natgillin/translations-raw huggingface dataset:
- If children have had a kidney transplant, growth hormone treatment will be stopped.
- Pri otrocih se mora zdravljenje z rastnimi hormoni po presaditvi ledvic prekiniti.
- If the child has Turner syndrome, the child’ s doctor should carefully check for ear infections
- Če ima otrok Turnerjev sindrom, mora njegov zdravnik pozorno pregledati, ali ima vnetje ušesa,
such as otitis media, because Turner syndrome patients have an increased risk of ear or other hearing disorders.
na primer vnetje srednjega ušesa, saj je pri bolnikih s Turnerjevim sindromom tveganje za okvare sluha ali ušesnih bolezni povečano.
Occurrence of certain side effects:
Pojavnost določenih neželenih učinkov:
- If symptoms like headache (severe and recurrent), visual changes, nausea and/ or vomiting
- Če se pojavijo simptomi, kot so glavobol (hud in ponavljajoči se), motnje vida ter slabost in/ ali
occur, please ask your doctor for advice.
bruhanje, se posvetujte z zdravnikom.
- If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood
- Če so vam zdravilo Valtropin pomotoma injicirali v mišico, namesto pod kožo, se lahko raven
sugar may become too low (hypoglycaemia).
sladkorja v krvi preveč zniža (hipoglikemija).
- Too much growth hormone can cause greater than normal growth of ears, nose, lips, tongue and
- Preveč rastnega hormona lahko povzroči povečano rast ušes, nosu, jezika in ličnic
cheekbone (acromegaly), high blood sugar (hyperglycaemia) and presence of sugar in the urine (glucosuria).
(akromegalija), povišano raven sladkorja v krvi (hiperglikemija) in prisotnost sladkorja v urinu (glukozurija).
- If sensitivity to solvent occurs, the vials should be reconstituted with water for injections
- Če se pojavi občutljivost za vehikel, je treba vialo rekonstituirati z vodo za injekcije brez
without preservative and used as a single use vial (see section 5 ‘ How to store Valtropin’).
konzervansov in uporabiti kot vialo za enkratno uporabo (glejte poglavje 5, "Shranjevanje zdravila Valtropin").
Do not use the supplied solvent if you have a known sensitivity to metacresol preservative.
Če imate znano preobčutljivost za konzervans metakrezol, priloženega vehikla ne uporabljajte.
Monitoring during treatment by your doctor:
Zdravniško spremljanje med zdravljenjem:
Your doctor may
- Zdravilo Valtropin lahko vpliva na to, kako vaše telo presnavlja sladkor, ki ga zaužijete s hrano
check the amount of sugar in your urine or blood.
Zdravnik bo morda pregledal količino sladkorja v urinu ali krvi.
- Valtropin can affect the amount of thyroid hormone in the blood, so you must have thyroid
- Zdravilo Valtropin lahko vpliva na količino hormonov ščitnice v krvi, zato morate občasno
function tests from time to time.
opraviti preizkuse delovanja ščitnice.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli izmed naslednjih zdravil:
- adrenal steroid hormone such as cortisone or prednisolone
- steroidne hormone nadledvične žleze, kot sta kortizon ali prednizolon
- oral oestrogen
- peroralni estrogen
- other prescription medicines (e. g. sex steroids, corticosteroids, anticonvulsants or cyclosporine),
- druga zdravila na recept (npr. spolne steroide, kortikosteroide, antikonvulzive ali ciklosporin) ali
or non-prescription medicines.
druga zdravila, ki so na voljo brez recepta.
20 Pregnancy Valtropin should not be used during pregnancy unless clearly necessary.
Nosečnost Zdravila Valtropin ne smete uporabljati med nosečnostjo, razen če je nujno.
Breast-feeding If you are breast-feeding or intend to breast-feed, please ask your doctor for advice before using Valtropin.
20 Dojenje Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden uporabite zdravilo Valtropin.
Important information about some of the ingredients of Valtropin The accompanying solvent of Valtropin contains metacresol.
Priloženi vehikel zdravila Valtropin vsebuje metakrezol.
Do not use this solvent if you are allergic (hypersensitive) to metacresol (see section 2, ‘ Do not use Valtropin’).
Tega vehikla ne uporabljajte, če ste alergični na (preobčutljivi za) metakrezol (glejte poglavje 2, "Ne uporabljajte zdravila Valtropin").
