Pyrazinamide tablets

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

pyrazinamide

Tillgänglig från:

Macleods Pharmaceuticals Ltd.

ATC-kod:

J04AK01

INN (International namn):

pyrazinamide

Dos:

400mg

Läkemedelsform:

tablets

Enheter i paketet:

(672/24x28/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2023-03-10

Bipacksedel

Pyrazinamide 400 mg Tablets PIL/P5/PYRA/2022, Version I
Macleods Pharmaceuticals Limited, India
Page 1 of 7
17
th
June 2022
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
PYRAZINAMIDE 400 MG TABLETS
PYRAZINAMIDE
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your
pharmacist.
- This medicine has been prescribed for you personally and you should
not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet.
IN THIS LEAFLET
:
1.
What Pyrazinamide 400 mg Tablets is and what it is used for
2.
What you need to know before you take Pyrazinamide 400 mg Tablets
3.
How to take Pyrazinamide 400 mg Tablets
4.
Possible side effects
5.
How to store Pyrazinamide 400 mg Tablets
6.
Contents of the pack and other information
1. WHAT PYRAZINAMIDE 400 MG TABLETS ARE AND WHAT IT IS USED FOR
Pyrazinamide 400 mg Tablets is used in combination with other
antituberculosis agents for
the treatment of all forms of tuberculosis caused by
_Mycobacterium tuberculosis. _
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRAZINAMIDE 400 MG
TABLETS
DO NOT TAKE PYRAZINAMIDE 400 MG TABLETS
-
if
you
are
hypersensitive
(allergic)
to
pyrazinamide
or
any
of
the
other
ingredients
of Pyrazinamide 400 mg Tablets (see section 6, What Pyrazinamide 400
mg
Tablets contains).
-
if you have severe liver impairment
-
if you have acute gout.
WARNINGS AND PRECAUTIONS
If you have a kidney disease, diabetes, or a history of gout, your
doctor will monitor you
carefully. In case of impaired kidney function your doctor may decide
to adjust the dose.
Pyrazinamide 400 mg Tablets PIL/P5/PYRA/2022, Version I
Macleods Pharmaceuticals Limited, India
Page 2 of 7
17
th
June 2022
Before starting therapy, and at regular intervals during treatment
with Pyrazinamide 400 mg
Tab

Produktens egenskaper

Pyrazinamide 400 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTIC
Macleods Pharmaceuticals Limited, India 17
th
June 2022 Page 1 of 8
SPC/P7/PYRI/2022, Version no: I
1.
NAME OF THE MEDICINAL PRODUCT
Pyrazinamide 400 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Pyrazinamide 400 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM:
Tablets
White, circular, convex, bevelled-edge tablets, plain on both sides.
The tablets should not be
divided.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pyrazinamide 400 mg Tablets is indicated in combination with other
antituberculosis agents
for the treatment of all forms of tuberculosis caused by
_Mycobacterium tuberculosis. _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Pyrazinamide 400 mg Tablets must always been given in combination with
other
antituberculosis agents.
DAILY REGIMEN
25 mg/kg (20-30 mg/kg) body weight as a single daily dose.
35 mg/kg (30-40 mg/kg) body weight for children weighing less than 30
kg, as a single daily
dose.
_NUMBER OF PYRAZINAMIDE 400 MG TABLETS FOR TREATMENT ACCORDING TO
WEIGHT BANDS _
Daily regimen (adults and children)
Weight in kg
11-20
21-39
40-54
55-70
>70
Number of tablets per day
1
2
3
4
5
INTERMITTENT REGIMEN
35 mg/kg (30-40 mg/kg) body weight 3 times a week as a single dose or
50 mg/kg (40-60
mg/kg)
body weight 2 times a week as a single dose (The latter 50 mg twice
weekly
regimen, however, is not recommended by WHO).
Pyrazinamide 400 mg Tablets should preferably be taken without food
_(1)_
. Tablets should
be swallowed whole with drinking water. Tablets should neither be
crushed nor chewed.
In
patients
requiring
less
than
400
mg
pyrazinamide per dose, another formulation
containing less pyrazinamide should be used.
Pyrazinamide 400 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTIC
Macleods Pharmaceuticals Limited, India 17
th
June 2022 Page 2 of 8
SPC/P7/PYRI/2022, Version no: I
_Renal impairment_
: Dose adjustment is necessary in patients with CrCL <30 ml/min. It is
recommended to a