CARBOPLATINO 10 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Carboplatino Hikma, 10 mg/ml, Infusion Solution
2. Carboplatino
   1. What is Carboplatino Hikma and what is it used for
   2. What you need to know before using Carboplatino Hikma
   3. How to use Carboplatino Hikma
   4. Possible side effects
   5. How to store Carboplatino Hikma
   6. Contents of the pack and other information

Carboplatino Hikma, 10 mg/ml, Infusion Solution

(50 mg/5ml, 150 mg/15 ml, 450 mg/45ml and 600 mg/60ml)

Carboplatino

Equivalent Medicinal Product

Read this leaflet carefully before you use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Carboplatino Hikma is and what it is used for
• 2. What you need to know before you use Carboplatino Hikma
• 3. How to use Carboplatino Hikma
• 4. Possible side effects
• 5. How to store Carboplatino Hikma
• 6. Contents of the pack and other information

1. What is Carboplatino Hikma and what is it used for

Carboplatino Hikma is an antineoplastic drug containing carboplatin in the form of
a solution for infusion (a solution that can be administered as a slow
drip infusion).
Treatment with an antineoplastic drug is called chemotherapy.
Carboplatino is used in the treatment of some types of lung cancer and advanced ovarian cancer and as adjuvant treatment for testicular germ cell tumors.

2. What you need to know before using Carboplatino Hikma

Do not use Carboplatino Hikma:

• if you are allergic (hypersensitive) to carboplatin or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems;
• if you have fewer blood cells than normal (your doctor will check this);
• if you are breastfeeding;
• if you have a tumor that is bleeding;
• if you have received a vaccination against yellow fever.

Warnings and precautions
Talk to your doctor or pharmacist before using Carboplatino Hikma:

• if you have headache, altered mental function, seizures and abnormal vision from blurred vision to loss of vision.
• if you develop extreme fatigue and shortness of breath with a reduced number of red blood cells (symptoms of hemolytic anemia), alone or in combination with a low platelet count, unusual bruising (thrombocytopenia) and kidney disease in which you produce little or no urine (symptoms of hemolytic-uremic syndrome).
• if you have a fever (temperature greater than or equal to 38 ° C), or chills, which may be signs of infection. You may be at risk of contracting a blood infection.

Carboplatin must be administered with particular caution in:

• Patients with myelosuppression (decreased number of blood cells produced by the bone marrow). Combined treatment with other myelosuppressive drugs (leading to a decrease in blood cells) may require dosage adjustment;
• Patients with hematological toxicity (lowering of blood cell production);
• Patients with impaired kidney function;
• Patients with allergic reactions to platinum-based drugs;
• Patients over 65 years of age and/or patients previously treated with cisplatin (drugs used to treat cancer);
• Patients receiving treatment with a live vaccine;
• Children. In this population, long-term audiometric follow-up is recommended.

Carboplatin may react with aluminum, therefore aluminum-containing needles, syringes, catheters or intravenous administration systems should not be used in the preparation or administration of carboplatin, in order to avoid any interaction.
During treatment with carboplatin, medicines will be administered to help reduce a potentially life-threatening complication known as tumor lysis syndrome, caused by chemical disturbances in the blood due to the breakdown of dead cancer cells that release their contents into the blood.

Other medicines and Carboplatino Hikma
Tell your doctor if you are taking, have recently taken or may take any other medicine.
Treatment of patients with oral anticoagulants (blood-thinning medications) implies increased frequency of monitoring of the International Normalized Ratio (INR).
The administration of Carboplatino Hikma:

• is contraindicated in concomitant use with the yellow fever vaccine;
• is not recommended in concomitant use with live attenuated vaccines (except for the yellow fever vaccine) and phenytoin or fosphenytoin (medicines used to treat seizures);
• must be administered with particular caution in concomitant use with cyclosporine, tacrolimus and sirolimus (medicines that decrease the body's natural defenses against foreign substances), aminoglycosides, vancomycin or capreomycin (antibiotics), phenytoin and fosphenytoin (used to treat various types of seizures and convulsions) and loop diuretics (medicines used to lower blood pressure).

