qanastek/EMEA-V3 huggingface dataset:
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other.
Stikla (1. tips) k rtridžs, kas ir aizv kots ar lateksu nesaturošu (brombutila) gumijas virzuli no viena gala un lateksu nesaturošu (brombutila/ poliizopr na) gumijas aizb zni no otra.
The cartridge contains a glass ball to facilitate resuspension.
K rtridž ir stikla lod te, lai var tu veikt saskalošanu.
Each cartridge contains 3 ml suspension.
Katr k rtridž ir 3 ml suspensijas.
Cartons of 5 or 10 cartridges.
5 vai 10 k rtridži.
The cartridges are designed to be used with Novo Nordisk delivery systems (durable devices for repeated use) and NovoFine needles.
K rtridži ir paredz ti lietošanai kop ar Novo Nordisk insul na ievad šanas ier c m (iztur gas ier ces atk rtotai lietošanai) un NovoFine adat m.
Detailed instruction accompanying the cartridge and delivery system must be followed.
J iev ro k rtidžu un ievad šanas ier ces iepakojum pievienot lietošanas instrukcija.
NovoMix 30 Penfill is for use by one person only.
NovoMix 30 Penfill paredz ts tikai individu lai lietošanai.
The cartridge must not be refilled.
NovoMix 30 Penfill nedr kst atk rtoti uzpild t.
9 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Pacients paši j inform par nepieciešam bu saskalot NovoMix 30 suspensiju tieši pirms lietošanas.
The resuspended liquid must appear uniformly white and cloudy.
Saskalotajam š idrumam j b t vienm r gi baltam un du ainam.
NovoMix 30 which has been frozen must not be used.
NovoMix 30, kas ir bijis sasalis, nedr kst lietot.
The patient should be advised to discard the needle after each injection.
Pacientam j iesaka p c katras injekcijas izmest lietoto adatu.
Any unused product or waste material should be disposed of in accordance with local requirements.
Neizlietot s z les vai izlietotie materi li j izn cina atbilstoši viet j m pras b m.
MARKETING AUTHORISATION NUMBERS
RE ISTR CIJAS NUMURI
Date of first authorisation:
Re istr cijas datums:
1 August 2000 Date of last renewal:
2000. gada 1. augusts P rre istr cijas datums:
1 August 2005
2005. gada 1. augusts
NovoMix 50 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 50 Penfill 100 V/ ml, suspensija injekcij m k rtridž.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 50/ 50
Š stošs asparta insul ns * / kristaliz ts protam na asparta insul ns * ……. 100 V/ ml attiec b 50/ 50.
NovoMix 50 is a white suspension.
NovoMix 50 ir balta suspensija.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 50 to be given immediately before a meal.
Asparta insul na straujais darb bas s kums un agr n maksim l iedarb ba auj NovoMix 50 ievad t tieši pirms dienreizes.
When necessary, NovoMix 50 can be given soon after start of a meal.
Ja nepieciešams, NovoMix 50 var ievad t t l t p c dienreizes uzs kšanas.
Dosage of NovoMix 50 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Devas NovoMix 50 devas ir individu las un tiek noteiktas pamatojoties uz rsta ieteikumu, emot v r pacienta nepieciešam bu.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 50.
Individu l nepieciešam ba p c insul na pieaugušajiem parasti ir robež s no 0, 5 l dz 1, 0 vien bai/ kg dien un ar NovoMix 50 to var nodrošin t piln gi vai da ji.
In patients with type 2 diabetes, NovoMix 50 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
2. tipa diab ta pacientiem NovoMix 50 var lietot monoterapij vai kombin cij ar metform nu, ja glikozes l me a asin s kontrole ir nepietiekama lietojot tikai metform nu.
Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration.
P rejot no citiem insul na prepar tiem uz NovoMix 50, var b t nepieciešama devas un ievad šanas laika piel gošana.
As with all insulins, close glucose monitoring is recommended during transition and the initial weeks thereafter (see section 4.4).
T pat k visiem insul niem, p rejas period un dažas ned as p c t ir ieteicama r p ga glikozes l me a nov rošana (skat t apakšpunktu 4. 4).
Adjustment of dosage may also be necessary if patients change their diet.
Devas piel gošana var b t nepieciešama ar tad, ja pacienti maina ierasto di tu.
Physical activity may reduce the patients’ insulin requirements.
Fizisk aktivit te var samazin t pacienta nepieciešam bu p c insul na.
In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications.
Uzlabota metabol kontrole cukura diab ta pacientiem efekt vi aizkav diab ta v l no komplik ciju rašanos un pal nina to progresiju.
Optimised metabolic control, including glucose monitoring, is therefore recommended.
T d ir ieteicama uzlabota metabol kontrole, iek aujot glikozes l me a nov rošanu.
11 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
11 T pat k visiem insul niem, gados vec kiem pacientiem un pacientiem ar pav jin tu aknu vai nieru darb bu, glikozes l me a nov rošana ir j intensific un deva j piel go, emot v r individu lo nepieciešam bu.
