natgillin/translations-raw huggingface dataset:
If you miss a dose of Viread, take it as soon as you can, and then take your next dose at its regular time.
Če ste pozabili vzeti odmerek zdravila Viread, ga vzemite čim prej in nato vzemite naslednji odmerek ob običajnem času.
• Don’t stop taking Viread without your doctor’s advice.
• Ne prenehajte jemati zdravila Viread, ne da bi se posvetovali z zdravnikom.
Talk to your doctor before you stop taking Viread for any reason, particularly if you are experiencing any side effects or you have another illness.
Preden prenehate jemati zdravilo Viread iz kateregakoli razloga, se pogovorite z zdravnikom, še zlasti če imate kakršnekoli neželene učinke ali kakšno drugo bolezen.
• If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Viread treatment without talking to your doctor first.
• Če ste okuženi s hepatitisom B ali sočasno okuženi z virusom HIV in hepatitisom B, je zelo pomembno, da ne prenehate z zdravljenjem z zdravilom Viread, ne da bi se prej posvetovali z zdravnikom.
Like all medicines, Viread can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Viread neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (These can affect at least 10 in every 100 patients)
Zelo pogosti neželeni učinki (Prizadenejo lahko najmanj 10 od 100 bolnikov)
• diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness
• driska, bruhanje, slabost, omotičnost
Common side effects (These can affect up to 10 in every 100 patients)
Pogosti neželeni učinki (Prizadenejo lahko do 10 na 100 bolnikov)
• headache, stomach pain, feeling tired, feeling bloated, flatulence
• glavobol, bolečine v trebuhu, utrujenost, občutek napihnjenosti, napenjanje
33 Rare side effects (These can affect up to 1 in every 1,000 patients)
33 Redki neželeni učinki (Prizadenejo lahko do 1 od 1. 000 bolnikov)
• excess lactic acid in the blood (lactic acidosis, a serious side effect that can be fatal).
• povečana količina mlečne kisline v krvi (laktacidoza, resen neželeni učinek, ki je lahko usoden).
deep rapid breathing drowsiness feeling sick (nausea), being sick (vomiting) and stomach pain
globoko, hitro dihanje dremavost slabost, bruhanje in bolečine v trebuhu
• rash
• izpuščaj
Very rare side effects (These can affect less than 1 in every 10,000 patients)
Zelo redki neželeni učinki (Prizadenejo lahko manj kot 1 na vsakih 10. 000 bolnikov)
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Razpad mišičnega tkiva, mehčanje kosti (z bolečinami v kosteh, včasih tudi zlom), bolečine v mišicah, mišična oslabelost in zmanjšanje količine kalija ali fosfatov v krvi se lahko pojavi zaradi okvare celic ledvičnih tubulov.
In the treatment of HIV, combination antiretroviral therapy (including Viread) may change your body shape, by changing the way body fat is distributed.
Pri zdravljenju okužbe z virusom HIV lahko kombinirano protiretrovirusno zdravljenje (vključno z zdravilom Viread) povzroči spremembe telesne oblike zaradi sprememb v razporeditvi maščob.
You may lose fat from your legs, arms and face; gain fat around the tummy (abdomen) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’).
Izgubite lahko maščevje na nogah, rokah in obrazu; pridobite maščevje na trebuhu in notranjih organih; lahko se vam povečajo prsi ali maščobna bula na tilniku (“ bivolja grba ”).
In the treatment of HIV, combination antiretroviral therapy may also cause increased fats in the blood (hyperlipaemia) and resistance to insulin.
34 Pri zdravljenju okužbe z virusom HIV lahko kombinirano protiretrovirusno zdravljenje povzroči povišano količino maščob v krvi (hiperlipidemijo) in odpornost na insulin.
34 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE VIREAD
SHRANJEVANJE ZDRAVILA VIREAD
Do not use Viread after the expiry date which is stated on the bottle and carton after {EXP}.
