Morphini sulfas wzf

Package leaflet: Information for the patient

MORPHINI SULFAS WZF, 10 mg/ml, solution for injection
MORPHINI SULFAS WZF, 20 mg/ml, solution for injection
Morphini hemisulfas 2,5-hydricus
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Morphini sulfas WZF is and what it is used for
2. Important information before using Morphini sulfas WZF
3. How to use Morphini sulfas WZF
4. Possible side effects
5. How to store Morphini sulfas WZF
6. Contents of the pack and other information

1. What Morphini sulfas WZF is and what it is used for

Morphini sulfas WZF contains morphine, a very potent analgesic.
Morphine belongs to a group of medicines called opioid analgesics.
Morphini sulfas WZF is intended for subcutaneous, intramuscular, and intravenous administration.
Upon medical advice, the medicine may be administered orally to adult patients after dilution with water.
Morphini sulfas WZF is used to treat acute and chronic pain of varying intensity, from moderate to severe. Morphine is used in postoperative and chronic pain, most commonly of neoplastic origin, except for pain caused by smooth muscle spasm, e.g. hepatic colic.

2. Information before using Morphini sulfas WZF

When not to use Morphini sulfas WZF:

• if the patient is allergic to morphine, other opioid medicines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has difficulty breathing or a disease causing breathing difficulties or shortness of breath (known as upper airway obstructive disease);
• if the patient has acute pain in the upper right abdomen under the ribs (which may be a sign of hepatic colic);
• if the patient has acute alcohol intoxication;
• if the patient is taking or has taken within the last 2 weeks antidepressant medicines known as monoamine oxidase inhibitors (MAOIs);
• if the patient has conditions associated with seizures;
• if the patient has suffered a head injury;
• if the patient has acute abdomen syndrome (symptoms: severe abdominal pain with bloating, nausea, vomiting, constipation);
• if the patient has a phaeochromocytoma (a tumour located in the glands situated above the kidneys);
• if the patient has increased intracranial pressure (symptoms, e.g., headache, disturbances in consciousness and balance, visual disturbances);
• if the patient is in a coma.

Tolerance, dependence and abuse
This medicine contains morphine, which is an opioid medicine. Repeated use of opioids may
lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as
tolerance). Repeated use of Morphini sulfas WZF may also lead to dependence, abuse and
habit-forming use, which may result in life-threatening overdose. The risk of these adverse
effects may increase with increasing dose and prolonged duration of use.
Dependence or habit-forming use may cause the patient to feel a loss of control over how much
medicine should be taken or how often it should be taken.
The risk of dependence or habit-forming use varies between individuals. The risk of dependence
on Morphini sulfas WZF or its habit-forming use may be higher if:

• the patient or any of their relatives have ever abused or been dependent on alcohol, prescription medicines or drugs ("addiction");
• the patient smokes cigarettes;
• the patient has ever had mood disorders (depression, anxiety disorders or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur while taking Morphini sulfas WZF, they may indicate
dependence or habit-forming use:

• the patient needs to take this medicine for longer than prescribed by the doctor;
• the patient needs to take a higher dose than prescribed;
• the patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g., "to calm down" or "to be able to sleep";
• the patient has made several unsuccessful attempts to stop or control the use of this medicine;
• after stopping the medicine, the patient feels unwell, and well-being improves when the medicine is taken again ("withdrawal effect"). If any of these symptoms are observed, discuss with the doctor the best treatment strategy for the patient, including when it is appropriate to discontinue treatment and how it can be safely stopped (see section 3 "Discontinuing use of Morphini sulfas WZF").

Warnings and precautions
Before starting Morphini sulfas WZF, consult a doctor, pharmacist or nurse.
Acute generalised exanthematous pustulosis (AGEP) has been reported during treatment with Morphini sulfas WZF. Symptoms usually occur within the first 10 days of treatment. Inform the doctor if, after taking Morphini sulfas WZF or other opioids, the patient has ever experienced severe skin rash, skin peeling, blisters and/or mouth ulcers. Morphini sulfas WZF should be discontinued and medical advice sought immediately if the patient notices any of the following symptoms: appearance of blisters, extensive skin peeling or pustular lesions accompanied by fever.
Breathing disorders during sleep
Morphini sulfas WZF may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact the doctor. The doctor may consider reducing the dose.
Consult the doctor if the patient experiences severe upper abdominal pain radiating to the back, nausea, vomiting or fever, as these may be symptoms related to pancreatitis and biliary tract disease.
If any of the following symptoms occur during treatment with Morphini sulfas WZF, consult the doctor:

• Increased sensitivity to pain despite increasing the dose of the medicine (hyperalgesia). The doctor will decide whether a dosage adjustment or a stronger analgesic is needed (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure. These may be symptoms of adrenal insufficiency (inadequate cortisol production), and hormone supplementation may be necessary.
• Loss of libido, impotence, amenorrhea. This may be due to reduced secretion of sex hormones.
• If the patient has previously been dependent on drugs or alcohol. Also inform the doctor if the patient notices signs of dependence on Morphini sulfas WZF during treatment, e.g., when starting to frequently think about taking another dose even when not needed for pain relief.
• Symptoms of withdrawal or dependence. The most common withdrawal symptoms are listed in section 3. In such cases, the doctor may change the medicine or adjust the interval between doses.

The doctor will exercise particular caution and take appropriate measures in patients:

• with reduced thyroid function (hypothyroidism);
• with reduced adrenal cortex function (insufficient hormone production);
• with asthma or other breathing problems, e.g., emphysema;
• with benign prostatic hyperplasia or difficulty urinating;
• with low blood pressure;
• in shock (sudden drop in blood pressure and reduced blood flow to body tissues);
• with inflammatory bowel diseases or impaired intestinal patency;
• with muscle weakness (myasthenia);
• abusing drugs;
• weakened or debilitated by illness;
• with biliary tract disorders (morphine may worsen pain symptoms);
• with impaired liver function;
• with impaired kidney function;
• of advanced age.

Children and adolescents
Morphini sulfas WZF can be used in children and adolescents (see section 3: "How to use Morphini sulfas WZF"). In case of any doubts, consult the doctor.
Morphini sulfas WZF and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
This is particularly important when using the following medicines:

• Rifampicin, used in the treatment of, e.g., tuberculosis.

• Concomitant use of Morphini sulfas WZF and sedative medicines, e.g., benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression) or coma, which may be life-threatening. Therefore, combined treatment should only be considered when no other treatment options are available. If Morphini sulfas WZF is used together with sedative medicines, the doctor should limit the dose and duration of concomitant use. The patient should inform the doctor about all sedative medicines being taken and strictly follow the prescribed dose. It may be helpful to inform a relative or close friend about the possibility of these symptoms occurring. If the described symptoms occur, consult the doctor.

• Certain medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken together with morphine.

• Gabapentin or pregabalin, used in the treatment of epilepsy and nerve-related pain (neuropathic pain), may interact with injectable morphine sulfate, which may significantly alter their effects.

The following may affect morphine's action:

• monoamine oxidase inhibitors (antidepressants), e.g., moclobemide, especially if the patient has taken these medicines within the last 2 weeks. Do not use medicines from this group with morphine – see section 2, subsection: "When not to use Morphini sulfas WZF";
• tricyclic antidepressants, e.g., amitriptyline;
• sleeping medicines, e.g., phenobarbital;
• sedatives, anxiolytics, e.g., diazepam;
• phenothiazine derivatives, e.g., promethazine, chlorpromazine;
• blood pressure-lowering medicines;
• smooth muscle relaxants and heart rhythm regulators, e.g., atropine;
• ciprofloxacin (an antibiotic used in bacterial infections);
• medicines accelerating gastrointestinal transit, e.g., cisapride, antiemetics (metoclopramide, domperidone);
• medicines used in Parkinson's disease, e.g., selegiline;
• mexiletine (a medicine for heart rhythm disorders);
• cimetidine (a medicine for gastric or duodenal ulcers). Anaesthetic medicines enhance the sedative effect of morphine. If the patient has recently received such medicines or had surgery, they should inform the doctor.

Morphini sulfas WZF and alcohol
Avoid drinking alcohol while taking morphine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a
child, she should consult her doctor or pharmacist before using this medicine.

• The decision on using morphine during pregnancy and breastfeeding will be made by the doctor.
• If Morphini sulfas WZF has been used during pregnancy for a prolonged period, there is a risk that the newborn may develop withdrawal syndrome symptoms, which should be treated by a doctor.
• Use of Morphini sulfas WZF during labour is not recommended. Newborns born to mothers who have taken morphine long-term may develop withdrawal symptoms – see section 3, subsection: "Discontinuing use of Morphini sulfas WZF".

