Voriconazol STADA 200 mg, filmomhulde tabletten

Страна: Нидерланды

Язык: голландский

Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активный ингредиент:

VORICONAZOL

Доступна с:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

код АТС:

J02AC03

ИНН (Международная Имя):

VORICONAZOLE

Фармацевтическая форма:

Filmomhulde tablet

состав:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Администрация маршрут:

Oraal gebruik

Терапевтические области:

Voriconazole

Обзор продуктов:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Дата Авторизация:

2014-05-26

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOL STADA 200 MG, FILMOMHULDE TABLETTEN
Voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Voriconazol STADA is and what it is used for
2. What you need to know before you take Voriconazol STADA
3. How to take Voriconazol STADA
4. Possible side effects
5. How to store Voriconazol STADA
6. Contents of the pack and other information
1. WHAT VORICONAZOL STADA IS AND WHAT IT IS USED FOR
Voriconazol STADA contains the active substance voriconazole.
Voriconazol STADA is an
antifungal medicine. It works by killing or stopping the growth of the
fungi that cause
infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:

invasive aspergillosis (a type of fungal infection due to _Aspergillus
sp_),

candidaemia (another type of fungal infection due to _ Candida sp_) in
non-neutropenic
patients (patients without abnormally low white blood cells count),

serious invasive _ Candida sp. _ infections when the fungus is
resistant to fluconazole
(another antifungal medicine),

serious fungal infections caused by _ Scedosporium sp. _ or _ Fusarium
sp_. (two different
species of fungi).
Voriconazol STADA is intended for patients with worsening, possibly
life-threatening, fungal
infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be taken under the supervision of a doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORICONAZOL STADA
DO

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Voriconazol STADA 200 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
Excipients with known effect
Each tablet contains 259.76 mg lactose monohydrate and 1.90 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white, oval (approximately 16 mm long x 8 mm in width),
biconvex coated tablet
debossed with “V9CN” on one side and “200” on the reverse.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voriconazole is a broad spectrum, triazole antifungal agent and is
indicated in adults and
children aged 2 years and above as follows:
Treatment of invasive aspergillosis.
Treatment of candidaemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive _Candida
_infections (including _C. krusei_).
Treatment of serious fungal infections caused by _Scedosporium _spp.
and _Fusarium _spp.
[Product name] should be administered primarily to patients with
progressive, possibly life-
threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell
transplant (HSCT) recipients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances
such
as hypokalaemia,
hypomagnesaemia and hypocalcaemia
should be monitored and corrected, if necessary, prior to initiation
and during voriconazole
therapy (see section 4.4).
[Product name] is also available as 200 mg powder for solution for
infusion. Additionally,
other brands have voriconazole available as 50 mg film-coated tablets
and 40 mg/ml powder
for oral suspension.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or
oral voriconazole to achieve plasma concentrations on Day 1 that are
close to steady state.
On the basis of the high oral bioavailability (96 %; see section 5.2),
switching between
intravenous and oral administration is appropriate when clinically