natgillin/translations-raw huggingface dataset:
In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).
Pri zdravljenju nestabilne angine pektoris in srčne kapi se zdravilo Inhixa daje v kombinaciji z aspirinom (acetilsalicilno kislino).
Why is Inhixa approved?
Zakaj je bilo zdravilo Inhixa odobreno?
For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Inhixa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In addition, a study in 20 healthy subjects has shown the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Poleg tega je študija pri 20 zdravih osebah z različnimi merili, ki kažejo na način delovanja zdravila v telesu, pokazala, da enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročijo podobne učinke na faktorje strjevanja krvi.
Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.
Obsežne laboratorijske študije, v katerih so zdravilo Inhixa primerjali z zdravilom Clexane, so pokazale, da je zdravilo Inhixa po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Clexane.
The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Zdravilna učinkovina v zdravilu Inhixa, enoksaparin, spada v skupino antikoagulacijskih zdravil, imenovanih „nizkomolekularni heparini“.
For the full list of all side effects reported with Inhixa, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Inhixa, glejte navodilo za uporabo.
• to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
• zdravljenje nestabilne angine pektoris (hude vrste bolečine v prsnem košu, ki je posledica oviranega pritoka krvi v srce);
The reference medicine for Inhixa is Clexane.
Referenčno zdravilo za zdravilo Inhixa je zdravilo Clexane.
Inhixa is available as a solution for injection in pre-filled syringes.
Zdravilo Inhixa je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
Doses must be adjusted in patients with severely reduced kidney function.
Pri bolnikih s hudo okvaro delovanja ledvic je treba odmerke prilagoditi.
Inhixa is a ‘biosimilar medicine'.
Zdravilo Inhixa je „podobno biološko zdravilo“.
How does Inhixa work?
Kako zdravilo Inhixa deluje?
How is Inhixa used?
Kako se zdravilo Inhixa uporablja?
It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood.
Pri zdravljenju določene vrste srčne kapi, imenovane akutni miokardni infarkt z dvigom spojnice ST (STEMI), se najprej da v obliki injekcije v veno.
The active substance in Inhixa is enoxaparin sodium.
Zdravilna učinkovina v zdravilu Inhixa je natrijev enoksaparinat.
In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).
Zelo pogost neželeni učinek (ki se lahko pojavi pri več kot 1 bolniku od 10) so zvišane ravni jetrnih encimov v krvi (znak možnih težav z jetri).
• to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;
zlasti pri bolnikih, pri katerih bo opravljen kirurški poseg ali ki jih strdki bolj ogrožajo, ker morajo zaradi bolezni ležati v postelji;
Anaerobes are generally less sensitive.
Anaerobi so na splošno manj občutljivi.
References (not all submitted are listed)
Reference (seznam ne vsebuje vseh predloženih referenc)
The treatment should be continued for at least three days after the signs of the infection have disappeared.
Zdravljenje mora trajati še vsaj tri dni po tem, ko so znaki okužbe izginili.
• children aged below 5 years
• otroci, mlajši od 5 let,
Adequate hydration must be ensured.
Zagotoviti je treba ustrezno hidracijo.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Kemično in fizikalno varnost uporabe so dokazali za 24 ur pri 25 °C.
To be used immediately after the bag is opened.
Uporabite takoj po odprtju vrečke.
It is advisable never to use several medicines at the same time without consulting your doctor first.
Ni priporočljivo, da sočasno uporabljate več zdravil, ne da bi se o tem najprej posvetovali z zdravnikom.
If a prolonged treatment is necessary, a reassessment of treatment should be done at 2 months at the latest.
Če je potrebno podaljšanje zdravljenja je ponovna ocena zdravljenja potrebna najpozneje pri 2 mesecih.
This condition is life-threatening and may have a fatal outcome.
To stanje je življenjsko nevarno in ima lahko smrtni izid;
Furthermore, you should drink a sufficient amount of liquid (about 1.5 - 2 litres daily).
Poleg tega morate piti zadostno količino tekočine (približno 1,5-2 litra na dan);
I-37063 Isola della Scala (VR), Italy
I-37063 Isola della Scala (VR), Italija
Very rare: psychotic reactions.
Zelo redki: psihotične reakcije.
Sequential therapy can also be used.
Uporabiti je mogoče tudi sekvenčno terapijo.
Mixing with other solutions: see sections 6.2 and 6.6.
Mešanje z drugimi raztopinami: glejte poglavji 6.2 in 6.6.
