KETOTIFEN SYRUP

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

KETOTIFEN FUMARATE

Dostępny od:

HOVID BERHAD

INN (International Nazwa):

KETOTIFEN FUMARATE

Sztuk w opakowaniu:

100 ml; 1000 ml; 3600 ml

Wyprodukowano przez:

HOVID BERHAD

Ulotka dla pacjenta

08 March 2023
_ _
_ _
Head of Generic Section
Centre of Product Evaluation and Cosmetic
National Pharmaceutical Regulatory Agency (NPRA)
Ministry of Health Malaysia
Lot 36, Jalan Universiti
(Jalan Profesor Diraja Ungku Aziz),
46200 Petaling Jaya, Selangor,
Malaysia.
RE
: LETTER OF COMMITMENT TO SUBMIT PIL & RIMUP
PRODUCT NAME
: KETOTIFEN SYRUP
MAL NO.
: MAL19940059AZ
Dear Sir/Madam,
We hereby commit that we will submit the PIL and RiMUP to
pharmacovigilance unit review
and to update QUEST3+ via variation after the PIL & RiMUP had been
approved by
pharmacovigilance unit.
Thank you.
Yours Sincerely
CHONG YEN LENG (MS)
Regulatory Affairs Department
HOVID Bhd.

Charakterystyka produktu

KETOTIFEN SYRUP
DESCRIPTION
Colourless, transparent liquid with strawberry flavour.
COMPOSITION
Each 5 ml contains:
Ketotifen (as Fumarate) 1 mg/5 ml.
PHARMACODYNAMICS
Ketotifen is a histamine-H1 receptor antagonist. It diminishes
or abolishes the main actions of histamine in the body by
competitive, reversible blockade of histamine receptor sites.
It can also inhibit bronchoconstriction by preventing release
of mediators of the allergic response including histamine and
slow reacting substance of anaphylaxis (SRS-A) from mast
cells.
PHARMACOKINETICS
Ketotifen is readily absorbed from the gastrointestinal tract. It
undergoes hepatic metabolism and is excreted in the urine
and faeces.
INDICATIONS
Ketotifen is used for the prophylactic treatment of asthma. It
is also used in allergic conditions such as rhinitis and
conjunctivitis.
CONTRAINDICATIONS
Ketotifen should not be given to premature infants and
neonates and also patients during acute attacks of asthma.
Caution should be exercised when it is used in conditions
such
as
narrow
angle
glaucoma,
urinary
retention
and
prostatic hypertrophy.
PRECAUTIONS
•
Previous anti-asthmatic treatment should be continued for
a
minimum
of
two
weeks
after
initiation
of
ketotifen
treatment.
•
Ketotifen may suppress positive skin test results and
should be stopped several days before the test.
•
Patients
hypersensitive
to
anti-histamines
may
be
hypersensitive to this medication also.
•
It may cause dizziness, sedation, mental confusion and
hypotension in geriatric patients.
•
This medication may cause drowsiness. Patients affected
should not drive or operate machinery.
•
Patients should be warned not to take charge of vehicles
or machinery.
PREGNANCY AND LACTATION
Use of Ketotifen during pregnancy is not recommended.
Ketotifen is excreted in breast-milk, use by nursing mothers
is not recommended.
MAIN SIDE/ADVERSE EFFECTS
•
Increased appetite and weight gain
•
Sedation
•
Tiredness
•
Gastrointestinal disturbances such as nausea, vomiting,
diarrhoea or constipation