Renal or hepatic impairment may reduce the patient’ s insulin requirements.
Pav jin ta aknu vai nieru darb ba var samazin t pacienta nepieciešam bu p c insul na.
No studies have been performed with NovoMix 50 in children and adolescents under the age of 18 years.
Nav veikti p t jumi ar NovoMix 50 b rniem un pusaudžiem l dz 18 gadu vecumam.
NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Lietošanas veids NovoMix 50 ievada injic jot subkut ni augšstilb vai v dera priekš j sien.
Injection sites should be alternated within the same region.
Injekcijas vietas viena anatomisk apvidus robež s j maina.
As with all types of insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
T pat k visu tipu insul niem, darb bas ilgums b s atš ir gs atkar b no devas, injekcijas vietas, asinsrites, temperat ras un fizisk s aktivit tes l me a.
The influence of different injection sites on the absorption of NovoMix 50 has not been investigated.
Nav p t ts, k NovoMix 50 uzs kšanos ietekm injekciju izdar šana atš ir g s viet s.
NovoMix 50 should never be administered intravenously.
NovoMix 50 nekad nedr kst ievad t intravenozi.
NovoMix 50 should be administered in immediate relation to a meal.
NovoMix 50 j ievada tieš saist b ar dienreizi.
Patients taking NovoMix 50 may need a change in dosage from that used with their usual insulin.
Pacientiem, kuri sa em NovoMix 50, var b t nepieciešama devas mai a, sal dzinot ar iepriekš lietotajiem insul niem.
On rare occasions, injection site reactions may require discontinuation of NovoMix 50.
Retos gad jumos reakcijas injekcijas viet var pras t NovoMix 50 terapijas p rtraukšanu.
12 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 satur metakrezolu, kas var izrais t aler iskas reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
12 4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
There is limited clinical experience with NovoMix 50 in pregnancy.
Kl nisk pieredze par NovoMix 50 lietošanu gr tniec bas laik ir ierobežota.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
Dz vnieku reprodukcijas p t jumi attiec b uz embriotoksicit ti vai teratogenit ti neliecin ja par jebk du asparta insul na un cilv ka insul na atš ir bu.
There are no restrictions on treatment with NovoMix 50 during lactation.
Nav ierobežojumu rst šanai ar NovoMix 50 z d šanas laik.
However, the NovoMix 50 dosage may need to be adjusted.
Tom r var b t nepieciešams piel got NovoMix 50 devu.
In clinical trials and during marketed use the frequency varies with patient population and dose
Kl nisko p t jumu laik hipoglik mijas visp r jais biežums neatš r s pacientiem, kuri tika rst ti ar asparta insul nu un cilv ka insul nu.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
13 Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuras ir attiecin tas uz asparta insul nu, uzskait tas zem k.
Generalised hypersensitivity reactions are potentially life threatening.
Visp r j s paaugstin tas jut bas reakcijas var b t potenci li b stamas dz v bai.
Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Nervu sist mas trauc jumi Reti - perif r neirop tija. 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.
It is therefore recommended that the diabetic patient always carry sugar-containing products • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
T d diab ta pacientiem iesaka vienm r n s t l dzi dažus cukuru saturošus produktus. • Smagu hipoglik miju, kad pacients zaud sama u, var rst t ar glikagonu (0, 5 l dz 1 mg), ko apm c ta persona ievada intramuskul ri vai subkut ni, vai ar glikozi, ko medic nas darbinieks ievada intravenozi.
NovoMix 50 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 50 ir divf zu suspensija, kas sast v no asparta insul na (tras darb bas cilv ka insul na analoga) un kristaliz ta protam na asparta insul na (vid jas darb bas cilv ka insul na analoga).
The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
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.
NovoMix 50 is a biphasic insulin, which contains 50% soluble insulin aspart.
NovoMix 50 ir divf zu insul ns, kas satur 50% š stoša asparta insul na.
The crystalline phase (50%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Krist lisko f zi (50%) veido kristaliz ts protam na asparta insul ns, kam ir cilv ka NPH insul nam l dz gs darb bas profils.
When NovoMix 50 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Ja NovoMix 50 tiek injic ts subkut ni, darb ba s kas 10 l dz 20 min šu laik p c injekcijas.
The duration of action is up to 14 hours to 24 hours (Figure 1).
Darb bas ilgums ir no 14 l dz 24 stund m (1. att.).
Glucose Infusion Rate
Glikozes inf zijas trums
Hours NovoMix 50
Stundas NovoMix 50
Activity Profile for NovoMix 50 in Healthy Caucasian Subjects.
NovoMix 50 darb bas profils veseliem kauk ziešu rases p rst vjiem.
15 5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 50, as compared with soluble human insulin.
Asparta insul na B28 poz cij aminosk bi prol nu aizvietojot ar asparag nsk bi, nov ro samazin tu tendenci veidoties heksam riem NovoMix 50 š stoš frakcij, sal dzinot ar š stošo cilv ka insul nu.
