natgillin/translations-raw huggingface dataset:
Initially, doses of 2.5 microgram iloprost should be administered using Ventavis 10 microgram/ml with dosing intervals of 3-4 hours (corresponds to administration of max. 6 times per day).
Ob uvedbi zdravljenja mora med biti interval med posameznimi 2,5-mikrogramskimi odmerki iloprosta v zdravilu Ventavis 10 mikorgramov/ml 3 - 4 ure (kar ustreza največ 6 aplikacijam na dan).
This system generates droplets by ultrasound, which forces the solution through a mesh.
Nebulatorski sistem s pomočjo ultrazvoka potiska raztopino skozi mrežico in tako ustvarja kapljice.
Multipack: 90 (3 x 30) ampoules with 2 ml.
Večkratno pakiranje: 90 (3 x 30) ampul z 2 ml
Other people might accidentally be exposed to Ventavis through the room air.
Zaradi neustreznega zračenja lahko pride do naključne izpostavljenosti drugih oseb zdravilu Ventavis.
Be sure to ventilate or air the room in which you have taken your Ventavis treatment.
Poskrbite, da bo prostor, v katerem ste inhalirali zdravilo Ventavis, ustrezno ventiliran oziroma prezračen.
Dose of iloprost at mouthpiece
Odmerek iloprosta v ustniku
30 ampoules with 2 ml.
30 ampul z 2 ml.
Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator 1 ml raztopine vsebuje 10 mikrogramov iloprosta (v obliki trometamolijevega iloprostata).
Ventavis 10 microgram/ml nebuliser solution 4 years.
Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator 4 leta
Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator 1 ml raztopine vsebuje 20 mikrogramov iloprosta (v obliki trometamolijevega iloprostata).
• throat irritation
• draženje v grlu
42 ampoules with 1 ml.
42 ampul z 1 ml.
Close supervision by the treating physician is necessary if switching from Ventavis 10 microgram/ml to Ventavis 20 microgram/ml to control the acute tolerance relating to faster delivery rate of iloprost with the double concentration.
Pri prehodu z zdravila Ventavis 10 mikrogramov/ml na zdravilo Ventavis 20 mikrogram/ml mora lečeči zdravnik skrbno nadzorovati kako bolnik prenaša hitrejše dovajanje iloprosta z dvakrat večjo koncentracijo.
Skin and eye contact, oral ingestion
Stik s kožo in očmi, zaužitje
90 ampoules with 2 ml.
90 ampul z 2 ml
• P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
• P2 Program 2: 2,5 mikrogramov učinkovine v ustniku, 10 inhalacijskih ciklov.
• P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
• P1 Program 1: 5 mikrogramov učinkovine v ustniku, 25 inhalacijskih ciklov.
Multipack: 168 (4 x 42) ampoules with 1 ml.
Večkratno pakiranje: 168 (4 x 42) ampul z 1 ml
The ampoules containing 1 ml are marked with two coloured rings (white - yellow).
Ampule, ki vsebujejo 1 ml raztopine, so označene z dvema barvnima obročema (bel-rumen).
100 ampoules with 2 ml.
100 ampul z 2 ml
At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser.
Ob uvedbi zdravljenja z zdravilom Ventavis naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja.
Posology
Pripomoček
The nebulising device delivers 5 microgram iloprost at the mouthpiece.
Nebulator skozi ustnik dovede 5 mikrogramov iloprosta.
300 ampoules with 2 ml.
300 ampul z 2 ml
42 AMPOULES WITH 1 ML
42 AMPUL Z 1 ML
Contents of the pack and other information
Shranjevanje zdravila Ventavis Vsebina pakiranja in dodatne informacije
Ventavis 20 microgram/ml is available in the following packs: - Pack containing 30 ampoules or 42 ampoules for use with the Breelib and I-Neb nebuliser.
Zdravilo Ventavis 20 mikrogramov/ml je na voljo v naslednjih pakiranjih: - pakiranje s 30 ampulami ali z 42 ampulami za uporabo z nebulatorjem Breelib ali I-Neb - večkratno pakiranje s 168 (4 x 42) ampulami za uporabo z nebulatorjem Breelib ali I-Neb - večkratno pakiranje, ki vsebuje 168 (4 x 42) ampul in set za uporabo nebulatorja Breelib
Each ampoule with 1 ml contains 10 microgram iloprost.
