Zomacton 4mg Injection | 合法醫療器材資訊網

Zomacton4mgInjection-SummaryofProductCharacteristics(SmPC)byFerringPharmaceuticalsLtd....4.6Fertility,pregnancyandlactation.ForZomacton ...

The maximum recommended daily dose should not be exceeded (see section 4.2).

Due to the presence of benzyl alcohol as excipient, ZOMACTON may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates.

ZOMACTON is not indicated for the long term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome, unless they also have a diagnosis of GH deficiency.

There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea or unidentified respiratory infection.

Rare cases of benign intra-cranial hypertension have been reporte...