Oxicodone Kalceks

Leaflet accompanying the packaging: information for the user

Oxycodone Kalceks, 10 mg/ml, solution for injection/infusion

Oxycodone Kalceks, 50 mg/ml, solution for injection/infusion

Oxycodone hydrochloride

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Oxycodone Kalceks and what is it used for
• 2. Important information before using Oxycodone Kalceks
• 3. How to use Oxycodone Kalceks
• 4. Possible side effects
• 5. How to store Oxycodone Kalceks
• 6. Contents of the packaging and other information

1. What is Oxycodone Kalceks and what is it used for

This medicine has been prescribed by your doctor to relieve moderate to severe pain. The active substance is oxycodone, which has a strong analgesic effect. Oxycodone Kalceks is indicated for use only in adults.

2. Important information before using Oxycodone Kalceks

When not to use Oxycodone Kalceks:

• if the patient is allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6);
• if the patient is sensitive to morphine or other opioids;
• if the patient has breathing disorders, such as severe chronic obstructive pulmonary disease, severe asthma, or severe respiratory depression. The presence of these conditions should be diagnosed by the attending physician. Symptoms may include shortness of breath, cough, or slower or weaker breathing than expected;
• if the patient has heart disease, diagnosed as cor pulmonale (changes in the heart due to chronic lung disease);
• in cases of disorders such as improper functioning of the small intestine (intestinal obstruction) or severe abdominal pain;
• if the patient has prolonged constipation;
• if the patient is under 18 years old.

Warnings and precautions

Before starting treatment with Oxycodone Kalceks, the patient should discuss the following with their doctor, pharmacist, or nurse:

• elderly and frail patients;
• patients with reduced thyroid function (hypothyroidism) due to possible need for dose reduction;
• patients with myxedema, a condition affecting thyroid function, characterized by dry skin, decreased body temperature, swelling (edema) of the skin of the face and limbs;
• patients with head injury, severe headaches, or nausea, as this may indicate increased intracranial pressure;
• patients with low blood pressure (hypotension);
• patients with reduced blood volume (hypovolemia), which may be a consequence of severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
• patients with mental disorders caused by infections (toxic psychosis);
• patients with pancreatitis (causing severe abdominal and back pain);
• patients with gallbladder or bile duct disorders;
• patients with inflammatory bowel disease;
• men with difficulty urinating due to an enlarged prostate;
• patients with significantly impaired adrenal function (adrenal glands not functioning properly, which can cause symptoms such as weakness, weight loss, dizziness, vomiting, or nausea), e.g., Addison's disease;
• patients with breathing difficulties related to conditions such as severe lung disease. The presence of such a condition should be determined by the attending physician. Possible symptoms include shortness of breath and cough;
• patients with kidney or liver disease;
• patients with a history of symptoms resulting from withdrawal, such as agitation, anxiety, tremors, or sweating, after stopping alcohol or drug use;
• patients with increased sensitivity to pain;
• patients who need to take increasingly larger doses of Oxycodone Kalceks to relieve pain (tolerance).

The patient should consult their doctor if they experience severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disorders. Before planned surgery, the patient should inform their doctor about taking Oxycodone Kalceks. During treatment with this medicine, hormonal changes may occur. The attending physician may decide to monitor these changes. Tolerance, dependence, and addiction This medicine contains oxycodone, which is an opioid. It can cause dependence and (or) addiction. This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers can lead to reduced effectiveness of the medicine (the patient's body gets used to it, which is called tolerance). Repeated use of Oxycodone Kalceks may lead to dependence, abuse, and addiction, which can lead to life-threatening overdose. The risk of these side effects may be higher when using a higher dose for a longer period. Dependence or addiction can lead to the patient not being able to control how much medicine they take or how often they take it. The patient may feel the need to take the medicine even if it does not relieve pain. The risk of developing dependence or addiction varies from person to person. The risk of addiction or dependence on Oxycodone Kalceks may be higher if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription drugs, or street drugs ("addiction");
• the patient is a smoker;
• the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental disorders.

If the patient notices any of the following symptoms while taking Oxycodone Kalceks, it may indicate that they are developing dependence or addiction.