The insulin aspart in the soluble phase of NovoMix 50 comprises 50% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Asparta insul ns NovoMix 50 š stošaj f z veido 50% no kop j insul na: no zem das tas uzs cas daudz tr k nek divf zu cilv ka insul na sast v esoš š stoš insul na da a.
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Atlikušie 50% ir krist lisk form k kristaliz ts protam na asparta insul ns; tas uzs cas l n k, l dz gi k cilv ka NPH insul ns.
In healthy volunteers a mean maximum serum concentration of 445 ± 135 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
15 Veseliem br vpr t gajiem vid ji maksim l koncentr cija serum 445 ± 135 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 30 V/ kg erme a masas devas ievad šanas subkut ni.
In type 2 patients with diabetes, the maximum concentration was reached about 95 minutes after dosing.
2. tipa cukura diab ta pacientiem maksim l koncentr cija tika sasniegta apm ram 95 min šu laik p c devas ievad šanas.
The pharmacokinetics of NovoMix 50 has not been investigated in elderly, children or patients with impaired renal or liver function.
NovoMix 50 farmakokin tika nav p t ta gados vec kiem cilv kiem, b rniem vai pacientiem ar pav jin tu nieru vai aknu funkciju.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glicer ns Fenols Metakrezols Cinks (k hlor ds) N trija hlor ds Din trija fosf ta dihidr ts Protam na sulf ts N trija hidroks ds (pH korekcijai) S lssk be (pH korekcijai) dens injekcij m
16 NovoMix 50 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 Penfill k rtridži lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab ti apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
Keep the cartridges in the outer carton in order to protect from light.
K rtridžus uzglab t r j iepakojum, lai pasarg tu no gaismas.
After removing NovoMix 50 Penfill from the refrigerator it is recommended to allow NovoMix 50 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 50 Penfill iz emšanas no ledusskapja, ir ieteicams aut tam sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Cartons of 1, 5 or 10 cartridges.
Iepakojuma lielumi ir 1 vai 5, vai 10 k rtridži.
NovoMix 50 Penfill is for use by one person only.
NovoMix 50 Penfill ir paredz ts tikai individu lai lietošanai.
The cartridge must not be refilled.
K rtridžu nedr kst atk rtoti uzpild t.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.
Pacients paši j inform par nepieciešam bu saskalot NovoMix 50 suspensiju tieši pirms lietošanas.
NovoMix 50 which has been frozen must not be used.
NovoMix 50, kas ir bijis sasalis, nedr kst lietot.
NovoMix 70 Penfill 100 U/ ml, suspension for injection in a cartridge.
NovoMix 70 Penfill 100 V/ ml, suspensija injekcij m k rtridž.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*…… ..100 U/ ml in the ratio of 70/ 30
Š stošs asparta insul ns * / kristaliz ts protam na asparta insul ns * ……. 100 V/ ml attiec b 70/ 30.
NovoMix 70 is a white suspension.
NovoMix 70 ir balta suspensija.
The rapid onset of action and early peak of activity of insulin aspart allows NovoMix 70 to be given immediately before a meal.
Asparta insul na straujais darb bas s kums un agr n maksim l iedarb ba auj NovoMix 70 ievad t tieši pirms dienreizes.
When necessary, NovoMix 70 can be given soon after start of a meal.
Ja nepieciešams, NovoMix 70 var ievad t t l t p c dienreizes uzs kšanas.
Dosage of NovoMix 70 is individual and determined on the basis of the physician’ s advice in accordance with the patient’ s needs.
Devas NovoMix 70 devas ir individu las un tiek noteiktas pamatojoties uz rsta ieteikumu, emot v r pacienta nepieciešam bu.
The individual insulin requirement is usually between 0.5 and 1.0 Units/ kg/ day in adult patients and this may be fully or partially supplied with NovoMix 70.
Individu l nepieciešam ba p c insul na pieaugušajiem parasti ir robež s no 0, 5 l dz 1, 0 vien bai/ kg dien un ar NovoMix 70 to var nodrošin t piln gi vai da ji.
In patients with type 2 diabetes, NovoMix 70 can be given in monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone.
2. tipa diab ta pacientiem NovoMix 70 var lietot monoterapij vai kombin cij ar metform nu, ja glikozes l me a asin s kontrole ir nepietiekama lietojot tikai metform nu.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
P rejot no citiem insul na prepar tiem uz NovoMix 70, var b t nepieciešama devas un ievad šanas laika piel gošana.
18 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
18 T pat k visiem insul niem, gados vec kiem pacientiem un pacientiem ar pav jin tu aknu vai nieru darb bu, glikozes l me a nov rošana ir j intensific un deva j piel go, emot v r individu lo nepieciešam bu.
No studies have been performed with NovoMix 70 in children and adolescents under the age of 18 years.
Nav veikti p t jumi ar NovoMix 70 b rniem un pusaudžiem l dz 18 gadu vecumam.
NovoMix 70 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Lietošanas veids NovoMix 70 ievada injic jot subkut ni augšstilb vai v dera priekš j sien.
The influence of different injection sites on the absorption of NovoMix 70 has not been investigated.
