qanastek/EMEA-V3 huggingface dataset:
(See section 4.4.)
Lietojot TESAVEL kombin cij ar sulfonilur nvielas atvasin jumu, vajadz tu apsv rt maz k s sulfonilur nvielas atvasin jumu devas lietošanu, lai var samazin tu hipoglik mijas risku (skat t apakšpunktu 4. 4).
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
14 Pacienti ar nieru mazsp ju Pacientiem ar vieglu nieru mazsp ju (kreatin na kl renss [CrCl] ≥ 50 ml/ min) TESAVEL deva nav j piel go.
Elderly No dosage adjustment is necessary based on age.
Gados vec ki Vecuma d devas piel gošana nav nepieciešama.
Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
15 Metform ns: lietojot vienlaikus vair kas 1000 mg metform na devas divreiz dien kop ar 50 mg sitaglipt na, pacientiem ar 2. tipa cukura diab tu noz m gas sitaglipt na farmakokin tikas p rmai as nekonstat ja.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Metabolisms, tai skait CYP3A4 medi tais, tikai nedaudz ietekm sitaglipt na kl nrensu pacientiem ar norm lu nieru funkciju.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Kl niskos p t jumos sitaglipt ns noz m gi neietekm ja metform na, glibur da, simvastat na, rosiglitazona, varfar na vai peror lo kontracepcijas l dzek u farmakokin tiku, sniedzot in vivo pier d jumus par mazu iesp ju izrais t z u mijiedarb bu ar CYP3A4, CYP2C8, CYP2C9 substr tiem un organisko katjonu transportvielu (OKT).
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
Sitaglipt nam ir neliela ietekme uz digoks na koncentr ciju plazm, in vivo tas var tu b t v jš p- glikoprote na inhibitors.
16 4.8 Undesirable effects
16 4. 8 Nev lam s blakuspar d bas
Frequency of adverse reaction by treatment regimen
rst šanas rež ma Blakuspar d bu biežums atkar b no rst šanas rež ma
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
Sitaglipt ns ar sulfonilur nvielas 2
Sitagliptin with
Sitaglipt ns ar metform nu un
Metformin
atvasin
a Sulfonylurea
jumiem
17 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
17 Papildus vienu gadu ilg p t jum, lietojot reizi dien 100 mg sitaglipt na kombin cij ar metform nu, ar z u lietošanu saist tu blakuspar d bu sastopam ba ar sitaglipt nu/ metform nu rst tiem pacientiem sal dzin jum ar sulfonilur nvielas atvasin jumu/ metform nu, bija attiec gi 14, 5% un 30, 3%.
18 Post-marketing Experience:
18 P cre istr cijas pieredze
Prolonged hemodialysis may be considered if clinically appropriate.
Ja tas ir kl niski piem rots, var apsv rt ilgstošu hemodial zi.
Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
Turkl t GLP- 1 neietekm norm lu glikagona atbildreakciju hipoglik mijaas gad jum.
19 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
19 Kopum, sitaglipt ns lietots monoterapij, kombin cij ar metform nu (s kotn ji vai pievienots terapijas laik), kombin cij ar sulfonilur nvielas atvasin jumiem (ar vai bez metform na) un lietots kombin cij ar tiazolid ndionu, uzlaboja glik mijas kontroli, ko noteica p c ar kl niski b tiskas HbA1c l me a samazin šan s no s kotn j l me a, kas bija m r a parametrs (skat t 2. tabulu).
The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
24 ned u placebo kontrol t s kotn jas terapijas faktori l p t jum, lietojot sitaglipt nu 50 mg divas reizes dien kombin cij ar metform nu (500 mg vai 1000 mg divas reizes dien) uzr d ja noz m gus uzlabojumus glik mijas parametros, sal dzinot ar katra monoterapiju. erme a svara samazin šan s ar sitaglipt na un metform na kombin ciju bija l dz ga tai, kas tika nov rota ar metform na monoterapiju vai placebo; nebija nek du izmai u no s kotn j svara pacientiem ar sitaglipt na monoterapiju.
baseline HbA1c (%)
HbA1c s kotn jais vid jais l menis (%)
Week 24†
Vid j s izmai as no HbA1c s kotn j l me a (%) 24. ned †
at Week 24†
Placebo kori tas vid j s HbA1c izmai as (%) (95% TI) 24. ned † - 0, 6 ‡
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
reizi dien § N=193 Sitaglipt ns 100 mg vienu
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
(- 0, 8; - 0, 4) - 0, 8 ‡
Placebo-corrected mean
20 Kombin t s terapijas p t jums Pievienojot sitaglipt nu - 0, 7 ‡ 100 mg reizi dien metform na terapijai (N=453) Pievienojot sitaglipt nu 100 mg reizi dien
Sitagliptin 100 mg once daily added to
pioglitazona terapijai (N=163) Pievienojot sitaglipt nu 100 mg reizi dien
Plasma AUC of sitagliptin increased in a dose-proportional manner.
21 Sitaglipt na plazmas AUC palielin j s proporcion li devai.
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metabolisms Sitaglipt ns tiek prim ri elimin ts neizmain t veid ar ur nu, un metabolisms ir neliels.
Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
P c [14C] sitaglitp na peror las lietošanas aptuveni 16% radioakt v savienojuma izdal j s sitaglipt na metabol tu veid.
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
22 izvad ja ar hemodial zi (13, 5% 3 – 4 stundu ilga hemodial zes seansa laik, s kot to 4 stundas p c devas lietošanas).
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Tabletes kodols: mikrokrist lisk celuloze (E460), kalcija hidrog nfosf ts, bez dens (E341), kroskarmelozes n trija s ls (E468), magnija stear ts (E470b), n trija stearilfumar ts.
TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg apvalkot s tabletes
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Katra tablete satur sitaglipt na fosf ta monohidr tu, kas atbilst 100 mg sitaglipt na (sitagliptin).
Round, beige film-coated tablet with “ 277” on one side.
Apa a, b ša apvalkot tablete ar “ 277 ” vien pus.
(See section 4.4.)
Lietojot TESAVEL kombin cij ar sulfonilur nvielas atvasin jumu, vajadz tu apsv rt maz k s sulfonilur nvielas atvasin jumu devas lietošanu, lai samazin tu hipoglik mijas risku (skat t apakšpunktu 4. 4).
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
26 Pacienti ar nieru mazsp ju Pacientiem ar vieglu nieru mazsp ju (kreatin na kl renss [CrCl] ≥ 50 ml/ min) TESAVEL deva nav j piel go.
Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
27 Metform ns: lietojot vienlaikus vair kas 1000 mg metform na devas divreiz dien kop ar 50 mg sitaglipt na, pacientiem ar 2. tipa cukura diab tu noz m gas sitaglipt na farmakokin tikas p rmai as nekonstat ja.
28 4.8 Undesirable effects
28 4. 8 Nev lam s blakuspar d bas
hypoglycaemia*
Hipoglik mija *
In clinical trials of TESAVEL as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Kl niskos p t jumos, lietojot Januvia monoterapijas veid un sitaglipt nu k kombin tas terapijas da u kop ar metform nu vai pioglitazonu, sitaglipt na lietot jiem nov rotais hipoglik mijas biežums bija l dz gs k placebo lietot jiem.
29 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
29 Papildus vienu gadu ilg p t jum, lietojot reizi dien 100 mg sitaglipt na kombin cij ar metform nu, ar z u lietošanu saist tu blakuspar d bu sastopam ba ar sitaglipt nu/ metform nu rst tiem pacientiem sal dzin jum ar sulfonilur nvielas atvasin jumu/ metform nu, bija attiec gi 14, 5% un 30, 3%.
In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
Turkl t monoterapijas p t jumos l dz 24 ned m ilgi, lietojot tikai 100 mg sitaglipt na sal dzin jum ar placebo, ar z u lietošanu saist tas blakuspar d bas, par kur m ar sitaglipt nu rst tiem pacientiem zi ots biež k (> 0, 2% un atš ir ba > 1 pacients) nek ar placebo rst tiem pacientiem, ir galvass pes, hipoglik mija, aizciet jums un reibonis.
30 Post-marketing Experience:
30 P cre istr cijas pieredze
During post-marketing experience the following additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Period p c z u re istr cijas zi ots par sekojoš m nev lam m blakuspar d b m (biežums nav zin ms): paaugstin tas jut bas reakcijas, tai skait anafilakse, angioneirotisk t ska, izsitumi, n trene un eksfoliat vi das boj jumi, ieskaitot St vensa- Džonsona sindromu (skat t apakšpunktu 4. 4).
31 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
31 Kopum, sitaglipt ns lietots monoterapij, kombin cij ar metform nu (s kotn ji vai pievienots terapijas laik), kombin cij ar sulfonilur nvielas atvasin jumiem (ar vai bez metform na) un lietots kombin cij ar tiazolid ndionu, uzlaboja glik mijas kontroli, ko noteica p c kl niski b tiskas HbA1c l me a samazin šan s no s kotn j l me a, kas bija m r a parametrs (skat t 2. tabulu).
Placebo-corrected mean
32 Kombin t s terapijas p t jums Pievienojot sitaglipt nu - 0, 7 ‡ 100 mg reizi dien metform na terapijai (N=453) Pievienojot sitaglipt nu 100 mg reizi dien
Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glipizide (-1.5 vs. +1.1 kg).
Ar sitaglipt nu rst tiem pacientiem konstat ja noz m gu vid j s erme a masas samazin jumu, sal dzinot ar s kotn jo, pretstat noz m gam erme a masas pieaugumam pacientiem, kam lietots glipiz ds (- 1, 5 vs. + 1, 1 kg).
Plasma AUC of sitagliptin increased in a dose-proportional manner.
33 Sitaglipt na plazmas AUC palielin j s proporcion li devai.
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metabolisms Sitaglipt ns tiek prim ri elimin ts neizmain t veid ar ur nu, un metabolisms ir neliels.
An approximately 2-fold increase in the plasma AUC of sitagliptin was observed in patients with moderate renal insufficiency, and an approximately 4-fold increase was observed in patients with severe renal insufficiency and in patients with ESRD on hemodialysis, as compared to normal healthy control subjects.
Aptuveni divk ršu sitaglipt na plazmas AUC palielin šanos nov roja pacientiem ar m renu nieru mazsp ju, un aptuveni etrk ršu palielin jumu nov roja pacientiem ar smagu nieru mazsp ju un pacientiem ar NSBS, kam veic hemodial zi, sal dzinot ar veseliem kontrolgrupas cilv kiem.
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
Sitaglipt nu neliel daudzum izvad ja ar hemodial zi (13, 5% 3 – 4 stundu ilga hemodial zes seansa laik, s kot to 4 stundas p c
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Tabletes kodols: mikrokrist lisk celuloze (E460), kalcija hidrog nfosf ts, bez dens (E341), kroskarmelozes n trija s ls (E468), magnija stear ts (E470b), n trija stearilfumar ts.
Merck Sharp & Dohme (Italia) S. p. A.
Merck Sharp & Dohme (It lija) S. p. A.
