Synagis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Palivizumab 50mg;  

Available from:

AstraZeneca Limited

INN (International Name):

Palivizumab 50 mg

Dosage:

100 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Palivizumab 50mg   Excipient: Glycine Histidine Water for injection

Prescription type:

Prescription

Manufactured by:

MedImmune LLC

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).

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type 1, 0.5 mL fill - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2015-01-05

Patient Information leaflet

Synagis

011021
1(3)
S
YNAGIS

PALIVIZUMAB (RMC), 50 MG/0.5 ML AND 100 MG/1 ML SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
SYNAGIS. It does not contain all the information
that is known about SYNAGIS. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have 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 taking 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
humanised 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 YOU USE 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

Summary of Product characteristics

S
YNAGIS
Data Sheet 011021
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SYNAGIS
®
50 mg/0.5 mL solution for injection
SYNAGIS
®
100 mg/1 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYNAGIS 50 mg: Each vial contains 50 mg/0.5 mL palivizumab (100
mg/mL).
SYNAGIS 100 mg: Each vial contains 100 mg/1 mL palivizumab (100
mg/mL).
Palivizumab is produced by DNA technology in recombinant mouse myeloma
cells (rmc).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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
Palivizumab is to be administered by intramuscular injection only.
Each palivizumab vial is for use in one patient on one occasion only.
To prevent the
transmission of infectious diseases, sterile disposable syringes and
needles should be used.
Do not reuse syringes and needles.
DOSE
The recommended dose of palivizumab is 15 mg/kg of body weight, given
once a month during
anticipated periods of RSV risk in the community.
Where possible, the first dose should be
administered prior to commencement of the RSV season and subsequent
doses should be
administered monthly throughout the RSV season.
To avoid risk of reinfection, it is
recommended that children receiving palivizumab who become infected
with RSV continue to
receive monthly doses of palivizumab for the duration of the RSV
season.
The efficacy of SYNAGIS at doses less than 15 mg/kg, or dosing less
frequently than m