If sensitivity to the solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial (see section 5 ‘ How to store Valtropin’).
Če se pojavi občutljivost za vehikel, je treba vialo rekonstituirati z vodo za injekcije in uporabiti kot vialo za enkratno uporabo (glejte poglavje 5, "Shranjevanje zdravila Valtropin").
Dosage Your doctor will tell you how much to use.
Odmerjanje Zdravnik vam bo povedal, koliko zdravila si odmerite.
Growth hormone deficiency in children Inject 0.025 - 0.035 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Pomanjkanje rastnega hormona pri otrocih Injicirajte 0, 025 - 0, 035 miligramov (mg) na kilogram telesne teže enkrat dnevno pod kožo (subkutano).
Children with Turner syndrome Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Otroci s Turnerjevim sindromom Injicirajte 0, 045 - 0, 050 miligramov (mg) na kilogram telesne teže enkrat dnevno pod kožo (subkutano).
Pre-pubertal children with chronic renal insufficiency Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Otroci pred puberteto s kroničnim oslabljenim delovanjem ledvic Injicirajte 0, 045 - 0, 050 miligramov (mg) na kilogram telesne teže enkrat dnevno pod kožo (subkutano).
Growth hormone deficiency in adults Inject 0.15 - 0.30 milligrams (mg) once daily under the skin (subcutaneously).
Pomanjkanje rastnega hormona pri odraslih Injicirajte 0, 15 - 0, 30 miligramov (mg) enkrat dnevno pod kožo (subkutano).
If necessary, your doctor will gradually increase this dose according to your individual requirements based on the clinical outcome and measurement of your blood levels of a so called “ growth factor” (known as IGF-1).
Po potrebi vam bo zdravnik postopno povečeval odmerek glede na potrebe, pri čemer bo upošteval klinični učinek in meritev ravni tako imenovanega "rastnega faktorja" v krvi (znanega kot IGF- 1).
IGF-1 concentrations need to be
Koncentracije IGF- 1 je treba redno meriti ter vzdrževati pod zgornjo mejo za vašo starost in spol.
Dosage adjustment In elderly patients a dose reduction may be necessary.
21 Prilagoditev odmerjanja Pri starejših bolnikih bo morda potrebno zmanjšanje odmerka.
The dosage of somatropin should be reduced in cases of long lasting swelling (oedema) or severe abnormal sensation (paraesthesia), in order to avoid the development of a rare side effect called carpal tunnel syndrome (hand numbness and pain).
Odmerjanje somatropina je treba zmanjšati v primeru dolgotrajnega otekanja (edem) ali hudega nenormalnega čutenja (parestezija), da bi se izognili pojavu redkega neželenega učinka, imenovanega sindrom karpalnega kanala (otrplost in bolečine v roki).
When using other medicines the dose of Valtropin or of the other medicine may need to be adjusted (see section 2, ‘ Using other medicines’).
Pri sočasni uporabi drugih zdravil bo morda treba odmerek zdravila Valtropin ali drugega zdravila prilagoditi (glejte poglavje 2, "Uporaba drugih zdravil").
Administration Valtropin is intended for subcutaneous use after reconstitution.
Uporaba Zdravilo Valtropin je namenjeno za subkutano uporabo po rekonstituciji.
Detailed instructions for subcutaneous administration are provided with this leaflet (see section ‘ Information on how to self-inject Valtropin’ at the end of this leaflet).
Natančna navodila za subkutano injiciranje so v tem navodilu za uporabo (glejte poglavje "Informacije za samoinjiciranje zdravila Valtropin" na koncu tega navodila).
If you have used too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone (acromegaly).
Če ste dalj časa uporabljali preveč zdravila Valtropin, lahko pride do povečane rasti ušes, nosu, ustnic, jezika in ličnic (akromegalija).
If you forget to use Valtropin Do not take a double dose to make up for forgotten doses.
Če ste pozabili uporabiti zdravilo Valtropin Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If you stop using Valtropin Please ask your doctor for advice before stopping treatment.
