natgillin/translations-raw huggingface dataset:
Olazax has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Zdravilo OLAZAX dokazano preprečuje ponoven pojav teh simptomov pri bolnikih z bipolarno motnjo, pri katerih se je manična epizoda po zdravljenju z olanzapinom izboljšala.
6.4 Special precautions for storage Store below 30ºC
6.4 Posebna navodila za shranjevanje Shranjujte pri temperaturi do 30 °C.
Children and adolescents Olazax is not for patients who are under 18 years
Zdravilo Olazax ni namenjeno bolnikom, mlajšim od 18 let.
SPECIAL STORAGE CONDITIONS Store below 30°C
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28 or 56 tablets
Olazax 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg tablete so na voljo v aluminijastih pretisnih omotih po 28 & 56 tablet.
Phenylalanine Olazax tablet contains aspartame, which is a source of phenylalanine.
Zdravilo Olanzapin Glenmark tablete vsebuje aspartam, ki je vir fenilalanina.
Do not drink any alcohol if you have been given Olazax as together with alcohol it may make you feel drowsy.
Jemanje zdravila Olazax skupaj z alkoholom Če ste dobili zdravilo Olazax, ne pijte nobenega alkohola, saj lahko zdravilo Olazax in alkohol skupaj povzročita občutek zaspanosti.
Ventricular tachycardia/fibri llation, sudden death (see section 4.4)11
Prekatna tahikardija/fibril acija, nenadna smrt (glejte poglavje 4.4)11
There is a risk of feeling drowsy when you are given Olazax.
Vpliv na sposobnost upravljanja vozil in strojev Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olazax, počutili zaspane.
Photosensitivity reaction
Fotosenzitivnostn e reakcije
Dystonia (including oculogyration)11 Tardive dyskinesia11
(vključno z okulogiracijo)11 Tardivne diskinezije11
Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
OLANZAPINE , moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
How to take Olazax
Kako jemati zdravilo Olazax
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension,
Druge zdravstveno pomembne posledice prevelikega odmerjanja vključujejo delirij, konvulzije, komo, možen nevroleptični maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo,
What Olazax looks like and contents of the pack
Izgled zdravila Olazax in vsebina pakiranja
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter .
Priporoča se ustrezno klinično spremljanje v skladu z znanimi priporočili za antipsihotike, npr. merjenje glukoze v krvi na začetku, 12 tednov po začetku jemanja olanzeapina in nato enkrat na leto.
The following symptoms may occur in newborn babies, of mothers that have used OLAZAX in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Olazax, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
(at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
64,4 %, 31,7 % in 12,3 %).
If you forget to take Olazax Take your tablets as soon as you remember.
Vzemite tablete, kakor hitro se spomnite.
500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
[QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Mannitol E 421
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol E 421 mikrokristalna celuloza aspartam E 951 krospovidon magnezijev stearat
You should swallow the Olazax X tablets whole, with water.
Olazax tablete pogoltnite cele z vodo.
(≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l
(≥ 1,467 mmol/l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment.
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, ALT, AST, posebno na začetku zdravljenja.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic, maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe (diskinezijo), zaprtje, suha usta, izpuščaj, izgubo moči, hudo utrujenost, zadrževanje vode, ki vodi v otekanje rok, gležnjev ali nog, vročino, bolečine v sklepih ter spolne disfunkcije, kot na primer zmanjšan libido pri moških in ženskah ter erektilna disfunkcija pri moških.
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 01/10,000), not known (cannot be estimated from the data available).
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ocena ni možna iz danih podatkov).
Olazax contains the active substance olanzapine.
Zdravilo Olazax vsebuje zdravilno učinkovino olanzapin.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax.
• Pri bolnikih, ki so jemali zdravilo OLANZAPINE , so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
V primerih, kjer je ugotovljen hepatitis (vključno s hepatocelularno, holestatsko ali mešano okvaro jeter),
5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
5Opazovano pri osnovnih normalnih ravneh na tešče (< 1,69 mmol/l), ki so se povišale na visoke (≥ 2,26 mmol/l).
