ZYNATEN SYRUP

Država: Malezija

Jezik: engleski

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

Kupi sada

Preuzimanje Uputa o lijeku (PIL)
12-07-2019
Preuzimanje Svojstava lijeka (SPC)
19-12-2017

Aktivni sastojci:

KETOTIFEN FUMARATE

Dostupno od:

DYNAPHARM (M) SDN BHD

INN (International ime):

KETOTIFEN FUMARATE

Jedinice u paketu:

60 ml

Proizveden od:

DYNAPHARM (M) SDN BHD

Uputa o lijeku

                                ZYNATEN SYRUP
Ketotifen Fumarate (1mg/ 5ml)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What ZYNATEN SYRUP is used
for
2.
How ZYNATEN SYRUP works
3.
Before you use ZYNATEN SYRUP
4.
How to use ZYNATEN SYRUP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ZYNATEN
SYRUP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What ZYNATEN SYRUP is used for
ZYNATEN SYRUP indicated in the
preventive treatment of asthma and in
the treatment of allergic conditions such
as rhinitis and conjunctivitis.
How ZYNATEN SYRUP works
Ketotifen has the properties of the
antihistamines and works by blocking a
certain natural substances (histamine)
that your body makes during an allergic
reaction.
Before you use ZYNATEN SYRUP
-
When you must not use it
Hypersensitivity to the medicine or
other ingredients of this product.
Pregnancy and lactation
Ask your doctor or pharmacist for
advice before taking any medicine.
Although there is no evidence of birth
defects, it should be given to pregnant
and nursing women only under
compelling circumstances.
-
Before you start to use it
Please inform doctor if you have
infection
-
Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
A reversible fall in the platelet count
has been observed in individuals
receiving Ketotifen concomitantly with
oral antidiabetic agents it has been
suggested that this combination should
therefore be avoided.
Zynaten may potentiate the effects of
sedatives, hypnotics and antihistamines.
How to use ZYNATEN SYRUP
-
How much to use
Adults: 1 teaspoonful (5 ml) twice
daily with food, increased if necessary
to 2 teaspoonfuls (10 ml) twice daily.
Children over 3 years: 1 teaspoonful
(5 ml) twice daily.
Children from 6 months to 3 years: ½
teaspoonfuls (2.5 ml) twice daily.
Individuals known to be easily sedated
should begin treatment with ½ to 1
teaspoonful (2
                                
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Svojstava lijeka

                                ZYNATEN SYRUP
MAL19940359AZ
DESCRIPTION:
SYRUP
Colour : Colourless
Flavour : Cherry
CONTENT:
Each 5 ml Contains:
Ketotifen Fumarate Equivalent To Ketotifen................1 mg
Preservatives: Methyl Paraben 0.1% w/v, Propyl Paraben 0.01% w/v &
Sodium Benzoate 0.1% w/v.
PHARMACODYNAMICS:
Ketotifen has the properties of the antihistamines in additions on
mast cells analogous to those of sodium cromoglycate. A review of
the pharmacology of Ketotifen and the conclusion that its
anti-allergic action properties.
In addition to its antihistaminic action, inhibition of
phosphodiasterases, blockade of calcium channels, inhibition of the
release of the
mixture of leukotrienes, known as slow reacting substance of
anaphylaxis (SRS-A), and functional antagonism of the effect of SRS-A
has
been demonstrated, and there is now some evidence for an effect on
beta-receptor mediated reactions.
PHARMACOKINETICS:
Ketotifen is readily absorbed from the gastro-intestinal tract,
metabolised in the liver, and excreted usually mainly as metabolites
in
the urine. Maximal plasma concentration is reached within 2 to 4
hours. Protein binding is 75%. The pattern of metabolism for children
is the same as for adults but the clearance is higher in children.
Therefore it is recommended that children above 3 years old require
the same dosage regimen as adult and those between 6 months to 3
years, half the adult dose. In the prevention of bronchial asthma it
may take several weeks of treatment to achieve the full effect.
INDICATION:
Indicated in the prophylactic treatment of asthma and in the treatment
of allergic conditions such as rhinitis and conjunctivitis.
RECOMMENDED DOSAGE:
Adults: 1 teaspoonful (5 ml) twice daily with food, increased if
necessary to 2 teaspoonfuls (10 ml) twice daily.
Children over 3 years: 1 teaspoonful (5 ml) twice daily.
Children from 6 months to 3 years: ½ teaspoonful (2.5 ml) twice
daily.
Patients known to be easily sedated should begin treatment with ½ to
1 teaspoonful (2.5 ml to 5 ml) at night for the first few days.

                                
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