HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION levetiracetam 500 mg/5 mL concentrate for infusion vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

levetiracetam, Quantity: 500 mg

Disponível em:

Pfizer Australia Pty Ltd

DCI (Denominação Comum Internacional):

Levetiracetam

Forma farmacêutica:

Injection, concentrated

Composição:

Excipient Ingredients: nitrogen; sodium acetate trihydrate; sodium chloride; glacial acetic acid; water for injections

Via de administração:

Intravenous

Unidades em pacote:

10

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Hospira? Levetiracetam concentrate for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. Levetiracetam is indicated for: use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation; monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy and add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy.

Resumo do produto:

Visual Identification: Clear, colourless solution presented in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

2014-07-28

Folheto informativo - Bula

HOSPIRA™ LEVETIRACETAM CONCENTRATE FOR IV
INFUSION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV
INFUSION?
Hospira Levetiracetam concentrate for IV infusion contains the active
ingredient levetiracetam. Hospira Levetiracetam concentrate
for IV infusion is used to control epilepsy.
For more information, see Section 1. Why am I being treated with
Hospira Levetiracetam concentrate for IV infusion? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH HOSPIRA LEVETIRACETAM
CONCENTRATE FOR IV
INFUSION?
Do not start treatment if you have ever had an allergic reaction to
Hospira Levetiracetam concentrate for IV infusion or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with Hospira Levetiracetam concentrate for IV infusion?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Hospira Levetiracetam concentrate
for IV infusion and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the
full CMI.
4.
HOW IS HOSPIRA LEVETIRACETAM CONCENTRATE FOR IV INFUSION GIVEN?
Your doctor will decide how much Hospira Levetiracetam concentrate for
IV infusion you will receive. This depends on your age,
your condition and whether or not you are taking any other
medicines.More instructions can be found in Section 4. How is Hospira
Levetiracetam concentrate for IV infusion given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH HOSPIRA LEVETIRACETAM
CONCENTRATE FOR IV
INFUSION?
THINGS
YOU
SHOULD DO
•
Call your doctor

Características técnicas

Version: pfplevti11021
Supersedes: pfplevti10221
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION –
HOSPIRA
™ LEVETIRACETAM
(LEVETIRACETAM) CONCENTRATE FOR IV
INFUSION
1.
NAME OF THE MEDICINE
Levetiracetam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hospira Levetiracetam concentrate for IV infusion contains 500 mg of
levetiracetam in 5 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrated injection for intravenous infusion.
Hospira Levetiracetam concentrate for IV infusion is a clear,
colourless and sterile aqueous
solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hospira Levetiracetam concentrate for IV infusion after dilution is an
alternative for patients
when oral administration is temporarily not feasible.
Levetiracetam is indicated for:
•
use in epileptic patients aged 4 years and older, initially as add-on
therapy, in the treatment
of partial onset seizures with or without secondary generalisation,
•
monotherapy in the treatment of partial onset seizures, with or
without secondary
generalisation, in patients from 16 years of age with newly diagnosed
epilepsy.
•
add-on therapy in the treatment of myoclonic seizures in adults and
adolescents from
12 years of age with Juvenile Myoclonic Epilepsy, and
•
add-on therapy in the treatment of primary generalised tonic-clonic
seizures in adults and
children from 4 years of age with idiopathic generalised epilepsy.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Levetiracetam therapy can be initiated with either intravenous or oral
administration (oral
dosage forms including tablets and oral solution are available as
other registered products).
Version: pfplevti11021
Supersedes: pfplevti10221
Page 2 of 29
Conversion to or from oral to intravenous can be done directly without
titration. The total daily
dose and frequency of administration should be maintained.
Hospira Levetiracetam concentrate for IV infusion is for intravenous
use only and must be
diluted in at least 100 mL of a compatible diluent