natgillin/translations-raw huggingface dataset:
A test to determine your liver function will be performed before the start of Galvus treatment, at three-month intervals for the first year and periodically thereafter.
Pred začetkom zdravljenja z zdravilom Galvus boste opravili preiskavo delovanja jeter, med zdravljenjem pa boste v prvem letu opravljali kontrolne preiskave na tri mesece in kasneje v rednih časovnih intervalihTo je potrebno za čimprejšnje odkrivanje znakov zvišanih vrednosti jetrnih encimov.
You should not use Galvus during pregnancy.
Med nosečnostjo zdravila Galvus ne smete uporabljati.
Table 6 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Preglednica 6 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 100 mg zdravila Galvus dnevno v kombinaciji z insulinom (z metforminom ali brez njega) v dvojno slepih študijah (N=371)
Table 5 Adverse reactions reported in patients who received Galvus 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Preglednica 5 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 50 mg zdravila Galvus dvakrat dnevno v kombinaciji z metforminom in sulfonilureo (N=157)
However, the magnitude of change is not clinically significant, so that Galvus can be given with or without food.
Zaradi uživanja vildagliptina skupaj s hrano se je znižala Cmax (19 %), vendar velikost te spremembe ni klinično pomembna, zato se lahko zdravilo Galvus uživa s hrano ali brez nje.
Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
V spodnjih preglednicah so po organskih sistemih in po absolutni pogostnosti za vsako indikacijo navedeni neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v dvojno slepih študijah kot monoterapijo ali v shemah zdravljenja z dodatno terapijo.
Some patients have had the following side effects while taking Galvus alone:
Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus samo:
Some patients have had the following side effects while taking Galvus, metformin and a sulphonylurea:
Pri nekaterih bolnikih je med jemanjem zdravila Galvus, metformina in sulfoniluree prišlo do naslednjih neželenih učinkov:
Table 1 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with metformin in double-blind studies (N=208)
Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno v kombinaciji z metforminom v dvojno slepih študijah (N=208)
Galvus works by making the pancreas produce more insulin and less glucagon.
Zdravilo Galvus deluje tako, da spodbuja trebušno slinavko, da tvori več insulina in manj glukagona, kar pomaga uravnavati koncentracijo sladkorja v krvi.
Table 4 Adverse reactions reported in patients who received Galvus 100 mg daily as monotherapy in double-blind studies (N=1,855)
Preglednica 4 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno kot monoterapijo v dvojno slepih študijah (N=1.855)
Table 2 Adverse reactions reported in patients who received Galvus 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Preglednica 2 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 50 mg dnevno v kombinaciji s sulfonilureo v dvojno slepih študijah (N=170)
Some patients have had the following side effects while taking Galvus and a glitazone:
Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj z glitazonom:
Table 3 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Preglednica 3 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Galvus v odmerku 100 mg dnevno v kombinaciji s tiazolidindionom v dvojno slepih študijah (N=158)
Some patients have had the following side effects while taking Galvus and a sulphonylurea:
Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj s sulfonilureo:
• Uncommon: Diarrhoea, flatulence
• občasni: driska, vetrovi.
Nasopharyngitis Metabolism and nutrition disorders Uncommon
Infekcijske in parazitske bolezni zelo redki nazofaringitis Presnovne in prehranske motnje pogosti hipoglikemija
Some patients have had the following side effects while taking Galvus and metformin:
Nekateri bolniki so imeli naslednje neželene učinke, če so jemali zdravilo Galvus skupaj z metforminom:
Talk to your doctor, pharmacist or nurse before taking Galvus
Pred začetkom jemanja zdravila Galvus se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
How to store Galvus
Shranjevanje zdravila Galvus
ATC vet code: QP54AA55.
oznaka ATC vet: QP54AA55
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/02/2017.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 09/02/2017
Clear, colourless to yellow solution.
Čista, brezbarvna do rumena raztopina.
During clinical field testing, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.
Pri testiranju na terenu niso opazili nikakršnega medsebojnega delovanja med tem zdravilom in drugimi rutinsko uporabljenimi zdravili.
