natgillin/translations-raw huggingface dataset:
The VZV specific immune responses to ZOSTAVAX at Week 4 post-vaccination were comparable whether administered by SC or IM route.
Za VZV specifični imunski odziv na cepivo ZOSTAVAX je bil 4 tedne po cepljenju podoben po subkutani in po intramuskularni uporabi.
Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe without needle (solvent) 10 vials (powder) + 10 pre-filled syringes without needle (solvent) 20 vials (powder) + 20 pre-filled syringes without needle (solvent)
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna viala (prašek) + 1 napolnjena injekcijska brizga brez igle (vehikel) 10 enoodmernih vial (prašek) + 10 napolnjenih injekcijskih brizg brez igle (vehikel) 20 enoodmernih vial (prašek) + 20 napolnjenih injekcijskih brizg brez igle (vehikel)
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Cepivo ZOSTAVAX z vehiklom za rekonstitucijo v napolnjeni injekcijski brizgi Prašek v viali (steklo) z zamaškom (butilna guma) in s prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma) z eno ali dvema nepritrjenima iglama.
Arthralgia, Myalgia, Pain in extremity
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, mialgija, bolečina v okončini pogosti
VIAL OF SOLVENT
VIALA Z VEHIKLOM
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Če opazite prisotnost tujih delcev in/ali neobičajen izgled cepiva pred injiciranjem, je treba cepivo zavreči.
Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe with needle (solvent) 10 vials (powder) + 10 pre-filled syringes with needle (solvent)
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga z iglo (vehikel) 10 vial (prašek) + 10 napolnjenih injekcijskih brizg z iglo (vehikel)
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber), in a pack size of 1 or 10.
Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in z iglo z zaščito (naravna guma).
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with attached needle Pack of 1,
ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi brez igle - pakiranje po 1,
The SPS study was a placebo-controlled, double-blind clinical trial in which 38,546 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 3.1 years (range 31 days to 4.9 years).
Študija preprečevanja pasovca (SPS - Shingles Prevention Study) pri osebah, starih 60 let ali več: Študija SPS je bila s placebom nadzorovano, dvojno slepo klinično preskušanje, v katerem so 38.546 oseb randomizirali na prejetje enega odmerka cepiva ZOSTAVAX ali placeba.
OTHER
ZDA
ZOSTAVAX Powder and solvent for suspension for injection shingles (herpes zoster) vaccine (live)
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje cepivo proti pasovcu (herpesu zostru) (živo)
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
Cepivo v obliki praška za suspenzijo za injiciranje se nahaja v enoodmerni viali.
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1, 10 or 20.
Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in s pokrovčkom (stiren-butadienska guma) brez igle.
It usually occurs in one part of the body and can last for several weeks.
Lahko traja več tednov.
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti pasovcu (herpesu zostru) (živo)
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
Cepivo ZOSTAVAX z vehiklom za rekonstitucijo v viali Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v viali (steklo) z zamaškom (klorobutilna guma) in s prekrivno zaporko (aluminij).
At four weeks post-vaccination, the VZV-specific immune responses following concomitant use were not similar to the VZV-specific immune responses following nonconcomitant administration.
Imunski odziv, specifičen za VZV, štiri tedne po cepljenju v skupini, ki je prejela obe cepivi sočasno, ni bil podoben kot v skupini, ki cepiv ni prejela sočasno.
ZOSTAVAX was administered either subcutaneously (SC) or intramuscularly (IM) in subjects 50 years of age or older (see section 5.1).
Cepivo ZOSTAVAX so osebam, starim 50 let ali več, injicirali subkutano (s.c.) ali intramuskularno (i.m.)
Subjects who received ZOSTAVAX by SC (subcutaneous) or IM (intramuscular) route In an open-label, randomised, controlled clinical trial, ZOSTAVAX was administered either by SC route or by IM route to 353 subjects 50 years of age or older.