Nav p t ts, k NovoMix 70 uzs kšanos ietekm injekciju izdar šana atš ir g s viet s.
NovoMix 70 should never be administered intravenously.
NovoMix 70 nekad nedr kst ievad t intravenozi.
NovoMix 70 should be administered in immediate relation to a meal.
NovoMix 70 j ievada tieš saist b ar dienreizi.
Patients taking NovoMix 70 may need a change in dosage from that used with their usual insulin.
Pacientiem, kuri sa em NovoMix 70, var b t nepieciešama devas mai a, sal dzinot ar iepriekš lietotajiem insul niem.
On rare occasions, injection site reactions may require discontinuation of NovoMix 70.
Retos gad jumos reakcijas injekcijas viet var pras t NovoMix 70 terapijas p rtraukšanu.
19 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 satur metakrezolu, kas var izrais t aler iskas reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
19 4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
There is limited clinical experience with NovoMix 70 in pregnancy.
Kl nisk pieredze par NovoMix 70 lietošanu gr tniec bas laik ir ierobežota.
There are no restrictions on treatment with NovoMix 70 during lactation.
Nav ierobežojumu rst šanai ar NovoMix 70 z d šanas laik.
However, the NovoMix 70 dosage may need to be adjusted.
Tom r var b t nepieciešams piel got NovoMix 70 devu.
During clinical trials the overall rates of hypoglycaemia did not differ between patients treated with insulin aspart compared to human insulin.
20 Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuras ir attiecin tas uz asparta insul nu, uzskait tas zem k.
NovoMix 70 is a biphasic suspension of insulin aspart (rapid-acting human insulin analogue) and protamine-crystallised insulin aspart (intermediate-acting human insulin analogue).
NovoMix 70 ir divf zu suspensija, kas sast v no asparta insul na (tras darb bas cilv ka insul na analoga) un kristaliz ta protam na asparta insul na (vid jas darb bas cilv ka insul na analoga).
NovoMix 70 is a biphasic insulin, which contains 70% soluble insulin aspart.
NovoMix 70 ir divf zu insul ns, kas satur 70% š stoša asparta insul na.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Krist lisko f zi (30%) veido kristaliz ts protam na asparta insul ns, kam ir cilv ka NPH insul nam l dz gs darb bas profils.
When NovoMix 70 is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection.
Ja NovoMix 70 tiek injic ts subkut ni, darb ba s kas 10 l dz 20 min šu laik p c injekcijas.
Hours NovoMix 70
Stundas NovoMix 70
Activity Profile for NovoMix 70 in Healthy Caucasian Subjects.
NovoMix 70 darb bas profils veseliem kauk ziešu rases p rst vjiem.
22 5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers in the soluble fraction of NovoMix 70, as compared with soluble human insulin.
Asparta insul na B28 poz cij aminosk bi prol nu aizvietojot ar asparag nsk bi, nov ro samazin tu tendenci veidoties heksam riem NovoMix 70 š stoš frakcij, sal dzinot ar š stošo cilv ka insul nu.
The insulin aspart in the soluble phase of NovoMix 70 comprises 70% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin.
Asparta insul ns NovoMix 70 š stošaj f z veido 70% no kop j insul na: no zem das tas uzs cas daudz tr k nek divf zu cilv ka insul na sast v esoš š stoš insul na da a.
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Atlikušie 30% ir krist lisk form k kristaliz ts protam na asparta insul ns; tas uzs cas l n k, l dz gi k cilv ka NPH insul ns.
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
22 Veseliem br vpr t gajiem vid ji maksim l koncentr cija serum 645 ± 185 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 30 V/ kg erme a masas devas ievad šanas subkut ni.
In type 2 patients with diabetes, the maximum concentration was reached about 75 minutes after dosing.
2. tipa cukura diab ta pacientiem maksim l koncentr cija tika sasniegta apm ram 75 min šu laik p c devas ievad šanas.
In type 1 patients with diabetes a mean maximum serum concentration of 721 ± 184 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
1. tipa diab ta pacientiem maksim l koncentr cija serum 721 ± 184 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 30 V/ kg erme a masas devas ievad šanas subkut ni.
The pharmacokinetics of NovoMix 70 has not been investigated in elderly, children or patients with impaired renal or liver function.
NovoMix 70 farmakokin tika nav p t ta gados vec kiem cilv kiem, b rniem vai pacientiem ar pav jin tu nieru vai aknu funkciju.
23 6.4 Special precautions for storage
6. 4 paši uzglab šanas nosac jumi
NovoMix 70 Penfill cartridges in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 Penfill k rtridži lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab ti apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
After removing NovoMix 70 Penfill from the refrigerator it is recommended to allow NovoMix 70 Penfill to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 70 Penfill iz emšanas no ledusskapja, ir ieteicams aut tam sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
6.5 Nature and contents of container
23 6. 5 Iepakojuma veids un saturs
NovoMix 70 Penfill is for use by one person only.
NovoMix 70 Penfill ir paredz ts tikai individu lai lietošanai.
