qanastek/EMEA-V3 huggingface dataset:
Hormone effects • Subnormal activity of the thyroid gland (hypothyroidism): common • Breast enlargement (gynaecomastia): very rare (children); uncommon (adults)
Ietekme uz hormoniem • Vairogdziedzera samazināta aktivitāte (hipotireoīdisms): bieži • Krūšu palielināšanās (ginekomastija): ļoti reti (bērniem), retāk (pieaugušajiem)
Effects on metabolism • Mild increase in blood sugar (mild hyperglycaemia): common • Insulin resistance.
Ietekme uz metabolismu • Neliela asins cukura līmeņa paaugstināšanās (viegla hiperglikēmija): bieži • Insulīna rezistence.
Insulin resistance means that the normal effect of insulin on muscle, fat, and liver cells is reduced.
Insulīna rezistence nozīmē to, ka normālā insulīna ietekme uz muskuļiem, taukaudiem un aknu šūnām ir samazināta.
Nerve effects • Symptoms of benign increased brain pressure (benign intracranial hypertension): rare • Headache: very common (adults) • Insomnia: very rare (children); common (adults) • Abnormal sensation (paraesthesia): rare (children); very common (adults)
Ietekme uz nervu sistēmu • Labdabīga palielināta spiediena simptomi uz smadzenēm (labdabīga intrakraniāla hipertensija): reti • Galvassāpes: ļoti bieži (pieaugušajiem) • Bezmiegs: ļoti reti (bērniem); bieži (pieaugušajiem) • Neparastas ādas sajūtas (parestēzijas): reti (bērniem); ļoti bieži (pieaugušajiem)
Vascular effects • High blood pressure (hypertension): rare (children); common (adults)
Ietekme uz asins sistēmu • Augsts asinsspiediens (hipertensija): reti (bērniem); bieži (pieaugušajiem)
Joint and muscle effects • Joint pain and disorder (arthralgia): very common (adults) • Localised muscle pain (myalgia): common (adults)
Ietekme uz locītavām un muskuļiem • Locītavu sāpes un bojājumi (artralģija): ļoti bieži (pieaugušajiem) • Lokalizētas sāpes muskuļos (mialģija): bieži (pieaugušajiem)
As with all medicines containing growth hormone a small percentage of patients may develop blocking chemicals called antibodies to growth hormone.
Līdzīgi kā lietojot visus citus medikamentus, kas satur augšanas hormonu, nelielai procentuālai pacientu daļai var izveidoties bloķējošas ķīmiskas vielas, kas tiek sauktas par antivielām pret augšanas hormonu.
In a clinical study with Valtropin 3% of children with growth hormone deficiency developed such antibodies.
Klīniskā Valtropin pētījumā 3% bērnu ar augšanas hormona deficītu izveidojās šādas antivielas.
However, these antibodies did not have an effect on the growth response to Valtropin.
Tomēr šīs antivielas neietekmēja Valtropin izraisīto augšanas reakciju.
If you are failing to respond to therapy with Valtropin, your doctor will test for antibodies.
Ja Jūs nereaģēsiet uz ārstēšanu ar Valtropin, Jūsu ārsts pārbaudīs, vai Jums nav izveidojušās antivielas.
There was one patient (< 1%) who experienced acute hypersensitivity reactions involving hives (urticaria) and itching (pruritus) after administration of Valtropin.
Vienam pacientam (< 1%) pēc Valtropin lietošanas novēroja akūtu paaugstinātas jutības reakciju, kas ietvēra nātreni un niezi.
Children Leukaemia has been reported in a small number of children treated with somatropin.
Bērni Ir ziņots par leikēmijas attīstību nelielam skaitam bērnu, kas tika ārstēti ar somatropīnu.
However, there is no evidence that somatropin causes leukaemia when there are no other risk factors.
Tomēr, nav pierādījumu, ka somatropīns izraisa leikēmiju, ja nav citu faktoru risks.
Adults Swelling, muscle pain, joint pain and disorders have been reported early in therapy with somatropin but these effects tended to be transient (short-lived).
Pieaugušie Ir ziņots par pietūkumu, muskuļu sāpēm, locītavu sāpēm un traucējumiem ārstēšanas sākumā ar somatropīnu, bet šiem simptomiem bija tendence būt īslaicīgiem.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Ja novērojat jebkādas blakusparādības, kas šajā instrukcijā nav minētas vai kāda no minētajām blakusparādībām Jums izpaužas smagi, lūdzam, par tām izstāstīt ārstam vai farmaceitam.
HOW TO STORE Valtropin
KĀ UZGLABĀT Valtropin
• Keep out of the reach and sight of children. • Do not use Valtropin after the expiry date which is stated on the labels and the carton.
• Uzglabāt bērniem nepieejamā un neredzamā vietā. • Nelietot Valtropin pēc derīguma termiņa beigām, kas norādīts uz etiķetes un kastītes.
The expiry date refers to the last day of that month.
Derīguma termiņš attiecās uz norādītā mēneša pēdējo dienu.
Storage conditions of the unopened product: • Store in a refrigerator (2°C - 8°C).
Neatvērta produkta uzglabāšanas nosacījumi: • Uzglabāt ledusskapī (2°C - 8°C).
Do not freeze. • The non-reconstituted product can be kept at room temperature (not above 25°C) for one single period of up to 4 weeks before use.
Nesasaldēt. • Neizšķīdinātu produktu pirms lietošanas var uzglabāt istabas temperatūrā (līdz 25°C) laika posmā, kas nav ilgāks par 4 nedēļām.
Shelf-life after reconstitution with solvent: • After reconstitution with the solvent provided the product may be stored in the refrigerator (2°C - 8°C) for a maximum of 21 days.
Derīguma termiņš pēc izšķīdināšanas, izmantojot šķīdinātāju: • Pēc izšķīdināšanas, izmantojot piegādāto šķīdinātāju, produktu var uzglabāt ledusskapī (2°C - 8°C) maksimāli 21 dienu.
Shelf-life after reconstitution with water for injections (NOT tap water): • After reconstitution with water for injections the product must be used immediately and as a single use vial.
