MECOLZINE 1G Αφρός, ορθικός

Land: Kýpur

Tungumál: gríska

Heimild: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Virkt innihaldsefni:

MESALAZINE

Fáanlegur frá:

FAES FARMA SA (0000002088) MAXIMO AQUIRRE 14, LEIOA(VIZCAYA), 48940

ATC númer:

A07EC02

INN (Alþjóðlegt nafn):

MESALAZINE

Skammtar:

1G

Lyfjaform:

Αφρός, ορθικός

Samsetning:

MESALAZINE (0000089576) 1g

Stjórnsýsluleið:

RECTAL USE

Gerð lyfseðils:

Ειδική άδεια άρθρο 126A

Lækningarsvæði:

MESALAZINE

Vörulýsing:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 APPLICATIONS (33S006701) 14 DOSE(S) - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Upplýsingar fylgiseðill

Mecolzine 1g Malta
1/1
24/01/19
P2184b1
ROBERTO
UM GR.60
NERO
300x210
03002417
SOFAR
75x105
_POR MERCEDES FEO, CONTROL DE CALIDAD, FAES FARMA S.A. FECHA 11:54 ,
11/02/2019_
5. HOW TO STORE MECOLZINE
Keep the medicine out of sight and reach of children.
Do not store at over 30 ºC.
This container is a pressurised aerosol spray containing an
inflammable
propellant. Keep away from heat, flames and ash, including cigarettes.
Keep out of direct sunlight and do not smash or burn, even when
empty. Do not use MECOLZINE after the expiry date indicated on the
container. The expiry date is the last day of the indicated month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of unwanted medicines
and containers. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Composition of MECOLZINE
- The
active
ingredient
in
this
medicine
is
mesalazine
(1g
per
application)
- The other ingredients are sorbitan monooleate, polysorbate 20,
emulsifying wax, colloidal anhydrous silica, sodium metabisulphate
(E223),
disodium
edetate,
methyl
paraben
(E218),
propyl
parahydroxybenzoate
(E216),
sodium
hydrogen
phosphate
dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol,
polyethylene glycol 300, purified water, propane, iso-butane, and
n-butane.
Appearance of product and contents of packaging
Enema foam for rectal administration. The case includes:
- 1 aerosol spray dispensing 14 applications
- a kit consisting of a base or rack with 14 compartments (containing
a small amount of Vaseline), and in which 14 disposable applicators
are introduced. The goal of Vaseline is to facilitate the introduction
of the applicators in the rectum.
- 14 disposable plastic bags
- a prospect.
Marketing authorisation holder and manufacturer:
FAES FARMA, S.A. - Máximo Aguirre, 14 - 48940 Leioa
Exceptional Marketing Authorization Holder in Cyprus: FAES
FARMA, S.A
This leaflet was approved in March 2018
03002417 - P2184b1 IDG 01/19
Contenido del prospecto:
1. Qué es MECOLZ