Therefore the bleeding time should be monitored.
zato je treba spremljati čas krvavitve;
During the referral procedure the Applicant/Marketing Authorisation Holder was requested to submit:
Med napotitvenim postopkom je moral vlagatelj/imetnik dovoljenja za promet predložiti:
In very rare cases these allergic reactions may lead to life-threatening shock.
V zelo redkih primerih lahko te alergijske reakcije povzročijo življenjsko nevaren šok;
This may lead to a prolongation of the bleeding time.
To lahko povzroči podaljšanje časa krvavitve.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki predstavljeni po padajoči resnosti.
• In this case the kidney function must be frequently (twice per week) monitored.
• V tem primeru je treba pogosto spremljati delovanje ledvic (dvakrat na teden);
The recommended duration of treatment is 10 - 14 days.
Priporočeno trajanje zdravljenja je 10 - 14 dni.
The patient should be monitored closely and treated symptomatically with supportive measures.
Bolnika je treba natančno nadzirati in ga simptomatsko zdraviti s podpornimi ukrepi.
Local reaction:
Lokalna reakcija:
Further intravenous administration is not contraindicated unless the reactions reoccur or worsen.
Nadaljnja intravenska uporaba ni kontraindicirana, v kolikor se reakcije ne ponovijo ali poslabšajo.
These events were observed predominantly among patients with further risk factors for QTc prolongation.
Ti dogodki so bili opaženi predvsem med bolniki z nadaljnimi faktorji tveganja za podaljšanje QTc intervala.
This may increase the risk of methotrexate associated toxic reactions.
To lahko poveča tveganje za pojav toksičnih reakcij povezanih z metotreksatom.
• Mycobacerium tuberculosis test.
• Test za bakterijo Mycobacerium tuberculosis.
If you suffer from dizziness, do not drive or operate machines, which require your full concentration.
Če imate omotico, ne vozite ali upravljajte strojev, ki zahtevajo popolno koncentracijo.
Before starting treatment - if you suffer or have suffered from one of the following diseases:
Pred začetkom zdravljenja - če imate ali ste imeli katero od naslednjih bolezni:
• you are pregnant or wish to become pregnant
• če ste noseči ali načrtujete nosečnost,
N-1753 Halden Norway
N-1753 Halden Norveška
During or after treatment - if one of the following conditions occurs:
Med ali po zdravljenju - če se pojavi katero od naslednjih stanj:
These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products.
Ta priporočila so usklajena s trenutno veljavnimi smernicami za zdravljenje, s klinično prakso v večini evropskih držav in s priporočili za že odobrene evropske originalne in generične izdelke, ki vsebujejo ciprofloksacin.
This medicine may cause these side effects, particularly if you are older or take a medicine of the socalled steroid group, such as hydrocortisone.
Zdravilo lahko povzroči te neželene učinke, predvsem če ste starejši ali jemljete zdravila iz tako imenovane steroidne skupine, kot je hidrokortizon.
Other studies comparing efficacy of low and higher dose ciprofloxacin showed superiority of the higher dose both in short term (1, 2) and long term efficacy (2).
Druge raziskave, v katerih so primerjali učinkovitost nižjih in višjih odmerkov ciprofloksacina, so pokazale prednost višjih odmerkov pri kratkoročni učinkovitosti (1, 2) kot tudi dolgoročni učinkovitosti (2).
Monitoring the level of active substance in the blood provides the most reliable basis for dose adjustment.
Spremljenje koncentracije zdravilne učinkovine v krvi daje najzanesljivejšo osnovo za prilagoditev odmerka.
Your doctor will monitor you for signs of methotrexate overdose.
Zdravnik vas bo spremljal za znake prevelikega odmerjanja metotreksata.
This may cause epileptic seizures.
To lahko povzroči epileptične napade;
• local reactions after administration of this medicine.
• Lokalne reakcije po uporabi tega zdravila.
Due to the increased risk of local reactions, higher intravenous doses in particular should only be administered via a large vein or a central line.
Zaradi povečanega tveganja za lokalne reakcije, je treba posebej večje intravenske odmerke aplicirati v veliko veno ali centralno linijo.
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 odpornosti za izbrane vrste se lahko razlikuje zemljepisno in časovno, zato so zaželeni lokalni podatki o odpornosti, zlasti za zdravljenje hudih okužb.
Depression or psychoses lead to self-endangering behaviour in some cases.
