ZYPADHERA 300 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

OLANZAPINE

Disponível em:

ELI LILLY ISRAEL LTD

Código ATC:

N05AH03

Forma farmacêutica:

POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION

Composição:

OLANZAPINE 300 MG

Via de administração:

I.M

Tipo de prescrição:

Required

Fabricado por:

LILLY S.A., SPAIN

Área terapêutica:

OLANZAPINE

Indicações terapêuticas:

Zypadhera is indicated for the treatment of schizophrenia.The use of Zypadhera is limited to patients who have been diagnosed as non-compliant regarding taking prescribed medicines and as a consequence are prone to outbursts of psychotic episodes .Zypadhera is not to be used in patients whose condition is adequately controlled with oral Zyprexa .

Data de autorização:

2015-11-30

Folheto informativo - Bula

Page 1 of 9
Patient Package Insert in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed by a doctor’s prescription only
ZYPADHERA 405 mg
Powder and solvent for preparation of
prolonged release suspension for
injection
ZYPADHERA 300 mg
Powder and solvent for preparation
of prolonged release suspension for
injection
Name and quantity of active ingredient:
Each vial of powder contains:
Each vial of powder contains:
Olanzapine pamoate monohydrate
equivalent to 405 mg Olanzapine
Olanzapine pamoate monohydrate
equivalent to 300 mg Olanzapine
The reconstituted suspension contains:
The reconstituted suspension contains:
Olanzapine 150 mg/ml
Olanzapine 150 mg/ml
For a list of the inactive ingredients, please see section 6.
Read this patient leaflet carefully in its entirety before using this
medicine. This leaflet contains
concise information regarding this medicine. If you have any further
questions, please contact
your doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not give this medication
to others. it might harm them even if you think your illness is
similar.
Very important information about this medicine:
Antipsychotics (like ZypAdhera) can increase the risk of death in
elderly people who are
experiencing confusion, memory loss, and loss of touch with reality
(dementia associated with
psychosis). This medicine is not intended for adult patients who
suffer from psychosis related to
dementia.
ZypAdhera is usually not intended for children and adolescents under
the age of 18, since there
is limited experience with this group.
This medicine is intended for adults who have previously been treated
with olanzapine tablets.
Page 2 of 9
1.
WHAT IS THIS MEDICINE INTENDED FOR?
ZypAdhera is an antipsychotic preparation containing the active
ingredient Olanzapine.
The preparation is administered as a prolonged release injection, for
the treatment of
schizophrenic patients.
Therapeutic group:
Atypical antipsychotic drugs.
2.
BEFORE USING T

Características técnicas

X ZYPAVL A 09
Page 1 of 21
1.
NAME OF THE MEDICINAL PRODUCT
ZYPADHERA 300 mg powder and solvent for prolonged release suspension
for injection
ZYPADHERA 405 mg powder and solvent for prolonged release suspension
for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYPADHERA 300 mg powder and solvent for prolonged release suspension
for injection
Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg
olanzapine. After
reconstitution each ml of suspension contains 150 mg olanzapine.
ZYPADHERA 405 mg powder and solvent for prolonged release suspension
for injection
Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg
olanzapine. After
reconstitution each ml of suspension contains 150 mg olanzapine.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged release suspension for injection
Powder: yellow solid
Solvent: clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased
risk of death. Although the causes of death were varied, most of the
deaths appeared to be either
cardiovascular (e.g., heart failure, sudden death) or infectious
(e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic
drugs, treatment with conventional
antipsychotic drugs may increase mortality. The extent to which the
findings of increased mortality in
observational studies may be attributed to the antipsychotic drug as
opposed to some characteristic(s)
of the patients is not clear.
ZYPADHERA
(olanzapine) is not approved for the treatment of patients
with dementia-related psychosis
4.1
THERAPEUTIC INDICATIONS
ZYPADHERA is indicated for the treatment of schizophrenia.
The use of ZYPADHERA is limited to patients who have been diagnosed as
non-compliant regarding
taking prescribed medicines and as a consequence are prone to
outbur