NEVIRAPINE VIATRIS nevirapine 200 mg tablet bottle

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

nevirapine, Quantity: 200 mg

Beszerezhető a:

Alphapharm Pty Ltd

INN (nemzetközi neve):

Nevirapine

Gyógyszerészeti forma:

Tablet, uncoated

Összetétel:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type A; magnesium stearate; povidone

Az alkalmazás módja:

Oral

db csomag:

100, 60

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Nevirapine Viatris in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Termék összefoglaló:

Visual Identification: White to off-white, oval shaped, biconvex uncoated tablet, debossed with 'NE" scoreline "200' on one side and "M" scoreline on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Registered

Engedély dátuma:

2012-04-17

Betegtájékoztató

NEVIRAPINE VIATRIS
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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 USING NEVIRAPINE VIATRIS?
NEVIRAPINE VIATRIS contains the active ingredient nevirapine.
NEVIRAPINE VIATRIS is used in the treatment of the infection
caused by the Human Immunodeficiency Virus (HIV-1).
For more information, see Section 1. Why am I using NEVIRAPINE
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEVIRAPINE VIATRIS?
Do not use if you have ever had an allergic reaction to nevirapine or
any of the ingredients listed at the end of the CMI.
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.
For more information, see Section 2. What should I know before I use
NEVIRAPINE VIATRIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEVIRAPINE VIATRIS 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 USE NEVIRAPINE VIATRIS?
Adults 16 years and older:
•
First 14 days: Take one NEVIRAPINE VIATRIS tablet once daily.
•
After the first 14 days: Take one NEVIRAPINE VIATRIS tablet twice
daily.
More instructions can be found in Section 4. How do I use NEVIRAPINE
VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEVIRAPINE VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using
NEVIRAPINE VIATRIS.
•
Contact your doctor immediately if the rash is accompanied by other
symptoms such as fever, blisters,
mouth sores, conjunctivitis, facial swelling, muscle or joint aches or
swollen lymph glands.
THINGS YOU
SHOULD NOT DO
•
Do not take NEVIRAPINE VIATRIS to treat any other complaints unless
your doctor tells you to.
•
Do not stop taking your medicine or change the dosage without first
checking wit

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION
NEVIRAPINE VIATRIS
_nevirapine tablet _
1
NAME OF THE MEDICINE
Nevirapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NEVIRAPINE VIATRIS tablet contains 200 mg of nevirapine as the
active ingredient.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NEVIRAPINE VIATRIS 200 mg tablets are white to off-white, oval shaped,
biconvex uncoated tablets,
debossed with “NE” scoreline “200” on one side and “M”
scoreline on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEVIRAPINE VIATRIS in combination with antiretroviral agents is
indicated for the treatment of HIV-1
infection in adults.
Resistant virus emerges rapidly when nevirapine is administered as
monotherapy or in dual combination
therapy with an antiretroviral agent. Therefore, nevirapine should
always be administered in combination with
at least two additional antiretroviral agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS 16 YEARS AND OLDER
The recommended dose is NEVIRAPINE VIATRIS 200 mg daily for the first
14 days (this lead-in period
should be used because it has been found to lessen the frequency of
rash), followed by 200 mg twice daily, in
combination with at least two additional antiretroviral agents. For
concomitantly administered antiretroviral
therapy, the manufacturer’s recommended dosage and monitoring should
be followed.
NEVIRAPINE VIATRIS can be taken with or without food.
DOSAGE MANAGEMENT CONSIDERATIONS
Patients should be advised of the need to take nevirapine every day as
prescribed. If a dose is missed the
patient should not double the next dose but should take the next dose
as soon as possible.
Clinical chemistry tests, which include liver function tests, should
be performed prior to initiating nevirapine
therapy and at appropriate intervals during therapy.
Nevirapine
administration
should
be
discontinued
if
patients
who
experience
severe
rash
or
a
rash
accompanied by constitutional s