• need to take the medicine for a longer period than prescribed by the doctor;
• need to take a higher dose than prescribed;
• using the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep";
• making repeated, unsuccessful attempts to stop or reduce the use of the medicine;
• feeling unwell after stopping the use of the medicine and improving after resuming it ("withdrawal effect").

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop treatment (see section 3 "Stopping Oxycodone Kalceks"). Sleep breathing disorders Oxycodone Kalceks may cause sleep breathing disorders, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Oxycodone Kalceks and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription. When using this medicine with certain other medicines, the effect of this medicine or other medicines may change. Concurrent use of opioids and benzodiazepines increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible. However, if the attending physician has prescribed benzodiazepines or related medicines concurrently with opioids, the doctor should limit the dosage and duration of concurrent treatment. The patient should follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the signs and symptoms mentioned above. In case of such symptoms, the patient should contact their doctor. The risk of side effects increases if the patient is taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, elevated body temperature above 38°C. In case of the above symptoms, the patient should contact their doctor. The patient should also inform their doctor or pharmacist about taking the following medicines:

• monoamine oxidase inhibitors, even if the patient has taken this type of medicine within the last two weeks;
• medicines that help with sleep or sedatives (e.g., anxiolytics, sleep aids, or sedatives);
• medicines used to treat depression (such as paroxetine);
• medicines used to treat mental or psychiatric disorders (such as phenothiazines or neuroleptics);
• other strong painkillers;
• muscle relaxants;
• medicines used to treat high blood pressure;
• quinidine (a medicine used to treat rapid heart rate);
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole, and posaconazole);
• antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• protease inhibitors used to treat HIV infections (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin (used to treat tuberculosis);
• carbamazepine (a medicine used to treat seizures or certain types of pain);
• phenytoin (a medicine used to treat seizures or certain types of pain);
• the herbal remedy St. John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines used to treat Parkinson's disease.

The patient should also inform their doctor if they have recently undergone anesthesia.

Using Oxycodone Kalceks with alcohol and drinking

Drinking alcohol while using Oxycodone Kalceks may cause drowsiness or increase the risk of side effects, such as shallow breathing with the risk of respiratory arrest and loss of consciousness. The patient should avoid drinking alcohol while using Oxycodone Kalceks. The patient should also avoid drinking grapefruit juice while using Oxycodone Kalceks.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Data on the use of oxycodone in pregnant women are limited. Long-term use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Use of oxycodone during delivery may cause breathing difficulties in the newborn. While being treated with Oxycodone Kalceks, the patient should stop breastfeeding. Oxycodone passes into breast milk and may affect the health of the breastfed child, especially after taking multiple doses. Data on the impact of oxycodone on human fertility are not available.

Driving and using machines

This medicine may cause a range of side effects, such as drowsiness, which can affect the ability to drive and use machines (see section 4 for full information on side effects). These are usually most noticeable when the medicine is first injected or when the dose is increased. If this applies to the patient, they should not drive or operate machinery. The patient should consult their doctor or pharmacist if they are unsure whether they can drive while using this medicine.

Oxycodone Kalceks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml and is considered "sodium-free".

3. How to use Oxycodone Kalceks

The medicine will be prepared and administered by a doctor or nurse. The medicine should be used immediately after opening. The dose and frequency of administration may be adjusted according to the severity of the pain. Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Oxycodone Kalceks, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxycodone Kalceks"). Adults (over 18 years) The initial dose depends on the route of administration. The recommended initial doses are as follows:

• Intravenous single injection: The recommended dose is 1-10 mg, administered slowly over 1-2 minutes. This can be repeated every 4 hours.
• Intravenous infusion: The recommended initial dose is 2 mg per hour.
• Subcutaneous single injection: The recommended initial dose is 5 mg, repeated every 4 hours as needed.
• Subcutaneous infusion: The recommended initial dose is 7.5 mg per day.
• When using patient-controlled analgesia (PCA), the dose is calculated based on body weight (0.03 mg per kg of body weight). The doctor or nurse will determine the appropriate frequency of administration.

Children and adolescents Do not give this medicine to children and adolescents under 18 years old. Patients with liver and kidney disorders The patient should inform their doctor if they have kidney or liver disease, as the doctor may recommend a lower dose depending on the patient's condition. Do not exceed the dose recommended by the doctor. If in doubt, consult the doctor or pharmacist. If the patient still experiences pain while using the medicine, they should discuss this with their doctor.

