natgillin/translations-raw huggingface dataset:
Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml), which is used when the medicine cannot be given by mouth.
Briviact je dostupan u obliku tableta (10, 25, 50, 75 i 100 mg), u obliku otopine za peroralnu upotrebu (10 mg/ml) te u obliku otopine za injekciju ili infuziju (drip) u venu (10 mg/ml), koja se može upotrebljavati ako se lijek ne može primijeniti peroralno.
The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness.
Najčešće nuspojave lijeka Briviact (mogu se javiti u više od 1 na 10 osoba) jesu somnolencija (pospanost) i omaglica.
For more information about using Briviact, see the package leaflet or contact a doctor or pharmacist.
Više informacija o primjeni lijeka Briviact pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Briviact have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Briviact nalaze se u sažetku opisa svojstava i u uputi o lijeku.
As for all medicines, data on the use of Briviact are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Briviact kontinuirano se prate.
Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Briviact pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain).
Briviact je lijek za epilepsiju koji se upotrebljava kao dodatak drugim lijekovima za epilepsiju za liječenje parcijalnih epileptičkih napadaja (epileptičkih napadaja koji počinju u jednom određenom dijelu mozga).
Either Briviact or placebo was added to patients' usual epilepsy treatment.
Ili Briviact ili placebo dodani su bolesnikovom uobičajenom liječenju za epilepsiju.
Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 4 years of age.
Klinička ispitivanja pokazala su da je dodatno liječenje lijekom Briviact učinkovitije od placeba u kontroli parcijalnih napadaja u odraslih i djece starije od četiri godine.
Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.
Briviact se ne smije upotrebljavati u bolesnika koji su preosjetljivi (alergični) na brivaracetam, na druge derivate pirolidona (tvari koje su kemijski slične brivaracetamu) ili na bilo koje druge sastojke.
An overview of Briviact and why it is authorised in the EU
Pregled informacija o lijeku Briviact i zašto je odobren u EU-u
Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day.
U ispitivanjima je učestalost napadaja bila barem prepolovljena u 34 do 38 % onih bolesnika u kojih je dodan lijek Briviact u dozama od 25 do 100 mg dva puta dnevno.
What are the risks associated with Briviact?
Koji su rizici povezani s lijekom Briviact?
Briviact is more effective than placebo (a dummy treatment) at reducing seizures.
Briviact je učinkovitiji od placeba (prividno liječenje) u smanjenju napadaja.
The European Medicines Agency decided that Briviact's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Briviact nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Why is Briviact authorised in the EU?
Zašto je lijek Briviact odobren u EU-u?
Most side effects of Briviact were of mild or moderate severity and were considered manageable.
Većina nuspojava lijeka Briviact bila je blaga ili umjerena te su se smatrale rješivima.
How does Briviact work?
Kako djeluje Briviact?
(brivaracetam)
Briviact1 (brivaracetam)
The recommended starting dose in adults and younger patients weighing more than 50 kg is either 25 mg twice a day or 50 mg twice a day, depending on the patient's condition.
Preporučena početna doza u odraslih i mlađih bolesnika tjelesne težine veće od 50 kg je ili 25 mg dva puta dnevno ili 50 mg dva puta dnevno, ovisno o stanju bolesnika.
In those weighing less than 50 kg the dose is based on body weight and the usual starting dose is 0.5 mg per kg body weight twice a day.
U bolesnika tjelesne težine manje od 50 kg, doza se temelji na tjelesnoj težini te je uobičajena početna doza 0,5 mg po kilogramu tjelesne težine dva puta dnevno.
What benefits of Briviact have been shown in studies?
Koje su koristi od lijeka Briviact utvrđene u ispitivanjima?
The dose can then be adjusted according to the patient's needs up to a maximum of 100 mg or 2 mg per kg respectively, twice a day.
Dozu je moguće prilagoditi u skladu s bolesnikovim potrebama do najviše 100 mg, odnosno 2 mg po kilogramu, dva puta dnevno.
This compares with 20% in those adding placebo.
U bolesnika kojima je dodan placebo je, za usporedbu, to bilo 20 %.