Stronghold Plus should not enter water courses as this may be dangerous to aquatic organisms.
Stronghold Plus ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
Pogostnost zdravljenja in ponovno zdravljenje mora biti v skladu z navodili veterinarja.
Used pipettes should be disposed of immediately.
Uporabljene tube odvrzite takoj.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Osebe z občutljivo kožo ali znano alergijo na tovrstna zdravila naj s tem zdravilom ravnajo previdno.
- The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
- Zdravilo se lahko uporabljakot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis (FAD).
Following topical administration of the Stronghold Plus both selamectin and sarolaner are well absorbed with bioavailability mean values of 40.5% and 57.9%, respectively and distribute systemically.
Po lokalem nanosu Stronghold Plus se oba selamektin in sarolaner dobro resorbirata in dosežeta povprečno biološko razpoložljivost 40,5% in 57,9% ter se sistemsko porazdelita.
Avoid eye contact including hand-to-eye-contact.
Izogibajte se stiku z očmi vključno s stikom oči z rok.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na blistru.
Use of this veterinary medicinal product is indicated in cats aged at least 8 weeks old and weighing at least 1.25 kg bodyweight.
Zdravilo lahko dajemo mačkam, ki so stare vsaj 8 tednov ali tehtajo vsaj 1,25 kg.
Appropriate combination of pipettes
Ustrezna kombinacija tub.
No clinically significant adverse reactions were observed in kittens from 8 weeks of age treated with up to 5 times the maximum recommended dose of the product for up to 8 consecutive treatments at 28 day intervals, apart from a single cat administered 5 times the maximum dose that displayed transient hypersensitivity to touch, piloerection, mydriasis and mild tremor which resolved without treatment.
Nobenih klinično pomembnih neželenih učinkov niso opazili pri mačjih mladičih starih najmanj 8 tednov zdravljenih s petkratnim priporočenim maksimalnim odmerkom, v osmih zaporednih zdravljenjih z 28 dnevnimi intervali, z izjemo ene mačke, ki ji je bil dan 5 kratni maksimalni odmerek in je kazala prehodne znake preobčutljivost na dotik, naježeno dlako, midrijazo in rahlo tresenje in so izzveneli brez zdravljenja.
The product may cause eye irritation.
Izdelek lahko draži oči.
Stronghold Plus 60 mg/10 mg (green cap)
Stronghold Plus 60 mg/10 mg (zelen pokrovček)
Interactions with other medicinal products and other forms of interactions:
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Niso znane.
While the safety of sarolaner has not been evaluated in breeding, pregnant or lactating cats, laboratory studies with sarolaner in rats and rabbits have not produced any evidence of teratogenic effects.
Medtem, ko varnost sarolanerja ni bila ugotovljena pri vzrejnih in brejih mačkah ter mačkah v laktaciji pa z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni učinki.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1 toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere).
Stronghold Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Stronghold Plus se daje kot enkratni kožni nanos (lokalno), v skladu s tabelo (ki zagotavlja najmanj 6 mg selamektina na kg telesne mase in 1 mg sarolanerja na kg telesne mase):
Stronghold Plus 30 mg/5 mg (orange cap)
Stronghold Plus 30 mg/5 mg (oranžen pokrovček)
Sarolaner is active against adult fleas (Ctenocephalides spp.)
Sarolaner deluje na odrasle bolhe (Ctenocephalides spp.)
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Zdravilna učinkovina:
It is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more, living in countries where a vector exists should be tested for existing adult heartworm infection before beginning preventive use with the veterinary medicinal product.
Kljub temu se priporoča (v skladu z dobro veterinarsko prakso), da vse živali stare 6 mesecev in več, ki živijo v državah, kjer obstaja prenašalec mikrofilarij, pred pričetkom zatiranja s tem zdravilom, testiramo na prisotnost infestacije z odraslimi oblikami Dirofilarie immitis.