Zdravila Viread ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatlici poleg oznake {Uporabno do}.
- The active substance is tenofovir.
- Zdravilna učinkovina je tenofovir.
Each Viread tablet contains 245 mg of tenofovir disoproxil
Ena tableta zdravila Viread vsebuje 245 mg
(in the form of 300 mg tenofovir disoproxil fumarate), equivalent to 136 mg of tenofovir.
tenofovirdizoproksila (v obliki 300 mg tenofovirdizoproksil fumarata), kar je ekvivalentno 136 mg tenofovirja.
- The other ingredients are microcrystalline cellulose (E460), pregelatinised starch (gluten free),
- Pomožne snovi so mikrokristalna celuloza (E460), predgelirani škrob (brez glutena),
croscarmellose sodium, lactose monohydrate, and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glycerol triacetate (E1518) and indigo carmine aluminium lake (E132) which make up the tablet coating.
premreženi natrijev karmelozat, laktoza monohidrat in magnezijev stearat (E572), ki so vsebovane v jedru tablete, in laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), triacetin (E1518) in barvilo indigo karmin (E132), ki so vsebovane v filmski oblogi tablete.
Viread 245 mg film-coated tablets are almond-shaped and light blue in colour.
Viread 245 mg filmsko obložene tablete so mandljaste oblike in svetlo modre barve.
The tablets are marked on one side with “GILEAD” and “4331” and on the other side with “300”.
Tablete imajo na eni strani znaka “ GILEAD ” in “ 4331 ” ter na drugi strani znak “ 300 ”.
35 or
35 Izdelovalec:
Invented Name
izmišljeno jakost ime
5 ml
intravenska uporaba viala (steklena) 5 ml
It contains the active substance cidofovir (75 mg/ ml).
Vsebuje zdravilno učinkovino cidofovir (75 mg/ ml).
Before receiving Vistide, the patient’ s kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Pred začetkom jemanja zdravila Vistide je treba preveriti delovanje ledvic bolnika, saj bolniki z ledvičnimi obolenji zdravila ne smejo jemati.
During the ‘ induction’ phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Med obdobjem uvajanja se zdravilo Vistide prva dva tedna daje enkrat tedensko kot eno uro trajajoča infuzija v odmerku 5 mg na kilogram telesne mase.
Then, during the ‘ maintenance’ phase, it is given once every two weeks.
Nato se med vzdrževalnim obdobjem daje enkrat vsaka dva tedna.
The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘ nucleotide analogues’.
Zdravilna učinkovina v zdravilu Vistide, cidofocir, je protivirusno zdravilo, ki spada v razred „ nukleotidnih analogov “.
It blocks the activity of enzymes called ‘ DNA polymerases ’ in CMV, which the virus uses to produce DNA.
Zavira aktivnost encimov v citomegalovirusu, imenovanih DNK polimeraze, ki jih virus uporablja za tvorjenje DNK.
The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/ kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
V vzdrževalni študiji so primerjali dva vzdrževalna odmerka zdravila Vistide (5 in 3 mg/ kg telesne mase) pri 100 bolnikih, ki so se nehali odzivati na druga zdravila za citomegalovirusni retinitis (ganciklovir ali foskarnet) ali pa teh niso mogli jemati.
In the maintenance study, the 5-mg/ kg dose was more effective than the 3-mg/ kg dose (115 days and 49 days, respectively).
V vzdrževalni študiji je bil odmerek 5 mg/ kg učinkovitejši od odmerka 3 mg/ kg (115 oziroma 49 dni do napredovanja bolezni).
It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘ sulfa-containing’ medicines.
Zdravila prav tako ne smejo uporabljati bolniki z ledvičnimi obolenji, bolniki, ki jemljejo druga zdravila, ki lahko škodujejo ledvicam, ali bolniki, ki ne morejo jemati probenecida ali drugih zdravil, ki vsebujejo žveplo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide’ s benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vistide pri zdravljenju citomegalovirusnega retinitisa pri bolnikih z AIDS- om, ki nimajo obolenja ledvic, večje od z njim povezanih tveganj.