Via Emilia 21 IT-27100 Pavia Italy
Via Emilia 21 IT- 27100 Pavia It lija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Farmakovigilances sist ma Pirms produkta non kšanas tirg un tik ilgi, kam r produkts atrodas tirg, re istr cijas apliec bas pašniekam j nodrošina farmakovigilances sist ma un t s darb ba, k tas aprakst ts re istr cijas apliec bas ieg šanai iesniegt s dokument cijas 1. 8. 1. modu a 2. versij.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Riska vad bas pl ns Re istr cijas apliec bas pašnieks ap emas veikt p t jumus un citas farmakovigilances aktivit tes, kas detaliz ti aprakst tas farmakovigilances pl n un iek autas apstiprin t riska vad bas pl na (Risk Management Plan – RMP) 1. 1. versij re istr cijas apliec bas ieg šanai iesniegt s dokument cijas 1. 8. 2. modul, un, saska ojot ar CHMP, turpm k atjaunot RMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Saska ar CHMP vadl niju par cilv kiem paredz to z u riska vad bas pl nu, atjaunotais RMP j iesniedz kop ar n kamo periodiski atjaunojamo droš bas zi ojumu (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Pie tam, atjaunotais RMP j iesniedz: • Ja ir sa emta jauna inform cija, kas var ietekm t esošo droš bas raksturojumu, farmakovigilances pl nu vai riska mazin šanas aktivit tes. • 60 dienu laik p c b tiskas (farmakovigilances vai riska mazin šanas) inform cijas ieg šanas. • P c EMEA piepras juma.
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
Outer carton for TESAVEL 25 mg film-coated tablets
TESAVEL 25 mg apvalkoto tablešu r j k rba
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 25 mg apvalkot s tabletes Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Katra tablete satur sitaglipt na fosf ta monohidr tu, kas atbilst 25 mg sitaglipt na.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
14 apvalkot s tabletes 28 apvalkot s tabletes 56 apvalkot s tabletes 84 apvalkot s tabletes 98 apvalkot s tabletes 50 x 1 apvalkot s tabletes
Oral use.
Iekš gai lietošanai.
EXP
Der gs l dz
Batch
S rija
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 MINIM L INFORM CIJA IZVIETOJAMA UZ BLISTERA VAI PL KSN TES
Blister for TESAVEL 25 mg film-coated tablets
TESAVEL 25 mg apvalkoto tablešu blisteris
TESAVEL 25 mg tablets Sitagliptin
TESAVEL 25 mg tabletes Sitagliptin
EXP
Der. l dz
Batch
S r.
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
Outer carton for TESAVEL 50 mg film-coated tablets
TESAVEL 50 mg apvalkoto tablešu r j k rba
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg apvalkot s tabletes Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Katra tablete satur sitaglipt na fosf ta monohidr tu, kas atbilst 50 mg sitaglipt na.
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 MINIM L INFORM CIJA IZVIETOJAMA UZ BLISTERA VAI PL KSN TES
Blister for TESAVEL 50 mg film-coated tablets
TESAVEL 50 mg apvalkoto tablešu blisters
TESAVEL 50 mg tablets Sitagliptin
TESAVEL 50 mg tabletes Sitagliptin
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
Outer carton for TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg apvalkoto tablešu r j k rba
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 100 mg apvalkot s tabletes Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Katra tablete satur sitaglipt na fosf ta monohidr tu, kas atbilst 100 mg sitaglipt na.
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 MINIM L INFORM CIJA IZVIETOJAMA UZ BLISTERA VAI PL KSN TES
Blister for TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg apvalkoto tablešu blisteris
TESAVEL 100 mg tablets Sitagliptin
TESAVEL 100 mg tabletes Sitagliptin
51 PACKAGE LEAFLET:
51
Read all of this leaflet carefully before you start taking this medicine.
Pirms lietošanas uzman gi izlasiet visu instrukciju.
- Keep this leaflet.
- Saglab jiet šo instrukciju.
- If you have any further questions, ask your doctor or pharmacist.
- Ja Jums rodas jebk di jaut jumi, vaic jiet rstam vai farmaceitam.
- This medicine has been prescribed for you.
- Š s z les ir parakst tas Jums.
It may harm them, even
T s var nodar t aunumu pat tad, ja šiem
if their symptoms are the same as yours.
cilv kiem ir l dz gi simptomi.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Ja J s nov rojat jebk das blakuspar d bas, kas šaj instrukcij nav min tas vai k da no
please tell your doctor or pharmacist.
min t m blakuspar d b m Jums izpaužas smagi, l dzu, izst stiet to savam rstam vai farmaceitam.
What TESAVEL is and what it is used for 2.
Kas ir TESAVEL un k dam nol kam to lieto 2.
Before you take TESAVEL 3.
Pirms TESAVEL lietošanas 3.
How to take TESAVEL 4.
K lietot TESAVEL 4.
Possible side effects 5.
Iesp jam s blakuspar d bas 5.
How to store TESAVEL 6.
K uzglab t TESAVEL 6.
WHAT TESAVEL IS AND WHAT IT IS USED FOR
KAS IR TESAVEL UN K DAM NOL KAM TO LIETO
TESAVEL is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.
TESAVEL ir iekš gi lietojamu z u grupas, ko sauc par DPP- 4 inhibitoriem (dipeptidilpeptid zes- 4 inhibitoriem), prepar ts, kas pazemina cukura l meni asin s pacientiem ar 2. tipa cukura diab tu.
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
2. tipa cukura diab tu sauc ar par neinsul natkar gu cukura diab tu jeb NIACD.
TESAVEL helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
TESAVEL pal dz uzlabot insul na l meni p c dienreizes un samazina organisma ražoto cukura daudzumu.
It is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Tas nerada zemu cukura l meni asin s, jo nedarbojas, ja cukura l menis asin s ir zems.