Stronghold Plus ≤2.5 kg Stronghold Plus >2.5-5 kg Stronghold Plus >5-10 kg
Stronghold Plus >2,5-5 kg Stronghold Plus >5-10 kg
Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats
Stronghold Plus kožni nanos, raztopina za mačke Stronghold Plus kožni nanos, raztopina za mačke Stronghold Plus kožni nanos, raztopina za mačke
Apply the tip of the pipette directly to the skin, without massaging.
Konico tube z zdravilom namestimo neposredno na kožo in ne masiramo.
Cats ≤2.5 kg
Stronghold Plus ≤2,5 kg
For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Za optimalni nadzor nad infestacijami z bolhami in klopi, zdravilo dajemo v mesečnih intervalih skozi celo sezono bolh in klopov v skladu z lokalno epidemiološko situacijo.
The product is available in packs of three pipettes (all pipette sizes) and six pipettes (all pipette sizes).
Zdravilo se nahaja v ovojnini s tremi tubami (vse velikosti tub), s šestimi tubami (vse velikosti tub).
Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Da bi preprečili otrokom dostop do izdelka, izdelek do uporabe hranite v originalni ovojnini.
The product is available in packs of three pipettes (all pipette sizes) and six pipettes (all pipette sizes) placed in cardboard boxes.
Zdravilo je na voljo v pakiranju s tremi merilnimi kapalkami (vse velikosti merilnih kapalk), s šestimi merilnimi kapalkami (vse velikosti merilnih kapalk).
Strength and number of pipettes to be administered Stronghold Plus 15 mg/2.5 mg (yellow cap)
Moč in število merilnih kapalk, ki jih moramo dati Stronghold Plus 15 mg/2,5 mg (rumen pokrovček)
Excipients: 0.2 mg/ml butylated hydroxytoluene.
Pomožne snovi: 0,2% butilhidroksitoluen.
For ticks (I. ricinus), the onset of efficacy is within 24 hours of attachment for one month after product application.
Pri klopih (I.ricinus), začne zdravilo učinkovati znotraj 24 ur po pritrditvi in deluje en mesec.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Učinkovina(e):
Treatment of roundworm and hookworm infections A single dose of the product should be administered.
Zdravljenje infestacij z valjastimi in kavljastimi črvi Za zdravljenje zadostuje enkraten odmerek.
Medicines should not be disposed of via wastewater.
Ne odvrzite zdravila v odpadno vodo, ali med gospodinjske odpadke.
These measures should help to protect the environment.
Ti ukrepi pomagajo varovati okolje Selamektin lahko negativno učinkuje na vodne organizme.
BLISTER
raztopina
NAME OF THE MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zoetis Belgium SA
DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA {DD/MM/LLLL}
Total volume of unit dose (ml)
Vsebnost tube (ml)
3 pipettes 6 pipettes
VELIKOST PAKIRANJA 3 merilne kapalke 6 merilnih kapalk
Butylated hydroxytoluene
Raztopina kožnih kapljic.
The pipette should be removed from the protective package immediately prior to administration.
Tub vzamete iz zaščitne ovojnine tik pred nanosom.
Dipropyleneglycol monomethyl ether
6.1 Seznam pomožnih snovi butilhidroksitoluen, Dipropilenglikol monometil eter, Isopropilni alkohol
Pipettes with yellow caps contain 0.25 ml of product and deliver 15 mg selamectin and 2.5 mg sarolaner Pipettes with orange caps contain 0.5 ml of product and deliver 30 mg selamectin and 5 mg sarolaner Pipettes with green caps contain 1 ml of product and deliver 60 mg selamectin and 10 mg sarolaner
- merilna kapalka z oranžnim pokrovčkom vsebuje 0,5 ml raztopine in sprosti 30 mg selamektina in 5 mg sarolanerja.
Keep away from heat, sparks, open flame or other sources of ignition.
Izdelek je lahko vnetljiv, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
These effects do not affect the safety or efficacy of the veterinary medicinal product.
Ti učinki običajno izginejo v 24 urah po nanosu in ne vplivajo na varnost niti na učinkovitost zdravila.
PACKAGE SIZE
Vsebnost tube
A single dose of the product should be administered.
