natgillin/translations-raw huggingface dataset:
Consistent with the monotherapy formulation, food had no effect on the pharmacokinetics of amlodipine in the
Uživanje hrane sočasno s tableto z že pripravljeno kombinacijo pa ni vplivalo na farmakokinetiko amlodipina, kar se ujema z odmerjanjem amlodipina v samostojni formulaciji.
A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicinal products known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
Med temi bolniki jih je veliko imelo v anamnezi angioedem oziroma simptome, ki nakazujejo angioedem, do česar je v nekaterih primerih prišlo po uporabi drugih zdravil, ki lahko povzročajo angioedem, med drugim tudi po uporabi zaviralcev sistema renin-angiotenzin-aldosteron (zaviralcev angiotenzinske konvertaze ali antagonistev angiotenzinskih receptorjev).
Smaller changes in furosemide pharmacokinetics and efficacy were
Pri uporabi aliskirena v odmerku 150 mg/dan so opažali manjše spremembe farmakokinetike in učinkovitosti furosemida.
The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, macrogol, talc and yellow iron oxide (E172).
Druge sestavine zdravila so: mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, makrogol, smukec in rumeni železov oksid (E172).
Light yellow, convex, ovaloid tablet with a bevelled edge, with “T2” debossed on one side and
Svetlo rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T2” vtisnjeno na eni strani
The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Druge sestavine zdravila so: mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, titanov dioksid (E171), makrogol, smukec in rumeni železov oksid (E172).
Rasilamlo 150 mg/10 mg film-coated tablets are yellow, convex, oval film-coated tablets, with “T7” debossed on one side and “NVR” on the other.
Rasilamlo 150 mg/10 mg filmsko obložene tablete so rumene konveksne ovalne filmsko obložene tablete z oznako “T7” vtisnjeno na eni strani in oznako “NVR” na drugi.
Rasilamlo 300 mg/10 mg film-coated tablets
Rasilamlo 300 mg/10 mg filmsko obložene tablete
• severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
• hude kožne reakcije (toksična epidermalna nekroliza in/ali reakcije ustne sluznice - rdeča koža, nastajanje mehurjev na ustnicah, očeh ali v ustih, luščenje kože, zvišana telesna
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is
Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6) Kontraindicirana je sočasna uporaba aliskirena s ciklosporinom oziroma z itrakonazolom, ki sta zelo močna zaviralca P-glikoproteina (P-gp), in z drugimi močnimi zaviralci P-gp (na primer s
Dark yellow, convex, ovaloid tablet with a bevelled edge, with “T11” debossed on one side and
Temno rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T11” vtisnjeno na eni strani
Rasilamlo 300 mg/5 mg film-coated tablets are dark yellow, convex, oval film-coated tablets, with “T11” debossed on one side and “NVR” on the other.
Rasilamlo 300 mg/5 mg filmsko obložene tablete so temno rumene konveksne ovalne filmsko obložene tablete z oznako “T11” vtisnjeno na eni strani in oznako “NVR” na drugi.
, cough a,am
, srbenje a,am
Rasilamlo 150 mg/10 mg film-coated tablets
Rasilamlo 150 mg/10 mg filmsko obložene tablete
Rasilamlo 300 mg/10 mg film-coated tablets are brown-yellow, convex, oval film-coated tablets, with “T12” debossed on one side and “NVR” on the other.
Rasilamlo 300 mg/10 mg filmsko obložene tablete so rjavo rumene konveksne ovalne filmsko obložene tablete z oznako “T12” vtisnjeno na eni strani in oznako “NVR” na drugi.
Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than
Pri odmerjanju enkrat dnevno nastopi stanje dinamičnega ravnovesja koncentracij v plazmi v 5 do 7 dneh.
Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or amlodipine 10 mg alone or Rasilamlo 150 mg/10 mg or
Zdravilo Rasilamlo 300 mg/10 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo aliskirena v odmerku 300 mg oziroma amlodipina v odmerku 10 mg ali z zdravilom Rasilamlo 150 mg/10 mg ali z zdravilom Rasilamlo 300 mg/5 mg.
