qanastek/EMEA-V3 huggingface dataset:
4 Patients using CSII may be more prone to infection at the site of infusion.
Pacientiem, kuri lieto PSII, past v liel ka infekcijas iesp ja inf zijas ievad šanas viet.
Infections can be minimised by careful attention to personal hygiene of the hands and infusion site and by frequent changes of catheter (maximum usage 2 days).
Infekciju iesp jam bu var samazin t ar r p gu attieksmi pret roku un inf zijas vietas higi nu, un ar biežu (maksim lais lietošanas ilgums – 2 dienas) katetru mai u.
Velosulin contains metacresol, which may cause allergic reactions.
4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
4.5 Interaction with other medicinal products and other forms of interaction
Zin mi daudzi medikamenti, kas mijiedarbojas ar glikozes vielmai u, t d mijiedarb ba un vienm r j izvaic pacients par vis m lietotaj m z l m.
ed The following substances may reduce insulin requirement:
rstam j em v r iesp jam
is blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
Nepieciešam bu p c insul na var mazin t š das vielas:
or The following substances may increase insulin requirement:
peror lie hipoglikemiz jošie l dzek i (PHL), monoam noksid zes inhibitori (MAOI), neselekt vie beta
th Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth
s blokatori, angiotens na konvert još enz ma (AKE) inhibitori, salicil ti, alkohols, anabolie stero di vai
au hormone and danazol.
ta sulfonam di.
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from
rē Nepieciešam bu p c insul na var palielin t š das vielas: peror lie pretapaug ošan s l dzek i, tiaz di, glikokortiko di, vairogdziedzera hormoni un beta
er hypoglycaemia.
st simpatomim tiskie l dzek i, augšanas hormons un danazols.
Octreotide/ lanreotide may both decrease and increase insulin requirement. lo
ği Beta blokatori var mask t hipoglik mijas simptomus un kav t atlabšanu p c hipoglik mijas. re Oktreot ds/ lanreot ds var gan mazin t, gan palielin t nepieciešam bu p c insul na. v na
Alcohol may intensify and prolong the hypoglycaemic effect of insulin. no
Alkohols var pastiprin t un paildzin t insul na hipoglik misko darb bu.
4.6 Pregnancy and lactation
4. 6 Gr tniec ba un z d šana irs
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes ro
Nav ierobežojumu diab ta rst šanai ar insul nu gr tniec bas laik, jo insul ns neš rso placent ro barjeru. va
therapy, increase the risk of malformations and death in utero.
Gan hipoglik mija, gan hiperglik mija, kas var rasties nepietiekami kontrol tas diab ta terapijas laik, palielina iedzimtu kropl bu un n ves in utero risku.
Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when lp
T d sieviet m ieteicama pastiprin ta diab ta es
contemplating pregnancy.
rst šanas kontrole visu gr tniec bas laiku un tad, ja pl no gr tniec bu.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and a
Nepieciešam ba p c insul na parasti mazin s pirmaj trimestr un p c tam palielin s otraj un trešaj l Zā
third trimesters. in
trimestr.
After delivery, insulin requirements return rapidly to pre-pregnancy values. ic
P c dzemd b m nepieciešam ba p c insul na tri atjaunojas l men, k ds bijis pirms gr tniec bas.
However, the Velosulin dosage ed
Tom r var b t nepieciešams piel got Velosulin devu.
5 4.8 Undesirable effects
5 4. 8 Nev lam s blakuspar d bas
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Kl niskos p t jumos un p cre istr cijas nov rojumos t s biežums vari starp pacientu grup m un doz šanas rež miem, t d noteikts hipoglik mijas rašan s biežums nevar b t uzr d ts.
Frequencies of adverse drug reactions from clinical trials that are considered related to fast-acting ≥ human insulin (Actrapid) are listed below.
Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuri ir attiecin ti uz tras darb bas cilv ka insul nu (Actrapid), uzskait tas t l k.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to
Biežums tiek defin ts š di: ret k (> 1/ 1000, < 1/ 100).
is Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Katr sastopam bas biežuma grup nev lam s blakuspar d bas sak rtotas to nopietn bas samazin juma sec b.
or Nervous system disorders Uncommon - Peripheral neuropathy
Nervu sist mas trauc jumi
th Fast improvement in blood glucose control may be associated with a condition termed “ acute painful
ta tra glikozes l me a asin s kontroles uzlabošan s var apvienoties ar st vokli, ko sauc par ak tu s pju neirop tiju, kas parasti ir p rejoša.
au neuropathy”, which is usually reversible.
rē Acu slim bas
Eye disorders
st Ret k - refrakcijas trauc jumi.
er Uncommon - Refraction disorders Refraction anomalies may occur upon initiation of insulin therapy.
ği Uzs kot insul nterapiju iesp jami refrakcijas trauc jumi.
These symptoms are usually of ng transitory nature. lo
Parasti šie simptomi ir p rejoši. re oti reti - diab tisk retinop tija.
Very rare - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. no
Tom r v
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. ct
insul nterapijas intensifik cija ar p kš u glik mijas kontroles uzlabošanos var b t saist ta ar slaic gu na
Skin and subcutaneous tissue disorders du
diab tisk s retinop tijas pasliktin šanos.
Uncommon – Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites ro
das un zem das audu boj jumi irs
within an area. lp
Ret k - lipodistrofija.
General disorders and administration site conditions Uncommon - Injection site reactions a
Visp r ji trauc jumi un reakcijas ievad šanas viet Ret k - reakcijas injekcijas viet. es
Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may in
rst šanas laik ar insul nu iesp jamas reakcijas injekcijas viet (aps rtums, piet kums, nieze, s p gums un hematoma injekcijas viet).
Most reactions are transitory and disappear during continued treatment. ic ed
P rsvar reakcijas ir p rejošas un, turpinot rst šanu, izz d. l Zā
These symptoms are usually of transitory M
Šie simptomi parasti ir p rejoši.
nature.
Im n s sist mas trauc jumi Ret k - n trene, izsitumi.