Driving and operating machinery
Morphine may cause drowsiness and impair psychomotor performance. Patients should not drive or operate machinery while taking this medicine.
Morphini sulfas WZF contains sodium metabisulphite (E 223) and sodium
This medicine contains sodium metabisulphite (E 223) – rarely may cause severe hypersensitivity reactions and bronchospasm (symptoms: shortness of breath, wheezing, cough).
Patients with a history of allergic reactions should inform their doctor.
Morphini sulfas WZF, 10 mg/ml contains 0.148 mmol/ml (3.40 mg/ml) of sodium, i.e., less than 1 mmol (23 mg) of sodium per 1 ml of solution, meaning the medicine is considered "sodium-free".
Morphini sulfas WZF, 20 mg/ml contains 0.130 mmol/ml (2.99 mg/ml) of sodium, i.e., less than 1 mmol (23 mg) of sodium per 1 ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Morphini sulfas WZF

Morphini sulfas WZF is administered by medical personnel.
Before starting treatment and regularly during therapy, your doctor will discuss with you what to
expect from using Morphini sulfas WZF, when and for how long it should be used, when to contact a doctor,
and when to stop using the medicine (see also "Discontinuation of Morphini sulfas WZF" in this section).

• The morphine dosage is individually determined by the doctor for each patient.
• Morphini sulfas WZF is administered to adult patients subcutaneously, intramuscularly, or intravenously; the doctor may recommend diluting the ampoule contents with water and oral administration.
• Morphini sulfas WZF may be administered to children and adolescents subcutaneously, intramuscularly, or intravenously. The medicine should not be given orally to children.
• Newborns and infants must remain under constant medical supervision during morphine administration.
• Morphini sulfas WZF should be used regularly, according to the schedule prescribed by the doctor.

Use of a higher than recommended dose of Morphini sulfas WZF
Morphine is administered by medical personnel, so it is unlikely that a patient will receive more
medicine than intended.
If a higher than recommended dose of Morphini sulfas WZF has been administered, aspiration pneumonia
due to inhalation of vomit or foreign bodies may occur. Symptoms may include shortness of breath,
cough, and fever.
After administration of a higher than recommended dose, the following may occur: extreme pupil constriction
("pinpoint pupils"), coma, shallow breathing, cyanosis, cold skin, and flaccidity of limbs. This may lead to
respiratory difficulties resulting in loss of consciousness, and even death, significant drop in blood pressure
with cardiac failure, lowered body temperature, seizures (especially in infants and children), and severe
muscle pain.
If such symptoms occur, medical personnel must be informed immediately.
Appropriate management will then be initiated.

Missed dose of Morphini sulfas WZF
Do not administer a double dose to make up for a missed dose.

Discontinuation of Morphini sulfas WZF
Sudden cessation of morphine, especially in dependent individuals, may lead to withdrawal symptoms.
Do not stop using Morphini sulfas WZF unless otherwise instructed by a doctor. To discontinue Morphini sulfas WZF,
consult your doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms.
Withdrawal symptoms may include body aches, seizures, diarrhea, stomach pain, nausea, flu-like symptoms,
rapid heartbeat, and dilated pupils. Psychological symptoms include intense feelings of unease, anxiety, and irritability.
Dependence is rare in patients receiving morphine for medical reasons.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment must be discontinued and immediate medical advice must be sought if the patient experiences:

• severe allergic reactions causing difficulty in breathing or dizziness. Initial signs of hypersensitivity include swelling of the face, lips, tongue, or throat, leading to difficulty in breathing or swallowing. Such symptoms are rare (occurring in less than 1 in 1,000 patients) after intravenous administration of morphine.
• severe skin reactions with blistering, extensive peeling of the skin, pustular eruptions accompanied by fever. This may be a condition known as acute generalized exanthematous pustulosis (AGEP).
• breathing difficulties leading to loss of consciousness, usually after administration of a higher than recommended dose of the medicine (see above section: "Use of a higher than recommended dose of Morphini sulfas WZF").
• withdrawal symptoms or dependence (symptoms are described in section 3, subsection: "Discontinuation of Morphini sulfas WZF").

