bila blagih.
What benefit has Zostavax shown during the studies?
Kakšne koristi je zdravilo Zostavax izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Zostavax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zostavax.
In patients who have bleeding problems, the vaccine should be given under the skin.
Pri bolnikih s težavami s krvavitvami je treba cepivo injicirati v podkožje.
A risk management plan has been developed to ensure that Zostavax is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zostavax je bil pripravljen načrt obvladovanja tveganj.
The main measure of effectiveness was based on the number of people who developed shingles and post-herpetic pain.
Glavno merilo učinkovitosti je bilo število ljudi, pri katerih sta se razvila pasovec in postherpetična bolečina.
The effect was seen both in patients aged between 50 and 59 years and in those aged 60 years and older.
Ta učinek so opazili pri bolnikih, starih od 50 do 59 let, in tudi pri tistih, starejših od 60 let.
Other information about Zostavax
Druge informacije o zdravilu Zostavax
For more information about treatment with Zostavax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zostavax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Zostavax.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The patients were followed for 2 to 4.5 years after vaccination.
Bolnike so nadzorovali od dveh do štirih let in pol po cepljenju.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zostavax, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In studies, the most common side effects with Zostavax are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising), headache and pain in the arm or leg.
V študijah so bili najpogostejši neželeni učinki zdravila Zostavax reakcije na mestu injiciranja (rdečina, bolečina, oteklina, srbenje, toplota in podplutba), glavobol in bolečine v okončinah.
The vaccine must not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, acquired immune deficiency syndrome (AIDS), or because they are taking medicines that affect the immune system.
Prav tako ga ne smejo uporabljati osebe, ki imajo težave z imunskim sistemom, bodisi ker imajo bolezen, kot je levkemija, limfom ali sindrom pridobljene imunske pomanjkljivosti (aids), ali ker jemljejo zdravilo, ki vpliva na imunski sistem.
What is the risk associated with Zostavax?
Kakšna tveganja so povezana z zdravilom Zostavax?
Zostavax was more effective than placebo in preventing shingles.
Zdravilo Zostavax je bilo pri preprečevanju pasovca učinkovitejše od placeba.
The studies looked at the ability of the vaccine to stimulate the production of antibodies against varicella-zoster virus in the blood, four weeks after injection.
V študijah so proučevali zmožnost cepiva za spodbujanje tvorbe protiteles proti virusu varicella-zoster v krvi štiri tedne po prejetju cepiva.
Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Herpes zoster ali pasovec je bolezen, ki jo povzroči reaktivacija virusa varicella-zoster, tj. istega virusa, ki povzroči tudi norice.
Two further studies looked at Zostavax in over 1,000 patients aged 50 years or older, of whom 389 were between 50 and 59 years of age.
V nadaljnjih dveh študijah so cepivo Zostavax proučevali pri več kot 1 000 bolnikih, starejših od 50 let, med katerimi jih je 389 bilo starih od 50 do 59 let.
Zostavax must not be used in people who are hypersensitive (allergic) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine such as neomycin (an antibiotic).
Cepivo Zostavax ne sme uporabljati osebe, ki so preobčutljive za (alergične na) katere koli sestavine zdravila ali katero koli snov, ki jo je mogoče v cepivu najti v sledeh (v zelo nizkih koncentracijah), kot je na primer neomicin (antibiotik).
Zostavax shingles (herpes zoster) vaccine (live)
Zostavax cepivo proti pasovcu (herpesu zostru) (živo)
Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).
Zdravilo Zostavax se uporablja za cepljenje ljudi, starejših od 50 let, za preprečevanje herpesa zostra (znanega tudi kot zoster ali pasovec) in dolgotrajne bolečine v živcu, ki se lahko razvije po bolezni (postherpetična nevralgija).
The risk of developing shingles increases with age and seems to be linked to a decline in immunity (protection) against varicella-zoster virus.
Tveganje za razvoj pasovca se povečuje s starostjo in je verjetno povezano z oslabitvijo imunosti (telesne obrambe) proti virusu varicella-zoster.
Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful,
Včasih postane virus po več letih iz razlogov, ki še niso povsem pojasnjeni, znova dejaven in pri bolniku povzroči razvoj pasovca.
The main study of Zostavax compared the vaccine with placebo (a dummy) vaccine in around 39,000 patients aged between 59 and 99 years.
V glavni študiji so cepivo Zostavax primerjali s placebom (cepivom brez zdravilne učinkovine) pri približno 39 000 bolnikih, starih od 59 do 99 let.
Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection.
Zostavax je cepivo, ki je na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje.