The necessity of resuspending the NovoMix 70 suspension immediately before use is to be stressed to the patient.
Pacients paši j inform par nepieciešam bu saskalot NovoMix 70 suspensiju tieši pirms lietošanas.
NovoMix 70 which has been frozen must not be used.
NovoMix 70, kas ir bijis sasalis, nedr kst lietot.
NovoMix 30 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 30 FlexPen 100 V/ ml, suspensija injekcij m pildspalvveida pilnš irc.
Soluble insulin aspart*/ protamine-crystallised insulin aspart*………… 100 U/ ml in the ratio of 30/ 70
Š stošs asparta insul ns * / kristaliz ts protam na asparta insul ns * ……. 100 V/ ml attiec b 30/ 70.
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 pildspalvveida pilnš irc ir 3 ml, kas atbilst 300 V.
When using
25 NovoMix 30 var uzs kt ar vienreiz dien ar 12 V vakari s (vakara dienreiz).
26 NovoMix 30 once daily, it is generally recommended to move to twice-daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
Ja lietojot NovoMix 30 vienreiz dien deva sasniedz 30 V, ir ieteicams p riet uz div m reiz m, sadalot devu vien d s brokastu un vakari u dev s.
27 Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2.
Stingr ka glikozes l me a kontrole var palielin t hipoglik mijas epizožu potenci lu un t d prasa pašu uzman bu devas intensifik cijas laik, k aprakst ts apakšpunkt 4. 2.
NovoMix 30 should be administered in immediate relation to a meal.
26 NovoMix 30 j ievada tieš saist b ar dienreizi.
28 4.6 Pregnancy and lactation
4. 6 Gr tniec ba un z d šana
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
27 Dz vnieku reprodukcijas p t jumi attiec b uz embriotoksicit ti vai teratogenit ti neliecin ja par jebk du asparta insul na un cilv ka insul na atš ir bu.
29 Nervous system disorders Rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible.
Nervu sist mas trauc jumi Reti - perif r neirop tija. 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.
30 The blood glucose lowering effect of insulin occurs when the molecules facilitate the uptake of glucose by binding to insulin receptors on muscle and fat cells - and simultaneously inhibit the output of glucose from the liver.
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.
Glucose infusion rate
29 Glikozes inf zijas trums
31 In patients with type 2 diabetes a meta-analysis showed a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia with NovoMix 30 compared to biphasic human insulin 30.
Pacientiem ar 2. tipa diab tu meta- anal ze uzr d ja samazin tu kop jo nakts hipoglik miju epizožu un smagas hipoglik mijas risku lietojot NovoMix 30, sal dzinot ar divf zu cilv ka insul nu 30.
In a smaller (54 subjects) and younger (age range 6 to 12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycaemic episodes and the postprandial glucose increase was significantly lower with NovoMix 30 compared to biphasic human insulin 30.
30 Maz k (54 pacienti) un jaun k (6 – 12 g. v.) popul cij, kas tika rst ta dubultmask t, krustot p t jum (12 ned as sa emot katru terapijas veidu), hipoglik mijas gad jumu biežums un postprandi l s glikozes l me a palielin šan s, lietojot NovoMix 30, bija daudz maz ka nek lietojot divf zu cilv ka insul nu 30.
Glycerol Phenol Metacresol Zinc (as chloride) Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Glicer ns Fenols Metakrezols Cinks (k hlor ds) N trija hlor ds Din trija fosf ta dihidr ts Protam na sulf ts N trija hidroks ds (pH korekcijai)
NovoMix 30 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 30 FlexPen lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab tas apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
Keep the cap on the pen when NovoMix 30 FlexPen is not in use in order to protect from light.
NovoMix 30 FlexPen, kad to nelietojat, vienm r turiet ar uzliktu uzgali, lai pasarg tu no gaismas.
After removing NovoMix 30 FlexPen from the refrigerator it is recommended to allow NovoMix 30 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 30 FlexPen iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
A glass (Type 1) cartridge which is closed with a latex-free (bromobutyl) rubber piston at one end and a latex-free (bromobutyl/ polyisoprene) rubber closure at the other in a multidose disposable pre-filled pen with a pen injector (plastic).
Stikla (1. tips) k rtridžs, kas ir aizv kots ar lateksu nesaturošu (brombutila) gumijas virzuli no viena gala un lateksu nesaturošu (brombutila/ poliizopr na) gumijas aizb zni no otra, vair kdevu vienreiz jas lietošanas pildspalvveida pilnš irc ar pildspalvveida injektoru (plastmasas).
Each pre-filled pen contains 3 ml suspension.
Katr pildspalvveida pilnš irc ir 3 ml suspensijas.
Cartons of 5 or 10 pre-filled pens.
5 vai 10 pildspalvveida pilnš irces.
NovoFine S needles are designed to be used with the pre-filled pen.
Pildspalvveida pilnš irce ir paredz ta lietošanai kop ar NovoFine S adat m.
Detailed instruction accompanying NovoMix 30 FlexPen must be followed.
