SYNAGIS palivizumab (rmc) 50 mg / 0.5 mL solution for injection vial

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Palivizumab, Quantity: 50 mg

Pieejams no:

AstraZeneca Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Palivizumab

Zāļu forma:

Injection, solution

Kompozīcija:

Excipient Ingredients: histidine; glycine; water for injections

Ievadīšanas:

Intramuscular

Vienības iepakojumā:

1

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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 Clinical Trials).

Produktu pārskats:

Visual Identification: Clear or slightly opalescent, sterile solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizācija statuss:

Licence status A

Autorizācija datums:

2015-09-24

Lietošanas instrukcija

SYNAGIS
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about your child using this medicine, speak to your doctor or
pharmacist.
1.
WHY IS MY CHILD BEING GIVEN SYNAGIS?
Synagis contains the active ingredient palivizumab. Synagis is used to
prevent a serious lung condition caused by a virus known as
respiratory syncytial virus (RSV).
For more information, see Section 1. Why is my child being given
Synagis? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN SYNAGIS?
Check the list of ingredients at the end of the CMI. Synagis should
not be given if your child has ever had an allergic reaction to any
of them, or to other medicines like Synagis.
TALK TO YOUR DOCTOR BEFORE YOUR CHILD IS GIVEN THIS MEDICINE IF HE/SHE
IS NOT AWARE THAT YOUR CHILD HAS ANY OTHER MEDICAL
CONDITIONS OR TAKES ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child is given Synagis? in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines can interfere with others and affect how they work.
This is unlikely to be a concern for Synagis. An explanation is
provided in Section 3. What if my child is taking other medicines? in
the full CMI.
4.
HOW IS SYNAGIS GIVEN?
•
The Synagis dose is calculated by your doctor according to your
child's weight.
•
It is given by injection into the muscle by your doctor or other
healthcare professional.
More instructions can be found in Section 4. How is Synagis given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE MY CHILD IS RECEIVING SYNAGIS?
THINGS YOU
SHOULD DO
•
Tell your doctor if your child is unwell when treatment is about to
start.
•
Keep all your child's appointments to ensure he/she receives all the
required injections.
•
Remind any doctor, dentist or pharmacist you visit that your child is
receiving Synagis.
THINGS YOU
SHOULD NOT DO
•
Once treatment has started, do not allow your child to miss any of the
monthly injections of Synagis
withou

Produkta apraksts

1 of 15
AUSTRALIAN PRODUCT INFORMATION
SYNAGIS
®
(PALIVIZUMAB) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Palivizumab (rmc)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Palivizumab is a humanized IgG1 monoclonal antibody directed to an
epitope in the A antigenic
site of the fusion protein of respiratory syncytial virus (RSV).
This humanized monoclonal antibody is composed of 95% human and 5%
murine amino acid
sequences.
Synagis 50 mg/0.5 mL vial: each single use vial contains 50 mg
palivizumab.
Synagis 100 mg/1 mL vial: each single use vial contains 100 mg
palivizumab.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clear or slightly opalescent sterile solution supplied in clear glass
vials.
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 Pharmacodynamic
properties-Clinical Trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
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.
Palivizumab is administered in a dose of 15 mg/kg once a month
intramuscularly, preferably in the
anterolateral aspect of the thigh. The gluteal muscle should not be
used routinely as an injectio