natgillin/translations-raw huggingface dataset:
therapy with CYSTAGON must be started as soon as possible.
zdravljenje z zdravilom CYSTAGON začeti čimprej.
- A few cases of skin lesions on elbows like little hard lumps have been reported in children
- Pri otrocih, zdravljenih z velikimi odmerki različnih pripravkov cisteamina, so poročali o nekaj
treated with high doses of different cysteamine preparations.
primerih kožnih lezij na komolcih, ki so bili podobni trdim bulicam.
Self examination of your or your child’ s skin is recommended.
Priporočamo samopregledovanje vaše kože ali kože vašega otroka.
- CYSTAGON has not been shown to prevent cystine crystals accumulating in the eye.
- Ni dokazano, da bi CYSTAGON preprečeval kopičenje cistinskih kristalov v očesu.
Where
Kadar se v
- In contrast to phosphocysteamine, another active substance close to cysteamine bitartrate,
ta namen uporablja raztopina cisteamina za oči, je treba s to terapijo nadaljevati.
- To avoid any risk of aspiration in the lungs, the capsules should not be given to children under
- V nasprotju s fosfocisteaminom, ki je druga zdravilna učinkovina, sorodna cisteaminijevemu
the age of approximately 6 years.
- Do približno 6. leta starosti otrokom ne smete dajati trdih kapsul, ker obstaja nevarnost, da bi
Using other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Using CYSTAGON with food and drink For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e. g. milk, potatoes or starch based foods) or mixed in formula.
Jemanje zdravila CYSTAGON skupaj s hrano in pijačo Pri otrocih, mlajših od 6 let, lahko trde kapsule odprete in vsebino stresete na obrok hrane (npr. mleko, krompir ali močnate jedi) ali primešate nadomestnemu mleku.
Do not add to acidic drinks e. g. orange juice.
Ne dodajajte zdravila kislim pijačam, npr. pomarančnemu soku.
Pregnancy You should not use CYSTAGON if you are pregnant.
Nosečnost Če ste noseči, zdravila CYSTAGON ne smete uporabljati.
Driving and using machines CYSTAGON may cause some drowsiness.
Vpliv na sposobnost upravljanja vozil in strojev CYSTAGON lahko povzroča zaspanost.
Always use CYSTAGON exactly as your doctor or your child’ s doctor has told you.
Pri uporabi zdravila CYSTAGON natančno upoštevajte navodila svojega ali otrokovega zdravnika.
For children up to age 12 years, the dose will be based on the body size (surface area), the usual dose being 1.30 g/ m2 of body surface area per day.
Pri otrocih do 12. leta starosti bo odmerek temeljil na velikosti telesa (površini), običajni odmerek je 1, 30 g/ m2 telesne površine na dan.
For patients over age 12 and over 50 kg weight, the usual dose is 2g/ day.
Pri bolnikih, starejših od 12 let in težjih od 50 kg, je običajni odmerek 2 g/ dan.
In any case the usual dose should not exceed 1.95 g/ m2/ day.
Običajni odmerek v nobenem primeru ne sme preseči 1, 95 g/ m2/ dan.
- Follow your doctor's directions exactly.
- Natančno upoštevajte zdravnikova navodila.
Do not increase or decrease the amount of medicine
Ne povečujte ali zmanjšujte količine zdravila brez
without your doctor's approval.
odobritve svojega zdravnika.
- Hard capsules should not be given to children under approximately six years of age because
- Do približno 6. leta starosti otrokom ne smete dajati trdih kapsul, ker jih morda ne bodo mogli
they may not be able to swallow them and they may choke.
pogoltniti in se lahko zadušijo.
For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e. g. milk, potatoes or starch based foods) or mixed in formula.
Pri otrocih, mlajših od 6 let, lahko trde kapsule odprete in vsebino stresete na obrok hrane (npr. mleko, krompir ali močnate jedi) ali primešate nadomestnemu mleku.
