natgillin/translations-raw huggingface dataset:
Instructions for administration of the vaccine in a multi-monodose (5 single dose) squeezable tube presentation connected by a bar:
Navodila za aplikacijo cepiva v tubi, ki je v kompletu večih enoodmernih (5 posameznih odmerkov) tub, med seboj povezanih s ploščico
Talk to your doctor/health care professional before your child receives Rotarix if :
Opozorila in previdnostni ukrepi Preden vaš otrok prejme cepivo Rotarix, se posvetujte z zdravnikom ali drugim zdravstvenim osebjem, če:
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Po aplikaciji prvega odmerka liofilizirane oblike cepiva Rotarix so s testom ELISA odkrili virusne antigene v 50 % vzorcev blata, po aplikaciji drugega odmerka cepiva pa v 4 % vzorcev blata.
Taking into account the PRAC Assessment Report on the PSUR(s) for rotavirus vaccine monovalent (live, oral), the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za cepivo proti rotavirusom, živo je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: -Dojenčki, ki imajo znano ali imajo sum na imunsko pomanjkljivost
During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group (N=4,222) versus 13 (0.3%) in the placebo group (N=4,185).
gastroenteritisa, med prejemniki placeba (n = 4.185) pa jih je bilo 13 (0,3 %).
Remove the protective tip cap from the oral applicator
Zaščitni pokrovček peroralnega aplikatorja
25 pre-filled oral applicators 25 x 1 dose (1.5 ml)
25 napolnjenih peroralnih aplikatorjev 25 x 1 odmerek (1,5 ml)
• pack size of 10 glass containers of powder plus 10 oral applicators of solvent
• pakiranje z 10 stekleničkami s praškom in 10 peroralnimi aplikatorji z vehiklom;
Discard the empty oral applicator and tip cap in approved biological waste containers according to local regulations.
Prazen peroralni aplikator in zaščitni pokrovček zavrzite v ustrezen vsebnik za odstranjevanje bioloških odpadkov v skladu z lokalnimi predpisi.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PERORALNI APLIKATOR Z VEHIKLOM ZA REKONSTITUCIJO S PRAŠKOM
NAME OF THE MEDICINAL PRODUCT Rotarix oral suspension Rotavirus vaccine, live
IME ZDRAVILA Rotarix peroralna suspenzija Cepivo proti rotavirusom, živo
Rotarix oral suspension in multi-monodose (5 single dose) squeezable tube presentation connected by a bar
Rotarix peroralna suspenzija v kompletu več enoodmernih tub (5 posameznih odmerkov), ki so med seboj povezane s ploščico
• pack size of 5 glass containers of powder plus 5 oral applicators of solvent
• pakiranje s 5 stekleničkami s praškom in 5 peroralnimi aplikatorji z vehiklom;
5 pre-filled oral applicators 5 x 1 dose (1.5 ml)
5 napolnjenih peroralnih aplikatorjev 5 x 1 odmerek (1,5 ml)
1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a membrane and a tube cap (polypropylene), in pack sizes of 1, 10 or 50.
1,5 ml peroralne suspenzije v stisljivi tubi (polietilen) z membrano in pokriti z zaporko tube (polipropilen).
How to store Rotarix
Shranjevanje cepiva Rotarix
G1P[8] G2P[4] G3P[8] G4P[8] G9P[8]
G1P[8] G2P[4] G3P[8] G4P[8] G9P[8] Sevi s P[8] genotipom
Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day.
Izločanje je največje približno sedmi dan po cepljenju.
- Do not use any of the oral tubes on the connecting bar if you notice anything unusual.
