natgillin/translations-raw huggingface dataset:
In contrast, intrathecal administration of 30 mg free cytarabine has shown a biphasic CSF concentration profile with a terminal phase half-life of about 3.4 hours.
V nasprotju s tem je intratekalno odmerjanje 30 mg prostega citarabina pokazalo dvofazni profil koncentracije v cerebrospinalni tekočini z razpolovnim časom terminalne faze približno 3, 4 ure.
Pharmacokinetic parameters of DepoCyte (75 mg) in neoplastic meningitis patients in whom the drug was administered either intraventricularly or by lumbar puncture suggest that exposure to the drug in the ventricular or lumbar spaces is similar regardless of the route of administration.
Farmakokinetični paramteri zdravila DepoCyte (75 mg) pri bolnikih z neoplastičnim meningitisom, katerim so zdravilo dajali intraventrikularno ali z lumbalno punkcijo, kažejo, da je izpostavljenost zdravilu v ventrikularnih ali lumbalnih prostorih podobna, ne glede na način uporabe.
Encapsulated cytarabine concentrations and the counts of the lipid particles in which the cytarabine is encapsulated in DepoCyte followed a similar distribution pattern.
Koncentracije inkapsuliranega citarabina in število lipidnih delcev, v katerih je citarabin inkapsuliran pri DepoCytu, so pokazale podobne vzorce razporeditve.
AUCs of free and encapsulated cytarabine after ventricular injection of DepoCyte appeared to increase linearly with increasing dose, indicating that the release of cytarabine from DepoCyte and the pharmacokinetics of cytarabine are linear in human CSF.
Videti je bilo, da se površini pod krivuljo (AUC) prostega in inkapsuliranega citarabina po ventrikularnem injiciranju DepoCyta linerano povečata z večjimi odmerki, kar kaže na to, da sta v človeški cerebrospinalni tekočini sproščanje citarabina iz DepoCyta in farmakokinetika citarabina linearni.
The transfer rate of cytarabine from CSF to plasma is slow and the conversion to uracil arabinoside (ara-U), the inactive metabolite, in the plasma is fast.
Stopnja prenosa citarabina iz cerebrospinalne tekočine v plazmo je počasna, pretvorba v uracil arabinozid (ara- U), neaktivni presnovek, v plazmi pa je hitra.
Systemic exposure to cytarabine was determined to be negligible following intrathecal administration of 50 mg and 75 mg of DepoCyte.
Za sistemsko izpostavljenost citarabinu so ugotovili, da je po intratekalnem odmerjanju 50 mg in 75 mg DepoCyta zanemarljiva.
Metabolism and elimination The primary route of elimination of cytarabine is metabolism to the inactive compound ara-U, (1-β -D- arabinofuranosyluracil or uracil arabinoside) followed by urinary excretion of ara-U.
Presnova in izločanje Primarna pot izločanja citarabina je presnova v neaktivno spojino ara- U (1- β- D- arabinofuranoziluracil ali uracil arabinozid), čemur sledi izločanje le- te z urinom.
In contrast with systemically administered cytarabine which is rapidly metabolised to ara-U, conversion to ara-U in the CSF is negligible after intrathecal administration because of the significantly lower cytidine deaminase activity in the CNS tissues and CSF.
V primerjavi s sistemsko danim citarabinom, ki se hitro presnovi v ara- U, je pretvorba v ara- U v cerebrospinalni tekočini po intratekalnem odmerjanju zanemarljiva zaradi značilno manjše aktivnosti citidin deaminaze v tkivih osrednjega živčevja in cerebrospinalni tekočini.
The CSF clearance rate of cytarabine is similar to the CSF bulk flow rate of 0.24 ml/ min.
Stopnja očistka citarabina iz cerebrospinalne tekočine je 0, 24 ml/ min in je podobna hitrosti pretoka cerebrospinalne tekočine.
The distribution and clearance of cytarabine and of the predominant phospholipid component of the lipid particle (DOPC) following intrathecal administration of DepoCyte was evaluated in rodents.