- Your or your child's medical treatment may include, in addition to CYSTAGON, one or more
- Vaše ali otrokovo zdravljenje lahko vključuje poleg CYSTAGONa še enega ali več dodatkov za
supplements to replace important electrolytes lost through the kidneys.
nadomeščanje pomembnih elektrolitov, ki se izgubljajo skozi ledvice.
- Regular blood tests to measure the amount of cystine inside white blood cells are necessary to
- Redni pregledi krvi z merjenjem količine cistina v belih krvničkah so potrebni za lažje
help determine the correct dose of CYSTAGON.
določanje pravilnega odmerka CYSTAGONa.
CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
30 CYSTAGON je treba jemati 4- krat na dan, vsakih 6 ur, po možnosti takoj po jedi ali med jedjo.
30 Treatment with CYSTAGON should continue indefinitely, as instructed by your doctor.
Zdravljenje s CYSTAGONom je treba nadaljevati neprekinjeno, tako kot vam je naročil vaš zdravnik.
You should contact your or your child's doctor or the hospital emergency department immediately if more medicine has been taken than has been prescribed, drowsiness develops.
Če je prišlo do zaužitja večje količine zdravila od predpisane ali če se pojavi zaspanost, se morate nemudoma obrniti na svojega ali otrokovega zdravnika oz. na urgentni oddelek bolnišnice.
The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
Poročali so o naslednjih neželenih učinkih: zelo pogostih (pojavijo se pri najmanj 1 od 10 bolnikov), pogostih (pojavijo se pri najmanj 1 od 100 bolnikov), občasnih (pojavijo se pri najmanj 1 od 1. 000 bolnikov), redkih (pojavijo se pri najmanj 1 od 10. 000 bolnikov), zelo redkih (pojavijo se pri najmanj 1 od 100. 000 bolnikov).
- Very common: vomiting, nausea, diarrhoea, loss of appetite, fever and sensation of sleep
- Zelo pogosto: bruhanje, slabost, driska, izguba teka, zvišana telesna temperatura in občutek
- Common: abdominal pain or discomfort, unpleasant breath and body odour, skin eruption,
- Pogosto: bolečine ali nelagodje v trebuhu, neprijeten zadah iz ust in telesni vonj, kožni
gastroenteritis, fatigue, headache, encephalopathy (brain disorder) and liver function test abnormalities.
izpuščaji, gastroenteritis (prebavne motnje), utrujenost, glavobol, encefalopatija (bolezen možganov) in nenormalni izvidi testov jetrnih funkcij.
- Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone
- Občasno: kožne strije, kožne lezije (trde bulice na komolcih), ohlapni sklepi, bolečine v
fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
spodnjih udih, zlomi kosti, skolioza (deformacija hrbtenice), deformacije in krhkost kosti, sprememba barve las, težke alergijske reakcije, zaspanost, krči, živčnost, halucinacije, padec števila belih krvničk, razjeda prebavnega trakta, ki se kaže kot krvavitev iz prebavil, ter prizadetost ledvic, ki je razvidna iz oteklih okončin in porasta telesne mase.
Since some of these side effects are serious, ask your or your child’ s doctor to explain their warning signs.
Ker so nekateri od teh neželenih učinkov resni, se o njihovih opozorilnih znakih posvetujte s svojim ali otrokovim zdravnikom.
What CYSTAGON contains
Kaj vsebuje zdravilo CYSTAGON
- The active substance is cysteamine bitartrate (mercaptamine bitartrate).
- Zdravilna učinkovina je cisteaminijev bitartrat (merkaptaminijev bitartrat).
Each hard capsule of
Ena trda kapsula
CYSTAGON 50 mg contains 50 mg of cysteamine (as mercaptamine bitartrate) Each hard capsule of CYSTAGON 150 mg contains 150 mg of cysteamine (as mercaptamine bitartrate)
Ena trda kapsula zdravila CYSTAGON 150 mg vsebuje 150 mg cisteamina (v obliki merkaptaminijevega bitartrata).
