qanastek/EMEA-V3 huggingface dataset:
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane InnoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane InnoLet paredz ta lietošanai kop ar 8 mm vai s k m NovoFine adat m.
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
31 lietot Protaphane, nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai p ris pirmo ned u vai m nešu laik.
32 4.7 Effects on ability to drive and use machines
32 4. 7 Ietekme uz sp ju vad t transportl dzek us un apkalpot meh nismus
33 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
33 asinsspiediena pazemin šan s un var b t dz v bai b stamas.
34 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.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
34 Elimin cija Termin lo elimin cijas pusperiodu nosaka uzs kšan s trums no zem das audiem.
Not all pack sizes may be marketed.
35 Visi iepakojuma lielumi tirg var neb t pieejami.
Protaphane InnoLet is for single person use only.
Protaphane InnoLet paredz ta tikai individu lai lietošanai.
After removing Protaphane InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
P c Protaphane InnoLet iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane FlexPen 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc
Protaphane FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane FlexPen paredz ta lietošanai kop ar 8 mm vai s k m NovoFine adat m.
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
38 lietot Protaphane, nepieciešams main t devu, to var dar t pirmaj lietošanas reiz vai p ris pirmo ned u vai m nešu laik.
39 4.7 Effects on ability to drive and use machines
39 4. 7 Ietekme uz sp ju vad t transportl dzek us un apkalpot meh nismus
40 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
40 asinsspiediena pazemin šan s un var b t dz v bai b stamas.
41 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.
Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
41 Elimin cija Termin lo elimin cijas pusperiodu nosaka uzs kšan s trums no zem das audiem.
42 6.5 Nature and contents of container
6. 5 Iepakojuma veids un saturs
Not all pack sizes may be marketed.
42 Visi iepakojuma lielumi tirg var neb t pieejami.
Protaphane FlexPen is for single person use only.
Protaphane FlexPen paredz ta tikai individu lai lietošanai.
After removing Protaphane FlexPen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
P c Protaphane FlexPen iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru (l dz 25°C) pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Protaphane Penfill and FlexPen
Protaphane Penfill un FlexPen
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 SV/ ml suspensija injekcij m flakon Insulinum humanum (rDNA)
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
Lietošanas laik: neatdzes t un uzglab t temperat r l dz 25°C.
Protaphane vial 40 IU/ ml
Protaphane flakons 40 IU/ ml
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 40 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 SV/ ml suspensija injekcij m flakon Insulinum humanum (rDNA)
Protaphane vial 100 IU/ ml
Protaphane flakons 100 IU/ ml
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Protaphane Penfill 100 SV/ ml suspensija injekcij m k rtridž Insulinum humanum (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Protaphane Penfill is for use by one person only
Protaphane Penfill ir paredz ts tikai individu lai lietošanai.
EU/ 1/ 02/ 234/ 005… 1 x 3 ml EU/ 1/ 02/ 234/ 006 5 x 3 ml EU/ 1/ 02/ 234/ 007 10 x 3 ml
EU/ 1/ 02/ 234/ 005… 1 x 3 ml EU/ 1/ 02/ 234/ 006 5 x 3 ml EU/ 1/ 02/ 234/ 007 10 x 3 m
Protaphane Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane Penfill 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane NovoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Subcutaneous use Protaphane NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Protaphane NovoLet is for use by one person only
Protaphane NovoLet ir paredz ta tikai individu lai lietošanai.
EU/ 1/ 02/ 234/ 008 5 x 3 ml EU/ 1/ 02/ 234/ 009 10 X 3 ml
EU/ 1/ 02/ 234/ 008 5 x 3 ml EU/ 1/ 02/ 234/ 009 10 X 3 m
Protaphane NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane NovoLet 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Subcutaneous use Protaphane InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Protaphane InnoLet is for use by one person only
Protaphane InnoLet ir paredz ta tikai individu lai lietošanai.
Protaphane InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane InnoLet 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane FlexPen 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Insulinum humanum (rDNA)
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Protaphane FlexPen is for use by one person only
Protaphane FlexPen ir paredz ta tikai individu lai lietošanai.
Protaphane FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane FlexPen 100 SV/ ml suspensija injekcij m Insulinum humanum (rDNA) s. c.
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 SV/ ml suspensija injekcij m flakon Cilv ka insul ns (insulinum humanum), rDNS
Protaphane Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Pirms z u lietošanas uzman gi izlasiet visu instrukciju. – Saglab jiet šo instrukciju!
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
KAS IR PROTAPHANE UN K DAM NOL KAM TO LIETO
Protaphane is human insulin to treat diabetes.
Protaphane ir cilv ka insul ns diab ta rst šanai.