Pri glodalcih so ocenili porazdelitev in očistek citarabina in prevladujoče fosfolipidne komponente lipidnega delca (DOPC) po intratekalnem dajanju DepoCyta.
More than
Radioaktivne oznake citarabina in DOPC so se hitro porazdelile po celi nevralni osi.
7 90% of cytarabine was excreted by day 4 and an additional 2.7% by 21 days.
Več kot 90% citarabina se je izločilo v prvih 4 dneh in še 2, 7% v nadaljnjih 21 dneh.
A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids to those in DepoCyte indicates that such lipids are well tolerated in various animal species even when administered for prolonged periods at doses in the g/ kg range.
Pregled toksikoloških podatkov, ki so na voljo za sestavne lipide (DOPC in DPPG) ali fosfolipide, podobne tistim v DepoCytu, kaže, da različne živalske vrste dobro prenašajo take lipide tudi, kadar jih prejemajo daljše obdobje v odmerkih ranga g/ kg.
The results of acute and subacute toxicity studies performed in monkeys suggested that intrathecal DepoCyte was tolerated up to a dose of 10 mg (comparable to a human dose of 100 mg).
Rezultati raziskav akutne in subakutne toksičnosti, ki so jih opravili na opicah, kažejo na to, da so DepoCyte prenašale do intratekalnega odmerka 10 mg (primerljivo z odmerkom 100 mg pri človeku).
Slight to moderate inflammation of the meninges in the spinal cord and brain and/ or astrocytic activation were observed in animals receiving intrathecal DepoCyte.
Pri živalih, ki so DepoCyte prejemale intratekalno, so opazili blago do zmerno vnetje mening v hrbtenjači in možganih in/ ali aktivacijo astrocitov.
Similar changes (generally described as minimal to slight) were also observed in some animals receiving DepoFoam alone (DepoCyte vesicles without cytarabine) but not in saline control animals.
Podobne spremembe (ki so jih na splošno opisali kot minimalne do blage) so opazili tudi pri nekaterih živalih, ki so prejemale samo DepoFoam (vezikli DepoCyta brez citarabina), niso pa jih opazili pri kontrolnih živalih, ki so prejemale fiziološko raztopino.
No carcinogenicity, mutagenicity or impairment of fertility studies have been conducted with DepoCyte.
Z DepoCytom niso opravili nikakršnih raziskav karcinogenosti, mutagenosti ali oslabitve plodnosti.
The active ingredient of DepoCyte, cytarabine, was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and sister chromatid exchange in human leukocytes) and in vivo (chromosome aberrations and sister chromatid exchange assay in rodent bone marrow, mouse micronucleus assay).
8 raziskavah in vitro (kromosomske aberacije in izmenjava med sestrskimi kromatidami v človeških levkocitih) in in vivo (test kromosomskih aberacij in izmenjave med sestrskimi kromatidami v kostnem mozgu glodalcev, test mikronukleusov pri miših).
Cytarabine was clastogenic to meiotic cells; a dose-dependent increase in sperm-head abnormalities and chromosomal aberrations occurred in mice given i. p. cytarabine.
Pri miših, ki so citarabin prejemale i. p. intraperitonealno, je prišlo do povečanja števila anomalij glav spermijev in kromosomskih aberacij, kar je bilo odvisno od odmerka.
Because the systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible, the risk of impaired fertility is likely to be low.
Sistemska izpostavljenost prostemu citarabinu po intratekalnem zdravljenju z DepoCytom je zanemarljiva, zato je tveganje oslabljene plodnosti verjetno majhno.
Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections
Holesterol Triolein Dioleoilfosfatidilholin (DOPC - Dioleylphosphatidylcholine) Dipalmitoilfosfatidilglicerol (DPPG - Dipalmitoylphosphatidylglycerol) Natrijev klorid Voda za injekcije
No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted.
Formalnih raziskav farmakokinetskih interakcij med DepoCytom in drugimi učinkovinami niso opravili.