Derīguma termiņš pēc izšķīdināšanas, izmantojot injekciju ūdeni (NEVIS krāna ūdeni): • Pēc izšķīdināšanas, izmantojot ūdeni injekcijām, produkts ir jāizlieto nekavējoties un jāizmanto kā vienreizējās lietošanas flakons.
Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or discoloured.
Nelietojiet Valtropin, ja pamanāt, ka šķīdinātājs vai izšķīdinātais šķīdums ir duļķains vai mainījis krāsu.
What Valtropin contains
Ko Valtropin satur
- The active substance is somatropin.
- Aktīvā viela ir somatropīns.
One vial of powder contains 5 mg somatropin
Pēc
After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg somatropin (corresponding to 10 IU).
izšķīdināšanas ar 1, 5 ml šķīdinātāja, 1 ml satur 3, 33 mg somatropīna (atbilst 10 SV).
- The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate
- Citas sastāvdaļas ir glicīns, mannitols, nātrija dihidrogēnfosfāts, dinātrija hidrogēnfosfāts, un pH
dibasic and for pH adjustment sodium hydroxide and hydrochloric acid.
korekcijai – nātrija hidroksīds un sālsskābe.
- The pre-filled syringe contains water for injections and metacresol (see section 2, ‘ Important
- Pilnšļirce satur ūdeni injekcijām un metakrezolu (skatīt apakšpunktu 2, ‘ Svarīga informācija par
information about some of the ingredients of Valtropin’).
kādu no Valtropin sastāvdaļām ’).
What Valtropin looks like and contents of the pack
Valtropin ārējais izskats un iepakojums
Valtropin is presented as a powder and solvent for solution for injection.
Valtropin tiek piegādāts kā pulveris un šķīdinātājs injekciju šķīduma pagatavošanai.
A single pack contains:
Viens iepakojums satur:
- 1 vial with white to almost white powder
- 1 flakonu ar baltu vai gandrīz baltu pulveri
- 1 pre-filled syringe with 1.5 ml of solvent for reconstitution as a clear solution.
- 1 pilnšļirci ar 1, 5 ml šķīdinātāja izšķīdināšanai caurspīdīga šķīduma veidā.
BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Germany Tel: +49 (0) 6142 70 8000 Fax: +49 (0) 6142 70 80 060
BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Vācija Tālr.: +49 (0) 6142 70 8000 Fakss: +49 (0) 6142 70 80 060
24 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
24 Lai iegūtu papildus informāciju par šīm zālēm, lūdzam kontaktēties ar Reģistrācijas apliecības īpašnieka vietējo pārstāvniecību:
INFORMATION ON HOW TO SELF-INJECT Valtropin
INFORMĀCIJA, KĀ PAŠAM INJICĒT Valtropin
Please read the following instructions carefully before using Valtropin.
Lūdzu, pirms Valtropin lietošanas uzmanīgi izlasiet šīs instrukcijas.
Introduction The following instructions explain how to inject Valtropin yourself.
Ievads Turpmākās instrukcijas izskaidro, kā pašam veikt Valtropin injekciju.
Please read the instructions carefully and follow them step by step.
Lūdzu, uzmanīgi izlasiet instrukcijas un izpildiet tās pa punktiem.
Your doctor or his/ her assistant will instruct you how to self-inject Valtropin.
Jūsu ārsts vai viņa/ viņas asistents paskaidros Jums, kā pašam veikt Valtropin injekciju.
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of self-injection.
Nemēģiniet veikt sev injekciju, ja neesat pārliecināts, ka saprotat procedūru un injekcijas noteikumus.
General notes For patients with a known sensitivity to metacresol, Valtropin should not be reconstituted with the supplied solvent (see section 2, ‘ Do not use Valtropin’).
Vispārīgas piezīmes Pacientiem ar zināmu paaugstinātu jutību pret metakrezolu Valtropin nedrīkst izšķīdināt, izmantojot piegādāto šķīdinātāju (skatīt apakšpunktu 2, ‘ Nelietojiet Valtropin šādos gadījumos ’).
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections (see section 5 ‘ How to store Valtropin’).
Ja parādās paaugstināta jutība pret piegādāto šķīdinātāju, flakona saturs jāšķīdina ūdenī injekcijām (skatīt apakšpunktu 5 ‘ Kā uzglabāt Valtropin ’).
Do not use tap water.
Nelietojiet krāna ūdeni!
Collect the necessary items before you begin.
Pirms uzsākšanas paņemiet visus nepieciešamos priekšmetus.
These are:
Tie ir:
Supplied in the pack
Piegādāti iesaiņojumā
the Valtropin vial with powder for solution for injection the pre-filled syringe with 1.5 ml solvent for solution for injection
Valtropin flakons ar pulveri injekciju šķīduma pagatavošanai pilnšļirce ar 1, 5 ml šķīdinātāja injekciju šķīduma pagatavošanai
NOT supplied in the pack
NAV piegādāti iesaiņojumā
sterile injection syringe and needles alcohol swabs dry gauze or cotton pad an adhesive plaster disposal box for used syringes and needles.
sterila injekcijas šļirce un adatas spirta tamponi sausa marles vai kokvilnas plāksnīte adhezīvs plāksteris atkritumu kārba izmantotām šļircēm un adatām.
Preparing the solution
Šķīduma sagatavošana
Wash your hands thoroughly with soap and water before preparing the medicine.
Pirms zāļu sagatavošanas rūpīgi nomazgājiet rokas ar ziepēm un ūdeni.
Take the Valtropin carton out of the refrigerator and take the powder vial and pre-filled syringe with solvent out of the box.
Izņemiet Valtropin kastīti no ledusskapja un izņemiet no kārbas flakonu ar pulveri un pilnšļirci ar šķīdinātāju.
Check that the medicine is within the expiry date.
Pārbaudiet, vai zālēm nav beidzies derīguma termiņš.
Remove the protective plastic cap from the powder vial.
Noņemiet no pulvera flakona plastmasas aizsargvāciņu.
Clean the rubber stopper on the top of the powder vial with an alcohol swab.
Notīriet pulvera flakona gumijas aizbāzni ar spirta tamponu.
After cleaning do not touch the top of the vial.
Pēc notīrīšanas nepieskarieties flakona virspusei.
