natgillin/translations-raw huggingface dataset:
The study showed that Somatropin Biopartners was as effective as Genotropin at promoting growth: children receiving Somatropin Biopartners grew around 11.7 cm in one year, compared with 12.0 cm in children receiving Genotropin.
Študija je pokazala, da je bilo zdravilo Somatropin Biopartners pri spodbujanju rasti enako učinkovito kot Genotropin: otroci, ki so prejemali zdravilo Somatropin Biopartners, so v enem letu zrasli za približno 11,7 cm, otroci, ki so prejemali zdravilo Genotropin, pa za 12,0 cm.
What measures are being taken to ensure the safe and effective use of Somatropin Biopartners?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Somatropin Biopartners?
A risk management plan has been developed to ensure that Somatropin Biopartners is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Somatropin Biopartners je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Somatropin Biopartners, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Somatropin Biopartners vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The patient or caregiver can inject Somatropin Biopartners themselves, after training by a doctor or a nurse.
Bolnik ali njegov negovalec lahko zdravilo Somatropin Biopartners injicira sam, potem ko ga o tem pouči zdravnik ali medicinska sestra.
It is also used in adults with a lack of growth hormone who may have either had growth hormone deficiency as children or developed it later during adulthood.
Uporablja se tudi pri odraslih s pomanjkanjem rastnega hormona, ki se je pojavilo v otroštvu ali pozneje v odrasli dobi.
In adults who lack growth hormone, Somatropin Biopartners has a modest effect in decreasing body fat.
Pri odraslih s pomanjkanjem rastnega hormona ima zdravilo Somatropin Biopartners zmeren učinek na zmanjšanje telesne maščobe.
Adults treated with Somatropin Biopartners had an average reduction of body fat of 1 kg while body fat in those treated with placebo increased by 0.5 kg.
Pri odraslih, ki so prejemali zdravilo Somatropin Biopartners, so zabeležili povprečno zmanjšanje telesne maščobe za 1 kg, medtem ko so pri odraslih, ki so prejemali placebo, zabeležili povečanje za 0,5 kg.
The study compared Somatropin Biopartners given once a week with another somatropin-containing medicine called Genotropin given once a day.
V študiji so primerjali zdravilo Somatropin Biopartners, dano enkrat na teden, z drugim zdravilom, ki vsebuje somatropin in se imenuje Genotropin, danim enkrat na dan.
In children, the most common side effects with Somatropin Biopartners (which may affect more than 1 in 10 people) are injection site swelling and development of antibodies (proteins that are produced in response to Somatropin Biopartners).
Pri otrocih so najpogostejši neželeni učinki zdravila Somatropin Biopartners (ki se lahko pojavijo pri več kot 1 od 10 oseb) oteklina na mestu injiciranja in razvoj protiteles (beljakovin, ki se tvorijo kot odziv na zdravilo Somatropin Biopartners).
It is produced by a method known as ‘recombinant DNA technology': the hormone is made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce it. Somatropin Biopartners replaces the natural hormone.
Proizvaja se z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri hormon izdelajo celice kvasovk, v katere so vstavili gen (DNK), s pomočjo katerega ga celice lahko tvorijo.
For more information about treatment with Somatropin Biopartners, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Somatropin Biopartners preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This study compared Somatropin Biopartners with placebo (a dummy treatment) and measured the decrease in body fat (which is normally high in adults with growth hormone deficiency) after 6 months of treatment.
V študiji so zdravilo Somatropin Biopartners primerjali s placebom (zdravilom brez zdravilne učinkovine) in merili zmanjšanje telesne maščobe (ki je običajno visoka pri odraslih s pomanjkanjem rastnega hormona) po 6 mesecih zdravljenja.
Regarding its safety, the side effects reported with Somatropin Biopartners were similar to those of other daily somatropin medicines, with the exception of increased injection site reactions in children, which should be balanced against the convenience of weekly injections.
V zvezi z njegovo varnostjo so bili neželeni učinki, o katerih so poročali pri zdravilu Somatropin Biopartners, podobni učinkom drugih zdravil, ki vsebujejo somatropin in se dajejo dnevno, razen povečanih reakcij na mestu injiciranja pri otrocih, kar je treba odtehtati s priročnostjo tedenskega injiciranja.
The active substance in Somatropin Biopartners, somatropin, is identical to the human growth hormone.
Zdravilna učinkovina v zdravilu Somatropin Biopartners, somatropin, je identična človeškemu rastnemu hormonu.
Somatropin Biopartners is available as a powder and solvent which are made into a suspension for injection.