Protaphane is a long-acting insulin.
Protaphane ir ilgstošas darb bas insul ns.
This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours.
Tas noz m, ka Protaphane s ks pazemin t j su glikozes l meni asin s apm ram p c 1 ½ stundas p c t ievad šanas un darb ba ilgs, apm ram, 24 stundas.
Protaphane is often given in combination with fast-acting insulin products.
Protaphane bieži noz m kop ar tras darb bas insul na prepar tiem.
BEFORE YOU USE PROTAPHANE
PIRMS PROTAPHANE LIETOŠANAS
Do not use Protaphane
Nelietojiet Protaphane š dos gad jumos
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Ja jums ir aler ija (paaugstin ta jut ba) pret šo insul nu, metakrezolu 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 a symptom of low blood sugar).
Ja j s saj tat hipoglik mijas tuvošanos (zema glikozes l me a asin s simptomus).
Take special care with Protaphane
paša piesardz ba, lietojot Protaphane, nepieciešama š dos gad jumos
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 stomach If you are exercising more than usual or if you want to change your usual diet 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 timing of your injections.
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.
75 Pregnancy and breast-feeding
75 Gr tniec ba un z d šanas periods
HOW TO USE PROTAPHANE
K LIETOT PROTAPHANE
Before using Protaphane
Pirms lietojat Protaphane
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.
Do not use Protaphane
Nelietojiet Protaphane
In insulin infusion pumps If the protective cap is loose or missing.
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 If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
Protaphane is for injection under the skin (subcutaneously).
Protaphane ir paredz ts injic šanai zem das (subkut ni).
Protaphane vials are for use with insulin syringes with the corresponding unit scale.
Protaphane flakoni j lieto kop ar insul na š irc m, kam ir atbilstoša vien bu skala.
To inject Protaphane on its own
Ja lietojat tikai Protaphane
Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly white and cloudy.
Apgrieziet flakonu un š irci otr di.
Resuspending is easier if the insulin has reached room temperature 2.
Ievelciet š irc nepieciešamo insul na devu.
Draw air into the syringe, in the same amount as the dose of insulin you need 3.
4.
Draw the right dose of insulin into the syringe 6.
Pavirpiniet Protaphane flakonu plaukst s.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 8.
Ievelciet š irc Protaphane devai atbilstošu gaisa daudzumu.
To mix Protaphane with fast-acting insulin
Ievadiet gaisu Protaphane flakon, tad izvelciet adatu.
Then turn the vial and syringe upside down 4.
8.
Check the dose 5.
P rbaudiet devu.
Now push the needle into the vial of Protaphane.
Ieduriet adatu Protaphane flakon.
Then turn the vial and syringe upside down 6.
1.
Draw the right dose of Protaphane into the syringe.
Ievelciet š irc nepieciešamo Protaphane devu.
Make sure there is no air left in the syringe, and check the dose 7.
1.
Use the injection technique advised by your doctor or diabetes nurse 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.
They must not give you any food or drink as it could choke you.
Jums nedr kst dot st vai dzert, jo tas var j s nosmac t.
77 Causes of a hypo
77 sast v ir cukurs.
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
T pat k citas z les, Protaphane var izrais t blakuspar d bas, kaut ar ne visiem t s izpaužas.
Protaphane may cause hypoglycaemia (low blood sugar).
Protaphane var izrais t hipoglik miju (zems glikozes l menis asin s).
You may have a very rare serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction).
78 Jums var b t reti sastopam, ta u nopietn aler isk reakcija uz Protaphane vai k du no t sast vda m (to sauc par sist misko aler isko reakciju).
See also warning in 2 Before you use Protaphane.
Pirms Protaphane lietošanas.
78 Side effects reported very rarely (in less than 1 patient in 10,000)
(maz k nek 1 pacientam no 10 000)
HOW TO STORE PROTAPHANE
K UZGLAB T PROTAPHANE
Do not use Protaphane after the expiry date which is stated on the label and the carton.
Nelietot Protaphane p c der guma termi a beig m, kas nor d ts uz eti etes un kast tes.
After removing the vial from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
P c Protaphane flakona iz emšanas no ledusskapja, ir ieteicams aut tam sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
See 3 How to use Protaphane.
K lietot Protaphane.
Protaphane must be protected from excessive heat and sunlight.
Protaphane j sarg no p rm r ga karstuma un saules gaismas.
Protaphane should not be disposed of via wastewater or household waste.
Protaphane nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
What Protaphane contains
Ko Protaphane satur
Protaphane is an isophane insulin suspension (NPH).
ir izof na (NPH) insul na suspensija.