Ena ampula z 1 ml raztopine vsebuje 10 mikrogramov iloprosta.
For the 5 microgram dose of Ventavis 20 microgram/ml the medication chamber with the gold coloured latch is used together with the gold control disc.
Za odmerek 5 mikrogramov zdravila Ventavis 20 mikrogramov/ml se uporablja prostor za zdravilo z zlatim zapahom in zlatim nadzornim diskom.
Part of a multipack containing 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Del škatle večkratnega pakiranja, ki vsebuje 168 (4 x 42) ampul z 1 ml in set za uporabo nebulatorja Breelib (1 ustnik in 1 prostor za zdravilo).
The dose of Ventavis and the duration of treatment that is right for you depend on your individual condition.
Od vašega splošnega stanja je odvisno, kolikšen odmerek zdravila Ventavis je primeren za vas in koliko časa naj traja zdravljenje.
Iloprost
Odmerek
Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Pri bolnikih s sočasno kronično obstruktivno pljučno boleznijo (KOPB) in hudo astmo koristnost zdravila Ventavis ni bila dokazana.
Rash
trismus
• For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc.
• Za odmerek 5 mikrogramov se uporablja prostor za zdravilo z vijoličastim zapahom in vijoličastim nadzornim diskom.
P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
• P2 Program 2: 2,5 mikrograma učinkovine v ustniku, 10 inhalacijskih ciklov.
168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
168 (4 x 42) AMPUL Z 1 ML IN SET ZA UPORABO NEBULATORJA BREELIB
• I-Neb nebuliser
• Nebulator I-Neb
Chest discomfort / chest pain Cough
- neprijeten občutek v prsnem košu/bolečine v prsnem košu
At initiation of Ventavis treatment with Venta-Neb the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 2 ml ampoule of Ventavis 10 microgram/ml.
Ob uvedbi zdravljenja z zdravilom Ventavis z nebulatorjem Venta-Neb naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja z uporabo 2 ml ampule zdravila Ventavis
Each ampoule with 2 ml contains 20 microgram iloprost.
Ena ampula z 2 ml raztopine vsebuje 20 mikrogramov iloprosta.
• 3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white - pink).
• Brezbarvne 3-mililitrske ampule iz stekla tipa I, ki vsebujejo 2 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (bel-rožnat).
• 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow - red).
• Brezbarvne 1-mililitrske ampule iz stekla tipa I, ki vsebujejo 1 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (rumen-rdeč).
As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
zaviranje delovanja trombocitov, dihalno stisko) in splošne znake zastrupitve, kot so apatija, motnje ravnotežja in motnje zaradi spremembe položaja telesa.
Ethanol 96%
(placebo 9 %).
Only patients who are maintained at the 5 microgram dose and who have repeatedly experienced extended inhalation times with Ventavis 10 microgram/ml, which could result in incomplete inhalation, may be considered suitable for switching to Ventavis 20 microgram/ml.
5 mikrogramov vijoličast vijoličast 6,5 min Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator Prehod na zdravilo 20 mikrogramov/ml je primeren le za bolnike, pri katerih se uporablja vzdrževalni odmerek 5 mikrogramov in pri katerih je bil čas inhaliranja zdravila Ventavis 10 mikrogramov/ml zaradi nepopolnih inhalacij večkrat podaljšan.
Ventavis 20 microgram/ml nebuliser solution Clear, colourless to slightly yellowish solution.
Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator bistra, brezbarvna do rahlo rumenkasta raztopina
Each ampoule with 1 ml contains 20 microgram iloprost.
Ena ampula z 1 ml raztopine vsebuje 20 mikrogramov iloprosta.
Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Večkratno pakiranje: 168 (4 x 42) ampul z 1 ml in set za uporabo nebulatorja Breelib (1 ustnik in 1 prostor za zdravilo).
• In general, you will need to take special care to try and avoid effects of low blood pressure,
da znižujejo krvni tlak, je treba paziti, da ne bi prišlo do dodatnega znižanja krvnega tlaka.
1 ml ampoule white - yellow ring
1 ml ampula bel-rumen obroč
A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost at the concentration of 10 microgram/ml: N=101; placebo n=102) with stable pulmonary hypertension.
10 mikrogramov/ml: n = 101, placebo: n = 102) s stabilno pljučno hipertenzijo.
Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator
Room ventilation
Zračenje prostora
• 2 ml ampoules for the use with Venta-Neb: Pack containing 30, 90, 100 or 300 ampoules.
