Telfast Oral Suspension 6 mgml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Fexofenadine 28 mg/5 ml eqv Fexofenadine hydrochloride

Beschikbaar vanaf:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

ATC-code:

R06AX26

Dosering:

30.00 mg/5 ml

farmaceutische vorm:

SUSPENSION

Samenstelling:

Fexofenadine 28 mg/5 ml eqv Fexofenadine hydrochloride 30.00 mg/5 ml

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

SANOFI MEDLEY FARMACÊUTICA LTDA.

Autorisatie-status:

ACTIVE

Autorisatie datum:

2012-07-20

Bijsluiter

INDICATIONS AND USAGE
Ŧ
 SEASONAL ALLERGIC RHINITIS
TELFAST is indicated for the relief of symptoms associated with
seasonal allergic rhinitis in 
adults and children 2 years of age and older.
Ŧ
 CHRONIC IDIOPATHIC URTICARIA
TELFAST is indicated for treatment of uncomplicated skin
manifestations of chronic idiopathic 
urticaria in adults and children 6 months of age and older.
DOSAGE AND ADMINISTRATION
Seasonal Allergic Rhinitis
_Children 2 to 11 Years:_ The recommended dose of TELFAST oral
suspension is 30 mg twice daily. 
A dose of 30 mg (5 mL) once daily is recommended as the starting dose
in pediatric patients with 
decreased renal function _[see Clinical Pharmacology]_.
Shake bottle well, before each use.
Chronic Idiopathic Urticaria
_Children 6 Months to 11 years:_ The recommended dose of TELFAST
oral suspension is 30 mg (5 mL) 
twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL)
twice daily for patients 6 months 
to less than 2 years of age. For pediatric patients with decreased
renal function, the recommended 
starting doses of TELFAST oral suspension are 30 mg (5 mL) once daily
for patients 2 to 11 years of 
age and 15 mg (2.5 mL) once daily for patients 6 months to less than 2
years of age _[see Clinical _
_Pharmacology]_
Shake bottle well, before each use.
DOSAGE FORMS AND STRENGTHS
TELFAST oral suspension is available as 30 mg/ 5 mL (6 mg/mL).
CONTRAINDICATIONS
TELFAST oral suspension is contraindicated in patients with known
hypersensitivity to fexofenadine 
and any of the ingredients of  TELFAST. Rare cases
of hypersensitivity reactions with manifestations 
such as angioedema, chest tightness, dyspnea, flushing and systemic
anaphylaxis have been 
reported.
ADVERSE REACTIONS
CLINICAL STUDIES EXPERIENCE
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates 
observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of 
another drug and may not reflect the rates obse

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