Aptivus 100mgml oral solution

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Tipranavir

Доступно од:

Boehringer Ingelheim Ltd

АТЦ код:

J05AE09

INN (Међународно име):

Tipranavir

Дозирање:

100mg/1ml

Фармацеутски облик:

Oral solution

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 05030100; GTIN: 5012816050099

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
APTIVUS 100 MG/ML ORAL SOLUTION
tipranavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your child’s doctor or
pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as your child’s.
-
If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aptivus is and what it is used for
2.
What you need to know before your child takes Aptivus
3.
How to take Aptivus
4.
Possible side effects
5.
How to store Aptivus
6.
Contents of the pack and other information
1.
WHAT APTIVUS IS AND WHAT IT IS USED FOR
Aptivus contains the active substance tipranavir. It belongs to a
group of medicines called protease
inhibitors and is used in the treatment of Human Immunodeficiency
Virus (HIV) infection. It blocks
an enzyme called protease that is involved in the reproduction of HIV.
When the enzyme is blocked,
the virus does not reproduce normally, slowing down the infection.
Your child must take Aptivus
together with:
−
low dose ritonavir (this helps Aptivus to reach a high enough level in
your child’s blood)
−
other HIV medicines. Your child’s doctor, together with you, will
decide which other medicines
your child should take. This will depend on, for example:
−
which other medicines your child has already taken for HIV
−
which medicines your child’s HIV is resistant to. If your child’s
HIV is resistant to
some HIV medicines, this means that the medicine will not work so
well, or will not
work at all.
Aptivus is specifically used for the treatment of HIV which is
resistant to most other protease
inhibitors. Before starting treatment, your child�

Карактеристике производа

OBJECT 1
APTIVUS 100 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 24-Nov-2017 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Aptivus 100 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 100 mg tipranavir.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear yellow viscous liquid.
4. Clinical particulars
4.1 Therapeutic indications
Aptivus, co-administered with low dose ritonavir, is indicated for
combination antiretroviral treatment of
HIV-1 infection in highly pre-treated children from 2 to 12 years of
age with virus resistant to multiple
protease inhibitors. Aptivus should only be used as part of an active
combination antiretroviral regimen in
patients with no other therapeutic options (see sections 4.4 and 5.1).
In deciding to initiate treatment with Aptivus, co-administered with
low dose ritonavir, careful
consideration should be given to the treatment history of the
individual patient and the patterns of
mutations associated with different agents. Genotypic or phenotypic
testing (when available) and
treatment history should guide the use of Aptivus. Initiation of
treatment should take into account the
combinations of mutations which may negatively impact the virological
response to Aptivus, co-
administered with low dose ritonavir (see section 5.1).
4.2 Posology and method of administration
Aptivus must always be given with low dose ritonavir as a
pharmacokinetic enhancer, and in combination
with other antiretroviral medicinal products. The Summary of Product
Characteristics of ritonavir must
therefore be consulted prior to initiation of therapy with Aptivus
(especially as regards the
contraindications, warnings and undesirable effects sections).
Aptivus should be prescribed by physicians who are experienced in the
treatment of HIV-1 infection.
Aptivus with ritonavir should not be used in treatment-naïve
patients.
Posology
The recommended dose for children (age 2 to 12 years) is 375 m