- Če opazite kakršnokoli nenormalnost, ne uporabite nobene od tub na povezovalni ploščici.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED ORAL APPLICATOR
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU NAPOLNJENI PERORALNI APLIKATOR
All G1P[8] G2P[4]
< 2 leti vsi G1P[8] G2P[4]
Powder for oral suspension Rotavirus vaccine, live Oral use
Prašek za peroralno suspenzijo Cepivo proti rotavirusom, živo peroralna uporaba
PARTICULARS TO APPEAR ON THE OUTER PACKAGING GLASS CONTAINER WITH ORAL APPLICATOR AND TRANSFER ADAPTER, PACK SIZE OF 1, 5, 10 OR 25
STEKLENIČKA Z PERORALNIM APLIKATORJEM IN NASTAVKOM ZA PRENOS, VELIKOST PAKIRANJA 1, 5, 10 ALI 25
Rotarix oral suspension in squeezable tube Rotavirus vaccine, live
Rotarix peroralna suspenzija v tubi cepivo proti rotavirusom, živo
Circulating rotavirus strains
Krožeči sevi rotavirusov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTI-MONODOSE (5 SINGLE DOSE) SQUEEZABLE TUBE PRESENTATION CONNECTED BY A BAR
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH KOMPLET VEČ ENOODMERNIH TUB (5 POSAMEZNIH ODMERKOV), KI SO MED SEBOJ
Very rare
Zelo redki urtikarija
What Rotarix looks like and contents of the pack
Izgled cepiva Rotarix in vsebina pakiranja Peroralna suspenzija.
- Do not use the affected oral tube if you notice anything unusual.
- Če opazite kakršnokoli nenormalnost, prizadete tube ne uporabite.
10 pre-filled oral applicators 10 x 1 dose (1.5 ml)
10 napolnjenih peroralnih aplikatorjev 10 x 1 odmerek (1,5 ml)
Any rotavirus gastro-enteritis Rotarix N=2,974 Placebo N=1,443
Rotavirusni gastroenteritis katerekoli jakosti Rotarix n=2.974 Placebo n=1.443
Contents of the pack and other information What Rotarix contains - The active substances are: Human rotavirus RIX4414 strain (live, attenuated)*
Po rekonstituciji 1 odmerek (1 ml) vsebuje: Humani rotavirus, sev RIX4414 (živ, atenuiran)*
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine):
Pri tem cepivu lahko pride do naslednjih neželenih učinkov: ♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 10 odmerkov cepiva):
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Peroralni aplikator pustite pritrjen in stekleničko pretresite.
Administer the vaccine
Dajanje cepiva
Circulating rotavirus strains Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis [95% CI]
Učinkovitost cepiva (%) proti hudemu rotavirusnemu gastroenteritisu [95 % IZ]
The powder is white.
Bel prašek.
- The other ingredients in Rotarix are: sucrose (see also section 2, Rotarix contains sucrose), Di sodium Adipate, Dulbecco's Modified Eagle Medium (DMEM), sterile water What Rotarix looks like and contents of the pack Oral suspension.
*Pridobljen na Vero celicah - Pomožne snovi cepiva Rotarix so: saharoza, (glejte tudi poglavje 2, Cepivo Rotarix vsebuje saharozo), dinatrijev adipat, Dulbekov spremenjeni nujni medij (DMEM - »Dulbecco's Modified Eagle Medium«) in voda za injekcije.
< 3 yrs 6-11 m
< 3 leta 6-11 mesecev
< 4 yrs 3-11 m
< 4 leta 3-11 mesecev
Rotarix N=2,572
Rotarix n= 5.263 placebo n= 5.256
Multi-monodose (5-single dose) squeezable tube presentation connected by a bar 1.5 ml of oral suspension in a squeezable tube (polyethylene) presented in a multi-monodose (5-single dose) squeezable tube presentation connected by a bar, in pack size of 50 tubes.
1,5 ml peroralne suspenzije v stisljivi tubi (polietilen) v kompletu več enoodmernih tub (5 posameznih odmerkov), ki so med seboj povezane s ploščico.
The solvent should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
Pred rekonstitucijo morate preveriti videz vehikla glede morebitne prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza.