Treatment associated with other myelosuppressive agents (drugs that lead to a decrease in blood cells) may require dose adjustment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safe use of carboplatin during pregnancy has not been established, but it is suspected that it may cause serious birth defects when administered during pregnancy.
Carboplatin is not indicated in pregnancy or in women of childbearing potential who may become pregnant, unless the potential benefits to the mother outweigh the possible risks to the fetus.
If the drug is used during pregnancy, or if the patient becomes pregnant during the use of the drug, the patient should be informed of the potential risk to the fetus. Women of childbearing potential should be warned of the potential danger to the fetus and to avoid pregnancy and use contraceptive measures during and for at least 7 months after the end of therapy.
Men of sexually mature age treated with carboplatin are advised not to father a child during treatment and to use effective contraceptive methods during treatment and for 4 months after completion of treatment.
Fertility
Gonadal suppression may occur in patients undergoing antineoplastic therapy, resulting in amenorrhea or azoospermia. These effects appear to be dose- and duration-dependent and may be irreversible. Predicting the degree of testicular or ovarian functional impairment is complicated by the frequent use of combinations of different antineoplastics, making it difficult to assess the effects of individual agents. Before starting therapy, both male and female patients should seek advice on preserving their fertility due to the possibility of irreversible infertility due to carboplatin therapy.
Breastfeeding
Carboplatin and its metabolites are excreted in breast milk. To avoid possible harmful effects on the newborn, breastfeeding should be discontinued during therapy with carboplatin and for one month after the last dose.

Driving and using machines
Studies have not been conducted on the ability to drive vehicles and use machinery. However, carboplatin may cause nausea, vomiting, vision problems and ototoxicity; therefore, patients should be informed of the potential effect of these events on the ability to drive or operate machinery.

3. How to use Carboplatino Hikma

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor.
The dose you will receive will depend on your age, your health, the proper functioning of your
kidneys and any other medicines you may be taking.
The product can be diluted with glucose (sugar solution) or sodium chloride (salt water) before
administration. It will be given to you slowly, usually through an infusion into a vein for 15-60
minutes. Another dose of this medicine may be given after 4 weeks.
During treatment with carboplatino, your doctor will regularly perform blood tests.
This is to assess what effect the medicine is having and additional doses of carboplatino may be
required.
Since this medicine will be administered to you while you are in hospital, it is unlikely that
lower or higher quantities of medicine will be administered; however, inform your doctor or
pharmacist if you have any doubts.
Safety measures used in the preparation and administration of substances classified as hazardous
must be applied. Preparation must be carried out by professionals trained in safe use, using
protective gloves, face mask and protective clothing.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Use in children
Use in children and infants is not recommended due to a lack of sufficient data in this area.

If you use more Carboplatino Hikma than you should
This medicine will be administered to you in hospital, under the supervision of a doctor. It is
unlikely that you will be given too much or too little, however, inform your doctor or
nurse if you have any doubts.
There is no known antidote for carboplatino overdose.
During clinical studies, there have been no cases of overdose. If this occurs, the patient may
require appropriate supportive treatment for complications related to myelosuppression,
renal and hepatic insufficiency, renal insufficiency and impaired hearing.
In reports for doses up to 1,600 mg / m patients felt extremely ill, with diarrhea and alopecia.
The use of carboplatino doses higher than those recommended has been associated with loss of
vision.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency of observed side effects is defined as:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (the frequency cannot be estimated from the available data).
If you experience any of the following side effects, inform your doctor immediately:

• Unusual bruising, bleeding or signs of infection such as sore throat and high fever;
• Severe allergic reaction (anaphylaxis/anaphylactic reactions): may manifest as a severe itchy rash (urticaria), swelling of the face, lips, mouth or throat (which may cause difficulty swallowing or breathing), you may feel a sensation of fainting;
• Chest pain which may indicate a potentially serious allergic reaction called Kounis syndrome.
• Stomatitis/mucositis (e.g. sore lips or mouth ulcers);
• Hemolytic-uremic syndrome (a disease characterized by acute renal failure), decreased urination or blood in the urine;
• Muscle cramps, muscle weakness, confusion, loss or disturbances of vision, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumor lysis syndrome which may be caused by the rapid breakdown of tumor cells) (see section 2);
• Stroke (sudden numbness or weakness of the face, arm or leg, particularly on one side of the body);
• Blockage of blood vessels (embolism and veno-occlusive disease), swelling or tenderness of leg/arm.

Other side effects that may be detected during treatment are indicated below:
Very common side effects (may affect more than 1 in 10 people)

• Thrombocytopenia (decreased number of platelets in the blood), neutropenia and leukopenia (reduced white blood cell count in the blood), anemia (decreased number of red blood cells);
• Decreased creatinine clearance;
• Elevated serum levels of: urea, alkaline phosphatase, aspartate aminotransferase
• Abnormal liver function tests;
• Decreased serum levels of sodium, potassium, calcium, magnesium.
• Vomiting, nausea, abdominal pain

Common side effects (may affect up to 1 in 10 people)

• Infections
• Bleeding
• Hypersensitivity (allergies);
• Peripheral neuropathy (nerve disease), decreased osteotendinous reflexes (related to bones and tendons), change in sensation;
• Paresthesia (tingling or pins and needles), dysgeusia (altered perception of taste and flavor of food);
• Visual disturbances, including rare cases of vision loss;
• Tinnitus (ringing in the ears), hearing impairment and loss of hearing;
• Cardiovascular problems
• Respiratory problems, interstitial lung disease (lung disease with inflammation), bronchospasm (contraction of the bronchial muscles causing difficulty breathing);
• Diarrhea, constipation;
• Hair loss (alopecia), skin problems;-
• Musculoskeletal disorders
• Reproductive system or urinary tract disorders;
• Asthenia (weakness);
• Increased bilirubin in the blood, increased creatinine in the blood, increased uric acid in the blood.