6 4.9 Overdose
6 4. 9 P rdoz šana
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to
Glikoze intravenozi j ievada ar tad, ja 10 – 15 min šu laik nav atbildes reakcijas uz glikagonu.
is patient in order to prevent relapse.
Atg stot sama u, pacientam ieteicams peror li lietot og hidr tus, lai izvair tos no atk rtotas hipoglik mijas.
th au 5.1 Pharmacodynamic properties
s ta 5. 1 Farmakodinamisk s paš bas
ATC
rē Farmakoterapeitisk grupa: insul ni un analogi injekcij m, tras darb bas, insul ns (cilv ka).
er code:
AT kods:
The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose lo
st ği Insul ns pazemina glikozes l meni asin s, jo tas saist s ar musku š nu un taukš nu receptoriem, veicinot glikozes nok šanu audos un vienlaikus nom cot glikozes izdal šanos no akn m. re Kl niskaj p t jum vien intens v s apr pes noda, kur tika rst ta hiperglik mija (glikozes l menis v
A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/ l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 – 6.1 mmol/ l) induced by intravenous treatment with another fast ct
asin s virs 10 mmol/ l) 204 cukura diab ta slimniekiem un 1344 pacientiem bez cukura diab ta, kuriem na
acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%). du
tika veikta plaša irur iska iejaukšan s, nov rots, ka ar intravenozu rst šanu ar citu tras darb bas cilv ka insul nu (Actrapid) ieg t normoglik mija (glikozes l menis asin s 4, 4 l dz 6, 1 mmol/ l) mazin ja mirst bu par 42% (8% pret 4, 6%). irs
Velosulin is a fast-acting insulin. ro
Velosulin ir tras darb bas insul na prepar ts. va
When Velosulin is administered as a bolus injection onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours. lp
Ja Velosulin ievada k bolus injekciju, darb ba s kas ½ stundas laik, maksimumu sasniedz 1 ½ – 3 ½ stundu laik un kop jais darb bas ilgums ir aptuveni 7 - 8 stundas. es
5.2 Pharmacokinetic properties a in
5. 2 Farmakokin tisk s paš bas l Zā
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. ic ed
T tad insul na prepar tu darb bas laiku raksturo tikai t uzs kšan s.
The pharmacokinetics of insulin products are therefore affected M
Šo procesu ietekm vair ki faktori (piem ram, insul na deva, injekcijas veids un vieta, zem das tauku sl a biezums, cukura diab ta tips), t d nov ro b tiskas insul na prepar tu farmakokin tikas atš ir bas vienam un tam pašam pacientam, k ar, sal dzinot vair kus pacientus.
Continuous subcutaneous infusion eliminates some of the variations/ fluctuations inherent to injection therapy.
Past v ga subkut na inf zija nov rš dažas no vari cij m/ sv rst b m, kas rakstur gas injekciju terapijai.
The relatively fast absorption of soluble insulin ensures a constant supply of insulin to the blood from a relatively small pool under the skin.
Š stoš insul na relat vi tr uzs kšan s nodrošina past v gu insul na pieg di asin s no relat vi maza tilpuma zem d.
Absorption The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Uzs kšan s Maksim l koncentr cija plazm tiek sasniegta 1 ½ l dz 2 ½ stundu laik p c subkut nas ievad šanas.
7 Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
7 Izplat šan s Nav nov rota izteikta saist šan s ar plazmas olbaltumiem, iz emot asinsrit cirkul još s insul na antivielas (ja t das ir).
Metabolism Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolisms Zi ots, ka cilv ka insul nu š e insul na prote ze vai insul nu š e ošie enz mi, un, iesp jams, prote nu disulf du izomer ze.
The
Elimin cija Termin lo elimin cijas pusperiodu nosaka uzs kšan s trums no zem das audiem.
ed terminal half-life (t½) is therefore a measure of the absorption rather than of the elimination per se of insulin from plasma (insulin in the blood stream has a t½ of a few minutes).
T p c termin lais elimin cijas pusperiods (t1/ 2) vair k ir uzs kšan s, nevis pašas insul na elimin cijas no plazmas funkcija (asinsrit insul na t1/ 2 ir dažas min tes).
Trials have indicated a t½
P t jumos nov rots, ka t1/ 2 ir aptuveni 2 l dz 5 stundas.
is of about 2-5 hours.
B rni un pusaudži
or Chrildren and adolescents The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 6-
s Farmakokin tisk s paš bas p t tas nelielam skaitam (n=18) b rnu (6 – 12 g. v.) un pusaudžu (13 – 17 g. v.)
th 12 years) and adolescents (aged 13-17 years) using another fast-acting human insulin, (Actrapid).
ta ar cukura diab tu, kuri lieto citu tras darb bas cilv ka insul nu (Actrapid).
The
Tom r
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
rē daž d s vecuma grup s bija atš ir ga Cmax, kas v lreiz uzsver individu las devas titr šanas noz m gumu.
5.3 Preclinical safety data er ng Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo
st 5. 3 Prekl niskie dati par droš bu
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. no
ği Nekl niskajos standartp t jumos ieg tie dati par farmakolo isko droš bu, atk rtotu devu toksicit ti, re genotoksicit ti, iesp jamu kancerogenit ti un toksisku ietekmi uz reproduktivit ti neliecina par pašu risku cilv kam. v na
PHARMACEUTICAL PARTICULARS ct
FARMACEITISK INFORM CIJA irs
6.1 List of excipients du
6. 1 Pal gvielu saraksts va
Glycerol Metacresol lp
Cinka hlor ds Glicer ns Metakrezols es
Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) a
N trija hidrog nfosf ta dihidr ts N trija hidroks ds (pH korekcijai) l Zā
Hydrochloric acid (for pH adjustment) in
S lssk be (pH korekcijai) dens injekcij m
Water for injections ic
6. 2 Nesader ba
M
Insul na prepar tus dr kst pievienot tikai tiem mais jumiem, kas ir zin mi k savienojami.
