natgillin/translations-raw huggingface dataset:
It is used for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/ or not getting to the toilet in time and wetting yourself (urge incontinence).
Z njim zdravimo simptome čezmerno aktivnega sečnega mehurja, kot so nenadna močna nuja po mokrenju, potreba po pogostem mokrenju ali urgentna urinska inkontinenca, pri kateri se pomočite, ker ne pridete pravočasno do stranišča.
BEFORE YOU TAKE EMSELEX
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EMSELEX
Do not take Emselex: • if you are allergic (hypersensitive) to darifenacin or any of the other ingredients of Emselex. • if you suffer from urinary retention (inability to empty your bladder). • if you have gastric retention (problems emptying the contents of the stomach). • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated). • if you have myasthenia gravis (a disease marked by abnormal fatigue and weakness of selected muscles). • if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon associated with amoebic or ulcerative colitis). • if you have severe liver problems. • There are some medicines such as ciclosporin, verapamil, antifungal medicines (e. g. ketoconazole and itraconazole) and some antiviral medicines (e. g. ritonavir) that must not be taken with Emselex.
Ne jemljite zdravila Emselex: • če ste alergični (preobčutljivi) na darifenacin ali katerokoli sestavino zdravila Emselex, • če imate težave zaradi zastajanja seča (nezmožnosti praznjenja mehurja), • če imate zastoj v želodcu (težave pri praznjenju želodčne vsebine), • če imate neobvladan glavkom z zaprtim zakotjem (zvišan tlak v očeh z izgubo vida, ki ni ustrezno zdravljen), • če imate miastenijo gravis (bolezen, za katero sta značilni nenormalna utrujenost in šibkost nekaterih mišic), • če imate hud ulcerativni kolitis ali toksični megakolon (akutna razširitev debelega črevesa, povezana z amebnim ali ulcerativnim kolitisom), • če imate hude težave z jetri, • Nekaterih zdravil, na primer ciklosporina, verapamila, protiglivičnih zdravil (na primer ketokonazola in itrakonazola) in nekaterih protivirusnih zdravil (npr. ritonavirja) ne smete jemati z zdravilom Emselex.
39 Take special care with Emselex: • if you have autonomic neuropathy - your doctor will have told you if you have this. • if you have heartburn and belching. • if you have difficulties in passing urine and a weak stream of urine. • if you have severe constipation (less than or equal to 2 bowel movements per week). • if you have an obstructive gastrointestinal disorder - your doctor will have told you if you have this. • if you are receiving treatment for narrow-angle glaucoma. • if you have liver problems. • if you have kidney problems.
39 Bodite posebno pozorni pri uporabi zdravila Emselex: • če imate avtonomno nevropatijo, na katero vas je opozoril že vaš zdravnik, • če imate zgago in riganje, • če imate težave pri odvajanju vode in šibek curek seča, • če ste zelo zaprti (če greste na blato največ dvakrat na teden), • če imate obstruktivno bolezen prebavil, za katero vam je že povedal vaš zdravnik, • če se zdravite zaradi glavkoma z zaprtim zakotjem, • če imate težave z jetri, • če imate težave z ledvicami.
If any of these apply to you, tell your doctor before you take Emselex.
Če kaj od navedenega velja za vas, povejte to svojemu zdravniku, še preden boste vzeli Emselex.
Taking other medicines with Emselex Some medicines may interact with Emselex.
Jemanje drugih zdravil Nekatera zdravila lahko z zdravilom Emselex medsebojno delujejo.
These include some antibiotics (e. g. erythromycin and clarithromycin), antifungal medicines (e. g. ketoconazole and itraconazole), antipsychotic medicines (e. g. thioridazine), some antidepressants (e. g. imipramine), antiviral medicines (e. g. nelfinavir and ritonavir), some medicines used to treat heart problems (e. g. flecainide, verapamil and digoxin) and other antimuscarinic medicines (e. g. tolterodine, oxybutynin and flavoxate).
Med njimi so nekateri antibiotiki (na primer eritromicin in klaritromicin), antimikotiki (na primer ketokonazol in itrakonazol), antipsihotična zdravila (na primer tioridazin), nekateri antidepresivi (na primer imipramin), protivirusna zdravila (na primer nelfinavir in ritonavir), nekatera zdravila, ki se uporabljajo za zdravljenje težav s srcem (na primer flekainid, verapamil in digoksin) in druga antimuskarinska zdravila (na primer tolterodin, oksibutinin in flavoksat).
