Viramune 50mg5ml oral suspension

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Nevirapine hemihydrate

MAH:

Boehringer Ingelheim Ltd

ATC_code:

J05AG01

INN:

Nevirapine hemihydrate

dosage:

10mg/1ml

pharmaceutical_form:

Oral suspension

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 05030100; GTIN: 5012816049994

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAMUNE 50 MG/5 ML ORAL SUSPENSION
nevirapine
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 further questions, please ask your doctor 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Viramune is and what it is used for
2.
What you need to know before you take Viramune
3.
How to take Viramune
4.
Possible side effects
5.
How to store Viramune
6.
Contents of the pack and other information
1.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
Viramune belongs to a group of medicines called antiretrovirals, used
in the treatment of Human
Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Reverse transcriptase is an
enzyme that HIV needs in order to multiply. Nevirapine stops reverse
transcriptase from working. By
stopping reverse transcriptase from working, Viramune helps control
HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults,
adolescents, and children of any age.
You must take Viramune together with other antiretroviral medicines.
Your doctor will recommend
the best medicines for you.
IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRAMUNE
DO NOT TAKE VIRAMUNE
-
if you are allergic to nevirapine or any of the other ingredients of
this medicine (listed in section
6 “
_W

SPC

OBJECT 1
VIRAMUNE 50MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 28-Nov-2017 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Viramune 50 mg/5 ml oral suspension
2. Qualitative and quantitative composition
Each ml of oral suspension contains 10 mg of nevirapine (as
hemihydrate).
Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 ml of
Viramune oral suspension.
Excipient with known effect
Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol,
1.8 mg of methyl
parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension
White to off-white homogenous suspension.
4. Clinical particulars
4.1 Therapeutic indications
Viramune is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adults, adolescents, and children of any age (see
section 4.2).
Most of the experience with Viramune is in combination with nucleoside
reverse transcriptase inhibitors
(NRTIs). The choice of a subsequent therapy after Viramune should be
based on clinical experience and
resistance testing (see section 5.1).
4.2 Posology and method of administration
Viramune should be administered by physicians who are experienced in
the treatment of HIV infection.
Posology
_Patients 16 years and older _
The recommended dose for Viramune is 20 ml (200 mg) oral suspension
once 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
20 ml (200 mg) oral suspension twice daily, in combination with at
least two additional antiretroviral
agents.
Viramune is also available as a 200 mg tablet for patients 16 years
and older, or for older children,
particularly adolescents, weighing 50 kg or more or whose BSA is above
1.25 m
2
.
If a dose is recognized as missed within 8 hours of when it was due,
the patient should take the missed
dose as soon as possible. If a dose is missed and it is m