However, when TESAVEL is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
Tom r, lietojot TESAVEL kombin cij ar sulfonilur nvielas atvasin jumiem, var samazin ties cukura l meni asin s (hipoglik mija).
Your doctor has prescribed TESAVEL to help lower your blood sugar, which is too high because of your type 2 diabetes.
rsts Jums ir izrakst jis TESAVEL, lai pal dz tu pazemin t cukura l meni asin s, kas ir p r k augsts, jo J s slimojat ar 2. tipa cukura diab tu.
TESAVEL is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
TESAVEL lieto kombin cij ar daž m cit m z l m, kas pazemina cukura l meni asin s un ko J s jau lietojat diab ta rst šanai vienlaikus ar uztura un fizisko vingrin jumu pl nu.
Your doctor is now prescribing TESAVEL as an additional medicine to help control your blood sugar.
Tagad rsts Jums izraksta TESAVEL k papildus z les, kas pal dz s kontrol t cukura l meni asin s.
What is type 2 diabetes?
Kas ir 2. tipa cukura diab ts?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
2. tipa cukura diab ts ir st voklis, kad J su organisms neražo pietiekami daudz insul na, un insul ns, ko J su organisms ražo, nedarbojas tik labi, k tam vajadz tu.
Your body can also make too much sugar.
J su organisms ar var saražot p r k daudz cukura.
When this happens, sugar (glucose) builds up in the blood.
Ja t notiek, asin s uzkr jas cukurs (glikoze).
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Tas var izrais t nopietnas medic niskas probl mas, piem ram, sirds slim bu, nieru slim bu, aklumu un amput ciju.
BEFORE YOU TAKE TESAVEL
PIRMS TESAVEL LIETOŠANAS
Do not take TESAVEL
Nelietojiet TESAVEL š dos gad jumos
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
- ja Jums ir aler ija (paaugstin ta jut ba) pret sitaglipt nu vai k du citu TESAVEL sast vda u.
Take special care with TESAVEL Tell your doctor if you have or have had:
paša piesardz ba, lietojot TESAVEL, nepieciešama š dos gad jumos Past stiet savam rstam, ja Jums ir vai agr k ir bijis:
- type 1 diabetes
- 1. tipa cukura diab ts;
- an allergic reaction to TESAVEL
probl mas ar nier m, TESAVEL var tu b t Jums nepiem rotas z les;
If you are taking a sulphonylurea with TESAVEL you may experience low blood sugar.
Lietojot sulfonilur nvielas atvasin jumus kombin cij ar TESAVEL, Jums var samazin ties cukura l menis asin s.
Your doctor may reduce the dose of your sulphonylurea medication.
J su rstam vajadz tu samazin t sulfonilur nvielas medikamenta devu.
Taking other medicines TESAVEL may be taken with most medicines.
Citu z u lietošana TESAVEL var lietot kop ar liel ko da u z u.
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
Past stiet rstam vai farmaceitam par vis m z l m, ko J s lietojat pašlaik vai lietoj t nesen.
This includes prescription and non-prescription medicines, and herbal supplements.
Tas ietver recepšu un bezrecepšu z les, k ar rstniec bas augu papildterapiju.
Taking TESAVEL with food and drink You can take TESAVEL with or without food and drink.
TESAVEL lietošana kop ar uzturu J s varat lietot TESAVEL kop ar uzturu vai neatkar gi no t.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking TESAVEL.
Gr tniec ba un z d šanas periods Sieviet m, kam ir gr tniec ba vai kas pl no gr tniec bu, j konsult jas ar rstu pirms TESAVEL lietošanas.
You should not use TESAVEL during pregnancy.
J s nedr kstat lietot TESAVEL gr tniec bas laik.
It is not known if TESAVEL passes into breast milk.
Nav zin ms, vai TESAVEL izdal s m tes pien.
You should not use TESAVEL if you are breast- feeding or plan to breast-feed.
Ja J s barojat b rnu ar kr ti vai pl nojat to dar t, J s nedr kstat lietot TESAVEL.
Driving and using machines TESAVEL is not expected to interfere with your ability to drive or to use machines.
Transportl dzek u vad šana un meh nismu apkalpošana Nav sagaid ms, ka TESAVEL ietekm s J su sp ju vad t transportl dzek us vai apkalpot meh nismus.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Tom r, ja j vada transportl dzeklis vai j apkalpo meh nismi, j em v r, ka zi ots par reiboni un miegain bu.
HOW TO TAKE TESAVEL
K LIETOT TESAVEL
Always take TESAVEL exactly as your doctor has told you.
Vienm r lietojiet TESAVEL tieši t, k farmaceitam.
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
Parast deva ir: − viena 100 mg apvalkot tablete, − reizi dien, − iekš gi.
Your doctor will prescribe TESAVEL along with certain other medicines that lower blood sugar.
rsts Jums parakst s TESAVEL kop ar daž m cit m z l m, kas pazemina cukura l meni asin s.
Continue to take TESAVEL as long as your doctor prescribes it so you can continue to help control your blood sugar.
Turpiniet lietot TESAVEL, kam r rsts to nor d jis, lai t d j di pal dz tu kontrol t cukura l meni asin s.
Diet and exercise can help your body use its blood sugar better.
Di ta un fiziskie vingrin jumi var pal dz t J su organismam lab k izlietot asins cukuru.
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking TESAVEL.
Svar gi iev rot di tu, fizisk s aktivit tes un erme a masas samazin šanas programmu, ko Jums TESAVEL lietošanas laik ieteicis rsts.
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
Ja esat lietojis TESAVEL vair k nek noteikts Ja esat lietojis TESAVEL vair k nek nor d ts, nekav joties sazinieties ar savu rstu.
