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Carboplatin 10mg/Ml Concentrate For Solution For Inj Bp

Document: leaflet MAH GENERIC_PL 14510-0014 change

EBEWE    PL 14510/0014-6 Patient Information Leaflet

Carboplatin 10mg/ml Concentrate for Solution    16/09/2016

for Injection BP

PACKAGE LEAFLET

Carboplatin 10mg/ml Concentrate for Solution for Injection BP

Carboplatin

Read all of this leaflet carefully before you are given this medicine.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or nurse.

In this leaflet:

•    1. What is carboplatin and what is it used for?

•    2.    Before you are given carboplatin

•    3.    How carboplatin will be given to you

•    4.    Possible side effects

•    5.    Storing carboplatin

The active substance in the injection is carboplatin.

The other ingredient is water for injections.

Marketing Authorisation Holder and Manufacturer:

EBEWE Pharma Ges.m.b.H. Nfg. KG,

A-4866 Unterach, Austria

1. WHAT IS CARBOPLATIN AND WHAT IS IT USED FOR?

Carboplatin 10mg/ml Concentrate for Solution for Injection BP is a concentrate for solution for infusion. It is available as a single 5ml vial containing 50mg of carboplatin, a single 15ml vial containing 150mg of carboplatin, a single 45ml vial containing 450mg of carboplatin and a single 60ml vial containing 600mg of carboplatin.

Carboplatin 10mg/ml Concentrate for Solution for Injection BP is a clear colourless or almost colourless solution free from particles.

Carboplatin belongs to a group of medicines known as cytotoxics, which are used in the treatment of cancer. Carboplatin is used to treat cancer of the ovaries and lung.

2. BEFORE YOU ARE GIVEN CARBOPLATIN

You will not be given carboplatin:

•    if you are allergic to carboplatin, drugs containing platinum or any of the other ingredients,

•    if you have severe kidney problems,

•    if you have impaired bone marrow function

•    if you are taking certain antibiotics known as aminoglycosides (e.g. neomycin, streptomycin) or other medicines that may damage kidney function, because they may increase the toxicity of carboplatin

•    Your doctor will take special care when giving you carboplatin if you have mild to moderate liver or kidney problems or blood disorders

•    if you have previously been treated with cisplatin

Consult your doctor if any of the above warnings applies to you or has applied to you in the past.

Your doctor will check your kidney function, liver function and blood before, during and after every treatment cycle. If the results of any of these tests are abnormal treatment will only be resumed when all readings are back to normal. Your doctor will also make checks on your nervous system (reflexes, etc) at regular intervals.

Warnings and precautions

•    If you have headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss, tell your doctor.

•    If you develop extreme tiredness and shortness of breath with decreased number of red blood cells (symptoms of haemolytic anaemia), alone or combined with a low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uremic syndrome), tell your doctor.

•    If you have fever (temperature greater than or equal to 38°C), or chills, which could be signs of infection, tell your doctor immediately. You may be at risk of getting an infection of the blood.

You may be given a drug to stop you feeling sick or being sick after your treatment with carboplatin starts.

You will be carefully monitored at all times during your treatment.

Pregnancy

Carboplatin should not be given to you if you are pregnant, because it can cause serious birth defects.

Female patients should also avoid getting pregnant for at least six months after being treated with carboplatin. Male patients receiving carboplatin should take adequate precautions to ensure that their partner does not become pregnant for the same period. If you are considering becoming parents after the treatment, you should discuss this with your doctor.

Men who wish to father children in the future should seek advice about freezing sperm before the carboplatin treatment is started.

Breast-feeding

Carboplatin should not be given to you if you are breast-feeding.

Driving and using machines:

If you are experiencing side effects which could affect your ability to drive or operate machines, you should avoid driving or operating machinery until these have worn off.

Being given carboplatin at the same time as other medication

Being given carboplatin at the same time as other medication which affects the functioning of the liver or kidneys, including alcohol, could make carboplatin more toxic.

Tell your doctor or pharmacist about medicines you are currently taking or have taken recently. This also applies to medicines you may have bought yourself from a pharmacy or supermarket.

3. HOW CARBOPLATIN WILL BE GIVEN TO YOU

Carboplatin will only be given to you under the supervision of a doctor specialised in this type of treatment.

The carboplatin concentrate will be diluted with a solution of glucose before it is injected into a vein (intravenously) through a drip over a period of 15-60 minutes.

