natgillin/translations-raw huggingface dataset:
87 Are there any interactions with an influenza vaccination?
90 Ali prihaja s cepivom proti gripi do medsebojnega delovanja?
Taking Tamiflu with food and drink Tamiflu oral suspension can be taken with or without food, although it is recommended to take Tamiflu with food to reduce the chance of feeling or being sick (nausea or vomiting).
Priporočljivo je, da vzamete zdravilo Tamiflu s hrano, zato da zmanjšate možnost slabega počutja (slabost ali bruhanje).
It can also be taken with a drink of water.
Lahko ga vzamete tudi z vodo.
Important information about some of the ingredients of Tamiflu Before you take Tamiflu, make sure your prescribing doctor knows if you have hereditary fructose intolerance.
Pomembne informacije o nekaterih sestavinah zdravila Tamiflu Preden boste vzeli zdravilo Tamiflu, obvestite svojega zdravnika, če imate dedno intoleranco za fruktozo.
This medicine contains sorbitol which is a form of fructose.
To zdravilo vsebuje sorbitol, ki je oblika fruktoze.
How Much Tamiflu should be given to infants 1 year of age and older and Children 2 to 12 years of age)
Koliko zdravila Tamiflu smejo prejeti otroci (od 1 do 12 let)
Treatment You must give the amount of oral suspension to your child as prescribed by your doctor.
Zdravljenje Svojemu otroku dajte količino peroralne suspenzije, ki jo je predpisal vaš zdravnik.
30 mg and 45 mg capsules can be used as an alternative to suspension.
Namesto suspenzije lahko jemljejo 30- mg in 45- mg kapsule.
The usual dose for treatment of influenza in children depends on the body weight of the child (see table below):
Običajni odmerek za zdravljenje gripe pri otrocih je odvisen od telesne mase otroka (glejte spodnjo preglednico):
Recommended dose for 5 days (Treatment)
Priporočeni odmerek za 5- dnevno zdravljenje
(75 mg is made up of a 30 mg dose plus a 45 mg dose)
(75 mg odmerek sestavljata 30 mg in 45 mg odmerek)
Tamiflu can also be used to prevent influenza following exposure to an infected individual, such as family members.
Zdravilo Tamiflu lahko uporabljate tudi za preprečevanje gripe po stiku z okuženo osebo, kot so družinski člani.
88 30 mg and 45 mg capsules can be used as an alternative to suspension.
91 Namesto suspenzije lahko uporabite 30- mg in 45- mg kapsule.
It is best to take this dose in the mornings with breakfast.
Odmerek je priporočljivo zaužiti zjutraj z zajtrkom.
Children weighing more than 40 kg and can swallow capsules may take a 75 mg dose of Tamiflu capsules once daily for 10 days.
Otroci, ki tehtajo več kot 40 kg in zmorejo pogoltniti kapsulo, lahko jemljejo 75- mg kapsule zdravila Tamiflu enkrat na dan 10 dni.
How Much Tamiflu should be given to Adolescents (13 to 17 years of age) and Adults
Koliko zdravila Tamiflu naj vzamejo mladostniki (od 13. do 17. leta starosti) in odrasli
The suspension can be used by adults and adolescents instead of the capsule.
Namesto kapsul lahko odrasli in mladostniki vzamejo tudi suspenzijo.
30 mg and 45 mg capsules can be used as an alternative to suspension.
Namesto suspenzije lahko jemljejo tudi 30- mg in 45- mg kapsule.
Treatment Usually, your doctor will prescribe a 75 mg dose of Tamiflu twice daily for 5 days.
Zdravljenje Običajno vam bo zdravnik predpisal 75- mg odmerek zdravila Tamiflu dvakrat na dan 5 dni.
Prevention Usu ally, your doctor will prescribe a 75 mg dose of Tamiflu once daily for 10 days.
Preprečevanje Običajno vam bo zdravnik predpisal 75- mg odmerek zdravila Tamiflu enkrat na dan 10 dni.
Your doctor will recommend the length of time you will need to take Tamiflu.
Vaš zdravnik vam bo povedal, koliko časa morate jemati zdravilo Tamiflu.