Use in older people Emselex can be used by people older than 65.
Uporaba pri starejših ljudeh Ljudje, starejši od 65 let, lahko jemljejo Emselex.
If you are older than 65, you will be given the same dose as other adults.
Če ste starejši od 65 let, boste dobili enak odmerek kot drugi odrasli bolniki.
Pregnancy and breast-feeding If you are pregnant or think you may be pregnant, tell your doctor.
Nosečnost in dojenje Če ste noseči ali če mislite, da ste mogoče noseči, povejte svojemu zdravniku.
Emselex should be taken with caution while breast-feeding.
Med dojenjem je treba Emselex jemati previdno.
Driving and using machines No studies of the effects of Emselex on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študije o učinkih zdravila Emselex na sposobnost upravljanja vozil in strojev niso bile izvedene.
However, Emselex, like other antimuscarinic medicines, may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
Vendar pa Emselex lahko tako kot druga antimuskarinska zdravila povzroča učinke, kot so vrtoglavica, zamegljen vid, nespečnost ali zaspanost.
For Emselex, these side effects have been reported to be uncommon.
Poročajo, da so bili ob zdravilu Emselex našteti neželeni učinki občasni.
HOW TO TAKE EMSELEX
KAKO JEMATI ZDRAVILO EMSELEX
How much Emselex to take Emselex is intended for use in adults (people aged 18 years or older).
Koliko zdravila Emselex jemati Emselex je namenjen za zdravljenje odraslih (ljudi, ki so stari 18 let ali več).
Emselex is not recommended for use in children.
Zdravilo Emselex za otroke ni priporočljivo.
40 For adults and older people, the recommended starting dose is 7.5 mg daily.
Priporočeni začetni odmerek za odrasle in starejše je 7, 5 mg na dan.
Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
Odvisno od vašega odziva na Emselex vam bo zdravnik dva tedna po začetku zdravljenja mogoče zvečal odmerek na 15 mg na dan.
These doses are suitable for people with mild liver problems or people with kidney problems.
40 Navedeni odmerki so primerni za ljudi z blagimi jetrnimi težavami in za bolnike z ledvičnimi težavami.
Eating food has no effect upon Emselex.
Uživanje hrane ne vpliva na Emselex.
However, the adjustment of Emselex doses is not necessary.
Grenivkin sok lahko medsebojno deluje z zdravilom Emselex, vendar prilagajanje njegovih odmerkov ni potrebno.
Please tell your doctor if you have liver problems.
Če imate težave z jetri, povejte svojemu zdravniku.
Emselex is not recommended for use in patients with moderate liver problems.
Jemanje zdravila Emselex za bolnike z zmernimi jetrnimi težavami ni priporočljivo.
Do not take Emselex, if you have severe liver problems.
Če imate hude težave z jetri, ne jemljite zdravila Emselex.
Patients taking some other medicines (e. g. erythromycin, clarithromycin, telithromycin and fluconazole) must not normally take more than 7.5 mg of Emselex as a daily dose.
Bolniki, ki jemljejo še nekatera druga zdravila (na primer eritromicin, klaritromicin, telitromicin in flukonazol), običajno ne smejo vzeti več kot 7, 5 mg zdravila Emselex na dan.
However, the dose could be increased to 15 mg if well tolerated.
Vendar pa se odmerjanje lahko poveča na 15 mg, če ga bolnik dobro prenaša.
There are some medicines e. g. ciclosporin, verapamil, ketoconazole, itraconazole and some antiviral medicines (e. g. ritonavir) that must not be taken with Emselex.
Sočasno z zdravilom Emselex se ne sme jemati tudi nekaterih drugih zdravil, kot so ciklosporin, verapamil, ketokonazol, itrakonazol in nekatera protivirusna zdravila (npr. ritonavir).
When and how to take Emselex Take Emselex tablets once a day with water, at about the same time each day.
Kdaj in kako jemati zdravilo Emselex Tablete Emselex vzemite enkrat na dan z vodo, in sicer vsak dan približno ob istem času.
How long to take Emselex Your doctor will tell you how long your treatment with Emselex will last.