- Each Rasilamlo 150 mg/5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
- Vsaka filmsko obložena tableta zdravila Rasilamlo 150 mg/5 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina (v obliki besilata).
• vomiting
• nespečnost
As for other RAAS blockers, headache is a common adverse event in children treated with aliskiren.
Tako kot pri uporabi drugih učinkovin, ki zavirajo sistem renin-angiotenzinaldosteron, je pri zdravljenju otrok z aliskirenom glavobol pogost neželeni dogodek.
Rasilamlo 150 mg/5 mg film-coated tablets
Rasilamlo 150 mg/5 mg filmsko obložene tablete
Magnesium stearate
- Furosemid in torasemid
Visual disturbance (including diplopia)
, periferna nevropatija občasni motnje vida (vključno z dvojnim vidom)
Symptoms
Zdravljenje
- Each Rasilamlo 300 mg/10 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
- Vsaka filmsko obložena tableta zdravila Rasilamlo 300 mg/10 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina (v obliki besilata).
Chest pain
• vnetje jeter
Rasilamlo 300 mg/5 mg film-coated tablets
Rasilamlo 300 mg/5 mg filmsko obložene tablete
, nausea a,am
, navzea a,am bruhanje a,am
Brown-yellow, convex, ovaloid tablet with a bevelled edge, with “T12” debossed on one side and
Rjavo rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T12” vtisnjeno na eni strani
Aliskiren should be used with caution in patients with heart failure treated with furosemide or
Previdnost je potrebna pri uporabi aliskirena pri bolnikih, ki imajo srčno popuščanje in se zdravijo s furosemidom ali torasemidom (glejte poglavje 4.5).
, pruritus a,am
, urtikarija a,am
- Each Rasilamlo 300 mg/5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
- Vsaka filmsko obložena tableta zdravila Rasilamlo 300 mg/5 mg vsebuje 300 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina (v obliki besilata).
- Each Rasilamlo 150 mg/10 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
- Vsaka filmsko obložena tableta zdravila Rasilamlo 150 mg/10 mg vsebuje 150 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina (v obliki besilata).
Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg alone or with Rasilamlo 150 mg/5 mg.
Zdravilo Rasilamlo 300 mg/5 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo aliskirena v odmerku 300 mg ali z zdravilom Rasilamlo 150 mg/5 mg.
Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the
Zato lahko induktorji P-gp (šentjanževka, rifampicin) zmanjšajo biološko uporabnost aliskirena.
If renal failure occurs, treatment
V primeru ledvične odpovedi je treba z zdravljenjem prekiniti.
Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone or with Rasilamlo 150 mg/5 mg.
Zdravilo Rasilamlo 150 mg/10 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen samo z uporabo amlodipina v odmerku 10 mg ali z zdravilom Rasilamlo 150 mg/5 mg.
Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or amlodipine 5 mg alone.
Zdravilo Rasilamlo 150 mg/5 mg je lahko primerno za bolnike, katerih krvni tlak ni ustrezno urejen z uporabo samo aliskirena 150 mg ali samo amlodipina v odmerku 5 mg.
Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in postmarketing experience.
Med izkušnjami v obdobju trženja zdravila so pri bolnikih s povečanim tveganjem, ki so jemali aliskiren, opisovali akutno ledvično odpoved, ki je bila reverzibilna po prekinitvi zdravljenja.
Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate) and 5 mg amlodipine (as
Ena tableta vsebuje 300 mg aliskirena (v obliki aliskirenijevega hemifumarata) in 5 mg amlodipina
Yellow, convex, ovaloid tablet with a bevelled edge, with “T7” debossed on one side and “NVR” on
Rumena konveksna ovalna tableta z zaobljenim robom, z oznako “T7” vtisnjeno na eni strani in
Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate) and 10 mg amlodipine (as
Ena tableta vsebuje 300 mg aliskirena (v obliki aliskirenijevega hemifumarata) in 10 mg amlodipina
Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate) and 5 mg amlodipine (as
Ena tableta vsebuje 150 mg aliskirena (v obliki aliskirenijevega hemifumarata) in 5 mg amlodipina
Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate) and 10 mg amlodipine (as
Ena tableta vsebuje 150 mg aliskirena (v obliki aliskirenijevega hemifumarata) in 10 mg amlodipina
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina
The adverse reactions observed with Rasilamlo or with monotherapy with one or both of the two components are included in the table below.
