What SYNAGIS contains
- The active substance is palivizumab. 100 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.
- The other ingredients are, -for the powder: histidine, glycine and mannitol. -for the solvent: water for injections.
What SYNAGIS looks like and contents of the pack
SYNAGIS is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
SYNAGIS is a white to off-white cake.
Marketing Authorisation holder
Abbott Laboratories Ltd
Abbott House,
Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire
SL6 4XE
United Kingdom
Manufacturer
Abbott SRL,
I 04010 Campoverde di Aprilia
(Latina) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Abbott SA TélTel 32 10 475311 LuxembourgLuxemburg Abbott SA BelgiqueBelgienTélTel 32 10 475311
.. ..Te. 359 2 489 19 50 Magyarország Abbott Laboratories Magyarország Kft. Tel. 36 1 465 2100
eská republika Abbott Laboratories s. r. o. Tel 420 267 292 111 Malta V.J.Salomone Pharma Limited Tel 356 22983201
Danmark Abbott Laboratories AS Tlf 45 39 77-00-00 Nederland Abbott B.V. Tel 31 0 88 8222 688
Deutschland Abbott GmbH Co. KG Tel 49 0 6122 58-0 Norge Abbott Norge AS Tlf 47 81 55 99 20
Eesti Abbott Laboratories Baltics LätiTel 371 67605580 Österreich Abbott Ges.m.b.H. Tel 43 1 891-22
Abbott Laboratories .... 30 21 0 9985-222 Polska Abbott Laboratories Poland Sp. z o.o. Tel. 48 22 606-10-50
España Abbott Laboratories, S.A. Tel 34 9 1 337-5200 Portugal Abbott Laboratórios, Lda. Tel 0035121 4727100
France Abbott France Tél 33 0 1 45 60 25 00 România Abbott Laboratories S.A. Tel 40 21 529 30 00
Ireland Abbott Laboratories, Ireland, Ltd Tel 353 0 1 469-1500 Slovenija Abbott Laboratories d.o.o. Tel 386 123 63 160
Ísland Vistor hf. Tel 354 535 7000 Slovenská republika Abbott Laboratories Slovakia s.r.o. Tel 421 0 2 4445 4176
Italia Abbott SRL Tel 39 06 928921 SuomiFinland Abbott OY PuhTel 358 0 9 7518 4120
Lifepharma Z.A.M. Ltd . 357 22 34 74 40 Sverige Abbott Scandinavia AB Tel 46 0 8 5465 67 00
Latvija Tel 371 67605580 United Kingdom Abbott Laboratories Ltd Tel 44 0 1628 773355
Lietuva
Abbott Laboratories Baltics
LatvijaTel: + 371 67605580
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
ADMINISTRATOR?S INSTRUCTIONS
SLOWLY add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming. After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
DO NOT SHAKE VIAL.
Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies. Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation. Any remaining contents should be discarded after use.
When reconstituted as recommended the final concentration is 100 mg/ml.
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique. Injection volumes over 1 ml should be given as a divided dose.
Palivizumab dose per month (ml) = patient weight (kg) x dose (15 mg/kg)
100 mg/ml palivizumab
For example, for a baby with a bodyweight of 3 kg, the calculation becomes:
3 x 15 = 0.45 ml palivizumab dose per month
100