Kako dolgo je treba jemati zdravilo Emselex Zdravnik vam bo povedal, kako dolgo naj traja vaše zdravljenje z zdravilom Emselex.
If you take more Emselex than you should If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately.
Če ste vzeli večji odmerek zdravila Emselex, kot bi smeli Če ste vzeli več tablet, kot so vam naročili, naj jih vzamete, ali če kdo drug po nesreči vzame vaše tablete, nemudoma odidite po nasvet k zdravniku ali v bolnišnico.
Show them your pack of tablets.
Pokažite jim škatlico s svojimi tabletami.
If you forget to take Emselex If you forget to take Emselex at the usual time, take it as soon as you remember, unless it is the time for your next dose.
Če ste pozabili vzeti zdravilo Emselex Če ste pozabili vzeti Emselex ob običajnem času, ga vzemite, takoj ko se spomnite, razen če je že čas za naslednji odmerek.
If you stop taking Emselex It has been shown that taking all doses at the appropriate times can greatly increase the effectiveness of your medicine.
Če ste prenehali jemati zdravilo Emselex Izkazalo se je, da lahko jemanje vseh odmerkov ob ustreznem času močno zveča učinkovitost vašega zdravila.
Therefore, it is important to keep taking Emselex correctly, as described above.
Zato je pomembno, da ves čas jemljete Emselex pravilno, kot je opisano zgoraj.
The side effects caused by Emselex are usually mild and temporary.
Neželeni učinki, ki jih povzroča Emselex, so navadno blagi in začasni.
Other side effects Very common side effects (affecting 10 or more in every 100 patients) Dry mouth, constipation.
Drugi neželeni učinki Zelo pogosti neželeni učinki (Pojavijo se pri 10 ali več na vsakih 100 bolnikov.) Suha usta, zapeka.
41 Common side effects (affecting less than 10 in every 100 patients) Headache, abdominal pain, indigestion, feeling sick, dry eyes.
41 Pogosti neželeni učinki (Pojavijo se pri manj kot 10 na vsakih 100 bolnikov.) Glavobol, bolečine v trebuhu, prebavne motnje, slabo počutje, suhe oči.
Uncommon side effects (affecting less than 1 in every 100 patients) Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleep disturbance, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Občasni neželeni učinki (Pojavijo se pri manj kot 1 na vsakih 100 bolnikov.) Utrujenost, nezgodne poškodbe, otekanje obraza, visok krvni tlak, driska, vetrovi, vnetje ustne sluznice, zvišana raven jetrnih encimov, otekanje, vrtoglavost, motnje spanja, zaspanost, motnje mišljenja, nahod (rinitis), kašelj, kratka sapa, suha koža, srbenje, izpuščaj, znojenje, motnje vida vključno z zamegljenim vidom, motnje čuta za okus, bolezen ali okužba sečil, impotenca, izcedek iz nožnice in srbenje v nožnici, bolečina v sečnem mehurju, nezmožnost praznjenja mehurja.
• Keep out of the reach and sight of children. • Keep the blister packs in the outer carton in order to protect from light. • Do not use after the expiry date which is stated on the carton. • Do not use if the pack is damaged or shows signs of tampering.
• Zdravilo shranjujte nedosegljivo otrokom! • Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo. • Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici. • Ne uporabite zdravila, če je ovojnina poškodovana ali kaže znake, da jo je nekdo že odprl.
- The active substance is darifenacin (as hydrobromide).
Vsaka tableta
Each tablet contains 7.5 mg darifenacin.
vsebuje 7, 5 mg darifenacina.
- The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium
- Pomožne snovi so: brezvodni kalcijev hidrogenfosfat, hipromeloza, magnezijev stearat,
stearate, polyethylene glycol, titanium dioxide (E171) and talc.
polietilenglikol, titanov dioksid (E171) in smukec.
What Emselex looks like and contents of the pack Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with “ DF” on one side and “ 7.5” on the other.
Izgled zdravila Emselex in vsebina pakiranja Emselex 7, 5 mg tablete s podaljšanim sproščanjem so okrogle, konveksne bele tablete, ki imajo na eni strani vtisnjen napis “ DF ”, na drugi pa “ 7. 5 ”.
The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks comprising 10 packs, each pack containing 14 tablets.