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
- Citas sast vda as ir cinka hlor ds, glicer ns, metakrezols, fenols, n trija hidrog nfosf ta
What Protaphane looks like and contents of the pack
dihidr ts, n trija hidroks ds, s lssk be, protam na sulf ts un dens injekcij m.
The suspension for injection comes as a cloudy, white, aqueous suspension.
79 Protaphane r jais izskats un iepakojums
79 Marketing Authorisation Holder and Manufacturer
Re istr cijas apliec bas pašnieks un ražot js
INFORMATION FOR THE USER
LIETOŠANAS INSTRUKCIJA:
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 SV/ ml suspensija injekcij m flakon Cilv ka insul ns (insulinum humanum), rDNS
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 asymptom of low blood sugar).
Ja j s saj tat hipoglik mijas tuvošanos (zema glikozes l me a asin s simptomus).
Pregnancy and breast-feeding
81 Gr tniec ba un z d šanas periods
81 Driving and using machines
Transportl dzek u vad šana un meh nismu apkalpošana
Make sure there is no air left in the syringe: point the needle upwards and push the air out 8.
82 8.
To mix Protaphane with fast-acting insulin
Protaphane sajaukšana ar tras darb bas insul nu
Roll the vial of Protaphane between your hands.
Pavirpiniet Protaphane flakonu plaukst s.
Draw as much air into the syringe as the dose of Protaphane you need.
Ievelciet š irc Protaphane devai atbilstošu gaisa daudzumu.
Causes of a hypo
83 Hipoglik mijas c lo i
You may have a very rare serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction).
Jums var b t oti reti sastopam, ta u nopietn aler isk reakcija uz Protaphane vai k du no t sast vda m (to sauc par sist misko aler isko reakciju).
Diabetic retinopathy (eye background changes).
84 Diab tisk retinop tija (izmai as acs diben).
After removing the vial from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use.
P c Protaphane flakona iz emšanas no ledusskapja, ir ieteicams aut flakonam sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
Protaphane Protaphane should not be disposed of via wastewater or household waste.
Protaphane nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
The suspension for injection comes as a cloudy, white, aqueous suspension.
85 Protaphane r jais izskats un iepakojums
Not all packs may be marketed.
Re istr cijas apliec bas pašnieks un ražot js
Marketing Authorisation Holder and Manufacturer Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, D nija
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Protaphane Penfill 100 SV/ ml suspensija injekcij m k rtridž Cilv ka insul ns (insulinum humanum), rDNS
Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper).
Vienm r p rbaudiet k rtridžu, k ar gumijas virzuli.
Don’ t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band.
Nelietojiet to, ja redzams boj jums vai, ja starp gumijas virzuli un balto joslu ir atstarpe.
Take it back to your supplier.
Atdodiet k rtridžu atpaka pieg d t jam.
In insulin infusion pumps If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
Do not refill Protaphane Penfill.
Protaphane Penfill nedr kst atk rtoti uzpild t.
If you are treated with Protaphane Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Ja j s tiekat rst ts ar Protaphane Penfill un k du citu insul nu Penfill k rtridž, jums j lieto divas insul na ievad šanas ier ces – katram insul na tipam sava.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store Protaphane without the needle attached.
P c katras injekcijas p rliecinieties vai adata ir no emta un izmesta, un uzglab jiet Protaphane bez uzliktas adatas.
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Ja injekciju izdar t pats, p r k bieži injic jot vien • un taj paš viet, taukaudi zem das šaj viet var sarukt (lipoatrofija) vai sabiez t (lipohipertrofija).
You may have a very rare serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction).
90 Jums var b t oti reti sastopam, ta u nopietn aler isk reakcija uz Protaphane vai k du no t sast vda m (to sauc par sist misko aler isko reakciju).
The suspension for injection comes as a cloudy, white, aqueous suspension.
91 Protaphane r jais izskats un iepakojums
91 PACKAGE LEAFLET:
92 LIETOŠANAS INSTRUKCIJA:
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane NovoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Cilv ka insul ns (insulinum humanum), rDNS
What Protaphane is and what it is used for 2.
Kas ir Protaphane un k dam nol kam to lieto 2.
Before you use Protaphane 3.
Pirms Protaphane lietošanas 3.
How to use Protaphane 4.
K lietot Protaphane 4.
How to store Protaphane 7.
Iesp jam s blakuspar d bas 6 K uzglab t Protaphane 7.
Protaphane is human insulin to treat diabetesProtaphane is a long-acting insulin.
Protaphane ir ilgstošas darb bas insul ns.