Vial containing the powder of your medicine
Flakons, kas satur pulveri ar Jūsu zālēm
Take the pre-filled syringe with solvent supplied in the pack to prepare your medicine.
Paņemiet pilnšļirci ar šķīdinātāju, kas piegādāta ar iesaiņojumu, lai sagatavotu zāles.
Remove the rubber tip cap and firmly attach a needle to the syringe.
Noņemiet gumijas gala vāciņu un stingri pievienojiet adatu šļircei.
Your doctor or his/her assistant will tell you what size of needle to use.
Jūsu ārsts vai viņa/ viņas asistents pastāstīs Jums, kāda izmēra adatu lietot.
Remove the needle guard without touching the needle.
Noņemiet adatas aizsargu, nepieskaroties adatai.
Slowly insert the needle straight through the centre of the rubber stopper of the vial.
Lēnām ieduriet adatu tieši flakona gumijas aizbāžņa centrā.
Slowly inject all of the solvent (1.5 ml) into the powder vial aiming the stream of liquid against the side of the vial.
Lēnām injicējiet visu šķīdinātāju (1, 5 ml) flakonā ar pulveri, vēršot šķidruma strūklu pret flakona sāniem.
DO NOT aim it at the white powder at the bottom of the vial.
NEVĒRSIET šķidruma strūklu uz balto pulveri, kas atrodas flakona dibenā.
Before taking the syringe out of the vial, draw in the same amount of air (1.5 ml) as the solvent you injected to reduce the pressure in the vial.
Pirms izņemat šļirci no flakona, lai samazinātu spiedienu flakonā, ievelciet šļircē tādu pašu gaisa daudzumu (1, 5 ml) kā injicētā šķīdinātāja daudzums.
Withdraw the syringe and replace the needle guard.
Izvelciet šļirci un uzlieciet adatas aizsargu.
Swirl the vial GENTLY to completely dissolve the contents.
UZMANĪGI rotējiet flakonu, lai pilnībā izšķīdinātu tā saturu.
Dissolving up your medicine
Jūsu zāļu izšķīdināšana
The resulting solution should be clear, without particles.
Gatavam šķīdumam jābūt caurspīdīgam, bez piemaisījumiem.
Label the vial with the date on which you prepared the solution.
Uzrakstiet uz flakona datumu, kurā Jūs sagatavojāt šķīdumu.
28 Preparing the injection
Injekcijas sagatavošana
Clean the rubber stopper on the top of the vial with an alcohol swab again.
Vēlreiz notīriet flakona gumijas aizbāzni ar spirta tamponu.
Vial containing the solution of your medicine
28 Flakons, kas satur šķīdumu ar Jūsu zālēm
Take the injection syringe and the needle supplied by your pharmacy or hospital, to withdraw the solution of medicine.
Paņemiet injekcijas šļirci un adatu, ko piegādājusi aptieka vai slimnīca, lai atvilktu zāļu šķīdumu.
Remove the injection syringe from its sterile packaging and attach the needle to the syringe.
Izņemiet injekcijas šļirci no sterilā iesaiņojuma un piestipriniet šļircei adatu.
Fill the syringe with air by pulling the plunger back to the level that represents your dose as prescribed by your doctor.
Uzpildiet šļirci ar gaisu, velkot virzuli atpakaļ līdz līmenim, kas atbilst devai, kuru izrakstījis Jūsu ārsts.
Gently push the plunger to discharge the air in the syringe into the vial.
Uzmanīgi spiediet uz virzuļa, lai izspiestu gaisu no šļirces flakonā.
Turn the vial upside down with the needle still in it and hold the vial in one hand.
Pagrieziet flakonu ar augšpusi uz leju, adatai joprojām esot flakonā, un paņemiet flakonu ar vienu roku.
Hold the syringe with the needle in the vial pointing up.
Turiet šļirci ar adatu flakonā virzienā uz augšu.
Ensure that the tip of the needle is in the solution.
Pārliecinieties, ka adatas gals atrodas šķīdumā.
Using your other hand slowly pull back the plunger in a continuous motion to draw the correct dose into the syringe ensuring that the needle tip remains in the solution.
Izmantojot otru roku, lēnām vienmērīgi velciet šļirces virzuli atpakaļ, lai ievilktu šļircē pareizo devu, pārliecinoties, ka adatas gals atrodas šķīdumā.
Withdrawing the right volume of your medicine with the help of the syringe markings
Pareizā zāļu tilpuma ievilkšana šļircē, izmantojot atzīmes uz šļirces
Remove the syringe from the needle leaving the needle in the vial without touching the tip of the syringe.
Atvienojiet šļirci no adatas, atstājot adatu flakonā, nepieskaroties šļirces galam.
Withdraw the needle, replace the needle guard and dispose in a closed container.
Izvelciet adatu, uzlieciet tai adatas aizsargu un izmetiet to slēgtā atkritumu kārbā.
For handling the vial see ‘Injecting the solution’, step 32.
Par rīkošanos ar flakonu skatīt ‘ Šķīduma injicēšana ’, 32 punkts.
Take a new needle (one that is suitable for subcutaneous injection) and place it firmly onto the tip of the syringe.
Paņemiet jaunu adatu (tādu, kas der zem ādas injekcijām) un stingri pievienojiet to šļirces galam.
Syringe containing your medicine being attached to a new needle
Jaunas adatas pievienošana šļircei, kas satur Jūsu zāles
Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Noņemiet adatas aizsargu no šļirces adatas un pārbaudiet, vai šļircē nav gaisa burbuļu.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Ja ir redzami burbuļi, nedaudz atvelciet atpakaļ virzuli, viegli uzsitiet pa šļirci, adatas galam esot vērstam uz augšu, kamēr gaisa burbuļi izzūd.
Push the plunger slowly back up to the correct dose.
Lēnām atbīdiet virzuli atpakaļ līdz pareizai devai.
Replace the needle guard and place the syringe with the needle on a flat surface.
Uzlieciet adatas aizsargu un novietojiet šļirci ar adatu uz plakanas virsmas.
30 Injecting the solution
30 Šķīduma injicēšana
Ensure the solution is at room temperature.
