Voractiv tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Ethambutol hydrochloride; Pyrazinamide; Isoniazid; Rifampicin

Dostupné z:

Genus Pharmaceuticals Ltd

ATC kód:

J04AM06

INN (Medzinárodný Name):

Ethambutol hydrochloride; Pyrazinamide; Isoniazid; Rifampicin

Dávkovanie:

275mg ; 400mg ; 75mg ; 150mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Never Valid To Prescribe As A VMP

Prehľad produktov:

BNF: 05010900; GTIN: 5030451004338

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
WHAT IS IN THIS LEAFLET
1. What Voractiv is and what it is used for
2. What you need to know before you take
Voractiv
3. How to take Voractiv
4. Possible side effects
5. How to store Voractiv
6. Contents of the pack and other information
1. What Voractiv is and what it is used for
Voractiv belongs to a group of medicines called
antituberculosis agents. It is a fixed combination
of four very effective antituberculosis agents. It is
used to treat infections caused by mycobacteria.
These mycobacteria cause tuberculosis.
Voractiv is used for the initial treatment of
tuberculosis.
2.What you need to know before you take Voractiv
DO NOT TAKE VORACTIV:
•
if you are allergic (hypersensitive) to
rifamycins, isoniazid, pyrazinamide,
ethambutol hydrochloride or to any of the
ingredients of this medicine (listed in
section 6)
•
if you have acute liver problems or previously
have had a liver problem which was caused
by drugs
•
if you are known to have a condition called
porphyria
•
if you have acute gouty arthritis
•
if you have severe kidney problems
•
if you are currently taking any of the following
medications:
-
voriconazole
-
protease inhibitors except ritonavir when
prescribed to you at full dose or 600 mg
twice daily.
Do not take Voractiv if any of the above apply
to you.
If you are not sure about anything, ask your
doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Voractiv.
Tell your doctor if you have one of the following
illnesses before taking this medicine:
•
Liver problems and chronic liver disease
•
Kidney problems
•
Gout
•
Diabetes mellitus
•
Epilepsy
•
Inflammation of peripheral nerves or the optic
nerve
•
Eye defects
•
Chronic alcoholism
•
Underfeeding.
You should not take Voractiv if your body
weight is below 30 kg.
You should not interrupt treatment with Voractiv
without consulting your doctor.
You should employ additional means of
contraception apart from taking the pill as long
as you ta

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rimstar
®
,150 mg/75 mg/400 mg/275 mg Film-coated Tablet
Voractiv
®
Film-coated Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of rifampicin, 75 mg of
isoniazid,
400 mg of pyrazinamide and 275 mg of ethambutol hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablet is brown, ovaloid and biconvex, plain on both
sides.
Dimensions:
- Length (22.2 ± 0.5 mm) 21.7-22.7 mm
- Width (9.6 ± 0.3 mm) 9.3-9.9 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For initial treatment of tuberculosis according to World Health
Organisation
(WHO) guidelines.
Consideration should also be given to other official guidance on the
appropriate use
of anti-tuberculosis agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rimstar should be administered under the supervision of a physician
trained
in the management of tuberculosis.
The recommended dose and dosage schedules for Rimstar are based on
WHO guidelines:
-
Fixed-dose-combination tablets for the treatment of tuberculosis;
WHO/CDS/CPC/TB/99.267, 1999.
-
The rationale for recommending fixed-dose combination tablets for
treatment of tuberculosis; Bulletin of the World Health Organisation,
2001, 79: 61-68.
-
Informal Consultation on 4-drug Fixed-Dose Combination, Geneva
2001.
-
Treatment of Tuberculosis Guideline, 4th Ed.
WHO/HTM/TB/2009.420.
These dose and dose schedules may differ from recommendations on the
use
of anti-tuberculosis agents given in other official guidance.
Rimstar
is
a
fixed
combination
product
intended
for
use
in
the
initial
intensive
phase
of
anti-tuberculous
treatment.
Rimstar
should
be
administered
on
a
daily
basis
throughout
the
2
month
initial
phase
of
treatment. When indicated, other anti-tuberculous medicinal products
such
as streptomycin may be added in the initial phase of treatment.
Rimstar is a fixed combination product that should only be used when
the
fixed rat