Zerit
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-03-2019
Charakterystyka produktu
(SPC)
27-03-2019
Sprawozdanie z oceny publicznego
(PAR)
02-06-2016
Składnik aktywny:
stavudine
Dostępny od:
Bristol-Myers Squibb Pharma EEIG
Kod ATC:
J05AF04
INN (International Nazwa):
stavudine
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.
Podsumowanie produktu:
Revision: 31
Status autoryzacji:
Withdrawn
Data autoryzacji:
1996-05-08
Ulotka dla pacjenta
57
B. PACKAGE LEAFLET
Approved
1.0
v
58
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZERIT 15 MG HARD CAPSULES
Stavudine
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 any further questions, 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 Zerit is and what it is used for
2.
What you need to know before you take Zerit
3.
How to take Zerit
4.
Possible side effects
5.
How to store Zerit
6.
Contents of the pack and other information
1.
WHAT ZERIT IS AND WHAT IT IS USED FOR
Zerit belongs to a particular group of antiviral medicines, also known
as antiretrovirals, called
nucleoside reverse transcriptase inhibitors (NRTIs).
These are used to treat Human Immunodeficiency Virus (HIV) infection.
This medicinal product, in combination with other antiretrovirals,
reduces the HIV viral load and
keeps it at a low level. It also increases CD4 cell counts. These CD4
cells play an important role in
maintaining a healthy immune system to help fight infection. Response
to treatment with Zerit varies
between patients. Your doctor will therefore be monitoring the
effectiveness of your treatment.
Zerit may improve your condition, but it is not a cure for your HIV
infection. You can still pass on
HIV when taking this medicine, although the risk is lowered by
effective antiretroviral therapy.
Discuss with your doctor the precautions needed to avoid infecting
other people.
During treatment, other infections linked to a weakened immunity
(opportunistic infections) may arise.
These will require specific and sometimes preventive treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZERIT
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Approved
1.0
v
2
1.
NAME OF THE MEDICINAL PRODUCT
Zerit 15 mg hard capsules
Zerit 20 mg hard capsules
Zerit 30 mg hard capsules
Zerit 40 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zerit 15 mg hard capsules
Each hard capsule contains 15 mg of stavudine.
Excipients with known effect
Each hard capsule contains 80.84 mg of lactose anhydrous.
Each hard capsule contains 40.42 mg of lactose monohydrate.
Zerit 20 mg hard capsules
Each hard capsule contains 20 mg of stavudine.
Excipients with known effect
Each hard capsule contains 121.30 mg of lactose anhydrous.
Each hard capsule contains 60.66 mg of lactose monohydrate.
Zerit 30 mg hard capsules
Each hard capsule contains 30 mg of stavudine.
Excipients with known effect
Each hard capsule contains 121.09 mg of lactose anhydrous.
Each hard capsule contains 60.54 mg of lactose monohydrate.
Zerit 40 mg hard capsules
Each hard capsule contains 40 mg of stavudine.
Excipients with known effect
Each hard capsule contains 159.06 mg of lactose anhydrous.
Each hard capsule contains 79.53 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Zerit 15 mg hard capsules
The hard capsule is red and yellow, opaque and imprinted with
“BMS” over a BMS code “1964” on
one side and “15” on the other side.
Zerit 20 mg hard capsules
The hard capsule is brown, opaque and imprinted with “BMS” over a
BMS code “1965” on one side
and “20” on the other side.
Zerit 30 mg hard capsules
The hard capsule is light and dark orange, opaque and imprinted with
“BMS” over a BMS code
“1966” on one side and “30” on the other side.
Approved
1.0
v
3
Zerit 40 mg hard capsules
The hard capsule is dark orange, opaque and imprinted with “BMS”
over a BMS code “1967” on one
side and “40” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zerit is indicated in combination with other antiretroviral medicinal
products for the treatmen
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