A single 75 mg dose of Tamiflu requires two doses of the suspension: one 30 mg dose and one 45 mg dose.
En 75 mg odmerek zdravila Tamiflu sestavljata dva odmerka suspenzije – 30- mg in 45- mg odmerek.
a) HOW TO PREPARE THE ORAL SUSPENSION:
a) KAKO PRIPRAVIMO PERORALNO SUSPENZIJO
Your pharmacist may have prepared the oral suspension for you when you collected your prescription.
Priporočljivo je, da peroralno suspenzijo pripravi farmacevt takoj, ko prejmete recept, lahko pa jo preprosto pripravite sami.
However, if they have not done this, then you can do it easily yourself.
Suspenzijo morate pripraviti samo enkrat, in sicer na začetku zdravljenja.
You only need to prepare the suspension once, at the beginning of your course.
Po tem suspenzijo samo dobro pretresete in odvzamete priporočeni odmerek. zaporka
After that, all you need to do is shake the suspension well and draw up the appropriate recommended dose.
nastavek za steklenico
Cap ←Bottle Adapter Measuring Cup ← To the indicated level
merilna čaša ← do oznake
Tap the closed bottle gently several times to loosen the powder.
Zaprto steklenico večkrat rahlo pretresite, da se prašek zrahlja.
Measure 52 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Odmerite 52 ml vode, tako da jo napolnite v merilno čašo do označenega roba (merilna čaša je priložena v škatli).
You should always use 52 ml of water, irrespective of the recommended dose you are taking.
Vedno vzemite 52 ml vode, ne glede na priporočeni odmerek, ki ga boste zaužili.
Add all 52 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
V steklenico dodajte 52 ml vode, jo ponovno zaprite in dobro pretresite (15 sekund).
Place the cap tightly over the top of the bottle, which now includes the bottle adapter.
Zaporko namestite natančno prek vrha steklenice, ki ima tudi nastavek za steklenico.
b) HOW TO MEASURE AND GIVE A DOSE OF ORAL SUSPENSION
b) KAKO ODMERITI IN DATI ODMEREK PERORALNE SUSPENZIJE
Always shake Tamiflu oral suspension well before use!
Pred uporabo peroralno suspenzijo zdravila Tamiflu vedno dobro pretresite!
Oral Dispenser Plunger
peroralni odmernik
Tip Figure 2
Slika 2
How to measure the correct amount of suspension:
Kako odmeriti pravilen odmerek suspenzije
Shake the closed bottle of Tamiflu oral suspension well before use.
Pred uporabo zaprto steklenico peroralne suspenzije zdravila Tamiflu dobro pretresite.
Take the dispenser (see figure 2) and push the plunger completely down toward the tip of the dispenser.
Vzemite odmernik (glejte sliko 2) in potisnite bat navzdol proti vrhu odmernika.
The dispenser provided with your medicine must always be used to measure to correct dose.
Odmernik, ki je priložen vašemu zdravilu, uporabite vedno zaradi pravilnega odmerjanja zdravila.
Remove the cap from the bottle of oral suspension.
Odstranite zaporko s steklenice, v kateri je peroralna suspenzija.
Insert the tip of the dispenser into the bottle adapter.
Vstavite vrh odmernika v nastavek za steklenico.
Turn the entire unit (bottle and dispenser) upside down (see figure 3).
Oboje (steklenico in odmernik) obrnite od zgoraj navzdol (glejte sliko 3).
Slowly pull out the plunger to the graduation which marks the dose you need.
Počasi izvlecite bat do oznake, ki označuje vaš odmerek.
Turn the entire unit upright.
Steklenico in odmernik ponovno obrnite pokončno.
Slowly remove the dispenser from the bottle.
Počasi odstranite odmernik iz steklenice.
Push the suspension directly into the mouth by pushing down the plunger of the dispenser.
Suspenzijo dajte v usta tako, da potisnete bat odmernika navzdol.
Swallow the medicine.
Zdravilo pogoltnite.
Immediately after administration, take the dispenser apart and rinse both parts of the dispenser under running tap water.