V odprtem, randomiziranem nadzorovanem kliničnem preskušanju so 353 osebam, starim 50 let ali več, cepivo ZOSTAVAX dali subkutano ali intramuskularno.
Number of subjects
Št. oseb
All patients were receiving standard treatment.
Vsi bolniki so prejemali standardno zdravljenje.
Treatment with Cablivi may continue for longer if necessary.
Zdravljenje z zdravilom Cablivi se lahko po potrebi nadaljuje tudi dalj časa.
Patients also receive treatments to reduce the immune system's activity.
Bolniki prejmejo tudi zdravilo za zmanjšanje dejavnosti imunskega sistema.
The most important side effect of treatment is bleeding but it is considered manageable.
Najpomembnejši neželeni učinek zdravljenja je krvavitev, vendar velja za obvladljivega.
The European Medicines Agency decided that Cablivi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Cablivi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Cablivi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cablivi?
Further information on Cablivi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Cablivi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patients or their carers may be able to inject Cablivi themselves after appropriate training.
Bolniki ali njihovi negovalci si lahko po ustreznem usposabljanju zdravilo Cablivi injicirajo sami.
As for all medicines, data on the use of Cablivi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cablivi stalno spremljajo.
What benefits of Cablivi have been shown in studies?
Kakšne koristi zdravila Cablivi so se pokazale v študijah?
The most common side effects with Cablivi (which may affect more than 1 in 10 people) are nosebleeds, headache and bleeding from gums.
Najpogostejši neželeni učinki zdravila Cablivi (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so krvavitev iz nosu, glavobol in krvavitev iz dlesni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cablivi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cablivi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Cablivi
Druge informacije o zdravilu Cablivi
The company is expected to provide results of a study on Cablivi's safety and effectiveness over a longer period.
Pričakuje se, da bo podjetje priskrbelo rezultate študije glede dolgoročne varnosti in učinkovitosti zdravila Cablivi.
Why is Cablivi authorised in the EU?
Zakaj je bilo zdravilo Cablivi odobreno v EU?
An overview of Cablivi and why it is authorised in the EU
Pregled zdravila Cablivi in zakaj je odobreno v EU
What are the risks associated with Cablivi?
Kakšna tveganja so povezana z zdravilom Cablivi?
For more information about using Cablivi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Cablivi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Cablivi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Cablivi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Treatment should be started and supervised by doctors experienced in managing patients who have clotting disorders affecting small blood vessels.
Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami strjevanja krvi, ki prizadenejo majhne krvne žile.
The company that markets Cablivi will provide materials, including a patient alert card, on the risk of serious bleeding and how the risk should be managed.
Podjetje, ki trži zdravilo Cablivi, bo priskrbelo gradivo, vključno z opozorilno kartico za bolnika, o tveganju za resno krvavitev in njegovem obvladovanju.
What is Cablivi and what is it used for?
Kaj je zdravilo Cablivi in za kaj se uporablja?
In patients with aTTP, levels of a substance called von Willebrand factor are increased.
Pri bolnikih s pridobljeno trombotično trombocitopenično purpuro se zvišajo ravni snovi, imenovane von Willebrandov faktor.
Cablivi is used together with plasma exchange (in which certain antibodies are removed from the blood) and treatments to reduce the activity of the immune system (the body's defences).
Zdravilo Cablivi se uporablja skupaj z izmenjavo plazme (pri tej se iz krvi odstranijo določena protitelesa) in zdravili za zmanjševanje dejavnosti imunskega sistema (naravnega obrambnega mehanizma telesa).
This reduces platelets sticking together and forming clots in blood vessels and, as a result, platelet levels in the blood rise because they are no longer taken up to form clots.
To zmanjšuje zlepljenje krvnih ploščic in nastanek strdkov v krvnih žilah, to pa posledično zviša raven krvnih ploščic v krvi, ker ne tvorijo več strdkov.
aTTP is rare, and Cablivi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Pridobljena trombotična trombocitopenična purpura je redka, zato je bilo zdravilo Cablivi 30. aprila 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Treatment is continued with 10 mg daily given by injection under the skin in the belly after daily plasma exchange and continued for 30 days after daily plasma exchange is stopped.