Medicinal products added to the insulin solution may cause degradation of the insulin, e. g. if the medicinal products contain thiols or sulphites.
Insul na š dumam pievienoti rstnieciski prepar ti var izrais t insul na sadal šanos, piem ram, ja pievienot prepar ta sast v ir tioli vai sulf ti.
Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section 6.6.
Kas attiecas uz sader bu ar insul na inf zijas s k iem, rezervu riem, katetriem un adat m skat t apakšpunktu 6. 6.
8 After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
8 P c pirm s lietošanas inf zij, insul na š dumu var uzglab t s k a rezervu r sešas dienas temperat r l dz 37°C (tuvu pie erme a).
Do not store them in or too near the freezer section or cooling element.
Neuzglab t sald tavas nodal jum vai p r k tuvu tam vai aukstuma elementam.
After first use as infusion: the insulin solution may be stored in the pump reservoir at up to 37°C (close to the body).
P c pirm s lietošanas inf zij: insul na š dumu var uzglab t s k a rezervu r l dz 37°C (tuvu pie erme a).
ed Keep the vial in the outer carton in order to protect from light.
Flakonu uzglab t r j iepakojum, lai pasarg tu no gaismas.
is Protect from excessive heat and sunlight.
Sarg t no p rm r ga karstuma un saules gaismas.
or 6.5 Nature and contents of container
s 6. 5 Iepakojuma veids un saturs
th 10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective
ta 10 ml stikla (1. tipa) flakons, kas aizv kots ar brombutila/ poliizopr na gumijas aizb zni un plastmasas
au tamper-proof cap.
rē aizsargv ci u.
Pack sizes:
st Iepakojuma lielumi:
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
1 vai 5 flakoni x 10 ml un grupveida iepakojumi pa 5 x (1 x 10 ml) flakoniem.
6.6 Special precautions for disposal and other handling er ng Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to lo
ği 6. 6 paši nor d jumi atkritumu likvid šanai un nor d jumi par sagatavošanu lietošanai re Sajaucot Velosulin ar inf ziju š idrumiem, neparedzamu insul na daudzumu adsorb s inf zijas materi ls. v
Monitoring of the patient's blood glucose during infusion is therefore recommended. no
T p c inf zijas laik ieteicams kontrol t glikozes l meni pacienta asin s. na
When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin. ct du
Ja ievada ar PSII, inf zijas s k a rezervu r, kur ir Velosulin, nedr kst pievienot citus rstnieciskus prepar tus vai citus insul nus. irs
Velosulin should not be mixed with insulin zinc suspensions ro
Ja ir nepieciešama kombin cija ar ilgstošas darb bas insul nu, t ir iesp jama tikai jaucot Velosulin kop va
since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way. lp
T k fosf ta bufers var savstarp ji iedarboties ar suspensij esošo cinku un neparedzam veid main t iedarb bas laiku, Velosulin nedr kst jaukt kop ar insul na cinka suspensij m. es
Insulin preparations which have been frozen must not be used. a
Insul na prepar tus, kas bijuši sasaluši, nedr kst lietot. l Zā
Insulin solutions should not be used if they do not appear water clear and colourless. in
Insul na š dumus nedr kst lietot, ja tie neizskat s dens dzidri un bezkr saini.
Insulin infusion (CSII): ic
Insul na inf zijas (PSII):
Use only syringes made of polyethylene, polypropylene or glass. ed
Lietot tikai no polietil na, polipropil na vai stikla izgatavotas š irces.
M
Lietot tikai katetrus, kuros materi ls, kas ir kontakt ar insul nu, ir izgatavots no polietil na vai polipropil na.
Use only teflon-coated or stainless steel needles.
Lietot tikai ar teflonu p rkl tas vai ner s još t rauda adatas.
Date of first suthorisation:
s Re istr cijas datums:
07 October 2002
2002. gada 7. oktobris
Date of latest renewal:
ta P rre istr cijas datums:
10 ed is or th au ANNEX II er ng
TEKSTA P D J S P RSKAT ŠANAS DATUMS
A.
st ği re v na irs va es l Zā
MANUFACTURER OF THE BIOLOGICAL ACTIVE lo
10 s ta rē st ği PIELIKUMS II re A.
SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE no
PAŠNIEKS, KURŠ ATBILD PAR S RIJAS IZLAIDI na
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
RE ISTR CIJAS APLIEC BAS NOSAC JUMI irs va es l Zā
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK-2880 Bagsværd Denmark Denmark
Novo Nordisk A/ S Novo Nordisk A/ S Novo Allé Hallas Allé DK- 2880 Bagsvaerd D nija D nija
Name and address of the manufacturers responsible for batch release
Ražot ja, kas atbild par s rijas izlaidi, nosaukums un adrese
ed Novo Nordisk A/ S
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsvaerd D nija
th au B.
s ta B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
rē • NOSAC JUMI UN IEROBEŽOJUMI ATTIEC B UZ PIEG DI UN LIETOŠANU, KAS
THE MARKETING AUTHORISATION HOLDER
st UZLIKTI RE ISTR CIJAS APLIEC BAS PAŠNIEKAM
Medicinal product subject to medical prescription lo
ği Recepšu z les re •
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT no
NOSAC JUMI VAI IEROBEŽOJUMI ATTIEC B
Not applicable. ct du ro ed M
UZ DROŠU UN EFEKT VU ŠO Z v
ic
U
in
LIETOŠANU
a
na
lp
Nav piem rojama. irs va es l Zā
12 ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
12 s ta rē st ği PIELIKUMS III re MAR JUMA TEKSTS UN LIETOŠANAS INSTRUKCIJA v na irs va esl Zā
13 M ed ic in alp ro du ct
13 Zā les va
14 no
14 na v re JUMA TEKSTS ği st rē ta s INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 SV/ ml Š dums injekcij m vai inf zij m flakon Insulinum humanum (rDNA)
is 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
1 ml š duma satur 100 SV (3, 5 mg) cilv ka insul na (rDNS),
or th 3.
s ta 3.