How is Briviact used?
Kako se Briviact koristi?
For the full list of side effects of Briviact, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Briviact potražite u uputi o lijeku.
In Asian countries: reported as rare d
U azijskim državama: prijavljenji kao rijetko d
Your doctor will not prescribe PROTELOS for you if you are at particular risk.
Vaš liječnik neće Vam propisati PROTELOS ako ste u osobitom riziku.
What protelos is and what it is used for
Što je PROTELOS i za što se koristi
PROTELOS contains aspartame:
PROTELOS sadrži aspartam:
Like all medicines, this medecine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
What PROTELOS is and what it is used for What you need to know before you take PROTELOS How to take PROTELOS
Sto je PROTELOS i za što se koristi Što morate znati prije nego počnete uzimati PROTELOS
If you are of Asian origin, talk to your doctor before taking PROTELOS as you may be at higher risk of skin reactions.
Ako ste azijskog porijekla, porazgovarajte sa svojim liječnikom prije uzimanja PROTELOS -a budući da možete imati veći rizik nastanka kožnih reakcija.
However, it is recommended to drink the suspension immediately after preparation (see section 3) Do not throw away any medicines via wastewater or household waste.
Međutim, preporučuje se suspenziju popiti odmah nakon njene pripreme (vidjeti dio 3.) Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
Heart attack may occur commonly in patients at high risk for heart disease.
Srčani udar može se dogoditi često kod bolesnika s visokim rizikom za nastanak srčanih bolesti.
The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Sigurnost i djelotvornost lijeka PROTELOS u djece starosti do 18 godina nisu još ustanovljene.
It is important that you continue taking PROTELOS for as long as your doctor prescribes the medicine.
Važno je da PROTELOS uzimate onoliko dugo koliko Vam je liječnik odredio.
Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Stoga razmak između uzimanja PROTELOS-a i tih proizvoda mora iznositi najmanje dva sata (vidjeti dio 5.2)
If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again
Ukoliko ste prestali uzimati lijek zbog reakcija preosjetljivosti, ne smijete ponovo započeti uzimanje PROTELOS-a
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Nositelj odobrenja će osigurati da, nakon rasprave i dogovora sa nacionalnim nadležnim tijelom svake države članice gdje je PROTELOS prisutan na tržištu, svi liječnici za koje se očekuje da će propisivati
After approval of the protocol, annual reports from this study shall be provided within the PSUR until submission of the final study report, which is due by December 2017.
PSURom sve dok se ne preda završno izvješće koje se treba predati do prosinca 2017. godine.
What you need to know before you take protelos Do not take PROTELOS:
Što morate znati prije nego počnete uzimati PROTELOS
PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Pomoćna tvar PROTELOS sadržava izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.
The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common:may affect up to 1 in 10 people uncommon: mayaffect up to 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: mayaffect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
vrlo često: mogu se pojaviti u više od 1 na 10 osoba često: mogu se pojaviti u do 1 na 10 osoba manje često: mogu se pojaviti u do 1 na 100 osoba rijetko: mogu se pojaviti u do 1 na 1000 osoba vrlo rijetko: mogu se pojaviti u do 1 na 10 000 osoba nepoznato: učestalost se ne može procijeniti iz dostupnih podataka Često:
During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking PROTELOS and seek medical advice.
Ukoliko Vam se tijekom liječenja dogodi alergijska reakcija (npr. oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju, kožni osip), morate odmah prekinuti uzimanje PROTELOS -a i potražiti pomoć liječnika.
Statistically significant increases in BMD were observed as early as 6 months following initiation ofPROTELOS treatment versus placebo.
Povećanje BMD-a bilo je statistički značajno već 6 mjeseci nakon početka uzimanja PROTELOS-a u usporedbi s placebom.
If you take too many sachets of PROTELOS, tell your doctor or pharmacist.
Uzmete li previše vrećica PROTELOS-a, kažite to svome liječniku ili ljekarniku.
Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively).
