natgillin/translations-raw huggingface dataset:
4.6 Adverse reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostnost in resnost)
1 Antigenic units
1 antigenske enote
Concurrent active and passive immunisation (emergency vaccination)
Sočasna aktivna in pasivna imunizacija (cepljenje v nujnih situacijah)
Thereafter a maximum interval of two years is recommended (see scheme).
Nato je najdaljši priporočeni razmik dve leti (glejte shemo).
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
Only healthy animals should be vaccinated.
Cepimo samo zdrave živali.
Store at 2-8°C, protected from light.
Shranjujte pri 2-8 °C, zaščiteno pred svetlobo.
A primary vaccination course may be considered necessary in horses that have not been suitably primed.
Osnovno cepljenje bi lahko bilo potrebno pri konjih, ki niso bili ustrezno tretirani.
35 041 Marburg
35 041 Marburg Nemčija
The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
Allow the vaccine to reach room temperature before use.
Cepivo pred uporabo ogrejte na sobno temperaturo.
It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine.
Priporočljivo je, da en obnovitven odmerek dobijo samo tisti konji, ki so že dobili osnovno cepljenje s cepivi, ki vsebujejo iste seve virusa influence konj, kot so v tem cepivu.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI" IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
Administer one dose (1 ml), by strict intramuscular injection, according to the following schedule:
Po en odmerek (1 ml) strogo intramuskularno po naslednji shemi:
In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
V zelo redkih primerih se lahko pojavi lokalna reakcija, ki je večja od 5 cm in ki lahko traja dlje kot 2 dni.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
O varnosti in učinkovitosti sočasne uporabe cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen z zgoraj navedenim izdelkom, ni podatkov.
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
V redkih primerih je možna bolečina na mestu dajanja, ki lahko povzroči začasno funkcijsko neugodje (togost).
MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/057/001-004
Package size:
Velikost pakiranja:
• Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
• Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje.
Phosphate buffer, traces of thiomersal, traces of formaldehyde
Fosfatni pufer, tiomersal v sledeh, formaldehid v sledeh
Emil-von-Behring-Str. 76
GSK Vaccines GmbH Emil-von-Behring-Str. 76
The second dose of the vaccine (V2) should be administered 4 weeks later.
Drugi odmerek cepiva (C2) moramo dati 4 tedne pozneje.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti ni vključena v Uredbo (ES) št.
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
To vzbudi pasivno zaščito pred tetanusom, ki traja najmanj 21 dni po sočasnem dajanju.
use
uporaba
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera do primera.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
Lahko se pojavi neostro omejena trda ali mehka oteklina (premera največ 5 cm) na mestu vboda, ki mine v 2 dneh.
V1 V2
C1 C2
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE V EGP, ČE STA RAZLIČNA
Tetanus toxoid
Toksoid tetanusa
A/equine-2/ South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU), Tetanus toxoid 40 Lf.
A/konjski-2/Južna Afrika/4/03 (50 AU), A/konjski-2/Newmarket/2/93 (50 AU), toksoid tetanusa 40 Lf
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
V tem primeru lahko damo prvi odmerek (V1) za osnovno cepljenje sočasno z ustreznim profilaktičnim odmerkom Intervetovega Tetanus-Seruma, na drugo mesto in s posebnimi brizgami in iglami.
Store at 2-8 °C, protected from light.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri 2-8 °C, zaščiteno pred svetlobo.
62.5 micrograms For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
V zelo redkih primerih se lahko pojavi vročina, včasih z letargijo in neješčnostjo, ki traja 1 dan, izjemoma do 3 dni.
This revaccination results in immunity to equine influenza lasting at least 12 months.
Ta revakcinacija vzbudi imunost proti influenci konj, ki traja najmanj 12 mesecev.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da lahko cepivo dajemo isti dan, toda ne pomešano z Intervetovim Tetanus-Serumom (glejte poglavje 4.9).
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da lahko cepivo dajemo isti dan, toda ne pomešano z Intervetovim Tetanus-Serumom (glejte poglavje 8).
Adjuvants: Purified Saponin
Prečiščeni saponin
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - na veterinarski recept
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v 4.6, razen blage depresivnosti na dan cepljenja.
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur.
2 flokulacijski ekvivalenti; ustreza ≥30 i.e/ml seruma budre v preizkusu potentnosti v Ph.Eur.
PHARMACEUTICAL FORM Clear opalescent suspension for injection
Bistra opalescentna suspenzija za injiciranje
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samoinjiciranja, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course.
Prvo revakcinacijo (tretji odmerek) proti influenci konj opravimo 5 mesecev po osnovnem cepljenju.
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
Primary vaccination course
Osnovno cepljenje
Equine influenza virus strains:
Sevi virusa influence konj:
Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Viala iz stekla tipa I, zaprta z zamaškom iz halogenobutilne gume in zatesnjena z aluminijasto zaporko.