• 2 ml ampule za uporabo z nebulatorjem Venta-Neb: pakiranje, ki vsebuje 30, 90, 100 ali 300 ampul večkratno pakiranje, ki vsebuje 90 (3 x 30) ali 300 (10 x 30) ampul Ampule, ki vsebujejo 2 ml raztopine, so označene z dvema barvnima obročema (bel-rožnat).
The dose delivered by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc. Each medication chamber is colour coded and has a corresponding colour coded control disc.
Vsak prostor za zdravilo je označen z barvno oznako in ima nadzorni disk, označen z ustrezno barvo.
Symptoms can include chest pain, a heart attack within the last six months, a weak heart (decompensated cardiac failure) which is not under close medical observation, severe unstable heartbeat, a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension),
srčno popuščanje (dekompenzirana srčna bolezen), ki ni pod skrbnim zdravniškim nadzorom, hudo neenakomerno bitje srca,
Common (may affect up to 1 in 10 people):
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use.
Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis 20 mikrogramov/ml, označena z dvema barvnima obročema (rumen-rdeč), neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
Ampoules with 1 ml nebuliser solution (for the use of Breelib or I-Neb AAD): Packages containing:
Ampule z 1 ml inhalacijske raztopine za nebulator (za uporabo z nebulatorjem Breelib ali I-Neb AAD) Pakiranje vsebuje: - 30 ampul - 42 ampul.
Just before you start to inhale, take the yellow-red colour coded ampoule of Ventavis 20 microgram/ml, break the glass ampoule and pour the complete contents of 1 ml into the nebuliser medication golden chamber.
20 mikrogramov/ml, prelomite stekleno ampulo in celotno vsebino 1 mililitra zlijte v zlat prostor za zdravilo v nebulatorju.
Different nebuliser devices can be used to administer Ventavis 20µg/ml.
Za dovajanje zdravila Ventavis 20 mikrogramov/ml se lahko uporabljajo različni nebulatorji.
For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Za vsako inhalacijo se vsebina ene 2-mililitrske ampule Ventavis 10 mikrogramov/ml inhalacijske raztopine za nebulator, označena z dvema barvnima obročema (bel-rožnat) neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
Ventavis 10 microgram/ml, Nebuliser solution Iloprost
Ventavis 10 mikrogramov/ml, inhalacijska raztopina za nebulator iloprost
In general, when starting Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece.
Na začetku zdravljenja z zdravilom Ventavis naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik.
Ventavis 10 mcg/ml (1 ml ampoule with white and yellow rings)
Ventavis 10 mikrogramov/ml (z belim in rumenim obročem).
Drug product
Z ZDRAVILOM
The need to adapt and/or change the therapy should be considered (see section 4.8).
Pogostejše pojavljanje sinkope je lahko znak nezadostnega zdravljenja, premalo učinkovitega zdravljenja in/ali poslabšanja bolezni, zato je treba razmisliti o prilagoditvi in/ali spremembi obstoječega zdravljenja (glejte poglavje 4.8).
Multipack containing 90 (3x30) or 300 (10x30) ampoules.
- 90 (3 x 30) ampul - 300 (10 x 30) ampul.
Ventavis 20 mcg/ml 1 ml ampoule yellow-red ring
20 mikrogramov/ml (1 ml ampula rumen-rdeč obroč)
Always take Ventavis exactly as your doctor has told you.
Pri uporabi zdravila Ventavis natančno upoštevajte navodila zdravnika.
• 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow).
• Brezbarvne 1-mililitrske ampule iz stekla tipa I, ki vsebujejo 1 ml inhalacijske raztopine za nebulator, označene z dvema barvnima obročema (bel-rumen).
Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Ventavis 10 mikrogramov/ml (1 ml ampula bel-rumen obroč)
General disorders and administration site condition
Splošne težave in spremembe na mestu aplikacije periferni edem§
Dyspnoea Pharyngolaryngeal pain
Druge posebne skupine bolnikov Okvara ledvic
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use.
Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis, označena z dvema barvnima obročema (bel-rumen), neposredno pred uporabo prenese v prostor za zdravilo.
Marketing Authorisation Holder:
SEZNAM POMOŽNIH SNOVI Pomožne snovi:
For the 5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the purple coloured latch is used together with the purple control disc.