DepoCyte should not be diluted or mixed with any other medicinal products, as any change in concentration or pH may affect the stability of the microparticles.
DepoCyta ne smete redčiti ali mešati z nobenim drugim zdravilom, kajti vsaka sprememba koncentracije ali pH lahko vpliva na stabilnost mikro delcev.
8 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
DepoCyte is supplied in individual cartons each containing one single-dose Type I glass vial containing 50 mg (in 5 ml), closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal.
Vsaka vsebuje 1 enoodmerno stekleno vialo iz stekla vrste I, s 50 mg (v 5 ml), zaprto z zamaškom iz butilne gume, ki je prevlečen s fluorovo smolo in z aluminijasto zaporko flip- off.
Given its toxic nature, special precautions should be taken in handling DepoCyte.
Pri ravnanju z zdravilom DepoCyte morate biti zaradi njegove toksičnosti zelo pozorni.
See ‘ Precautions for the handling and disposal of DepoCyte’ below.
Glejte poglavje "Previdnostni ukrepi za ravnanje z DepoCytom in njegovo odlaganje" spodaj.
Avoid vigorous shaking.
Izogibajte se močnemu tresenju.
DepoCyte administration
9 Dajanje DepoCyta
DepoCyte must only be administered by the intrathecal route.
DepoCyte naj bo dan le intratekalno.
Since it is a single use vial and does not contain any preservative, the drug should be used within 4 hours of withdrawal from the vial.
DepoCyte je na voljo v viali za enkratno uporabo in ne vsebuje nikakršnih konzervansov, zato ga morate porabiti v 4 urah po tem, ko ga vzamete iz viale.
Unused drug must be discarded and not used subsequently.
Neporabljeno zdravilo morate zavreči – ne smete ga hraniti za kasnejšo uporabo.
Do not mix DepoCyte with any other medicinal products (see section 6.2).
Ne mešajte zdravila DepoCyte z drugimi zdravili (glejte poglavje 6. 2).
Do not dilute the suspension.
Suspenzije ne redčite.
DepoCyte is administered directly into the CSF via an intraventricular reservoir or by direct injection into the lumbar sac.
DepoCyte se daje neposredno v cerebrospinalno tekočino skozi ventrikularni rezervoar ali z neposredno injekcijo v lumbalno vrečko.
DepoCyte should be injected slowly over a period of 1-5 minutes.
DepoCyte morate počasi injicirati v roku 1– 5 minut.
Following drug administration by lumbar puncture, the patient should be instructed to lie flat for one hour.
Bolniku naročite, da po dajanju zdravila z lumbalno punkcijo leži še eno uro.
Patients should be observed by the physician for immediate toxic reactions.
Zdravniki morajo bolnike opazovati, zaadi možnosti takojšnjih toksičnih reakcij.
Patients should be started on corticosteroids (e. g. dexamethasone 4 mg twice daily either orally or intravenously) for 5 days beginning on the day of DepoCyte injection.
Bolniki morajo na dan injiciranja DepoCyta začeti jemati kortikosteroide (na primer 4 mg deksametazona dvakrat dnevno peroralno ali intravensko) in jih jemati 5 dni.
Precautions for the handling and disposal of DepoCyte
Previdnostni ukrepi za ravnanje z DepoCytom in njegovo odlaganje
The following protective recommendations are given due to the toxic nature of this substance: • personnel should be trained in good technique for handling anticancer agents • male and female staff who are trying to conceive and female staff who are pregnant should be excluded from working with the substance • personnel must wear protective clothing: goggles, gowns, disposable gloves and masks • a designated area should be defined for preparation (preferably under a laminar flow system).
Zaradi toksičnosti priporočamo naslednje zaščitne ukrepe: • Osebje mora biti izobraženo v tehniki dela z učinkovinami proti raku. • Za moške in ženske, ki poskušajo spočeti otroka, ali noseče ženske ni dopustno rokovanje s to snovjo. • Osebje mora nositi zaščitna oblačila: očala, halje, rokavice za enkratno uporabo in maske. • Za pripravo morate opredeliti določeno območje (po možnosti v sistemu z laminarnim pretokom zraka).
