natgillin/translations-raw huggingface dataset:
After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9 % and 4 % compared with placebo (p<0.001).
Po 19 mesecih (mediana) zdravljenja se je mineralna gostota kosti (BMD) povišala v ledvenem delu hrbtenice oziroma celem kolku, za 9 % oziroma 4 % v primerjavi s placebom (p < 0,001).
A new, sterile needle must be used for every injection.
Za vsako injiciranje morate uporabiti novo, sterilno iglo.
Do not use this medicine after the expiry date which is stated on the carton and pen after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in injekcijskem peresniku po oznaki EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
Če vnos s hrano ne zadošča, naj bolniki prejemajo dodatek kalcija in vitamina D.
The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Učinki zdravila FORSTEO na okostje so odvisni od načina izpostavljanja sistema.
If pregnancy occurs, FORSTEO should be discontinued.
Če zanosijo, mora biti zdravilo FORSTEO ukinjeno.
5) Pull off the small needle protector and throw away.
5) Odstranite manjšo zaščito igle in jo zavrzite.
Multiple vertebral fractures (≥2) a
Več zlomov vretenc (≥ 2)a
Cases of fainting have been reported in association with teriparatide use.
Pri uporabi teriparatida so poročali o primerih omedlevice.
• Prior external beam or implant radiation therapy to the skeleton
• Teleradioterapija ali brahiradioterapija za zdravljenje okostja v preteklosti
To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
11 žensk zdraviti mediano 19 mesecev.
FORSTEO should be stored in a refrigerator (2°C to 8°C) at all times.
Zdravilo FORSTEO vedno shranjujte v hladilniku (2 °C - 8 °C).
In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2 % versus −1.9 %; p<0.001) and total hip (3.8 % versus 0.9 %; p=0.005).
Pri ženskah pred menopavzo je bilo povišanje mineralne gostote kosti (BMD) z osnove na končno točko po 18 mesecih značilno višje v skupini zdravila FORSTEO v primerjavi s skupino alendronata za ledveni del hrbtenice (4,2 % proti -1,9 %; p < 0,001) in celi kolk (3,8 % proti 0,9 %; p < 0,005).
• increase in blood cholesterol levels
• povišanje koncentracij holesterola v krvi
However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/kg.
Vendar se je pojavila resorpcija ploda in zmanjšanje zaroda pri brejih kuncih, ki so prejemali dnevne odmerke od 3
Pull out black injection button until it stops.
Potegnite ven črni gumb za injiciranje, dokler se ne ustavi.
Pull off small needle protector and throw away.
Odstranite manjšo zaščito igle in jo zavrzite.
All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Vsem bolnikom so ponudili 1000 mg kalcija na dan in
Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
IMETNIK DOVOLJENJA ZA PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
and that it has not expired.
dokler se ne ustavi.
• Severe renal impairment
• Hudo okvarjeno delovanje ledvic
- The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections.
- Pomožne snovi so koncentrirana ocetna kislina, natrijev acetat (brezvodni), manitol, metakrezol in voda za injekcije.
Posology The recommended dose of FORSTEO is 20 micrograms administered once daily.
Odmerjanje Priporočeni odmerek zdravila FORSTEO je 20 mikrogramov enkrat dnevno.
The pen should be discarded 28 days after the first use.
Injekcijski peresnik zavrzite 28 dni po prvi uporabi.
Talk to your doctor or pharmacist before or while using FORSTEO:
Pred ali med uporabo zdravila FORSTEO se posvetujte s svojim zdravnikom ali farmacevtom:
Never share your FORSTEO pen with others.
Svojega peresnika za zdravilo FORSTEO nikoli ne delite z drugimi.
1 pen of 2.4 mL solution.
1 injekcijski peresnik z 2,4 ml raztopine.
Uncommon: Emphysema
Občasno: Emfizem
Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
Preberite in sledite navodilom v Navodilu za uporabo glede shranjevanja zdravila.
Hydrochloric acid solution and/or sodium hydroxide solution (for pH adjustment).
Po potrebi raztopina klorovodikove kisline in/ali raztopina natrijevega hidroksida (za uravnavanje pH).
3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
3) Odvijte iglo do konca s 3 do 5 popolnimi obrati večjega pokrova igle.
Store in a refrigerator (2°C - 8°C) at all times.
Vedno shranjujte v hladilniku (2 °C - 8 °C).
FORSTEO must not be used in patients with severe renal impairment (see section 4.3.).
Zdravila FORSTEO pri bolnikih s hudo okvarjenim delovanjem ledvic ne smemo uporabljati (glejte poglavje 4.3).