Pārliecinieties, ka šķīdums ir istabas temperatūrā.
If the solution is cold, warm the syringe between your palms.
Ja šķīdums ir auksts, sasildiet šļirci, turot to starp plaukstām.
Inspect the solution prior to administration: if the solution is discoloured or if you can see any solid particles in the liquid the solution MUST NOT be injected.
Ja šķīdums ir mainījis krāsu vai, ja tajā redzami piemaisījumi, šķīdumu NEDRĪKST injicēt.
Select the injection site according to the recommendation of your doctor.
Izvēlieties injekcijas vietu atbilstoši ārsta ieteikumiem.
It is very important that you vary the injection site each time you give the medicine.
Ļoti svarīgi ir mainīt injekcijas vietu katru reizi, kad tiek injicētas zāles.
Cleanse the injection site with an alcohol swab and wait for the area to dry.
Notīriet injekcijas vietu ar spirta tamponu un uzgaidiet, kamēr tā nožūst.
Check that the correct dose of Valtropin solution is in the syringe.
Pārbaudiet, vai šļircē ir ievilkta pareiza Valtropin šķīduma deva.
Hold the syringe in your hand as you would hold a pencil.
Paņemiet šļirci rokā tā, kā Jūs turiet zīmuli.
Squeeze a big skin fold between your thumb and index finger.
Saspiediet lielu ādas kroku ar īkšķi un rādītājpirkstu.
Insert the needle into the pinched skin at a 45° to 90° angle with a quick, firm motion.
Ar ātru, noteiktu kustību ieduriet adatu saspiestajā ādas krokā 45° līdz 90° leņķī.
This hurts less than pushing the needle in slowly.
Veicot injekciju šādi sāpes ir mazākas, nekā iedurot adatu lēni.
Slowly (over a few seconds) inject the solution by gently depressing the plunger until the syringe is empty.
Lēni (dažu sekunžu laikā) injicējiet šķīdumu, viegli spiežot uz virzuli, kamēr šļirce ir tukša.
Withdraw the needle quickly and apply pressure over the injection site with a dry gauze or cotton pad for several seconds.
Ātri izvelciet adatu un dažas sekundes uzspiediet uz injekcijas vietas ar sausu marles vai kokvilnas plāksnīti.
If there is bleeding, cover the injection site with an adhesive plaster.
Ja redzama asiņošana, pārsedziet injekcijas vietu ar adhezīvu plāksteri.
Dispose the used syringe in a closed container.
Izmetiet izlietoto šļirci noslēgtā atkritumu kārbā.
Be sure to return the vial to the refrigerator.
Pārliecinieties, ka ievietojat flakonu atpakaļ ledusskapī.
When empty, discard the vial as well.
Kad flakons ir tukšs, izmetiet to.
For shelf-life after reconstitution see section 5 ‘How to store Valtropin’.
Derīguma termiņu pēc izšķīdināšanas skatīt apakšpunktā 5 ‘ Kā uzglabāt Valtropin ’.
If the powder is reconstituted with water for injections, then the vial is for single use only.
Ja pulveris tiek izšķīdināts ūdenī injekcijām, tad flakons ir paredzēts tikai vienreizējai izmantošanai.
Any unused solution should be discarded.
Jebkāds neizmantotais šķīdums ir jāizlej.
What is Vaniqa?
Kas ir Vaniqa?
Vaniqa is a white cream that contains 11.5% of the active substance eflornithine.
Vaniqa ir balts krēms, kas satur 11, 5% eflornitīna.
What is Vaniqa used for?
Kāpēc lieto Vaniqa?
Vaniqa is used for the treatment of facial hirsutism in women.
Vaniqa lieto sejas hirsutisma ārstēšanai sievietēm.
Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.
Sejas hirsutisms ir pastiprināta rupja apmatojuma veidošanās uz sejas, bieži vīriešiem raksturīgā veidā.
How is Vaniqa used?
Kā lietot Vaniqa?
Vaniqa is applied in a thin layer to clean and dry affected areas twice daily (at least eight hours apart) and rubbed in.
Vaniqa plānā slānī uzklāj tīrām un sausām skartajām vietām divreiz dienā (ar vismaz astoņu stundu starplaiku) un rūpīgi ierīvē.
A benefit may be noticed within eight weeks of starting treatment.
Stāvokļa uzlabošanos var novērot astoņu nedēļu laikā pēc ārstēšanas uzsākšanas.
Continued treatment may give further improvement and is necessary to maintain beneficial effects.
Ilgstoša ārstēšana var sniegt tālākus uzlabojumus un ir nepieciešama, lai labvēlīgo ietekmi saglabātu.
Vaniqa should be stopped if no beneficial effects are noticed within four months of starting treatment.
Vaniqa lietošana ir jāpārtrauc, ja četru mēnešu laikā pēc ārstēšanas uzsākšanas nav novērojama pozitīva iedarbība.
Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).
Sievietēm, kas lieto Vaniqa, iespējams jāturpina citu matu likvidēšanas metodi (izplūkšanu, skūšanu).
How does Vaniqa work?
Kā Vaniqa darbojas?
Vaniqa contains the active substance eflornithine.
Vaniqa aktīvā viela ir eflornitīns.
Eflornithine blocks the action of an enzyme, ornithine decarboxylase.
Eflornitīns neatgriezeniski kavē ornitīndekarboksilāzi, fermenta aktivitāti.
This enzyme is found in the bulb of the hair follicle where it controls hair production.
Ferments atrodas matu folikulas sīpoliņā, kur tas kontrolē matu augšanu.
When this enzyme is blocked, the growth of hair is slowed down.
Kad šis ferments ir bloķēts, matu augšana palēninās.
How has Vaniqa been studied?
Kā norisēja Vaniqa izpēte?
The effectiveness of Vaniqa has been studied in two clinical trials including 596 women treated for up to 24 weeks with Vaniqa, or with a placebo (a dummy treatment, in this case the cream without any active substance).
Vaniqa iedarbību apsekoja divos klīniskos pētījumos, iesaistot 596 sievietes, kuras ārstēja ar Vaniqa vai ar placebo (indiferentu vielu; šajā gadījumā krēms ir bez aktīvās vielas) līdz 24 nedēļām.