A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Tretje cepljenje z Equilisom Prequenza Te in Tetanus-Serumom moramo ponoviti najmanj štiri tedne pozneje.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D. DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Napolnjena brizga iz stekla tipa I, v kateri je bat z nastavkom iz halogenobutila, zaprta z zamaškom iz halogenobutilne gume.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE OSKRBE IN UPORABE
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later)
mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Sočasna uporaba Equilisa Prequenza Te in Intervetovega Tetanus-Seruma lahko zmanjša aktivno imunost proti tetanusu v primerjavi s konji, cepljenimi z Equilisom Prequenza Te, ki niso prejeli seruma z antitoksinom tetanusa.
4.2 Indications for use, specifying the target species Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi in aktivna imunizacija proti tetanusu za preprečevanje smrtnosti
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sprostitev serije
The second revaccination is given 12 months after the first revaccination.
Drugo revakcinacijo opravimo 12 mesecev po prvi revakcinaciji.
To stimulate active immunity against Equine influenza and tetanus ATC-vet code: QI05AL01
Oznaka ATC-vet: QI05AL01
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Zaradi možnega medsebojnega vplivanja s protitelesi, pridobljenimi od matere, žrebet ne smemo cepiti pred starostjo 6 mesecev, zlasti ne tistih, katerih matere so bile revakcinirane v zadnjih dveh mesecih brejosti.
The first revaccination is given not later than 17 months after the primary vaccination course.
Prvo revakcinacijo opravimo najpozneje 17 mesecev po osnovnem cepljenju.
Zero days
Nič dni
Vaccination schedule:
Shema cepljenja:
TARGET SPECIES Horses
CILJNA ŽIVALSKA VRSTA
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Zloženka z 10 vialami po 1 ml Zloženka z 1, 5 ali 10 napolnjenimi brizgami z iglami.
INDICATION(S) Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi in aktivna imunizacija proti tetanusu za preprečevanje umrljivosti
PACKAGE LEAFLET FOR: Equilis Prequenza Te suspension for injection for horses
Equilis Prequenza Te, suspenzija za injiciranje za konje
INDICATION(S) Active immunisation of horses against equine influenza and tetanus
Aktivna imunizacija konj proti influenci konj in tetanusu
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Poligono Ind. El Montalvo I
Poligono Ind. El Montalvo I C/Zeppelin 6, Parcela 38
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te [a clear pictogram of a horse]
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Equilis Prequenza Te (jasen piktogam konja) KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus.
Cepivo lahko uporabljamo hkrati z Intervetovim Tetanus-Serumom za zdravljenje poškodovanih konj,
6.5 Nature and composition of immediate packaging
6.5 Vrsta ovojnine in vsebine
A/equine-2/ Newmarket/2/93
A/konjski-2/ Južna Afrika/4/03 50 AU1 A/konjski-2/ Newmarket/2/93
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
mesecev, ustreznega cepiva proti influenci konj, ki vsebuje seve A/konjski- 2/Južna Afrika/4/03 in A/konjski 2/Newmarket-2/93 (glejte shemo).
Influenza
Revakcinacija Influenca
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children.
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM Zdravilo shranjujte nedosegljivo otrokom.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN(E)
24 months after the first revaccination
17 mesecev po osnovnem cepljenju 24 mesecev po prvi revakcinaciji
EXPIRY DATE
DATUM IZTEKA ROKA UPORABNOSTI
C. STATEMENT OF THE MRLs
C. NAVEDBA NAJVIŠJIH DOVOLJENIH OSTANKOV ZDRAVILA (MRL)
1 ml.
V odmerku po 1 ml:
CLINICAL PARTICULARS
FARMACEVTSKA OBLIKA
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
12 months after the first revaccination
5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
OTHER INFORMATION
Dodatek
Phosphatidylcholine
Fosfatidilholin
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
(Izmišljeno) ime Jakost
Pack size
Farmacevtska oblika
Alcohol should be avoided.
Alkoholu se je treba izogibati.
Other symptoms may include:
Drugi simptomi lahko vključujejo:
Over 75% of patients were less than 13 years of age.
Več kot 75 % bolnikov je bilo mlajših od 13 let.
This difference was not statistically significant.
Razlika ni bila statistično značilna.
The duration of the long-term safety study was limited to 52 weeks.
Dolgoročna študija varnosti je bila omejena na 52 tednov.
• sudden unexplained death,
• nenadna nepojasnjena smrt,
Patients should be closely monitored throughout this period.
Bolnike je treba ves ta čas natančno nadzorovati.
• prolonged and/or painful erection,
• dolgotrajna in/ali boleča erekcija,
• altered or increased sexual interest;
• spremenjeno ali povečano spolno zanimanje,
• thoughts of suicide, suicide attempt and suicide,
• samomorilne misli, poskus samomora in samomor,
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Takšni simptomi se lahko začasno poslabšajo ali se celo pojavijo po prekinitvi zdravljenja.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Če ga ne morete dobiti, pojdite v najbližjo bolnišnico in škatlo z zdravilom vzemite s seboj.
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.1, vendar pa priporočil o odmerjanju ni mogoče dati.
Recurrence prevention was not established.
Preprečevanja ponovitev niso vrednotili.
Consequently, the frequency of these adverse events is qualified as "not known”.
Zato je pogostnost teh neželenih učinkov opredeljena kot »neznana«.