2) Use the large needle cover to unscrew the needle.
2) Uporabite večji pokrov igle za odvijanje igle.
OTHER SPECIAL WARNING(S), IF NECESSARY To open, lift here and pull.
Če hočete odpreti, dvignite tukaj in potegnite.
Nausea, vomiting, dizziness, and headache can also occur.
Pojavijo se lahko tudi slabost, bruhanje, omotica in glavobol.
The mean increase in BMD from 18 to 24 months was 1.4 %, 1.2 %, and 1.6 % at the lumbar spine, total hip and femoral neck, respectively.
Povprečno povečanje BMD od 18. do 24. meseca je bilo v ledvenem delu hrbtenice 1,4 %, celem kolku 1,2 % in vratu stegnenice 1,6 %.
5 How to store FORSTEO Content of the pack and other information
Shranjevanje zdravila FORSTEO Vsebina pakiranja in dodatne informacije
Uncommon: Tachycardia
Občasno: tahikardija
FORSTEO contains a clear and colourless solution.
Zdravilo FORSTEO vsebuje bistro in brezbarvno raztopino.
FORSTEO can be injected at meal times.
Zdravilo FORSTEO si lahko injicirate v času obrokov.
Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle from skin.
Držite ga pritisnjenega in p-o-č-a-s-i štejte do 5.
In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7 %, 0.9 %, and 0.4 %, respectively.
Pri bolnikih zdravljenih s teriparatidom, se je BMD ledvenega dela hrbtenice od 18. do 24. meseca dodatno povečala za 1,7 %, celega kolka za 0,9 % in vratu stegnenice za 0,4 %.
Small needle protector
Manjša zaščita igle
4) If you still cannot get the needle off, ask someone to help you.
4) Če še vedno ne morete odstraniti igle,
• irregular heart beats
• nepravilni srčni utripi
Common: Hypotension
Pogosto: hipotenzija
Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Povprečni T-vrednosti osnovne mineralne gostote kosti hrbtenice in vratu stegnenice sta bili-2,2 in -2,1.
The recommended treatment time of 24 months should not be exceeded.
Ne smete preseči priporočenega časa zdravljenja 24 mesecev.
For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in Forsteo- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001.
Pri bolnicah, pri katerih so opravili radiografijo osnovnega stanja in radiografijo za spremljanje stanja, je bila incidenca novih zlomov vretenc 28/516 (5,4 %) v skupini z zdravilom Forsteo in 64/533 (12,0 %) pri bolnicah, zdravljenih z rizedronatom, relativno tveganje (95
Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Odvijte iglo do konca s 3 do 5 popolnimi obrati večjega pokrova igle.
No special caution is required for patients with mild renal impairment.
Pri bolnikih z blago okvarjenim delovanjem ledvic posebna previdnost ni potrebna.
3 pens of 2.4 mL solution each.
3 injekcijski peresniki, vsak z 2,4 ml raztopine.
Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Ženske, ki bi lahko zanosile morajo med uporabo zdravila FORSTEO uporabljati učinkovito metodo kontracepcije.
Injection needles are not included with the pen.
Igle za injiciranje injekcijskemu peresniku niso priložene.
Studies in rabbits have shown reproductive toxicity (see section 5.3).
Plodnost Študije na kuncih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Pull off needle and throw away as directed by your doctor or pharmacist.
Odstranite iglo in jo zavrzite v skladu z navodili vašega zdravnika ali farmacevta.
• shortness of breath
• težko dihanje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FORSTEO 20 micrograms/80 microliters, injection Teriparatide
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA FORSTEO 20 mikrogramov/80 mikrolitrov, injekcija teriparatid za subkutano uporabo
Follow the directions carefully when using the pen.
Pri uporabi injekcijskega peresnika pozorno sledite navodilom.
FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Kaj je zdravilo FORSTEO in za kaj ga uporabljamo Zdravilo FORSTEO vsebuje učinkovino teriparatid, ki jo uporabljamo za krepitev kosti in zmanjšanje tveganja za zlome s spodbujanjem tvorjenja kostnine.
• loss of energy
• izguba energije • utrujenost
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL TEXT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
This user manual was last revised in {MM/YYYY}
Datum zadnje revizije navodil za uporabo: {MM/YYYY}
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov:
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
6.1 Seznam pomožnih snovi koncentrirana ocetna kislina natrijev acetat (brezvodni) manitol metakrezol klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
Immune System Disorder
Bolezni imunskega sistema
Transient, orthostatic hypotension or dizziness was observed in some patients.