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility [95% CI] Circulating rotavirus strains
Krožeči sevi rotavirusov Učinkovitost cepiva (%) proti hudemu rotavirusnemu gastroenteritisu, ki je zahteval sprejem v bolnišnico in/ali rehidracijsko zdravljenje v zdravstveni ustanovi [95 % IZ].
Read the leaflet for the shelf-life of the reconstituted medicine.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Rok uporabnosti rekonstituiranega cepiva preverite v navodilu za uporabo.
Squeezable tube EU/1/05/330/009 EU/1/05/330/010
EU/1/05/330/009 EU/1/05/330/010 EU/1/05/330/011
Strains Effectiveness % [95% CI]
% [95 % IZ]
2, 3 months France,
2. in 3. mesec
Contents of the pack and other information
Shranjevanje cepiva Rotarix Vsebina pakiranja in dodatne informacije
Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live
Rotarix peroralna suspenzija v napolnjenem peroralnem aplikatorju cepivo proti rotavirusom, živo
LIST OF EXCIPIENTS Sucrose
SEZNAM POMOŽNIH SNOVI Saharoza
Oral suspension Rotavirus vaccine, live Oral use
Rotarix peroralna suspenzija Cepivo proti rotavirusom, živo peroralna uporaba
Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Rotarix prašek in vehikel za peroralno suspenzijo Cepivo proti rotavirusom, živo
< 2 yrs 6-11 m
< 2 leti 6-11 mesecev vsi
6.1 List of excipients
6.1 Seznam pomožnih snovi saharoza dinatrijev adipat
Monodose oral tube
Enoodmerna peroralna tuba
Efficacy (%) [95% CI ]
Učinkovitost (%)
There are no restrictions on your child's consumption of food or liquids, either before or after vaccination.
Otrok lahko pred in po cepljenju brez omejitev uživa tako hrano kot tekočine
- Multi-monodose (5 single dose) squeezable tube presentation connected by a bar: 2 years The vaccine should be used immediately after opening.
- Komplet več enoodmernih tub (5 posameznih odmerkov), ki so med seboj povezane s ploščico: 2 leti
< 3 yrs
< 3 leta
< 3 yrs 3-11 m
< 3 leta 3-11 mesecev
Strains with P[8] genotype Circulating rotavirus strains Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention [95% CI]
Učinkovitost cepiva (%) proti rotavirusnemu gastroenteritisu, pri katerem je potrebno zdravljenje [95% IZ]
The vaccine (1 ml liquid) will be given orally.
(1 ml tekočine) prejel peroralno (skozi usta).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTI-MONODOSE (5 SINGLE DOSE) SQUEEZABLE TUBE PRESENTATION CONNECTED BY A BAR, PACK SIZE OF 50 TUBES
Komplet več enoodmernih tub (5 posameznih odmerkov), ki so med seboj povezane s ploščico
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy
oznaka ATC: J07BH01
e.g., a person with cancer or who is taking medicines that may weaken the immune system.
če: • je otrok v tesnem stiku z družinskim članom, ki ima oslabljen imunski sistem, npr. z bolnikom z rakom ali bolnikom, ki jemlje zdravila, ki bi lahko oslabila imunski sistem; • ima otrok kakršnekoli težave s prebavili;
1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl), in pack sizes of 1, 5, 10 or 25.
1,5 ml peroralne suspenzije v napolnjenem peroralnem aplikatorju (steklo tipa 1) z batnim zamaškom
• he/she has a close contact such as a household member who has a weakened immune system,
• je otrok v tesnem stiku z družinskim članom, ki ima oslabljen imunski sistem, npr. z bolnikom z rakom ali bolnikom, ki jemlje zdravila, ki bi lahko oslabila imunski sistem; • ima otrok kakršnekoli težave s prebavili;
In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was comparable to the one elicited by Rotarix lyophilised formulation.