- The other ingredients are microcrystalline cellulose, starch, pregelatinized, magnesium
- Pomožne snovi so mikrokristalna celuloza, predgelirani škrob, magnezijev stearat/ natrijev
stearate/ sodium lauryl sulphate, colloidal silicon dioxide, croscarmellose sodium, capsule shells: gelatin, titanium dioxide, black ink on hard capsules (E172).
lavrilsulfat, koloidni silicijev dioksid, premreženi natrijev karmelozat, ovoj kapsule: želatina, titanov dioksid, črnilo na trdih kapsulah (E172).
What CYSTAGON looks like and contents of the pack Hard Capsules
Izgled zdravila CYSTAGON in vsebina pakiranja Trde kapsule
- Cystagon 50 mg: white, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
- Cystagon 50 mg: bele, neprosojne trde kapsule z napisom CYSTA 50 na spodnjem delu in MYLAN
- Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on
- Cystagon 150 mg: bele, neprosojne trde kapsule z napisom CYSTAGON 150 na spodnjem delu in
the cap.
MYLAN na zgornjem delu.
Orphan Europe SARL, Immeuble “ Le Wilson”, F-92058 Paris La Défense, France
Orphan Europe SARL, Immeuble “ Le Wilson ”, F- 92058 Paris La Défense, Francija
32 Deutschland Orphan Europe (Germany) GmbH Max-Planck Str.
32 Deutschland Orphan Europe (Germany) GmbH Max- Planck Str.
33 Κύπρος Orphan Europe SARL Immeuble “ Le Wilson” F - 92058 Paris La Défense Γαλλία Τηλ: +33 1 47 73 64 58
33 Κύπρος Orphan Europe SARL Immeuble “ Le Wilson ” F - 92058 Paris La Défense Γαλλία Τηλ: +33 1 47 73 64 58
Dafiro is a medicine containing two active substances, amlodipine and valsartan.
Dafiro je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
„ Esencialna “ pomeni, da visok krvi tlak ni posledica nobenega drugega bolezenskega stanja.
Dafiro is not recommended for use in patients below 18 years of age.
Uporaba zdravila Dafiro ni priporočljiva pri bolnikih, mlajših od 18 let.
Dafiro is taken by mouth as one tablet once a day with some water, with or without food.
Zdravilo Dafiro se zaužije peroralno kot ena tableta na dan z malo vode, skupaj s hrano ali brez nje.
The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Velikost odmerka zdravila Dafiro, ki ga je treba vzeti, je odvisna od odmerkov amlodipina ali valsartana, ki ju je bolnik prejemal prej.
Dafiro should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Bolniki, ki imajo težave z jetri ali obstruktivno biliarno bolezen (težave z izločanjem žolča), morajo zdravilo Dafiro jemati previdno..
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.
Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Dafiro, in ljudeh, ki so jemali obe zdravilni učinkovini ločeno.
The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Najpogostejši neželeni učinki zdravila Dafiro (opaženi pri 1 do 10 bolnikov izmed 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
For the full list of all side effects reported with Dafiro, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dafiro, glejte navodilo za uporabo.
Dafiro should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘ dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients.
Zdravila Dafiro ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda „ derivatov dihidropiridina “, valsartan ali katero koli drugo sestavino zdravila.
Dafiro should also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Zdravila Dafiro prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri, ledvicami ali izločanjem žolča, ali bolniki na dializi (postopek prečiščevanja krvi).
The Committee for Medicinal Products for Human Use (CHMP) decided that Dafiro’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Dafiro pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče ustrezno urejati samo z amlodipinom ali valsartanom, večje od z njim povezanih tveganj.
The Committee recommended that Dafiro be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Dafiro odobri dovoljenje za promet.
Other information about Dafiro:
Druge informacije o zdravilu Dafiro:
The European Commission granted a marketing authorisation valid throughout the EU for Dafiro to Novartis Europharm Limited on 16 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Dafiro, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 16. januarja 2007.
