ADCO-LAMIVUDINE SOLUTION

国: 南アフリカ

言語: 英語

ソース: South African Health Products Regulatory Authority (SAHPRA)

から入手可能:

Adcock Ingram Limited

投薬量:

See ingredients

医薬品形態:

SOLUTION

構図:

EACH 1,0 ml SOLUTION CONTAINS LAMIVUDINE 10,0 mg

認証ステータス:

Registered

承認日:

2007-08-06

情報リーフレット

Page 1 of 10
PATIENT INFORMATION LEAFLET FOR ADCO-LAMIVUDINE SOLUTION
SCHEDULING STATUS
S4
ADCO-LAMIVUDINE SOLUTION, 10 MG/ML, SOLUTION
LAMIVUDINE
CONTAINS SUGAR: SUCROSE 200 MG/ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ADCO-LAMIVUDINE SOLUTION
•
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-LAMIVUDINE SOLUTION 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-LAMIVUDINE SOLUTION is and what it is used for
2.
What you need to know before you take ADCO-LAMIVUDINE SOLUTION
3.
How to take ADCO-LAMIVUDINE SOLUTION
4.
Possible side effects
5.
How to store ADCO-LAMIVUDINE SOLUTION
6.
Contents of the pack and other information
1. WHAT ADCO-LAMIVUDINE SOLUTION IS AND WHAT IT IS USED FOR
Page 2 of 10
Lamivudine 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. Lamivudine helps control HIV infection by inhibiting or
interfering with the reverse
transcriptase enzyme that HIV needs to multiply. This helps keep HIV
from reproducing.
ADCO-LAMIVUDINE SOLUTION is used in combination with other antiviral
medicines in the
treatment of HIV infection in adults and children. It has been shown
to work particularly well
in combination with zidovudine-containing medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-LAMIVUDINE SOLUTION
IF YOU ARE TAKING MEDICINES ON A REGULAR BASIS, USING ADCO-LAMIVUDINE
SOLUTION
AT THE SAME TIME WITH ANOTHER MEDICINE MAY CAUSE UNDESIRABLE
INTERACTIONS. PLEASE
CONSULT YOUR DOCTOR, PHARMACIST OR OTHER HEALTHCARE PROVIDER FOR
ADVICE. IF YOU ARE
PREGNANT OR
BREASTFEEDING YOUR BABY, PLEASE CONSULT YOUR DOCTOR, PHARMACIST OR
OTHER HEALTHCARE PROVIDER FOR ADVICE BEFORE TAKING ADCO-LAMIVUDINE
SOLUTION.
ADC

製品の特徴

Page 1 of 17
PROFESSIONAL INFORMATION FOR ADCO-LAMIVUDINE SOLUTION
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
ADCO-LAMIVUDINE SOLUTION, 10 mg/ml, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains: 10 mg lamivudine.
Contains preservatives:
1,80 mg methylparaben (0,18
%
_m/v_)
0,20 mg propylparaben (0,02
%
_m/v_)
Contains sugar: Sucrose 200 mg/ml
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution
A clear, colourless to pale yellow liquid with a passionfruit flavour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Page 2 of 17
ADCO-LAMIVUDINE SOLUTION is indicated as part of antiretroviral
combination therapy for
the treatment of HIV infected adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS MORE THAN 12 YEARS OF AGE:
The recommended dose of ADCO-LAMIVUDINE SOLUTION is 300 mg daily. This
may be
administered as either 300 mg once daily or 150 mg twice daily.
The professional information for zidovudine must be consulted for
information on its dosage
and administration.
For patients with low body weights (less than 50 kg), the recommended
oral dose of ADCO-
LAMIVUDINE SOLUTION is 2 mg/kg twice daily.
CHILDREN ≥ 3 MONTHS TO 12 YEARS OF AGE:
The recommended dose is 4 mg/kg twice daily up to a maximum of 300 mg
daily.
CHILDREN < 3 MONTHS OF AGE:
There are limited data to propose specific dosage recommendations (see
section 5.2).
ADCO-LAMIVUDINE SOLUTION can be taken with or without food.
RENAL AND HEPATIC IMPAIRMENT
Renal impairment, whether disease- or age-related, affects lamivudine
elimination. For
recommended dosage regimens in patients with a creatinine clearance
below 50 ml/min see
table below.
Page 3 of 17
ADULTS AND ADOLESCENTS > 12 YEARS OF AGE:
CREATININE
CLEARANCE (ML/MIN)
RECOMMENDED DOSE OF ADCO-LAMIVUDINE SOLUTION
≥ 50
150 mg twice daily
30 – 49
150 mg once daily
15 – 29
150 mg first dose, then 100 mg once daily
5 – 14
150 mg first dose, then 50 mg once daily
< 5
50 mg first dose, then 25 mg once daily
CHIL