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
rē cinka hlor du, glicer nu, metakrezolu, n trija hidrog nfosf ta dihidr tu, n trija hidroks du, s lssk bi un
er ng 4.
ği re 4.
PHARMACEUTICAL FORM AND CONTENTS lo
U FORMA UN SATURS
Solution for injection or infusion no
Š dums injekcij m vai inf zij m na
1 x 10 ml 5 x 10 ml ct du
1 x 10 ml 5 x 10 ml irs
METHOD AND ROUTE(S) OF ADMINISTRATION ro
LIETOŠANAS METODE UN IEVAD ŠANAS VEIDS va
Subcutaneous or intravenous use Read the package leaflet before use
Subkut nai vai intravenozai lietošanai. es
a
Pirms lietošanas izlasiet instrukciju. l Zā
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT in
PAŠI BR DIN JUMI PAR Z
OF THE REACH AND SIGHT OF CHILDREN ic
U UZGLAB ŠANU B RNIEM NEPIEEJAM UN
Keep out of the reach and sight of children ed M
Uzglab t b rniem nepieejam un neredzam viet.
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C May be kept in an infusion pump at up to 37°C for 6 days
Var tur t inf zijas s kn l dz 37°C sešas dienas.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PAŠI PIESARDZ BAS PAS KUMI, IZN CINOT NEIZLIETOTO PREPAR TU VAI IZMANTOTOS MATERI LUS, KAS BIJUŠI SASKAR AR ŠO PREPAR TU (JA PIEM ROJAMS)
th Novo Nordisk A/ S
s ta Novo Nordisk A/ S Novo Allé
au Novo Allé DK-2880 Bagsværd Denmark
rē DK- 2880 Bagsværd D nija
er ng 12.
st ği 12.
MARKETING AUTHORISATION NUMBERS lo
RE ISTR CIJAS NUMURS( I) re EU/ 1/ 02/ 232/ 001 1 x 10 ml v
EU/ 1/ 02/ 232/ 001 1 x 10 ml EU/ 1/ 02/ 232/ 002 5 x 10 ml no
EU/ 1/ 02/ 232/ 002 5 x 10 ml na
BATCH NUMBER ct du
S RIJAS NUMURS irs
Batch: ro
S rija: va es
GENERAL CLASSIFICATION FOR SUPPLY lp
IZSNIEGŠANAS K RT BA l
Medicinal product subject to medical prescription a in ic
Zā
INSTRUCTIONS ON USE ed
NOR D JUMI PAR LIETOŠANU
INFORMATION IN BRAILLE M
INFORM CIJA BRAILA RAKST
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
Velosulin 100 IU/ ml solution for injection or infusion Insulin human (rDNA) SC, IV use
Velosulin 100 SV/ ml Š dums injekcij m vai inf zij m Insulinum humanum (rDNA) s. c., i. v.
is or 3.
s ta 3.
th au EXP/
rē EXP /
ng
v na
CONTENTS BY WEIGHT, BY VOLUME OR
SATURA SVARS, TILPUMS VAI VIEN BU DAUDZUMS
10 ml ct du
10 ml irs va
OTHER ro
CITA es
Novo Nordisk A/ S
Novo Nordisk A/ S l Zā
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
17 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN TIEŠ IEPAKOJUMA
Velosulin 100 IU/ ml solution for injection or infusion in a vial Insulin human( rDNA)
Velosulin 100 SV/ ml Š dums injekcij m vai inf zij m flakon Insulinum humanum (rDNA)
is 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
s 1 ml š duma satur 100 SV (3, 5 mg) cilv ka insul na (rDNS),
or th 3.
ta rē 3.
au zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
st cinka hlor du, glicer nu, metakrezolu, n trija hidrog nfosf ta dihidr tu, n trija hidroks du, s lssk bi un
er ng 4.
ği deni 4.
PHARMACEUTICAL FORM AND CONTENTS lo
Z U FORMA UN SATURS
Solusion for injection or infusion 1 x 10 ml no
Š dums injekcij m vai inf zij m 1 x 10 ml Š ir da a no grupveida iepakojuma un nav paredz ta p rdošanai pa atseviš iem flakoniem. irs va
METHOD AND ROUTE(S) OF ADMINISTRATION du
LIETOŠANAS METODE UN IEVAD ŠANAS VEIDS es
Subcutaneous or intravenous use ro
Subkut nai vai intravenozai lietošanai.
Read the package leaflet before use lp
PAŠI BR DIN JUMI PAR Z
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT a
U UZGLAB ŠANU B RNIEM NEPIEEJAM UN
OF THE REACH AND SIGHT OF CHILDREN in ic
NEREDZAM VIET
Keep out of the reach and sight of children ed
Uzglab t b rniem nepieejam un neredzam viet.
OTHER SPECIAL WARNING(S), IF NECESSARY M
CITI PAŠI BR DIN JUMI, JA NEPIECIEŠAMS
is or 11.
s 11.
th Novo Nordisk A/ S
ta Novo Nordisk A/ S
au Novo Allé DK-2880 Bagsværd Denmark
rē Novo Allé DK- 2880 Bagsværd
er ng 12.
st D nija
MARKETING AUTHORISATION NUMBERS lo
RE ISTR CIJAS NUMURS( I) v
EU/ 1/ 02/ 232/ 003 no
EU/ 1/ 02/ 232/ 003 na
BATCH NUMBER ct
S RIJAS NUMURS irs
Batch: du ro
S rija: va es
Medicinal product subject to medical prescription a in
Zā
INSTRUCTIONS ON USE ic ed
NOR D JUMI PAR LIETOŠANU
19 PARTICULARS TO APPEAR ON THE PACKAGING
19 INFORM CIJA, KAS J NOR DA UZ IEPAKOJUMA
OUTER WRAPPER LABLE ON MULTIPACKS
R J APVILKT ETI ETE GRUPVEIDA IEPAKOJUMAM
Velosulin 100 IU/ ml Solution for injection or infusion in a vial Insulin human (rDNA)
Velosulin 100 SV/ ml Š dums injekcij m vai inf zij m flakon Insulinum humanum (rDNA)
ed 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
s 1 ml š duma satur 100 SV (3, 5 mg) cilv ka insul na (rDNS),
is or 3.
ta rē 3.
th zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric
st cinka hlor du, glicer nu, metakrezolu, din trija fosf ta dihidr tu, n trija hidroks du, s lssk bi un deni
au acid and water for injections.
