Carboplatin 50mg/5ml concentrate for solution for infusion vials

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Carboplatin

Предлага се от:

Accord-UK Ltd

АТС код:

L01XA02

INN (Международно Name):

Carboplatin

дозиране:

10mg/1ml

Лекарствена форма:

Solution for infusion

Начин на приложение:

Intravenous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 08010500; GTIN: 5060149312193

Листовка

PATIENT INFORMATION LEAFLET
CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Carboplatin
Read all of this leaflet carefully before you starts using this
medicine.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or nurse.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
IN THIS LEAFLET:
1. What Carboplatin Infusion is and what it is used for
2. Before you are given Carboplatin Infusion
3. How you are given Carboplatin Infusion
4. Possible side effects
5. How to store Carboplatin Infusion
6. Further information
1.
WHAT CARBOPLATIN INFUSION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Carboplatin 10mg/ml concentrate for
solution for infusion’ but in the rest of the leaflet it will be
called ‘Carboplatin Infusion’.
WHAT CARBOPLATIN INFUSION IS
Carboplatin Infusion contains carboplatin, which belongs to a group of
medicines known as platinum coordination compounds,
which are used to treat cancer.
WHAT CARBOPLATIN INFUSION IS USED FOR
Carboplatin Infusion is used against advanced cancer of the ovary and
small cell cancer of the lung.
2. BEFORE YOU ARE GIVEN CARBOPLATIN INFUSION
DO NOT USE CARBOPLATIN INFUSION

If you are allergic (hypersensitive) to Carboplatin or to any of the
ingredients of Carboplatin Infusion

If you are allergic to another drug that belongs to the group of
platinum containing compound.

If you have severe problems with your kidneys (creatinine clearance at
or below 20 ml/min)

If you have an imbalance of your blood cells (sever myelosuppression)

If you have tumour that bleeds

If you are pregnant or breast feeding
If any of these apply to you and you have not already discussed this
with your doctor or nurse, you should do so as soon as
possible and before rece

Данни за продукта

OBJECT 1
CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 26-Feb-2014 | Accord
Healthcare Limited
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:
- first line therapy
- 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/m
2
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]
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/m
2
. Calvert's
formula should not be used in patients who have received extensive
pretreatment**.
**Patients are considered heavily pretreated if they have received any