Modecate Concentrate 100mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluphenazine decanoate

Available from:

Sanofi

ATC code:

N05AB02

INN (International Name):

Fluphenazine decanoate

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020200; GTIN: 5012712000501

Patient Information leaflet

1. What Modecate Concentrate
is and what it is used for
2. Before you are given Modecate
Concentrate
_I_
1041180B1
4651
4651
4651
4651
Phone [phone] for help
Benzyl alcohol 15 mg/ml
Live Text:
Yes /
No
Production Site:
Anagni
Parisi
Pag 1/2
Country:
SANGB
Printing Colours:
Black
Reflex Blue
Product Code:
1041180B1
Barcode Type:
2/5 (4651)
Format/Dimension:
Tech. Drawing No.:
Min. Font Size Text:
8 pt
Proof No.: 2
16.02.2015
Cirene
Phone contact: [phone]
e-mail contact: [e-mail]
www.grafimed.it
Product Name:
INS MODECATE CONC 100MG
Technical Colours:
CTM:
148 x 592 (148 x 38) mm
Diecut
3. How Modecate Concentrate is given
4. Possible side effects
5. How to store Modecate Concentrate
6. Further Information
February 2015
1041180B1
This leaflet was last revised in 02/2015
© Sanofi, 1996– 2015
•
Benzyl alcohol. Modecate Concentrate
contains 15 mg/ml of benzyl alcohol.
It must not be given to premature
or newborn babies. Benzyl alcohol
may cause toxic reactions and allergic
reactions in infants and children up to
3 years old.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.
colourless glass ampoules with an
OPC (one point cut) breaking system.
email: uk-medicalinformation@sanofi.com
Tel: [phone]
Sanofi, One Onslow Street,
Colourless type I glass ampoules with an OPC (one
point cut) breaking system
Live Text:
Yes /
No
Production Site:
Anagni
Parisi
Pag 2/2
Country:
SANGB
Printing Colours:
Black
Reflex Blue
Product Code:
1041180B1
Barcode Type:
2/5 (4651)
Format/Dimension:
Tech. Drawing No.:
Min. Font Size Text:
8 pt
Proof No.: 2
16.02.2015
Cirene
Phone contact: [phone]
e-mail contact: [e-mail]
www.grafimed.it
Product Name:
INS MODECATE CONC 100MG
Technical

Summary of Product characteristics

OBJECT 1
MODECATE CONCENTRATE INJECTION 100MG/ML
Summary of Product Characteristics Updated 25-Mar-2015 | SANOFI
1. Name of the medicinal product
Modecate Concentrate Injection 100mg/ml.
2. Qualitative and quantitative composition
Each ampoule contains 100mg/ml of the active substance Fluphenazine
Decanoate.
Also contains sesame oil (q.s.).
Benzyl alcohol 15 mg/ml.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
Pale yellow clear, oily liquid.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment and maintenance of schizophrenic patients and those
with paranoid psychoses.
While Modecate concentrate injection has been shown to be effective in
acute states, it is particularly
useful in the maintenance treatment of chronic patients who are
unreliable at taking their oral medication,
and also of those who do not absorb their oral phenothiazine
adequately.
4.2 Posology and method of administration
Dosage and Administration
Adults
It is recommended that patients be stabilised on the injection in
hospital.
Recommended dosage regimes for all indications:
A. Patients without previous exposure to a depot fluphenazine
formulation:
Initially 0.125ml ie. 12.5mg (0.0625ml ie 6.25mg for patients over 60)
by deep intramuscular injection
into the gluteal region.
The onset of action generally appears between 24 and 72 hours after
injection and the effects of the drug
on psychotic symptoms become significant within 48 to 96 hours.
Subsequent injections and the dosage
interval are determined in accordance with the patient's response.
When administered as maintenance
therapy, a single injection may be effective in controlling
schizophrenic symptoms for up to four weeks or
longer.
It is desirable to maintain as much flexibility in the dose as
possible to achieve the best therapeutic
response with the least side-effects; most patients are successfully
maintained within the dose range
0.125ml (12.5mg) to 1ml (100mg) given at a dose interval of 2 to 5
weeks.
Patients previously