Za zdravljenje zadostuje enkraten odmerek.
Treatment of biting lice A single dose of the product should be administered.
Zdravljenje infestacij z ušmi Za zdravljenje zadostuje enkraten odmerek.
PHARMACEUTICAL FORM Spot-on solution.
Zdravilo ne učinkuje na odrasle oblike
PACKAGE LEAFLET Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Stronghold Plus 15 mg/2.5 mg raztopina kožnih kapljic za mačke ≤2.5 kg Stronghold Plus 30 mg/5 mg raztopina kožnih kapljic za mačke >2.5-5 kg Stronghold Plus 60 mg/10 mg raztopina kožnih kapljic za mačke >5-10 kg
PIPETTE
Odmerjanje
NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
NAVODILO ZA UPORABO Stronghold Plus 15 mg/2.5 mg raztopina kožnih kapljic za mačke ≤2.5 kg Stronghold Plus 30 mg/5 mg raztopina kožnih kapljic za mačke >2.5-5 kg Stronghold Plus 60 mg/10 mg raztopina kožnih kapljic za mačke >5-10 kg
Selamectin may adversely affect aquatic organisms.
Selamektin učinkovito uniči tudi razvojne oblike Dirofilarie immitis.
Treatment schedule
FARMACEVTSKI PODATKI
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi)
Keep out of the sight and reach of children.
Izogibajte se dotikanja oči z rokami.
NAME OF THE VETERINARY MEDICINAL PRODUCT Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg Selamectin/sarolaner
Stronghold Plus 15 mg/2,5 mg kožni nanos, raztopina za mačke ≤ 2,5 kg Stronghold Plus 30 mg/5 mg kožni nanos, raztopina za mačke > 2,5-5 kg Stronghold Plus 60 mg/10 mg kožni nanos, raztopina za mačke > 5-10 kg
EU Procedure number Invented name Strength Pharmaceutical Form
Številka EU Izmišljeno ime Jakost Farmacevtska oblika Način uporabe zdravila
Most (61%) had a normal outcome with regard to term and normal birth.
Večina (61 %) je imela normalen izid z ozirom na trajanje in normalno rojstvo.
• Then drink a large glass of water or any other drink.
• Nato spijte velik kozarec vode ali drugega napitka.
Depending on the dose you take, these tests may be performed every two weeks or every two months.
Odvisno od odmerka, ki ga jemljete, bodo te teste opravljali vsaka dva tedna ali vsaka dva meseca.
This can cause acute pain crises and organ damage.
To lahko povzroči akutno bolečo krizo in poškodovanje organov.
Children less than 2 years of age
Posebne populacije Otroci, mlajši od 2 let
Date of first authorisation: 29/06/2007 Date of latest renewal: 24/04/2017
Datum prve odobritve: 29/06/2007 Datum zadnjega podaljšanja: 24/04/2017
It can be taken with a glass of water or a very small amount of food.
Lahko ga vzamete s kozarcem vode ali z zelo majhno količino hrane.
Do not stop your treatment unless advised by your doctor.
Ne prekinite zdravljenja, razen če vam tako svetuje zdravnik.
• Need for contraception
• Potreba po kontracepciji
E-mail : contact@addmedica.com
Elektronska pošta: contact@addmedica.com
In the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice.
V drugih primerih z znanim potekom je bila nosečnost prekinjena bodisi prostovoljno ali po nasvetu zdravnikov.
If you cannot swallow the tablets, you can disintegrate them in water immediately before use:
Če tablet ne morete pogoltniti, jih lahko raztopite v vodi tik pred uporabo:
• Risk of medication error due to the availability of two different strengths
• Tveganje za napake pri odmerjanju zdravila zaradi dveh različnih jakosti.
An updated RMP shall be submitted on a yearly basis.
Posodobljen RMP je treba predložiti na letni osnovi.
The use of effective contraception is strongly recommended.
Zelo priporočljiva je uporaba učinkovite kontracepcije.
The same decrease was observed for the number of hospital admissions and the number of days of hospitalisation in the treated groups.