ği injekcij m.
er 4.
Z
ng
re
Solusion for injection or infusion 5 x (1 x 10 ml) lo
Š dums injekcij m vai inf zij m 5 x (1 x 10 ml) Šis ir grupveida iepakojums un nav paredz ts p rdošanai pa atseviš iem flakoniem. irs va
METHOD AND ROUTE(S) OF ADMINISTRATION ct
LIETOŠANAS METODE UN IEVAD ŠANAS VEIDS es
Subcutaneous or intravenous use du
Subkut nai vai intravenozai lietošanai.
Read the package leaflet before use ro
PAŠI BR DIN JUMI PAR Z
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
U UZGLAB ŠANU B RNIEM NEPIEEJAM UN
OF THE REACH AND SIGHT OF CHILDREN a
NEREDZAM VIET
Keep out of the reach and sight of children in ic
Uzglab t b rniem nepieejam un neredzam viet.
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
CITI PAŠI BR DIN JUMI, JA NEPIECIEŠAMS
MARKETING AUTHORISATION NUMBER(S) lo
RE ISTR CIJAS NUMURS( I) v
21 M ed ic in alp ro du ct
21 s ta rē st ği B.
22 no lo B.
22
PACKAGE LEAFLET ng er au th or is ed PACKAGE LEAFLET:
LIETOŠANAS INSTRUKCIJA:
Velosulin 100 IU/ ml solution for injection in a vial Insulin human (rDNA)
Velosulin 100 SV/ ml š dums injekcij m flakon Cilv ka insul ns (insulinum humanum), rDNS
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
Iesp jams, ka v l k to vajadz s p rlas t. – Ja jums rodas v l k di jaut jumi, vaic jiet rstam, diab ta apr pes m sai vai farmaceitam. – Š s z les ir parakst tas tieši jums.
WHAT VELOSULIN IS AND WHAT IT IS USED FOR
KAS IR VELOSULIN UN K DAM NOL KAM TO LIETO
or Velosulin is human insulin to treat diabetes.
s ta Velosulin ir cilv ka insul ns diab ta rst šanai.
Velosulin is a fast-acting insulin.
Velosulin ir tras darb bas insul ns.
This means that it will start to lower your blood sugar about half an hour after you take it.
Tas noz m, ka Velosulin s ks pazemin t glikozes l meni asin s apm ram p c ½ stundas p c t ievad šanas.
th au 2.
rē st 2.
BEFORE YOU USE VELOSULIN
PIRMS VELOSULIN LIETOŠANAS
er Do not use Velosulin
ği Nelietojiet Velosulin š dos gad jumos re Ja jums ir aler ija (paaugstin ta jut ba) pret šo insul nu, metakrezolu vai k du citu sast vda u v
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
S k ka inform cija).
Look out for the signs of allergy in 5 Possible side lo
Aler ijas simptomus skat t 5.
effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom no
Iesp jam s blakuspar d bas. na
of low blood sugar).
Ja j s saj tat hipoglik mijas tuvošanos (zema glikozes l me a asin s simptomus).
See 4 What to do in an emergency for more about hypos.
K r koties neatliekam situ cij. irs
Take special care with Velosulin ct du
paša piesardz ba, lietojot Velosulin, nepieciešama š dos gad jumos va
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty ro
Ja jums ir nieru vai aknu, virsnieru dziedzera, hipof zes vai vairogdziedzera darb bas trauc jumi.
stomach If you are exercising more than usual or if you want to change your usual diet lp
Ja lietojat alkoholu: uzmanieties no hipoglik mijas simptomiem un nekad nelietojiet alkoholu tukš d š. es
If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the a
Slimošanas laik: nep rtrauciet insul na lietošanu. l Zā
timing of your injections. in
Ja j s dodaties uz rvalst m: laika zonu starp ba daž d s valst s ietekm s nepieciešam bu p c insul na un ievad šanas laiku.
Using other medicines ic ed
Citu z u lietošana
Talk to your M
T l k uzskait ti izplat t kie medikamenti, kuri var ietekm t j su rst šanu ar insul nu.
doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Past stiet savam rstam vai farmaceitam par vis m z l m, kuras lietojat vai p d j laik esat lietojis, ieskaitot z les, ko var ieg d ties bez receptes.
23 Driving and using machines
23 Gr tniec ba un z d šanas periods
If you drive or use tools or machines: watch out for signs of a hypo.
Ja esat gr tniece, pl nojat gr tniec bu vai barojat ar kr ti: l dzu, konsult jieties ar savu rstu.
Your ability to concentrate or to react will be less during a hypo.
Ja j s vad t transportl dzek us vai apkalpojat iek rtas vai meh nismus: paturiet pr t hipoglik mijas simptomu iesp jam bu.
Never drive or use machinery if you feel a hypo coming on.
J su sp jas koncentr ties vai rea t hipoglik mijas laik var pav jin ties.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Konsult jieties ar rstu vai j s varat vad t transportl dzekli vai apkalpot meh nismus, ja jums bieži rodas hipoglik mija vai hipoglik mijas br din juma paz mes ir v ji izteiktas.
HOW TO USE VELOSULIN
K LIETOT VELOSULIN
Talk about your insulin needs with your doctor and diabetes nurse.
