Carboplatin 10mg/ml concentrate for solution for infusion concentrate for solution for infusion

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

carboplatin

から入手可能:

Accord Healthcare Polska Sp. z o.o.

ATCコード:

L01XA02

INN（国際名）:

carboplatin

投薬量:

10mg/ml

医薬品形態:

concentrate for solution for infusion

パッケージ内のユニット:

60ml glass vial

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2021-03-18

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Carboplatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor. This includes any
possible side effect not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Carboplatin Infusion is and what it is used for
2. What you need to know before you use Carboplatin Infusion
3. How to use Carboplatin Infusion
4. Possible side ffects
5. How to store Carboplatin Infusion
6. Contents of the pack and other information
1. WHAT CARBOPLATIN INFUSION IS AND WHAT IT IS USED FOR
Carboplatin Infusion contains carboplatin, which belongs to a group of
medicines known as platinum coordination
compounds, which are used to treat cancer.
Carboplatin Infusion is used against advanced cancer of the ovary and
small cell cancer of the lung.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOPLATIN INFUSION
DO NOT USE CARBOPLATIN INFUSION

If you are allergic to Carboplatin or any of the other ingredients of
this medicine (listed in section 6) or
similar platinum containing medicines

if you have severe kidney disease

if you have fewer blood cells than normal (your doctor will check this
with a blood test)

if you have tumour that bleeds

if you plan to receive a yellow fever vaccination or have just
received one.
Tell your doctor if any of the above applies to you before this
medicine is used.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Carboplatin
Infusion

if you are pregnant or if there is a chance you may be pregnant

if you are breast feeding

if you have mild renal disease. Your doctor will want to monitor you
more regularly.

if you are elderly (over 65 years old)
if you have been treated with cisplatin or simi

製品の特徴

Module 1.3.1
Page 1 of 16
1. NAME OF THE MEDICINAL PRODUCT
Carboplatin 10 mg/ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 10mg of
Carboplatin
Each 5 ml vial contains 50 mg carboplatin
Each 15 ml vial contains 150 mg carboplatin
Each 45 ml vial contains 450 mg carboplatin
Each 60 ml vial contains 600 mg carboplatin
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless to slightly pale yellow solution free from
particles
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carboplatin is indicated for the treatment of:
1.
advanced ovarian carcinoma of epithelial origin in:
(a)
first line therapy
(b)
second line therapy, after other treatments have failed.
2. small cell carcinoma of the lung.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and Administration:
Carboplatin should be used by the intravenous route only. The
recommended dosage of
Carboplatin in previously untreated adult patients with normal kidney
function, i.e. creatinine
clearance > 60 ml/min is 400 mg/m² as a single short term IV dose
administered by a 15 to 60
minutes infusion. Alternatively, the Calvert formula shown below may
be used to determine
dosage:
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
Module 1.3.1
Page 2 of 16
DOSE (MG) = TARGET AUC (MG/ML X MIN) X [GFR ML/MIN + 25]
TARGET AUC
PLANNED CHEMOTHERAPY
PATIENT TREATMENT STATUS
5-7mg/ml .min
single agent Carboplatin
Previously untreated
4-6 mg/ml .min
single agent Carboplatin
Previously treated
4-6mg/ml .min
Carboplatin plus cyclophosphamide
Previously untreated
Note: With the Calvert formula, the total dose of Carboplatin is
calculated in mg, not mg/m².
Therapy should not be repeated until four weeks after the previous
Carboplatin course and/or
until the neutrophil count is at least 2,000 cells/mm³ and the
platelet count is at least 100,000
cells/mm³.
Initial dosage should be reduced by 20-25% in patients w