Morphini sulfas Vzf

Leaflet accompanying the packaging: patient information

MORPHINI SULFAS WZF, 10 mg/ml, solution for injection

MORPHINI SULFAS WZF, 20 mg/ml, solution for injection

Morphine hemisulfate 2.5-hydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any side effects 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 Morphini sulfas WZF and what is it 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 packaging and other information

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

Morphini sulfas WZF contains morphine, which is a strong pain reliever.
Morphine belongs to a group of pain relievers called opioids.
Morphini sulfas WZF is intended for subcutaneous, intramuscular, and intravenous administration.
On the doctor's recommendation, the patient can take the medicine orally, after dilution with water.
Morphini sulfas WZF is used for acute and chronic pain of various severity, from moderate to severe. Morphine is used for post-operative and chronic pain, most often of tumor origin, except for pain caused by smooth muscle spasm, e.g. biliary colic.

2. Important information before using Morphini sulfas WZF

When not to use Morphini sulfas WZF:

• if the patient is allergic to morphine, other opioids, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has breathing difficulties or a disease that causes breathing difficulties, or shortness of breath (called obstructive disease of the upper airways);
• if the patient has acute pain on the right side of the abdomen under the ribs (may be a symptom of biliary colic);
• if the patient has acute alcohol poisoning;
• if the patient is taking or has taken within the last 2 weeks medicines for depression from the group of medicines called monoamine oxidase inhibitors;
• if the patient has diseases that occur with seizures;
• if the patient has had head injuries;
• if the patient has been diagnosed with acute abdominal syndrome (symptoms: very severe abdominal pain with bloating, nausea, vomiting, constipation);
• if the patient has a chromaffin tumor of the adrenal gland (a tumor located in the glands on the kidneys);
• if the patient has increased intracranial pressure (symptoms, e.g. headache, impaired consciousness and balance, vision disturbances);
• if the patient is in a coma.

Tolerance, dependence, and addictive use
This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient gets used to it, which is known as tolerance to the medicine). Repeated use of Morphini sulfas WZF may also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and duration of use.
Dependence or addictive use can cause the patient to feel a loss of control over how much medicine to take or how often to take it.
The risk of dependence on Morphini sulfas WZF or its addictive use varies from person to person. The risk of dependence on Morphini sulfas WZF or its addictive use may be higher if:

• the patient or any of their relatives have ever abused or been dependent on alcohol, prescription drugs, or narcotics ("dependence");
• the patient smokes;
• 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, it may indicate dependence or addictive use:

• the patient needs to take the medicine for a longer period than prescribed by the doctor;
• the patient needs to take a higher dose than recommended;
• the patient uses the medicine for reasons other than those for which the doctor prescribed it, e.g. "to calm down" or "to fall asleep";
• the patient has repeatedly made unsuccessful attempts to stop or control the use of the medicine;
• after stopping the use of the medicine, the patient feels unwell and feels better when they take the medicine again ("withdrawal effect"). If any of these symptoms are noticed, the patient should discuss the best treatment strategy with their doctor, including when it is appropriate to stop the treatment and how it can be safely terminated (see section 3 "Stopping the use of Morphini sulfas WZF").

Warnings and precautions

Before starting treatment with Morphini sulfas WZF, consult a doctor, pharmacist, or nurse.
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphini sulfas WZF treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever had a severe skin rash or skin peeling after taking Morphini sulfas WZF or other opioids, or if you have had blisters and (or) ulcers in the mouth. Stop taking Morphini sulfas WZF and seek medical attention immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pustular rash with fever.
Sleep apnea
Morphini sulfas WZF may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level 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 these symptoms, they should contact their doctor. The doctor may consider reducing the dose.
Consult a doctor if the patient experiences severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disease.
If any of the following symptoms occur during treatment with Morphini sulfas WZF, consult a doctor:

• Increased sensitivity to pain, despite increased dose of the medicine (hyperalgesia). The doctor will decide whether a dose change or the use of a strong pain reliever is necessary (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms that the adrenal glands are not producing enough cortisol and hormone supplements may be necessary.
• Loss of sexual desire, impotence, cessation of menstruation. This may be due to decreased production of sex hormones.
• If the patient has a history of drug or alcohol addiction. The patient should also tell their doctor if they notice that they are becoming dependent on Morphini sulfas WZF during treatment. For example, when they start thinking about taking the next dose frequently, even if they don't need it to relieve pain.
• Withdrawal symptoms or dependence. The most common withdrawal symptoms are listed in section 3. In such a case, the doctor may change the medicine or the time between doses.

The doctor will exercise particular caution when using morphine and will take appropriate action in patients:

• with reduced thyroid function (hypothyroidism);
• with reduced adrenal cortex function (too little hormone production);
• with asthma or other breathing problems, e.g. chronic obstructive pulmonary disease (COPD);
• with an enlarged prostate or difficulty urinating;
• with low blood pressure;
• in shock (sudden drop in blood pressure and reduced blood flow to the body's tissues);
• with inflammatory bowel disease or impaired bowel patency;
• with muscle weakness (myasthenia);
• abusing drugs;
• weakened or exhausted by disease;
• with biliary tract disorders (morphine may exacerbate pain);
• with liver function disorders;
• with kidney function disorders;
• elderly.

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 a doctor.