NovoMix 30 FlexPen lietošanas instrukcij ir iek auta inform cija par pildspalvveida pilnš irceslietošanu, kas j iev ro.
NovoMix 30 FlexPen is for use by one person only.
NovoMix 30 FlexPen paredz ta tikai individu lai lietošanai.
NovoMix 30 FlexPen must not be refilled.
NovoMix 30 FlexPen nedr kst atk rtoti uzpild t.
33 The necessity of resuspending the NovoMix 30 suspension immediately before use is to be stressed to the patient.
Pacients paši j inform par nepieciešam bu saskalot NovoMix 30 suspensiju tieši pirms lietošanas.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Alle
NovoMix 50 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 50 FlexPen 100 V/ ml, suspensija injekcij m pildspalvveida pilnš irc.
35 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
34 T pat k visiem insul niem, gados vec kiem pacientiem un pacientiem ar pav jin tu aknu vai nieru darb bu, glikozes l me a nov rošana ir j intensific un deva j piel go, emot v r individu lo nepieciešam bu.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin- dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Neatbilstošu devu lietošana vai terapijas p rtraukšana, paši insul natkar ga diab ta pacientiem, var izrais t hiperglik miju un diab tisko ketoacidozi – st vok us, kas var beigties let li.
36 NovoMix 50 contains metacresol, which may cause allergic reactions.
NovoMix 50 satur metakrezolu, kas var izrais t aler iskas reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
35 4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
37 regimens therefore no specific frequency can be presented.
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 biežums nevar b t uzr d ts.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
36 Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuras ir attiecin tas uz asparta insul nu, uzskait tas zem k.
The duration of action is up to 14 hours to 24 hours (Figure 1).
Darb bas ilgums ir no 14 l dz 24 stund m (1. att ls).
39 5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
The remaining 50% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Atlikušie 50% ir krist lisk form k kristaliz ts protam na asparta insul ns, tas uzs cas l n k, l dz gi k cilv ka NPH insul ns.
In healthy volunteers a mean maximum serum concentration of 445 ± 135 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
38 Veseliem br vpr t gajiem vid ji maksim l koncentr cija serum 445 ± 135 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 30 V/ kg erme a masas devas ievad šanas subkut ni.
40 NovoMix 50 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 50 FlexPen lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab tas apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
Keep the cap on the pen when NovoMix 50 FlexPen is not in use in order to protect from light.
NovoMix 50 FlexPen, kad to nelietojat, vienm r turiet ar uzliktu uzgali, lai pasarg tu no gaismas.
After removing NovoMix 50 FlexPen from the refrigerator it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 50 FlexPen iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
6.5 Nature and contents of container
39 6. 5 Iepakojuma veids un saturs
Cartons of 1, 5 or 10 pre-filled pens.
Iepakojuma lielumi ir 1 vai 5, vai 10 pildspalvveida pilnš irces.
Detailed instruction accompanying NovoMix 50 FlexPen must be followed.
NovoMix 50 FlexPen lietošanas instrukcij ir iek auta inform cija par pildspalvveida pilnš irces lietošanu, kas j iev ro.
NovoMix 50 FlexPen is for use by one person only.
NovoMix 50 FlexPen ir paredz ta tikai individu lai lietošanai.
NovoMix 50 FlexPen must not be refilled.
NovoMix 50 FlexPen nedr kst atk rtoti uzpild t.
NovoMix 70 FlexPen 100 U/ ml, suspension for injection in a pre-filled pen.
NovoMix 70 FlexPen 100 V/ ml, suspensija injekcij m pildspalvveida pilnš irc.
42 As with all insulins, in elderly patients and patients with hepatic or renal impairment, glucose monitoring should be intensified and dosage adjusted on an individual basis.
41 T pat k visiem insul niem, gados vec kiem pacientiem un pacientiem ar pav jin tu aknu vai nieru darb bu, glikozes l me a nov rošana ir j intensific un deva j piel go, emot v r individu lo nepieciešam bu.
43 NovoMix 70 contains metacresol, which may cause allergic reactions.
NovoMix 70 satur metakrezolu, kas var izrais t aler iskas reakcijas.
4.5 Interaction with other medicinal products and other forms of interaction
42 4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
44 regimens therefore no specific frequency can be presented.
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 biežums nevar b t uzr d ts.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to insulin aspart are listed below.
43 Z u nev lam s blakuspar d bas kl niskajos p t jumos, kuras ir attiecin tas uz asparta insul nu, uzskait tas zem k.
The crystalline phase (30%) consists of protamine-crystallised insulin aspart, which has an activity profile that is similar to that of human NPH insulin.
Krist lisk f ze (30%) sast v no kristaliz ta protam na asparta insul na, kam ir cilv ka NPH insul nam l dz gs darb bas profils.
46 5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Atlikušie 30% ir krist lisk form k kristaliz ts protam na asparta insul ns, tas uzs cas l n k, l dz gi k cilv ka NPH insul ns.
In healthy volunteers a mean maximum serum concentration of 645 ± 185 pmol/ l was reached about 60 minutes after a subcutaneous dose of 0.30 U/ kg body weight.
