Oxaliplatino hikma 5 mg/ml concentrado para solucion para perfusion efg
Introduction
Product Information for the User
Oxaliplatino Hikma 5 mg/ml Concentrate for Solution for Infusion EFG
Read this entire product information carefully before starting to use this medicine, as it contains important information for you.
- Keep this product information, as you may need to read it again.
If you have any questions, consult your doctor or nurse. - This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information. See section 4.
1. What is Oxaliplatino Hikma and how is it used
2. What you need to know before starting to use Oxaliplatino Hikma
3. How to use Oxaliplatino Hikma
4. Possible adverse effects
5. Storage of Oxaliplatino Hikma
6. Contents of the container and additional information
1. What is Oxaliplatino Hikma and what is it used for
Oxaliplatino Hikmais a cancer medication and contains the active ingredient oxaliplatino.
Oxaliplatino is used to treat colon cancer after surgery or when it has spread.
This medication is used in combination with other cancer medications called 5-fluorouracil (5-FU) and folinic acid (FA).
2. What you need to know before starting to use Oxaliplatino Hikma
No use Oxaliplatino Hikma:
- if you areallergicto oxaliplatino or any of the other components of this medication (listed in section 6).
- if you are in thelactation period.
- if you already have areduced number of blood cells.
- if you already suffer fromtingling or numbness in the fingers of the hand and feetand havedifficulty performing delicate tasks, such as buttoning a shirt.
- if you have anyserious kidney disease.
Warnings and Precautions
Consult your doctor or pharmacist before starting to receive Oxaliplatino Hikma: If you have ever had an allergic reaction to medications containing platinum, such as carboplatino and cisplatino. Allergic reactions can occur during oxaliplatino infusion.
- If you have anymild or moderate kidney disorder.
- If you have any liver problems or abnormal liver activity test results during your treatment.
- If you have or have had heart problems, such as an abnormal electrical signal called prolonged QT interval, irregular heartbeat, or family history of heart problems.
- If you have been administered or are planned to be administered any vaccine. During treatment with oxaliplatino, you should not be vaccinated with live or attenuated vaccines, such as the yellow fever vaccine.
Other Medications and Oxaliplatino Hikma
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Pregnancy, Lactation, and Fertility
Pregnancy
- It is not recommended that you become pregnant during treatment with oxaliplatino and you should use an effective contraceptive method. Patients should take appropriate contraceptive measures during treatment and for 4 months after its completion.
- If you are pregnant or thinking of becoming pregnant, it is very important that you discuss this with your doctorbeforereceiving any treatment.
- If you become pregnant during treatment, you should inform your doctor immediately.
Lactation
- Stop breastfeeding during treatment with oxaliplatino
Fertility
- Oxaliplatino may affect fertility in an irreversible way. Male patients should seek advice on sperm conservation before treatment.
- Warn male patients not to have children during treatment and for 6 months after treatment and take appropriate contraceptive measures during this time.
Consult your doctor or pharmacist before taking any medication.
Driving and Operating Machines
Treatment with oxaliplatino may increase the risk of experiencing dizziness, nausea, and vomiting, as well as other neurological symptoms that may affect walking and balance. If you are affected by any of these symptoms, do not drive or operate machines. If you experience vision problems while on treatment with oxaliplatino, do not drive, operate heavy machinery, or engage in hazardous activities.
3. How to Use Oxaliplatino Hikma
This medication will be administered by medical personnel; do not use it yourself.
Oxaliplatino is only indicated for adults.
Dose
The dose of Oxaliplatino depends on your body surface area, which is calculated from your height and weight.
The usual dose in adults (including elderly patients) is 85 mg/m2 of body surface area. The dose you receive will also depend on the results of blood tests and if you have previously experienced adverse effects with this medication.
Form and route of administration
- Oxaliplatino will be prescribed by a specialist doctor in cancer treatment.
- You will be treated by a healthcare professional, and this person will have calculated the dose of medication you need.
- Oxaliplatino is administered through a slow injection into a vein (intravenous infusion) over a period of 2-6 hours. If you feel a sense of discomfort or pain at the injection site, inform the healthcare professionals immediately.