Using a higher dose of Oxycodone Kalceks than recommended

If a higher dose of the medicine is used than recommended, the patient should immediately contact their doctor. In severe cases, overdose can lead to loss of consciousness or even death. People who have taken a higher dose of the medicine than recommended may feel drowsy, nauseous, or dizzy. They may also have difficulty breathing, leading to loss of consciousness or even death, and may require immediate hospital treatment. Overdose can lead to brain disorder (toxic leukoencephalopathy). When seeking medical help, the patient should bring this leaflet and all remaining ampoules to show the doctor. Do not stop using Oxycodone Kalceks without consulting a doctor. If it is no longer necessary to use Oxycodone Kalceks, it is recommended to gradually reduce the daily dose to avoid unpleasant side effects. If treatment is stopped abruptly, withdrawal syndrome may occur (symptoms: agitation, anxiety, palpitations, tremors, sweating). In case of further doubts about using this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although severe allergic reactions are rare. The patient should immediately inform their doctorif they experience symptoms such as sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially if these symptoms spread across the whole body. The most serious side effect is a condition in which the patient breathes more slowly or with more difficulty than they should (respiratory failure). The patient should immediately inform their doctorif this happens. As with all strong painkillers, there is a risk of dependence on this medicine.

Very common side effects (may affect more than 1 in 10 people)

• constipation (the doctor may prescribe laxatives to solve this problem)
• nausea or vomiting (these should resolve on their own after a few days, but the doctor may prescribe an anti-emetic if the symptoms do not resolve)
• drowsiness (this usually occurs after starting the medicine or after increasing the dose, but it should resolve on its own after a few days)
• dizziness
• headache
• itching of the skin

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

• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea
• confusion, depression, feeling of unusual weakness, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal thoughts or dreams
• breathing difficulties or wheezing, shortness of breath, reduced cough reflex
• rash
• sweating

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

• difficulty swallowing, belching, hiccups, gas, a condition in which the intestine does not function properly (intestinal obstruction), gastritis, changes in taste
• dizziness or feeling of "spinning", hallucinations, mood changes, unpleasant mood, feeling of extreme happiness, restlessness, agitation, general malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness of hands or feet, seizures, convulsions, blurred vision, fainting, abnormal stiffness or relaxation of muscles, involuntary muscle contractions
• difficulty urinating, impotence, decreased sex drive, low hormone levels in the blood (hypogonadism, observed in blood tests)
• rapid or irregular heartbeat, flushing of the skin
• dehydration, thirst, chills, swelling of hands, ankles, or feet
• dry skin, severe peeling or flaking of skin
• flushing of the face, decreased pupil size, muscle spasms, high body temperature
• need to take increasingly larger doses of this medicine to achieve the same level of pain relief (tolerance)
• colicky abdominal pain or discomfort
• worsening of liver function (observed in blood tests)

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

• low blood pressure
• feeling of fainting, especially when standing up
• itchy rash (hives)

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

• increased sensitivity to pain
• aggression
• sleep apnea (pauses in breathing during sleep)
• tooth decay
• amenorrhea (absence of menstruation)
• bile flow obstruction from the liver (cholestasis), which can cause itching, yellowing of the skin, very dark urine, and very pale stools
• a disorder affecting the intestinal valve, which can cause severe abdominal pain (dysfunction of the Oddi sphincter)
• long-term use of Oxycodone Kalceks during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms observed in the child include irritability, hyperactivity, and abnormal sleep pattern, high-pitched crying, tremors, vomiting, diarrhea, and failure to gain weight

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Oxycodone Kalceks

The medicine should be kept out of sight and reach of children. This medicine should be stored in a closed and secure place, inaccessible to others. It can be very harmful and may cause death if taken by someone it was not prescribed for. There are no special storage instructions for this medicine. Do not freeze. Shelf life after first opening:The medicine should be administered immediately after opening. Shelf life after dilution:Chemical and physical stability has been demonstrated for 24 hours at 25°C and 2-8°C (after dilution to 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection). From a microbiological point of view, the medicine should be administered immediately after dilution. If the medicine is not used immediately, the responsibility for the storage time and conditions before use lies with the user, and the storage time should generally not exceed 24 hours if the solution is stored at a temperature between 2°C and 8°C, unless dilution takes place in controlled and validated aseptic conditions. Do not use this medicine if visible signs of deterioration are observed (e.g., particles in the solution). Do not use this medicine after the expiry date stated on the label and carton after (EXP). The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Oxycodone Kalceks contains

Oxycodone Kalceks 10 mg/ml:

• The active substance of the medicine is oxycodone hydrochloride. One 1 ml ampoule contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone). One 2 ml ampoule contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone).

