Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Palivizumab 100mg (;+overage = 122mg/vial)
AbbVie Limited
Palivizumab 100 mg (;+overage = 122mg/vial)
100 mg
Injection with diluent
Active: Palivizumab 100mg (;+overage = 122mg/vial) Excipient: Glycine Histidine Mannitol Nitrogen Transferrin Water for injection
Ampoule, glass, Diluent, 2 mL
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
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).
Package - Contents - Shelf Life: Ampoule, glass, Diluent - 2 mL - 48 months from date of manufacture 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, 10ml nominal volume (powder) - 100 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1998-11-09
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 Read the complete document
_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 Read the complete document