Rotarix primerljiv z imunskim odzivom po aplikaciji liofilizirane oblike cepiva Rotarix.
B. PACKAGE LEAFLET
B. Priprava tube
Remove the oral applicator from the transfer adapter
Peroralni aplikator odstranite iz nastavka za prenos.
• flatulence
-Urtikarija
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools.
(SCID), lahko dobijo vnetje želodca ali črevesja (gastroenteritis) in izločajo virus iz cepiva z blatom.
NAME OF THE MEDICINAL PRODUCT Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Navodilo za uporabo Rotarix prašek in vehikel za peroralno suspenzijo cepivo proti rotavirusom, živo
Gastrointestinal disorders
(gastroenteritis katerekoli jakosti).
Oral administration only
Samo za peroralno uporabo
- The other ingredients in Rotarix are: sucrose (see also section 2, Rotarix contains sucrose), Di sodium Adipate, Dulbecco's Modified Eagle Medium (DMEM), sterile water What Rotarix looks like and contents of the pack Oral suspension in pre-filled oral applicator.
*Pridobljen na Vero celicah - Pomožne snovi cepiva Rotarix so: Prašek: dekstran, saharoza, sorbitol, (glejte tudi poglavje 2, Cepivo Rotarix vsebuje saharozo in sorbitol), aminokisline, Dulbekov spremenjeni nujni medij (DMEM - »Dulbecco's Modified Eagle Medium«) Vehikel: kalcijev karbonat, ksantanski gumi, voda za injekcije Izgled cepiva Rotarix in vsebina pakiranja Prašek in vehikel za peroralno suspenzijo Cepivo Rotarix je na voljo v enoodmerni steklenički z belkastim praškom in v ločenem z vehiklom napolnjenem peroralnem aplikatorju, ki vsebuje počasi usedajočo se belo usedlino in brezbarven supernatant.
Transfer adapter
Nastavek za prenos
All G1P[8]
< 3 leta vsi G1P[8]
Intussusception
Odmerjanje
(see section 4.4)
Sevi z genotipom P[4]
Age range
Starostni razpon
NAME OF THE MEDICINAL PRODUCT Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live
Rotarix peroralna suspenzija v napolnjenem peroralnem aplikatorju Cepivo proti rotavirusom, živo
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent.
Med shranjevanjem se v peroralnem aplikatorju z vehiklom pojavi bela usedlina in bister supernatant.
2nd year of life Rotarix N=2,554 Placebo N=1,294 Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Drugo leto življenja Rotarix n=2.554 Placebo n=1.294
10 x 5 single dose tubes connected by a bar 1 dose (1.5 ml)
10 x 5 enoodmernih tub, povezanih s ploščico
These data should be interpreted with caution # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group) A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI: 20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] genotype during the first year of life.
Združena analiza petih študij* kaže, da je bila med prvim letom življenja učinkovitost proti hudemu rotavirusnemu gastroenteritisu (Vesikari ≥ 11), ki ga povzroča genotip G2P[4] rotavirusa 71,4
• Hold for at least 30 seconds.
• Držite vsaj 30 sekund.
Drinking alcohol may make these effects worse.
Pitje alkohola lahko te učinke poslabša.
Adults and Children:
Odrasli in otroci:
{Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov} {tel.} {faks} {e-pošta}
If your pain gets worse
Če se bolečina poslabša
You may need urgent medical treatment.
Morda boste potrebovali nujno zdravniško pomoč.
If this happens, do not drive or use any tools or machines.
Če se to zgodi, ne vozite ali uporabljajte orodij ali strojev.
How quickly will the patches work?
Kako hitro bodo obliži delovali?
- see below for more information
- več informacij najdete spodaj
• You are elderly - you may be more sensitive to the effects of this medicine.
• če ste starejši - lahko boste bolj občutljivi za učinke tega zdravila
The tendency of tolerance development varies widely among individuals.
Nagnjenost k razvoju tolerance je med posamezniki zelo različna.