The effectiveness of the treatment was assessed by the doctor at the end of the study who graded the hirsutism as: ‘ clear/ almost clear’, ‘ marked improvement’, ‘ improved’ or ‘ no improvement/ worse ’, 48 hours after women had shaved the treated areas of the face and under the chin.
„ tīrs/ gandrīz tīrs ”, „ ievērojama uzlabošanās ”, „ uzlabošanās ” vai „ bez uzlabošanās/ sliktāk ” 48 stundas pēc tam, kad sievietes bija noskuvušas skartās sejas un zemzoda vietas.
What benefit has Vaniqa shown during the studies?
Kāds ir Vaniqa iedarbīgums šajos pētījumos?
Improvement was seen as early as 8 weeks after the start of treatment.
Uzlabošanās bija redzama jau 8 nedēļas pēc ārstēšanas uzsākšanas.
Significant improvement for Vaniqa versus placebo was seen in both studies.
Abos pētījumos tika novērota ievērojamāka uzlabošanās, lietojot Vaniqa, nevis placebo.
When the results were combined, a successful outcome (graded as ‘ clear/ almost clear’ or ‘ marked improvement ’) was seen in 35% of women treated with Vaniqa, against 9% of those treated with placebo.
Kad rezultātus apvienoja, veiksmīgu rezultātu (vērtēts kā „ tīrs/ gandrīz tīrs ” vai „ ievērojama uzlabošanās ”) novēroja 35% sieviešu, kuras ārstēja ar Vaniqa, salīdzinot ar 9% sieviešu, kuras ārstēja ar placebo.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What is the risk associated with Vaniqa?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kāds pastāv risks, lietojot Vaniqa?
The most common side effect (seen in more than 1 patient in 10) is acne.
Visbiežāk novērotā nevēlamā blakusparādība (sastopama vairāk nekā 1 pacientei no 10) ir pinnes.
Other common side effects are pseudofolliculitis barbae (ingrown hairs), alopecia (hair loss), stinging skin, burning skin, dry skin, pruritus (itching), erythema (redness), tingling skin, irritated skin, rash, and folliculitis (infected hair follicles).
Citas plaši izplatītas blakusparādības bija ieauguši mati (pseudofolliculitis barbae), matu izkrišana, ādas dzelšana, ādas dedzināšana, sausa āda, prurīts (nieze), ādas eritēma (sarkanums), ādas tirpas, ādas kairinājumi, izsitumi un folikulīts (inficētas matu folikulas).
For the full list of all the side effects reported with Vaniqa, please see the Package Leaflet.
Pilns Vaniqa izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or to any of the other ingredients.
Vaniqa nedrīkst lietot cilvēki, kuri ir īpaši jutīgi (alerģiski) pret eflornitīnu vai citu sastāvdaļu.
Why has Vaniqa been approved?
Kāpēc Vaniqa tika apstiprināts?
The Committee for Medicinal products for Human Use (CHMP) decided that Vaniqa’ s benefits are greater than its risks for the treatment of facial hirsutism in women.
Cilvēkiem paredzēto zāļu komiteja (CHMP) nolēma, ka Vaniqa ieguvumi pārsniedz tā radīto risku, ārstējot sejas hirsutismu sievietēm.
They recommended that Vaniqa be given marketing authorisation (made available to doctors).
Komiteja ieteica izsniegt Vaniqa reģistrācijas apliecību (pieejamu ārstiem).
Other information about Vaniqa:
Cita informācija par Vaniqa:
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa in on 20 March 2001.
Eiropas Komisija 2001. gada 20. martā piešķīra Vaniqa reģistrācijas apliecību, kas derīga visā Eiropas Savienībā.
The marketing authorisation holder is Laboratorios Almirall, S. A.
Reģistrācijas apliecības īpašnieks ir uzņēmums Laboratorios Almirall, S. A.
The full EPAR for Vaniqa is available here.
Pilns Vaniqa EPAR teksts ir atrodams šeit.
This summary was last updated in 08-2008
Šis kopsavilkums pēdējo reizi tika atjaunināts 2008. gada martā.
EU-Numbers
Es numurs
Content (concentration) Package sizes
Saturs (koncentrācija)
Cream Cream Cream
Krēms Krēms Krēms
Cutaneous use Cutaneous use Cutaneous use
Lietošanai uz ādas Lietošanai uz ādas Lietošanai uz ādas
Tube (HDPE) Tube (HDPE) Tube (HDPE)
Tūbiņa (HDPE/ LDPE) Tūbiņa (HDPE/ LDPE) Tūbiņa (HDPE/ LDPE)
1 tube 1 tube 1 tube
1 Tūbiņa 1 Tūbiņa 1 Tūbiņa
Vaniqa 11.5% cream
Vaniqa 11, 5% kr ms
Each gram of Vaniqa 11.5% w/ w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Katrs grams Vaniqa 11, 5% kr ma satur 115 mg eflornit na (eflornithine) (hidrohlor da monohidr ta veid).
Excipients:
Pal gvielas:
Cetostearyl alcohol Stearyl alcohol.
Cetostearilspirts Stearilspirts
For a full list of excipients, see section 6.1.
Pilnu pal gvielu sarakstu skat t apakšpunkt 6. 1
Cream.
Kr ms.
White to off white cream
Baltas vai gandr z baltas kr sas kr ms.
4.1 Therapeutic indication
4. 1 Terapeitisk s indik cijas
Treatment of facial hirsutism in women.
Sejas hirsutisma rst šana sieviet m.
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight hours apart.
Divreiz dien ar vismaz asto u stundu starplaiku pl ns kr ma sl n tis j uzkl j t r m un saus m skartaj m viet m.
The cream should be rubbed in thoroughly.
Kr ms r p gi j ier v.
Hands should be washed after applying this medicine.
P c kr ma uzkl šanas rokas j nomazg.
For maximal efficacy, the treated area should not be cleansed within four hours of application.
Lai sasniegtu maksim lo efektivit ti, apstr d to vietu nedr kst t r t etras stundas p c kr ma lietošanas.
Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.