92 Using other medicines
93 Citu z u lietošana
In insulin infusion pumps If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
After removing the NovoLet from the refrigerator it is recommended to let it reach room
P c NovoLet iz emšanas no ledusskapja, ir ieteicams aut tai sasniegt istabas temperat ru pirms insul na saskalošanas, k nor d ts pirmo reizi lietojot.
The suspension for injection comes as a cloudy, white, aqueous suspension.
Protaphane r jais izskats un iepakojums
96 Information on how to use Protaphane NovoLet
97 Inform cija, k lietot Protaphane NovoLet
Please read the following instructions carefully before using your Protaphane NovoLet.
L dzu, r p gi izlasiet šo instrukciju pirms Protaphane NovoLet lietošanas.
Protaphane NovoLet is a simple, compact pre-filled pen.
Protaphane NovoLet ir vienk rša, kompakta pildspalvveida pilnš irce.
Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin.
P rbaudiet eti eti lai p rliecin tos, vai Protaphane NovoLet satur pareizo insul na tipu.
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
P rbaudiet, vai k rtridž ir atlikušas vismaz 12 vien bas insul na, lai var tu veikt saskalošanu. • Ja atlikušas maz k nek 12 vien bas, izmantojiet jaunu Protaphane NovoLet.
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
Sv rstiet pildspalvveida pilnš irci augšup un lejup no poz cijas a l dz b un atpaka (skat t A • z m jumu), lai stikla lod te p rvietotos no viena k rtridža gala l dz otram vismaz 20 reizes.
The movement must always be repeated, until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Protaphane NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
P c saskalošanas n kam s darb bas izdariet nekav joties. • Dezinfic jiet gumijas membr nu ar medic nisko salveti. • Vienm r lietojiet jaunu adatu katrai injekcijai, lai nov rstu infic šanos. • No emiet no NovoFine adatas aizsarguzl mi. • Adatu taisni un cieši uzskr v jiet uz Protaphane NovoLet (skat t B z m jumu). • No emiet adatas r jo un iekš jo uzgali.
To avoid injection of air and ensure proper dosing: • Hold Protaphane NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Turiet Protaphane NovoLet ar adatu uz augšu. • • Ar pirkstu viegli piesitiet k rtridžam vair kas reizes.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Protaphane NovoLet horizontally.
Ja tas t nav, pagrieziet uzgali, l dz • spiedpoga ir piln b nospiesta.
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
Lai p rbaud tu nom r to devu Apskatiet skaitli uz uzga a, kas ir iepretim devas indikatoram. • Apskatiet liel ko skaitli, ko varat redz t uz spiedpogas skalas. • Saskaitot abus skait us, ieg siet devu, ko esat nom r jis. • Ja esat nom r jis nepareizu devu, vienk rši pagrieziet uzgali uz priekšu vai atpaka, l dz ir • ieg ts pareizais vien bu skaits.
Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator.
100 Tad no emiet uzgali un uzlieciet to atkal atpaka t, lai 0 atrastos iepretim devas indikatoram.
Now set the dose again.
Tagad v lreiz nom riet devu.
Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Stingri aiztaisiet savu Protaphane NovoLet, lai 0 atrastos iepretim devas indikatoram.
Dispose of your used Protaphane NovoLet carefully without the needle attached.
Uzman gi izn ciniet izlietoto Protaphane NovoLet, iepriekš no emot adatu.
Your Protaphane NovoLet is designed to work accurately and safely.
Protaphane NovoLet ir rad ta prec zai un drošai darb bai.
Do not refill Protaphane NovoLet.
Neuzpildiet atk rtoti Protaphane NovoLet.
You can clean the exterior of your Protaphane NovoLet by wiping it with a medicinal swab.
J s varat t r t Protaphane NovoLet no rpuses, noslaukot to ar medic nisko salveti.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Cilv ka insul ns (insulinum humanum), rDNS
Using other medicines
102 Citu z u lietošana
Talk to your 102 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.
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
103 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
T s var b t š das: auksti sviedri, v sa, b la da, galvass pes, pa trin ta sirdsdarb ba, slikta pašsaj ta, liels izsalkums, slaic gas redzes izmai as, miegain ba, neparasts nogurums un v jums, nervozit te vai tr ce, trauksmes saj ta, apjukums, apgr tin ta sp ja koncentr ties.
The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
105 InnoLet, kas netiek lietotas, j uzglab ledusskap (2°C – 8°C).
105 Protaphane should not be disposed of via wastewater or household waste.
Protaphane nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
106 Information on how to use Protaphane InnoLet
106 Inform cija, k lietot Protaphane InnoLet
Please read the following instructions carefully before using your Protaphane InnoLet.
L dzu, r p gi izlasiet šo instrukciju pirms Protaphane InnoLet lietošanas.