- This medication will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.
Frequency of administration
Generally, you will receive an infusion every 2 weeks.
Duration of treatment
Your doctor will determine the duration of treatment.
Your treatment will last a maximum of 6 months when used after complete tumor resection.
If you use more Oxaliplatino Hikma than you should
Since this medication will be administered by a healthcare professional, it is unlikely that you will receive too much or too little medication.
In the event of an overdose, you may experience an increase in adverse effects. Your doctor may give you the appropriate treatment for these adverse effects.
If you forgot to take Oxaliplatino Hikma
Your doctor will decide at what time you will receive this medication. If you think you have forgotten a dose, contact your doctor as soon as possible.
If you have any questions about your treatment, consult your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, it is very important that you inform your doctor before starting the next treatment.
Inform your doctor immediately if you experience any of the following symptoms:
- Signs of an allergic reaction or anaphylaxis, accompanied by sudden symptoms such as rash, itching, or hives on the skin, difficulty swallowing, swelling of the face, lips, tongue, or other parts of the body, difficult breathing, wheezing, or difficulty breathing, extreme fatigue (you may feel like you are going to faint). These symptoms usually occur during infusion or shortly after, but delayed allergic reactions have also been observed hours or even days after infusion (very common).
- Abnormal bruises, bleeding, or signs of infection, such as sore throat and fever (very common).
- Persistent or severe diarrhea or vomiting (very common).
- Respiratory symptoms such as dry or wet cough, difficulty breathing, or crepitations (very common), difficulty breathing and wheezing, which may be indicative of a severe lung disease that can be fatal.
- Stomatitis/mucositis (lips and mouth sores) (very common).
- Presence of blood or dark brown particles in vomit (frequent).
- A set of symptoms such as headache, altered mental activity, seizures, and abnormal vision (from blurred vision to loss of vision) (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder) (rare).
- Stroke symptoms (which include sudden and severe headache, confusion, difficulty seeing with one or both eyes, numbness or weakness of the face, arm, or leg on one side, dropped face, difficulty walking, dizziness, loss of balance, and difficulty speaking).
- Extreme fatigue, accompanied by a decrease in red blood cell count and shortness of breath (hemolytic anemia) (rare), alone or accompanied by a decrease in platelet count, abnormal cardinals (thrombocytopenia) (rare), and kidney problems where little or no urine is produced (symptoms of hemolytic uremic syndrome) (unknown frequency).
- Tickling and/or numbness in the fingers of the hands and feet, around the mouth or throat, which sometimes occurs in association with cramps and can also lead to difficulty performing delicate tasks, such as buttoning a shirt (symptoms of peripheral neuropathy) (very common).
Other side effects ofOxaliplatino Hikmaare:
Very common(may affect more than 1 in 10 people)
- Oxaliplatino can affect the nerves (peripheral neuropathy). You may feel tingling or numbness in the fingers of the hands and feet, around the mouth or throat, which sometimes occurs in association with cramps.
These side effects are usually triggered by exposure to cold, such as opening the refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks, such as buttoning a shirt. Although in most cases these symptoms resolve completely on their own, there is a possibility that the symptoms of peripheral sensory neuropathy may persist after completing treatment.
Some people have experienced sudden tingling in the arms or trunk when flexing the neck.
- Oxaliplatino can cause an unpleasant sensation in the throat, specifically when swallowing, and can give the sensation of lack of air. This sensation, if it occurs, usually happens during infusion or in the hours following and can be triggered by exposure to cold.
Although it is unpleasant, it does not last long and disappears without the need for treatment. Your doctor may decide to modify your treatment as a result of this.
- Oxaliplatino can cause diarrhea, mild nausea (feeling of dizziness) and vomiting (indisposition). However, your doctor will give you a treatment to prevent this discomfort before starting treatment and it should be continued after treatment.
- Oxaliplatino can cause a temporary reduction in the number of blood cells. The decrease in red blood cells can cause anemia (decrease in red blood cell count), abnormal bleeding or appearance of petechiae (due to a decrease in platelet count). The decrease in white blood cell count can facilitate the appearance of infections.