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
Ja esat aizmirsis lietot TESAVEL Ja esat izlaidis devu, ie emiet to tikl dz atceraties.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Ja neatceraties par to l dz n kam s devas lietošanas laikam, izlaidiet neie emto devu pavisam un atgriezieties pie parast s lietošanas sh mas.
Do not take a double dose of TESAVEL.
Nelietojiet dubultu TESAVEL devu.
Like all medicines, TESAVEL may cause side effects, although not everybody gets them.
T pat k citas z les, TESAVEL var izrais t blakuspar d bas, kaut ar ne visiem t s izpaužas.
53 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Ret k sastopamas blakuspar d bas (maz k nek 1 no 100, bet vair k nek 1 no 1000 pacientiem).
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Dažiem pacientiem p c sitaglipt na pievienošanas metform nam rad s š das blakuspar d bas:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Ret k: erme a masas zudums, stgribas zudums, s pes v der, caureja, zems cukura l menis asin s, miegain ba.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Dažiem pacientiem, uzs kot kombin tu terapiju ar sitaglipt nu un metform nu, rad s diskomforta saj ta v der.
Very common: low blood sugar
Dažiem pacientiem TESAVEL un sulfonilur nvielas atvasin jumu kombin t s lietošanas laik rad s š das blakuspar d bas: oti bieži: zems cukura l menis asin s.
Some patients have experienced the following side effects while taking TESAVEL in combination with a sulphonylurea and metformin:
Dažiem pacientiem, kombin jot TESAVEL ar sulfonilur nvielas atvasin jumu un metform nu, rad s š das blakuspar d bas: oti bieži: zems cukura l menis asin s.
Very common: low blood sugar Common: constipation
Bieži: aizciet jums.
Some patients have experienced the following side effects while taking TESAVEL and pioglitazone:
Dažiem pacientiem TESAVEL un pioglitazona lietošanas laik rad s š das blakuspar d bas:
Common: low blood sugar and flatulence.
Bieži: zems cukura l menis asin s un v dera uzp šan s.
In addition, some patients have reported foot swelling while taking TESAVEL and pioglitazone.
Pie tam, dažiem pacientiem tika zi ots par p du piet kumu, lietojot TESAVEL un pioglitazonu.
These side effects may be seen with sitagliptin and any glitazone (e. g., rosiglitazone).
Š s blakuspar d bas var tu nov rot ar sitaglipt nu un jebkuru glitazonu (piem ram, roziglitazonu).
Some patients have experienced the following side effects while taking TESAVEL alone:
Dažiem pacientiem, lietojot tikai TESAVEL, rad s š das blakuspar d bas:
Common: low blood sugar, headache Uncommon: dizziness, constipation
Ret k: reibonis, aizciet jums.
In addition, some patients have reported the following side effects while taking TESAVEL:
Pie tam, dažiem pacientiem, lietojot TESAVEL, tika zi ots par sekojoš m blakuspar d b m:
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
Bieži: augš jo elpce u infekcija, aizlikts vai pilošs deguns un iekaisis kakls, osteoartr ts, s pes rok s vai k j s.
During post-marketing experience the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
P cre istr cijas period zi ots ar par sekojoš m nev lam m blakuspar d b m (biežums nav zin ms): aler iskas reakcijas, kuras var b t nopietnas, tai skait izsitumi, n trene un sejas, l pu, m les un r kles t ska, kas var apgr tin t elpošanu un r šanu.
If you have an allergic reaction, stop taking TESAVEL and call your doctor right away.
Ja Jums ir aler iska reakcija, p rtrauciet lietot TESAVEL un t l t zvaniet savam rstam.
Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.
J su rsts var izrakst t z les aler isk s reakcijas rst šanai un citas z les cukura diab t terapijai.
HOW TO STORE TESAVEL
K UZGLAB T TESAVEL
Do not use TESAVEL after the expiry date which is stated on the blister and the carton.
Nelietojiet TESAVEL p c der guma termi a, kas nor d ts uz blistera un kartona k rbas.
This medicinal product does not require any special storage conditions.
54 Š m z l m nav nepieciešami paši uzglab šanas apst k i.
What TESAVEL contains
Ko TESAVEL satur
- The active substance is sitagliptin.
- Akt v viela ir sitaglipt ns.
Each film-coated tablet contains sitagliptin phosphate
Katra apvalkot tablete satur sitaglipt na fosf ta monohidr tu, kas
monohydrate, equivalent to 25 mg sitagliptin.
atbilst 25 mg sitaglipt na.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- Citas sast vda as ir mikrokrist lisk celuloze (E460), kalcija hidrog nfosf ts, bez dens (E341),
anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
kroskarmelozes n trija s ls (E468), magnija stear ts (E470b) un n trija stearilfumar ts.
The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Tabletes apvalks satur polivinilspirtu, makrogolu 3350, talku (E553b), tit na dioks du (E171), sarkano dzelzs oks du (E172) un dzelteno dzelzs oks du (E172).
What TESAVEL looks like and contents of the pack
TESAVEL r jais izskats un iepakojums
Round, pink film-coated tablet with “ 221” on one side.
Apa a, roz apvalkota tablete ar “ 221 ” vien pus.
Opaque blisters (PVC/ PE/ PVDC and aluminum).
Necaursp d gi blisteri (PVH/ PE/ PVDH un alum nijs).
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Iepakojumi pa 14, 28, 56, 84 vai 98 apvalkot m tablet m un 50 x 1 apvalkot s tabletes blister ar atseviš m dev m kont rligzd s.