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
J s varat nom r t devu no 1 l dz 50 vien b m, ar soli - 1 vien ba.
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Protaphane InnoLet paredz ta lietošanai kop ar 8 mm vai s k m NovoFine S adat m.
Check the label to make sure that your Protaphane InnoLet contains the correct type of insulin.
P rbaudiet eti eti lai p rliecin tos, vai Protaphane InnoLet satur pareizo insul na tipu.
Before every injection: • Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
Ja atlikušas maz k nek 12 vien bas, izmantojiet jaunu Protaphane InnoLet.
If there are less than 12 units left, use a new Protaphane InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Sv rstiet pildspalvveida pilnš irci augšup un lejup no poz cijas A l dz B un atpaka, lai stikla • lod te p rvietotos no viena k rtridža gala l dz otram (skat t 1A z m jumu) vismaz 20 reizes.
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Protaphane InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
Dezinfic jiet gumijas membr nu ar medic nisko salveti. • Vienm r lietojiet jaunu adatu katrai injekcijai, lai nov rstu infic šanos. • No emiet no NovoFine S adatas aizsarguzl mi. • Adatu taisni un cieši uzskr v jiet uz Protaphane InnoLet (skat t 1B z m jumu). • No emiet adatas r jo un iekš jo uzgali.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Protaphane InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C) • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Adatas gal j par d s insul na pilienam.
Dispose of your used Protaphane InnoLet carefully without the needle attached.
Uzman gi izn ciniet izlietoto Protaphane InnoLet, iepriekš no emot adatu.
Your Protaphane InnoLet is designed to work accurately and safely.
Protaphane InnoLet ir rad ta prec zai un drošai darb bai.
Do not refill Protaphane InnoLet.
Neuzpildiet atk rtoti Protaphane InnoLet.
You can clean your Protaphane InnoLet by wiping it with a medicinal swab.
J s varat t r t Protaphane InnoLet, noslaukot to ar medic nisko salveti.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane FlexPen 100 SV/ ml suspensija injekcij m pildspalvveida pilnš irc Cilv ka insul ns (insulinum humanum), rDNS
Using other medicines
111 Citu z u lietošana
Talk to your 111 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.
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Ja p c saskalošanas tas nav vienm r gi balts un du ains.
112 The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
T s var b t š das: auksti sviedri, v sa, b la da, galvass pes, pa trin ta sirdsdarb ba, slikta pašsaj ta, liels izsalkums, slaic gas redzes izmai as, miegain ba, neparasts nogurums un v jums, nervozit te vai tr ce, trauksmes saj ta, apjukums, apgr tin ta sp ja koncentr ties.
113 Side effects reported uncommonly (in less than 1 patient in 100)
(maz k nek 1 pacientam no 100)
Do not use Protaphane the expiry date which is stated on the label and the carton.
Nelietot Protaphane p c der guma termi a beig m, kas nor d ts uz eti etes un kast tes.
114 Protaphane should not be disposed of via wastewater or household waste.
Protaphane nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
Please read the following instructions carefully before using your Protaphane FlexPen.
L dzu, r p gi izlasiet šo instrukciju pirms Protaphane FlexPen lietošanas.
Protaphane FlexPen Pen cap
Protaphane FlexPen Uzgalis
Preparing your Protaphane FlexPen
Protaphane FlexPen sagatavošana
This makes it easier to resuspend.
No emiet pilnš irces uzgali.
116 Pull off the pen cap.
116 A
What is PROTELOS?
Kas ir PROTELOS?
PROTELOS is a medicine containing the active substance strontium ranelate.
PROTELOS ir zāles, kas satur aktīvo vielu stroncija ranelātu.
It is available as 2-g sachets containing yellow granules, which are made up into an oral suspension.
Tās ir pieejamas kā 2 g paciņas ar dzeltenām granulām, no kurām pagatavo suspensiju iekšķīgai lietošanai.
What is PROTELOS used for?
Kāpēc lieto PROTELOS?
PROTELOS is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
PROTELOS lieto osteoporozes ārstēšanai pēcmenopauzes vecuma sievietēm, lai samazinātu mugurkaula skriemeļu un gūžas kaula lūzumu risku.
The medicine can only be obtained with a prescription.
Osteoporoze ir slimība, kas padara kaulus trauslus.
How is PROTELOS used?
Kā lieto PROTELOS?
PROTELOS is taken as one sachet once a day.
PROTELOS lieto pa vienai paciņai vienreiz dienā.
The contents of the sachet are made up into a suspension in a glass of water and drunk just after being prepared.
Paciņas saturu ieber glāzē ar ūdeni, samaisa un izdzer uzreiz pēc šķīduma pagatavošanas.
