Zypadhera

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

olanzapine pamoate

MAH:

Eli Lilly Nederland B.V.

ATC_code:

N05AH03

INN:

olanzapine

therapeutic_group:

Psycholeptics

therapeutic_area:

Schizophrenia

therapeutic_indication:

Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.

leaflet_short:

Revision: 21

authorization_status:

Authorised

authorization_date:

2008-11-19

PIL

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYPADHERA 210 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION
FOR INJECTION
ZYPADHERA 300 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION
FOR INJECTION
ZYPADHERA 405 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION
FOR INJECTION
olanzapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ZYPADHERA is and what it is used for
2.
What you need to know before you are given ZYPADHERA
3.
How ZYPADHERA is given
4.
Possible side effects
5.
How to store ZYPADHERA
6.
Contents of the pack and other information
1.
WHAT ZYPADHERA IS AND WHAT IT IS USED FOR
ZYPADHERA contains the active substance olanzapine. ZYPADHERA belongs
to a group of
medicines called antipsychotics and is used to treat schizophrenia - a
disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken
beliefs, unusual suspiciousness, and
becoming withdrawn. People with this disease may also feel depressed,
anxious or tense.
ZYPADHERA is intended for adult patients who are sufficiently
stabilised during treatment with oral
olanzapine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZYPADHERA
_ _
YOU SHOULD NOT BE GIVEN ZYPADHERA IF YOU HAVE:
•
an allergy (hypersensitivity) to olanzapine or any of the other
ingredients of this medicine (listed in
section 6). AN ALLERGIC REACTION
may be recognised as a rash, itching, a swollen face, swollen lips or
shortness of breath. If this has happened to you, tell your nurse or
doctor.
•
been previously diagnosed with eye problems such as certain kinds of
glaucoma (increased pressure
in the eye).
WARNINGS AND PRECAUTIONS
Talk to your doctor or n

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZYPADHERA 210 mg powder and solvent for prolonged release suspension
for injection
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 210 mg powder and solvent for prolonged release suspension
for injection
Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg
olanzapine. After
reconstitution each ml of suspension contains 150 mg olanzapine.
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 the 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
4.1
THERAPEUTIC INDICATIONS
Maintenance treatment of adult patients with schizophrenia
sufficiently stabilised during acute treatment
with oral olanzapine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged
release suspension for
injection must not be confused with olanzapine 10 mg powder for
solution for injection.
Posology
Patients should be treated initially with oral olanzapine before
administering ZYPADHERA, to
establish tolerability and response.
In order to identify the first ZYPADHERA dose for all patients the
scheme in Table 1 should be
considered.
3
TABLE 1
RECOMMENDED DOSE SCHEME BETWEEN ORAL OLANZAPINE AND ZYPADHERA
Target oral olanzapine dose Re