Depresija ali psihoze v nekaterih primerih povzročijo vedenje, ki ogroža bolnika samega.
Other xanthine derivatives
Drugi ksantinski derivati
An additional factor for consideration is the emergence of increasing ciprofloxacin resistance, particularly in the last 10-15 years.
Dodatni dejavnik, ki ga je treba upoštevati, je pojav naraščajoče odpornosti na ciprofloksacin, ki je še posebej prisoten v zadnjih 10-15 letih.
Physicians are recommended to follow current national and/or international consensus documents regarding the treatment of anthrax.
Zdravniki naj upoštevajo veljavne nacionalne in/ali mednarodne dokumente o soglasju glede zdravljenja antraksa.
The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
Vezava ciprofloksacina na beljakovine v plazmi je med 16 in 28 % ter ni odvisna od koncentracije in pH (določeno z ultrafiltracijo).
Use only clear solutions and undamaged containers.
Uporabite samo bistro raztopino in nepoškodovane vsebnike.
The above-mentioned substances are converted by a specific enzyme (CYP1A2).
Zgoraj omenjene učinkovine presnavlja poseben encim (CYP1A2).
Teratogenic effects have not been observed in animal experimental research.
V raziskavah na živalih niso ugotovili teratogenih učinkov.
When photosensibility occurs the treatment must be discontinued.
Če se pojavi fotosenzibilnost, je treba zdravljenje prekiniti.
• increased skin sensitivity to sunlight or UV light.
• Povečana občutljivost kože na sončno ali ultravijolično svetlobo.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Poročali so o odmerku 12 g, ki je privedel do blagih simptomov zastrupitve.
The frequency of side effects is classified into the following categories: Very common in more than 1 in 10 patients
Pogostnost neželenih učinkov je razvrščena v naslednje skupine: Zelo pogosti pri več kot 1 od 10 bolnikov
• cyclosporine (used to prevent rejection reactions after organ transplantations).
• Ciklosporin (uporablja se za preprečevanje reakcij zavrnitve po presaditvi organov).
These reactions may occcur particularly when the infusion time is 30 minutes or less.
Te reakcije se lahko pojavijo predvsem takrat, kadar je čas infundiranja 30 minut ali manj.
The MIC of the Bacillus anthrax strain that was applied in this study was 0.08 µg/ml.
MIK za sev bakterije Bacillus anthrax, uporabljen v tej študiji, je bila 0,08 µg/ml.
If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe you another medicine or to adjust the dose of Ciprofloxacin Kabi or the other medicine.
Če se kateri od zgoraj naštetih primerov nanaša na vas, se bo zdravnik morda odločil, da vam predpiše drugo zdravilo ali da vam prilagodi odmerek zdravila Ciprofloxacin Kabi ali drugega zdravila.
• allergic reactions after the first administration of this medicine.
• Alergijske reakcije po prvi uporabi zdravila.
If you are older than 65 years your doctor may prescribe you a dose based on your kidney function and severity of disease.
Če ste starejši od 65 let, vam bo zdravnik odmerek predpisal na podlagi delovanja ledvic in resnosti bolezni.
These reactions occur more frequently when the infusion time is 30 minutes or less.
Te reakcije so pogostejše, če je čas infundiranja 30 minut ali manj.
You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation.
Izogibajte se dolgi izpostavljenosti močni sončni svetlobi, solarijem ali drugim virom ultravijoličnega sevanja.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Posvetujte se s strokovnjakom v primeru, ko lokalna prevalence rezistence to zahteva, če je vprašljiva uporabnost učinkovine pri vsaj nekaterih tipih okužb.
Medical practice in the treatment of complicated UTI's with ciprofloxacin has developed and changed since the time of first licensing in 1987 and the proposed dosing is in line with current medical practice (5) and supported by the published literature.
Zdravstvena praksa zdravljenja zapletenih okužb sečil s ciprofloksacinom se je razvila in spremenila od tiste, ki je veljala v času prve podelitve licence leta 1987, predlagano odmerjanje pa je usklajeno s trenutno medicinsko prakso (5) in ga podpira tudi objavljena literatura.
Compatibility with these solutions has been proven in the dilution range of 1+1 and 1+4, corresponding to ciprofloxacin concentrations of 0.4 to 1 mg/ml.
Združljivost s temi raztopinami so dokazali pri redčenju 1+1 in 1+4, kar ustreza koncentracijam ciprofloksacina 0,4 do 1 mg/ml.
