SOLONEX CO TABLET

Valsts: Dienvidāfrikas Republika

Valoda: angļu

Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)

Pieejams no:

Macleods Pharmaceuticals SA (Pty) Ltd

Deva:

See ingredients

Zāļu forma:

TABLET

Kompozīcija:

EACH TABLET CONTAINS ISONIAZID 300,0 mgRIFAPENTINE 300,0 mg

Autorizācija statuss:

Registered

Lietošanas instrukcija

ZA_CTD_Jul12_v5
August 2012
1.3.2 page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
SOLONEX CO 300 MG/300 MG (film coated tablet)
Isoniazid 300 mg and Rifapentine 300 mg
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SOLONEX CO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
SOLONEX CO has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What SOLONEX CO is and what it is used for
2. What you need to know before you take SOLONEX CO
3. How to take SOLONEX CO
4. Possible side effects
5. How to store SOLONEX CO
6. Contents of the pack and other information
1. WHAT SOLONEX CO IS AND WHAT IT IS USED FOR
SOLONEX CO contains isoniazid and rifapentine. It is used to prevent
progression of inactive (latent)
tuberculosis infection (LTBI) to active tuberculosis disease in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLONEX CO
VR
ZA_CTD_Jul12_v5
August 2012
1.3.2 page 2 of 11
DO NOT TAKE SOLONEX CO:
-
If you are hypersensitive (allergic) to isoniazid or rifapentine or to
any of the ingredients of
SOLONEX CO listed in section 6.1.
-
If
you
are
hypersensitive
to
medicines
which
are
chemically
related
to
isoniazid
such
as
ethionamide, pyrazinamide (used for TB) and niacin (Vitamin B3).
-
If you are pregnant, breastfeeding or planning to become pregnant
during treatment.
-
If you have acute or chronic liver disease
-
If you have a condition called porphyria (a group of disorders that
can cause nerve or skin problems
(blisters and itching) due to a problem with the production of haem
(blood pigment) and red blood
cells within the body).
-
If you experience fits.
-
If you are alcoholic.
-
If you have severe kidney probems
-
If you are currently on specific antiretroviral therapy belonging to
the classes protease inhibitors
(e.g. indinavir, ata

Produkta apraksts

ZA_CTD_Jul12_v5
August 2012
1.3.1.1 page 1 of 20
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE
SOLONEX CO 300 MG/300 MG (film coated tablet)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 300 mg Isoniazid and 300 mg
Rifapentine.
Sugar free
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablet
SOLONEX CO
Reddish brown coloured, capsule shaped, biconvex, film-coated tablets
debossed with "J" and "21"
on either side of breakline on one side and plain on the other side.
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SOLONEX CO is indicated for the prevention of active tuberculosis in
adults presenting with :
(1) latent tuberculosis infection (LTBI) caused by _Mycobacterium
tuberculosis_ who are at high risk of
progression to tuberculosis disease (including those in close contact
with active tuberculosis patients,
recent conversion to a positive tuberculin skin test),
(2) HIV-infected patients not receiving protease inhibitors or
non-nucleoside reverse transcriptase
inhibitors (NNRTIs) as antiretroviral therapy (ART),
VR
ZA_CTD_Jul12_v5
August 2012
1.3.1.1 page 2 of 20
(3) Patients with pulmonary fibrosis on radiograph with no signs and
symptoms of TB regardless of
HIV status.
Active tuberculosis disease should be ruled out before initiating
treatment with SOLONEX CO.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
SOLONEX CO should be administered once-weekly for 12 weeks as directly
observed therapy (DOT).
_Adults: _
The recommended dose of rifapentine should be determined based on
weight of the patient up to a
maximum of 900 mg once weekly (see Table 1). The recommended dose of
isoniazid is 15 mg/kg
(rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg
once weekly for 12 weeks.
TABLE
1:
WEIGHT
BASED
DOSE
OF
SOLONEX
CO
IN
THE
PROPHYLACTIC
TREATMENT
OF
LATENT
TUBERCULOSIS INFECTION IN ADULTS AT HIGH RISK OF PROGRESSION TO
TUBERCULOSIS DISEASE.
WEIGHT RANGE
RIFAP