V spodnji preglednici so navedeni neželeni učinki, ki so jih opažali pri uporabi zdravila Rasilamlo ali pri uporabi katere od obeh zdravilnih učinkovin v monoterapiji.
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Ena filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 5 mg amlodipina
• dry skin, rash, itchy rash
• suha koža, izpuščaj, srbeč izpuščaj
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Ena filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Ena filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 10 mg amlodipina
a, oral mucosal reactions a, rash a,am
a, reakcije ustne sluznice a,
What Rasilamlo looks like and contents of the pack Rasilamlo 150 mg/5 mg film-coated tablets are light yellow, convex, oval film-coated tablets, with “T2” debossed on one side and “NVR” on the other.
Rasilamlo 150 mg/5 mg filmsko obložene tablete so svetlo rumene konveksne ovalne filmsko obložene tablete z zaobljenim robom, z oznako “T2” vtisnjeno na eni strani in oznako “NVR” na
• severe upper stomach pain
• huda bolečina v zgornjem delu trebuha
Cellulose microcrystalline Crospovidone Povidone
Obloga hipromeloza makrogol smukec rumeni železov oksid (E172)
Steady-state plasma levels are reached after continuous administration for 7-8 days.
Plazemska koncentracija v stanju dinamičnega ravnovesja je dosežena po 7 do
The adverse reactions previously reported with one or both of the two active substances (aliskiren and amlodipine) of Rasilamlo and listed below may occur with
Pri uporabi zdravila Rasilamlo lahko pride do neželenih učinkov, ki so navedeni spodaj in o katerih so že poročali pri uporabi ene ali obeh posameznih učinkovin (aliskirena in amlodipina).
Hypersensitivity reactions including anaphylactic reactions have also been reported in post-marketing
Med zdravljenjem z aliskirenom je prišlo do preobčutljivostnih reakcij, vključno z anafilaktičnimi
Transporters
Preiskave
Liver enzyme increased a, weight increase weight decrease
Preiskave pogosti hiperkaliemija a občasni zvišane vrednosti jetrnih encimov a, povečanje telesne mase
Vial (glass)
Velikost pakiranja viala (steklo)
Ref.: EMEA/758620/2009 EMEA/H/C/557
: EMEA/758620/2009 EMEA/H/C/557
It should be given up to 15 minutes before or just after a meal.
Daje se do 15 minut pred obrokom ali takoj po njem.
The European Commission granted a marketing authorisation valid throughout the European Union for Apidra to Sanofi-Aventis Deutschland GmbH on 27 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Apidra, veljavno po vseh Evropski uniji, odobrila družbi Sanofi-Aventis Deutschland GmbH dne 27. septembra 2004.
Other information about Apidra:
Druge informacije o zdravilu Apidra:
However, there was not enough information to show whether Apidra was effective in children aged below six years.
Vendar pa ni bilo dovolj podatkov, ki bi pokazali ali je zdravilo Apidra učinkovito pri otrocih, mlajših od šest let.
Apidra insulin glulisine EPAR summary for the public
Apidra insulin glulisin Povzetek EPAR za javnost
It must not be used in patients who already have hypoglycaemia.
Zdravilo se ne sme uporabljati pri bolnikih, ki že imajo hipoglikemijo.
Patients can inject Apidra under the skin themselves.
Bolniki si lahko zdravilo Apidra pod kožo vbrizgajo sami.
Apidra can also be injected into a vein, but this can only be done by a doctor or nurse.
Zdravilo Apidra se lahko injicira tudi v veno, vendar lahko to naredi samo zdravnik ali medicinsko osebje.
The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Apidra večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet.
