Carboplatin 450mg/45ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carboplatin

Available from:

Pfizer Ltd

ATC code:

L01XA02

INN (International Name):

Carboplatin

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5015997168614

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOPLATIN 10 MG/ML INTRAVENOUS INFUSION
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.

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 Intravenous Infusion is and what it is used for
2.
What you need to know before you use Carboplatin Intravenous Infusion
3.
How to use Carboplatin Intravenous Infusion
4.
Possible side effects
5.
How to store Carboplatin Intravenous Infusion
6.
Contents of the pack and other information
1. WHAT CARBOPLATIN INTRAVENOUS INFUSION IS AND WHAT IT IS
USED FOR
Carboplatin Intravenous Infusion is an anti-cancer medicine. Treatment
with an anti-
cancer medicine is sometimes called cancer chemotherapy.
Carboplatin is used in the treatment of some types of lung cancer and
ovarian cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOPLATIN
INTRAVENOUS INFUSION
DO NOT USE CARBOPLATIN INTRAVENOUS INFUSION

if you have shown signs of hypersensitivity (severe allergy) to
carboplatin or
similar platinum containing medicines in the past

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 a 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

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 similar anti-cancer
medicines in the
past, carboplatin may cause abnorm

Summary of Product characteristics

OBJECT 1
CARBOPLATIN 10 MG/ML INTRAVENOUS INFUSION
Summary of Product Characteristics Updated 02-Jun-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Carboplatin 10 mg/ml Intravenous Infusion
2. Qualitative and quantitative composition
Carboplatin 10 mg/ml
For the full list of excipients excipients, see 6.1
3. Pharmaceutical form
Solution for infusion
4. Clinical particulars
4.1 Therapeutic indications
Antineoplastic agent indicated in the treatment of:
• ovarian carcinoma of epithelial origin
• small cell lung carcinoma.
4.2 Posology and method of administration
Dosage and Method of administration
Carboplatin injection should be used by the intravenous route only.
The recommended dose of carboplatin in previously untreated adults
with normal renal function is 400
mg/m
2
, given as a single short term intravenous infusion over 15 to 60
minutes. 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]
TARGET AUC
PLANNED CHEMOTHERAPY
PATIENT TREATMENT STATUS
5-7 mg/ml.min
single agent carboplatin
previously untreated
4-6 mg/ml.min
single agent carboplatin
previously treated
4-6 mg/ml.min
carboplatin plus cyclophosphamide
previously untreated
Note: With the Calvert formula, the total dose of carboplatin is
calculated in mg, not mg/m
2
.
Therapy should not be repeated until 4 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 with risk
factors such as previous
myelosuppressive therapy and/or poor performance status (ECOG-Zubrod
2-4 or Karnofsky below 80).
Determination of haematologic nadir by weekly blood counts during
initial courses is recommended for
future dosage adjustment and scheduling of carboplatin.
Needles or intravenous sets containing aluminium parts that may come
in contact with carboplatin
injection should not be used for preparation or administration