Do not use this medicine in children and adolescents under 13 years of age.
To zdravilo ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 13 let.
This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.
To je treba upoštevati, ko je potrebna popolna zbranost, npr. pri vožnji avtomobila ali upravljanja strojev.
• withdrawal symptoms in newborn babies in case of exposure during pregnancy,
• odtegnitveni sindromi pri novorojenčkih v primeru izpostavljenosti zdravilu v času nosečnosti,
Some patients may benefit from a higher dose.
Nekaterim bolnikom lahko koristi večji odmerek.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 June 2015
Datum prve odobritve: 30. Junij 2015 Datum zadnjega podaljšanja:
There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Ustreznih in dobro kontroliranih preskušanj aripiprazola pri nosečnicah ni.
Caution should be taken, particularly if you are an elderly patient or have some debility.
Potrebna je previdnost, zlasti če ste starejši ali oslabeli bolnik.
Thus, no dosage adjustment is required for smokers.
Zato odmerka pri kadilcih ni treba prilagajati.
The maximum daily dose should not exceed 30 mg.
Največji dnevni odmerek ne sme preseči 30 mg.
The possibility of multiple medicinal product involvement should be considered.
Upoštevati je treba možnost, da je vpletenih več zdravil.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Pogostnosti neželenih učinkov, o katerih so poročali med uporabo v obdobju trženja, ni mogoče določiti, saj je pridobljena iz spontanih poročil.
Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
O prilagoditvi dnevnega odmerka, vključno z zmanjšanjem odmerka, je treba presoditi na osnovi kliničnega stanja.
It is especially important to mention the following to your doctor:
Zlasti je pomembno, da svojega zdravnika obvestite, če jemljete naslednja zdravila:
• double vision,
• dvojni vid,
Increased mortality
Večja umrljivost
Pharmacokinetics in special patient groups
Farmakokinetika pri posebnih skupinah bolnikov
• more saliva in mouth than normal,
• večja količina sline v ustih kot običajno,
No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.
Dolgoročni podatki za učinkovitost in varnost aripiprazola pri tej spremenljivi motnji niso na voljo.
Elderly patients with dementia-related psychosis
Starejši bolniki s psihozo, povezano z demenco
In addition, cases of stroke or "mini" stroke have been reported.
Poleg tega so poročali tudi o primerih možganske kapi ali "male" kapi.
Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Zaradi nezadostnih podatkov o varnosti pri človeku in zaradi pomislekov, ki jih porajajo študije razmnoževanja pri živalih, se tega zdravila pri nosečnicah ne sme uporabljati, razen če pričakovana korist nedvomno prevlada nad možnim tveganjem za plod.
Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Manj kot 1 % aripiprazola se je nespremenjenega izločilo v urinu in približno 18 % ga je bilo mogoče nespremenjenega najti v blatu.
Patients with rare glucose-galactose malabsorption should not take this medicine.
Bolniki z redko malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Therefore, cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Zato je treba takoj uvesti kardiovaskularni nadzor, ki mora vključevati stalno elektrokardiografsko spremljanje za odkritje morebitnih motenj srčnega ritma.
Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Aripiprazol je učinkovit v razponu odmerkov od 10 do 30 mg/dan.
• difficulty controlling core body temperature or overheating,
• težave z uravnavanjem jedrne telesne temperature ali pregretje,
• fits (seizures) since your doctor may want to monitor you more closely
• imate epileptične krče (konvulzije), saj bo zdravnik v tem primeru morda želel natančneje spremljati vaše stanje,
Consequently, newborn infants should be monitored carefully (see section 4.8).
Posledično je treba takšne novorojenčke skrbno nadzirati (glejte poglavje 4.8).
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Študije na živalih niso mogle izključiti možnosti toksičnih učinkov na razvoj (glejte poglavje 5.3).
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
Največja netumorogena izpostavljenost samic podgan je bila 7- krat večja od izpostavljenosti človeka pri priporočenem odmerku.
The absolute oral bioavailability of the tablet formulation is 87 %.
Absolutna peroralna biološka uporabnost zdravila v tabletah je 87 %.
• sensitivity to light,
• občutljivost na svetlobo,
People with this condition may also feel depressed, guilty, anxious or tense.
Osebe s to boleznijo imajo lahko tudi občutke potrtosti, krivde, tesnobnosti ali napetosti.
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Obvestite svojega zdravnika, če vi sami ali vaša družina/skrbnik opazite, da se pri vas razvija nagib ali želja po vedenju, ki za vas ni običajno, in se ne morete upreti impulzu, težnji ali skušnjavi po dejanjih, ki bi lahko škodila vam ali drugim.
These trials included patients with or without psychotic features and with or without a rapid-cycling course.
V ta preskušanja so bili vključeni bolniki s psihotičnimi simptomi ali brez in s hitrim cikličnim potekom ali brez.
It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Upoštevati je treba, da je lahko motnja nadzora impulzov povezana z osnovno boleznijo, vendar so v nekaterih primerih poročali, da so impulzi izzveneli po zmanjšanju odmerka ali ukinitvi zdravila.