The dosage of carboplatin depends on whether you have had carboplatin before and whether you are having other cancer therapy. The usual dose of carboplatin is 400mg per square metre of body surface area, calculated from your height and weight. The dosage of carboplatin may be adjusted If you suffer from kidney problems or bone marrow depression (a reduced ability to produce blood cells), if you are elderly, or if carboplatin is being given to you in combination with other treatments.

Your general condition and your response to the treatment will be closely observed before, during and after the carboplatin treatment.

4.    POSSIBLE SIDE EFFECTS

Like any other medication, carboplatin may cause side-effects.

Most patients experience either vomiting or nausea after a carboplatin injection, but these symptoms usually disappear within 24 hours. Your doctor may give you an anti-emetic to stop you from being sick.

Carboplatin can make you more likely to be prone to infections. If you think you have an infection, a sore throat, mouth ulcers, fever, chills or achiness during treatment you should tell your doctor immediately.

Less commonly, carboplatin causes loss of appetite, a tendency to bleed or bruise easily, anaemia, kidney problems, rash, itchiness, reddening and blistering of the skin, high frequency hearing loss or ringing in the ears, numbness and pins and needles, liver problems, fever, chills, weakness, hair loss and altered taste.

Certain other unwanted side effects can only be detected by your doctor by testing your blood, liver and kidney function.

Very rarely, severe allergic reactions to carboplatin may occur, with difficulty breathing, swelling of the face, lips and eyes, rash, rapid pulse and profuse sweating. If you develop any of these symptoms, contact your doctor or nurse immediately.

Frequency not known (frequency cannot be estimated from the available data)

•    A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder)

•    Pancreatitis

• Lung infection.

Carboplatin can harm unborn babies or cause miscarriage (see section on pregnancy). It can also affect fertility in men and women.

During the treatment with carboplatin your general condition will be closely monitored.

If you notice any side-effects not mentioned in this leaflet, please tell your doctor or nurse.

5.    STORING CARBOPLATIN

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the container in the outer carton in order to protect form light.

Do not use after the expiry date stated on the label.

After dilution, the product should be used within 24 hours if stored at 2-8°C.

This leaflet was prepared in 09/2016

The following information is intended for medical or healthcare professionals only: Instructions for Use/Handling

This product is for single dose use only.

Solutions should only be used if clear and particle free.

Trained personnel should prepare carboplatin for infusion in designated areas. Protective clothing (including gloves) should be worn. The eyes should be protected. In the event of contact with the eyes, wash with water and/or saline.

Pregnant staff should not handle cytotoxics.

Any unused product, syringes, containers, absorbent material or other waste material should be disposed of using adequate care and precautions. Excess material and body waste may be disposed of by placing in double sealed polythene bags and incinerating at a temperature of 1000°C. Liquid waste may be flushed with copious amounts of water.

Carboplatin for infusion may be prepared by dilution with Glucose 5% Solution.

Incompatibilities

Needles or intravenous sets containing aluminium parts that may come into contact with carboplatin should not be used for preparation or administration of carboplatin.

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 is 400 mg/mas a single i.v. dose administered by a 15 to 60 minutes infusion. Alternatively, see Calvert formula below:

Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]

Patient treatment status

Planned chemotherapy

Target AUC

Previously untreated

Single agent carboplatin

5-7 mg/ml.min

Previously treated

Single agent carboplatin

4-6 mg/ml.min

Previously untreated

Carboplatin plus cyclophosphamide

4-6 mg/ml

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.

Reduction of the initial dosage by 20-25% is recommended for those patients who present with risk factors such as prior myelosuppressive treatment and low performance status (ECOG-Zubrod 2-4 or Karnofsky below 80).

Determination of the haematological nadir by weekly blood counts during the initial courses of treatment with carboplatin is recommended for future dosage adjustment.

Impaired Renal Function:

The optimal use of carboplatin in patients presenting with impaired renal function requires adequate dosage adjustments and frequent monitoring of both haematological nadirs and renal function.

Combination Therapy:

The optimal use of carboplatin in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.

Paediatrics:

There is insufficient information to support a dosage recommendation in the paediatric population

Elderly:

Dosage adjustment, initially or subsequently, may be necessary, dependent on the physical condition of the patient.

Shelf life

18 months (unopened)

After dilution:

24 hours under refrigeration (2 - 8°C)

Special precautions for storage

Do not store above 25 °C. Keep container in the outer carton. After dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for solutions with a final concentration of carboplatin 0.4mg/ml or 2.0mg/ml after dilution of the carboplatin10mg/ml with glucose solution 5%.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

N005: Update to SPC and PIL in

accordance to PSUR, Re

submission of N003

PIL.0014-6.003.0d IS