Oxycodone Kalceks 50 mg/ml:

• One 1 ml ampoule contains 50 mg of oxycodone hydrochloride (equivalent to 45 mg of oxycodone).

Other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injection.

What Oxycodone Kalceks looks like and contents of the pack

Clear, colorless solution for injection/infusion, free from visible particles. Oxycodone Kalceks is available in colorless glass ampoules of 1 ml and 2 ml, in a cardboard box. The ampoules are marked with a special code in the form of a ring of a different color for each strength and volume. Pack sizes: Oxycodone Kalceks 10 mg/ml5, 10, or 25 ampoules of 1 ml 5 or 10 ampoules of 2 ml Oxycodone Kalceks 50 mg/ml5 or 10 ampoules of 1 ml Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS Krustpils iela 71E, 1057 Rīga, Latvia Tel.: +371 67083320 E-mail: kalceks@kalceks.lv

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Estonia Oxycodone Kalceks Germany Oxycodon Ethypharm Kalceks 10 mg/ml Injektions-/Infusionslösung Oxycodon Ethypharm Kalceks 50 mg/ml Injektions-/Infusionslösung Denmark Oxycodone Kalceks Finland Oxycodone Kalceks France OXYCODONE KALCEKS 10 mg/mL, solution injectable/pour perfusion OXYCODONE KALCEKS 50 mg/mL, solution injectable/pour perfusion Ireland Oxycodone Hydrochloride 10 mg/ml, 50 mg/ml solution for injection/infusion Lithuania Oxycodone Kalceks 10 mg/ml, 50 mg/ml injekcinis ar infuzinis tirpalas Latvia Oxycodone Kalceks 10 mg/ml, 50 mg/ml šķīdums injekcijām/infūzijām Netherlands Oxycodon Kalceks 10 mg/ml, 50 mg/ml oplossing voor injectie/infusie Norway Oxycodone Kalceks Poland Oxycodone Kalceks Sweden Oxycodone Kalceks United Kingdom (Northern Ireland) Oxycodone Hydrochloride 10 mg/ml solution for injection/infusion Oxycodone Hydrochloride 50 mg/ml solution for injection/infusion