Zdravljenje se nadaljuje z odmerkom 10 mg enkrat na dan s podkožno injekcijo v trebuh po dnevni izmenjavi plazme in se nadaljuje 30 dni po tem, ko je izmenjava plazme zaključena.
The Agency considered that, in patients with aTTP, Cablivi combined with plasma exchange and immunosuppression can reduce the time it takes for platelet counts to return to the normal range, which is associated with shorter duration of plasma exchange treatment and shorter stay in intensive care facility.
Agencija je menila, da pri bolnikih s pridobljeno trombotično trombocitopenično purpuro zdravilo Cablivi v kombinaciji z izmenjavo plazme in imunosupresijo lahko zmanjša čas, potreben za vrnitev števila krvnih ploščic na normalno raven, to pa je povezano s krajšim časom zdravljenja z izmenjavo plazme in bivanja na oddelku za intenzivno nego.
The second study, involving 145 patients, measured how long it took for the platelet count to return to the normal range and for sufficient improvement in the condition to allow daily plasma exchange to be stopped within 5 days.
Druga študija je vključevala 145 bolnikov, v njej pa so proučevali, po koliko časa se je število krvnih ploščic vrnilo na normalno raven in se je stanje ustrezno izboljšalo, da se je izmenjava plazme lahko zaključila v petih dneh.
In the first study, involving 75 patients, platelet counts returned to the normal range after 3 days on average in patients treated with Cablivi, compared with nearly 5 days in those receiving placebo (a dummy treatment).
V prvi študiji, ki je vključevala 75 bolnikov, se je število krvnih ploščic vrnilo na normalno raven v povprečju po treh dneh pri bolnikih, zdravljenih z zdravilom Cablivi, in po skoraj petih dneh pri bolnikih, ki so prejemali placebo (zdravilo brez učinkovine).
Two main studies have investigated the effectiveness of Cablivi in patients with aTTP who required plasma exchange to treat their condition.
V dveh glavnih študijah so preučevali učinkovitost zdravila Cablivi pri bolnikih s pridobljeno trombotično trombocitopenično purpuro, ki so za zdravljenje bolezni potrebovali izmenjavo plazme.
For the full list of side effects and restrictions with Cablivi, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cablivi glejte navodilo za uporabo.
Caplacizumab, the active substance in Cablivi, is a nanobody (a small antibody) which has been designed to attach to von Willebrand factor in a way that stops it acting on platelets.
Učinkovina zdravila Cablivi, kaplacizumab, je nanotelo (majhno protitelo), ki je zasnovano za pritrditev na von Willebrandov faktor tako, da zavira njegovo delovanje na krvne ploščice.
Cablivi is started with a dose of 10 mg given by injection into a vein before plasma exchange.
Zdravljenje z zdravilom Cablivi se začne z odmerkom 10 mg in se daje z injiciranjem v veno pred izmenjavo plazme.
During an episode of aTTP, blood clots form in small blood vessels and the patient has a low count of platelets (components that help the blood to clot).
Med epizodo pridobljene trombotične trombocitopenične purpure v majhnih krvnih žilah nastajajo strdki in bolnik ima nizko število krvnih ploščic (sestavine krvi, ki sodelujejo pri strjevanju krvi).
Cablivi is a medicine used for treating adults who have an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a blood clotting disorder.
Zdravilo Cablivi se uporablja za zdravljenje odraslih, ki imajo epizode pridobljene trombotične trombocitopenične purpure, motnje strjevanja krvi.
The study found that platelet count was likely to return to the normal range more quickly in patients treated with Cablivi compared with those receiving placebo.
V študiji so ugotovili, da je bilo verjetneje, da se število krvnih ploščic na normalno raven vrne hitreje pri bolnikih, zdravljenih z zdravilom Cablivi, kot pri bolnikih, zdravljenih s placebom.