Če ste prenehali uporabljati zdravilo Valtropin Preden prekinete zdravljenje, se posvetujte z zdravnikom.
happening in more than 1 in 10 patients happening in 1 in 100 to 1 in 10 patients
zelo pogosti pogosti občasni redki neželeni zelo redki
happening in 1 in 1,000 to 1 in 100 patients happening in 1 in 10,000 to 1 in 1,000 patients happening in less than 1 in 10,000 patients, including isolated reports
ki se pojavijo pri več kot 1 bolniku od 10 bolnikov ki se pojavijo pri 1 od 100 do 1 od 10 bolnikov ki se pojavijo pri 1 od 1. 000 do 1 od 100 bolnikov ki se pojavijo pri 1 od 10. 000 do 1 od 1. 000 bolnikov ki se pojavijo pri manj kot 1 bolniku od 10. 000 bolnikov, vključno s posameznimi primeri
General and local effects • Weakness: uncommon • Pain or reaction at the injection site: common • Swelling (local or generalised oedema): common (more common in adults than in children)
22 Splošni in lokalni učinki • Šibkost: občasno • Bolečina ali reakcije na mestu injiciranja: pogosto • Otekanje (lokaliziran ali splošni edem): pogosto (bolj često pri odraslih kot pri otrocih)
Hormone effects • Subnormal activity of the thyroid gland (hypothyroidism): common • Breast enlargement (gynaecomastia): very rare (children); uncommon (adults)
Hormonski učinki • Manjša kot normalna aktivnost ščitnice (hipotiroidizem): pogosto • Povečanje dojk (ginekomastija): zelo redko (otroci), občasno (odrasli)
Effects on metabolism • Mild increase in blood sugar (mild hyperglycaemia): common • Insulin resistance.
Učinki na presnovo • Rahlo zvišanje ravni sladkorja v krvi (blaga hiperglikemija): pogosto • Odpornost na insulin.
Insulin resistance means that the normal effect of insulin on muscle, fat, and liver cells is reduced.
Odpornost na insulin pomeni, da je normalni učinek insulina na celice mišic, maščobne celice in jetrne celice zmanjšan.
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)
Učinki na živčevje • Simptomi benignega povečanja tlaka v možganih (benigna intrakranialna hipertenzija): redko • Glavobol: zelo pogosto (odrasli) • Nespečnost: zelo redko (otroci), pogosto (odrasli) • Nenormalno čutenje (parestezija): redko (otroci), zelo pogosto (odrasli)
Vascular effects • High blood pressure (hypertension): rare (children); common (adults)
Učinki na ožilje • Visok krvni tlak (hipertenzija): redko (otroci), pogosto (odrasli)
Joint and muscle effects • Joint pain and disorder (arthralgia): very common (adults) • Localised muscle pain (myalgia): common (adults)
Učinki na sklepe in mišice • Bolečine v sklepih in okvare sklepov (artralgija): zelo pogosto (odrasli) • Lokalizirana bolečina v mišicah (mialgija): pogosto (odrasli)
As with all medicines containing growth hormone a small percentage of patients may develop blocking chemicals called antibodies to growth hormone.
Kot pri vseh zdravilih, ki vsebujejo somatropin, se pri majhnem odstotku bolnikov razvijejo ovirajoče snovi, t. i. protitelesa proti rastnem hormonu.
In a clinical study with Valtropin 3% of children with growth hormone deficiency developed such antibodies.
V klinični študiji z zdravilom Valtropin so se taka protitelesa razvila pri 3% otrok s pomanjkanjem rastnega hormona.
However, these antibodies did not have an effect on the growth response to Valtropin.
Vendar ta protitelesa niso vplivala na rast zaradi zdravila Valtropin.
If you are failing to respond to therapy with Valtropin, your doctor will test for antibodies.
Če se ne odzivate na zdravljenje z zdravilom Valtropin, bo zdravnik pregledal prisotnost protiteles.
There was one patient (< 1%) who experienced acute hypersensitivity reactions involving hives (urticaria) and itching (pruritus) after administration of Valtropin.
Pri enem bolniku (< 1%) so se po uporabi zdravila Valtropin pojavile akutne preobčutljivostne reakcije, ki sta jih spremljala koprivnica (urtikarija) in srbenje (pruritus).
Children Leukaemia has been reported in a small number of children treated with somatropin.
Otroci Pri manjšem številu otrok, zdravljenih s somatropinom, so poročali o levkemiji.
However, there is no evidence that somatropin causes leukaemia when there are no other risk factors.
Vendar pa ni nobenih dokazov, da somatropin povzroča levkemijo, kadar ni drugih dejavnikov tveganja.
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).
