pdp-Pyrazinamide

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Pyrazinamide 500mg;  

可用日期:

AFT Pharmaceuticals Ltd

INN（国际名称）:

Pyrazinamide 500 mg

剂量:

500 mg

药物剂型:

Tablet

组成:

Active: Pyrazinamide 500mg   Excipient: Colloidal silicon dioxide Microcrystalline cellulose Pregelatinised maize starch Starch Stearic acid

每包单位数:

Bottle, plastic, White HDPE with white PP cap, 100 tablets

类:

Prescription

处方类型:

Prescription

厂商:

Calyx Chemicals and Pharmaceuticals Limited

疗效迹象:

pdp-PYRAZINAMIDE is indicated in patients with active tuberculosis caused by Mycobacterium tuberculosis. pdp-PYRAZINAMIDE is not active against the atypical mycobacteria. pdp-PYRAZINAMIDE should be given only in combination with other effective anti-tuberculous agents.

產品總結:

Package - Contents - Shelf Life: Bottle, plastic, White HDPE with white PP cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C

授权日期:

2004-02-18

资料单张

PDP-PYRAZINAMIDE
Pyrazinamide 500 mg Tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Pdp-Pyrazinamide.
It does not contain all the available information. 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 Pdp-
Pyrazinamide against the benefits they expect it will have for you.
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 THE MEDICINE IS USED FOR
Your medicine is used in combination with other medicines to treat
tuberculosis, also known
as TB.
Tuberculosis is a bacterial infection that mainly affects the lungs,
but it can also spread to
other organs in the body._ _
It belongs to a group of medicines called anti-infectives.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU
.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
pdp-Pyrazinamide is available only with a doctor’s prescription.
This medicine is not expected to affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE THIS MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PDP-PYRAZINAMIDE IF:
•
You have an allergy to any medicine containing Pyrazinamide
•
You have an allergy to any of the ingredients listed at the end of
this leaflet.
•
You are breast-feeding. Like most medicines, Pdp-Pyrazinamide is not
recommended for
use while breast-feeding.
•
You have liver disease
•
You have gout or gouty arthritis
You have too much uric acid in your blood (also called hyperuricaemia)
which may or may not
cause gout or gouty arthritis.
DO NOT GIVE PDP-PYRAZINAMIDE TO A CHILD.
The safety of this medicine has not been established in children.
Do not take this medicine after the expiry date printed on the pack or
if the packaging is torn
or shows signs of tampering.
If it has expired or is damaged, return it to your pha

产品特点

NEW ZEALAND DATA SHEET
Page 1 of 5
1 PDP-PYRAZINAMIDE
pdp-Pyrazinamide 500mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of pyrazinamide
3 PHARMACEUTICAL FORM
pdp-PYRAZINAMIDE is available as white round tablets, scored on one
side with “PMS” on
the other side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
pdp-PYRAZINAMIDE
is
indicated
in
patients
with
active
tuberculosis
caused
by
Mycobacterium
tuberculosis.
pdp-PYRAZINAMIDE
is
not
active
against
the
atypical
mycobacteria. pdp-PYRAZINAMIDE should be given only in combination
with other effective
anti-tuberculous agents.
4.2
Dose and method of administration
Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once
daily.
Older regimens employed 3 or 4 divided doses daily, but most current
recommendations are
for once a day. Three grams per day should not be exceeded. The CDC
recommendations do
not exceed 2 g per day when given as a daily regimen.
Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice
weekly based on lean
body weight) has been developed to promote patient compliance with a
regimen on an
outpatient basis. In studies evaluation the twice weekly regimen,
doses of Pyrazinamide in
excess
of
3
g
twice
weekly
have
been
administered.
This
exceeds
the
recommended
maximum 3 g/daily dose. However, an increased incidence of adverse
reactions has not been
reported. pdp-PYRAZINAMIDE should be administered with at least one
other effective anti-
tuberculous medicine. The use of pdp-PYRAZINAMIDE in combination
therapy does not
modify the accepted dosages of other anti-tuberculous agents.
The tablet should not be divided.
4.3
Contraindications
•
Patients who are hypersensitive to any component of this product;
•
Patients with hepatic disease
•
Patients with hyperuricaemia and/or gouty arthritis.
•
Safety for use in children has not been established
•
Nursing mothers. If use of this medicine is deemed essential, the
patient should stop
nursing.
NEW ZEALAND DATA SHEET
Page 2 of 5
4.4
Specia