How is Cablivi used?
Kako se zdravilo Cablivi uporablja?
How does Cablivi work?
Kako zdravilo Cablivi deluje?
Cablivi can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Cablivi je le na recept.
von Willebrand factor acts on platelets to cause them to stick together and form blood clots.
Ta deluje na krvne ploščice in povzroči, da se zlepijo in tvorijo krvne strdke.
Cablivi contains the active substance caplacizumab.
Zdravilo Cablivi vsebuje učinkovino kaplacizumab.
Then continue your treatment as before.
Potem zdravljenje nadaljujte kot prej.
Date of first authorisation: 22 November 2018
Datum prve odobritve: 22. november 2018
This will help by:
To lahko pomaga, ker:
Blood tests may also show:
Preiskave krvi lahko pokažejo tudi:
3; these characteristics were similar between treatment groups.
3; te značilnosti so bile med terapevtskima skupinama podobne.
Do not give this medicine to anybody aged less than 18 years.
Tega zdravila ne smete dati nikomur, ki je mlajši od 18 let.
Talk to your doctor about what you can do to avoid infecting other people.
Z zdravnikom se posvetujte, kaj lahko storite, da ne boste okužili drugih oseb.
The recommended dose is 1 tablet once a day.
Priporočeni odmerek zdravila je 1 tableta enkrat na dan.
On study but missing data in window
V študiji, toda z manjkajočimi podatki v oknu
The patient should not take 2 doses at one time.
Bolnik ne sme vzeti 2 odmerkov naenkrat.
Treatment results are shown in Table 5.
Rezultati zdravljenja so prikazani v preglednici 5.
No Virologic Data Within the Time Window
Brez viroloških podatkov znotraj časovnega okna
Your doctor may need to do additional tests to check your bones.
Zdravnik vam bo morda moral opraviti dodatne preiskave za kontrolo kosti.
Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Imunski sistem se vam lahko okrepi in se začne boriti proti okužbam, ki so bile že dolgo skrite v telesu.
• This medicine can be taken with food or between meals.
• To zdravilo lahko vzamete hkrati s hrano ali med enim in drugim obrokom.
A similar effect was not seen in rats even at very high systemic exposure.
Pri podganah podobnega učinka niso opazili niti pri zelo veliki sistemski izpostavljenosti.
It belongs to a group of medicines called ‘antiretroviral medicines'.
Spada v skupino zdravil, imenovanih "protiretrovirusna zdravila".
mannitol, lactitol or maltitol), if taken regularly
manitol, laktitol ali maltitol), če jih jemljete redno.
These tumours are unlikely to be of relevance to humans.
Ni verjetno, da so ti tumorji pomembni za človeka.
Physicians are encouraged to register patients in this registry.
Zdravnike prosimo, naj takšne bolnice zabeležijo v ta register.
Passing HIV to others
Prenašanje virusa HIV na druge osebe
This should be considered when assessing a patient's ability to drive or operate machinery.
To je treba upoštevati pri ocenjevanju bolnikove sposobnosti za vožnjo in upravljanje strojev.
There may be more than one in the bottle.
V plastenki je lahko več kot eno sušilo.
Do not stop taking this medicine without first talking to your doctor.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
Discontinued study for Other Reasons
Prenehanje sodelovanja v študiji zaradi drugih razlogov
If you take certain medicines your doctor may need to change the amount of doravirine you take.
Če jemljete določena druga zdravila, vam bo zdravnik morda moral spremeniti količino doravirina, ki jo jemljete.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Biliary excretion of unchanged medicinal product may contribute to the elimination of doravirine, but this elimination route is not expected to be significant.
Biliarno izločanje nespremenjenega zdravila lahko pripomore k izločanju doravirina, vendar ni pričakovati, da bi bila to pomembna pot za odstranjevanje.