Takoj po zaužitju zdravila razstavite odmernik in pod tekočo vodo sperite oba dela.
Children (aged 1 to 12 years) Other less common side effects, which may also be caused by influenza, are ear inflammation, inflammation of the lungs, sinusitis, bronchitis, aggravation of pre-existing asthma, nose bleeding, ear disorders, inflammation of the skin, swelling of the lymph nodes ,conjunctivitis, visual disturbances and heart rhythm abnormalities.
Otroci (od 1 do 12 let) Drugi manj pogosti neželeni učinki, ki jih prav tako lahko povzroči gripa, so vnetje ušes, vnetje pljuč, sinusitis, bronhitis, poslabšanje astme, krvavitev iz nosu, bolečine v ušesu, vnetje kože, otekanje limfnih žlez, konjunktivitis, motnje vida in nenormalen srčni ritem.
Do not use Tamiflu powder for oral suspension after the expiry date which is stated on the carton and bottle after EXP.
Peroralne suspenzije zdravila Tamiflu ne uporabljajte po datumu izteka roka uporabnosti, ki je označen na škatli in steklenici poleg oznake Uporabno do in EXP.
91 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
- The active substance is oseltamivir phosphate (12 mg/ml oseltamivir after reconstitution).
- Zdravilna učinkovina je oseltamivirjev fosfat (12 mg/ ml oseltamivirja po rekonstituciji).
- The other ingredients are sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum
- Druge pomožne snovi so sorbitol (E420), natrijev dihidrogencitrat (E331[ a]), ksantanski gumi
(E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and flavour.
(E415), natrijev benzoat (E211), natrijev saharinat (E954), titanov dioksid (E171) in aroma.
Tamiflu 12 mg/ml powder for oral suspension is available in a bottle containing 30 g powder for mixing with 52 ml of water.
Prašek za peroralno suspenzijo zdravila Tamiflu 12 mg/ ml je na voljo v steklenici, ki vsebuje 30 g praška za mešanje z 52 ml vode.
The box also contains 1 plastic measuring cup (52 ml), 1 plastic bottle adapter (to help get the drug into the dispenser) and 1 plastic oral dispenser (to give the correct amount of medicine via the mouth).
Škatla vsebuje tudi plastično merilno čašo (52 ml), plastični nastavek za steklenico (da lažje damo zdravilo v odmernik) in plastični peroralni odmernik (za natančno odmerjanje zdravila v usta).
Shown on the oral dispenser are marks for 30 mg, 45 mg and 60 mg of the medicine (see figures 1 and 2 above).
Na peroralnem odmerniku so oznake za 30 mg, 45 mg in 60 mg zdravila (glejte zgornji sliki 1 in 2).
For details on how to prepare the oral suspension and how to measure and take the medicine, read section 3, “How to take Tamiflu”.
Kako jemati zdravilo Tamiflu.
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
95 Norge Deutschland Roche Norge AS Roche Pharma AG Tlf: +47 - 22 78 90 00 Tel: +49 (0) 7624 140
93 This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno {MM/ LLLL}
94
96
Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Tandemact je zdravilo, ki vsebuje dve zdravilni učinkovini: pioglitazon in glimepirid.
It is available as white, round tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Na voljo je v obliki belih okroglih tablet (30 mg pioglitazona in 2 ali 4 mg glimepirida oziroma 45 mg pioglitazona in 4 mg glimepirida).
Tandemact is used to treat adult patients who have type 2 diabetes (also known as non-insulin- dependent diabetes).
Tandemact se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2 (znano tudi kot od insulina neodvisna sladkorna bolezen).
It is used in patients for whom metformin (a type of anti-diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances, pioglitazone and glimepiride.
Uporablja se pri bolnikih, za katere metformin (vrsta zdravila proti sladkorni bolezni) ni primeren in ki so že bili zdravljeni s kombinacijo tablet, ki vsebujejo dve zdravilni učinkovini, pioglitazon in glimepirid.
Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i. e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Bolniki, ki jemljejo pioglitazon skupaj z drugim zdravilom iz istega razreda, kot je glimepirid (npr. drugo sulfonilsečnino), morajo s te druge sulfonilsečnine najprej preiti na glimepirid, preden lahko začnejo uporabljati zdravilo Tandemact.
Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Bolniki, pri katerih se je pojavila hipoglikemija (nizke ravni krvnega sladkorja), ko so jemali zdravilo Tandemact, bodo morda morali vzeti nižji odmerek ali se vrniti k uporabi ločenih tablet.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze (sladkorja) v krvi ali pri kateri telo ne more učinkovito izrabiti insulina.
Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Glimepirid je sulfonilsečnina: spodbuja trebušno slinavko, da proizvede več insulina.
As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Kot posledica delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, to pa prispeva k nadzoru sladkorne bolezni tipa 2.
Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Ker je pioglitazon v Evropski uniji (EU) odobren od leta 2000 pod imenom Actos in ker se glimepirid že uporablja v odobrenih zdravilih v EU, je družba predložila podatke iz predhodnih študij in iz objavljene literature.
Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Zdravilo Actos je odobreno za uporabo skupaj s sulfonilsečnino pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče doseči zadovoljivega nadzora.
The company used three studies to support the use of Tandemact in the same indication.
Družba je v podporo uporabi zdravila Tandemact za isto indikacijo predložila tri študije.
The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
V študije je bilo vključenih 1390 bolnikov, ki so dodajali pioglitazon svojemu že obstoječemu zdravljenju s sulfonilsečnino.
The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Študije so trajale od štiri mesece do dve leti in so merile raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Družba je predložila dokaze, da je bila raven zdravilne učinkovine v krvi enaka pri osebah, ki so jemale zdravilo Tandemact, in pri osebah, ki so jemale ločene tablete.
In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
V vseh treh študijah se je pri bolnikih, ki so uporabljali kombinacijo pioglitazona in sulfonilsečnine, izboljšal nadzor glukoze v krvi.
The patients’ HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Bolnikove ravni HbA1c so od izhodiščne vrednosti nad 7, 5% padle za med 1, 22 in 1, 64%.
At least 64% of the patients treated were classified as ‘ responders’, since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Vsaj 64% zdravljenih bolnikov je bilo razvrščenih med „ odzivne bolnike “, ker so njihove ravni Hb1Ac med trajanjem študije padle za vsaj 0, 6% od izhodiščne vrednosti, ali pa so bile njihove ravni HbA1c ob koncu študije 6, 1% ali manj.
The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are weight gain, dizziness, flatulence (gas) and oedema (swelling).
Najpogostejši neželeni učinki zdravila Tandemact (opaženi pri 1 do 10 bolnikih izmed 100) so povečanje telesne mase, omotica, napenjanje (vetrovi) in edem (otekanje).
For the full list of all side effects reported with Tandemact, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tandemact, glejte navodilo za uporabo.
Tandemact should not be used in people who may be hypersensitive (allergic) to pioglitazone, glimepiride or any of the other ingredients, or to other sulphonylureas or to sulphonamides.
Zdravilo Tandemact se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) pioglitazon, glimepirid ali katero koli drugo sestavino zdravila, ali na druge sulfonilsečnine ali na sulfonamide.
It should not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Zdravila ne smejo jemati bolniki s srčnim popuščanjem, ter bolniki ki imajo težave z jetri ali huda obolenja ledvic.
It should not be used in patients with type 1 diabetes (insulin-dependent diabetes), patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breast-feeding.
Ne smejo ga uporabljati bolniki s sladkorno boleznijo tipa 1 (od insulina odvisna sladkorna bolezen), bolniki z zapletom sladkorne bolezni (diabetično ketoacidozo ali diabetično komo) ali nosečnice ali doječe matere.
Doses of Tandemact may need to be adjusted when given with some other medicines.
Odmerke zdravila Tandemact bo morda treba prilagoditi, ko se jemlje z nekaterimi drugimi zdravili.
The full list of these medicines is available in the Summary of Product Characteristics, which is also part of the EPAR.
Za celoten seznam teh zdravil glejte povzetek glavnih značilnosti zdravila, ki je prav tako del EPAR.