R p gi
Follow their advice carefully.
ta iev rojiet vi u nor d jumus.
ed If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Ja rsts jums nomaina iepriekš lietoto insul na tipu vai z molu uz citu, rstam deva var b t j piel go.
is Eat a meal or snack containing carbohydrates within 30 minutes of administration.
rē Ne v l k k 30 min šu laik p c ievad šanas j ietur malt te vai j ap d og hidr tus saturoša uzkoda.
or Before using Velosulin
st ği Pirms lietojat Velosulin
th au Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Dezinfic jiet gumijas membr nu ar medic nisko salveti. v na
er Do not use Velosulin ng If the protective cap is loose or missing.
Nelietojiet Velosulin
Each vial has a protective, tamper-proof plastic cap.
Ja plastmasas aizsargv ci š ir va gs vai t nav.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier lo
Katrs flakons ir nosl gts ar plastmasas irs
If it hasn’ t been stored correctly or been frozen (see 6 How to store Velosulin) If it does not appear water clear and colourless. no
K uzglab t Velosulin). va
Use in infusion pump ct
Ja tas nav densdzidrs un bezkr sains.
Follow the instructions and recommendations from your doctor regarding the use of Velosulin in a du
Lietošana inf zijas s kn es
Velosulin should never be mixed with any other insulin when used in a pump. ro
Iev rojiet j su rsta instrukcijas un rekomend cijas par Velosulin lietošanu s kn. l Zā
Read and follow carefully the instructions that accompany your insulin pump.
Lietojot s kn, nek d gad jum nejauciet Velosulin kop ar k du citu insul nu.
Always have ordinary syringes available in case of pump interruption or failure. lp
Izlasiet un r p gi iev rojiet instrukcijas, kuras pievienotas j su insul na s knim.
Use in syringes a in
Lietošana š irc s
Velosulin is for injection under the skin (subcutaneously).
Velosulin ir paredz ts injic šanai zem das (subkut ni).
The best places to give yourself an injection are: the front of your ic
Iesp jam s blakuspar d bas).
Your insulin will work more ed
Ja injekciju izdar t pats, piem rot k s vietas insul na ievad šanai ir: v dera priekš j sien, s žas apvid, augšstilbu priekšpus vai augšdelmos.
quickly if you inject it around the waist.
Insul ns iedarbosies tr k, ja injic siet viduk a apvid.
M
Velosulin flakoni j lieto kop ar insul na š irc m, kam ir atbilstoša vien bu skala.
Velosulin may also be administered intravenously in special situations by medical professionals.
paš s situ cij s medic nas darbinieki Velosulin var ievad t ar intravenozi.
To inject Velosulin on its own
24 Ja lietojat tikai Velosulin
Check you have the right dose 24 8.
P rbaudiet, vai deva ir pareiza.
Inject the insulin straight away under the skin.
Nekav joties injic jiet insul nu zem das.
Use the injection technique advised by your doctor or diabetes nurse 9.
Iev rojiet rsta vai diab ta apr pes m sas sniegtos nor d jumus par injic šanas tehniku.
Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Paturiet adatu zem das vismaz 6 sekundes, lai b tu droši, ka ievad ta visa deva.
To mix Velosulin with long acting insulin
K sajaukt Velosulin kop ar ilgstošas darb bas insul nu
Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
s ta emiet v r j su rsta vai diab ta apr pes m sas nor d jumus par pareizu sajaukšanas proced ru.
ed If you get a hypo
st ği Ja jums ir hipoglik mija Hipoglik mija noz m p r k zemu glikozes l meni asin s.
is A hypo means your blood sugar level is too low.
Hipoglik mijas br din juma paz mes var par d ties p kš v
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin;
T s var b t š das: auksti sviedri, v sa, b la
or headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling
da, galvass pes, pa trin ta sirdsdarb ba, saj ta, ka esat slims, liels izsalkums, slaic gas redzes izmai as, na
th confused; difficulty in concentrating.
miegain ba, neparasts nogurums un v jums, nervozit te vai tr ce, trauksmes saj ta, apjukums, apgr tin ta sp ja koncentr ties.
au If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
(saldumus, cepumus, aug u sulu), tad atp tieties.
Don’ t take any insulin if you feel a hypo coming on.
Neinjic jiet insul nu, ja j tat hipoglik mijas tuvošanos. va
er Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Katram gad jumam n s jiet l dzi glikozes tabletes, saldumus, cepumus vai aug u sulu.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they ng must: turn you on your side and seek medical advice straight away.
Izst stiet saviem radiniekiem, draugiem un tuv kajiem kol iem, ka gad jum, ja jums iest jas bezsama a, vi iem j pagriež j s uz s niem un nekav joties j mekl medic niska pal dz ba.
They must not give you any food or drink as it could choke you. lo
Jums nedr kst es
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death no
Ja smagu hipoglik miju ne rst, t var izrais t smadze u boj jumu (p rejošu vai past v gu) un pat l Zā
If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Ja jums bijusi hipoglik mija ar bezsama u vai hipoglik mijas jums ir bieži, aprun jieties ar rstu.
The amount or timing of insulin, food or exercise may need to be adjusted. ct
Var b t nepieciešams piel got insul na devu, ievad šanas laiku, uzturu vai fizisko slodzi.
Using glucagon du
Glikagona lietošana
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by ro
J s atg sieties no bezsama as tr k, ja k ds, kurš zina, k ar to r koties, jums injic s hormonu glikagonu.
If you do not respond to glucagon treatment, you will have to be treated lp
Ja nerea jat uz glikagona terapiju, j s j rst stacion r.
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more. a in
P c glikagona injekcijas mekl jiet medic nisku padomu, lai konstat tu hipoglik mijas c loni un nov rstu t s atk rtošanos.
Causes of a hypo ic
Hipoglik mijas c lo i
This might happen: ed
Jums ir hipoglik mija, ja glikozes l menis asin s ir p r k zems.
• If you take too much insulin • If you eat too little or miss a meal M
Tas var notikt: • ja esat ievad jis p r k daudz insul na, • ja esat par maz dis vai dienreize ir izlaista,
• If you exercise more than usual.