Date of last revision of the leaflet: February 2025

------------------------------------------------------------------------------------------------------------------------ Information intended for healthcare professionals only: Dosage The dosage should be adjusted according to the severity of the pain, the patient's overall condition, and the medicines used previously and currently. Adults over 18 years oldThe following initial doses are recommended. Gradual increase in dose may be necessary if the analgesic effect is insufficient or if the pain intensity increases. Intravenous, iv.(bolus): The medicine should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection. It is recommended to administer 1-10 mg of oxycodone hydrochloride slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours. Intravenous, iv.(infusion): The medicine should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection. The recommended initial dose is 2 mg per hour. Intravenous, iv.(PCA): The medicine should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection. The dose is 0.03 mg/kg of body weight, administered slowly over 1-2 minutes (PCA - patient-controlled analgesia). Subcutaneous, sc.(bolus): The recommended concentration is 10 mg/ml. Oxycodone Kalceks 50 mg/ml should be diluted in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection. The recommended initial dose is 5 mg, and the dose can be repeated every 4 hours. Subcutaneous, sc.(infusion): If necessary, the medicine should be diluted in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection. The initial dose of 7.5 mg per day is recommended for patients not previously treated with opioids. The dose should be gradually increased according to the symptoms. Patients with cancer who have been switched from oral oxycodone to parenteral oxycodone may require a much higher dose (see below). Switching from oral to parenteral oxycodone:The following conversion ratio can be used: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is a guideline for the required dose. Due to differences between patients, the appropriate dose should be selected individually. The patient should be closely monitored to achieve a stable condition after switching the opioid formulation. Switching from intravenous morphine to intravenous oxycodone:In patients who have received intravenous morphine before intravenous oxycodone, the daily dose should be determined based on a 1:1 equivalence ratio. It should be emphasized that this is a guideline for the required dose. Due to differences between patients, the appropriate dose should be selected individually. The patient should be closely monitored to achieve a stable condition after switching the opioid formulation. Elderly patientsIn elderly patients, treatment should be started with caution. The smallest dose should be administered and gradually increased to control the pain. Patients with renal and hepatic impairment:In these patients, the initial dose should be determined with caution, on a conservative basis. The recommended initial dose for adults should be reduced by 50% (e.g., total daily dose of 10 mg orally in patients not previously treated with opioids), then the effective dose should be estimated individually for the patient, taking into account the patient's clinical situation (see section 5.2). Children and adolescentsThere are no data on the use of oxycodone in the form of injections in patients under 18 years old. Use in non-cancer pain:Opioids are not the treatment of choice for chronic non-cancer pain, nor are they recommended as the only treatment method. The types of chronic pain for which the effectiveness of strong opioids has been demonstrated include chronic pain caused by degenerative joint disease and intervertebral disc disease. The need for further treatment of non-cancer pain should be regularly reassessed. Endocrine systemOpioids may affect the hypothalamic-pituitary-adrenal or gonadal axis. Some changes that may be observed include increased prolactin levels in serum and decreased cortisol and testosterone levels in serum. These hormonal changes may cause clinical symptoms. Combination therapy:Enhanced central nervous system depressant effects may occur, which can cause deep sedation, respiratory failure, coma, and death when this medicine is used concurrently with benzodiazepines or other central nervous system depressants, such as sedatives, hypnotics, or anxiolytics. Duration of treatment:Oxycodone should not be used for longer than necessary. Stopping treatment:When the patient no longer requires treatment with oxycodone, it may be advisable to gradually reduce the dose to prevent withdrawal symptoms. Administration Subcutaneous injection or infusion. Intravenous injection or infusion.

Incompatibilities

Cyclizine at concentrations of 3 mg/ml or less, when mixed with Oxycodone Kalceks, undiluted or diluted with water for injection, does not cause precipitation of a sediment within 24 hours at room temperature. Precipitation of a sediment has been observed in mixtures of oxycodone injection with cyclizine at concentrations exceeding 3 mg/ml or after dilution with 9 mg/ml (0.9%) sodium chloride solution. However, if the dose of Oxycodone Kalceks is small, and the solution is sufficiently diluted with water for injection, concentrations greater than 3 mg/ml can be used. It is recommended to use water for injection as a diluent when cyclizine and oxycodone hydrochloride are administered concurrently by intravenous or subcutaneous infusion. Prochlorperazine is chemically incompatible with Oxycodone Kalceks.

Instructions for use/handling

Each ampoule is intended for single use in one patient. The medicine should be used immediately after opening the ampoule, and all unused remnants of the medicine should be discarded. Do not use if signs of deterioration are visible (e.g., solid particles). Chemical and physical stability has been demonstrated for 24 hours at 25°C and 2-8°C. From a microbiological point of view, the medicine should be administered immediately after dilution. If the medicine is not used immediately, the responsibility for the storage time and conditions before use lies with the user, and the storage time should generally not exceed 24 hours if the solution is stored at a temperature between 2°C and 8°C, unless dilution takes place in controlled and validated aseptic conditions. Oxycodone Kalceks 10 mg/ml, undiluted or diluted to a concentration of 1 mg/ml with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection, and Oxycodone Kalceks 50 mg/ml, undiluted or diluted to a concentration of 3 mg/ml with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injection, is physically and chemically stable in contact with representative brands of polypropylene or polyethylene syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags for 24 hours at room temperature (25°C) and at 2-8°C. Oxycodone Kalceks, both undiluted and diluted in infusion fluids used in these studies, does not need to be protected from light. The medicine is also compatible with the following medicines: hyoscine butylbromide, hyoscine hydrobromide, dexamethasone sodium phosphate, haloperidol, midazolam hydrochloride, metoclopramide hydrochloride, levomepromazine hydrochloride, glycopyrronium bromide, ketamine hydrochloride. Improper handling of the undiluted medicine after opening the ampoule, as well as the diluted solution, may compromise the sterility of the product.