Terapija je prekidana uglavnom zbog mučnine (1,3% u skupini koja je uzimala placebo i 2,2
Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
faze bili barem moguće povezani s liječenjem stroncijevim ranelatom, navedene su niže i prema učestalosti razvrstane su na sljedeći način (učestalost u odnosu na placebo): vrlo često (>1/10); često (>1/100, <1/10); manje često (>1/1000, <1/100); rijetko (>1/10 000, <1/1000); vrlo rijetko (<1/10 000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate.
Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima i/ili nakon stavljanja stroncijevog ranelata u promet.
How to take protelos
Kako uzimati PROTELOS
If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
PROTELOS nehotice u trudnoći, liječenje se mora obustaviti.
- If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
- Uzimate li lijekove koji sadržavaju kalcij, PROTELOS smijete uzeti tek nakon što prođu najmanje dva sata od uzimanja tih lijekova.
However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists
No osteoporoza povećava sklonost prijelomima kostiju (frakturama), osobito prijelomima kralješnice, kukova i zapešća
Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
SOTI i TROPOS, sudjelovalo je 1556 bolesnica starijih od 80 godina pri uključivanju u ispitivanju
As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
PROTELOS-a mora se obustaviti za vrijeme liječenja peroralnim tetraciklinskim ili kinolonskim antibioticima.
This is especially common in women after the menopause Many people with osteoporosis have no symptoms and you may not even know that you have it.
Mnoge osobe s osteoporozom nemaju nikakvih simptoma, tako da možda ni ne znaju da imaju osteoporozu.
• PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
o Bolesnika sa značajnim čimbenicima rizika za nastanak kardiovaskularnih događaja kao što su hipertenzija, hiperlipidemija, diabetes mellitus ili pušenje.
EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
EU/1/04/288/004 56 vrećica EU/1/04/288/005 84 vrećica(3 pakiranja od 28 vrećica) EU/1/04/288/006 100 vrećica
Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed.
Tijekom 12 mjeseci uočeno je statistički značajno povećanje BMD-a lumbalne kralježnice, glavnog kriterija djelotvornost (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001), je održano tijekom 12
Talk to your doctor or pharmacist before taking PROTELOS: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes,
- ako imate rizik za srčanu bolest, što uključuje visoki krvni tlak, visoku razinu kolesterola,
In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
U ispitivanjima III. faze klirens kreatinina u 85 % ispitanika bio je između 30 i 70 ml/min, a u njih 6 % bio je manji od 30
Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration
Uzimanjem stroncijeva ranelata s kalcijem ili s hranom smanjuje se bioraspoloživost stroncija za oko 60-70 % u usporedbi s primjenom 3 sata nakon jela.
- If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
- Uzimate li antacide (lijekovi protiv žgaravice), smijete ih uzeti tek nakon što prođu najmanje dva sata od uzimanja PROTELOS-a.
The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Liječenje osteoporoze u poslijemenopauzi: Program ispitivanja PROTELOS-a u sprječavanju prijeloma sastojao se od dvaju placebom kontroliranih ispitivanja III. faze: ispitivanje SOTI i ispitivanje TROPOS.
In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
U ispitivanjima III. faze, kojima je dokazana djelotvornost PROTELOS -a u sprječavanju prijeloma, izmjerena BMD povećavala se pri uzimanju PROTELOS -a u odnosu na početnu vrijednost za oko 4 % godišnje u slabinskim kralješcima i oko 2 % godišnje u vratu bedrene kosti te se do kraja istraživanja, nakon 3 godine, ovisno o istraživanju, povećala za ukupno 13 % do
The outcome of DRESS is favorable in most cases upon discontinuation of PROTELOS and after initiation of corticosteroid therapy when necessary.
DRESS-a povoljan nakon prestanka primjene PROTELOS-a i nakon uvođenja liječenja kortikosteroidima kada je neophodno.
Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo.
Health perception score) ljestvicom SF-36 također je pokazala koristi PROTELOS-a u odnosu na placebo.