25 • ja fizisk slodze ir liel ka nek parasti.
Then seek medical advice straight away.
Ja jums rodas k da no š m paz m m, p rbaudiet glikozes l meni asin s; ja iesp jams, nosakiet ketonvielu kl tb tni ur n; mekl jiet medic nisku pal dz bu.
25 Causes of hyperglycaemia
• Aizmirstat ievad t insul nu.
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
ta • Infekcijas slim ba vai drudzis. • dat vair k nek parasti.
POSSIBLE SIDE EFFECTS
T pat
ed Like all medicines, Velosulin can cause side effects, although not everybody gets them.
IESP JAM S BLAKUSPAR D BAS k citas z les, Velosulin var izrais t blakuspar
Velosulin may cause hypoglycaemia (low blood sugar).
izrais t hipoglik miju (zems glikozes l menis asin s).
See the advice in 4 What to do in an emergency.
K r koties v
is Side effects reported uncommonly (in less than 1 patient in 100)
(maz k nek 1 pacientam uz 100) va
or Vision problems.
Redzes trauc jumi.
When you first start your treatment, it may disturb your vision, but the reaction
Kad j s pirmoreiz s kat insul nterapiju, t var izrais t redzes trauc jumus, ta u tie parasti izz d. es
au Changes at the injection site (Lipodystrophy).
Izmai as injekcijas viet (lipodistrofija).
Changing the
Mainot l Zā
er site with each injection may help to prevent such skin changes.
injekcijas vietu katrai injekcijai, var pal dz t izvair ties no š d m das izmai m.
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become ng more severe, or they may change the absorption of your insulin if you inject in such a site. lo
Ja j s nov rojat, ka j su d veidojas iedobumi vai pac lumi injekcijas apvid, past stiet par to savam rstam vai diab ta apr pes m sai, jo š s reakcijas var k t daudz nopietn kas, vai ar var main ties insul na uzs kšan s, ja turpin siet injic t š d viet.
If they do not disappear, no
Ja simptomi neizz d, konsult jieties ar savu rstu.
Seek medical advice immediately: • if signs of allergy spread to other parts of the body, or ct
Nekav joties mekl jiet medic nisku padomu: • ja aler ijas paz mes v rojamas ar cit s erme a da s, vai • ja p kš i j taties slikti: s kat sv st, rodas slikta pašsaj ta (vemšana), ir apgr tin ta elpošana, pa trin ta sirdsdarb ba, reibonis, j taties k nema.
• if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty du
Jums var b t oti reti sastopam, ta u nopietn aler isk reakcija uz Velosulin vai k du no t sast vda m (to sauc par sist misko aler isko reakciju).
See also warning in 2 Before you use Velosulin. lp
Pirms Velosulin lietošanas.
Painful neuropathy (nerve related pain).
26 S pju neirop tija (s pes uz nervu pamata).
If a
To sauc par ak tu s pju neirop tiju un t parasti ir p rejoša.
it does not disappear, see your doctor. in
Ja t nep riet, konsult jieties ar savu rstu.
When you start taking insulin, water retention may cause swelling around your ankles ic
oti reti sastopam s blakuspar d bas
This soon disappears. ed
(maz k nek 1 pacientam uz 10 000)
Side effects reported very rarely (in less than 1 patient in 10,000) M
Parasti tas dr z p riet.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
Ja nov rojat jebk das blakuspar d bas, kas šaj instrukcij nav min tas vai k da no min taj m blakuspar d b m jums izpaužas smagi, l dzam par t m izst st t savam rstam, diab ta apr pes m sai vai
26 6 HOW TO STORE VELOSULIN
K UZGLAB T VELOSULIN
Keep out of the reach and sight of children.
st Uzglab t z les b rniem nepieejam un neredzam viet!
Do not use Velosulin after the expiry date which is stated on the label and the carton.
ği Nelietot Velosulin p c der guma termi a beig m, kas nor d ts uz eti etes un kast tes.
The vials that is not being used is to be stored in a refrigerator (2°C - 8°C).
Der guma termi š attiecas uz nor d t m neša p d jo dienu. re Flakonus, kas netiek lietoti, j uzglab ledusskap (2°C – 8°C).
Do not store them in or too near the freezer section or cooling element.
Neuzglab t sald tavas nodal jum vai p r k tuvu tam, vai aukstuma elementam. v
Do not freeze.
Nesasald t. na
ed The vials that are being used or about to be used is not to be kept in a refrigerator.
Flakoni, kas tiek lietoti vai t l t tiks lietoti, nav j uzglab ledusskap.
You can keep it in the pump reservoir for 6 days at up to 37°C (close to the body).
J s varat tur t Velosulin s k a rezervu r 6 dienas l dz 37 °C (tuvu pie erme a). irs
is temperature (not above 25°C) for 6 weeks after first opening.
P c pirm s atv ršanas flakonu var uzglab t istabas temperat r (l dz 25°C) ne ilg k par 6 ned m.
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Flakonu, kad to nelietojat, vienm r glab jiet r j iepakojum, lai pasarg tu no gaismas. va
or Velosulin must be protected from excessive heat and sunlight.
Velosulin j sarg no p rm r ga karstuma un saules gaismas.
th Velosulin should not be disposed of via wastewater or household waste.
Velosulin nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
Ask your pharmacist how to
Vaic jiet farmaceitam par es
au dispose of medicines no longer required.
nevajadz go z u likvid šanu.
These measures will help to protect the environment.
Šie pas kumi pal dz s aizsarg t apk rt jo vidi. l Zā
FURTHER INFORMATION ng What Velosulin contains lo
Ko Velosulin satur
– The active substance is insulin human made by recombinant biotechnology.
- Akt v viela ir cilv ka insul ns, kas ražots, izmantojot rekombinanto biotehnolo iju.
1 ml contains 100 IU of insulin human.
1 ml satur
1 vial contains 10 ml equivalent to 1000 IU no
Vien flakon ir 10 ml, kas atbilst 1000 SV.
