STREFEN ORANGE - SUGAR FREE

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

FLURBIPROFEN

Dostupno od:

RECKITT BENCKISER (NEAR EAST) LTD

ATC koda:

S01BC04

Farmaceutski oblik:

LOZENGES

Sastav:

FLURBIPROFEN 8.75 MG

Administracija rute:

PER OS

Tip recepta:

Not required

Proizveden od:

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD, UK

Područje terapije:

FLURBIPROFEN

Terapijske indikacije:

For the short term relief of symptoms of sore throat such as throat pain and soreness in adults and children over the age of 12 years

Datum autorizacije:

2020-01-31

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Strefen Honey and Lemon
Strefen Orange flavour Sugar Free
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient; Flurbiprofen 8.75mg
Excipient(s) with known effect:
STREFEN HONEY AND LEMON
Glucose
Sucrose
Wheat Starch*
Sulphites
–
sulphur Dioxide (E220)*
d-Limonene**
Linalool**
Citral**
Citronellol**
Farnesol**
Geraniol**
Butylate Hydroxyanisole (E220)**
*present in liquid glucose
**present in Lemon Flavour
STREFEN ORANGE FLAVOUR SUGAR FREE
Maltitol Liquid 0.5
09
g/lozenge. Total maximum daily dose (MDD) is 2.55 g.
Isomalt 2.03
3
g/lozenge. Total maximum daily dose (MDD) is 10.195 g.
Citral**
Citronellol**
d-Limonene**
Geraniol**
Linalool**
**present in Orange flavour
2
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Lozenges.
STREFEN HONEY AND LEMON:
A round, pale yellow to brown lozenge with an icon intagliated on both
sides
of the lozenge.
STREFEN ORANGE FLAVOUR SUGAR FREE.
A white to pale yellow circular lozenge, with a characteristic orange
taste with
an icon intagliated on both.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Strefen Honey and Lemon & Strefen Orange flavour Sugar Free are
indicated
for the short term relief of symptoms of sore throat such as throat
pain and
soreness in adults and children over the age of 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and children over the age of 12 years:
One lozenge sucked/dissolved slowly in the mouth every 3 - 6 hours as
required.
Maximum 5 lozenges in a 24 hour period.
It is recommended that this product should be used for a maximum of
three
days.
Children: Not indicated for children under 12 years.
Elderly: A general dose recommendation cannot be given, since to date
clinical
experience is limited. The elderly are at increased risk of the
serious
consequences of adverse reactions.
Impaired hepatic: In patients with mild to moderate impairment of
hepatic
function no dose reduction is required. In patients with severe
hepatic
insufficiency fl