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Ukoliko su prisutni simptomi ili znakovi SJS ili TEN (npr. progresivni kožni osip s mjehurićima ili mukoznim lezijama) ili DRESS (npr. osip, vrućica, eozinofilija i sustavni simptomi (npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska bolest pluća) treba odmah prekinuti primjenu
- if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
- ako ste preosjetljivi (alergični) na stroncijev ranelat ili na bilo koji drugi sastojak PROTELOS
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Združena analiza podataka iz ispitivanja SOTI i TROPOS u bolesnica starijih od 80 godina pri uključivanju u ispitivanje, pokazala je da je PROTELOS tijekom 3 godine smanjio relativni rizik od novih prijeloma kralješnice za 32 % (pojavnost prijeloma 19,1 % u skupini koja je uzimala stroncijev ranelat naspram 26,5 % u skupini koja je uzimala placebo).
Each sachet contains 2 g of strontium ranelate.
Jedna vrećica sadrži 2 g stroncijeva ranelata.
PROTELOS 2 g granules for oral suspension Strontium ranelate
PROTELOS 2 g granule za oralnu suspenziju stroncijev ranelat
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Ukoliko ste razvili osip ili gore nabrojane kožne simptome prestanite uzimati PROTELOS, hitno zatražite savjet liječnika i recite mu da uzimate ovaj lijek.
Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Iskustvo nakon stavljanja lijeka u promet b Porast vrijednosti mišićno-koštane frakcije > 3 puta iznad gornje granice normalnog raspona.
In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Zbirni podaci iz placebom kontroliranih kliničkih ispitivanja na bolesnicama s postmenopauzalnom osteoporozom, bolesnice liječene stroncijevim ranelatom (N=3803, 11 270 bolesnik-godina liječenja)
Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough).
(kao npr. vrijed u ustima ili upala desni), bol u kostima, mišićima i/ili u zglobovima, mišični grčevi, gubitak kose, smanjena proizvodnja krvnih stanica u koštanoj srži, svrbež, koprivnjača, pojava mjehurića, angioedem (oticanje lica, jezika ili grla, poteškoće u gutanju ili disanju), otekline na rukama ili nogama, malaksalost, osjećaj smetenosti, bronhijalna hiperreaktivnost (simptomi uključuju piskanje, nedostatak zraka i kašalj).
You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Ako morate uzimati kroz usta tetracikline ili kinolone (dvije vrste antibiotika), morate prestati uzimati
In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
lumbalne kralješnice i/ili vrata bedrene kosti na početku ispitivanja bila u rasponu osteopenije, bez prisutnosti prijeloma, no s najmanje jednim dodatnim čimbenikom rizika za prijelom (N = 176), pokazala je da je PROTELOS tijekom 3 godine smanjio rizik od prvog prijeloma kralješnice za 72 % (incidencija prijeloma kralješnice 3,6 % u skupini koja je uzimala stroncijev ranelat naspram 12,0 % u skupini koja je uzimala placebo).
Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding.
Fizikalno-kemijski podaci ukazuju da se stroncijev ranelat izlučuje u majčino mlijeko.
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Stroncijev se ranelat ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina manji od 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
INFORMATION IN BRAILLE PROTELOS 2 g
16. PODACI NA BRAILLEOVOM PISMU PROTELOS
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8).
Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnica s osteoporozom u postmenopauzi primjećen je značajan porast infarkta miokarda kod bolesnica liječenih PROTELOS
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
(Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza i teške reakcije preosjetljivosti (DRESS)).
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in PROTELOS treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
om u usporedbi s placebom (1,7% u usporedbi s 1,1 %), s relativnim rizikom od 1,6 (95% CI = [1,07 ;
PROTELOS is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible.
- u žena u poslijemenopauzi - u muškaraca s visokim rizikom za nastanak prijeloma, kod kojih drugo liječenje nije moguće.
Excipient
Dispepsija
PROTELOS 2 g granules for oral suspension
NAZIV LIJEKA PROTELOS 2 g granule za oralnu suspenziju
NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate
Uputa o lijeku: Informacija za bolesnika PROTELOS 2 g granule za oralnu suspenziju stroncijev ranelat
PROTELOS is for oral use.
Način primjene Za peroralnu primjenu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate.
Jedna vrećica sadržava 2 g stroncijeva ranelata.