ARIPIPRAZOLE SANDOZ 15

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ARIPIPRAZOLE

Dostopno od:

NOVARTIS ISRAEL LTD

Koda artikla:

N05AX12

Farmacevtska oblika:

TABLETS

Sestava:

ARIPIPRAZOLE 15 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

LEK PHARMACEUTICALS D.D., SLOVENIA

Terapevtsko območje:

ARIPIPRAZOLE

Terapevtske indikacije:

Aripiprazole Sandoz is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Sandoz is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode.Aripiprazole Sandoz is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).

Datum dovoljenje:

2019-11-27

Navodilo za uporabo

ARI APL May 21 CL
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
It is advisable to have a person close to you read this leaflet.
ARIPIPRAZOLE SANDOZ
® 5
ARIPIPRAZOLE SANDOZ
® 10
ARIPIPRAZOLE SANDOZ
® 15
ARIPIPRAZOLE SANDOZ
® 30
Tablets
ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet of ARIPIPRAZOLE SANDOZ 5 contains aripiprazole 5 mg, and
also contains 71.02 mg
lactose monohydrate.
Each tablet of ARIPIPRAZOLE SANDOZ 10 contains aripiprazole 10 mg, and
also contains 65.97 mg
lactose monohydrate.
Each tablet of ARIPIPRAZOLE SANDOZ 15 contains aripiprazole 15 mg, and
also contains 97.75 mg
lactose monohydrate.
Each tablet of ARIPIPRAZOLE SANDOZ 30 contains aripiprazole 30 mg, and
also contains 196.50
mg lactose monohydrate.
For the list of inactive ingredients and allergens, please see section
"Important information about
some of this medicine’s ingredients" and section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
The medicine is not intended for children below the age of 6.
1. WHAT IS ARIPIPRAZOLE SANDOZ INTENDED FOR?
ARIPIPRAZOLE SANDOZ 5, 10, 15, 30 are intended:
For treatment of schizophrenia.
For treatment of moderate to severe manic states in bipolar disorder
type 1 and for the prevention
of new manic episodes in patients who predominantly experienced manic
episodes and whose
previous manic episodes responded to aripiprazole treatment.
In addition, ARIPIPRAZOLE SANDOZ 5, 10, 15 are intended:
For combined treatment of major depressive disorder (MDD) in patients
who experienced a
partial response to treatment with antidepressants.
ARI APL May 21