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bila učinkovitost pioglitazona in glimepirida pri zdravljenju sladkorne bolezni tipa 2 dokazana in da zdravilo Tandemact poenostavlja zdravljenje ter pomaga bolnikom, da ostanejo pri predvidenem zdravljenju, kadar je potrebna kombinacija dveh zdravilnih učinkovin.
The Committee decided that Tandemact’ s benefits are greater than its risks for the treatment of type 2 diabetes in patients who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Odbor je odločil, da so koristi zdravila Tandemact pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih, ki ne prenašajo metformina ali pri katerih je metformin kontraindiciran in ki se že zdravijo z kombinacijo pioglitazona in glimepirida, večje od z njim povezanih tveganj.
The Committee recommended that Tandemact be given marketing authorisation.
Zato je priporočil, da se za zdravilo Tandemact odobri dovoljenje za promet.
Other information about Tandemact:
Druge informacije o zdravilu Tandemact:
The European Commission granted a marketing authorisation valid throughout the EU for Tandemact to Takeda Global Research and Development Centre (Europe) Ltd on 8 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Tandemact, veljavno po vsej EU, odobrila družbi Takeda Global Research and Development Centre (Europa) Ltd dne 8. januarja 2007.
The full EPAR for Tandemact is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tandemact je na voljo tukaj.
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
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Tandemact 30 mg/ 2 mg tablets.
Tandemact 30 mg/ 2 mg tablete
Each tablet contains approximately 125 mg lactose monohydrate.
Vsaka tableta vsebuje približno 125 mg laktoze monohidrata.
White to off-white, round, convex and embossed ‘ 4833 G’ on one face and ‘ 30/ 2’ on the other.
Tablete so bele do umazano bele barve, okrogle, izbočene z oznako ‘ 4833 G ’ na eni strani in ‘ 30/ 2 ’ na drugi.
Tandemact is indicated for the treatment of patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
- Tandemact je indiciran za zdravljenje sladkorne bolezni tipa 2 pri bolnikih, ki kažejo
4.2 Posology and method of administration
intoleranco za metformin, ali pri bolnikih, pri katerih je metformin kontraindiciran in se že zdravijo s kombinacijo pioglitazona in glimepirida.
The tablets are taken orally once daily shortly before or with the first main meal.
Tablete se jemljejo peroralno enkrat na dan neposredno pred ali s prvim glavnim obrokom.
The tablets should be swallowed whole with some liquid.
Tablete je treba pogoltniti cele z nekaj tekočine.
If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered.
Če bolniki poročajo o hipoglikemiji, je treba odmerek Tandemacta znižati ali razmisliti o kombinacijski terapiji.
If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.
Bolnike, ki prejemajo pioglitazon v kombinaciji z drugimi sulfonilsečninami (razen glimepirida), je treba pred prehodom na Tandemact stabilizirati s hkratnim dajanjem pioglitazona in glimepirida.
Tandemact should not be used in patients with severe renal function disorders (creatinine clearance < 30 ml/ min, see section 4.3).
Tandemact se ne sme uporabljati pri bolnikih s hudo motnjo ledvičnega delovanja (očistek kreatinina < 30 ml/ min, glejte poglavje 4. 3).
Tandemact should not be used in patients with hepatic impairment (see section 4.3).
Tandemacta pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavje 4. 3).
Tandemact is not recommended for use in patients below age 18 due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba Tandemacta pri otrocih pod 18 leti ni priporočljiva.
Tandemact is contraindicated in patients with:
Tandemact je kontraindiciran pri:
- Hypersensitivity to the active substances, or to any of the excipients, or other sulphonylureas or
- preobčutljivosti za zdravilne učinkovine ali katerokoli pomožno snov ali druge sulfonilsečnine
sulphonamides
ali sulfonamide
- Cardiac failure or history of cardiac failure (NYHA stages I to IV)
- srčnemu popuščanju ali anamnezi srčnega popuščanja (klasifikacija NYHA, stadiji I do IV)
- Hepatic impairment
- oslabljenem delovanju jeter
- Type 1 diabetes mellitus
- sladkorni bolezni tipa 1