Before starting treatment and before each cycle of treatment, your doctor will perform a blood test to check that you have a sufficient number of cells in your blood.
- Sensation of discomfort around or at the injection site during infusion.
- Fever, chills (shivering), mild or extreme fatigue, body pain.
- Weight changes, loss or lack of appetite, taste alterations, constipation.
- Headache, back pain.
- Muscle inflammation, neck stiffness, abnormal sensation in the tongue that can make speaking difficult.
- Abdominal pain
- Unusual bleeding, including nosebleed.
- Cough, difficulty breathing.
- Allergic reactions, red rash that can be itchy, moderate hair loss (alopecia).
- Alterations in blood tests, including changes in liver function tests.
Common(may affect up to 1 in 10 people)
- Infection due to a decrease in white blood cell count.
- Severe blood infection, in addition to a decrease in white blood cell count (neutropenic sepsis) that can be fatal.
- Decrease in white blood cell count, accompanied by fever >38.3 °C or prolonged fever
>38 °C for more than an hour (febrile neutropenia).
- Indigestion and heartburn, hiccups, dizziness.
- Increased sweating and nail alterations, skin peeling.
- Chest pain.
- Pulmonary alterations and coughing.
- Joint pain and bone pain.
- Urinary pain and kidney function alterations, changes in urination frequency, dehydration.
- Blood in urine/stool, venous inflammation, pulmonary embolism.
- High blood pressure.
- Depression and insomnia.
- Conjunctivitis and vision problems.
- Decreased calcium levels in the blood.
- Fall.
Rare(may affect up to 1 in 100 people)
- Severe blood infection (sepsis) that can be fatal.
- Intestinal obstruction or inflammation.
- Anxiety.
Rare(may affect up to 1 in 1,000 people)
- Loss of hearing.
- Formation of scars and thickening of the lungs, accompanied by difficulty breathing, which sometimes is fatal (interstitial lung disease).
- Temporary and reversible loss of vision.
- Bleeding or unexpected bruises due to the dissemination of blood clots in the small blood vessels of the body (disseminated intravascular coagulation), which can be fatal.
Very rare(may affect up to 1 in 10,000 people)
- Kidney problems that make you urinate very little or not at all (symptoms of acute renal failure).
- Liver vascular disorders.
Unknown frequency(cannot be estimated from available data)
- Allergic vasculitis (inflammation of blood vessels).
- Autoimmune reaction that causes a decrease in all blood cell lines (pancytopenia autoimmune), pancytopenia.
- Severe blood infection or low blood pressure (septic shock), which can be fatal.
- Seizures (uncontrolled body agitation).
- Throat spasm that can cause difficulty breathing.
- Extreme fatigue, accompanied by a decrease in red blood cell count and shortness of breath (hemolytic anemia), alone or accompanied by a decrease in platelet count, and kidney problems that make you urinate little or not at all (symptoms of hemolytic uremic syndrome), which can be fatal.
- Abnormal heart rhythm (prolongation of the QT interval), which can be observed on the electrocardiogram (ECG) and can be fatal.
- Myocardial infarction (heart attack), angina (chest pain or discomfort)
- Muscle pain and swelling, accompanied by weakness, fever, or brownish-red urine (symptoms of a muscle damage called rhabdomyolysis), which can be fatal.
- Esophageal inflammation (inflammation of the inner lining of the esophagus - the tube that connects the mouth to the stomach - which causes pain and difficulty swallowing).
- Gastrointestinal ulcers, with possible bleeding or perforation, which can be fatal.
- Intestinal ischemia (decreased blood flow to the intestine), which can be fatal.
- Risk of new cancers. Leukemia, a type of blood cancer, has been reported in patients after taking oxaliplatine in combination with certain other medications. Talk to your doctor about the potential risk of increased risk of this type of cancer when taking oxaliplatine and certain other medications.
- Abnormal liver nodules, non-cancerous (focal nodular hyperplasia).
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Oxaliplatino Hikma
Keep this medication out of the sight and reach of children.
Oxaliplatino should not come into contact with the eyes or skin. In the event of an accidental spill, inform the doctor or nurse immediately.
