ADCO-ZIDOVUDINE SYRUP

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Adcock Ingram Limited

כמות:

See ingredients

טופס פרצבטיות:

SYRUP

הרכב:

EACH 5,0 ml SYRUP CONTAINS ZIDOVUDINE 50,0 mg

מצב אישור:

Registered

תאריך אישור:

2007-08-06

עלון מידע

PATIENT INFORMATION LEAFLET
Date of approval: 31 July 2023
SCHEDULING STATUS
ADCO-ZIDOVUDINE SYRUP, 50 MG/5 ML SYRUP
ZIDOVUDINE
CONTAINS SWEETENERS:
SUGAR INVERT 2750,00 MG AND GLYCEROL 400,00 MG PER 5 ML SYRUP.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ADCO-ZIDOVUDINE SYRUP
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
ADCO-ZIDOVUDINE SYRUP has been prescribed for you personally and you
should
not share your medicine with other people. It may harm them, even if
their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1. What ADCO-ZIDOVUDINE SYRUP is and what it is used for
2. What you need to know before you take ADCO-ZIDOVUDINE SYRUP
3. How to take ADCO-ZIDOVUDINE SYRUP
4. Possible side effects
5. How to store ADCO-ZIDOVUDINE SYRUP
6. Contents of the pack and other information
1. WHAT ADCO-ZIDOVUDINE SYRUP IS AND WHAT IT IS USED FOR
Zidovudine is an anti-virus medicine used in the treatment of the
infection caused by the
Human Immunodeficiency Virus (HIV). HIV grows and multiplies through
DNA chain
formation. Zidovudine becomes incorporated into the DNA chain and
causes chain
termination. This helps keep HIV from reproducing.
This medicine is used in combination with other antiretroviral
medicines in the treatment of
HIV infection in adults, children and mothers who are not
breastfeeding. It is used to slow the
progression of the disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-ZIDOVUDINE SYRUP
DO NOT TAKE ADCO-ZIDOVUDINE SYRUP:
-
If you are hypersensitive (allergic) to zidovudine or any of the other
ingredients of ADCO-
ZIDOVUDINE SYRUP (listed in section 6).
-
If you have anaemia or other blood problems.
-
If you are taking other medicines containing these active ingredients:
stavudine and
ribavirin.
S4
PATIENT INFORMATION LEAFLET
Date of approval: 31 July 2023
-
If you are breastfeeding.
-
Pregnancy: this medicine has not been shown to be safe during the
first tr

מאפייני מוצר

PROFESSIONAL INFORMATION
Date of approval: 31 July 2023
SCHEDULING STATUS
1. NAME OF THE MEDICINE
ADCO-ZIDOVUDINE SYRUP, 50 mg/5 ml syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Every 5 ml contains 50 mg zidovudine.
Contains a preservative: 10,00 mg sodium benzoate (0,20 % m/v) per 5
ml.
Contains sweeteners: Sugar invert 2750,00 mg and glycerol 400,00 mg
per 5 ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup.
A clear, colourless to pale yellow liquid with smell and taste of kiwi
and banana.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADCO-ZIDOVUDINE SYRUP is indicated in combination with other
antiretroviral agents for
the treatment of Human Immunodeficiency Virus (HIV) infection in
adults, children and
mothers who are not breastfeeding.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE IN ADULTS:
_ADCO-ZIDOVUDINE SYRUP in combination with other antiretroviral
agents: _
500 or 600 mg daily in two or three divided doses.
More than 1000 mg daily in divided doses has been used. The
effectiveness of dosages
lower than 1000 mg daily in the treatment or prevention of
HIV-associated neurological
dysfunction is unknown.
_For dosages of other antiretroviral agents used in combination
therapy in advanced HIV _
_infection:_
Please consult the package inserts of the individual agents.
RECOMMENDED DOSAGE IN CHILDREN 3 MONTHS TO 12 YEARS OF AGE:
_ADCO-ZIDOVUDINE SYRUP in combination with other antiretroviral
agents: _
360 to 480 mg/m
2
daily in three or four divided doses.
For the treatment or prevention of HIV-associated neurological
dysfunction, the effectiveness
of dosages less than 720 mg/m
2
daily, i.e. 180 mg/m
2
every six hours is unknown. The
maximum dosage should not exceed 200 mg every six hours.
S4
PROFESSIONAL INFORMATION
Date of approval: 31 July 2023
RECOMMENDED DOSAGE IN THE PREVENTION OF MOTHER-TO-FOETUS TRANSMISSION:
_Pregnant women over 14 weeks of gestation: _
500 mg orally per day i.e. 100 mg five times per day, until the
beginning of labour. During
l