DYNA TERBUTALINE SYRUP

国家: 马来西亚

语言: 英文

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

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资料单张 资料单张 (PIL)
14-03-2023
产品特点 产品特点 (SPC)
14-03-2023

有效成分:

TERBUTALINE SULPHATE

可用日期:

DYNAPHARM (M) SDN BHD

INN(国际名称):

TERBUTALINE SULPHATE

每包单位数:

60 ml mL; 120 ml mL

厂商:

DYNAPHARM (M) SDN BHD

资料单张

                                DYNA TERBUTALINE SYRUP
Terbutaline Sulphate (1.5mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dyna Terbutaline Syrup is used
for
2.
How Dyna Terbutaline Syrup works
3.
Before you use Terbutaline Syrup
4.
How to use Dyna Terbutaline Syrup
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dyna
Terbutaline Syrup
8.
Product Description
9.
Manufacturer and Product &
Registration Holder
10.
Date of revision
WHAT DYNA TERBUTALINE SYRUP IS USED
FOR
Used for the treatment of asthma,
chronic airway inflammation, air sacs
damages in the lungs and other
respiratory disorders involving the
constriction of airway.
HOW DYNA TERBUTALINE SYRUP WORKS
Terbutaline is a bronchodilator, a
medication that dilates (expands) air
passages in the lungs. Wider air passages
allow more air to flow in and out of the
lungs. Increased airflow reduces
shortness of breath, wheezing, and cough
BEFORE YOU USE DYNA TERBUTALINE
SYRUP
-
_When you must not use it _
Do not use this medication in people
with high blood pressure, heart failure
and overactive thyroid gland._ _
_Pregnancy and lactation _
Do not take Dyna Terbutaline Syrup if
you are pregnant, trying to get pregnant
or think you may be pregnant.
The amount excreted in breast milk is
too small to be harmful.
-
_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.
Beta-blocking agents (including eye
drops) such as
-
Propranolol - used to treat high blood
pressure
-
Corticosteroids – relief inflammation
Diuretics such as
-
Acetazolamide - prevent and reduce
the symptoms of altitude sickness
-
Loop diuretics and Thiazides - treat
high blood pressure and swelling
Theophylline - medication used to treat
asthma and other lung diseases
HOW TO USE DYNA TERBUTALINE SYRUP
-
_How much to use _
Adults
2 to 3 teaspoonfuls (10 ml to 15 ml).
Children
Under 3 years: ½ teaspoonful (2.5 ml).
3 to 5 years: ½ to 1 teasp
                                
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产品特点

                                DYNA TERBUTALINE SYRUP
MAL19910178AZ
DESCRIPTION:
SYRUP
Colour
:
Colourless
Flavour
:
Pineapple
CONTENT:
Each 5 ml contains:
Terbutaline Sulphate
.................................................. 1.5 mg
Preservatives: Methyl Paraben 0.1% w/v & Propyl Paraben 0.01% w/v.
PHARMACODYNAMICS:
Terbutaline Sulphate is a directly acting sympathomimetic amine with
bronchodilator actions. It acts on the adrenergic
receptors in the bronchi and the respiratory tract.
PHARMACOKINETICS
Terbutaline Sulphate is partially absorbed after oral administration.
After an oral dose of 5 mg of Terbutaline Sulphate, peak
serum concentrations of about 3 to 6 ng/ml are attained in 1 to 3
hours. The serum half-life is 3 to 4 hours. Small amount of the
drug is secreted in the milk. Terbutaline Sulphate is subjected to
first pass metabolism mainly by Sulphate conjugation;
glucuronic acid conjugates are formed to some extent but the drug does
not appear to be methylated. After an oral dose, up to
about 50% is excreted in the urine, mostly as the Sulphate.
INDICATION:
In the treatment of asthma, chronic bronchitis, emphysema and other
bronchopulmonary disorders involving bronchospasm.
RECOMMENDED DOSE:
Adults
: 2 to 3 teaspoonfuls (10 ml to 15 ml).
Children
: under 3 years : ½ teaspoonful (2.5 ml).
3 to 5 years
: ½ to 1 teaspoonful (2.5 ml to 5 ml).
6 to 12 years
: 1 to 2 teaspoonfuls (5 ml to 10 ml).
To be given 3 times daily.
CONTRAINDICATION:
It is contraindicated in patients with hypertension, myocardial
insufficiency and hyperthyroidism.
WARNING AND PRECAUTIONS:
It should not be administered with non-selective beta-adrenoreceptor
blocking drugs such as Propranolol or Oxprenolol.
Tocolysis: Serious adverse reactions including death have been
reported after administration of Terbutaline to women in labor.
In the mother, these include increased heart rate, transient
hyperglycaemia, hypokalaemia, cardiac arrhythmias, pulmonary
oedema and myocardial ischaemia. Increase fetal heart rate and
neonatal hypoglycaemia may occur as a result of mater
                                
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