ISG-DSG, Difference (95 % CI)*
ISG-DSG, razlika (95 % IZ)*
• increasing the number of white blood cells called ‘CD4
• poveča število belih krvnih celic, imenovanih "celice CD4
Cross-resistance has been observed among NRTIs.
Med NRTI je bila opažena navzkrižna odpornost.
• Do not use this medicine after the expiry date which is stated on the bottle after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki poleg oznake EXP.
• feeling of incomplete defecation
• občutek nepopolnega iztrebljanja
Delstrigo may have a minor influence on the ability to drive and use machines.
Zdravilo Delstrigo lahko ima manjši vpliv na sposobnost za vožnjo in upravljanje strojev.
The most frequently reported adverse reactions considered possibly or probably related to doravirine were nausea (4 %) and headache (3 %).
Najpogosteje poročana neželena učinka, ki veljata za morda ali verjetno povezana z doravirinom, sta bila navzea (4 %) in glavobol (3 %).
Investigations Common alanine aminotransferase increased
Preiskave Pogosti zvišanje alanin-aminotransferaze
NNRTI substitutions and use of doravirine
Z NNRTI povezane substitucije in uporaba doravirina
These medicinal products include, but are not limited to the following:
Med takšna spadajo naslednja zdravila (toda ne samo ta):
Co-administration should be avoided.
Sočasni uporabi se je treba izogniti.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Delstrigo.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se z zdravnikom posvetujte o tveganjih in koristih jemanja zdravila Delstrigo.
GM: Geometric mean, %CV: Geometric coefficient of variation
GS: geometrična sredina, % KV: geometrični koeficient variacije
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
• Do not take two doses of Delstrigo at the same time to make up for a missed dose.
• Ne vzemite dveh odmerkov zdravila Delstrigo hkrati, da bi nadomestili izpuščeni odmerek.
Antiviral activity in cell culture
Protivirusna aktivnost v celični kulturi
HIV is spread by contact with blood or through sexual contact with a person with HIV.
Virus HIV se širi s stikom z okuženo krvjo ali s spolnimi stiki z okuženo osebo.
If you stop taking Delstrigo, your doctor will need to check your health often and do blood tests regularly for several months to check your HIV infection.
Če nehate jemati zdravilo Delstrigo, bo moral zdravnik pogosto preverjati vaše zdravstveno stanje in še več mesecev redno izvajati preiskave krvi za spremljanje okužbe s HIV.
Following oral administration, lamivudine is rapidly absorbed and extensively distributed.
Po peroralni uporabi se lamivudin hitro absorbira in obsežno porazdeli.
The clinical relevance of a 5-10 fold change reduction in susceptibility is unknown.
Klinični pomen od 5- do 10-kratnega zmanjšanja občutljivosti ni znan.
Table 3: Resistance development up to week 96 in protocol defined virologic failure population + early discontinuation population
Preglednica 3: Razvoj odpornosti do 96. tedna v populaciji z virološkim neuspehom, opredeljenim po protokolu in v populaciji z zgodnjim prenehanjem
The doravirine-based regimens demonstrated consistent efficacy across demographic and baseline prognostic factors.
Shemi zdravljenja na osnovi doravirina sta bili dosledno učinkoviti po vseh demografskih in izhodiščnih prognostičnih dejavnikih.
There is insufficient information on the effects of tenofovir in newborns/infants.
O učinkih tenofovirja pri novorojenčkih/dojenčkih ni dovolj informacij.
Although the effect of supplementation with calcium and Vitamin D was not studied, such supplementation may be beneficial in all patients.
Učinek dodajanja kalcija in vitamina D sicer ni raziskan, toda njuno dodajanje lahko koristi vsem bolnikom.
• abnormal dreams, difficulty in sleeping (insomnia)
• nenormalne sanje, težave s spanjem (nespečnost)
These differences in pharmacokinetics are not clinically relevant.
Te razlike v farmakokinetiki niso klinično pomembne.
Parameter GM ( %CV)
Parameter GS (% KV)