Only take other medicines while you are on Olazax if your doctor tells you that you can. You might feel drowsy if Olazax is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Če jemljete zdravilo Olazax v kombinaciji z zdravili za zdravljenje depresije, zdravili za zdravljenje občutkov tesnobe ali zdravili, ki vam pomagajo spati (pomirjevala), se lahko počutite zaspani.
Olazax 5mg is supplied as a yellow coloured circular flat beveled edge tablet with ‘B' debossed on one side.
Olazax 5 mg je na voljo kot rumena, okrogla, ploščata tableta z zaobljenim robom in oznako 'B' na eni strani.
Neuroleptic malignant syndrome (see section
Nevroleptični maligni sindrom
The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglavje 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama-glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatin-fosfokinaze in edem.
Nervous system disorders Somnolence
DisartrijaJecljanje Sindrom nemirnih nog
Urinary incontinence, urinary retention
Urinska inkontinenca, zastajanje urina Težave z začetkom mokrenja11
High Gamma Glutamyltransferase 10
Visoka raven gamaglutamiltransferaze10
If you suddenly stop taking Olazax, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Če nenadno prenehate jemati zdravilo Olazax, se lahko pojavijo simptomi, kot so znojenje,
Olazax 7.5 mg tablets
Olazax 7,5 mg tablete olanzapin
Reversible neutropenia, thrombocytopenia, or anaemiaa developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/kg/dan (celotno izpostavljanje olanzapinu [AUC] je 12- do 15-krat večje kot pri človeku, ki dobi 12-miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
Changes in total fasting cholesterol levels from borderline at baseline
Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Občasno ( ≥ 0.1% in < 1%) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
What you need to know before you take Olazax
Kaj morate vedeti, preden boste vzeli zdravilo Olanzapin Glenmark Ne jemljite zdravila Olazax:
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti (≥ 5,56 mmol/l - < 7 mmol/l) na visoke (≥ 7 mmol/l).
NAME OF THE MEDICINAL PRODUCT Olazax 7.5 mg tablets
IME ZDRAVILA Olazax 7,5 mg tablete
Olazax 20 mg tablets
Olazax 20 mg tablete olanzapin
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Občasni neželeni učinki (lahko prizadenejo do 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje, upočasnjen srčni utrip, občutljivost za sončno svetlobo,
Caution should be exercised and follow-up organized in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Pri bolnikih s zvišano ALT in/ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo,
13Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
13 S kratkotrajnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), ≥ 15 % pogosto (7,1 %) in za ≥ 25 %
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
DODATEK II A. IZDELOVALCI ZDRAVILA, ODGOVORNI ZA
Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term exposure
Zvečanje osnovne telesne mase za ≥ 7 %, ≥ 15 % in
Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,69 mg aspartama.
Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,46 mg aspartama.
Contents of the pack and other information
Shranjevanje zdravila Olazax Vsebina pakiranja in dodatne
Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2%), ≥ 15% was common (4.2%) and ≥25% was uncommon
S kratkoročnim zdravljenjem (srednje trajanje 47 dni) povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), ≥ 15 %
NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
IME ZDRAVILA Olazax 20 mg tablete
Olazax 5 mg tablets
Olazax 5 mg tablete olanzapin
What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Pomožne snovi so manitol (E 421), mikrokristalna celuloza, aspartam (E 951), krospovidon, magnezijev stearat.
NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
IME ZDRAVILA Olazax 10 mg tablete
Olazax 15 mg tablets
Olazax 15 mg tablete olanzapin
Olazax 10 mg tablets
Olazax 10 mg tablete olanzapin
Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,23 mg aspartama.
Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
rumena, okrogla, ploščata tableta z zaobljenim robom in oznako 'C' na eni strani.
NAME OF THE MEDICINAL PRODUCT Olazax 5 mg tablets
IME ZDRAVILA Olazax 5 mg tablete
Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
vznemirjenost/nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
NAME OF THE MEDICINAL PRODUCT Olazax 15 mg tablets
IME ZDRAVILA Olazax 15 mg tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg aspartame For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom: Ena tableta vsebuje 0,92 mg aspartama.