The work surface should be protected by disposable, plastic backed, absorbent paper • all items used during administration or cleaning should be placed in high risk, waste-disposal bags for high temperature incineration • in the event of accidental contact with the skin, exposed areas should be washed immediately with soap and water • in the event of accidental contact with the mucous membranes, exposed areas should be treated immediately by copious lavage with water; medical attention should be sought.
Delovno površino morate zaščititi z vpojnim papirjem, ki je na eni strani plastificiran in je za enkratno uporabo. • Vse predmete, ki jih uporabite med dajanjem zdravila ali med čiščenjem, morate dati v vreče za odlaganje visokorizičnih snovi, ki bodo nato sežgane pri visoki temperaturi. • V primeru nenamernega stika s kožo izpostavljene površine takoj umijte z milom in vodo. • V primeru nenamernega stika s sluznicami izpostavljene površine sperite z obilico vode in poiščite zdravniško pomoč.
Pacira Limited West Forest Gate, Wellington Road Wokingham, Berkshire RG40 2AQ United Kingdom
Pacira Limited West Forest Gate, Wellington Road Wokingham, Berkshire RG40 2AQ Velika Britanija
11 July 2001 Date of last renewal:
11. julij 2001 Datum podaljšanja dovoljenja za promet:
11 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
11 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Almac Pharma Services Limited 20 Seagoe Industrial Estate Craigavon, Co Armagh BT63 5QD United Kingdom
Almac Pharma Services Limited 20 Seagoe Industrial Estate Craigavon, Co Armagh BT63 5QD Velika Britanija
The Marketing Authorisation Holder will continue to submit yearly PSURs unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet bo vlagal letne PSUR- e, razen če drugače določi CHMP.
Cytarabine.
DepoCyte 50 mg suspenzija za injiciranje citarabin
Each vial contains 50 mg cytarabine (10 mg/ ml).
Vsaka viala vsebuje 50 mg citarabina (10 mg/ ml).
Store in a refrigerator (2ºC - 8ºC) Do not freeze
Shranjujte v hladilniku (2ºC - 8ºC) Ne zamrzujte.
Contains 5 ml.
5 ml
Read all of this leaflet carefully before you receive this medicine.
Pred uporabo natančno preberite navodilo.
- If you have further questions, please ask your doctor.
Če imate dodatna vprašanja, se posvetujte z zdravnikom.
What DepoCyte is and what it is given for 2.
Kaj je zdravilo DepoCyte in za kaj ga uporabljamo 2.
Before you are given DepoCyte 3.
Kaj morate vedeti, preden boste vzeli zdravilo DepoCyte 3.
How DepoCyte is given 4.
Kako uporabljati zdravilo DepoCyte 4.
How to store DepoCyte 6.
Shranjevanje zdravila DepoCyte 6.
WHAT DEPOCYTE IS AND WHAT IT IS GIVEN FOR
KAJ JE ZDRAVILO DEPOCYTE IN ZA KAJ GA UPORABLJAMO
DepoCyte is used to treat lymphomatous meningitis.
DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa.
DepoCyte is used in adults to kill lymphoma tumour cells.
DepoCyte se uporablja pri odraslih za uničevanje tumorskih celic limfoma.
BEFORE YOU ARE GIVEN DEPOCYTE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO DEPOCYTE
DepoCyte should not be given
Ne uporabljajte zdravila DepoCyte Če ste alergični na (preobčutljivi za) citarabin ali katerokoli drugo sestavino zdravila.
- If you have a meningeal infection.
Če imate okužbo možganskih ovojnic.
Taking other medicines Please inform your doctor or physician if you are taking or using any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika, če jemljete ali uporabljate katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Pregnancy and breast-feeding DepoCyte should not be given to pregnant women as it may harm an unborn child.
Nosečnost in dojenje Nosečnice ne smejo uporabljati DepoCyta, ker lahko škoduje nerojenemu otroku.