Before mixing this medication, it must be stored in its original container to protect it from light and should not be frozen. Store below 25°C.
Do not use this medication after the expiration date that appears on the box and on the vial label after CAD. The expiration date is the last day of the month indicated.
Once the infusion has been completed, the doctor or nurse will dispose of this medication with the necessary safety measures.
6. Contents of the packaging and additional information
Composition of Oxaliplatino Hikma
- The active ingredient is oxaliplatino.
- The other components are water for injection.
Aspect of the product and content of the packaging
The solution is transparent, colorless, and free of visible particles in suspension.
Each milliliter of solution contains 5 mg of the active ingredient oxaliplatino.
This medication is a concentrate for solution for infusion.
Each vial of 10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatino.
Each vial of 20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatino.
Each vial of 40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatino.
Packaging sizes:
50mg/10ml: 1 vial
100mg/20ml: 1 vial
200mg/40ml: 1 vial
With or without a plastic protective wrapper.
Only some packaging sizes may be commercially available.
Marketing Authorization Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença
2705-906 Terrugem SNT
Portugal
Responsible for manufacturing
Thymoorgan Pharmazie GmbH
Schiffgraben 23
38690 Goslar
Germany
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain
This medication is authorized in the member states of the European Economic Area with the following names:
Germany/Austria | Oxaliplatin Hikma 5 mg/ml Concentrate for the preparation of an infusion solution |
Spain | Oxaliplatino Hikma 5 mg/ml Concentrate for solution for infusion EFG |
France | Oxaliplatine Hikma 5 mg/ml Solution to be diluted for infusion |
Italy | Oxaliplatino Hikma 5 mg/ml |
Netherlands | Oxaliplatin Hikma 5 mg/ml concentrate for infusion solution |
Portugal | Oxaliplatina Hikma |
United Kingdom/Northern Ireland | Oxaliplatin 5 mg/ml Concentrate for Solution for infusion |
Last review date of this leaflet:March 2022
For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/
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This information is intended only for healthcare professionals:
Special precautions for handling and disposal
As with other potentially toxic compounds, extreme caution should be taken during handling and preparation of solutions containing oxaliplatino.
Handling instructions for the drug
The handling of this cytotoxic agent by healthcare personnel requires taking precautions to ensure the protection of the handler and the work area.
The preparation of injectable solutions of cytotoxic agents should be performed by qualified personnel in a dedicated area, in conditions that ensure the integrity of the drug, protection of the environment, and, in particular, protection of personnel handling the drug, in accordance with hospital regulations. A dedicated preparation area is required. Smoking, eating, or drinking is prohibited in this area.
Personnel should be equipped with appropriate materials for handling the medication, such as gloves, a protective mask, a hat, protective glasses, disposable sterile gloves, a protective suit for the work area, containers, and waste bags.
Feces and vomit should be handled with care.
Pregnant women should avoid handling cytotoxic agents.
Any broken container should be treated with the same precautions and considerations as contaminated waste. Contaminated waste should be incinerated in rigid containers properly labeled. See the sectionDisposalbelow.
If the concentrate or oxaliplatino infusion solution comes into contact with the skin, wash the affected area immediately with plenty of water.
If the concentrate or oxaliplatino infusion solution comes into contact with mucous membranes, wash the affected area immediately with plenty of water.
Special precautions for administration
- DO NOT use aluminum-containing injection material.
- DO NOT administer without dilution.
- Only use a 5% glucose solution as a diluent. DO NOT dilute with sodium chloride or chloride-containing solutions.
- DO NOT mix with other medications in the same infusion bag or administer simultaneously through the same infusion route.
- DO NOT mix with alkaline solutions, specifically 5-fluorouracil or folinic acid preparations containing trometamol as an excipient and trometamol salts of other medications. Alkaline solutions will negatively affect the stability of oxaliplatino.