The CHMP decided that Zostavax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zostavax večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Zostavax is given as a single dose injected under the skin or into the muscle, preferably around the shoulder.
Zdravilo Zostavax se injicira v enkratnem odmerku v podkožje ali mišico, po možnosti v predel ramena.
Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo.
Število oseb, pri katerih se je razvil pasovec, je bilo manjše v skupini, ki je prejela cepivo Zostavax, kot v skupini, ki je prejela placebo: med študijo se je pasovec pojavil pri 315 bolnikih od 19 254, ki so prejeli cepivo Zostavax, v primerjavi s 642 bolniki od 19 247 tistih, ki so prejeli placebo.
The active substance is the attenuated (weakened) varicella-zoster virus.
Zdravilna učinkovina je atenuiran (oslabljen) virus varicella-zoster.
The additional two studies showed that patients vaccinated with Zostavax had blood levels of antibodies against varicella-zoster virus that were about two to three times higher four weeks after vaccination.
Dodatni dve študiji sta pokazali, da so imeli bolniki, cepljeni z zdravilom Zostavax, štiri tedne po cepljenju v krvi okoli dva- do trikrat višje ravni protiteles proti virusu varicella-zoster.
Why has Zostavax been approved?
Zakaj je bilo zdravilo Zostavax odobreno?
For the full list of all side effects reported with Zostavax, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri zdravilu Zostavax, glejte navodilo za uporabo.
Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.
Cepivo Zostavax je bilo učinkovitejše od placeba tudi pri preprečevanju postherpetične nevralgije: razvila se je pri 27 bolnikih, ki so prejeli cepivo Zostavax, v primerjavi z 80 bolniki iz skupine, ki je prejela placebo.
Zostavax is a vaccine that was shown to ‘boost' this immunity, protecting against shingles and the pain associated with it.
Cepivo Zostavax dokazano okrepi omenjeno imunost, s čimer zagotavlja zaščito pred pasovcem in z njim povezano bolečino.
The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain (post-herpetic neuralgia) in the area where the rash was.
Po navadi izgine šele po nekaj tednih, zatem pa se lahko v predelu, na katerem je bil izpuščaj, pojavi dolgotrajna huda bolečina (postherpetična nevralgija).
What is Zostavax used for?
Za kaj se zdravilo Zostavax uporablja?
blistering rash typically in one part of the body.
Pasovec je boleč, mehurčast kožni izpuščaj, ki se običajno pojavi na enem delu telesa.
What is Zostavax?
Kaj je zdravilo Zostavax?
How has Zostavax been studied?
Kako je bilo zdravilo Zostavax raziskano?
How is Zostavax used?
Kako se zdravilo Zostavax uporablja?
Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant' (inactive) state.
Po noricah ostane virus varicella-zoster v telesu v živčnem sistemu v „speči“ (neaktivni) obliki.
How does Zostavax work?
Kako zdravilo Zostavax deluje?
23 August 2012
23. avgust 2012
The European Commission issued a decision on 23 August 2012.
Evropska komisija je sklep izdala dne 23. avgusta 2012.
Zinnat should be used twice a day at different doses depending on the condition it is used to treat.
Zdravilo Zinnat se mora jemati dvakrat dnevno v različnih odmerkih glede na bolezen, za katero se uporablja.
This prevents the bacteria from building their cell walls, and eventually kills them.
S tem bakterijam prepreči, da bi zgradile celične stene, zaradi česar te postopoma odmrejo.
Why was Zinnat reviewed?
Zakaj je bilo zdravilo Zinnat pregledano?
It is also available under other trade names: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
Na voljo je tudi pod drugimi lastniškimi imeni: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
Zinnat is authorised in the EU via national procedures.
Zdravilo Zinnat je v EU odobreno z nacionalnimi postopki.
On 24 May 2012, the European Medicines Agency completed a review of Zinnat.
Evropska agencija za zdravila je 24. maja 2012 je zaključila pregled zdravila Zinnat.
Zinnat is marketed in all EU Member States, as well as Iceland.
Zdravilo Zinnat je na trgu v vseh državah članicah EU in Islandiji.
Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinnat in adults and children and in patients with reduced kidney and liver function.
Po uskladitvi indikacij je CHMP uskladil tudi priporočila glede uporabe zdravila Zinnat pri odraslih in otrocih ter bolnikih z zmanjšanim delovanjem ledvic in jeter.
The active substance, cefuroxime axetil, belongs to the group ‘cephalosporins'.
Zdravilna učinkovina, cefuroksim aksetil, spada v skupino „cefalosporinov“.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the different EU countries.