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Mesto injiciranja je treba pri vsaki injekciji menjati, da se preprečijo spremembe na koži (kot je odebelitev), zaradi česar insulin lahko deluje slabše od pričakovanega.
What benefit has Apidra shown during the studies?
Kakšne koristi je zdravilo Apidra izkazalo med študijami?
Apidra doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Odmerke zdravila Apidra bo morda treba prilagoditi, če se jemlje sočasno z nekaterimi drugimi zdravili, ki bi lahko vplivala na raven glukoze v krvi.
In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, and a decrease of 0.14% for insulin lispro.
V prvi študiji z odraslimi bolniki s sladkorno boleznijo tipa 1 je prišlo do 0,14-odstotnega zmanjšanja (z 7,60 % na 7,46 %) po šestih mesecih ter 0,14-odstotnega zmanjšanja z insulinom lispro.
The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Apidra (opažen pri več kot 1 bolniku izmed 10) je hipoglikemija (nizka raven glukoze v krvi).
In type 2 diabetes (when the body is unable to use insulin effectively), Apidra has been studied in one study involving 878 adults.
Pri sladkorni bolezni tipa 2 (ko telo insulina ne more učinkovito izrabljati) je bilo zdravilo Apidra proučevano v eni študiji, ki je vključevala 878 odraslih bolnikov.
Apidra, used in combination with a long-acting insulin, has been studied in type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children and adolescents aged between four and 17 years.
Zdravilo Apidra, uporabljeno z insulinom z dolgotrajnim delovanjem, so proučevali pri sladkorni bolezni tipa 1(ko telo ne more proizvajati insulina) v dveh študijah s skupaj 1 549 odraslimi bolniki in v eni študiji s 572 otroki in mladostniki, starimi od štiri do 17 let.
It is supplied in vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).
Na voljo je v vialah, injekcijskih vložkih in predhodno napolnjenih injekcijskih peresnikih za enkratno uporabo (OptiSet in SoloStar).
The patient's blood glucose (sugar) levels should be regularly tested to find the lowest effective dose.
Raven glukoze (sladkorja) v krvi bolnika je treba redno preverjati, da določimo najmanjši učinkovit odmerek.
The main measure of effectiveness was the change in levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Glavno merilo učinkovitosti je bila sprememba količine snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
Blood glucose control with Apidra was at least as effective as that with the comparator insulins.
Nadzor glukoze v krvi je bil z zdravilom Apidra vsaj tako učinkovit kot s primerjalnimi insulini.
The difference means that insulin glulisine acts more rapidly, and has a shorter duration of action than a short-acting human insulin.
Razlika je v tem, da insulin glulisin učinkuje hitreje in deluje manj časa kot humani insulin s kratkotrajnim delovanjem.
Apidra is used to treat patients aged six years or over with diabetes, when they need insulin.
Zdravilo Apidra se uporablja za zdravljenje bolnikov, starejših od 6 let, kadar potrebujejo insulin.
The active substance in Apidra, insulin glulisine, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glulisine.
Zdravilno učinkovino v zdravilu Apidra, insulin glulisin, proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, Izdela ga bakterija, ki je prejela gen (DNK), s katerim lahko tvori insulin glulisin.
Insulin glulisine is very slightly different from human insulin.
Insulin glulisin se zelo malo razlikuje od humanega insulina.
In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro).
V vseh štirih študijah so zdravilo Apidra primerjali z drugimi insulini ali analogi insulina (običajnim humanim insulinom ali insulinom lispro).
What is the risk associated with Apidra?
Kakšna tveganja so povezana z zdravilom Apidra?
Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients.
Zdravila Apidra ne smejo jemati osebe, ki utegnejo biti preobčutljive za (alergične na) insulin glulisin ali katero koli drugo sestavino zdravila.
Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin.
Podobna zmanjšanja so bila opažena v drugi študiji pri odraslih, v kateri so zdravilo Apidra primerjali z običajnim humanim insulinom.
Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin).