VISTIDE 75 mg/ ml concentrate for solution for infusion.
VISTIDE 75 mg/ ml koncentrat za raztopino za infundiranje
Each vial contains 375 mg/ 5ml cidofovir anhydrous as the active substance.
Ena viala kot zdravilno učinkovino vsebuje 375 mg/ 5 ml brezvodnega cidofovira.
The formulation is adjusted to pH 7.4.
Ena viala vsebuje približno 2, 5 mmol (ali 57 mg) natrija na vialo (5 ml) kot sestavino pomožnih snovi. pH pripravka je uravnan na 7, 4.
VISTIDE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction.
Zdravilo VISTIDE je indicirano za zdravljenje citomegalovirusnega (CMV) retinitisa pri bolnikih s sindromom pridobljene imunske pomanjkljivosti (aidsom), ki nimajo motenega delovanja ledvic.
VISTIDE should be used only when other agents are considered unsuitable.
Zdravilo VISTIDE naj bi uporabljali le, če druga zdravila niso primerna.
Before each administration of VISTIDE, serum creatinine and urine protein levels should be investigated.
Pred vsako aplikacijo zdravila VISTIDE je treba izmeriti kreatinin v serumu in koncentracijo beljakovin v urinu.
VISTIDE must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid).
Z vsako infuzijo zdravila VISTIDE je treba uporabiti peroralni probenecid in intravensko fiziološko raztopino (za ustrezna priporočila glejte poglavje 4. 4, za informacije, kako dobiti probenecid, pa poglavje 6. 6).
The recommended dosage, frequency, or infusion rate must not be exceeded.
Ne sme se preseči priporočenega odmerjanja, pogostnosti uporabe in hitrosti infundiranja.
VISTIDE must be diluted in 100 millilitres 0.9% (normal) saline prior to administration.
Zdravilo VISTIDE je treba pred uporabo razredčiti s 100 mililitri 0, 9% (normalne) fiziološke raztopine.
To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each VISTIDE infusion.
Za zmanjšanje morebitne nefrotoksičnosti je treba z vsako infuzijo zdravila VISTIDE uporabiti peroralni probenecid in intravensko predhidracijo s fiziološko raztopino.
Dosage in adults
Odmerjanje pri odraslih
The recommended dose of cidofovir is 5 mg/ kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks.
Priporočeni odmerek cidofovira je 5 mg/ kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na teden, dva tedna zapored.
Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/ kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks.
Priporočeni vzdrževalni odmerek cidofovira je 5 mg/ kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na dva tedna.
Suspension of maintenance treatment with cidofovir should be considered in accordance with local recommendations for the management of HIV-infected patients.
Prenehanje vzdrževalnega zdravljenja s cidofovirom mora biti usklajeno z lokalnimi priporočili za vodenje bolnikov, okuženih s HIV.
2 Dosage in elderly The safety and efficacy of VISTIDE have not been established for the treatment of CMV disease in patients over 60 years of age.
Odmerjanje pri starejših Varnost in učinkovitost zdravljenja citomegalovirusne bolezni z zdravilom VISTIDE pri bolnikih, starejših od 60 let, nista ugotovljeni.
Since elderly individuals frequently have reduced glomerular function, particular attention should be paid to assessing renal function before and during administration of VISTIDE.
Starejši imajo pogosto zmanjšano delovanje glomerulov, zato je treba pred aplikacijo zdravila VISTIDE in med njo posebno pozornost nameniti oceni delovanja ledvic.
Dosage in children and neonates VISTIDE is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
2 Odmerjanje pri otrocih in novorojenčkih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila VISTIDE pri otrocih pod 18 let ni priporočljiva.