Drug withdraw al syndrome neonatal
Odtegnitveni sindrom pri novorojenčku
High Uric Acid 10
Visoka raven sečne kisline10
Gynaecomastia/breas t enlargement in males
Ginekomastija/po večanje dojk pri moških
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg olanzapine.
Ena tableta vsebuje 10 mg olanzapina.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Prekinitev zdravljenja Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥0.01% and < 0.1%) when olanzapine is stopped abruptly.
Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Pomožna snov z znanim delovanjem: Ena tableta vsebuje 0,35 mg aspartama.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg olanzapine.
Ena tableta vsebuje 5 mg olanzapina.
Crospovidone Magnesium stearate
Prehodna asimptomatska zvišanja jetrnih aminotransferaz
Photosensitivit y reaction Alopecia
Splošne težave in spremembe na mestu aplikacije Astenija
MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/002
Olazax with alcohol
Zdravilo Olazax vsebuje laktozo
Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Ena tableta vsebuje 20 mg olanzapina.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/001
MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/005
MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/004
Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'F' na drugi strani.
• Weight gain has been seen in patients taking Olazax.
• Pri bolnikih, ki so jemali zdravilo OLANZAPINE , so opazili porast telesne mase.
Dose escalation, when indicated, should be conservative in such patients (See sections 4.5 and 5.2.
Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/597/003
Tardive
Občasni
Bradycardia
Amenoreja
Your doctor will urgently review your treatment.
Vaš zdravnik bo nujno proučil vaše zdravljenje.
• For migraine prevention (in countries where this use is authorised)
• Za preprečevanje migrene (v državah, kjer je odobrena uporaba za ta namen)
In some EU Member States they are also authorised to prevent migraine headaches.
V nekaterih državah članicah EU so odobrena tudi za preprečevanje migrenskih glavobolov.
Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Zdravila, ki vsebujejo valproat, so bila z nacionalnimi postopki odobrena v vseh državah članicah EU ter na Norveškem in v Islandiji.
Healthcare professionals in the EU will be sent a dear healthcare professional letter plus additional educational material concerning these recommendations.
Zdravstveni delavci v EU bodo prejeli pismo za zdravstvene delavce in dodatno izobraževalno gradivo v zvezi s temi priporočili.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards across the EU for medicines authorised via national procedures.
Skupina CMDh, organ, ki predstavlja vse države članice EU, je odgovorna za zagotavljanje usklajenih varnostnih standardov po vsej EU za zdravila, odobrena z nacionalnimi postopki.
These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5
Ta priporočila so bila oblikovana po pregledu nedavnih študij, ki so pokazale težave v razvoju pri do 30 do 40 % predšolskih otrok, izpostavljenih valproatu v maternici, vključno s tem, da ti otroci kasneje shodijo in spregovorijo ter imajo težave s spominom, govorom in jezikom in manjše intelektualne sposobnosti.1,2,3,4,5
• If you can become pregnant, you should use an effective method of contraception.
• Če lahko zanosite, morate uporabljati učinkovito kontracepcijsko metodo.
• If you have any questions about your treatment or contraception, speak to your doctor or pharmacist.
• V kolikor imate kakršnokoli vprašanje o svojem zdravljenju ali kontracepciji, se posvetujte z zdravnikom ali farmacevtom.
• Tell your doctor at once if you become pregnant, think you might be pregnant or are planning to become pregnant.
• Nemudoma obvestite svojega zdravnika, če ste zanosili, če mislite, da bi lahko bili noseči, ali če nameravate zanositi.
As valproate medicines in the EU are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for a position.
Ker so vsa zdravila, ki vsebujejo valproat, v EU odobrena na nacionalni ravni, so bila priporočila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) za stališče.
They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Tržijo se pod različnimi tržnimi imeni, vključno z naslednjimi: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil in Valhel.
The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Pregled zdravil, ki vsebujejo valproat, se je začel oktobra 2013 na zahtevo regulatorne agencije Združenega kraljestva za zdravila in zdravstvene pripomočke (Medicines and Healthcare Products Regulatory Agency, MHRA) v skladu s členom 31 Direktive 2001/83/ES, in sicer po objavi novih podatkov o tveganju malformacij in težav v razvoju pri otrocih, ki so bili izpostavljeni valproatu v maternici.