PARLODEL bromocriptine 5mg (as mesilate) capsule bottle

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

bromocriptine mesilate, Quantity: 5.735 mg (Equivalent: bromocriptine, Qty 5 mg)

متاح من:

Sandoz Pty Ltd

الشكل الصيدلاني:

Capsule, hard

تركيب:

Excipient Ingredients: iron oxide red; Gelatin; magnesium stearate; titanium dioxide; lactose monohydrate; Shellac; indigo carmine; maleic acid; colloidal anhydrous silica; maize starch

طريقة التعاطي:

Oral

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Prevention of onset of lactation in the puerperium for clearly defined medical reasons. Therapy should be continued for 14 days to prevent rebound lactation. Parlodel should not be used to suppress established lactation. Treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. Precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. Where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, Parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. Adjunctive therapy in the management of acromegaly when: (1) The patient refuses surgery and/or radiotherapy; (2) Surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months; (3) A manifestation of the acromegaly needs to be brought under con

ملخص المنتج:

Visual Identification: Opaque white and blue capsule marked PS, length approx 16 mm diameter approx 6 mm; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

1991-08-21

نشرة المعلومات

ISONIAZID tablets – Consumer Medicine Information
Page 1 of 3
ISONIAZID TABLETS
_isoniazid _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ISONIAZID
tablets.
It does not contain all of the
available information about
ISONIAZID tablets. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ISONIAZID tablets against the
benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ISONIAZID IS
USED FOR
The name of your medicine is
ISONIAZID tablets which
contains the active ingredient
isoniazid.
_ _
Isoniazid belongs to a group of
medicines called tuberculostatic
agents. It acts by stopping the
growth of the bacteria responsible
for tuberculosis.
ISONIAZID is used to treat
tuberculosis in combination with
other antitubercular agents.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ISONIAZID HAS BEEN PRESCRIBED
FOR YOU.
Your doctor, however, may have
prescribed it for another purpose.
ISONIAZID tablets are available
only with a doctor’s prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ISONIAZID IF:
•
you are allergic to ISONIAZID
tablets or any of their
ingredients listed at the end of
this leaflet.
Some of the symptoms of an
allergic reaction to
ISONIAZID may include red,
itchy skin rashes, difficulty
breathing, hay fever, swelling
of the face or throat or
faintness.
•
you have had severe reactions
to ISONIAZID, for example
fever, chills or arthritis.
•
you have previously
experienced liver problems
after taking ISONIAZID tablets
or any other medicines.
•
you have acute liver problems
from any cause.
DO NOT USE ISONIAZID TABLETS
AFTER THE EXPIRY DATE (EXP.)
PRINTED ON THE PACK.
If you take it after the expiry date
has passed, it may have no effect at
all, or worse, there may be an
e

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION ISONIAZID
TABLETS
1
NAME OF THE MEDICINE
Isoniazid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of isoniazid
Isoniazid exists as colourless odourless crystals, or white
crystalline powder. It is freely
soluble in water, sparingly soluble in alcohol, slightly soluble in
chloroform, very slightly
soluble in ether.
List of excipients with known effect
•
Sodium benzoate
•
propyl hydroxybenzoate
•
lactose monohydrate
•
Gluten
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Isoniazid tablets - white scored 100mg tablets
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of pulmonary and extrapulmonary tuberculosis in combination
with other
antitubercular agents.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults: The usual dose is 4 to 5 mg/kg bodyweight in divided doses up
to a maximum of 300
mg daily. In tuberculous meningitis, up to 10 mg/kg daily may be given
for the first 1 or 2
weeks of treatment.
2
Isoniazid is administered orally.
Children: 5 to 20 mg/kg bodyweight daily.
4.3
C
ONTRAINDICATIONS
Patients who develop severe hypersensitivity reactions including drug
induced hepatitis.
Previous isoniazid associated hepatic injury; severe adverse reactions
to isoniazid, such as
drug fever, chills and arthritis; acute hepatic disease of any
aetiology. Patients with known
hypersensitivity to isoniazid or any of the excipients listed under
Description.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Severe and sometimes fatal hepatitis associated with isoniazid therapy
may occur and may
develop even after many months of treatment. The risk of developing
hepatitis is age related.
Approximate case rates by age are: 0/1,000 for people under 20 years
of age, 3/1,000 for
people in the 20 to 34-year age group, 12/1,000 for people in the 35
to 49 year age group,
23/1,000 for people in the 50 to 64 year age group, and 8/1,000 for
people over 65 years of
age. The risk of hepatitis is increased with daily consumption

خصائص المنتج

1
PARLODEL
®
(BROMOCRIPTINE MESYLATE)
NAME OF THE MEDICINE
Active ingredient: Bromocriptine mesylate
Chemical names: Ergotaman-3’,6’,18-trione,
2-bromo-12’-hydroxy-2’-(1-methylethyl)-5’-
(2-methylpropyl)-, (5’α)-;
2-Bromoergocryptine monomethanesulphonate;
2-bromo-

- ergocryptine mesylate;
CAS Number: 22260-51-1
Chemical structure:
H
CH
3
H
H
HN
N
Br
O
O
N
OH
H
CH
2
CH(CH
3
)
2
O
N
H
N
C
O
CH(CH
3
)
2
Chemical Formula: C
32
H
40
BrN
5
O
5
CH
4
O
3
S
Molecular weight: 750.7 (mesylate salt); 654.5 (free base)
DESCRIPTION
Bromocriptine
mesylate
is
a
peptide
ergot
alkaloid,
poorly
soluble
in
water
(<0.1%
at
20 - 25
0
C). Freely soluble in methanol. Solubility in ethanol (70% v/v) is
75%.
Parlodel tablets and capsules contain bromocriptine mesylate.
EXCIPIENTS
Tablets: magnesium stearate, silica colloidal anhydrous, maize starch,
disodium edetate, maleic
acid, and lactose.
Capsules: magnesium stearate, silica colloidal anhydrous, maize
starch, maleic
acid,
lactose,
gelatin, and titanium dioxide. The 5 mg capsules also contain shellac,
red iron oxide CI77491,
and indigo carmine CI73015.
2
PHARMACOLOGY
Parlodel has a pharmacological spectrum unlike that of most classical
ergot compounds, having
no uterotonic and little vasoconstrictor activity. Its principal
effects derive from dopaminergic
receptor stimulant activity. It inhibits prolactin secretion and the
effect can be demonstrated
after single or repeated oral administration of the drug. Moreover,
the effect is relatively
specific in that doses necessary to produce inhibition of prolactin
secretion do not interfere with
release of gonadotrophins or thyrotrophin. However, Parlodel elevates
growth hormone for a
few hours after each dose in normal or diabetic persons. This may not
be reflected by an
elevation of basal levels during chronic administration. However, it
may suppress the elevated
growth hormone levels of acromegalic patients.
Parlodel has been shown to arrest the growth or to reduce the size of
prolactin-secreting
pituitary adenomas (prol