What Velosulin looks like and contents of the pack The solution for injection or infusion comes as a clear, colourless, aqueous solution. ro
- Citas sast vda as ir cinka hlor ds, glicer ns, metakrezols, n trija hidrog nfosf ta dihidr ts, n trija
Not all packs may be marketed. lp
hidroks ds, s lssk be un dens injekcij m.
Marketing Authorisation Holder and Manufacturer a
Velosulin r jais izskats un iepakojums
Novo Allé, DK-2880 Bagsværd, Denmark ic
Š dums injekcij m vai inf zij m ir dzidrs, bezkr sains dens š dums 10 ml flakon, pa 1 vai 5 flakoniem iepakojum vai grupveida iepakojum pa 5 x (1 x 10 ml) flakoniem.
This leaflet was last approved in ed M
Visi iepakojuma lielumi tirg var neb t pieejami.
27
27 Re istr cijas apliec bas pašnieks un ražot js
What is Ventavis?
Kas ir Ventavis?
Ventavis is a solution for inhalation using a nebuliser.
Ventavis ir šķīdums inhalācijai, izmantojot izsmidzinātāju.
It contains the active substance iloprost.
Zāļu aktīvā viela ir iloprosts.
What is Ventavis used for?
Kāpēc lieto Ventavis?
Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Ventavis lieto tādu pieaugušu pacientu ārstēšanai, kas slimo ar III klases primāro plaušu hipertensiju, lai uzlabotu fizisko veiktspēju (spēju veikt fiziskās aktivitātes) un simptomus.
Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs. ‘ Primary ’ means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘ class’ reflects the severity of the symptoms caused by the disease: ‘ class III’ involves marked limitation of physical activity.
„ III klase ” nozīmē fiziskās veiktspējas ierobežojumu.
Because the number of patients with primary pulmonary hypertension is low, the disease is considered ‘ rare’, and Ventavis was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 29 December 2000.
Tā kā primārās plaušu hipertensijas pacientu skaits ir mazs, slimību uzskata par „ retu ”, un 2000. gada 29. decembrī Ventavis apstiprināja kā zāles retu slimību ārstēšanai.
How is Ventavis used?
Kā lietot Ventavis?
Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Ventavis paredzētas inhalēt, izmantojot izsmidzinātāju (speciālu ierīci, kas šķīdumu pārvērš sīku pilienu miglā, ko pacients ieelpo).
Treatment with Ventavis should be started and monitored by a doctor who has experience in the treatment of pulmonary hypertension.
Ventavis terapiju drīkst uzsāk un uzraudzīt tikai ārsts ar pieredzi plaušu hipertensijas ārstēšanā.
The recommended dose is 2.5 or 5.0 micrograms.
Ieteicamā deva ir 2, 5 mikrogrami vai 5, 0 mikrogrami.
Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second.
Sākumā jālieto zemākā – 2, 5 mikrogramu – deva pirmajai inhalācijai, kam seko 5, 0 mikrogramu deva otrajā inhalācijā.
The dose can then be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Ja pacients nepanes augstāko devu, to atkal var samazināt līdz 2, 5 mikrogramiem.
The medicine must be given using a type of nebuliser known as a ‘ dosimetric’ nebuliser, which stops automatically when the correct dose has been delivered.
Zāles lieto, izmantojot izsmidzinātāju, ko dēvē par „ dozimetrisko ” izsmidzinātāju, kas automātiski izslēdzas, tiklīdz noteiktā deva ir izsmidzināta.
It is taken six to nine times a day.
To lieto 6 līdz 9 reizes dienā.
Doses are lower if the patient has liver problems.
Devas ir mazākas, ja pacientam ir aknu darbības traucējumi.
How does Ventavis work?
Kā Ventavis darbojas?
Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Plaušu hipertensija ir dzīves kvalitāti pasliktinoša slimība, kas saistīta ar nopietnu sašaurinājumu plaušu asinsvados.
It causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Šis sašaurinājums rada ļoti augstu spiedienu asinsvados, kas asinis no sirds labās puses nogādā līdz plaušām.
Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Ventavis ir iloprosta inhalējama forma, viela, kas ļoti līdzinās prostaciklīnam, dabīgai molekulai, kas izraisa asinsvadu dilatāciju (paplašināšanos).
By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.
Paplašinot asinsvadus, asinsspiediens pazeminās, un simptomi uzlabojas.
How has Ventavis been studied?
Kā noritēja Ventavis izpēte?
Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adult patients with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Ventavis salīdzināja ar placebo (fiktīvu ārstēšanu) vienā pētījumā ar 203 pieaugušiem pacientiem ar stabilu III vai IV klases plaušu hipertensiju, kas bija vai nu primāra, vai arī citas slimības izraisīta.
The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks.
Galvenais iedarbīguma kritērijs bija pacientu skaits, kuri reaģēja pēc 12 nedēļu ilgas ārstēšanas.
A ‘ response’ was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient ’ s condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
„ Reakciju ” noteica gan pēc pacienta fiziskās veiktspējas uzlabošanās par 10% (kādu attālumu pacients varēja noiet sešās minūtēs), gan pēc pacienta stāvokļa uzlabošanās (slimības smaguma pakāpe pazeminājās vismaz par vienu klasi), ja plaušu hipertensija nesaasinājās un neiestājās nāve.
What benefit has Ventavis shown during the studies?
Kāds ir Ventavis iedarbīgums šajos pētījumos?
Ventavis was significantly more effective than placebo:
Ventavis bija ievērojami efektīvākas par placebo:
17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
17% pacientu, kas lietoja Ventavis, reaģēja uz ārstēšanu (17 no 101) salīdzinājumā ar 5% (5 no 102) pacientu placebo grupā.
However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.
Taču, vērtējot šī pētījuma dažādās pacientu grupas, būtisku Ventavis ieguvumu novēroja tikai pacientiem ar III klases primāro plaušu hipertensiju.
What is the risk associated with Ventavis?
Kāds pastāv risks, lietojot Ventavis?