To je privedlo do razhajanj glede uporabe zdravila po posameznih državah članicah , kot je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v različnih državah EU.
• Uncomplicated skin and soft tissue infections.
• nezapletenih okužb kože in mehkih tkiv;
The CHMP concluded that Zinnat should be used in adults and children from three months of age for the following conditions:
CHMP je zaključil, da se lahko zdravilo Zinnat uporablja pri odraslih in otrocih od tretjega meseca starosti za zdravljenje:
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinnat in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Zinnat.
Zinnat is an antibiotic used to treat certain infections caused by bacteria, including respiratory tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).
Zdravilo Zinnat je antibiotik, ki se uporablja za zdravljenje določenih bakterijskih okužb, vključno z okužbami dihal, kot sta tonzilitis in faringitis (okužbi žrela), okužbami sečil (okužbe struktur, ki proizvajajo in odvajajo urin), okužbami kože, okužbami mehkih tkiv (okužbe podkožnih tkiv) in lymske borelioze (bakterijska okužba, ki jo na ljudi prenašajo okuženi klopi).
The CHMP agreed that Zinnat should no longer be used to treat community acquired pneumonia (infection of the lungs acquired outside the hospital) and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae) because not enough clinical data are available to support these indications.
CHMP se strinja, da se zdravilo Zinnat ne sme več uporabljati za zdravljenje zunajbolnišnične pljučnice (okužba pljuč, pridobljena zunaj bolnišnice) in gonoreje (spolno prenosljiva bolezen, ki jo povzroča bakterija Neisseria gonorrhoeae), saj ni dovolj kliničnih dokazov, ki bi podpirali ti indikaciji.
What is Zinnat?
Kaj je zdravilo Zinnat?
The CHMP also decided that Zinnat should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
CHMP je odločil tudi, da se zdravilo Zinnat ne sme več uporabljati pri sekvenčnem zdravljenju (pri prehodu bolnikov z injekcij na peroralno zdravljenje) zaradi znatnega zmanjšanja izpostavljenosti zdravilni učinkovini pri prehodu na peroralno farmacevtsko obliko.
• Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat).
• akutnega streptokoknega tonzilitisa in faringitisa (okužbi mandeljnov in žrela);
• Treatment of early Lyme disease.
• zgodnje oblike Lymske borelioze.
On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinnat in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Zinnat v EU, je 20. aprila 2010 zadevo napotila na CHMP.
• Pyelonephritis (kidney infection).
• pielonefritisa (okužbe ledvic);
• Cystitis (infection of the bladder).
• cistitisa (okužbe mehurja);
• Acute bacterial sinusitis (infection of the sinuses).
• akutnega bakterijskega sinuzitisa (okužba obnosnih votlin);
Zinnat was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Zinnat potrebna uskladitev.
• Acute otitis media (infection of the middle ear).
• akutnega vnetja srednjega ušesa;
Methysergide containing products are currently authorised in the following EU countries: Belgium, France, the Netherlands and the United Kingdom.
Zdravila, ki vsebujejo metizergid, so trenutno odobrena v naslednjih državah EU: v Belgiji, Franciji, na Nizozemskem in v Združenem kraljestvu.
However, these results should be taken
Vendar pa je te rezultate treba obravnavati previdno, saj
Such adverse effects may be serious and in some cases irreversible and potentially fatal.
Ti neželeni učinki so lahko resni in v nekaterih primerih ireverzibilni, lahko pa so tudi smrtno nevarni;
Overall summary of the scientific evaluation of methysergide containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo metizergid (glejte Prilogo I)
Existing data seems to show that fibrosis development is not related to patient age.
Obstoječi podatki kažejo, da razvoj fibroze ni povezan s starostjo bolnika.
The CHMP highlighted that these results should be taken with caution as these studies are old and generally not carried out with the current upto-date methodology8.
Odbor CHMP je poudaril, da je te rezultate treba obravnavati previdno, saj so študije stare in na splošno niso bile izvedene z najnovejšo metodologijo, ki se uporablja danes8.
The majority of patients (92.4%) who developed fibrosis received daily doses of methysergide within the currently recommended (≤ 6 mg/day).
Večina bolnikov (92,4 %), pri katerih se je razvila fibroza, je prejemala dnevne odmerke metizergida, ki so bili znotraj trenutno priporočenih (≤ 6 mg/dan).
This is provided that the recommended risk minimisation measures are implemented;
Vse to velja pod pogojem, da se izvajajo priporočeni ukrepi za zmanjšanje tveganja;