ELIGARD 22.5MG POWDER & SOLVENT FOR SOLUTION FOR INJECTION

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

LEUPRORELINE ACETATE

Dostopno od:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

LEUPRORELINE ACETATE

Enote v paketu:

2units Units; 2 Units

Izdeluje:

Tolmar Inc.

Lastnosti izdelka

04006219
Other events: Cases of ureteral obstruction and spinal cord
compression, which may contribute to paralysis
with or without fatal complications, have been reported with GnRH
agonists. If spinal cord compression or renal
impairment develops, standard treatment of these complications should
be instituted.
Patients with vertebral and/or brain metastases as well as patients
with urinary tract obstruction should be
closely monitored during the first few weeks of therapy.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No pharmacokinetic drug-drug interaction studies have been performed
with ELIGARD. There have been no
reports of any interactions of leuprorelin acetate with other
medicinal products.
4.6 PREGNANCY AND LACTATION
Not applicable as ELIGARD is contraindicated in women.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No studies on the effects of ELIGARD on the ability to drive and use
machines have been performed. The ability
to drive and operate machines may be impaired due to fatigue,
dizziness and visual disturbances being possible
side effects of treatment or resulting from the underlying disease.
4.8 UNDESIRABLE EFFECTS
Adverse reactions seen with ELIGARD are mainly subject to the specific
pharmacological action of leuprorelin,
namely increases and decreases in certain hormone levels. The most
commonly reported adverse reactions are
hot flashes, malaise, nausea and fatigue and transient local
irritation at the site of injection. Mild or moderate hot
flashes occur in approximately 58% of patients.
The following adverse events were reported during clinical trials with
ELIGARD in patients with advanced prostatic
carcinoma. Adverse events are classified, by frequency, as very common
(≥1/10), common (≥100, <1/10), uncommon
(≥1,000, <1/100), rare (≥10,000, <1/1,000), and very rare
(<1/10,000), not known (cannot be estimated from the
available data).
_Table 1_: _UNDESIRABLE EFFECTS IN CLINICAL STUDIES WITH ELIGARD_
INFECTIONS AND INFESTATIONS
common
uncommon
nasoph