Odrasli Poročali so zgodaj v poteku zdravljenja s somatropinom o otekanju, bolečinah v mišicah in sklepih ter o obolenjih sklepov, vendar so bili ti učinki navadno prehodni.
• 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.
• Zdravilo shranjujte nedosegljivo otrokom! • Zdravila Valtropin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli.
Storage conditions of the unopened product: • Store in a refrigerator (2°C - 8°C).
Pogoji shranjevanja neodprtega zdravila: • Shranjujte v hladilniku (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.
Ne zamrzujte. • Nerekonstituirano zdravilo lahko pred uporabo za eno samo obdobje do štirih tednov shranjujete pri sobni temperaturi (do 25 °C).
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.
Rok uporabnosti po rekonstituciji z vehiklom: • Po rekonstituciji s priloženim vehiklom lahko zdravilo shranjujete v hladilniku (2 °C - 8 °C) največ 21 dni.
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.
Rok uporabnosti po rekonstituciji z vodo za injekcije (NE vodo iz pipe): • Po rekonstituciji z vodo za injekcije je treba zdravilo uporabiti takoj in kot vialo za enkratno uporabo.
Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or discoloured.
Ne uporabljajte zdravila Valtropin, če opazite, da sta vehikel ali rekonstituirana raztopina motna ali razbarvana.
- The active substance is somatropin.
- Zdravilna učinkovina je somatropin.
One vial of powder contains 5 mg somatropin
Ena viala praška vsebuje 5 mg somatropina (kar ustreza
(corresponding to 15 IU).
15 i. e.).
After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg somatropin (corresponding to 10 IU).
Po rekonstituciji z 1, 5 ml vehikla, 1 ml vsebuje 3, 33 mg somatropina (kar ustreza 10 i. e.).
- The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate
- Pomožne snovi so glicin, manitol, mononatrijev fosfat, dinatrijev fosfat ter natrijev hidroksid in
dibasic and for pH adjustment sodium hydroxide and hydrochloric acid.
klorovodikova kislina za uravnavanje pH.
- The pre-filled syringe contains water for injections and metacresol (see section 2, ‘ Important
- Napolnjena injekcijska brizga vsebuje vodo za injekcije in metakrezol (glejte poglavje 2,
information about some of the ingredients of Valtropin’).
"Pomembne informacije o nekaterih sestavinah zdravila Valtropin").
A single pack contains:
Posamezno pakiranje vsebuje:
- 1 vial with white to almost white powder
- 1 viala z belim do skoraj belim praškom
- 1 pre-filled syringe with 1.5 ml of solvent for reconstitution as a clear solution.
- 1 napolnjena injekcijska brizga z 1, 5 ml vehikla za rekonstitucijo v obliki bistre raztopine.
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 Nemčija Tel: +49 (0) 6142 70 8000
24 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Introduction The following instructions explain how to inject Valtropin yourself.
Uvod V nadaljevanju so navodila za samoinjiciranje zdravila Valtropin.
Your doctor or his/ her assistant will instruct you how to self-inject Valtropin.
Zdravnik ali medicinska sestra vam bosta razložila, kako si sami injicirate zdravilo Valtropin.
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’).
Splošne opombe Za bolnike, ki imajo znano občutljivost za metakrezol, se zdravilo Valtropin ne sme rekonstituirati s priloženim vehiklom (glejte poglavje 2, "Ne uporabljajte zdravila Valtropin").
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections (see section 5 ‘ How to store Valtropin’).
Če se pojavi občutljivost za priloženi vehikel, je treba vialo rekonstituirati z vodo za injekcije (glejte poglavje 5, "Shranjevanje zdravila Valtropin").
Supplied in the pack
Priloženi v pakiranju:
the Valtropin vial with powder for solution for injection the pre-filled syringe with 1.5 ml solvent for solution for injection
viala zdravila Valtropin s praškom za raztopino za injiciranje napolnjena injekcijska brizga z 1, 5 ml vehikla za raztopino za injiciranje
sterile injection syringe and needles alcohol swabs dry gauze or cotton pad an adhesive plaster disposal box for used syringes and needles.
sterilna brizga in igle za injiciranje alkoholne krpice suha gaza ali bombažne blazinice samolepilni obliž škatla za odstranjevanje brizg in igel.
Remove the rubber tip cap and firmly attach a needle to the syringe.
Odstranite gumijasto koničasto zaporko in iglo trdno namestite na brizgo.