Za odmerek 5 mikrogramov zdravila Ventavis 10 mikrogramov/ml se uporablja prostor za zdravilo z vijoličastim zapahom in vijoličastim nadzornim diskom.
Ampoule coloured rings
Barvni obroč na ampuli
Ventavis 20 microgram/ml nebuliser solution Iloprost
Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
Comparable systemic exposures (AUC (0-tlast)) and approximately 30% higher maximum serum concentrations (Cmax) were found following inhalation of Ventavis 20 microgram/ml compared to Ventavis 10 microgram/ml which was in line with the observed shorter inhalation time using Ventavis 20 microgram/ml.
Ventavis 20 mikrogramov/ml v primerjavi z zdravilom Ventavis 10 mikrogramov/ml, kar je v skladu z opaženim krajšim časom inhaliranja po uporabi zdravila Ventavis 20 mikrogramov/ml.
Vascular disorders
nitro vazodilatatorji,
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 10 microgram/ml, with two coloured rings (white - yellow), is transferred into the medication chamber immediately before use.
Za vsako inhalacijo z nebulatorjem I-Neb AAD se vsebina ene 1-mililitrske ampule zdravila Ventavis 10 mikrogramov/ml, označena z dvema barvnima obročema (bel-rumen), neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 2 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
5 mikrogramov iloprosta z uporabo 2 ml ampule zdravila Ventavis 10 mikrogramov/ml in ga vzdrževati.
• rash
• kašelj
Talk to your doctor, pharmacist or nurse before using Ventavis:
Pred začetkom uporabe zdravila Ventavis se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Symptoms can include chest pain, - a heart attack within the last six months, - a weak heart (decompensated cardiac failure) which is not under close medical observation, - severe unstable heartbeat, - a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension),
- srčni infarkt v zadnjih šestih mesecih - dekompenzirano srčno popuščanje, ki ni pod zdravniškim nadzorom
medication chamber).
Zapah prostora za zdravilo
Ventavis 20 microgram/ml nebuliser solution
Ventavis 20 mikrogramov/ml Breelib
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 1 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
5 mikrogramov iloprosta z uporabo 1 ml ampule zdravila Ventavis 10 mikrogramov/ml in ga vzdrževati.
Dysgeusia
• omotica
I-Neb AAD Estimated inhalation time
I-Neb AAD Zapah prostora za zdravilo
Other special populations
DRUGI PODATKI
Pain in jaw/trismus
- omotica - bruhanje - driska
Check with your doctor or pharmacist if you are unsure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
− Myocardial infarction within the last six months.
Simptomi lahko vključujejo bolečine v prsnem košu, srčni napad v zadnjih šestih mesecih,
At initiation of Ventavis treatment with I-Neb system the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 1 ml ampoule of Ventavis 10 microgram/ml.
Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator (1 ml ampula) Ob uvedbi zdravljenja z zdravilom Ventavis z nebulatorjem I-Neb naj bo prvi inhalirani odmerek 2,5 mikrogramov iloprosta, doveden skozi ustnik nebulatorja z uporabo 1 ml ampule zdravila Ventavis
• 90 (3x30) ampoules
90 (3 x 30) AMPUL Z 2 ML
2.5 mcg 5 mcg
2,5 mikrogramov 5 mikrogramov
Dose per inhalation session
Odmerek na posamezno inhalacijo
Medication chamber latch
Bayer HealthCare
ACE inhibitors.
zaviralci angiotenzinske konvertaze (zaviralci ACE).
Genotoxic potential, tumourigenicity
Genotoksičnost, kancerogeni potencial
Ventavis 10 mcg/ml
Ventavis 10 mikrogramov/ ml
Ventavis 10 microgram/ml nebuliser solution Iloprost
Ventavis 10 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
30 ampoules with 1 ml 42 ampoules with 1 ml Multipack: 168 (4 x 42) ampoules with 1 ml
30 AMPUL Z 1 ML 42 AMPUL Z 1 ML
Common: may affect up to 1 in 10 people
- oteklost udov (periferni edem) Pogosti: pojavijo se lahko pri 1 od 10 bolnikov
Package leaflet: Information for the user Ventavis 20 microgram/ml nebuliser solution
Navodilo za uporabo Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator iloprost
ILD may be fatal.
ILD je lahko smrtna.
Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018
Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 28. maj 2018
Take your next dose at the scheduled time.
Naslednji odmerek vzemite ob načrtovanem času.