Dosage in renal insufficiency Renal insufficiency [creatinine clearance ≤ 55 ml/ min or ≥ 2+ proteinuria (≥ 100 mg/ dl)] is a contraindication for the use of VISTIDE (see section 4.3 and 4.4).
Odmerjanje pri bolnikih z ledvično insuficienco Ledvična insuficienca [očistek kreatinina ≤ 55 ml/ min ali proteinurijo ≥ 2+ (≥ 100 mg/ dl)] je kontraindikacija za uporabo zdravila VISTIDE (glejte poglavji 4. 3 in 4. 4).
Dosage in hepatic insufficiency The safety and efficacy of VISTIDE have not been established in patients with hepatic disease and therefore it should be used with caution in this patient population.
Odmerjanje pri bolnikih z jetrno insuficienco Varnost in učinkovitost zdravila VISTIDE pri bolnikih z boleznijo jeter nista ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
Hypersensitivity to the active substance (cidofovir) or to any excipients.
Preobčutljivost za zdravilno učinkovino (cidofovir) ali katerokoli pomožno snov.
Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfa- containing medication (see section 4.4 Prevention of nephrotoxicity).
Uporaba cidofovira je kontraindicirana pri bolnikih, ki ne morejo dobivati probenecida ali drugih zdravil, ki vsebujejo žveplo (glejte poglavje 4. 4, Preprečevanje nefrotoksičnosti).
VISTIDE is contraindicated in patients with renal insufficiency (see section 4.2).
Zdravilo VISTIDE je kontraindicirano pri bolnikih z okvaro ledvic (glejte poglavje 4. 2).
Concomitant administration of VISTIDE and other potentially nephrotoxic agents is contraindicated (see section 4.4).
Sočasna uporaba zdravila VISTIDE in drugih potencialno nefrotoksičnih sredstev je kontraindicirana (glejte poglavje 4. 4).
Direct intraocular injection of VISTIDE is contraindicated; direct injection may be associated with significant decreases in intraocular pressure and impairment of vision.
Neposredno intraokularno injiciranje zdravila VISTIDE je kontraindicirano; neposredno injiciranje lahko spremljata pomembno znižanje očesnega tlaka in okvara vida.
VISTIDE is formulated for intravenous infusion only and must not be administered by intraocular injection.
Zdravilo VISTIDE je formulirano samo za intravensko infundiranje in se ne sme uporabljati za intraokularno injiciranje.
VISTIDE should be infused only into veins with adequate blood flow to permit rapid dilution and distribution.
Infundirati se ga sme samo v vene, v katerih je pretok krvi dovolj velik, da omogoča hitro razredčenje in porazdelitev.
Renal insufficiency/ Haemodialysis Treatment with VISTIDE must not be initiated in patients with creatinine clearance ≤ 55 ml/ min, or ≥ 2+ Proteinuria (≥ 100 mg/ dl), as the optimum induction and maintenance doses for patients with moderate to severe renal impairment are not known.
Okvara ledvic/ hemodializa Zdravljenja z zdravilom VISTIDE se ne sme začeti pri bolnikih, ki imajo očistek kreatinina ≤ 55 ml/ min ali proteinurijo ≥ 2+ (≥ 100 mg/ dl), ker optimalni začetni in vzdrževalni odmerki za bolnike z zmerno do hudo okvaro ledvic niso znani.
The fraction of the dose extracted during haemodialysis is 51.9 ± 11.0%.
Med hemodializo ekstrahirani delež odmerka znaša 51, 9 ± 11, 0%.
Nephrotoxicity Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to administration of cidofovir.
Nefrotoksičnost Od odmerka odvisni nefrotoksični učinki so med uporabo cidofovira glavni toksični pojavi, ki omejujejo odmerek.
The safety of cidofovir has not been evaluated in patients receiving other known potentially nephrotoxic agents (e. g. tenofovir, aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, adefovir and vancomycin).