Zdravilo Somatropin Biopartners je na voljo v obliki praška in vehikla za pripravo suspenzije za injiciranje.
The Committee concluded that Somatropin Biopartners is as effective in children who fail to grow normally as other somatropin-containing treatments given daily.
Odbor je zaključil, da je zdravilo Somatropin Biopartners pri otrocih, ki ne rastejo ustrezno, enako učinkovito kot druga zdravila, ki vsebujejo somatropin in se dajejo dnevno.
For practical information about using Somatropin Biopartners, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Somatropin Biopartners naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Somatropin Biopartners has also been studied in one main study involving 151 adults with growth hormone deficiency.
Zdravilo Somatropin Biopartners so preučevali tudi v eni glavni študiji, v katero je bilo vključenih 151 odraslih s pomanjkanjem rastnega hormona.
Other information about Somatropin Biopartners
Druge informacije o zdravilu Somatropin Biopartners
Somatropin Biopartners has been studied in one main study involving 180 children with a lack of growth hormone.
Zdravilo Somatropin Biopartners so preučevali v eni glavni študiji, v katero je bilo vključenih 180 otrok s pomanjkanjem rastnega hormona.
What is Somatropin Biopartners and what is it used for?
Kaj je zdravilo Somatropin Biopartners in za kaj se uporablja?
For the full list of all side effects reported with Somatropin Biopartners, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Somatropin Biopartners, glejte navodilo za uporabo.
Treatment with Somatropin Biopartners should be started and monitored by a doctor experienced in diagnosing and treating patients with growth hormone deficiency.
Zdravljenje z zdravilom Somatropin Biopartners lahko uvede in spremlja le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov s pomanjkanjem rastnega hormona.
Growth hormone is a substance secreted by the pituitary gland (a gland located at the base of the brain).
Rastni hormon je snov, ki jo izloča hipofiza (žleza, ki se nahaja na možganskem dnu).
What are the risks associated with Somatropin Biopartners?
Kakšna tveganja so povezana z zdravilom Somatropin Biopartners?
What benefits of Somatropin Biopartners have been shown in studies?
Kakšne koristi je zdravilo Somatropin Biopartners izkazalo v študijah?
Why is Somatropin Biopartners approved?
Zakaj je bilo zdravilo Somatropin Biopartners odobreno?
How is Somatropin Biopartners used?
Kako se zdravilo Somatropin Biopartners uporablja?
It is not intended to provide practical advice on how to use Somatropin Biopartners.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Somatropin Biopartners work?
Kako zdravilo Somatropin Biopartners deluje?
Your doctor will decide if this
Vaš zdravnik bo presodil, ali je to
Neither of these findings is of clinical relevance.
Nobena od teh ugotovitev ni klinično pomembna.
Discard open tubes 7 days after opening, even if they are not empty.
Tube zavrzite 7 dni po prvem odprtju, tudi če še niso prazne.
Re-evaluation of treatment
Ponovna ocena zdravljenja
Patients aged from 2 months to 24 months
Bolniki v starosti od 2 do 24 mesecev
Confidence interval was not adjusted for multiplicity.
Interval zaupanja ni bil prilagojen za raznolikost.
CI: confidence interval.
IZ: interval zaupanja.
It may harm them,
površine;
Hypersensitivity, including angioedema
Preobčutljivost, vključno z angioedemom
If the patient is a child less than two years old it is especially important that you tell your doctor about any other medicines that the child is being given, including medicines bought without a prescription.
Če je bolnik otrok, mlajši od dveh let, je še posebej pomembno, da zdravniku poveste za vsa druga zdravila, ki jih otrok dobiva, tudi za tista, ki so bila kupljena brez recepta.
Currently available data are described in section 5.2, but no recommendation on a
Podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, a priporočil za odmerjanje ni
They should not be kept for future use.
Ne smete jih shraniti za poznejšo uporabo.
Consideration should be given to official guidance on the appropriate use of antibacterial medicinal
Upoštevati je treba uradne smernice za ustrezno uporabo protibakterijskih zdravil.
Tell your doctor if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katerokoli drugo zdravilo.
95% Exact CI
95% natančen IZ
See also section 4 of this leaflet.
Glejte tudi poglavje 4 tega navodila.
In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
Pri bolnikih, ki so mlajši od 18 let, celotna zdravljena površina ne sme preseči 2 % telesne površine.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area.
Ne smete ga vnašati v oči, usta ali na ustnice, v notranjost nosu ali ženskih spolovil.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ‘EXP'.
Exact CI is calculated using the F-distribution method.
Natančen IZ je izračunan z metodo F-porazdelitve.