The Marketing Authorisation Holder is:
Re istr cijas apliec bas pašnieks:
The Manufacturer is:
Ražot js:
Via Emilia, 21 27100 - Pavia Italy
Via Emilia, 21 27100 - Pavia It lija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Lai ieg tu papildus inform ciju par š m z l m, l dzam kontakt ties ar Re istr cijas apliec bas pašnieka viet jo p rst vniec bu:
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck. com
! "##
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@msd. dk
55 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ msd. dk
Eλλάδα BIANEΞ Α .Ε Τηλ: +3 0210 80091 11 Mailbox@vianex. gr
(): +3 0210 80091 11 *
Τηλ: +357 22866700 info_cyprus@merck. com
Merck Sharp & Dohme (Middle East) Limited (): +357 22866700 *
56 This leaflet was last approved in {MM/ YYYY}.
Š lietošanas instrukcija akcept ta {MM/ GGGG}.
57 PACKAGE LEAFLET:
57
59 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Ret k sastopamas blakuspar d bas (maz k nek 1 no 100, bet vair k nek 1 no 1000 pacientiem).
This medicinal product does not require any special storage conditions.
60 Š m z l m nav nepieciešami paši uzglab šanas apst k i.
monohydrate, equivalent to 50 mg sitagliptin.
atbilst 50 mg sitaglipt na.
Round, light beige film-coated tablet with “ 112” on one side.
Apa a, gaiši b ša apvalkota tablete ar “ 112 ” vien pus.
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@msd. dk
61 Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ msd. dk
62 This leaflet was last approved in {MM/ YYYY}.
Š lietošanas instrukcija akcept ta {MM/ GGGG}.
63 PACKAGE LEAFLET:
63
Do not take TESAVEL
Nelietojiet TESAVEL š dos gad jumos:
Take special care with TESAVEL Tell your doctor if you have or have had:
paša piesardz ba, lietojot TESAVEL, nepieciešama š dos gad jumos:
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Tom r, ja j vada transportl dzeklis vai j pkalpo meh nismi, j em v r, ka zi ots par reiboni un miegain bu.
65 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Ret k sastopamas blakuspar d bas (maz k nek 1 no 100, bet vair k nek 1 no 1000 pacientiem).
This medicinal product does not require any special storage conditions.
66 Š m z l m nav nepieciešami paši uzglab šanas apst k i.
monohydrate, equivalent to 100 mg sitagliptin.
atbilst 100 mg sitaglipt na.
Round, beige film-coated tablet with “ 277” on one side.
Apa a, b ša apvalkota tablete ar “ 277 ” vien pus.
68 This leaflet was last approved in {MM/ YYYY}.
Š lietošanas instrukcija akcept ta {MM/ GGGG}.
What is TESLASCAN?
Kas ir TESLASCAN?
TESLASCAN is a solution for infusion (drip into a vein) containing the active substance mangafodipir trisodium.
TESLASCAN ir infūzijas šķīdums (ievadīšanai vēnā pa pilienam), kas satur aktīvo vielu mangafodipira trinātrija sāli.
What is TESLASCAN used for?
Kāpēc lieto TESLASCAN?
TESLASCAN is for diagnostic use.
TESLASCAN ir paredzēts lietošanai diagnostikā.
TESLASCAN is used in patients who are undergoing magnetic resonance imaging (MRI) to detect lesions (damaged tissue) in the liver that might be caused by liver cancer or cancer that has spread to the liver from other parts of the body.
TESLASCAN lieto pacientiem, kam veic magnētiskās rezonanses attēlveidošanu (MRA), lai noteiktu bojājumus (bojātus audus) aknās, ko varētu būt radījis aknu vēzis vai vēzis, kas izplatījies uz aknām no citām ķermeņa daļām.
TESLASCAN is a ‘ contrast medium ’ that is used to obtain a clearer scan.
TESLASCAN ir „ kontrastviela ”, ko izmanto skaidrāka skenējuma iegūšanai.
TESLASCAN can also be used with MRI to investigate lesions of the pancreas.
TESLASCAN var arī lietot MRA, lai pētītu bojājumus aizkuņģa dziedzerī.
How is TESLASCAN used?
Kā lieto TESLASCAN?
TESLASCAN is used as a single intravenous infusion at a dose of 0.5 ml per kilogram body weight.
TESLASCAN lieto kā vienreizēju intravenozu infūziju devā 0, 5 ml uz kilogramu ķermeņa svara.
The rate of infusion is 2 to 3 ml/ min for liver imaging and 4 to 6 ml/ min for imaging the pancreas.
Infūzijas ātrums ir 2 - 3 ml/ min aknu attēlveidošanā un 4 - 6 ml/ min aizkuņģa dziedzera attēlveidošanā.
The enhancement of imaging starts 15 to 20 minutes after the start of the infusion, and lasts for about 4 hours.
Attēlveidošanas uzlabojums sākas 15 – 20 minūtes pēc infūzijas sākuma un saglabājas apmēram 4 stundas.
How does TESLASCAN work?
Kā TESLASCAN darbojas?
The active substance in TESLASCAN, mangafodipir, contains manganese, a metal element.
TESLASCAN aktīvā viela mangafodipirs satur mangānu, metāla dabas ķīmisko elementu.
Manganese is used as a contrast medium to help obtain better pictures with MRI scanners.
Mangānu lieto kā kontrastvielu, lai palīdzētu iegūt labākus attēlus ar MRA skeneriem.
MRI is an imaging method that uses magnetic fields and radio waves.
MRA ir attēlveidošanas metode, kurā lieto magnētiskos laukus un radioviļņus.
Water molecules in the body are affected by the magnetic fields, and produce a signal when the radio waves are applied.
Magnētiskie lauki ietekmē ūdens molekulas ķermenī un tās dod signālu, kad iedarbojas ar radioviļņiem.