Instructions for use with folinic acid (such as calcium folinate or sodium folinate)
The intravenous infusion of 85 mg/m2of oxaliplatino in 250-500 ml of 5% glucose solution is administered at the same time as folinic acid (FA) diluted in a 5% glucose solution during 2-6 hours, using a Y-connector placed just before the infusion point. These two medications should not be combined in the same infusion bag. Folinic acid should not contain trometamol as an excipient and should only be diluted in an isotonic 5% glucose solution, and never in alkaline solutions or sodium chloride or chloride-containing solutions.
Instructions for use with 5-fluorouracil
Oxaliplatino should always be administered before fluoropyrimidines, such as 5-fluorouracil
After administering oxaliplatino, rinse the infusion site and then administer 5-fluorouracil.
For detailed information on the concurrent administration of medications, see the corresponding Technical Dossier.
Concentrate for infusion solution
Visually inspect the vial before use. Only solutions that are transparent and free of particles in suspension should be used.
This medication is for single use only. Any remaining concentrate should be discarded.
Dilution for intravenous infusion
Withdraw the required volume of concentrate from the vials and then dilute it with 250-500 ml of a 5% glucose solution to administer a concentration of oxaliplatino not less than 0.25 mg/ml.
Administer by intravenous infusion.
From a microbiological point of view, the infusion solution should be used immediately.
If not used immediately, the time and conditions of conservation prior to use are the responsibility of the user and should not exceed 24 hours at 2-8 °C, unless the dilution has been performed under controlled and validated aseptic conditions.
Chemical and physical stability has been demonstrated in use when diluted to concentrations of 0.25 mg/ml and with 5% glucose solution for 24 hours at 2-8 °C, as well as for 6 hours at 20-25 °C when diluted to a concentration of 0.25 mg/ml with 5% glucose solution.
Visually inspect the vial before use. Only solutions that are transparent and free of particles in suspension should be used.
This medication is for single use only. Any remaining infusion solution should be discarded (see the sectionDisposalbelow).
DO NOT useNEVERchloride-containing solutions or solutions containing chloride in the dilution.
Infusion
Oxaliplatino administration does not require prehydration.
Oxaliplatino diluted in 250-500 ml of a 5% glucose solution to obtain a concentration not less than 0.25 mg/ml should be infused through a central or peripheral vein over 2-6 hours. When administering oxaliplatino with 5-fluorouracil (5-FU), the infusion of oxaliplatino should precede that of 5-fluorouracil (5-FU).
Disposal
Dispose of unused medication and all materials that have come into contact with it during dilution and administration in accordance with local regulations on cytotoxic agents, in compliance with local legal requirements for the disposal of hazardous waste.
Dosage
Only for adults
The recommended dose of oxaliplatino for adjuvant treatment is 85 mg/m2by intravenous administration, repeated every two weeks for 12 cycles (6 months).
The recommended dose of oxaliplatino for metastatic colorectal cancer is 85 mg/m2by intravenous administration, repeated every two weeks, until disease progression or unacceptable toxicity occurs.
The administered dose should be adjusted according to tolerance (see section 4.4 Advertencias and precautions for use in the corresponding Technical Dossier).
Oxaliplatinoshould always be administered before fluoropyrimidines,such as 5-fluorouracil (5-FU).
Oxaliplatino is administered as an intravenous infusion of 2-6 hours' duration, diluted in 250-500 ml of a 5% glucose solution (50 mg/ml) to obtain a concentration of 0.2-0.7 mg/ml; in clinical practice, 0.7 mg/ml is the maximum concentration for a dose of oxaliplatino of 85 mg/m2.
Shelf life
Medicament packaged for sale: 24 months.
Stability in use, after dilution
From a microbiological point of view, the infusion solution should be used immediately.
If not used immediately, the time and conditions of conservation prior to use are the responsibility of the user and should not exceed 24 hours at 2-8 °C, unless the dilution has been performed under controlled and validated aseptic conditions.
Chemical and physical stability has been demonstrated in use when diluted to concentrations of 0.25 mg/ml and with 5% glucose solution for 24 hours at 2-8 °C, as well as for 6 hours at 20-25 °C when diluted to a concentration of 0.25 mg/ml with 5% glucose solution.
Special storage precautions
Store the vial in the outer packaging to protect it from light. Do not freeze.
Store below 25°C.
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