Date of first authorisation: 24 May 2007 Date of latest renewal: 20 April 2012
Datum zadnjega podaljšanja: 20. april 2012
Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine
Odrasli (stari od 18 do 65 let), mladostniki (stari od 12 do 17 let), dojenčki in otroci (stari od devet
Carton of 12 sachets.
Škatla z 12 vrečicami.
If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).
Če ste alergični na retapamulin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
However, due to the low systemic plasma levels that have been observed, no safety problems are foreseen.
Zaradi majhnih sistemskih plazemskih vrednosti, ki so bile opažene, težav z varnostjo ne pričakujemo.
In vitro, three mechanisms have been identified which reduce susceptibility to retapamulin.
In vitro so odkrili tri mehanizme, ki zmanjšujejo občutljivost za retapamulin.
Short term treatment of the following superficial skin infections in adults, adolescents, infants and children (aged from nine months) (see section 5.1):
Kratkotrajno zdravljenje naslednjih povrhnjih okužb kože pri odraslih, mladostnikih, dojenčkih in otrocih (od devetega meseca starosti naprej) (glejte poglavje 5.1):
Other medicines and Altargo
Druga zdravila in zdravilo Altargo
4.7 Effects on ability to drive and use machines Altargo has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Altargo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Any remaining ointment at the end of treatment should be discarded.
Mazilo, ki ostane po koncu zdravljenja, je treba zavreči.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
Bolnike, pri katerih v dveh do treh dneh ni kliničnega izboljšanja, je treba ponovno pregledati in po presoji uvesti alternativno zdravljenje (glejte poglavje 4.4).
If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments.
V primeru suma na superinfekcijo z neobčutljivim organizmom je treba zdravljenje usmerjati glede na klinične in mikrobiološke izvide.
$: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%)
: delež odziva za MRSA zaradi PVL+ MRSA je bil 8/13 (62 %)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden uporabite to zdravilo.
Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
Pri odraslih je bila opažena minimalna sistemska izpostavljenost, zato je verjetnost za izpostavljenost dojenega otroka malenkostna.
Wash your hands before and after applying the ointment.
Pred in po nanosu mazila si umijte roke.
If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.
Če opazite kakršnokoli poslabšanje okužbe ali pojav močnejše rdečine, draženja ali druge znake in simptome na mestu nanosa , morate zdravilo Altargo prenehati uporabljati in o tem obvestiti svojega zdravnika.
• Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.
• okužene spremembe, daljše od 10 cm ali s skupno površino > 100 cm2.
Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.
Pediatrična populacija Pogostnost, vrsta in izrazitost neželenih učinkov v pediatrični populaciji so enake kot pri odraslih.
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Prevalenca pridobljene odpornosti določenih vrst se lahko razlikuje tako glede na geografsko področje kot čas, zato je najprimernejša uporaba lokalnih podatkov o odpornosti, še posebej pri zdravljenju hudih okužb.
The following convention has been used for the classification of frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available
Pogostnost je navedena v skladu z naslednjim dogovorom: Zelo pogosti (> 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (> 1/10.000
* Activity has been satisfactorily demonstrated in clinical studies
* v kliničnih študijah je bila učinkovitost zadovoljiva.
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for
Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, antibiotiki za lokalno zdravljenje.
If you accidentally use Altargo inside your nose you could have a nose bleed.
Če zdravilo Altargo pomotoma uporabite v nosu, se vam lahko pojavi krvavitev iz nosu.
If you stop using Altargo too soon, the bacteria may start to grow again and your infection may come back.
Če ste prenehali uporabljati zdravilo Altargo Če zdravilo Altargo prenehate uporabljati prezgodaj, lahko bakterije znova začnejo rasti in okužba se lahko ponovi.
Abscesses
Abscesi
In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the
V primeru pojava preobčutljivosti ali hudega lokalnega draženja zaradi uporabe retapamulina v obliki mazila je treba zdravljenje prekiniti, mazilo previdno obrisati in uvesti primerno alternativno
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the
Pri odločanju o nadaljevanju/prekinitvi dojenja ali nadaljevanju/prekinitvi zdravljenja z zdravilom Altargo je treba upoštevati tako korist dojenja za otroka kot korist zdravljenja z zdravilom Altargo za mater.
Keep using Altargo for as long as your doctor advises.
Zdravilo Altargo uporabljajte tako dolgo, kot vam je svetoval zdravnik.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1. .
The reason for the reduced clinical efficacy observed in
Vzrok za manjšo klinično učinkovitost pri teh
Prolonged use and overgrowth of non-susceptible micro-organisms Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.