Manganese interacts with the water molecules.
Mangāns mijiedarbojas ar ūdens molekulām.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Šīs mijiedarbības rezultātā ūdens molekulas dod stiprāku signālu, un tas palīdz iegūt spilgtāku attēlu.
In TESLASCAN, the manganese is bound to another chemical in a ‘ chelate’.
TESLASCAN molekulā mangāns ir saistīts ar citu ķīmisko vielu – helātu.
Once the medicine is injected, the manganese is released and taken up by normal liver and pancreatic tissues more effectively than by the cancer cells.
Kad zāles tiek injicētas, mangāns atbrīvojas un normālās aknu un aizkuņģa dziedzera šūnās uzkrājas efektīvāk nekā vēža šūnās.
This allows the difference between normal and abnormal tissue to be seen.
Tas dod iespēju saskatīt atšķirību starp normālām un vēža šūnām.
How has TESLASCAN been studied?
Kā noritēja TESLASCAN izpēte?
The studies of TESLASCAN in MRI for liver lesions involved 617 patients.
TESLASCAN izpētē, lietojot MRA aknu bojājumu noteikšanai, bija iesaistīti 617 pacienti.
The patients had between one and five liver lesions that had already been detected using MRI, ultrasound, or computerised 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Galvenais 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The main measure of effectiveness was the difference in the number of liver lesions detected in the previous scan and when using TESLASCAN during MRI.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged efektivitātes kritērijs bija atšķirība aknu bojājumu skaitā, ko noteica ar iepriekšējo skenējumu un MRA, lietojot TESLASCAN.
The studies of pancreatic disease involved 292 patients, and compared the effectiveness of TESLASCAN-enhanced MRI with that of ‘ spiral CT’, another diagnostic method used to detect pancreatic lesions.
Aizkuņģa dziedzera pētījumā bija iesaistīti 292 pacienti, un tajā salīdzināja ar TESLASCAN uzlabota MRA skenējumu ar spirāles DT, citu diagnostikas metodi, ko lieto aizkuņģa dziedzera bojājumu noteikšanai.
The main measure of effectiveness was based on the agreement between the diagnosis made based on the scans, and the actual lesions as seen during surgery or biopsy.
Galvenais efektivitātes kritērijs bija sakritība starp diagnozi, ko ieguva skenējumos, un patiesajiem bojājumiem, ko novēroja ķirurģiskā operācijā vai biopsijā.
What benefit has TESLASCAN shown during the studies?
Kāds ir TESLASCAN iedarbīgums šajos pētījumos?
In the detection of liver lesions, the use of TESLASCAN-enhanced MRI resulted in more lesions being detected.
Aknu bojājumu noteikšanā ar TESLASCAN uzlabota MRA ļāva detektēt lielāku bojājumu skaitu.
Overall, during the studies, 33% of patients had more lesions detected after TESLASCAN but 20% of patients had fewer lesions.
Kopumā šajos pētījumos, skenējot ar TESLASCAN, 33% pacientu atrada vairāk bojājumu, bet 20% - mazāk bojājumu.
In the detection of pancreatic lesions, TESLASCAN-enhanced MRI was as effective as spiral CT.
Aizkuņģa dziedzera bojājumu noteikšanā, ar TESLASCAN uzlabota MRA bija tikpat efektīva kā spirāles DT.
What is the risk associated with TESLASCAN?
Kāds pastāv risks, lietojot TESLASCAN?
The most common side effects with TESLASCAN (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), flushing and feeling hot.
Visbiežāk novērotās TESLASCAN blakusparādības (novērotas 1 – 10 pacientiem no 100) ir galvassāpes, slikta dūša, pietvīkums un karstuma izjūta.
For the full list of all side effects reported with TESLASCAN, see the Package Leaflet.
Pilns visu TESLASCAN izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
TESLASCAN should not be used in people who may be hypersensitive (allergic) to mangafodipir trisodium or any of the other ingredients.
TESLASCAN nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģiju) pret mangafodipira trinātrija sāli vai kādu citu šo zāļu sastāvdaļu.
TESLASCAN should not be used in pregnant or breast- feeding women, patients with phaeochromocytoma (a tumour of the adrenal gland), or patients with severe problems with their liver or kidneys.
TESLASCAN nedrīkst lietot grūtniecēm vai zīdītājām, pacientiem ar feohromocitomu (virsnieru dziedzera vēzi) vai pacientiem ar smagiem aknu vai nieru darbības traucējumiem.
Why has TESLASCAN been approved?
Kāpēc TESLASCAN tika apstiprināts?
The Committee for Medicinal products for Human Use (CHMP) decided that TESLASCAN’ s benefits are greater than its risks as a contrast medium for diagnostic MRI, for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas, and as an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Cilvēkiem paredzēto zāļu komiteja (CHMP) nolēma, ka TESLASCAN sniegtie ieguvumi ir lielāki par risku, lietojot šīs zāles kā kontrastvielu diagnostikai ar MRA, lai noteiktu aknu bojājumus, kas būtu saistāmi ar metastāzēm vai aknu šūnu karcinomām, un kā palīglīdzekli MRA, lai palīdzētu pētīt fokālus aizkuņģa dziedzera bojājumus.
They recommended that TESLASCAN be given marketing authorisation.
Komiteja ieteica izsniegt TESLASCAN reģistrācijas apliecību.
Other information about TESLASCAN:
Cita informācija par TESLASCAN:
The European Commission granted a marketing authorisation valid throughout the European Union, for TESLASCAN to GE Healthcare AS on 22 May 1997.
Eiropas Komisija 1997. gada 22. maijā izsniedza TESLASCAN reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam GE Healthcare AS.