Enako zmanjšanje so opazili pri številu sprejemov v bolnišnico in številu dni hospitalizacije pri zdravljeni skupini.
It is currently unknown how long patients should be treated with Siklos.
Trenutno ni znano, kako dolgo je treba bolnike zdraviti z zdravilom Siklos.
Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Odsotnost ali nizka količina semenčic v spermi (azoospermija ali oligospermija).
The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Imetnik dovoljenja za promet z zdravilom mora ta izobraževalni načrt uvesti nacionalno pred začetkom trženja, in kot je dogovorjeno s pristojnimi organi države članice.
Patients who are stable on lower doses should be monitored every 2 months.
Bolnike, ki jemljejo nižje odmerke in so stabilni, je treba kontrolirati vsaka dva meseca.
Neutropenia is generally the first and most common manifestation of haematological suppression.
Nevtropenija je navadno prva in najpogostejša manifestacija hematološke supresije.
4 Oligospermia and azoospermia are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
4 Oligospermija in azoospermija sta na splošno reverzibilni, vendar ju je treba upoštevati, kadar obstaja želja po očetovstvu (glejte poglavje 5.3).
These disorders are also associated with the underlying disease.
Ti dve motnji sta prav tako povezani z boleznijo.
A dose producing haematological toxicity should not be tried more than two times.
Zdravljenje z odmerkom, ki povzroča hematološko toksičnost, se ne sme poskusiti več kot dvakrat.
No information is available regarding pharmacokinetic differences due to age (except paediatric patients), gender or race.
Podatki glede farmakokinetičnih razlik zaradi starosti (razen pri pediatričnih bolnikih), spola ali rase niso na voljo.
The duration of treatment is the responsibility of the treating physician and should be based on the clinical and haematological status of the individual patient.
Trajanje zdravljenja je odgovornost lečečega zdravnika in mora temeljiti na kliničnem in hematološkem statusu posameznega bolnika.
5 Weight gain may be an effect of improved general conditions.
5 Porast telesne mase je lahko posledica splošnega izboljšanja počutja.
Depending on these results your doctor will adjust your dose of Siklos.
Glede na te rezultate bo zdravnik prilagodil vaš odmerek zdravila Siklos.
Geriatric, gender, race
Starost, spol, rasa
Continue as normal when it is time to take the next dose as prescribed by your doctor.
Z jemanjem nadaljujte normalno, ko je čas za naslednji odmerek, kot vam je to predpisal zdravnik.
Conforming to the individual dose, the tablet or the half or quarter of the tablet should be taken once daily, preferably in the morning before breakfast and, where necessary, with a glass of water or a very small amount of food.
Skladno z individualnim odmerkom je treba vzeti eno tableto ali polovico ali četrtino tablete enkrat na dan, po možnosti zjutraj pred zajtrkom in, če je potrebno, s kozarcem vode ali z zelo majhno količino hrane.
Severe hepatic impairment (Child-Pugh classification C).
Huda jetrna okvara (Child-Pughova klasifikacija C).
Treatment with Siklos and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks.
Zdravljenje z zdravilom Siklos in hkratno imunizacijo s cepivi z živim virusom se sme opravljati le, če koristi brez dvoma prevladajo nad potencialnimi tveganji.
Thrombocytopenia and anaemia occur less frequently, and are rarely seen without a preceding neutropenia.
Trombocitopenija in anemija se pojavita manj pogosto in se ju redko opazi brez predhodne nevtropenije.
The patient information pack should contain the following key elements:
Informacije za bolnika morajo vsebovati naslednje ključne elemente:
Recovery from myelosuppression is usually rapid when therapy is discontinued.
Okrevanje od mielosupresije je običajno hitro, če se terapijo prekine.
The biotransformation pathways as well as the metabolites are not fully characterised.
Tako poti biotransformacije kot tudi presnovki niso popolnoma karakterizirani.
• Risk to male and female fertility, potential risk to foetus and breast feeding
• Tveganje za plodnost moških in žensk, potencialno tveganje za plod in dojenje