The full EPAR for Dafiro can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dafiro je na voljo tukaj.
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pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC) pretisni omot (PVC/ PVDC)
Package size 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 90 tablet 98 tablet 280 tablet 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 56 x 1 tableta (za enkratni odmerek) 98 x 1 tableta (za enkratni odmerek) 280 x 1 tableta (za enkratni odmerek) 280 tablet (4 x 70) 280 tablet (4 x 70) 280 tablet (4 x 70)
Dafiro 5 mg/ 80 mg film-coated tablets
Dafiro 5 mg/ 80 mg filmsko obložene tablete
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “ NVR ” on one side and “ NV” on the other side.
Temnorumene, okrogle filmsko obložene tablete s poševnimi robovi, ki imajo na eni strani oznako “ NVR ” in na drugi “ NV ”.
Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Zdravilo Dafiro je indicirano pri bolnikih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom ali valsartanom.
Dafiro 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Dafiro 5 mg/ 80 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali z 80 mg valsartana.
Dafiro can be used with or without food.
Bolnik lahko Dafiro vzame s hrano ali brez nje.
It is recommended to take Dafiro with some water.
Dafiro je priporočljivo vzeti z nekaj vode.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Dafiro containing the same component doses.
Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/ kapsulah, prevesti na Dafiro, ki vsebuje enaka odmerka sestavin.
Hepatic impairment Caution should be exercised when administering Dafiro to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Okvara jeter Previdnost je potrebna pri uporabi zdravila Dafiro pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4. 4).
2 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
2 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Dafiro ni priporočljivo uporabljati pri bolnikih, mlajših od 18 let.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Dafiro in placebo-controlled studies.
Bolniki s pomanjkanjem natrija in/ ali volumna V študijah, kontroliranih s placebom, so čezmerno hipotenzijo opažali pri 0, 4% bolnikov z nezapleteno hipertenzijo, ki so dobivali Dafiro.
In patients with an activated renin-angiotensin system (such as volume- and/ or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur.
Pri bolnikih z aktiviranim sistemom renin- angiotenzin (npr. pri bolnikih s pomanjkanjem volumna in/ ali soli, ki dobivajo velike odmerke diuretikov), ki dobivajo blokatorje receptorjev angiotenzina, se lahko pojavi simptomatska hipotenzija.
Renal artery stenosis No data are available on the use of Dafiro in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenoza ledvične arterije Ni podatkov o uporabi zdravila Dafiro pri bolnikih z obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice.
Kidney transplantation To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation.
Presaditev ledvice Doslej ni izkušenj glede varnosti uporabe zdravila Dafiro pri bolnikih, ki jim je bila nedavno presajena ledvica.
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
3 Okvara ledvic Pri bolnikih z blago do zmerno okvaro ledvic (hitrost glomerulne filtracije > 30 ml/ min/ 1, 73 m2) odmerka zdravila Dafiro ni treba prilagajati.
Dafiro has not been studied in any patient population other than hypertension.
Dafiro ni raziskan pri nobeni drugi populaciji, razen pri hipertenzivnih bolnikih.
Interactions common to the combination No drug interaction studies were performed with Dafiro and other medicinal products.
Interakcije, pogoste ob kombinaciji Študij medsebojnega delovanja z zdravilom Dafiro in drugimi zdravili ni bilo.
There is no experience on the use of Dafiro in pregnant women.
5 Z uporabo zdravila Dafiro pri nosečnicah ni izkušenj.
The safety of Dafiro has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Varnost zdravila Dafiro so ocenili v petih kontroliranih kliničnih študijah s 5. 175 bolniki, od katerih jih je 2. 613 dobivalo valsartan v kombinaciji z amlodipinom.
6 General disorders and administration site conditions
6 Splošne težave in spremembe na mestu aplikacije
Valsartan (mg)
valsartan (mg)