Xylozolin 0,5 mg/ml, neusspray, oplossing

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,43 mg/ml

Dostupno od:

Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM

ATC koda:

R01AA07

INN (International ime):

XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,43 mg/ml

Farmaceutski oblik:

Neusspray, oplossing

Sastav:

CITROENZUUR 1-WATER (E 330) ; GLYCEROL 85 PER CENT (E 422) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Administracija rute:

Nasaal gebruik

Područje terapije:

Xylometazoline

Proizvod sažetak:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); GLYCEROL 85 PER CENT (E 422); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Datum autorizacije:

2012-09-18

Uputa o lijeku

Xylometazoline-NL/H/2223+2237/001-002-27.03.23
1
rvg 109042-3 EU PIL IB/011/G met NL info-tracked
PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLOZOLIN 0,5 MG/ML, NEUSSPRAY, OPLOSSING
Xylometazoline hydrochloride 0.5 mg/ml
XYLOZOLIN 1 MG/ML, NEUSSPRAY, OPLOSSING_ _
Xylometazoline hydrochloride 1 mg/ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What {(Invented) name strength pharmaceutical form} is and what it
is used for
2. What you need to know before you use {(Invented) name strength
pharmaceutical form}
3. How to use {(Invented) name strength pharmaceutical form}
4. Possible side effects
5. How to store {(Invented) name strength pharmaceutical form}
6. Contents of the pack and other information
1.
WHAT {(INVENTED) NAME STRENGTH PHARMACEUTICAL FORM} IS AND WHAT IT IS
USED FOR
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
{(Invented) name strength pharmaceutical form} contains the active
ingredient xylometazoline, which is a
topical decongestant that relieves nasal congestion. A decongestant
reduces the swelling of the nasal mucosa.
{(Invented) name strength pharmaceutical form} is used for temporary
symptomatic treatment of nasal
congestion due to rhinitis or sinusitis.
{(INVENTED) NAME 0.5 MG/ML PHARMACEUTICAL FORM} IS INTENDED FOR
CHILDREN BETWEEN 2 AND 10 YEARS OF
AGE.
{(INVENTED) NAME 1 MG/ML PHARMACEUTICAL FORM} IS INTENDED FOR ADULTS
AS WELL AS FOR CHILDREN 10 YEARS
OF AGE AND OLDER.
2.
WHAT YOU NEED T

Svojstava lijeka

Xylometazoline-NL/H/2223+2237/001-002-27.03.23
1
rvg 109042-3 EU SPC IB/011/G met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Xylozolin 0,5 mg/ml, neusspray, oplossing
Xylozolin 1 mg/ml, neusspray, oplossing
_ _
Xylometazoline hydrochloride 1 / 0.5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{(INVENTED) NAME 1 MG/ML PHARMACEUTICAL FORM}
One actuation (equivalent to 0.09 ml nasal spray, solution) contains
0.09 mg xylometazoline hydrochloride.
{(INVENTED) NAME 0.5 MG/ML PHARMACEUTICAL FORM}
One actuation (equivalent to 0.09 ml nasal spray, solution) contains
0.045 mg xylometazoline hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray)
Clear, almost colourless solution (pH 5.5-6; Osmolality 250-300
mOsm/kg).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For temporary symptomatic treatment of nasal congestion due to
rhinitis or sinusitis.
{(INVENTED) NAME 1 MG/ML PHARMACEUTICAL FORM}
is intended for adults as well as for children 10 years of
age and older.
{(INVENTED) NAME 0.5 MG/ML PHARMACEUTICAL FORM}
is intended for children between 2 and 10 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is intended for nasal use.
{(INVENTED) NAME 1 MG/ML PHARMACEUTICAL FORM}:
The dose in adults and children 10 years of age and older is 1-2
sprays of
_{(Invented) name 1 mg/ml _
_pharmaceutical form}_
into each nostril, according to need, but up to a
MAXIMUM
of 3 times daily.
Dosages higher than those recommended must not be used.
{(INVENTED) NAME 1 MG/ML PHARMACEUTICAL FORM}
is suitable for adults as well as for children over 10
years of age. It must not be used in children below 10 years of age.
_ _
{(INVENTED) NAME 0.5 MG/ML PHARMACEUTICAL FORM}:
The dose in children between 2 and 10 years of age is one spray of
_{(Invented) name 0.5 mg/ml _
_pharmaceutical form}_
into each nostril, according to need, but up to a
MAXIMUM
of 3 times daily.
Dosages higher than those recommen