Pri nekaterih bolnikih so opažali prehodno ortostatsko hipotenzijo ali omotico.
Teriparatide was not genotoxic in a standard battery of tests.
V standardnem naboru testov niso ugotovili genotoksičnosti teriparatida.
FORSTEO is indicated in adults.
4.1 Terapevtske indikacije Zdravilo FORSTEO je indicirano pri odraslih.
Rare: Anaphylaxis
Pogosto: vrtoglavica
a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up spine radiographs.
Okrajšave: N = število bolnikov, naključno vključenih v vsako skupino zdravljenja; IZ = interval zaupanja aIncidenca vretenčnih zlomov je bila ocenjena pri 448 bolnikih, ki so prejemali placebo in 444 bolnikih, ki so prejemali zdravilo Forsteo in so imeli radiografijo osnovnega stanja in ponovne ocene hrbtenice.
Respiratory, thoracic and mediastinal disorders Common: Dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosto: Dispneja
FORSTEO is a bone formation agent to treat osteoporosis.
FORSTEO je zdravilo za tvorbo kostnine za zdravljenje osteoporoze.
If you cannot pull out the black injection button see
Če ne morete potegniti ven črnega gumba za injiciranje glejte Reševanje težav, Problem E.
The pen should be returned to the refrigerator immediately after use.
Injekcijski peresnik morate takoj po uporabi shraniti nazaj v hladilnik.
1) Put the large needle cover on the needle.
1) Namestite večji pokrov igle na iglo.
At the 18 month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2 %) compared with alendronate (3.4 %) (p<0.001).
18 mesecih je zdravilo FORSTEO značilno zvišalo mineralno gostoto kosti (BMD) v ledvenem delu hrbtenice (7,2 %) v primerjavi z alendronatom (3,6 %) (p < 0,01).
4) Pull out the black injection button until it stops.
4) Potegnite ven črni gumb za injiciranje,
• feeling faint
• občutek slabotnosti
• Store the FORSTEO with the white cap on.
• Injekcijski peresnik FORSTEO shranjujte s pritrjenim belim pokrovom.
Yellow Shaft
Rumeni valj
Uncommon: Injection site erythema, injection site reaction Rare: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral).
Redko: možne alergijske reakcije kmalu po injiciranju: akutna dispneja, edem ust/obraza,
• increase in blood calcium level
• povišan nivo kalcija v krvi
At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5 %, 2.6 % and 3.9 % respectively.
Po 24 mesecih se jim je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice v povprečju povečala za 10,5 %, v celem kolku za 2,6 % in v vratu stegnenice za 3,9 %.
Disposal of Pen Needles and Device Disposal of Pen Needles and FORSTEO Device
Odstranjevanje igel peresnika in medicinskega pripomočka
Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.
Za navodila, kako uporabiti injekcijski peresnik FORSTEO, preberite Priročnik za uporabo, ki je priložen v škatli.
A. The yellow shaft is still showing after I push in the black injection button.
A. Po tem ko pritisnem noter črni gumb za injiciranje se še vedno vidi rumeni valj.
Some patients may feel dizzy after injecting FORSTEO.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki lahko po injiciranju zdravila FORSTEO čutijo omotico.
Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use.
Za vsako injiciranje uporabite novo injekcijsko iglo, ki jo po uporabi zavrzite.
Put large needle cover on needle.
Namestite večji pokrov igle na iglo.
• Ask your healthcare professional about options to dispose of the pen and the sharps container properly.
• O pravilnem načinu odstranjevanja peresnika in vsebnika za ostre odpadke se posvetujte z zdravstvenim delavcem.
OTHER Store in a refrigerator
DRUGI PODATKI Shranjujte v hladilniku.
• breathlessness
• zadihanost
Non-vertebral fragility fractures c
Nevretenčni zlomi zaradi krhkostic
Please also refer to the user manual for instructions on how to use the pen.
Za navodila, kako uporabljati injekcijski peresnik, prosimo, glejte tudi priročnik za uporabo.
Renal impairment Caution should be exercised in patients with moderate renal impairment.
Okvarjeno delovanje ledvic Pri bolnikih z zmerno okvarjenim delovanjem ledvic je potrebna previdnost.
The pens are available in cartons containing one or three pens.
Injekcijski peresniki so na voljo v škatlah s po enim ali s tremi injekcijskimi peresniki.
Do not freeze FORSTEO.
Zdravila FORSTEO ne zamrzujte.
FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
FORSTEO, 20 mikrogramov (µg) 80 mikrolitrov raztopina za injiciranje v napolnjenem injekcijskem peresniku
Uncommon: Myalgia, arthralgia, back cramp/pain* Renal and urinary disorders
Občasno: mialgija, artralgija, krč/bolečina v hrbtu* Bolezni sečil
• haemorrhoids (piles)
• hemoroidi (zlata žila)
• increase in blood uric acid level
• povišan nivo sečnine v krvi
• increased heart rate
• porast telesne mase
STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 250 micrograms of teriparatide.
En ml vsebuje 250 mikrogramov teriparatida.
It is supplied in a cartridge contained in a pre-filled disposable pen.
Na voljo je v vložku v napolnjenem injekcijskem peresniku za enkratno uporabo.
• Refrigerate the FORSTEO immediately after every use.
• Takoj po vsaki uporabi položite injekcijski peresnik FORSTEO v hladilnik.
FORSTEO is contraindicated for use during breast-feeding.
Zdravilo FORSTEO je med dojenjem kontraindicirano.
Storing Your FORSTEO
Shranjevanje vašega injekcijskega peresnika FORSTEO
PEN USER MANUAL
PRIROČNIK ZA UPORABO
Uncommon: Weight increased, cardiac murmur, alkaline phosphatase increase *Serious cases of back cramp or pain have been reported within minutes of the injection.
*Nekaj minut po injiciranju so poročali o resnih primerih krča ali bolečine v hrbtu.
After 12 months, BMD had increased in the lumbar spine and total hip by 5 % and 1 %, respectively, compared with placebo.
Po 12 mesecih se je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice oziroma celem kolku povišala za 5 %
Common: Hypercholesterolaemia
Presnovne in prehranske motnje Pogosto: hiperholesterolemija
Push in the black injection button until it stops.
Pritisnite noter črni gumb za injiciranje,
PHARMACEUTICAL FORM Solution for injection.
FARMACEVTSKA OBLIKA raztopina za injiciranje Brezbarvna, bistra raztopina.
Musculoskeletal and connective tissue disorders Very common: Pain in limb
Zelo pogosto: bolečina v okončinah Pogosto: mišični krči
Glucocorticoid-induced osteoporosis
Osteoporoza povzročena z glukokortikoidi
Troubleshooting
Nosečnost
• abnormal heart sound
• nenormalno bitje srca
The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.
V kliničnih preskušanjih so z ≥ 1 % razliko v pogostnosti od placeba poročali o naslednjih reakcijah: vrtoglavica, slabost, bolečina v okončinah, omotica, depresija, dispneja.
Name and address of the manufacturer of the biological active substance
PRILOGA II A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN
• increased need to pass water
• naključno uhajanje seča • povečana potreba po mokrenju
When you have finished, the black injection button should be all the way in. 7) If you still see the yellow shaft showing, please contact your doctor or pharmacist 8) Put the large needle cover on needle.
7) Če še vedno vidite rumeni valj, se prosimo obrnite na vašega zdravnika ali farmacevta.
Cleaning Your FORSTEO
Deli injekcijskega peresnika Forsteo*
• Keep the FORSTEO out of the sight and reach of children.
• Zdravilo FORSTEO shranjujte nedosegljivo otrokom!
Tél/Tel: + 32 (0) 2 548 84 84
Luxembourg/Luxemburg Eli Lilly Benelux S.A. /N.V Tél/Tel: + 32-(0)2 548 84 84
This leaflet was last revised in
V splošnem so protitelesa prvič zaznali po
NAME OF THE MEDICINAL PRODUCT FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen Teriparatide
FORSTEO 20 mikrogramov/80 mikrolitrov raztopina za injiciranje v napolnjenem injekcijskem peresniku
FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen Instructions for use
FORSTEO 20 mikrogramov/80 mikrolitrov raztopina za injiciranje v napolnjenem injekcijskem peresniku teriparatid
ask your doctor.
Posvetujte se tudi,
België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
België/Belgique/Belgien Eli Lilly Benelux S.A./N.V Tél/Tel: + 32-(0)2 548 84 84
(See section 6.6.)
(Glejte poglavje 6.6.)
From a microbiological point of view, the product must be used immediately.
Z mikrobiološkega stališča je zdravilo treba uporabiti takoj.
Therefore, this medicine should not be used in children.
Tega zdravila se torej ne sme uporabljati pri otrocih.
Storage beyond 24 hours or freezing is not recommended.
Shranjevanje prek 24 ur ali zamrzovanje nista priporočljiva.