Medical advice should be sought for adverse reactions with unknown frequency (cannot be estimated from available data), such as:

• profound disturbances in consciousness (confusional state);
• development of tolerance to the medicine (characterized by progressively diminished effect of the medicine with prolonged use, necessitating dose escalation).
• difficulty in urination, ureteral spasm, and reduced urine volume;
• biliary tract spasm (severe pain on the right side under the ribs);
• slowed heart rate, palpitations, sudden drops in blood pressure upon changing position from lying to standing;
• headache, disturbances in consciousness and balance, vision problems (these may be symptoms of increased intracranial pressure);
• restlessness, mood disturbances, hallucinations;
• nausea, vomiting;
• constipation;
• drowsiness;
• dry mouth;
• sweating;
• facial flushing;
• dizziness;
• decreased body temperature;
• pupillary constriction.
• increased sensitivity to pain;
• headache, disturbances in consciousness and balance, vision problems (these may be symptoms of increased intracranial pressure);
• muscular rigidity (after administration of high doses of morphine);
• urticaria, itching;
• low blood pressure;
• contact dermatitis (a type of allergic reaction);
• sleep apnoea (episodes of breathing cessation during sleep);
• symptoms related to pancreatitis and biliary tract inflammation, e.g. severe upper abdominal pain radiating to the back, nausea, vomiting, or fever;
• pain and irritation at the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, they should be reported to a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Morphini sulfas WZF

Store below 25°C. Protect from light. Do not freeze.
Keep the medicine out of sight and reach of children.
After opening the ampoule, the contents should be used immediately.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Morphini sulfas WZF 10 mg/ml contains

• The active substance is morphine sulfate 2.5-hydrate. Each ml of solution contains 10 mg of morphine sulfate 2.5-hydrate.
• The other ingredients are: sodium chloride, sodium metabisulfite (E 223), disodium edetate, water for injections.

What Morphini sulfas WZF 20 mg/ml contains

• The active substance is morphine sulfate 2.5-hydrate. Each ml of solution contains 20 mg of morphine sulfate 2.5-hydrate.
• The other ingredients are: sodium chloride, sodium metabisulfite (E 223), disodium edetate, water for injections.

What Morphini sulfas WZF looks like and contents of the pack
Morphini sulfas WZF is a colourless or pale yellow, clear liquid.
Pack sizes: cardboard boxes containing 10 ampoules of 1 ml each.
Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. +48 22 364 61 01

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS

MORPHINI SULFAS WZF, 10 mg/ml, solution for injection
MORPHINI SULFAS WZF, 20 mg/ml, solution for injection
Morphini hemisulfas 2,5-hydricus
Please refer to the current Summary of Product Characteristics for Morphini sulfas WZF
Administration of Morphini sulfas WZF

• Dosage must be individually determined by a physician for each patient. The drug is administered subcutaneously, intramuscularly, or intravenously (see section below: "Dosage").
• After opening the ampoule, the contents should be used immediately.
• Morphini sulfas WZF may be administered without dilution or after dilution:
• in 0.9% sodium chloride injection solution
• in water for injections at a 1:10 ratio. The resulting morphine sulfate concentration after dilution is as follows: 1 mg/ml (Morphini sulfas WZF, 10 mg/ml); 2 mg/ml (Morphini sulfas WZF, 20 mg/ml). Chemical and physical stability has been demonstrated for 24 hours at 25 °C. The solution should be prepared immediately before administration. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the user is responsible for storage conditions and duration. If necessary, the prepared diluted solution may be stored for up to 24 hours at 25 °C, provided dilution is performed under controlled and validated aseptic conditions. Any unused solution after 24 hours must be discarded.
• Morphini sulfas WZF 20 mg/ml may be mixed with midazolam (Midanium 5 mg/ml product) (see also "Precautions for the use of Morphini sulfas WZF", below) within the following active substance proportions: 10 mg morphine sulfate with midazolam in doses ranging from 1.66 mg to 10 mg. To obtain a mixture of 10 mg morphine sulfate: 1.66 mg midazolam, mix 2.1 ml of Morphini sulfas WZF 20 mg/ml with 1.4 ml of Midanium 5 mg/ml. To obtain a mixture of 10 mg morphine sulfate: 10 mg midazolam, mix 1.0 ml of Morphini sulfas WZF 20 mg/ml with 4.0 ml of Midanium 5 mg/ml. The shelf life of the mixture of Morphini sulfas WZF 20 mg/ml with Midanium 5 mg/ml is 24 hours. Chemical and physical stability has been demonstrated for 24 hours at 25 °C. The mixture should be prepared immediately before administration. From a microbiological standpoint, the prepared mixture should be used immediately. If not used immediately, the user is responsible for storage conditions and duration. If necessary, the prepared mixture may be stored for up to 24 hours at 25 °C, provided it is prepared under controlled and validated aseptic conditions. Any unused mixture after 24 hours must be discarded. The prepared mixture does not require protection from light.
• For adult patients, physicians may recommend diluting the ampoule contents with water and administering orally. Oral administration of morphine is not recommended in children.
• When administering the drug to neonates or infants, continuous monitoring is recommended.
• The drug should be administered systematically.
• The drug must not be administered intrathecally or epidurally.
• Subcutaneous administration is not recommended in patients with poor local skin condition (skin damage, local inflammation, lymphatic edema) due to the risk of infection and impaired drug absorption.
• Morphine forms insoluble complexes with heparin. Morphine and heparin solutions must not be mixed in the same syringe.
• Physical incompatibility (precipitate formation) has been demonstrated between morphine sulfate solutions and 5-fluorouracil.

Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is located in the lower part of the ampoule.
Gently shake the ampoule or tap it with a finger to facilitate the flow of the solution downward.
Each ampoule has a colored dot (see Figure 1) indicating the location of the score line below it.

• To open the ampoule, hold it vertically in both hands with the colored dot facing toward you (see Figure 2). The upper part of the ampoule should be gripped so that the thumb is positioned above the colored dot.
• Press in the direction of the arrow shown in Figure 3. Ampoules are intended for single use only and should be opened immediately before use. Any remaining unused product must be destroyed in accordance with applicable regulations.

Figure 1.

Figure 2.

Figure 3.

Precautions for the use of Morphini sulfas WZF

• Opioid analgesics should be administered cautiously or in reduced doses to patients with hypothyroidism, adrenal insufficiency, asthma, reduced respiratory reserve, prostatic hypertrophy, hypotension, shock, inflammatory or obstructive intestinal disorders, myasthenia gravis, and to patients with a history of drug abuse.
• The concomitant use of midazolam and opioids increases the risk of respiratory depression; therefore, such cases require close monitoring.
• Morphine may cause liver function disturbances and spasm of the sphincter of Oddi, leading to increased biliary tract pressure. Therefore, in patients with hepatic colic or other biliary disorders, morphine may exacerbate pain symptoms. Morphine administered post-cholecystectomy has been associated with pain occurrence.
• Caution is advised when administering morphine to patients with impaired liver function, as morphine metabolism occurs in the liver.
• In patients with impaired renal function, prolonged and severe respiratory depression has been observed after morphine administration.
• With regular morphine use, dependence may develop rapidly; however, dependence is rare in patients receiving morphine for legitimate medical indications. Sudden discontinuation of morphine in a dependent individual may trigger withdrawal symptoms, the severity of which depends on the patient's condition, dose size, frequency of administration, and duration of treatment. Symptoms include: nausea, diarrhea, cough, dysphoria, lacrimation, pupillary dilation, rhinorrhea, insomnia (with persistent yawning), profuse sweating, elevated blood pressure, muscle tremors, piloerection, loss of appetite, slight increase in respiratory rate, diffuse body pain, intense drug craving, and hallucinations. Repeated use of Morphini sulfas WZF may lead to opioid use disorder (OUD). Higher doses and longer durations of opioid therapy may increase the risk of OUD. Misuse or intentional inappropriate use of Morphini sulfas WZF may lead to overdose and/or death. The risk of OUD is increased in patients with a personal or family history (parents or siblings) of substance use disorders (including alcohol), current tobacco use, or a history of other psychiatric disorders (e.g., severe depression, anxiety disorders, or personality disorders).
• Opioids may cause sleep-related breathing disorders, including central sleep apnea (CSA) and hypoxemia. Opioid use increases the risk of CSA in a dose-dependent manner. In patients with CSA, consideration should be given to reducing the total opioid dose.
• Cases of acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported with morphine therapy. Most such reactions occurred within the first 10 days of treatment.
• In elderly and debilitated patients, morphine doses should be reduced.

Dosage
Adults

• For acute pain: usually 10 mg to 15 mg (0.1 to 0.15 mg/kg body weight) subcutaneously or intramuscularly, or 2 mg to 8 mg intravenously (at a rate of 2 mg/min). Doses may be repeated every 4 hours as needed.
• For chronic pain: 5 mg to 20 mg orally, subcutaneously, or intramuscularly every 4 hours. Elderly patients usually receive half the dose recommended for younger adults.