Reference: Adapted from 1) Foley KM.
Referenci: povzeto po 1) Foley KM.
Your doctor will talk to you about this.
Zdravnik vam bo svetoval glede tega.
• The same place twice in a row.
• isto mesto dvakrat zaporedoma.
Symptoms and signs
Simptomi in znaki
In the next 12 hours, these analgesics should be provided based on clinical need.
V naslednjih 12 urah je treba te analgetike dajati glede na klinične potrebe.
• If you have been using them for some time your body may have got used to them.
• Če ste obliže uporabljali že dalj časa, se je vaše telo lahko navadilo nanje.
Use a new area of skin on:
Uporabite nov predel kože:
Effects on somatic development and behaviour of the offspring were not observed.
Vpliva na somatski razvoj in vedenje potomcev niso opazili.
• If you are using more than one patch, change all your patches at the same time.
• Če uporabljate več kot en obliž, vse obliže zamenjajte ob istem času.
• Reduced consciousness or loss of consciousness.
• Zmanjšana stopnja zavesti ali izguba zavesti.
This includes medicines that you buy without a prescription or herbal medicines.
To vključuje tudi zdravila, ki jih kupite brez recepta ali zdravila rastlinskega izvora.
Adequate body temperature and fluid intake should be maintained.
Vzdrževati je treba ustrezno telesno temperaturo in vnos tekočin.
Children 2 to 16 years old
Otroci, stari od 2 do 16 let
• You have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.
• če ste kadar koli zlorabljali ali bili odvisni od alkohola, zdravil na recept ali prepovedanih drog.
• Your child's upper back
• zgornji del hrbta vašega otroka.
• If you need to clean the skin, just use cold water
• Če morate kožo umiti, uporabite hladno vodo.
• You should change your patch every third day, unless your doctor has told you differently.
• Obliž morate zamenjati vsak tretji dan, razen če vam zdravnik ne naroči drugače.
Instead, clip the hair as close to the skin as possible.
Namesto tega dlake postrizite s škarjami čim bližje koži.
It may harm them, even if their signs of illness are the same as yours
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
• You can also swim while wearing the patch, but:
• Med uporabo obliža lahko tudi plavate, vendar:
• It is important that your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.
• Pomembno je, da vaš otrok obliža ne odstrani in ga da v usta, saj bi to lahko bilo življenjsko nevarno ali celo smrtno.
Do not drive while using this medicine until you know how it affects you.
Ne vozite, dokler uporabljate to zdravilo in ne veste, kako vpliva na vas.
After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level.
Po povečanju odmerka lahko traja do 6 dni, da bolnik na novem odmerku doseže ravnovesje.
Both the minimum effective concentration and the toxic concentration increase with tolerance.
Tako minimalna učinkovita koncentracija kot tudi toksična koncentracija s toleranco naraščata.
• Use each patch once only
• Vsak obliž uporabite le enkrat.
Dosage must not be increased in intervals of less than 72 hours.
Odmerka se ne sme povečevati v intervalih, krajših od 72 ur.
This may occur within the recommended dose.
To se lahko pojavi tudi pri jemanju priporočenega odmerka.
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• videnje, čutenje, slišanje ali vohanje stvari, ki jih ni (halucinacije)
NEJM 1985; 313 (2): 84-95 and 2) McPherson ML.
NEJM 1985; 313 (2): 84-95 in 2) McPherson ML. Introduction to opioid conversion calculations.
• Feeling cold
• občutek mraza
Its primary therapeutic actions are analgesia and sedation.
Njegova glavna terapevtska učinka sta analgezija in sedacija.
How long will you use the patches for?
Kako dolgo boste uporabljali obliže?
• Loss of memory
• izguba spomina
• Difficulty getting and keeping an erection (impotence) or problems having sex
• težave z vzpostavitvijo in ohranjanjem erekcije (impotenca) ali težave pri spolnosti
The risk of side effects increases if you are taking medicines such as certain antidepressants.
