RETROVIR IV INJECTION

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

GlaxoSmithKline South Africa (Pty) Limited

כמות:

See ingredients

טופס פרצבטיות:

INJECTION

הרכב:

EACH 20 ml VIAL CONTAINS ZIDOVUDINE 200 mg

מצב אישור:

Registered

תאריך אישור:

1996-07-08

עלון מידע

Page 1 of 11
GDS39
RETROVIR IV
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
RETROVIR IV CONCENTRATE FOR SOLUTION FOR INFUSION
ZIDOVUDINE 200 MG/20 ML
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN RETROVIR IV.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist,
nurse or other health care
provider.
WHAT IS IN THIS LEAFLET:
1. What RETROVIR IV is and what it is used for
2. What you need to know before you are given RETROVIR IV
3. How RETROVIR IV is given
4. Possible side effects
5. How to store RETROVIR IV
6. Contents of the pack and other information: 1. WHAT RETROVIR IV IS AND WHAT IT IS USED FOR:
RETROVIR_ _IV belongs to a group of antiviral medicines, also known as
anti-retrovirals, called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Page 2 of 11
GDS39
RETROVIR IV is used for the short-term management of serious HIV
infection in patients who
are unable to take zidovudine oral formulations. RETROVIR IV is also
used during labour and
at the birth to prevent the baby getting infected with HIV.
RETROVIR IV reduces the amount of HIV virus in the body and keeps it
at a low level. It also
increases CD4 cell counts. CD4 cells are a type of white blood cell,
that play an important role
in maintaining a healthy immune system to help fight infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RETROVIR IV:
YOU SHOULD NOT RECEIVE RETROVIR IV:
•
if you are hypersensitive (allergic) to zidovudine or to any of the
ingredients
of RETROVIR IV (listed in section 6)
•
if you have a very low white blood cell count (neutropenia) or very
low red
blood cell count (anaemia)
•
if you are also taking antiretroviral medicines containing stavudine.
If you think any of these apply to you, check with your doctor before
he administers
RETROVIR IV to you.
WARNINGS AND PRECAUTIONS:
Treatment with RETROVIR IV has not been shown to reduce the risk of
passing HIV infection on to
others by sexual contact or by blood transfer

מאפייני מוצר

Page 1 of 20
GDS39
RETROVIR IV
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE:
RETROVIR IV
ZIDOVUDINE 200 MG/20 ML
CONCENTRATE FOR SOLUTION FOR INFUSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 20 mL contains zidovudine 200 mg
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Concentrate for solution for infusion.
A clear, colourless or pale-yellow, sterile aqueous solution.
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS:
RETROVIR IV is indicated for the short-term management of serious
manifestations of Human
Immunodeficiency Virus (HIV) infections in patients who are unable to
take zidovudine oral
formulations.
Page 2 of 20
GDS39
RETROVIR IV is indicated in pregnancy to reduce the rate of
maternal-foetal
transmission of HIV.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
The required dose of RETROVIR IV must be administered by slow
intravenous infusion over a one-
hour period. It must NOT be given intramuscularly.
Dilution: RETROVIR IV must be diluted prior to administration (see
section 6.6).
DOSAGE IN ADULTS:
A dose of RETROVIR IV for infusion of 1,9 mg zidovudine/kg every 4
hours (or 800 mg/day) is
generally recommended for a 70 kg patient. This provides similar
exposure (AUC) to an oral dose
of approximately 2,9 mg zidovudine/kg every 4 hours (or 1 200 mg/day)
for a 70 kg patient. Patients
should receive RETROVIR IV for infusion only until oral therapy can be
administered_. _
In individual cases, medical practitioners may wish to select a lower
dosage, depending on relevant
factors such as the degree of bone marrow reserve of the patient.
DOSAGE ADJUSTMENTS IN PATIENTS WITH HAEMATOLOGICAL TOXICITY:
Dosage reduction or interruption of zidovudine therapy may be
necessary in patients whose
haemoglobin level falls to between 7,5 g/dL (4,65 mmol/ℓ) and 9 g/dL
(5,59 mmol/L) or whose
neutrophil count falls to between 0,75 x 10
9
/L and 1,0 x 10
9
/L.
DOSAGE IN CHILDREN:
Limited data are available on the use of RETROVIR IV in children.
DOSAGE IN THE PREVENTION OF MATE