Zeldox IM

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Ziprasidone mesilate 40.93mg equivalent to 30 mg ziprasidone

Disponibbli minn:

Upjohn New Zealand ULC

INN (Isem Internazzjonali):

Ziprasidone mesilate 40.93 mg (equivalent to 30 mg ziprasidone)

Dożaġġ:

20 mg/mL

Għamla farmaċewtika:

Powder for injection

Kompożizzjoni:

Active: Ziprasidone mesilate 40.93mg equivalent to 30 mg ziprasidone Excipient: Sulfobutyl betadex sodium Water for injection

Unitajiet fil-pakkett:

Ampoule, glass, Type 1glass, 1.2 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Pfizer Ireland Pharmaceuticals

Sommarju tal-prodott:

Package - Contents - Shelf Life: Ampoule, glass, Type 1glass - 1.2 mL -   - Combination pack, - 1 dose units - 24 hours reconstituted (not refrigerated) stored at or below 30°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 5ml; Type I glass - 1 dose units - 24 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

2000-11-20

Fuljett ta 'informazzjoni

ZELDOX
®
IM
1
ZELDOX
®
IM
(ZELL-DOCKS-I-M)
_ziprasidone (zi-pra-si-don)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common 
questions about Zeldox IM.
It does not contain all the available 
information.
It does not take the place of talking to 
your doctor or nurse.
All medicines have risks and 
benefits. Your doctor has weighed 
the risks of you using Zeldox IM 
against the benefits they expect it 
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, ASK YOUR 
DOCTOR OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZELDOX IM IS 
USED FOR
_WHAT ZELDOX IM IS FOR_
Zeldox IM is used to treat severe 
agitation or aggression in people with 
schizophrenia or similar illnesses.
Your doctor may have prescribed 
Zeldox IM for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY ZELDOX IM 
HAS BEEN PRESCRIBED FOR YOU.
After you have been given Zeldox 
IM, your symptoms should get better. 
Your doctor may then switch you to 
Zeldox capsules or another oral 
medicine to help manage your 
symptoms in the long term.
PLEASE ASK YOUR DOCTOR, NURSE OR 
PHARMACIST FOR INFORMATION ON 
YOUR PRESCRIBED ORAL MEDICINE.
_HOW ZELDOX IM WORKS_
Zeldox IM belongs to a group of 
medicines called antipsychotics. It 
contains the ingredient ziprasidone.
Ziprasidone is thought to work by 
correcting the imbalance of some 
chemicals in the brain. This, in turn, 
reduces the agitation or aggression 
caused by the illness.
_USING ZELDOX IM_
Zeldox IM is an injection. It is 
available only in a hospital with a 
doctor's prescription.
Only a doctor or nurse can give the 
injection.
Zeldox IM is not recommended for 
the treatment of elderly patients with 
dementia-related psychosis.
Zeldox IM is not recommended for 
use in children under 18 years of age. 
There is not enough information on 
its effects in this age group.
BEFORE YOU ARE GIVEN 
ZELDOX IM
_WHEN IT MUST NOT BE USED_
YOU MUST NOT BE GIVEN ZELD

Karatteristiċi tal-prodott

Version: pfdzeldv11018
Supersedes: pfdzeldv10618
Page 1 of 17
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ZELDOX IM
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ZELDOX IM for intramuscular injection as ziprasidone mesilate
containing the equivalent of
30 mg ziprasidone. When reconstituted, each mL contains 20 mg of
ziprasidone and 294 mg
of the inactive ingredient, sulfobutyl betadex sodium.
An ampoule containing 1.2 mL of Sterile Water for Injections Ph. Eur.
is also supplied for
reconstitution purposes.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for intramuscular injection
ZELDOX IM for intramuscular injection is presented as a sterile
lyophilised powder in a
single dose vial as ziprasidone mesilate.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZELDOX IM is indicated for the acute control and short-term management
of the agitated
psychotic patient. If indicated, the patient may continue with oral
ziprasidone.
In
two
one-week
open-label,
active-controlled
trials,
ziprasidone
were
administered
by
intramuscular injection for up to three days with patients
subsequently continuing on oral
ziprasidone. Maintenance of efficacy, safety and tolerability were
demonstrated for the
transition from intramuscular to oral administration of ziprasidone.
A
dose-related
reduction
in
agitated
behaviour
was
observed
with
onset
of
significant
improvement noted at 15 minutes and then from 1 hour post injection
until endpoint (2 hours)
with the 10 mg dose and from 30 minutes post injection until endpoint
(4 hours) with the
20 mg dose.
4.2 DOSE AND METHOD OF ADMINISTRATION
USE IN ADULTS
Ziprasidone IM is for intramuscular use only. Do not administer
intravenously.
The recommended dose is 10 to 20 mg administered as required up to a
maximum dose of
40 mg per day. Doses of 10 mg may be administered every 2 hours, doses
of 20 mg may be
administered every 4 hours.
Intramuscular administration of ziprasidone for more than 3
consecutive days has not been
studied.
Version: pfdzeldv11018
Supersedes: pf