Varnost cidofovira ni ugotovljena pri bolnikih, ki dobivajo druge potencialno nefrotoksične učinkovine (npr. tenofovir, aminoglikozide, amfotericin B, foskarnet, intravenski pentamidin, adefovir in vankomicin).
(See section 4.8).
Zdravljenje s potencialno nefrotoksičnimi sredstvi je priporočljivo opustiti vsaj 7 dni pred začetkom zdravljenja s cidofovirom (glejte poglavje 4. 8).
Patients treated at 3.0 mg/ kg, 5.0 mg/ kg or 10 mg/ kg without concomitant probenecid developed evidence of proximal tubular cell injury, including glycosuria, and decreases in serum phosphate, uric
Pri bolnikih, ki so prejemali odmerke 3, 0 mg/ kg, 5, 0 mg/ kg ali 10, 0 mg/ kg brez sočasne uporabe probenecida, so se pojavili znaki okvare celic proksimalnih tubulov, vključno z glikozurijo, znižanjem fosfata v serumu, sečne kisline in bikarbonata v serumu ter zvišanjem kreatinina v serumu.
Concomitant use of probenecid is essential for reducing the pronounced nephrotoxicity of cidofovir to an extent that results in an acceptable benefit/ risk balance of cidofovir therapy.
Sočasna uporaba probenecida je za zmanjševanje izrazite nefrotoksičnosti cidofovira bistvena, saj omogoča sprejemljivo razmerje med koristjo in tveganji za zdravljenje s cidofovirom.
Prevention of nephrotoxicity Therapy must be accompanied by administration of oral probenecid and adequate intravenous saline prehydration (see 6.6 for information on obtaining probenecid) with each cidofovir dose.
3 Vsak odmerek cidofovira mora spremljati uporaba peroralnega probenecida in primerna intravenska predhidracija s fiziološko raztopino (za informacije, kako dobiti probenecid, glejte poglavje 6. 6).
In order to reduce the potential for nausea and/ or vomiting associated with administration of probenecid, patients should be encouraged to eat food prior to each dose of probenecid.
Za zmanjšanje verjetnosti za navzeo in/ ali bruhanje, povezanih z uporabo probenecida, je treba bolnike spodbuditi, naj pred vsakim odmerkom probenecida zaužijejo hrano.
In patients who develop allergic or hypersensitivity symptoms to probenecid (e. g., rash, fever, chills and anaphylaxis), prophylactic or therapeutic use of an appropriate antihistamine and/ or paracetamol should be considered.
Pri bolnikih, ki doživijo simptome alergije ali preobčutljivosti za probenecid (npr. izpuščaj, zvišana telesna temperatura, mrzlica in anafilaksija), je treba razmisliti o profilaktični ali terapevtski uporabi antihistaminika in/ ali paracetamola.
In addition to probenecid, patients must receive a total of one litre of 0.9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir.
Poleg probenecida morajo bolniki tik pred vsako infuzijo cidofovira intravensko dobiti skupno en liter 0, 9% fiziološke raztopine.
Patients who can tolerate the additional fluid load may receive up to a total of 2 litres of 0.9% saline intravenously with each dose of cidofovir.
Bolniki, ki prenesejo dodatno obremenitev s tekočino, lahko z vsakim odmerkom cidofovira dobijo skupno do 2 litra 0, 9% fiziološke raztopine.
Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by ≥ 44 µmol/ l (≥ 0.5 mg/ dl), or if persistent proteinuria ≥ 2+ develops.
Če kreatinin v serumu naraste na ≥ 44 µmol/ l (≥ 0, 5 mg/ dl) ali se pojavi trajna proteinurija ≥ 2+, je treba zdravljenje s cidofovirom prekiniti in priporočljiva je intravenska hidracija.
Patient Monitoring Proteinuria appears to be an early and sensitive indicator of cidofovir-induced nephrotoxicity.
Opazovanje bolnikov Kaže, da je proteinurija zgoden in občutljiv kazalec nefrotoksičnih učinkov cidofovira.