PROTELOS should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
PROTELOS lieto ne agrāk kā divas stundas pēc ēdiena, piena, piena produktiem vai kalcija piedevām, vēlams pirms gulētiešanas.
PROTELOS is intended for long-term use.
PROTELOS ir paredzētas ilgstošai lietošanai.
Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.
Pacientiem ir jālieto arī kalciju vai D vitamīnu saturoši uztura bagātinātāji, ja šīs vielas netiek pietiekamā daudzumā uzņemtas ar uzturu.
How does PROTELOS work?
Kā PROTELOS darbojas?
The active substance in PROTELOS, strontium ranelate, acts on the bone structure.
PROTELOS aktīvā viela stroncija ranelāts iedarbojas uz kaulu struktūru.
Once in the gut, strontium ranelate releases strontium, which is similar to calcium and, like calcium, is absorbed into the bone.
Nonākot zarnās, stroncija ranelāts atbrīvo stronciju, kas ir līdzīgs kalcijam, un, tāpat kā kalcijs, uzsūcas kaulaudos.
The mechanism of action of strontium is not fully understood but it stimulates bone formation and reduces bone breakdown.
Stroncija darbības mehānisms vēl nav pilnībā noskaidrots, bet tas veicina kaulaudu veidošanos un samazina kaulaudu nodilumu.
How has PROTELOS been studied?
Kā noritēja PROTELOS izpēte?
PROTELOS has been studied in almost 7,000 postmenopausal elderly women in two large studies.
PROTELOS tika pētītas divos lielos pētījumos, iesaistot gandrīz 7000 vecākas sievietes pēcmenopauzes vecumā.
Nearly a quarter of the patients were over 80 years of age.
Gandrīz ceturtā daļa bija pacientes, kas vecākas par astoņdesmit gadiem.
The first study included 1,649 women with osteoporosis who already had vertebral fractures and the second included over 5,000 women whose osteoporosis affected the hip region in the thighbone.
Pirmajā pētījumā bija iekļautas 1649 sievietes ar osteoporozi, kurām jau bija skriemeļu lūzumi, bet otrajā pētījumā – vairāk nekā 5000 sievietes, kurām osteoporoze bija skārusi augšstilba kaulu gūžas apvidū.
In both studies, the effects of PROTELOS were compared with those of placebo (a dummy treatment).
Abos pētījumos PROTELOS iedarbīgumu salīdzināja ar placebo (fiktīvu ārstēšanu).
The main measure of effectiveness was the proportion of patients who, over three years, developed a new vertebral (spine) fracture in the first study, or a new osteoporosis peripheral fracture (at any site other than the spine) in the second study.
Galvenais iedarbīguma rādītājs bija pacientu daļa, kam triju gadu laikā radās jauns mugurkaula skriemeļa lūzums
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has PROTELOS shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged (pirmais pētījums) vai jauns perifērs (jebkurā citā vietā, izņemot mugurkaulu) osteoporozes izraisīts lūzums (otrais pētījums).
In the first study, PROTELOS was more effective than placebo in reducing the risk of new vertebral fractures.
Pirmajā pētījumā PROTELOS bija iedarbīgākas par placebo jaunu skriemeļu lūzumu riska samazināšanā.
The risk was reduced by 41% over three years, with 21% of the 719 women who took PROTELOS developing a new vertebral fracture, compared with 33% of those 723 who took placebo.
Triju gadu laikā risks tika samazināts par 41%; no 719 sievietēm, kas lietoja PROTELOS, jauns skriemeļa lūzums radās 21%, salīdzinot ar 33% no 723 sievietēm, kas lietoja placebo.
Overall, he results of the second study taken alone were insufficient to demonstrate a benefit of PROTELOS in preventing peripheral fractures.
Otrā pētījuma rezultātus vērtējot atsevišķi, tie kopumā nebija pietiekami pārliecinoši, lai pierādītu PROTELOS iedarbīgumu perifēro lūzumu profilaksē.
When looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of hip fractures with PROTELOS.
Novērtējot tikai 74 gadus vecas vai vecākas pacientes ar sevišķi vājiem gūžas kauliem, rezultāti liecināja par gūžas kaula lūzuma riska samazināšanos, lietojot PROTELOS.
When looking at results of the two studies taken together, fewer women in the PROTELOS group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with PROTELOS compared with 389 out of 3,256 for placebo).
Vērtējot abu pētījumu rezultātus kopā, PROTELOS grupā perifēro osteoporozes izraisīto lūzumu skaits jebkurā vietā (ieskaitot gūžu) bija mazāks nekā placebo grupā (331 no 3295 PROTELOS grupā, salīdzinot ar 389 no 3295 placebo grupā).