These may be manifested as local skin reactions, which rapidly disappear after the infusion has been completed.
Kažejo se lahko kot lokalne kožne reakcije, ki po koncu infundiranja hitro izginejo.
• certain lower respiratory tract infections including pneumonia
• določenih okužbah spodnjih dihal vključno s pljučnico
Osteomyelitis:
Osteomielitis:
Antiperistaltics are contraindicated.
Antiperistaltiki so kontraindicirani.
very common common uncommon rare very rare, including isolated reports
zelo pogosti pogosti občasni redki zelo redki, vključno s posameznimi primeri
The reconstituted solution is clear and colourless.
Rekonstituirana raztopina je bistra in brezbarvna.
Average duration of treatment can be 4-6 weeks.
Povprečno trajanje zdravljenja je 4 - 6 tednov.
Prior to initiation of therapy, bacteriological sensitivity tests should be conducted.
Pred začetkom zdravljenja je treba opraviti bakteriološke teste občutljivosti.
With respect to the maximal dose, the applicant reviewed 6 clinical studies addressing the safety and efficacy of the proposed high dose ciprofloxacin treatment regimens in critically ill patients.
Kar se tiče najvišjega odmerka, je vlagatelj pregledal 6 kliničnih raziskav, ki so preučevale varnost in učinkovitost predlaganih načinov zdravljenja z visokimi odmerki ciprofloksacina pri kritično bolnih bolnikih.
Unless compatibility is proven, the solution for infusion should always be administered separately (see also section 6.2).
Če združljivost ni dokazana, je treba raztopino za injiciranje vedno uporabljati posebej (glejte tudi poglavje 6.2).
Medicines should not be disposed via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
During the growth phase of bacteria, a partial rolling up and unfolding of chromosomes takes place.
Med fazo bakterijske rasti pride do delnega zvitja in razvitja kromosomov.
See leaflet for further information.
Glejte navodilo za uporabo za nadaljnje informacije.
• myastenia gravis (a particular type of muscle weakness).
• Miastenija gravis (posebna vrsta mišične šibkosti).
From a microbiological point of view, the product should be used immediately.
Zaradi možne mikrobiološke kontaminacije je treba raztopino uporabiti takoj.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN KABI AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CIPROFLOXACIN KABI IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
Therefore, the serum creatinine concentration must be checked regularly (twice per week) in these patients.
Pri takšnih bolnikih je zato treba redno (dvakrat na teden) kontrolirati koncentracijo kreatinina.
Ciprofloxacin Kabi is an antibiotic.
Ciprofloxacin Kabi je antibiotik.
Using other medicines If Ciprofloxacin Kabi and one of the following medicines are given at the same time, special care should be taken:
Uporaba drugih zdravil Če se zdravilo Ciprofloxacin Kabi in eno od naslednjih zdravil uporabljata sočasno, je treba biti posebno previden:
Fresenius Kabi AB SE-75174 Uppsala Sweden
Fresenius Kabi AB SE-75174 Uppsala Švedska
altered vision such as double vision (diplopia) and seeing all objects in a certain colour (chromatopsia)
spremembe vida, npr. dvojni vid (diplopija) ali videnje vseh stvari v določeni barvi (kromatopsija)
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient's compliance and dosing need to be adequate.
Da bi se izognili pojavu odpornosti in neuspehu pri zdravljenju, sta predpogoja za zdravljenje primerno sodelovanje bolnika in ustrezno odmerjanje.
Characteristics in patients:
Značilnosti pri bolnikih:
• crystalluria (presence of crystals in the urine with discomfort when passing urine).
• Kristalurija (prisotnost kristalov v urinu z neudobjem pri uriniranju).
In this case consult your doctor as your urine needs to be tested.
V tem primeru se posvetujte z zdravnikom, saj je treba preiskati urin.
If these reactions recur or exacerbate during a following infusion no further infusions should be administered.
Če se te reakcije ponovijo ali poslabšajo pri naslednjem infundiranju, se nadaljnjega infundiranja ne sme opraviti;
Signs of anaemia are a feeling of weakness and in more severe cases breathlessness and pale skin.
Znaki anemije so občutek šibkosti in pri hujših primerih kratka sapa in bledica.
The enzyme DNA-gyrase plays a crucial role in this process.
Ključno vlogo v tem dogajanju ima encim DNA-giraza.
All metabolites are active, but in a lesser degree than ciprofloxacin.