Tablete so na voljo v pretisnih omotih po 7, 14, 28, 49, 56 ali 98 tablet ali v skupnem pakiranju, ki vsebuje 10 škatel po 14 tablet.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Izdelovalec Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Nemčija
If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
45 Take special care with Emselex: • if you have autonomic neuropathy - your doctor will have told you if you have this. • if you have heartburn and belching. • if you have difficulties in passing urine and a weak stream of urine. • if you have severe constipation (less than or equal to 2 bowel movements per week). • if you have an obstructive gastrointestinal disorder - your doctor will have told you if you have this. • if you are receiving treatment for narrow-angle glaucoma. • if you have liver problems. • if you have kidney problems.
45 Bodite posebno pozorni pri uporabi zdravila Emselex: • če imate avtonomno nevropatijo, na katero vas je opozoril že vaš zdravnik, • če imate zgago in riganje, • če imate težave pri odvajanju vode in šibek curek seča, • če ste zelo zaprti (če greste na blato največ dvakrat na teden), • če imate obstruktivno bolezen prebavil, za katero vam je že povedal vaš zdravnik, • če se zdravite zaradi glavkoma z zaprtim zakotjem, • če imate težave z jetri, • če imate težave z ledvicami.
46 For adults and older people, the recommended starting dose is 7.5 mg daily.
Priporočeni začetni odmerek za odrasle in starejše je 7, 5 mg na dan.
These doses are suitable for people with mild liver problems or people with kidney problems.
46 Navedeni odmerki so primerni za ljudi z blagimi jetrnimi težavami in za bolnike z ledvičnimi težavami.
Do not stop taking Emselex until your doctor tells you to.
Ne prenehajte jemati zdravila Emselex, dokler vam tega ne naroči vaš zdravnik.
47 Common side effects (affecting less than 10 in every 100 patients) Headache, abdominal pain, indigestion, feeling sick, dry eyes.
47 Pogosti neželeni učinki (Pojavijo se pri manj kot 10 na vsakih 100 bolnikov.) Glavobol, bolečine v trebuhu, prebavne motnje, slabo počutje, suhe oči.
Each tablet contains 15 mg darifenacin.
vsebuje 15 mg darifenacina.
stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
polietilenglikol, smukec, titanov dioksid (E171), rdeči železov oksid (E172) in rumeni železov oksid (E172).
What Emselex looks like and contents of the pack Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “ DF” on one side and “ 15” on the other.
Izgled zdravila Emselex in vsebina pakiranja Emselex 15 mg tablete s podaljšanim sproščanjem so okrogle, konveksne tablete svetlo breskove barve z vtisnjenim napisom “ DF ” na eni strani in “ 15” na drugi
48 If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
It is available as white and light blue capsules (200 mg) and as an oral solution (10 mg/ ml).
Na voljo je v obliki belih in svetlo modrih kapsul (200 mg) in peroralne raztopine (10 mg/ ml).
It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
For patients who have taken medicines to treat their HIV infection before and failed to respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus ’ s response to any new antiviral medicines that might be prescribed.
Bolnikom, ki so že jemali zdravila za zdravljenje okužbe s HIV, a se na to vrsto zdravljenja niso odzvali, lahko zdravniki predpišejo zdravilo Emtriva šele, ko pregledajo, katera zdravila je bolnik jemal prej in ocenijo verjetnost za odziv virusa na zdravljenje s katerimi koli novimi zdravili, ki bi jih utegnil predpisati.
Emtriva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Emtriva ne ozdravi okužbe s HIV ali AIDS- a, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, ki so povezane z AIDS- om.
How has Emtriva been studied?
Reproduction is authorised provided the source is acknowledged Kako je bilo zdravilo Emtriva raziskano?
In the first study of treatment-naïve adults, more patients taking Emtriva had viral loads below 50 copies/ ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
V prvi študiji bolnikov, ki se še niso zdravili, je bila po 24 tednih zdravljenja virusna obremenitev pod 50 kopij/ ml pri več bolnikih, ki so jemali zdravilo Emtriva kot pri tistih, ki so jemali stavudin (81% oziroma 70%).
This difference was maintained after 48 weeks of treatment (73% and 56%).
Ta razlika se je ohranila tudi po 48 tednih zdravljenja (73% oziroma 56%).
In the second study, Emtriva was as effective as lamivudine: after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ ml, and slightly fewer had viral loads below 50 copies/ ml.