The mean age of the study population was 37.9 years.
Povprečna starost populacije študije je bila 37,9 let.
Potential to prolong the QT interval
Potencial za podaljšanje intervala QT
Characteristics in specific groups of patients
Značilnosti v specifičnih skupinah bolnikov
The study results are shown in Table 1.
Rezultati študije so prikazani v preglednici 1.
• balance problems.
• težave z ravnotežjem.
Efficacy in patients with high disease activity:
Učinkovitost pri bolnikih z zelo aktivno boleznijo:
These symptoms vary from patient to patient but usually involve:
Ti simptomi se razlikujejo od bolnika do bolnika, vendar običajno obsegajo:
This can cause physical disabilities that may interfere with your daily activities.
To lahko povzroči telesne nezmožnosti, ki motijo vaše dnevne dejavnosti.
Use of alternative contraceptive methods is recommended.
Priporočljiva je uporaba drugih metod kontracepcije.
However, this is most likely an underestimation since extensive organ distribution was observed in rats.
Vendar je to najverjetneje podcenjeno, ker so pri podganah opazili obsežno porazdelitev v organe.
- you have respiratory symptoms.
- če imate respiratorne simptome.
MS is a long-term illness that affects the central nervous system (CNS).
MS je dolgotrajna bolezen, ki prizadene centralni živčni sistem (CŽS).
If they become pregnant:
Če zanosijo:
The recovery time varied between months and years.
Trajanje okrevanja je bilo od nekaj mesecev do let.
Serious opportunistic infections occurred in 0.2% of each group.
Resne oportunistične okužbe so se v obeh skupinah pojavile pri 0,2 % bolnikov.
Information to educate the patient:
Informacije za izobraževanje bolnika:
Accelerated elimination procedure
Postopek pospešenega izločanja
The choice between the 3 elimination procedures should depend on the patient's tolerability.
Odločitev med 3 postopki izločanja naj temelji na bolnikovem prenašanju.
This stops nerves from working properly.
Zaradi tega živci ne delujejo več pravilno.
Please read section 4.
Preberite poglavje 4.
- you have an infection.
- če imate okužbo.
Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Ženske v rodni dobi ne smejo jemati tega zdravila brez uporabe zanesljive kontracepcije.
This may lead to an additive effect on the immune system and caution is, therefore, indicated.
To lahko privede do aditivnega učinka na imunski sistem, zato je potrebna previdnost.
TOWER-study
študija TOWER
These elevations occurred mostly within the first 6 months of treatment.
Do teh zvišanj je večinoma prišlo v prvih 6 mesecih zdravljenja.
What multiple sclerosis is
Kaj je multipla skleroza
For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
V primeru zvišanja ALT (SGPT) med 2in 3-kratno zgornjo mejo normalnih vrednosti, je treba spremljanje izvajati vsak teden.
- you are going to have a vaccination.
- če načrtujete cepljenje.
The mean number of relapses within the year before study inclusion was 1.4.
Povprečno število zagonov v letu pred vključitvijo v raziskavo je bilo 1,4.
Each wallet is placed in a protective sleeve.
Vsaka pretisna zgibanka je v zaščitnem ovoju.
Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Bolnike je treba natančno spremljati glede znakov in simptomov čezmerne izpostavljenosti zdravilom in preučiti možnost zmanjšanja odmerka teh zdravil.
Although human data are lacking, no effect on male and female fertility is anticipated.
Čeprav podatkov pri ljudeh ni, se učinki na plodnost pri moških in ženskah ne pričakujejo.
In such cases, patients should refrain from driving and using machines.
V takšnih primerih bolniki ne smejo voziti ali upravljati strojev.
The long term safety of these combinations in the treatment of multiple sclerosis has not been established.
Dolgoročna varnost teh kombinacij pri zdravljenju multiple skleroze ni bila raziskana.
AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
Zdravilo AUBAGIO se mora uporabljati previdno pri bolnikih, starih 65 let in več, zaradi nezadostnih podatkov o varnosti in učinkovitosti.
• Requires concomitant use of effective contraception in women of child-bearing potential
• zahteva sočasno uporabo učinkovite kontracepcije pri ženskah v rodni dobi,
• To remind both patients and HCP about the Pregnancy Registry (in countries where pregnancy registry is on-going)
• opomniti bolnice in zdravstvene delavce o registru nosečnosti (v državah, kjer register nosečnosti obstaja).