Women of childbearing potential should use a reliable contraceptive to avoid pregnancy whilst being treated with DepoCyte.
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo, da preprečijo nosečnost med zdravljenjem z DepoCytom.
Male patients undergoing DepoCyte treatment should use a reliable contraceptive method.
Moški bolniki morajo med zdravljenjem z DepoCytom uporabljati zanesljivo kontracepcijo.
Women should not breast-feed during treatment as DepoCyte may enter breast milk.
Ženske med zdravljenjem z DepoCytom ne smejo dojiti, kajti zdravilo lahko vstopi v mleko.
Driving and using machines Do not drive during treatment.
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila med zdravljenjem.
HOW DEPOCYTE IS GIVEN
KAKO UPORABLJATI ZDRAVILO DEPOCYTE
Before using DepoCyte, warm the vial to room temperature (18°C – 22°C) for at least 30 minutes.
Preden uporabite DepoCyte, ogrejte vialo na sobno temperaturo (18 °C – 22 °C) za najmanj 30 minut.
Just before withdrawing DepoCyte, gently invert the vial to mix the particles evenly.
Viale ne
Do not shake the vial vigorously.
19 stresajte močno.
A qualified and experienced doctor or physician in the treatment of cancer will inject DepoCyte in the spinal fluid or lumber sac.
Za zdravljenje raka usposobljeni in izkušeni zdravnik vam bo injiciral DepoCyte v hrbtenjačno tekočino ali lumbalno vrečko.
DepoCyte must not be administered by any other way.
DepoCyta ne smete uporabljati na noben drug način.
Injections are given slowly over a few minutes and you may be asked to lie flat for one hour afterwards.
Morda boste po injiciranju morali mirno ležati še eno uro.
You will also be given corticosteroids, such as dexamethasone, usually as tablets but possibly by intravenous injection for 5 days after you receive each DepoCyte dose to help reduce any side effects which might occur.
Po vsakem odmerku zdravila DepoCyte boste še 5 dni jemali kortikosteroide, kot je deksametazon, ponavadi v obliki tablet, morda tudi v obliki intravenske injekcije, da bi zmanjšali morebitne neželene učinke.
DepoCyte must be used as supplied without further dilution.
DepoCyte morate uporabljati takega, kot je pakiran, brez dodatnih redčenj.
The dose for adults is 50 mg (one vial of DepoCyte).
Odmerek za odrasle je 50 mg (ena viala DepoCyta).
For the treatment of lymphomatous meningitis, DepoCyte is given according to the following schedules:
Pri zdravljenju limfomatoznega meningitisa se DepoCyte daje po naslednjem režimu:
Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).
2 odmerka po eno vialo DepoCyta (50 mg) vsakih 14 dni (1. in 3. teden).
Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose at week 13.
3 odmerki po eno vialo DepoCyta (50 mg) vsakih 14 dni (5., 7. in 9. teden), ki jim sledi dodatni odmerek v 13. tednu.
Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
4 odmerki po eno vialo DepoCyta (50 mg) vsakih 28 dni (17., 21., 25. in 29. teden).
If you are given more DepoCyte than you should The recommended dose will be given to you by the doctor or physician as necessary.
Če ste dobili večji odmerek zdravila DepoCyte, kot bi smeli Zdravnik vam bo dal priporočeni odmerek.
There is no antidote for DepoCyte.
Za DepoCyte ni protistrupa.