V drugi študiji je bilo zdravilo Emtriva enako učinkovito kot lamivudin: po 48 tednih je bila pri dveh tretjinah bolnikov virusna obremenitev pod 400 kopij/ ml, pri nekoliko manjšem številu pa je bila virusna obremenitev pod 50 kopij/ ml.
In treatment- experienced patients, the number of patients switching from lamivudine to Emtriva with viral loads below 400 copies/ ml was similar to the number who continued taking lamivudine after 48 weeks (73% and 82%, respectively).
Pri zdravljenju bolnikov, ki so se zdravili že prej, je bilo število tistih, ki so prešli iz lamivudina na zdravilo Emtriva in pri katerih je bila virusna obremenitev manjša od 400 kopij/ ml, podobno številu bolnikov, ki so po 48 tednih zdravljenja še naprej jemali lamivudin (73% oziroma 82%).
As with all other NRTIs, Emtriva may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Emtriva during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Kot drugi NRTI- ji, lahko tudi zdravilo Emtriva povzroči acidozo zaradi povečane količine mlečne kisline v telesu, pri dojenčkih mater, ki med nosečnostjo prejemajo zdravilo Emtriva pa tudi mitohondrijsko disfunkcijo (poškodbe tistih delov celice, ki tvorijo energijo, kar lahko povzroči težave s krvjo).
The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Emtriva v kombinaciji z drugimi protivirusnimi sredstvi pri zdravljenju s HIV- 1 okuženih odraslih in otrok večje od z njim povezanih tveganj.
Other information about Emtriva:
2/ 3 Druge informacije o zdravilu Emtriva:
2/ 3 The full EPAR for Emtriva can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Emtriva je na voljo tukaj.
Pharmaceutical form Capsule, hard Capsule, hard
Kapsula, trda
Route of administration Oral use Oral use
Peroralna uporaba
Packaging Bottle (HDPE) Blister (Aclar/ polyethylene/ PVC)
Steklenica (HDPE)
Concentration
Kapsula, trda
Package size 30 capsules 30 capsules
30 kapsul
EU/ 1/ 03/ 261/ 003
(Aclar/ polietilen / PVC) EU/ 1/ 03/ 261/ 003
Bottle (polyethylene terephthalate)
Peroralna uporaba
10 mg/ ml
Steklenica 10 mg/ ml (polietilen tereftalat)
Each hard capsule contains 200 mg emtricitabine.
Vsaka trda kapsula vsebuje 200 mg emtricitabina.
Each capsule has a white opaque body with a light blue opaque cap.
Vsaka kapsula ima belo neprosojno telo s svetlo modrim neprosojnim pokrovčkom.
Each capsule is printed with “ 200 mg” on the cap and “ GILEAD” and [Gilead logo] on the body in black ink.
Oba odtisa sta črne barve.
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
4. 1 Terapevtske indikacije
There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
Z uporabo zdravila Emtriva pri bolnikih, pri katerih dotedanji ali večkratni režim zdravljenja ni bil uspešen ni izkušenj (glejte poglavje 5. 1).
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient.
Pri določanju novega režima zdravljenja pri bolnikih z neuspešnim predhodnim antiretrovirusnim režimom je potrebno posebno pozornost nameniti vzorcem mutacij kot posledico uporabe različnih zdravil in poteku zdravljenj pri posameznem bolniku.
The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Priporočeni odmerek zdravila Emtriva je ena 200 mg trda kapsula, peroralno, enkrat dnevno.
Children and adolescents up to 18 years of age:
Otroci in mladostniki do 18. leta starosti:
The recommended dose of Emtriva for children and adolescents weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
Priporočeni odmerek Emtriva za otroke in mladostnike, s telesno težo najmanj 33 kg, ki lahko pogoltnejo trdo kapsulo, je ena 200 mg trda kapsula, peroralno, enkrat dnevno.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
Ni podatkov glede učinkovitosti emtricitabina pri dojenčkih, mlajših od 4- ih mesecev, podatki glede varnosti emtricitabina pa so zelo omejeni.
Therefore Emtriva is not recommended for use in those aged less than 4 months.
Zato se uporaba zdravila Emtriva pri bolnikih, mlajših od 4- ih mesecev ne priporoča.
(For pharmacokinetic data in this age group, see section 5.2).
(Za farmakokinetične podatke v tej starostni skupini glejte poglavje 5. 2.)