Dolgotrajna uporaba in prekomerna rast neobčutljivih mikroorganizmov Dolgotrajna uporaba retapamulina lahko povzroči prekomerno rast neobčutljivih mikroorganizmov,
What Altargo is and what it is used for What you need to know before you use Altargo
Kaj je zdravilo Altargo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Altargo
No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.
Študije, ki bi ovrednotile vpliv retapamulina na pre-/postnatalni razvoj, niso bile izvedene.
Altargo is not expected to affect your ability to drive or use machines.
Ni pričakovati, da bi zdravilo Altargo vplivalo na vašo sposobnost upravljanja vozil in strojev.
If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort.
Če mazilo po nesreči pride v stik s temi področji, področje sperite z vodo in se v primeru težav posvetujte s svojim zdravnikom.
What you need to know before you use Altargo
Kaj morate vedeti, preden boste uporabili zdravilo Altargo
However, when adjusted for baseline wound characteristics including pathogen, wound size and severity, the clinical success rate of retapamulin was superior to placebo for the primary efficacy endpoint (p=0.0336).
Po prilagoditvi na izhodiščne značilnosti rane, vključno s patogenom, velikostjo rane in resnostjo, je bila klinična uspešnost retampulina glede na primarno končno točko za učinkovitost superiorna v primerjavi s placebom (p = 0,0336).
What Altargo is and what it is used for
Kaj je zdravilo Altargo in za kaj ga uporabljamo
Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple
Zdi se, da pleuromutilini zavirajo sintezo bakterijskih proteinov na več načinov.
Apply the ointment as soon as you remember, and apply the next dose at the usual time.
Naslednji odmerek nanesite ob običajnem času.
One involves mutations in ribosomal protein L3, the second is a non-specific efflux mechanism (ABC transporter vgaAv).
Eden vključuje mutacije ribosomskega proteina L3, drugi pa nespecifični mehanizem prenosa (ABC-prenašalec vgaAv).
Do not stop using this medicine before talking to your doctor or pharmacist.
Ne prenehajte uporabljati tega zdravila, ne da bi se pred tem posvetovali s svojim zdravnikom ali s farmacevtom.
However, in the two studies that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%).
V dveh študijah, ki sta vključevali bolnike s sekundarnimi okužbami odprtih ran, pa je bila učinkovitost retapamulina pri okužbah z MRSA nezadostna (75,7 %).
The following side effects have occurred on the skin where Altargo has been applied: Common side effects (may affect up to 1 in 10 people):
Naslednji neželeni učinki so se pojavili na predelu kože, kjer je bilo naneseno zdravilo Altargo: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 oseb):
Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).
Retapamulin je polsintetični derivat pleuromutilina, izoliranega pri fermentaciji glive Clitopilus passeckerianus (prej imenovane Pleurotus passeckerianus).
The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may have been influenced by the presence of a particular MRSA clone.
Vzrok za manjšo klinično učinkovitost proti MRSA pri sekundarnih okužbah odprtih ran ni jasen in je lahko posledica prisotnosti določenega klona MRSA.
ITTC- Intent to Treat Clinical Primary Efficacy Population; PPC -Per Protocol Clinical Primary Efficacy population; ITTB- Intent to Treat Bacteriological evaluable, Primary Efficacy Population; PPB - Per Protocol Bacteriologically evaluable, Primary Efficacy Population.
ITTC - populacija za primarno klinično učinkovitost, ki so jo nameravali zdraviti; PPC - populacija za primarno klinično učinkovitost, skladna s protokolom; ITTB - populacija za primarno klinično učinkovitost, ki so jo nameravali zdraviti in pri kateri je bila mogoča bakteriološka ocena; PPB - populacija za primarno klinično učinkovitost, skladna s protokolom, pri kateri je bila mogoče bakteriološka ocena.
Altargo is used to treat bacterial infections affecting small areas of skin.
Zdravilo Altargo uporabljamo za zdravljenje bakterijskih okužb na manjših predelih kože.
The study failed to meet the primary end point which was the clinical success rate at follow-up (day 12 - 14) for subjects in the Intent to Treat Clinical
Študija ni dosegla primarne končne točke, ki je bila delež klinične uspešnosti med spremljanjem (od 12. do 14. dneva) pri preizkušancih v skupini, ki so jo nameravali zdraviti (glejte spodnjo tabelo).
Application site irritation (including burning sensation)
Draženje na mestu uporabe (vključno s pekočim občutkom)
The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ml).
Večina vzorcev (89 %) je bila pod mejo dokazljivosti (0,5 ng/ml).