Vsi presnovki so aktivni, vendar manj kot ciprofloksacin.
The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.
Trajanje zdravljenje je odvisno od resnosti okužbe, kliničnega odziva in bakterioloških raziskav.
If such reactions occur, a physician must immediately be consulted.
Če se pojavijo takšne reakcije, se je treba takoj posvetovati z zdravnikom.
There is a linear correlation between dose on the one hand and plasma concentration and AUC on the other.
Obstaja linearna korelacija med odmerkom na eni strani ter koncentracijo v plazmi in AUC na drugi strani.
In patients with severely impaired renal function (creatinine clearance <30 ml/min) the elimination half-life may be prolonged by a factor of 2.
Pri bolnikih z zelo okvarjenim delovanjem ledvic (očistek kreatinina < 30 ml/min) je eliminacijski razpolovni čas lahko podaljšan za faktor 2.
Species for which acquired resistance may be a problem Gram-positive aerobes
Vrste za katere je pridobljena rezistenca lahko problematična
The daily dose of 1200 mg should not however be exceeded.
Vendar pa dnevni odmerek ne bi smel preseči 1200 mg.
Ciprofloxacin is mainly excreted unchanged.
Ciprofloksacin se v glavnem izloči nespremenjen.
Central nervous system:
Centralni živčni sistem:
If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Če je treba se odmerek antikoagulanta prilagodi po potrebi.
The treatment of acute pulmonary infections in children and adolescents with cystic fibrosis will take 10-14 days.
Zdravljenje akutnih pljučnih okužb pri otrocih in mladostnikih s cistično fibrozo bo trajalo 10-14 dni.
Rare: photosensibility.
Redki: fotosenzibilnost.
However the published data presented demonstrated the safety and efficacy of high-dose ciprofloxacin (daily dose of 1200 mg IV [or 1500 mg peroral]) with or without an option to oral switch, in various serious and life threatening infections.
Kljub temu pa so predloženi podatki pokazali varnost in učinkovitost visokih odmerkov ciprofloksacina (dnevni odmerek 1200 mg intravensko [ali 1500 mg peroralno]) z ali brez možnosti prehoda na peroralno uporabo pri različnih resnih in življenjsko nevarnih okužbah.
This relatively high distribution volume indicates an effective tissue and fluid penetration.
Sorazmerno velik volumen porazdelitve kaže na učinkovito prodiranje v tkiva in tekočine.
In case of mixed infections with anaerobes ciprofloxacin must be combined with other antibiotics effective against anaerobes.
V primeru mešanih okužb z anaerobi je treba ciprofloksacin kombinirati z drugimi antibiotiki, učinkovitimi proti anaerobom.
Because the MIC90 for ciprofloxacin of 70 other Bacillus anthrax strains varied between 0.03-0.06 µg/ml, it seems likely that ciprofloxacin would also be effective in other strains than the one that was applied in this study.
Ker je bila MIK90 ciprofloksacina za 70 drugih sevov bakterije Bacillus anthrax od 0,03 do 0,06 µg/ml, bi bil ciprofloksacin verjetno učinkovit tudi pri drugih sevih od tistega, ki je bil uporabljen v tej študiji.
The bioavailability is lower if antacids that contain aluminium and/or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Biološka uporabnost je manjša, če so sočasno uporabljeni antacidi, ki vsebujejo aluminijev in/ali magnezijev hidroksid, ali soli kalcija ali železa.
The undesirable effects sometimes occur already after the first administration of ciprofloxacin.
Neželeni učinki se včasih pojavijo že po prvi uporabi ciprofloksacina.
They may take the form of local skin reactions, such as reddening of the skin, irritation or pain, which usually disappear quickly after termination of the infusion.
Lahko se pojavijo v obliki lokalnih kožnih reakcij, kot so rdečica kože, razdraženost ali bolečina, ki navadno izginejo hitro po prenehanju infundiranja.
In case of very serious, life-threatening or recurrent infections the dosage can be increased to 400 mg three times daily.
V primeru zelo resnih, smrtno nevarnih ali ponavljajočih se okužb, je mogoče odmerek zvišati na 400 mg trikrat na dan.
This has to be taken into consideration for patients on a controlled sodium diet.
To je potrebno upoštevati pri bolnikih, ki so na dieti z malo natrija.
These side effects occur predominantly in patients at risk for certain heart disorders.
Ti neželeni učinki se večinoma pojavijo pri bolnikih s tveganjem za nekatere srčne bolezni.