Zdravilo Apidra je insulin s kratkotrajnim delovanjem, ki se uporablja v kombinaciji z insulini s srednjedolgim ali dolgotrajnim delovanjem ali analogi insulina (spremenjenimi oblikami insulina).
Apidra is given by injection under the skin in the abdominal wall (tummy), the thigh or the shoulder, or by continuous infusion using an insulin pump.
Zdravilo Apidra se injicira pod kožo v trebušno steno, stegno ali ramo ali s kontinuirano infuzijo z insulinsko črpalko.
In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.
Pri odraslih s sladkorno boleznijo tipa 2 je bilo z zdravilom Apidra doseženo 0,46-odstotno zmanjšanje HbA1c po šestih mesecih, v primerjavi z 0,30 % ob uporabi običajnega humanega insulina.
Why has Apidra been approved?
Zakaj je bilo zdravilo Apidra odobreno?
For the full list of all side effects reported with Apidra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Apidra, glejte navodilo za uporabo.
In all of the studies, the change in the level of HbA1c seen with Apidra was similar to that seen with the comparator insulins.
V vseh študijah je bila sprememba ravni HbA1c, opažena z zdravilom Apidra, podobna spremembi, opaženi s primerjalnimi insulini.
It may also be used in combination with antidiabetes medicines taken by mouth.
Lahko se uporablja tudi v kombinaciji s peroralnimi zdravili proti sladkorni bolezni.
Apidra is a replacement insulin that is very similar to the insulin made by the body.
Zdravilo Apidra je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja telo.
The full EPAR for Apidra can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Apidra je na voljo tukaj.
In this study, Apidra was used in combination with an intermediate-acting insulin and antidiabetes medicines taken by mouth.
V tej študiji je bilo zdravilo Apidra uporabljeno v kombinaciji z insulinom s srednjedolgim delovanjem ter peroralnimi zdravili proti sladkorni bolezni.
Apidra is a solution for injection that contains the active substance insulin glulisine.
Zdravilo Apidra je raztopina za injiciranje, ki vsebuje zdravilno učinkovino insulin glulisin.
In the study in children and adolescents, Apidra and insulin lispro produced similar changes in HbA1c after six months.
V študiji pri otrocih in mladostnikih so bile po šestih mesecih opažene podobne spremembe z zdravilom Apidra in insulinom lispro.
How has Apidra been studied?
Kako je bilo zdravilo Apidra raziskano?
What is Apidra used for?
Za kaj se zdravilo Apidra uporablja?
How does Apidra work?
Kako zdravilo Apidra deluje?
What is Apidra?
Kaj je zdravilo Apidra?
How is Apidra used?
Kako se zdravilo Apidra uporablja?
The full list is available in the Package Leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
However, talk to your doctor first.
Kljub temu se o tem najprej pogovorite z zdravnikom.
(4) Not statistically significant.
(4) Ni statistično značilno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 March 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 30. marec 2009
Children above 5 years old
Otroci, starejši od 5 let
Control vaccine N=10,201
Kontrolno cepivo N = 10.201
This is so that you and your doctor can talk about what steps need to be taken to protect your child.
Ob tem obisku se boste z vašim zdravnikom lahko pogovorili, kakšne ukrepe je potrebno sprejeti za zaščito vašega otroka.
Remove the needle protector, which on occasion can be a little stiff.
Odstranite ščitnik igle; to gre lahko včasih nekoliko trdo.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil morata biti jasno zabeležena ime in številka serije uporabljenega zdravila.
Please speak to your doctor for information on the number and timing of injections for your child.
Prosimo, pogovorite se s svojim zdravnikom o številu in časovnem razporedu injekcij, ki jih bo dobil vaš otrok.
If not used within 28 days it should be discarded.
Če ni porabljeno v 28 dneh, ga morate zavreči.
• allergic reactions such as skin allergies
• alergijske reakcije, npr. alergije na koži
The persistence of protection against B-CAP and C-CAP beyond the age of 36 months is currently not established.
Trajanje zaščite proti B-CAP in C-CAP v starosti nad 36 mesecev še ni bilo ocenjeno.