Rifinah 150/100mg

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Isoniazid 100mg; Rifampicin 150mg

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Alþjóðlegt nafn):

Isoniazid 100 mg

Lyfjaform:

Tablet

Samsetning:

Active: Isoniazid 100mg Rifampicin 150mg Excipient: Acacia Calcium stearate Carmellose sodium Carnauba wax Colloidal silicon dioxide Colophony Erythrosine Gelatin Hard Paraffin Kaolin Magnesium carbonate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Sodium laurilsulfate Sucrose Titanium dioxide White beeswax

Einingar í pakka:

Blister pack, Al/PVDC foil and PVC/PVDC transparent foil, 100 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Yuki Gosei Kogyo Co Ltd

Ábendingar:

Treatment of all forms of tuberculosis.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, Al/PVDC foil and PVC/PVDC transparent foil - 100 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, glass, - 100 tablets - 48 months from date of manufacture stored at or below 25°C

Leyfisdagur:

1975-05-08

Upplýsingar fylgiseðill

Rifinah®
1
RIFINAH®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING RIFINAH?
Rifinah contains the active ingredients rifampicin and isoniazid.
Rifinah is used to treat tuberculosis.
For more information, see Section 1. Why am I taking Rifinah? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE RIFINAH?
Do not take if you have ever had an allergic reaction to Rifinah or
any of the ingredients listed at the end of the CMI.
Do not take Rifinah if you have jaundice. Do not take Rifinah if you
are taking saquinavir or ritonavir. These are medicines used
to treat AIDS and HIV. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT
OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING OR PLANNING TO
BREASTFEED.
For more information, see Section 2. What should I know before I take
Rifinah? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rifinah and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE RIFINAH?
Follow the instructions provided when Rifinah was prescribed,
including the number of days it should be taken.
More instructions can be found in Section 4. How do I take Rifinah? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING RIFINAH?
THINGS YOU SHOULD DO
•
If you are about to be started on a new medicine, including oral
contraceptives, tell your
doctor you are taking Rifinah.
•
Remind any doctor, dentist, surgeon, or pharmacist you visit that you
are taking Rifinah.
•
You should see your doctor monthly for a check-up.
•
If you have a blood or urine test, tell your doctor you are taking
Rifinah.
•
Avoid foods containing tyramine and histamine, such as histamine
tablets, cheese, red
wine, tuna and other tropical fish.
•
Continue taking Rifinah exactly as prescribed by your doctor.
THINGS Y

Vara einkenni

rifinah-ccdsv15-dsv16-02apr24
Page 1
NEW ZEALAND DATA SHEET
1
RIFINAH TABLETS
Rifinah 150/100mg tablets
Rifinah 300/150mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifinah 150/100mg:
Active ingredients: rifampicin 150 mg and isoniazid 100 mg tablets
Rifinah 300/150mg:
Active ingredients: rifampicin 300 mg and isoniazid 150 mg tablets
Excipient with known effect: Sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Rifinah 150/100mg tablets are cyclamen biconvex, round, smooth, sugar
coated tablets.
Rifinah 300/150mg tablets are orange capsule shaped, sugar-coated
tablets, 18.7 mm in length and
8.5 mm in width.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rifinah 150/100mg and Rifinah 300/150mg are indicated in the treatment
of all forms of
tuberculosis.
rifinah-ccdsv15-dsv16-02apr24
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
Another anti-tuberculosis drug may be given concurrently until the
susceptibility of the infecting
organism to rifampicin and isoniazid has been confirmed.
Patients should be given the following single daily dose on an empty
stomach at least 30 minutes
before a meal or 2 hours after a meal.
Concomitant administration of pyridoxine (B6) is recommended in the
elderly, malnourished, in
those predisposed to neuropathy (e.g. diabetics) and in adolescents.
Rifinah 150/100mg
Patients weighing less than 50 kg
3 tablets
Rifinah 300/150mg
Patients weighing 50 kg or greater
2 tablets
The ratio of rifampicin and isoniazid present in Rifinah make it
difficult for both components to
be administered in a dosage suitable for children. Rifinah is
therefore not recommended for
paediatric use.
4.3
CONTRAINDICATIONS
Rifinah is contraindicated in patients with a history of sensitivity
to rifamycins, isoniazid, or any
of the components.
Rifinah is contraindicated in the presence of jaundice.
Rifinah use is contraindicated when given concurrently with the
combination of saquinavir /
ritonavir (see Section 4.5 Interaction with other medicines and other
f