What is the risk associated with PROTELOS?
Kāds pastāv risks, lietojot PROTELOS?
The most common side effects with PROTELOS (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), diarrhoea, loose stools, dermatitis (skin reactions) and eczema (flaky skin rash).
Visbiežāk novērotās blakusparādības, lietojot PROTELOS (no viena līdz desmit pacientēm no simt) ir galvassāpes, slikta dūša, caureja, šķidri izkārnījumi, dermatīts (ādas reakcijas) un ekzēma (zvīņaini ādas izsitumi).
For the full list of all side effects reported with PROTELOS, see the Package Leaflet.
Pilns visu PROTELOS izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
PROTELOS should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
PROTELOS nedrīkst lietot cilvēki ar paaugstināta jutību (alerģiju) pret stroncija ranelātu vai kādu citu šo zāļu sastāvdaļu.
Why has PROTELOS been approved?
Kāpēc PROTELOS tika apstiprinātas?
The Committee for Medicinal Products for Human Use (CHMP) decided that PROTELOS’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka ieguvumi, lietojot PROTELOS osteoporozes ārstēšanā pēcmenopauzes vecuma sievietēm, lai samazinātu skriemeļu un gūžas kaulu lūzumu risku, ir lielāki par šo zāļu radīto risku.
The Committee recommended that PROTELOS be given marketing authorisation.
Komiteja ieteica izsniegt PROTELOS reģistrācijas apliecību.
Other information about PROTELOS:
Cita informācija par PROTELOS:
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for PROTELOS on 21 September 2004.
Eiropas Komisija 2004. gada 21. septembrī izsniedza PROTELOS reģistrācijas apliecību, kas ir derīga visā Eiropas Savienībā, uzņēmumam LES LABORATORIES SERVIER.
The full EPAR for PROTELOS is available here.
Pilns PROTELOS EPAR teksts ir atrodams šeit.
PROTELOS 2 g granules for oral suspension
PROTELOS 2 g granulas iekšķīgi lietojamās suspensijas pagatavošanai.
Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures (see section 5.1).
Pēcmenopauzes osteoporozes ārstēšana, lai mazinātu mugurkaula skriemeļu un gūžas lūzuma risku (skatīt apakšpunktu 5. 1).
The recommended daily dose is one 2 g sachet once daily by oral administration.
4. 2 Devas un lietošanas veids
Due to the nature of the treated disease, strontium ranelate is intended for long-term use.
Ieteicamā dienas deva ir viena paciņa pa 2 g reizi dienā, lietojot iekšķīgi.
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
Stroncija ranelāta uzsūkšanos mazina pārtika, piens un tā produkti, tādēļ PROTELOS jālieto starp ēdienreizēm.
Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Ņemot vērā lēno uzsūkšanos, PROTELOS jālieto pirms gulētiešanas, vēlams vismaz divas stundas pēc ēšanas (skatīt apakšpunktus 4. 5 un 5. 2).
Use in children and adolescents PROTELOS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
2 Lietošana bērniem un pusaudžiem PROTELOS nav ieteicams lietošanai bērniem un pusaudžiem, jo nav informācijas par drošību un efektivitāti
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Tā kā nav datu par kaulu drošību pacientēm ar smagiem nieru darbības traucējumiem ārstētām ar stroncija ranelātu, PROTELOS nav ieteicams lietot pacientēm, kam kreatinīna klīrenss ir mazāks par 30 ml/ min (skatīt apakšpunktu 5. 2).
Continuation of treatment with PROTELOS in patients developing severe renal impairment should be considered on an individual basis.
Ārstēšanas turpināšana ar PROTELOS pacientēm, kam rodas smagi nieru darbības traucējumi, jāvērtē individuāli.
PROTELOS should be used with caution in patients at increased risk of VTE, including patients with a past history of VTE.
PROTELOS jālieto ar piesardzību pacientēm, kurām ir paaugstināts VTE risks, un pacietnēm, kurām ir VTE anamnēze.
PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
PROTELOS satur fenilalanīnu nelielā daudzumā, kas var nelabvēlīgi ietekmēt cilvēkus ar fenilketonūriju.
Treatment with PROTELOS should be discontinued in case of serious allergic reaction.
PROTELOS terapija ir jāpārtrauc nopietnu alerģisku reakciju gadījumā.
Cases of severe hypersensitivity syndromes, including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS), sometimes fatal, have been reported with the use of PROTELOS (see section 4.8).
Saistībā ar PROTELOS lietošanu (skat. apakšpunktā 4. 8) ir saņemti ziņojumi par smagiem hipersensitivitātes sindromiem, ieskaitot īpaši zāļu lietošanas izraisītus izsitumus ar eozinofīliju un sistēmiskiem simptomiem (drug rash with eosinophilia and systemic symptoms - DRESS), kas dažkārt ir bijuši letāli.
