Synagis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Palivizumab 50mg (;+ overage = 73mg/vial)

Available from:

AbbVie Limited

INN (International Name):

Palivizumab 50 mg (;+ overage = 73mg/vial)

Dosage:

50 mg

Pharmaceutical form:

Injection with diluent

Composition:

Active: Palivizumab 50mg (;+ overage = 73mg/vial) Excipient: Glycine Histidine Mannitol Nitrogen Water for injection

Units in package:

Ampoule, glass, Diluent, 2 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Therapeutic indications:

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of prematurity (gestational age < 35 weeks at birth) and children with haemodynamically significant congenital heart disease (CHD).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Diluent - 2 mL - 48 months Not applicable stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, powder vial/diluent ampoule - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 4ml nominal capacity, - 50 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1998-11-09

Patient Information leaflet

SYNAGIS CMI ANZ
Version 11
Page 1
_ _
SYNAGIS
®
_PALIVIZUMAB (RMC) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SYNAGIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your child using
SYNAGIS against the benefits they
expect it will have for him/her.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SYNAGIS IS USED
FOR
SYNAGIS is used to help prevent a
serious illness caused by a virus
called respiratory syncytial virus
(RSV).
RSV illness usually occurs during the
months of winter and early spring. It
can cause a serious infection in the
lungs of your child resulting in
him/her being hospitalised. Your
child is at high risk of getting this
illness.
SYNAGIS belongs to a group of
medicines called antibodies (or
disease fighting substances).
The active substance in SYNAGIS is
called palivizumab and is made from
humanized genetic material. It works
only against RSV.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR CHILD.
Your doctor may have prescribed
SYNAGIS for another reason.
BEFORE YOUR CHILD IS
GIVEN SYNAGIS
_WHEN YOUR CHILD MUST NOT BE _
_GIVEN IT _
SYNAGIS MUST NOT BE USED IF YOUR
CHILD IS ALLERGIC TO IT OR TO ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
SYNAGIS MUST NOT BE USED IF
YOUR CHILD IS ALLERGIC TO SIMILAR
MEDICINES.
_BEFORE YOUR CHILD BEGINS TO _
_USE IT _
IF YOUR CHILD IS UNWELL, TELL YOUR
DOCTOR AS THE USE OF SYNAGIS MAY
NEED TO BE DELAYED.
TELL YOUR DOCTOR IF YOUR CHILD HAS
ANY BLEEDING DISORDERS.
TELL YOUR DOCTOR IF YOUR CHILD HAS
ALLERGIES TO ANY OTHER MEDICINES,
ANY OTHER SUBSTANCES, SUCH AS
FOODS, PRESERVATIVES OR DYES.
_TAKING OTHER MEDICINES _
TELL YOUR DOCTOR IF YOUR CHILD IS
TAKING ANY OTHER MEDICINES,
I

Summary of Product characteristics

_Synagis DS _
_Version 18 _
_Clean copy _
_ 1 August 2018 _
_Page 1 of 17 _
NEW ZEALAND DATA SHEET
1.
SYNAGIS
® PALIVIZUMAB (RMC) POWDER FOR INJECTION WITH DILUENT
2.
SYNAGIS
® PALIVIZUMAB (RMC) SOLUTION FOR INJECTION
3.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Powder for Injection _
SYNAGIS 50 mg*: Each vial contains 50 mg palivizumab, providing 100
mg/mL of palivizumab when
reconstituted as recommended.
SYNAGIS 100 mg*: Each vial contains 100 mg palivizumab, providing 100
mg/mL of palivizumab
when reconstituted as recommended.
_Solution for Injection _
SYNAGIS 50 mg*: Each vial contains 50 mg/0.5 mL palivizumab.
SYNAGIS 100 mg: Each vial contains 100 mg/mL palivizumab.
Palivizumab is produced by DNA technology in recombinant mouse myeloma
cells (rmc).
For a full list of excipients, see section 6.1.
* This presentation is not currently available in New Zealand.
4.
PHARMACEUTICAL FORM
_Powder for Injection _
The powder is a white to off-white cake.
The reconstituted solution should appear clear or slightly opalescent.
_Solution for Injection. _The solution is clear or slightly
opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Synagis (palivizumab) is indicated for the prevention of serious lower
respiratory tract disease caused
by respiratory syncytial virus (RSV) in children at high risk of RSV
disease. Safety and efficacy were
established in children with bronchopulmonary dysplasia (BPD), infants
with a history of prematurity
(gestational age less than or equal to 35 weeks at birth) and children
with haemodynamically significant
congenital heart disease (CHD), see section 5.1 - Clinical Efficacy
and Safety.
4.2
DOSE AND METHOD OF ADMINISTRATION
Do not mix the different palivizumab presentations i.e. lyophilised
powder for injection and solution for
injection.
Palivizumab is to be administered by intramuscular injection only.
For powder for injection, palivizumab should not be mixed with any
medications or diluents other than
Water for Injections.
_Synagis DS _
_Version 18 _
_Clean copy _
_ 1 Au