Like all medicines, DepoCyte can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo DepoCyte neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Tell the medical staff, who will be monitoring you during this time, if you suffer from:
Obvestite zdravstveno osebje, ki vas bo v tem času nadzorovalo, če opazite kateregakoli od naštetih stranskih učinkov:
• Pain, numbness or tingling (feeling of sensation of pins and needles) • Nausea and/ or vomiting • Weakness • Confusion • Fever • Headaches • Fatigue • Convulsion • Dizziness • Neck pain • A stiff or rigid neck • Partial paralysis • Blindness and other visual disturbances • Shaking • Back pain
• Bolečina, odrevenelost ali zbadanje (občutek zbadanja z iglami) • Slabost in/ ali bruhanje • Šibkost • Zmedenost • Zvišana telesna temperatura • Glavoboli • Utrujenost • Konvulzije • Omotičnost • Bolečine v vratu • Tog ali trd vrat • Delna paraliza • Slepota in druge motnje vida • Tresenje • Bolečine v hrbtu • Trajna ali izredna zaspanost • Izguba sluha • Okužba možganskih ovojnic
20 • Persistent or extreme sleepiness • Hearing loss • Infection of the meninges
20 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite zdravstveno osebje, ki vas neguje.
STORING DEPOCYTE
SHRANJEVANJE DEPOCYTA
Do not use DepoCyte after the expiry date which is stated on the carton and on the vial.
Zdravila DepoCyte ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali.
What DepoCyte contains
Kaj vsebuje zdravilo DepoCyte
- The active substance is 50 mg cytarabine (10 mg/ ml)
- Zdravilna učinkovina je 50 mg citarabina (10 mg/ ml)
- The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine,
- Pomožne snovi so holesterol, triolein, dioleoilfosfatidilholin, dipalmitoilfosfatidilglicerol,
dipalmitoylphosphatidylglycerol, sodium chloride and water for injections.
natrijev klorid in voda za injekcije.
DepoCyte is a vial containing a white to off-white-suspension for injection.
DepoCyte je viala, ki vsebuje belo do umazano belo suspenzijo za injiciranje.
Each vial contains 5 ml of suspension for a single injection.
Vsaka viala vsebuje 5 ml suspenzije za eno injekcijo.
Each pack contains a single vial.
Vsako pakiranje vsebuje eno vialo.
Pacira Limited, West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United Kingdom.
Pacira Limited, West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, Velika Britanija.
Manufacturer Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, United Kingdom.
Izdelovalec Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, Velika Britanija.
21 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
21 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Diacomit is a medicine that contains the active substance stiripentol.
Diacomit je zdravilo, ki vsebuje zdravilno učinkovino stiripentol.
It is available as capsules and sachets (250 and 500 mg).
Na voljo je v obliki kapsul in vrečk, (250 mg in 500 mg).
Diacomit is an anti-epileptic medicine.
Zdravilo Diacomit je antiepileptik.
It is used in children with a very rare type of epilepsy called ‘ severe myoclonic epilepsy in infancy’ (SMEI), also known as Dravet ’ s syndrome.
Uporablja se pri otrocih z zelo redko vrsto epilepsije, imenovane huda mioklonična epilepsija v otroštvu (SMEI), ki je znana tudi kot Dravetov sindrom.
This type of epilepsy affects young children.
Ta vrsta epilepsije prizadene majhne otroke.
Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Zdravilo Diacomit se uporablja kot dodatek klobazamu in valproatu (druga antiepileptika) pri zdravljenju generaliziranih tonično- kloničnih epileptičnih napadov (hudih napadov, ki vključujejo izgubo zavesti), kadar jih ne moremo zadostno nadzorovati s klobazamom in valproatom.
Because the number of patients with SMEI is low, the disease is considered ‘ rare’, and Diacomit was designated as an ‘ orphan medicine ’ (a medicine used in rare diseases) on 5 December 2001.
Ker je število bolnikov s hudo mioklonično epilepsijo v otroštvu majhno, velja ta bolezen za redko, zato je bilo zdravilo Diacomit 5. decembra 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in infants and children (a paediatrician or paediatric neurologist).
Zdravljenje z zdravilom Diacomit mora potekati pod nadzorom zdravnika, specializiranega za diagnosticiranje in obravnavo epilepsije pri dojenčkih in otrocih (pediatra ali pediatričnega nevrologa).
The normal dose is 50 mg per kilogram body weight, divided into two or three doses during the day.
Običajni odmerek je 50 mg/ kg telesne mase, ki se razdeli v 2 do 3 odmerke dnevno.