• If you have ever had kidney disease.
• Če ste kadarkoli imeli bolezen ledvic.
The dose you will need is calculated based on your body weight.
Potreben odmerek se izračuna na podlagi vaše telesne mase.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali neznano (ni mogoče oceniti iz razpoložljivih podatkov).
• Tell your doctor if you have diabetes mellitus.
• Povejte zdravniku, če imate diabetes mellitus (sladkorno bolezen).
In both studies, tumours were observed within 3 months of dosing.
V obeh študijah so tumorje opazili v 3 mesecih uporabe.
Using Vistide with food and drink
Uporaba zdravila Vistide skupaj s hrano in pijačo
This medicinal product must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili ali topili razen s tistimi, ki so omenjena v poglavju 6.6.
The use of an anti-emetic may be necessary.
Potrebna utegne biti uporaba antiemetika.
The efficacy and safety of cidofovir in such conditions has not been established.
Učinkovitost in varnost cidofovira pod takšnimi pogoji nista ugotovljeni.
Patient monitoring
Opazovanje bolnikov
It is very important to tell your doctor if you are receiving other medicines that may damage your kidneys.
Zelo pomembno je, da zdravnika obvestite, ali jemljete druga zdravila, ki lahko okvarijo vaše ledvice.
Antiviral activity is seen at concentrations significantly below those which cause cell death.
Protivirusno delovanje je opazno v koncentracijah, bistveno manjših od tistih, ki povzročijo celično smrt.
Partially used vials should be discarded.
Delno porabljene viale je treba zavreči.
Probenecid increases the AUC of zidovudine.
Probenecid zveča AUC zidovudina.
Haemolytic anaemia has also occurred, and may be associated with G6DP deficiency.
Pojavila se je tudi hemolitična anemija, ki je lahko povezana s pomanjkanjem G6DP.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND Not applicable.
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO Navedba smiselno ni potrebna.
Women of childbearing potential/Contraception in males and females:
Ženske v rodni dobi/Kontracepcija pri moških in ženskah:
Handling and disposal
Ravnanje in odstranjevanje
Important information about some of the ingredients of Vistide
Pomembne informacije o nekaterih sestavinah zdravila Vistide
Cidofovir has negligible influence on the ability to drive and use machines.
Cidofovir ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
• Vistide is not used for the treatment of HIV infection.
• Zdravilo Vistide se ne uporablja za zdravljenje okužbe z virusom HIV.
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co. Cork Ireland
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co. Cork Irska
Vistide has been shown to cause damage in unborn animals and should not be used during pregnancy unless the potential benefits justify the risks to the foetus.
Dokazano je, da zdravilo Vistide povzroča okvare pri nerojenih živalih, in se ga med nosečnostjo ne sme uporabljati, razen če možne koristi upravičujejo tveganja za plod.
Appropriate precautions should continue to be employed to prevent transmission of HIV.
Nadaljevati je treba z ustreznimi previdnostnimi ukrepi, da bi preprečili prenos HIV na druge.
If you have kidney problems, Vistide may not be appropriate treatment for you.
Če imate težave z ledvicami, zdravilo Vistide za vas morda ni primeren način zdravljenja.
The fraction of the dose extracted during haemodialysis is 51.9 ± 11.0%.
Med hemodializo ekstrahirani delež odmerka znaša 51,9 ± 11,0%.
Both patients were hospitalised and received prophylactic oral probenecid and vigorous hydration for 3 to 7 days.
Oba bolnika sta bila hospitalizirana in sta dobila profilaktični peroralni probenecid in intenzivno hidracijo 3 do 7 dni.
The signs of nephrotoxicity were partially reversible in some patients.
Znaki nefrotoksičnosti so bili pri nekaterih bolnikih delno reverzibilni.
You must take 3 doses of probenecid tablets orally on the same day as Vistide as shown in the following table:
Vzeti morate 3 odmerke tablet probenecida peroralno na isti dan kot zdravilo Vistide, kot prikazuje naslednja tabela:
Dose in adults
Odmerek pri odraslih
What is CMV retinitis?
Kaj je citomegalovirusni retinitis?
Because many medicines are passed through to human milk, nursing mothers should stop Vistide or stop breast-feeding if they continue to receive
Ker se v materino mleko izločajo številna zdravila, morajo doječe matere nehati dobivati zdravilo Vistide, ali pa morajo nehati dojiti, če še naprej dobivajo
The formulation is adjusted to pH 7.4.
pH pripravka je uravnan na 7,4.