45 Veseliem br vpr t gajiem vid ji maksim l koncentr cija serum 645 ± 185 pmol/ l tika sasniegta apm ram 60 min šu laik p c 0, 30 V/ kg erme a masas devas ievad šanas subkut ni.
47 6.4 Special precautions for storage
6. 4 paši uzglab šanas nosac jumi
NovoMix 70 FlexPen in use or carried as a spare: can be kept at ambient temperature (below 30°C) for up to 4 weeks, but any remainder must then be discarded.
NovoMix 70 FlexPen lietošanas laik vai n s jot l dzi rezervei: var tikt uzglab tas apk rt j temperat r (l dz 30°C) ne ilg k k 4 ned as, bet tad jebk ds p rpalikums ir j izmet.
Keep the cap on the pen when NovoMix 70 FlexPen is not in use in order to protect from light.
NovoMix 70 FlexPen, kad to nelietojat, vienm r turiet ar uzliktu uzgali, lai pasarg tu no gaismas.
After removing NovoMix 70 FlexPen from the refrigerator it is recommended to allow NovoMix 70 FlexPen to reach room temperature before resuspending the insulin as instructed for the first time use.
P c NovoMix 70 FlexPen iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
6.5 Nature and contents of container
46 6. 5 Iepakojuma veids un saturs
Detailed instruction accompanying NovoMix 70 FlexPen must be followed.
NovoMix 70 FlexPen lietošanas instrukcij ir iek auta inform cija par pildspalvveida pilnš irces lietošanu, kas j iev ro.
NovoMix 70 FlexPen is for use by one person only.
NovoMix 70 FlexPen ir paredz ta tikai individu lai lietošanai.
NovoMix 70 FlexPen must not be refilled.
NovoMix 70 FlexPen nedr kst atk rtoti uzpild t.
49 ANNEX II
47 PIELIKUMS II
NovoMix 30 Penfill and NovoMix 30 FlexPen:
NovoMix 30 Penfill un NovoMix 30 FlexPen:
NovoMix 50 Penfill and NovoMix 50 FlexPen:
NovoMix 50 Penfill un NovoMix 50 FlexPen:
NovoMix 70 Penfill and NovoMix 70 FlexPen:
NovoMix 70 Penfill un NovoMix 70 FlexPen:
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Z u lietošanas instrukcij j uzr da ražot ja, kas atbild par attiec g s s rijas izlaidi, nosaukums un adrese.
Medicinal product subject to medical prescription.
Recepšu z les
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• NOSAC JUMI VAI IEROBEŽOJUMI ATTIEC B UZ DROŠU UN EFEKT VU ŠO Z U LIETOŠANU
51 ANNEX III
49 PIELIKUMS III
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
51 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 30 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 V/ ml Suspensija injekcij m k rtridž Insulinum aspartum
STATEMENT OF ACTIVE SUBSTANCE
AKT V S VIELAS NOSAUKUMS UN DAUDZUMS
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 30% and insulin aspart crystallised with protamine 70%),
1 ml suspensijas satur 100 V (3, 5 mg) asparta insul na (rDNS) (30% š stoša asparta insul na un 70% kristaliz ta protam na asparta insul na),
glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid, water for injections
glicer nu, fenolu, metakrezolu, cinku (k hlor du), n trija hlor du, din trija fosf ta dihidr tu, protam na sulf tu, n trija hidroks du, s lssk bi, deni injekcij m.
5 x 3 ml 10 x 3 ml
10 x 3 ml
Subcutaneous use NovoMix 30 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
NovoMix 30 Penfill k rtridži ir paredz ti lietošanai Novo Nordisk insul na ievad šanas ier c s.
OTHER SPECIAL WARNINGS, IF NECESSARY
CITI PAŠI BR DIN JUMI, JA NEPIECIEŠAMS
Resuspend according to instructions NovoMix 30 Penfill cartridges are for use by one person only
NovoMix 30 Penfill k rtridži ir paredz ti tikai individu lai lietošanai.
EXP/
Der gs l dz:
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cartridges in the outer carton in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
Izlietot 4 ned s.
55 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
LABEL
ETI ETE
NovoMix 30 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 Penfill 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
Resuspend according to instructions
Saskalot, iev rojot nor d jumus.
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
54 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 50 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 50 Penfill 100 V/ ml Suspensija injekcij m k rtridž Insulinum aspartum
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 50% and insulin aspart crystallised with protamine 50%),
1 ml suspensijas satur 100 V (3, 5 mg) asparta insul na (rDNS) (50% š stoša asparta insul na un 50% kristaliz ta protam na asparta insul na),
Subcutaneous use NovoMix 50 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
NovoMix 50 Penfill k rtridži ir paredz ti lietošanai Novo Nordisk insul na ievad šanas ier c s.
Resuspend according to instructions NovoMix 50 Penfill cartridges are for use by one person only
NovoMix 50 Penfill k rtridži ir paredz ti tikai individu lai lietošanai.
°
Nesasald t.