Uz apstr d taj m viet m var pielietot kosm tiskos l dzek us (ieskaitot saules aizsargkr mus), bet ne tr k par piec m min t m p c kr ma lietošanas.
Efficacy has only been demonstrated for affected areas of the face and under the chin.
Efektivit te ir nov rota tikai skartaj m sejas viet m un zem zoda.
Application should be limited to these areas.
Pielietošana ir j ierobežo ar min taj m viet m.
The product should be applied such that no visual residual product remains on the treated areas after rub-in.
L dzeklis ir j pielieto t, lai p c ier v šanas uz apstr d taj m viet m nepaliktu redzamas t atliekas.
Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Maksim l s devas, kas droši izmantotas kl niskajos izm in jumos, ir bijušas l dz 30 gramiem m nes.
Improvement in the condition may be noticed within eight weeks of starting treatment.
St vok a uzlabošanos var paman t asto u ned u laik p c rst šanas kursa uzs kšanas.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
Ilgstoša rst šana var sniegt turpm ku uzlabošanos un ir nepieciešama, lai labv l go ietekmi saglab tu.
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
P c rst šanas p rtraukšanas asto u ned u laik var atgriezties st voklis, k ds bijis pirms rst šanas.
Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Lietošana ir j p rtrauc, ja etru m nešu laik p c rst šanas uzs kšanas nav nov rojams pozit vs efekts.
Patients may need to continue to use a hair removal method (e. g. shaving or plucking) in conjunction with Vaniqa.
Pacient m var b t nepieciešams turpin t matu likvid šanas metodi (piem., sk šanu vai izpl kšanu) kop ar Vaniqa.
In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.
T d gad jum kr ms j lieto vismaz piecas min tes p c sk šanas vai citu matu likvid šanas metožu lietošanas, jo cit di var rasties pastiprin ta dzelšanas vai dedzin šanas saj ta.
Elderly:
Vec kiem cilv kiem:
(> 65 years) no dosage adjustment is necessary.
(> 65 gadiem) devas piel gošana nav vajadz ga.
Children and Adolescents:
B rniem un pusaudžiem:
(< 12 years) safety and efficacy of Vaniqa have not been established.
(< 12 gadi) Vaniqa drošums un efektivit te nav noteikta.
2 Hepatic/ renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
Vaniqa drošums un efektivit te sieviet m ar aknu vai nieru mazsp ju nav noteikta.
Hypersensitivity to eflornithine or to any of the excipients (see section 6.1).
6. 1. noda u).
4.4 Special warnings and precautions for use
2 4. 4 paši br din jumi un piesardz ba lietošan
Excessive hair growth can result from serious underlying disorders (e. g. polycystic ovary syndrome, androgen secreting neoplasm) or certain medications (e. g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
P rliec gu matu augšanu var izrais t nopietnas pamatslim bas (piem., oln cu policistozes sindroms, androg nu izdaloša neoplazma) vai daži medikamenti (piem., ciklospor ns, glikokortiko di, minoksidils, fenobarbit ls, fenito ns, kombin t estrog na- androg na hormonu aizst j jterapija).
These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa.
Šie faktori ir j em v r visp r j to pacientu rst šan, kuriem var tu noz m t Vaniqa.
Vaniqa is for cutaneous use only.
Vaniqa ir lietojams tikai uz das.
Contact with eyes or mucous membranes (e. g. nose or mouth) should be avoided.
No saskares ar ac m vai g ot d m (piem ram, deguna vai mutes g ot d m) ir j izvair s.
Transient stinging or burning may occur when the cream is applied to abraded or broken skin.
Ja kr mu uzkl j nobr ztai vai saplais jušai dai, var rasties p rejošas dzelšanas vai dedzin šanas saj tas.
If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day.
Ja izveidojas das kairin jums vai nepanesam ba, lietošanas biežums uz laiku ir j samazina l dz vienai reizei dien.
If irritation continues, treatment should be discontinued and the physician consulted.
Ja kairin jums nep riet, rst šana ir j p rtrauc un j konsult jas ar rstu.
It is recommended that hands are washed following use.
P c lietošanas ieteicams nomazg t rokas.
As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients.
T k Vaniqa drošums pacient m ar smagu nieru mazsp ju nav p t ts, j iev ro piesardz ba, noz m jot Vaniqa š d m pacient m.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e. g. contact dermatitis).
Šis produkts satur cetostearila spirtu un stearila spirtu, kas var izrais t lok las das reakcijas (piem., kontakta dermat tu).
No interaction studies have been performed.
Nav veikti mijiedarb bas p t jumi.
Pregnancy:
Gr tniec ba:
Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses.
Visi kl nisko izm in jumu dati ierobežotam skaitam sieviešu ar konstat tu gr tniec bu (22) r da, ka nav kl nisku pier d jumu tam, ka rst šana ar Vaniqa negat vi ietekm tu m tes vai aug us.
Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa.
No 22 gr tniec bas gad jumiem, kas radušies izm in jumu laik, tikai 19 gad jumos gr tniec ba iest j s, kam r pacientes lietoja Vaniqa.
Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down’ s Syndrome to a 35 year old).
No šiem 19 gr tniec bas gad jumiem bija 9 veseli b rni, 5 aborti p c sievietes izv les, 4 spont nie aborti un 1 iedzimts defekts (Dauna sindroms, 35 gadus veca sieviete).
To date, no other relevant epidemiological data are available.
L dz šim citi attiec gi epidemiolo iskie dati nav pieejami.
Animal studies have shown reproductive toxicity (see section 5.3).
5. 3. noda u).
The potential risk to humans is unknown.
Potenci lais risks cilv kam nav zin ms.
Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.
T d sieviet m, kam ir gr tniec ba vai kas to pl no, ir j lieto alternat vi sejas apmatojuma likvid šanas l dzek i.
Lactation: it is not known if eflornithine is excreted in human milk.
Z d šana: nav inform cijas par to, vai eflornit ns izdal s cilv ka pien.
Women should not use Vaniqa whilst breast-feeding.
Sieviet m, kas baro b rnu ar kr ti, Vaniqa nav j lieto.
No effect is expected.
Ietekme nav sagaid ma.
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment.
