Pedmarqsi

البلد: الاتحاد الأوروبي

اللغة: الإنجليزية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

Sodium thiosulfate

متاح من:

Fennec Pharmaceuticals (EU) Limited

INN (الاسم الدولي):

sodium thiosulfate

المجموعة العلاجية:

All other therapeutic products

المجال العلاجي:

Ear Diseases; Ototoxicity

الخصائص العلاجية:

Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

ملخص المنتج:

Revision: 1

الوضع إذن:

Authorised

تاريخ الترخيص:

2023-05-26

نشرة المعلومات

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEDMARQSI 80 MG/ML SOLUTION FOR INFUSION
sodium thiosulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
RECEIVING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask the doctor or nurse.
-
If you or your child get any side effects, talk to the doctor or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pedmarqsi is and what it is used for
2.
What you need to know before you or your child receives Pedmarqsi
3.
How Pedmarqsi is given
4.
Possible side effects
5.
How to store Pedmarqsi
6.
Contents of the pack and other information
1.
WHAT PEDMARQSI IS AND WHAT IT IS USED FOR
Pedmarqsi contains the active substance sodium thiosulfate.
Pedmarqsi is used to reduce the risk of hearing loss from the cancer
medicine cisplatin. It is given to
children and adolescents aged 1 month to 18 years who are being
treated with cisplatin for solid
tumours that have not spread to other areas of the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES PEDMARQSI
DO NOT GIVE PEDMARQSI
if the child is:
-
allergic to sodium thiosulfate or any of the other ingredients of this
medicine (listed in
section 6)
-
a baby under the age of 1 month
WARNINGS AND PRECAUTIONS
Talk to a doctor or nurse before you or your child receives Pedmarqsi
if the child:
-
has had an allergic reaction like a rash, hives or difficulty
breathing after a previous dose of
sodium thiosulfate
-
has a known allergy to chemicals called sulfites
–
this may mean you or the child is more likely
to have an allergic reaction to this medicine
-
has poor kidney function or serious kidney disease
-
needs a low salt diet because of another medical condition
OTHER MEDICINES AND PEDMARQSI
Tell the doctor or nurse if you or your child is taking, has recently
taken or might take any other
medicines.
PREGNANCY AND

خصائص المنتج

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pedmarqsi 80 mg/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 100 mL contains 8 g of sodium thiosulfate as an anhydrous
salt.
Each mL of solution for infusion contains 80 mg sodium thiosulfate.
Excipient(s) with known effect:
Each mL of solution for infusion contains 0.25 mg boric acid and 23 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
The solution for infusion is a clear, colourless solution essentially
free of particulate matter, with a pH
of 7.7 - 9.0 and an osmolality of 980 - 1 200 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pedmarqsi is indicated for the prevention of ototoxicity induced by
cisplatin chemotherapy in patients
1 month to < 18 years of age with localised, non-metastatic, solid
tumours.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pedmarqsi is intended for hospital use only, under the supervision of
an appropriately qualified
physician.
Posology
The recommended dose of sodium thiosulfate for the prevention of
cisplatin-induced ototoxicity is
weight based and normalised to body surface area according to the
table below:
Body Weight
Dose
Volume
> 10 kg
12.8 g/m
2
160 mL/m
2
5 to 10 kg
9.6 g/m
2
120 mL/m
2
< 5 kg
6.4 g/m
2
80 mL/m
2
Pre-treatment with antiemetics is recommended to reduce the incidence
of nausea and vomiting (see
section 4.4).
_Special populations _
_ _
_Preterm and term newborn infants from birth to less than 1 month of
age _
_ _
Sodium thiosulfate is contraindicated in preterm and term newborn
infants from birth to less than
1 month of age (see sections 4.3 and 4.4).
3
_Renal impairment _
No dose adjustment is recommended for patients with renal impairment
(see section 5.2). Due to the
sodium content of sodium thiosulfate, there is an increased risk of
adverse reactions in patients with
renal impairment (see section 4.4).
_Hepatic impairment _
No dose adjustment is recommended for patients w