Tveganje za pojav neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi.
An optimal therapeutic concentration range of fentanyl can therefore not be established.
Zaradi tega optimalne terapevtske koncentracije ne moremo določiti.
In such circumstances, the patient must be closely monitored.
Bolnika je treba skrbno spremljati.
Drug dependence and potential for abuse
Odvisnost od zdravila in možnost zlorabe
• Each patch is sealed in its own sachet
• Vsak obliž je zavarjen v svojo vrečico.
Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose.
Odvisno od dodatnih potreb po analgeziji in izraženosti bolečine pri otroku se je mogoče odločiti za povečanje odmerka.
• If you stop using the patches, don't start again without asking your doctor first.
• Če obliže prenehate uporabljati, jih ne začnite ponovno uporabljati ne da bi se pred tem najprej posvetovali z vašim zdravnikom.
• Do not take the patch out of its sachet until you are ready to use it
• Obliža ne vzemite iz vrečice, dokler niste pripravljeni, da ga boste uporabili.
Everyday activities while using the patches
Vsakodnevne aktivnosti med uporabo obliža
• There is enough medicine in each patch to last 3 days (72 hours).
• V vsakem obližu je dovolj zdravila, da zadostuje za 3 dni (72 ur).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: {DD. mesec LLLL} Datum zadnjega podaljšanja: {DD. mesec LLLL}
Eighty of the children were aged 2 to 6 years, inclusive.
Osemdeset otrok je bilo starih 2 do 6 let.
Step 1: Preparing the skin
1. korak: Priprava kože
A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Tveganje mutagenih učinkov se zdi pri uporabi terapevtskih odmerkov malo verjetno, saj so se učinki pojavili samo pri velikih koncentracijah.
Fentanyl can be abused in a manner similar to other opioid agonists.
Fentanil je možno zlorabiti na podoben način kot ostale opioidne agoniste.
• Your doctor may give you other painkillers as well for the first day or so
• Vaš zdravnik vam utegne dati še dodatna protibolečinska zdravila za prvi dan ali dva.
Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Standardne študije reproduktivne in razvojne toksičnosti so opravili s parenteralnim dajanjem fentanila.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije, povezane s farmakodinamiko
The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Neželeni učinki so navedeni po organskih sistemih in padajoči resnosti znotraj vsake kategorije pogostnosti.
Change the patch again after 3 days (72 hours) as usual.
Obliž ponovno zamenjajte po 3 dneh (72 urah) kot običajno.
• You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
• če imate bolečine, ki trajajo le krajše obdobje, npr. nenadna bolečina ali bolečina po kirurškem posegu,
• You have ever had persistent headaches or a head injury
• če ste kadar koli imeli vztrajne glavobole ali poškodbo glave
Abuse or intentional misuse of DUROGESIC may result in overdose and/or death.
Zloraba ali namerna napačna uporaba zdravila DUROGESIC lahko vodi v prekomerno odmerjanje in/ali smrt.
Opioids may cause hypotension, especially in patients with acute hypovolaemia.
Opioidi lahko povzročijo hipotenzijo, še posebno pri bolnikih z akutno hipovolemijo.
This may result in increased serum concentrations (see section 5.2) and the patient should be monitored closely.
To lahko privede do zvečanja serumskih koncentracij (glejte poglavje 5.2), zato je treba bolnika skrbno spremljati.
• Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band
• Poskrbite, da bo obliž nameščen pod ohlapnimi oblačili in ne pod tesnim ali elastičnim trakom.
Alternative routes of administration (oral, parenteral) should be considered.
Razmisliti je treba o drugih načinih uporabe (peroralna, parenteralna).
Studies in animals have shown some reproductive toxicity (see section 5.3).
Študije na živalih so pokazale nekaj reprodukcijske toksičnosti (glejte poglavje 5.3).