Liel kajai da ai ar du saist to nev lamo ietekmju, par kur m ir zi as, s kotn ji bija neliela intensit te, un t s izzuda, nep rtraucot Vaniqa lietošanu un neuzs kot rst šanu.
The most frequently reported undesirable effect was acne, which was generally mild.
Visbiež k ir zi ots par t du nev lamu blakuspar d bu k pinnes, kas parasti bijušas maz izteiktas.
In the vehicle controlled trials (n= 594), acne was observed in 41% of patients at baseline; 7% of patients
Izm in jumos ar saistvielas kontroli (n= 594) pinnes nov roja 41% pacienšu pie b zes l nijas; 7% pacienšu, ko rst ja ar Vaniqa, un 8% pacienšu, ko rst ja ar saistvielu, st voklis pasliktin j s.
Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
No t m, kam pie b zes l nijas pin u nebija, pinnes p c rst šanas ar Vaniqa vai ar saistvielu bija vien dam procentu lajam daudzumam (14%).
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Turpm kaj uzskait jum ir nor d ts kl niskajos izm in jumos konstat to nev lamo das reakciju biežums saska ar MedDRA biežuma iedal jumu.
MedDRA conventions for frequency are very common (> 10%), common (> 1% to < 10%), uncommon (> 0.1% to< 1%), rare (> 0.01% to < 0.1%), or very rare (< 0.01%), including isolated reports.
MedDRA biežuma iedal jums ir — oti bieži (> 10%), bieži (> 1% l dz < 10%), ret k (> 0, 1% l dz < 1%), reti (> 0, 01% l dz < 0, 1%), oti reti (< 0, 01%), ieskaitot atseviš us gad jumus.
Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
Iev rojiet, ka šajos izm in jumos vair k par 1350 pacient m rst ja ar Vaniqa no 6 m nešiem l dz vienam gadam, un tikai nedaudz vair k par 200 pacient m rst ja ar nes ju 6 m nešus.
Most events were reported at similar rates between Vaniqa and vehicle.
Vairum gad jumu biežums bija l dz gs, apstr d jot ar
The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
3 Vaniqa un ar saistvielu. das dedzin šana, dzelšana, durst šana, izsitumi un erit ma liel k m r ir nov rota, pacientu du apstr d jot ar Vaniqa, sal dzin jum ar saistvielu, k nor da zvaigzn te (*).
Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Nev lamu das reakciju biežums, kas nov rots Vaniqa kl niskajos izm in jumos (atbilstoši MedDRA biežuma iedal jumam).
Skin and subcutaneous tissue disorders
das un zem das audu slim bas
Very common (> 10%)
oti bieži (> 10%)
Acne
Pinnes
Common (> 1% to < 10%)
Bieži (> 1% l dz < 10%)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Pseudofolliculitis barbae, alop cija, “ das dzelšana ” *, “ das dedzin šana ” *, sausa da, nieze, erit ma *, “ das durst šana ” *, das kairin jums, izsitumi *, folikul ts
Uncommon (> 0.1% to < 1%)
Ret k (> 0, 1% l dz < 1%)
Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Ieauguši mati, sejas t ska, dermat ts, mutes t ska, papul ri izsitumi, das asi ošana, herpes simplex, ekz ma, heil ts, furunkuloze, kontaktdermat ts, anom la matu strukt ra, anom la matu augšana, hipopigment cija, das sarkanums, nejut gas l pas, das s p gums
Rare (> 0.01% to < 0.1%)
Reti (> 0, 01% l dz < 0, 1%)
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Acne rosacea, seboreiskais dermat ts, das neoplazma, makulo- papul ri izsitumi, das cistas, vezikulobullozi izsitumi, das boj jumi, hirsutisms, savilkta da
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
5. 2. noda u) p rdoz šanas varb t ba ir oti maza.
However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/ kg/ day or approximately 24 g/ day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.
Tom r, ja uz das ir aplic ta oti liela deva vai kr ms nejauši lietots peror li, ir j piev rš v r ba ietekm m, kas nov rojamas pie intravenozaj m terapeitiskaj m eflornit na dev m (400 mg/ kg/ dien, jeb aptuveni 24 g/ dien), k das lieto rst jot Trypanosoma brucei gambiense infekciju (frikas miega slim bu): matu izkrišana, sejas uzt kums, l kmes, dzirdes trauc jumi, ku a un zarnu darb bas trauc jumi, stgribas zudums, galvass pes, v jums, reibo i, an mija, trombocitop nija un leikop nija.
Pharmacotherapeutic group: other dermatologicals, ATC code:
Farmakoterapeitisk grupa: p r jie dermatolo iskie l dzek i, AT kods:
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Eflornit ns neatgriezeniski kav ornit ndekarboksil zi, fermentu, kas ir iesaist ts matu stumbra veidošan, ko veic mata folikuls.
Vaniqa has been shown to reduce the rate of hair growth.
Ir konstat ts, ka Vaniqa samazina matu augšanas trumu.
The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle- controlled clinical trials involving 594 women of skin types I-VI (393 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Vaniqa drošumu un efektivit ti nov rt ja divos dubultaklajos nejauš s izlases kl niskajos izm in jumos ar saistvielas kontroli, kuros bija iesaist tas 594 sievietes ar das tipu I- VI (393 izm in jumos ar Vaniqa, 201 ar saistvielu), kuras rst ja l dz 24 ned m.
Physicians assessed the change from baseline on a 4-point scale, 48 hours after women had shaved the treated areas of the affected areas of the face and under the chin, considering parameters such as hair length and density, and darkening of the
48 stundas p c tam, kad sievietes bija noskuvušas rst t s skart s sejas un pazodes vietas, rsti nov rt ja izmai as attiec b pret b zes l niju 4 punktu skal, emot v r t dus parametrus k matu garums un bl vums un das tumšums, kas saist ts ar termin lo matu kl tb tni.
Improvement was seen as early as 8 weeks after initiation of treatment.
Uzlabošan s bija redzama jau 8 ned as p c rst šanas uzs kšanas.