Slowly inject all of the solvent (1.5 ml) into the powder vial aiming the stream of liquid against the side of the vial.
Curek tekočine usmerite proti steni viale.
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.
Preden odstranite brizgo iz viale, povlecite enako količino zraka (1, 5 ml), kot ste vbrizgali vehikla, da zmanjšate tlak v viali.
28 Preparing the injection
28 Priprava injekcije
Turn the vial upside down with the needle still in it and hold the vial in one hand.
Vialo primite v eno roko.
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.
Pri tem pazite, da je konica igle ves čas v raztopini.
Remove the syringe from the needle leaving the needle in the vial without touching the tip of the syringe.
Pazite, da se ne dotaknete vrha brizge.
30 Injecting the solution
30 Injiciranje raztopine
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.
Raztopino pred injiciranjem preglejte: če je razbarvana ali če v tekočini vidite trdne delce, raztopine NE SMETE injicirati.
Vaniqa is a white cream that contains 11.5% of the active substance eflornithine.
Zdravilo Vaniqa je krema bele barve, ki vsebuje 11, 5% zdravilne učinkovine eflornitin.
Vaniqa is used for the treatment of facial hirsutism in women.
Vaniqa se uporablja za zdravljenje obraznega hirsutizma pri ženskah.
Vaniqa is applied in a thin layer to clean and dry affected areas twice daily (at least eight hours apart) and rubbed in.
Zdravilo Vaniqa se v tankem sloju nanese na čisto in suho kožo prizadetih predelov (v vsaj osemurnih presledkih) in dobro vtre v kožo.
A benefit may be noticed within eight weeks of starting treatment.
Učinki se lahko pokažejo v osmih tednih od začetka zdravljenja.
Continued treatment may give further improvement and is necessary to maintain beneficial effects.
Nadaljevanje zdravljenja izboljša učinek zdravila in je nujno za vzdrževanje ugodnega učinka zdravila.
Vaniqa should be stopped if no beneficial effects are noticed within four months of starting treatment.
Če po štirih mesecih zdravljenja ni opaziti izboljšanja stanja, je treba zdravljenje z zdravilom Vaniqa prekiniti.
Vaniqa contains the active substance eflornithine.
Vaniqa vsebuje zdravilno učinkovino eflornitin.
Eflornithine blocks the action of an enzyme, ornithine decarboxylase.
Eflornitin blokira delovanje encima ornitin dekarboksilaze.
This enzyme is found in the bulb of the hair follicle where it controls hair production.
Ta encim se nahaja v čebulici lasnega mešička, kjer nadzira izgradnjo dlak.
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).
Učinkovitost zdravila Vaniqa so raziskovali v dveh kliničnih preizkušanjih v katerih je sodelovalo 596 žensk, zdravljenih do 24 tednov z zdravilom Vaniqa ali s placebom (navideznim zdravilom, v tem primeru s kremo brez zdravilne učinkovine).
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.
Učinkovitost zdravljenja je ob koncu raziskave ocenil zdravnik, ki je stopnjo hirsutizma opredelil kot: ‘ čisto/ skoraj čisto ’, ‘ očitno izboljšanje ’, ‘ izboljšanje ’ ali ‘ ni izboljšanja/ slabše ’, 48 ur po tem, ko so si ženske obrile zdravljene predele obraza in pod brado.
What benefit has Vaniqa shown during the studies?
Kakšne koristi je zdravilo Vaniqa izkazalo med raziskavami?
Improvement was seen as early as 8 weeks after the start of treatment.
Izboljšanje je bilo opaziti že 8 tednov po začetku zdravljenja.
Significant improvement for Vaniqa versus placebo was seen in both studies.
Uporaba zdravila Vaniqa je v obeh raziskavah pokazala občutno izboljšanje v primerjavi s placebom.
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.
Po primerjavi vseh rezultatov je bilo uspešen rezultat (opredeljen kot ‘ čisto/ skoraj čisto ’ ali ‘ očitno izboljšanje ’) opaziti pri 35% žensk, zdravljenih z zdravilom Vaniqa, v primerjavi s 9% tistih, ki so prejemale 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 Kakšna tveganja so povezana z zdravilom Vaniqa?
The most common side effect (seen in more than 1 patient in 10) is acne.
Najpogostejši stranski učinek (opažen pri več kot 1 od 10 bolnic) so akne.