INVEGA HAFYERA paliperidone (as palmitate) 1000 mg in 5 mL modified release suspension for injection pre-filled syringe

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

paliperidone palmitate, Quantity: 1560 mg

Dostupné z:

Janssen-Cilag Pty Ltd

Forma lieku:

Injection, suspension

Zloženie:

Excipient Ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections

Spôsob podávania:

Intramuscular

Počet v balení:

One assembled pre-filled syringe per pack

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

INVEGA HAFYERA, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle.

Prehľad produktov:

Visual Identification: White to off-white suspension; Container Type: Syringe; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

2022-02-10

Príbalový leták

INVEGA HAFYERA®(220210)ACMI
1
INVEGA HAFYERA®
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 USING INVEGA HAFYERA?
INVEGA HAFYERA contains the active ingredient paliperidone palmitate.
INVEGA HAFYERA is used to treat schizophrenia in adults
(18 years of age and older).
For more information, see Section 1. Why am I using INVEGA HAFYERA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INVEGA HAFYERA?
Do not use if you have ever had an allergic reaction to paliperidone,
risperidone 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 I use
INVEGA HAFYERA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INVEGA HAFYERA 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 DO I USE INVEGA HAFYERA?
Your doctor or other healthcare professional will give the injection
into the muscle in the buttock (gluteal intramuscular
injection).
More instructions can be found in Section 4. How do I use INVEGA
HAFYERA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INVEGA HAFYERA?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using
paliperidone.
•
If you are planning to have operation on your eye, make sure you tell
your eye doctor that you are
taking this medicine.
•
Tell your doctor if you become pregnant or intend to become pregnant.
•
Call your doctor straight away if you notice any involuntary movements
of the tongue, mouth,
cheeks or jaw which may progress to the arms and legs.
THINGS YOU
SHOULD NOT DO
•
Do not miss an injection or stop the treatment without consulting your
doctor first.
DRIVING OR USING
MACHINES
�

Súhrn charakteristických

CCDS201022
Page 1 of 33
INVEGAHAFYERA(220210)API
INVEGA HAFYERA
®
PALIPERIDONE PALMITATE
AUSTRALIAN PRODUCT INFORMATION
1. NAME OF THE MEDICINE
Paliperidone palmitate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient, paliperidone palmitate, is a psychotropic agent
belonging to the chemical class
of benzisoxazole derivatives. INVEGA HAFYERA contains a racemic
mixture of (+)- and (-)-
paliperidone palmitate. Paliperidone palmitate is very slightly
soluble in ethanol and methanol,
practically insoluble in water, polyethylene glycol 400 and propylene
glycol, and slightly soluble in
ethyl acetate.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
INVEGA HAFYERA is available as a white to off-white sterile modified
release aqueous suspension
for intramuscular injection in dose strengths of 700 mg and 1000 mg
paliperidone (as 1092 mg and
1560 mg paliperidone palmitate, respectively).
INVEGA HAFYERA paliperidone (as palmitate)700 mg suspension for
injection pre-filled syringe.
Each 3.5 mL prefilled syringe contains 700 mg of paliperidone as 1092
mg paliperidone palmitate.
INVEGA HAFYERA paliperidone (as palmitate)1000 mg suspension for
injection pre-filled syringe.
Each 5.0 mL prefilled syringe contains 1000 mg of paliperidone as 1560
mg paliperidone palmitate.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INVEGA HAFYERA, a 6-month injection, is indicated for the maintenance
treatment of schizophrenia
in adult patients who have been adequately treated with the 1-month
paliperidone palmitate
injectable product for at least four months or the 3-month
paliperidone palmitate injectable product
following at least one 3-month injection cycle.
4.2 DOSE AND METHOD OF ADMINISTRATION
INVEGA HAFYERA is to be used only after the 1-month paliperidone
palmitate injectable product
has been established as adequate treatment for at least four months at
dosages of 100 mg or 150
mg (see Table 1) or the 3-month paliperidone palmitate injectable
product at dosages of 350 mg or