Time to onset was usually around 3-6 weeks and the outcome in most cases favourable upon discontinuation of PROTELOS and after initiation of corticosteroid therapy.
Slimības sākums parasti bija aptuveni pēc 3- 6 nedēļām, un iznākums lielākajā daļā gadījumu ir labvēlīgs, pārtraucot PROTELOS lietošanu un uzsākot kortikosteroīdu terapiju.
Patients should be informed to stop PROTELOS immediately and permanently when a rash occurs and to seek medical advice.
Pacientus ir jāinformē, ka PROTELOS terapija ir nekavējoties pilnībā jāpārtrauc gadījumā, ja parādās izsitumi, un jāmeklē medicīniska palīdzība.
Patients who have stopped treatment due to hypersensitivity reactions should not re-start therapy with PROTELOS.
Pacientiem, kas pārtraukuši terapiju hipersensitivitātes reakciju dēļ, PROTELOS terapiju atsākt nedrīkst.
Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Tādēļ PROTELOS vēlams ieņemt vismaz divas stundas pēc šo produktu lietošanas (skatīt apakšpunktu 5. 2).
An in vivo clinical interaction study showed that the administration of aluminium and magnesium hydroxides either two hours before or together with strontium ranelate caused a slight decrease in the absorption of strontium ranelate (20-25% AUC decrease), while absorption was almost unaffected
In vivo klīniskā mijiedarbības pētījumā konstatēja, ka alumīnija un magnija hidroksīdu lietošana divas stundas pirms vai kopā ar stroncija ranelātu izraisīja nelielu stroncija ranelāta uzsūkšanās mazināšanos (AUC samazināšanās par 20- 25%), bet uzsūkšanās netika ietekmēta gandrīz nemaz, lietojot antacīdu
3 when the antacid was given two hours after strontium ranelate.
3 divas stundas pēc stroncija ranelāta.
It is therefore preferable to take antacids at least two hours after PROTELOS.
Tādēļ antacīdus vēlams lietot vismaz divas stundas pēc PROTELOS.
However, when this dosing regimen is impractical due to the recommended administration of PROTELOS at bedtime, concomitant intake remains acceptable.
Taču, vienlaikus lietošana ir pieņemama ja šī dozēšanas shēma ir nepraktiska, jo PROTELOS lietošana ieteicama pirms gulētiešanas.
As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Piesardzības nolūkā ārstēšana ar PROTELOS jāatliek iekšķīgas ārstēšanas laikā ar tetraciklīnu vai hinolonu grupas antibiotikām.
No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTELOS in the target population were found during clinical trials.
Klīniskos pētījumos netika gūti pierādījumi par klīniski nelabvēlīgu mijiedarbību vai nozīmīgu stroncija līmeņa palielināšanos asinīs, lietojot kopā ar zālēm, kas varētu tikt bieži parakstītas vienlaikus ar PROTELOS mērķa grupai.
PROTELOS is only intended for use in postmenopausal women.
PROTELOS ir paredzēts lietošanai tikai pēcmenopauzes vecuma sievietēm.
If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
Ja PROTELOS nejauši lietots grūtniecības laikā, ārstēšana jāpārtrauc.
PROTELOS has been studied in clinical trials involving nearly 8,000 participants.
PROTELOS ir pētīts klīniskos pētījumos, iesaistot gandrīz 8000 dalībnieču.
0.2%)
Kuņģa- zarnu trakta traucējumi Bieži: slikta dūša (7, 1% pret 4, 6%), caureja (7, 0% pret 5, 0%), mīksti izkārnījumi (1, 0% pret 0, 2%).
1.4%)
4 Ādas un zemādas audu bojājumi Bieži: dermatīts (2, 3% pret 2, 0%), ekzēma (1, 8% pret 1, 4%),
There were no differences in the nature of adverse events between treatment groups regardless of whether patients were aged below or above 80 at inclusion.
Nekonstatēja atšķirības blakusparādību rakstura un biežuma ziņā starp ārstēšanas grupām neatkarīgi no tā, vai pacientes iekļaušanas brīdī bija jaunākas par 80 gadiem vai vecākas.
In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over 5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
3. fāzes pētījumos novērotā venozas trombembolijas (VTE) sastopamība gada laikā 5 gadu periodā bija aptuveni 0, 7%, ar stroncija ranelātu ārstētām pacientēm relatīvais risks bija 1, 4 (95% TI=[ 1, 0; 2, 0]), salīdzinot ar placebo lietotājām (skatīt apakšpunktu 4. 4).