NAVALPRO LIQUID

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

Pharmacare Limited û Woodmead

Dawkowanie:

Not Indicated

Forma farmaceutyczna:

Liquid

Skład:

Each 5,0 mlcontains SODIUM VALPROATE 200,0 mg

Status autoryzacji:

Registered

Data autoryzacji:

2024-02-07

Ulotka dla pacjenta

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
NAVALPRO LIQUID 200 MG/5 ML
SODIUM VALPROATE
CONTAINS SWEETENERS:
SACCHARIN SODIUM 4 MG, LIQUID SORBITOL 1 750 MG
SORBITOL IS A SOURCE OF FRUCTOSE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING/ARE GIVEN
NAVALPRO
LIQUID
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
•
NAVALPRO LIQUID 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 NAVALPRO LIQUID is and what it is used for
2.
What you need to know before you take NAVALPRO LIQUID
3.
How to take/give NAVALPRO LIQUID
4.
Possible side effects
5.
How to store NAVALPRO LIQUID
6.
Contents of the pack and other information
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1.
WHAT NAVALPRO LIQUID IS AND WHAT IT IS USED FOR
NAVALPRO LIQUID belongs to a group of medicines called anticonvulsants
or anti-
epileptics. It is used to treat epilepsy (fits) in adults and
children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAVALPRO LIQUID
DO NOT TAKE/GIVE NAVALPRO LIQUID:
•
if you or your child are hypersensitive (allergic) to sodium valproate
or any of the
other ingredients of NAVALPRO LIQUID (listed in section 6),
•
if you are breastfeeding your baby (see section titled Pregnancy,
breastfeeding
and fertility).
•
if you are pregnant -
_For the treatment of epilepsy: _
•
if you or your female (girl) child are pregnant, unless there is no
suitable
alternative treatment (see section titled Pregnancy, breastfeeding and
fertility),
•
if you or your female child are a female able to have a baby, you must
not take
NAVALPRO LIQUID unless you use an effective method of birth control
(contraception) at all times during your treatment with NAVALPRO
LIQUID and
the condition

Charakterystyka produktu

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINE FOR HUMAN USE
NAVALPRO LIQUID HAS A HIGH TERATOGENIC POTENTIAL AND WHEN USED IN
PREGNANCY,
MAY CAUSE
VARIOUS MAJOR AND MINOR CONGENITAL ABNORMALITIES OF BODY ORGANS AND/OR
BODY STRUCTURES AS WELL AS MAY HARM THE DEVELOPING BRAIN OF THE FOETUS
RESULTING IN
NEGATIVE EFFECTS IN CHILDHOOD WHICH MAY INCLUDE NEURODEVELOPMENTAL
DISORDERS SUCH
AS LATE WALKING AND TALKING, POOR LANGUAGE SKILLS, MEMORY PROBLEMS,
LOWER
INTELLECTUAL ABILITIES.
EXPOSURE TO NAVALPRO LIQUID _IN UTERO_ IS ALSO ASSOCIATED WITH AN
INCREASED RISK TO
DEVELOP AUTISTIC SPECTRUM DISORDER, CHILDHOOD AUTISM AND ATTENTION
DEFICIT
HYPERACTIVITY DISORDER (ADHD). NAVALPRO LIQUID TREATMENT SHOULD BE
INITIATED AND
SUPERVISED BY A MEDICAL PRACTITIONER EXPERIENCED IN THE TREATMENT OF
EPILEPSY AND
NAVALPRO LIQUID SHOULD NOT BE PRESCRIBED IF THE RELEVANT RISK
MINIMISATION
MEASURES/PREGNANCY PREVENTION PROGRAMME, CANNOT BE IMPLEMENTED AND
SUPERVISED AND PATIENTS ARE NOT COMMITTED TO ADHERE TO THESE MEASURES
(SEE
SECTIONS 4.4 AND 4.6).
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
NAVALPRO LIQUID 200 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of NAVALPRO LIQUID contains 200 mg sodium valproate.
Preservatives:
Sodium methyl parahydroxybenzoate 0,1 % _m/v _
Sodium propyl parahydroxybenzoate 0,04 % _m/v _
Contains sweeteners:
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Saccharin sodium 4 mg
Liquid sorbitol 1 750 mg
Sorbitol is a source of fructose.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liquid.
NAVALPRO LIQUID is a clear, red coloured liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NAVALPRO LIQUID is indicated in children, adolescents and adults for:
•
the treatment of generalised epilepsy, particularly with the following
patterns of seizures:
o
absence,
o
myoclonic,
o
tonic-clonic,
o
atonic,
o
mixed.
•
the treatment of partial epilepsy:
o
simple or complex