Uncommon side effects (may affect up to 1 in 100 people)

• Symptoms affecting the central nervous system, often associated with medicines used to control nausea or vomiting;
• Muscle and joint pain;
• Flu-like symptoms, chills, headache.

Rare side effects (may affect up to 1 in 1,000 people)

• Temporary vision loss
• Disease of white blood cells originating from the bone marrow (acute myeloid leukemia);
• Bone marrow disease in which the production of blood cells is altered (myelodysplastic syndrome (MDS));
• Fever, sepsis/septic shock;
• Angioedema (swelling);
• Dermatitis with skin scaling.

Very rare side effects (may affect up to 1 in 10,000 people)

• scarring of the lungs causing shortness of breath and/or cough (pulmonary fibrosis)

Side effects with unknown frequency (cannot be estimated from the available data)

• Cancer caused by previous treatment with carboplatin and radiotherapy (secondary neoplasms);
• Bone marrow failure (decreased ability to produce blood cells), febrile neutropenia (fever accompanied by low white blood cell counts);
• Disease with loss of red blood cells due to damage to small blood vessels (hemolytic uremic syndrome);
• Reduced number of red blood cells due to their excessive breakdown (hemolytic anemia);
• Mental alterations (encephalopathy);
• Blockage of a blood vessel (embolism and veno-occlusive disease), swelling or tenderness in a leg/arm-
• Dehydration, anorexia (loss of appetite), hyponatremia (sodium levels lower than normal);
• Stomatitis (inflammation of the mouth);
• A series of symptoms, such as headache, changes in mental functioning, convulsions and abnormal vision from blurring to vision loss (symptoms of posterior reversible leukoencephalopathy syndrome, a rare neurological disorder);
• Optic nerve inflammation;
• Vision loss due to brain damage;
• Cerebrovascular event;
• Heart failure (abnormal heartbeat - accelerated, slowed or irregular - or chest pain);
• Coronary artery disease (e.g. myocardial infarction, cardiac arrest, angina pectoris, myocardial ischemia), allergic angina (Kounis syndrome);
• Hypertension (blood pressure higher than normal), hypotension (blood pressure lower than normal);
• Pancreatitis;- Lung infection;
• Urticaria, rash, erythema (redness), itching
• Muscle cramps, muscle weakness, confusion, loss or disturbances of vision, irregular heartbeat, kidney failure or abnormal blood results (symptoms of tumor lysis syndrome which may be caused by the rapid breakdown of tumor cells) (see section 2).
• Redness, pain or swelling at the injection site, malaise

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Carboplatino Hikma

Store at a temperature below 25°C. Do not refrigerate or freeze.
Store in the original packaging to protect from light.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date
refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Carboplatino Hikma contains

• The active ingredient is carboplatin. Each millilitre (ml) of solution contains 10 milligrams (mg) of carboplatin.
• Each vial of Carboplatino Hikma contains 50 mg, 150 mg, 450 mg and 600 mg of carboplatin.
• The other ingredients are water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Description of the appearance of Carboplatino Hikma and contents of the pack
Carboplatino Hikma is a clear and colourless infusion solution contained in a
amber glass vial closed with a rubber stopper and an aluminium cap.
The pack with 1 vial contains respectively 5 ml, 15 ml, 45 ml or 60 ml of
infusion solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, 8, 8A e 8B, Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer:
Thymoorgan Pharmazie GmbH
Schiffgraben 23, 38690 Goslar
Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Belgium Carboplatine Hikma 50 mg/5ml Solution for perfusion / Oplossing voor
Infusion / Infusionslösung
Carboplatine Hikma 150 mg/15ml Solution for perfusion / Oplossing voor
infusie / Infusionslösung
Carboplatine Hikma 450 mg/45ml Solution for perfusion / Oplossing voor
infusie / Infusionslösung
Carboplatine Hikma 600 mg/60ml Solution for perfusion / Oplossing voor
infusie / Infusionslösung
Italy Carboplatino Hikma 10 mg/ml Solution for Infusion
Portugal Carboplatina Hikma
United Kingdom Carboplatin 10 mg/ml Solution for Infusion
Spain Carboplatino Hikma 10 mg/ml Solucion para Perfusion