Pyrazinamide tablets

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

pyrazinamide

Tilgængelig fra:

Macleods Pharmaceuticals Ltd.

ATC-kode:

J04AK01

INN (International Name):

pyrazinamide

Dosering:

400mg

Lægemiddelform:

tablets

Enheder i pakken:

(100/10x10/) and (672/24x28/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2016-10-06

Indlægsseddel

1.3.3 PATIENT INFORMATION LEAFLET
MACLEODS PHARMACEUTICALS LTD._ _
_ _
PYRAZINAMIDE TABLETS BP 400 MG
1.3.3
PATIENT INFORMATION LEAFLET
The Patient Information Leaflet for
PYRAZINAMIDE TABLETS BP 400 MG
as approved by WHO
under TB Prequalification Programme is enclosed overleaf
Pyrazinamide 400 mg Tablets
(Macleods), TB159
WHOPAR Part 3
September 2011
Section 6 updated: August 2015
Page 1 of 8
PATIENT INFORMATION LEAFLET
Pyrazinamide 400 mg Tablets
(Macleods), TB159
WHOPAR Part 3
September 2011
Section 6 updated: August 2015
Page 2 of 8
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
PYRAZINAMIDE 400 MG TABLETS
*
Pyrazinamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, health care
provider or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS 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 IS 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 seve

Produktets egenskaber

1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
MACLEODS PHARMACEUTICALS LTD._ _
_ _
PYRAZINAMIDE TABLETS BP 400 MG
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS
The Summary of Product Characteristics for
PYRAZINAMIDE TABLETS BP 400 MG
as approved
by WHO under TB Prequalification Programme is enclosed overleaf
Pyrazinamide 400 mg Tablets
WHOPAR Part 4
September 2011
(Macleods), TB159
Section 6 updated: February 2014
_ _
_ _
_PAGE 1 OF 8 _
SUMMARY OF PRODUCT CHARACTERISTICS
Pyrazinamide 400 mg Tablets
WHOPAR Part 4
September 2011
(Macleods), TB159
Section 6 updated: February 2014
_ _
_ _
_PAGE 2 OF 8 _
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 wat