Differential white blood cell counts should also be performed prior to each dose of cidofovir (see section 4.8).
Prav tako je treba pred vsakim odmerkom cidofovira pregledati diferencialno krvno sliko (glejte poglavje 4. 8).
Ocular Events Patients receiving cidofovir should be advised to have regular follow-up ophthalmologic examinations for possible occurrence of Uveitis/ Iritis and Ocular Hypotony.
Očesni neželeni učinki Bolnikom, ki dobivajo cidofovir, je treba svetovati, naj redno opravljajo oftalmološke preglede zaradi morebitnega pojava uveitisa/ iritisa in očesne hipotonije.
In case of Uveitis/ Iritis cidofovir should be discontinued if there is no response to treatment with a topical corticosteroid or the condition worsens, or if iritis/ uveitis reoccurs after successful treatment.
Če v primeru uveitisa/ iritisa ni odziva na zdravljenje z lokalnim kortikosteroidom ali če se stanje poslabša oziroma če se iritis/ uveitis po uspešnem zdravljenju ponovi, je treba uporabo cidofovira prekiniti.
4 Other Cidofovir should be considered a potential carcinogen in humans (see section 5.3 Preclinical safety data).
Drugo Cidofovir je treba obravnavati kot potencialen kancerogen za človeka (glejte poglavje 5. 3, Predklinični podatki o varnosti).
Appropriate precautions should continue to be employed to prevent transmission of HIV.
4 Nadaljevati je treba z ustreznimi previdnostnimi ukrepi, da bi preprečili prenos HIV na druge.
Interactions of cidofovir/ probenecid and anti-HIV drugs or drugs used to treat common chronic viral infections in this population, such as HCV and HBV-related hepatitis, have not been investigated in clinical trials.
V kliničnih preizkušanjih niso proučili interakcij cidofovira/ probenecida in drugih zdravil proti HIV, ali zdravil, ki se uporabljajo za zdravljenje običajnih kroničnih virusnih okužb v tej populaciji, kot je s HCV in HBV povezan hepatitis.
Probenecid is known to increase the exposure of many substances (e. g., paracetamol, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicyclic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine).
Znano je, da probenecid zveča izpostavljenost številnim zdravilom (npr. paracetamolu, acikloviru, zaviralcem angiotenzinske konvertaze, aminosalicilni kislini, barbituratom, benzodiazepinom, bumetanidu, klofibratu, metotreksatu, famotidinu, furosemidu, nesteroidnim protivnetnim zdravilom, teofilinu in zidovudinu).
Therefore, when co-prescribing cidofovir/ probenecid with other agents, it is important for prescribers to consult the current probenecid SPC (or an appropriate drug reference source) and the respective prescribing information of the other co-administered products for full information regarding drug interactions and other features of that product.
Zato je pomembno, da zdravniki, ki cidofovir/ probenecid predpišejo skupaj z drugimi zdravili, preverijo veljavni povzetek glavnih značilnosti probenecida (oz. ustrezen referenčni vir o zdravilu) ter navodila za predpisovanje drugih sočasno uporabljenih zdravil, da bi dobili celotne informacije o interakcijah zdravil in drugih lastnostih posameznega zdravila.
Cidofovir is embryotoxic in rats and rabbits at subtherapeutic dose levels.
Cidofovir je pri podganah in kuncih embriotoksičen v subterapevtskih odmerkih.
A significantly increased foetal incidence of external, soft tissue and skeletal anomalies occurred in rabbits at 1.0 mg/ kg/ day, which was also maternally toxic.
Pri kuncih se je pogostnost zunanjih anomalij, anomalij mehkih tkiv in okostja pri odmerku 1, 0 mg/ kg/ dan, ki je bil toksičen tudi za samice matere, pomembno zvečala.
Pregnancy There are no studies of cidofovir in pregnant women.
Nosečnost O uporabi cidofovira pri nosečnicah ni študij.