The combined results of these two trials are presented below:
4 Abu min to p t jumu apvienotie rezult ti ir par d ti turpm k.
Outcome* Clear / almost clear Marked improvement Improved No improvement / worse
Izn kums * T rs/ gandr z t rs Iev rojama uzlabošan s Uzlabošan s Nav uzlabošan s/ slikt k
Vaniqa 11.5% cream 6% 29% 35% 30%
Vaniqa 11, 5% kr ms 6% 29% 35% 30%
Vehicle 0% 9% 33% 58%
Nes js 0% 9% 33% 58%
* At end of therapy (Week 24).
* rst šanas kursa beig s (24. ned a).
For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Pacient m, kas p t juma laik p rtrauca rst šanu, p d jie nov rojumi izdar ti pirms 24. ned as.
Statistically significant (p 0.001) improvement for Vaniqa versus vehicle was seen in each of these studies for women with marked improvement and clear/ almost clear responses.
Statistiski noz m ga (p = 0, 001) uzlabošan s, rst jot ar Vaniqa sal dzin jum ar nes ju, bija redzama katr no min tajiem p t jumiem ar sieviet m, ieg stot atbildes reakciju “ iev rojama uzlabošan s ” un “ t rs / gandr z t rs ”.
These improvements resulted in a corresponding reduction in the darkening appearance of the facial skin associated with the presence of terminal hair.
Šo uzlabojumu rezult t attiec gi samazin j s sejas das tumšums, kas saist ts ar termin lo matu kl tb tni.
Subgroup analysis revealed a difference in treatment success where 27% of non-white women and 39% of white women showed a marked or better improvement.
Apakšgrupu anal ze atkl ja atš ir bas rst šanas efektivit tes zi, kur 27% sieviešu, kas nav balt s sievietes, un 39% balto sieviešu tika konstat ta iev rojama vai j tama uzlabošan s.
Subgroup analysis also showed that 29% of obese women (BMI 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
Apakšgrupu anal ze ar par d ja, ka 29% sieviešu ar aptaukošanos (BMI 30) un 43% sieviešu ar norm lu svaru (BMI < 30) tika konstat ta iev rojama vai j tama uzlabošan s.
About 12% of women in the clinical trials were postmenopausal.
Aptuveni 12% kl niskajos p t jumos iesaist to sieviešu bija p cklimakt rija vecum.
Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
Sieviet m p cklimakt rija vecum bija nov rojama iev rojama uzlabošan s (p < 0, 001), sal dzin jum ar saistvielu.
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Pacienšu pašv rt jums par d ja st vok a rad t psiholo isk diskomforta iev rojamu samazin šanos, ko noteica, vadoties no atbild m uz 6 jaut jumiem vizu li analog skal.
Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair.
Vaniqa iev rojami mazin ja pacienšu neapmierin t bu sejas apmatojuma d un laika d, ko vi as pavad ja likvid jot, apstr d jot vai sl pjot sejas apmatojumu.
Patient comfort in various social and work settings was also improved.
Uzlaboj s ar pacienšu komforts daž d s soci l s un darba vid s.
Patient self-assessments were found to correlate with physician observations of efficacy.
Tika konstat ts, ka pacienšu pašv rt jums korel ar rstu nov roto efektivit ti.
These patient-observable differences were seen 8 weeks after initiating treatment.
Min t s pacient m nov rot s atš ir bas bija redzamas 8 ned as p c rst šanas kursa uzs kšanas.
The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
P c rst šanas p rtraukšanas asto u ned u laik atgriez s st voklis, k ds bija pirms rst šanas.
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
Stabil st vokl eflornit na iek šana caur du no Vaniqa uz sejas das sieviet m, kas skujas, bija 0, 8%.
The steady state plasma half-life of eflornithine was approximately 8 hours.
Eflornit na pusizdal šan s laiks plazm stabil st vokl bija aptuveni 8 stundas.
Steady state was reached within four days.
Stabilo st vokli sasniedza etr s dien s.
The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ ml and 5 ng/ ml, respectively.
Eflornit na stabil st vok a maksim l s un minim l s koncentr cijas plazm attiec gi bija aptuveni 10 ng/ ml un 5 ng/ ml.
The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng. hr/ ml.
Stabil st vok a 12 stundu laukums zem l knes “ koncentr cija plazm attiec b pret laiku ” bija 92, 5 ng. st. / ml.
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Nav inform cijas, ka eflornit ns metaboliz tos, un tas izdal s galvenok rt ar ur nu.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
Ne- kl niskajos standartp t jumos ieg tie dati par atk rtoto devu toksicit ti, genotoksicit ti un iesp jamu kancerogenit ti, iek aujot vienu fotokancerogenit tes p t jumu ar pel m, neliecina par pašu risku cilv kam.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
Derm laj augl bas p t jum? ar žurk m negat va ietekme uz augl bu nav nov rota l dz dev m, kas 180 reižu p rsniedza cilv kam paredz to devu.
In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively.
Derm lajos teratolo ijas p t jumos? ar žurk m un trušiem teratog na ietekme nav nov rota l dz dev m, kas attiec gi 180 un 36 reizes p rsniedza cilv kam paredz to devu.
Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Liel kas devas izrais ja toksicit ti m tei un auglim bez pier d jumiem par teratogenit ti.
Cetostearyl alcohol; Macrogol cetostearyl ether; Dimeticone; Glyceryl stearate; Macrogol stearate; Methyl parahydroxybenzoate (E218); Liquid paraffin; Phenoxyethanol; Propyl parahydroxybenzoate (E216); Purified water Stearyl alcohol.
Cetostearilspirts, makrogola cetostearil teris, dimetikons, glicerilstear ts, 5 makrogola stear ts, metilparahidroksibenzo ts (E218), š idrais paraf ns, fenoksietanols, propilparahidroksibenzo ts (E216), att r ts dens, stearilspirts.
Do not store above 25°C.
Uzglab t temperat r l dz 25oC.
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Augsta bl vuma polietil na t bi a ar uzskr v jamu polipropil na v ci u, kas satur 15 g, 30 g vai 60 g kr ma,.
Ronda General Mitre, 151 08022 Barcelona, Spain.
Ronda General Mitre, 151 08022 Barcelona Sp nija
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
RE ISTR CIJAS / P RRE ISTR CIJAS DATUMS
20 March 2001
20. marts
7 ANNEX II
6 PIELIKUMS II