58 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NovoMix 50 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 Penfill 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 70 Penfill 100 U/ ml Suspension for injection in a cartridge Insulin aspart
NovoMix 70 Penfill 100 V/ ml Suspensija injekcij m k rtridž Insulinum aspartum
1 ml suspension contains 100 U (3.5 mg) of insulin aspart (rDNA) (soluble insulin aspart 70% and insulin aspart crystallised with protamine 30%),
1 ml suspensijas satur 100 V (3, 5 mg) asparta insul na (rDNS) (70% š stoša asparta insul na un 30% kristaliz ta protam na asparta insul na),
Subcutaneous use NovoMix 70 Penfill cartridges are for use with Novo Nordisk insulin devices Read the package leaflet before use
NovoMix 70 Penfill k rtridži ir paredz ti lietošanai Novo Nordisk insul na ievad šanas ier c s.
Resuspend according to instructions NovoMix 70 Penfill cartridges are for use by one person only
NovoMix 70 Penfill k rtridži ir paredz ti tikai individu lai lietošanai.
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NovoMix 70 Penfill 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 Penfill 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
60 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 30 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 30 FlexPen 100 V/ ml Suspensija injekcij m pildspalvveida pilnš irc Insulinum aspartum
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Read the package leaflet before use
Pirms lietošanas izlasiet instrukciju.
Resuspend according to instructions NovoMix 30 FlexPen is for use by one person only
NovoMix 30 FlexPen ir paredz ta tikai individu lai lietošanai.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the cap on the pen in order to protect from light ° During use: do not refrigerate or store above 30°C Use within 4 weeks
Izlietot 4 ned s.
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
62 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NovoMix 30 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 30 FlexPen 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
63 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 50 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 50 FlexPen 100 V/ ml Suspensija injekcij m pildspalvveida pilnš irc Insulinum aspartum
Resuspend according to instructions NovoMix 50 FlexPen is for use by one person only
NovoMix 50 FlexPen ir paredz ta tikai individu lai lietošanai.
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NovoMix 50 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 50 FlexPen 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
66 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
NovoMix 70 FlexPen 100 U/ ml Suspension for injection in a pre-filled pen Insulin aspart
NovoMix 70 FlexPen 100 V/ ml Suspensija injekcij m pildspalvveida pilnš irc Insulinum aspartum
Resuspend according to instructions NovoMix 70 FlexPen is for use by one person only
NovoMix 70 FlexPen ir paredz ta tikai individu lai lietošanai.
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 MINIM L INFORM CIJA IZVIETOJAM UZ MAZA IZM RA TIEŠ IEPAKOJUM
NovoMix 70 FlexPen 100 U/ ml Suspension for injection Insulin aspart SC use
NovoMix 70 FlexPen 100 V/ ml Suspensija injekcij m Insulinum aspartum s. c.
72 PACKAGE LEAFLET:
LIETOŠANAS INSTRUKCIJA:
NovoMix 30 Penfill 100 U/ ml suspension for injection in a cartridge Insulin aspart
NovoMix 30 Penfill 100 V/ ml suspensija injekcij m k rtridž Asparta insul ns (insulinum aspartum)
Read all of this leaflet carefully before you start using this medicine. – Keep this leaflet.
Pirms z u lietošanas uzman gi izlasiet visu instrukciju. – Saglab jiet šo instrukciju!
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 jebk di jaut jumi, vaic jiet savam rstam, diab ta apr pes m sai vai farmaceitam. – Š s z les ir parakst tas tieši jums.
WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR
KAS IR NOVOMIX 30 UN K DAM NOL KAM TO LIETO
NovoMix 30 is an insulin analogue to treat diabetes.
NovoMix 30 ir insul na analogs diab ta rst šanai.
It comes in a 3 ml cartridge, called Penfill, which fits into a delivery system.
Tas ir 3 ml k rtridž, nosaukt par Penfill, kurš j ievieto insul na ievad šanas ier c.
NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%).
NovoMix 30 ir tras darb bas insul na analoga (30%) un ilgstošas darb bas insul na analoga (70%) mais jums.
This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 24 hours.
Tas noz m, ka tas s ks pazemin t j su glikozes l meni asin s p c 10 l dz 20 min t m p c t ievad šanas, maksim l iedarb ba tiek sasniegta starp 1. un 4. stundu un darb ba turpin s l dz 24 stund m.
It may be used in combination with certain oral antidiabetic drugs.
To var lietot kombin cij ar noteiktiem peror liem pretdiab ta l dzek iem.
BEFORE YOU USE NOVOMIX 30
PIRMS NOVOMIX 30 LIETOŠANAS
Do not use NovoMix 30
Nelietojiet NovoMix 30 š dos gad jumos
If you are allergic (hypersensitive) to this insulin product or any of the other ingredients (see 7 Further information).
Ja jums ir aler ija (paaugstin ta jut ba) pret šo insul nu vai k du citu sast vda u (skat t 7.
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
Ja j s saj tat hipoglik mijas tuvošanos (zema glikozes l me a asin s simptomus).