The marketing authorisation was renewed on 22 May 2002 and 22 May 2007.
Reģistrācijas apliecība tika atjaunota 2002. gada 22. maijā un 2007. gada 22. maijā.
The full EPAR for TESLASCAN is available here.
Pilns TESLASCAN EPAR teksts ir atrodams šeit.
EU/ 1/ 97/ 040/ 001
Ievadīšanas veids
Teslascan
Iepakojums
0.01 mmol/ ml
Saturs
Vial (glass)
intravenozai lietošanai Flakons (stikla) 50 ml intravenozai lietošanai Flakons (stikla) 50 ml
10 vials
1 flakons 10 flakoni
TESLASCAN 0.01 mmol/ ml solution for infusion.
TESLASCAN 0, 01 mmol/ ml šķīdums infūzijām.
Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μ mol), equivalent to 6.91 mg of mangafodipir.
Katrs ml satur 7, 57 mg bezūdens mangafodipira trinātrija sāls (mangafodipir trisodium), 0, 01 mmol (10 μmol), kas ir ekvivalents 6, 91 mg mangafodipira.
50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 μ mol), equivalent to 345.5 mg of mangafodipir.
50 ml satur 378, 5 mg bezūdens mangafodipira trinātrija sāli, 0, 50 mmol (500 μmol), kas ir ekvivalents 345, 5 mg mangafodipira.
Sodium 0.16 mmol (3.6 mg)/ ml equivalent to 126 mg per normal dose of 35 ml.
Palīgviela: nātrijs 0, 16 mmol (3, 6 mg) / ml, kas ir ekvivalents 126 mg parasti lietojamā 35 ml devā.
A clear bright to dark yellow solution,
Caurspīdīgs šķīdums spilgti līdz tumši dzeltenā krāsā,
TESLASCAN has the following physicochemical properties:
TESLASCAN ir šādas fizikāli ķīmiskās īpašības:
Osmolality (mosmol/ kg H2O) at 37 °C Viscosity (mPa. s) at 20 °C Viscosity (mPa. s) at 37 °C Density (g/ ml) at 20 °C
Osmolalitāte (mosm/ kg H2O) pie 37 °C Viskozitāte (mPa. s) pie 20 °C Viskozitāte (mPa. s) pie 37 °C Blīvums (g/ ml) pie 20 °C
As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Magnētiskās rezonanses (MR) kontrastviela aknu patoloģisku veidojumu - metastāžu un hepatocellulāras karcinomas diagnostikai, kā arī fokālu aizkuņģa dziedzera veidojumu izmeklēšanai.
The medicinal product is for single intravenous use only as repeated dosing has not been studied.
Šis preparāts paredzēts vienreizējai intravenozai ievadīšanai, jo nav datu par atkārtotu tā ievadīšanu.
It should be administered as an intravenous infusion at the rate of 2-3 ml/ min for liver imaging and at a rate of 4-6 ml/ min for imaging of the pancreas.
Lai diagnosticētu aknu veidojumus, preparātu ievada intravenozā infūzijā ar ātrumu 2- 3 ml/ minūtē, aizkuņģa dziedzera patoloģiju diagnosticēšanai preparāts ievadāms ar ātrumu 4- 6 ml/ min.
Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.
Maksimālu neizmainītas aknu un aizkuņģa dziedzera parenhīmas kontrastēšanos novēro 15- 20 minūtes pēc kontrastvielas ievades sākuma, un tā ilgst aptuveni 4 stundas.
At the clinical dose the contrast agent has no T2-effect, and pre- and post- T2-weighted images are equivalent.
Klīniskajās devās kontrastvielai nav T2 efekta, un T2 attēli, kas izdarīti pirms un pēc kontrastvielas ievadīšanas, neatšķiras.
The clinical use of TESLASCAN has been investigated at field strengths from 0.5 to 2.0 Tesla.
TESLASCAN pielieto magnētiskā lauka stipruma diapazonā no 0, 5 līdz 2, 0 Tesla.
2 Dosage for adults The recommended dose is 0.5 ml/ kg bodyweight (5 µmol/ kg bodyweight).
Devas pieaugušajiem Ieteicamā deva pieaugušajiem ir 0, 5 ml/ kg ķermeņa svara (5 μmol/ kg ķermeņa masas).
This corresponds to a dose of 35 ml for a 70 kg person.
Tas atbilst 35 ml devai pacientam ar svaru 70 kg.
Above 100 kg body weight, 50 ml is usually sufficient to provide a diagnostically adequate contrast effect.
Ja pacienta svars pārsniedz 100 kg, adekvāta kontrastējuma sasniegšanai parasti pietiek ar 50 ml kontrastvielas.
However, clinical studies to date do not suggest that a dose adjustment is required.
2 Devas gados vecākiem cilvēkiem Farmakokinētika, ievadot preparātu gados vecākiem cilvēkiem, nav izpētīta, taču pašreizējie pētījumi neliecina par vajadzību pielietot atšķirīgas devas.
Children and adolescents Safety and efficacy in patients below the age of 18 have not been documented i. e. children (2-11 years) and adolescents (12-18 years).
Bērni un pusaudži Pašreiz nav datu par preparāta drošību un iedarbību pacientiem, kuri ir jaunāki par 18 gadiem, resp., bērniem (2- 11 g.) un pusaudžiem (12- 18 g.).
Phaeochromocytoma.
Feohromocitoma.
Severely reduced liver function (Child - Pugh class C), especially severe obstructive hepatobiliary disease.
Izteikti pavājināta aknu funkcija (Child- Pugh klasifikācija – C), īpaši pie izteiktas žultsceļu obstrukcijas.
Severely reduced renal function.
Izteikti pavājināta nieru funkcija.