Children and adolescents:
Oral administration of morphine is not recommended.
When administering morphine to neonates and young children, caution is required due to their low body weight, as these patient groups may be more sensitive to opioids.
Continuous monitoring is recommended when administering the drug to neonates or infants.
Subcutaneous or intramuscular administration

• Typically, 0.1 to 0.2 mg/kg body weight (100 to 200 micrograms/kg body weight) subcutaneously or intramuscularly, repeated every 4 hours as needed; the dose should not exceed 15 mg per administration;
• In neonates, the recommended dose is 0.1 mg/kg body weight (100 micrograms/kg body weight) subcutaneously, repeated every 4 to 6 hours as needed.

Intravenous administration
Due to the increased risk of respiratory depression associated with continuous intravenous infusions of morphine in children, monitoring of heart rate, respiratory rate, and blood oxygen saturation is recommended.

• Preterm neonates: 0.025 mg/kg body weight (25 micrograms/kg body weight) intravenously as a slow 30-minute infusion. Subsequent doses may be administered every 8 hours. In extremely premature infants, the dose may be repeated every 12 hours; the proposed continuous infusion rate is 0.01–0.02 mg/kg body weight/hour (10–20 micrograms/kg body weight/hour).
• Term neonates: 0.025–0.05 mg/kg body weight (25–50 micrograms/kg body weight) intravenously every 6 hours or continuous infusion at 0.01–0.03 mg/kg body weight/hour (10–30 micrograms/kg body weight/hour).
• Infants up to 6 months of age: 0.05 mg/kg body weight (50 micrograms/kg body weight) intravenously every 4–6 hours or continuous infusion at 0.01–0.03 mg/kg body weight/hour (10–30 micrograms/kg body weight/hour).
• Infants aged over 6 months to 12 months: 0.05–0.1 mg/kg body weight (50–100 micrograms/kg body weight) every 4 hours or continuous infusion at 0.01–0.04 mg/kg body weight/hour (10–40 micrograms/kg body weight/hour).
• Children over 1 year of age and adolescents up to 18 years: 0.05–0.1 mg/kg body weight (50–100 micrograms/kg body weight) intravenously every 2–4 hours or continuous infusion at 0.01–0.04 mg/kg body weight/hour (10–40 micrograms/kg body weight/hour).

Patient-controlled analgesia (PCA) may be used in children aged 6 years and older: intravenous bolus doses of 0.015–0.02 mg/kg body weight (15–20 micrograms/kg body weight), followed by a lockout period of 10 to 15 minutes. A continuous intravenous infusion of 0.005–0.02 mg/kg body weight/hour (5–20 micrograms/kg body weight/hour) may also be administered.
Hepatic impairment
Caution is advised when administering morphine to patients with impaired liver function, as morphine is metabolized in the liver.
Renal impairment
A reduced maintenance dose may be necessary in cases of moderate to severe renal impairment. In children, administer 75% of the dose if creatinine clearance is 10–50 ml/min/1.73 m² and 50% if <10 ml/min/1.73 m².
Since pediatric doses are often based on body weight, the table below is provided to assist in verifying calculated doses. The table uses age-based data based on average body weight values.
NOTE: Calculated data refer to a concentration of 10 mg/ml; adjustment is required when using 20 mg/ml.
Dose Approximate Patient's Body Dose Volume
(mg/kg body weight) Age Weight (mg) (ml)
(years) (kg)
(micrograms/kg body weight)
1 year 10 0.5–1 mg 0.05–0.1 ml
0.05–0.1 mg/kg body weight
3 years 15 0.75–1.5 mg 0.075–0.15 ml
5 years 18 0.9–1.8 mg 0.09–0.18 ml
(50–100 micrograms/kg body weight) 7 years 23 1.15–2.3 mg 0.115–0.23 ml
10 years 30 1.5–3 mg 0.15–0.3 ml
12 years 39 1.95–3.9 mg 0.195–0.39 ml
Doses and volumes for children must be calculated, measured, and carefully verified by competent medical personnel to prevent errors. Particular caution is required when measuring very small volumes.
After calculation, the data in the table above should be used to verify that the dose and volume are appropriate for the child's specific age and weight.
The drug should be administered systematically. If necessary, the physician may adjust the dosage regimen.