Morphini sulfas WZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take.
This is especially important when taking the following medicines:

• Rifampicin, used to treat e.g. tuberculosis.
• Concomitant use of Morphini sulfas WZF and sedatives, e.g. benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma that can be life-threatening. Therefore, combined treatment should only be considered when other treatment options are not available. If Morphini sulfas WZF is used with sedatives, the doctor should limit the dose and duration of concomitant use. The patient should tell their doctor about all sedatives they are taking and strictly follow the prescribed dose.

Morphini sulfas WZF may interact with:

• some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and reduced efficacy when taken with morphine.
• -Gabapentin or pregabalin used to treat epilepsy and pain caused by nervous system disorders (neuropathic pain) may interact with morphine sulfate injection, which may significantly alter their effect.

The following medicines may affect the action of morphine:

• monoamine oxidase inhibitors (antidepressants), e.g. moclobemide, especially if the patient has taken these medicines within the last 2 weeks. It is not recommended to take these medicines with morphine - see section 2, subsection: "When not to use Morphini sulfas WZF";
• tricyclic antidepressants, e.g. amitriptyline;
• sleeping pills, e.g. phenobarbital;
• sedatives, anxiolytics, e.g. diazepam;
• phenothiazine derivatives, e.g. promazine, chlorpromazine;
• blood pressure lowering medicines;
• smooth muscle relaxants and heart rate regulators, e.g. atropine;
• ciprofloxacin (an antibiotic);
• medicines that accelerate the passage of food through the digestive tract, e.g. cisapride, antiemetics (metoclopramide, domperidone);
• medicines used to treat Parkinson's disease, e.g. selegiline;
• mexiletine (a medicine for arrhythmias);
• cimetidine (a medicine for stomach or duodenal ulcers). Anesthetics enhance the sedative effect of morphine. If the patient has recently taken such medicines or had surgery, they should tell their doctor.

Morphini sulfas WZF and alcohol

It is recommended to avoid drinking alcohol while taking morphine.

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.

• The use of morphine during pregnancy and breastfeeding will be decided by the doctor.
• If Morphini sulfas WZF was taken during pregnancy for a longer period, there is a risk of withdrawal symptoms in the newborn, which should be treated by a doctor.
• Morphini sulfas WZF is not recommended during labor. Newborns born to mothers who have taken morphine for a long time may experience withdrawal symptoms - see section 3, subsection: "Stopping the use of Morphini sulfas WZF".

Driving and operating machinery

Morphine may cause drowsiness and impair psychophysical performance. While taking the medicine, do not drive vehicles or operate machinery.

Morphini sulfas WZF contains sodium metabisulfite (E 223) and sodium

The medicine contains sodium metabisulfite (E 223) - which can rarely cause severe hypersensitivity reactions and bronchospasm (symptoms: shortness of breath, wheezing, cough).
Patient 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, which means 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, which means the medicine is considered "sodium-free".

3. How to use Morphini sulfas WZF

Morphini sulfas WZF is administered by medical personnel.
Before starting and regularly during treatment, the doctor will discuss with the patient what to expect from Morphini sulfas WZF, when and for how long to take it, when to consult a doctor, and when to stop taking the medicine (see also "Stopping the use of Morphini sulfas WZF" in this section).

• The dose of morphine is determined by the doctor individually for each patient.
• Adult patients are given Morphini sulfas WZF subcutaneously, intramuscularly, or intravenously; the doctor may recommend diluting the contents of the ampoule with water and taking it orally.
• Morphini sulfas WZF can be administered to children and adolescents subcutaneously, intramuscularly, or intravenously. The medicine should not be given orally to children.
• Newborns and infants should be under constant medical supervision during morphine administration.
• Morphini sulfas WZF should be used systematically, according to the schedule prescribed by the doctor.

Using a higher dose of Morphini sulfas WZF than recommended

Morphine is administered by medical personnel, so it is unlikely that the patient will receive more medicine than they should.
If a higher dose of Morphini sulfas WZF than recommended is taken, it may cause pneumonia caused by aspiration of vomit or foreign bodies. Symptoms may include shortness of breath, cough, and fever.
After taking a higher dose of the medicine than recommended, the following symptoms may occur: very narrow pupils ("pinpoint pupils"), coma, shallow breathing, cyanosis, cold skin, limb weakness. There may be breathing difficulties leading to loss of consciousness, and even death, significant lowering of blood pressure with heart failure, lowering of body temperature, and seizures (especially in infants and children), severe muscle pain.
If such symptoms occur, the patient should immediately inform the medical personnel, who will take appropriate action.

Missing a dose of Morphini sulfas WZF

Do not take a double dose to make up for a missed dose.

Stopping the use of Morphini sulfas WZF

In case of sudden cessation of morphine use, especially in people who are dependent, withdrawal symptoms occur.
Do not stop taking Morphini sulfas WZF unless the doctor recommends it. To stop taking Morphini sulfas WZF, consult a 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 dissatisfaction, anxiety, and irritability.
Dependence on morphine is rare in patients who receive it for medical reasons. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist, or nurse.

4. Possible side effects

Like all medicines, Morphini sulfas WZF can cause side effects, although not everybody gets them.

Stop taking the medicine and contact a doctor immediately if the patient experiences:

• severe allergic reactions causing breathing difficulties or dizziness. The first symptoms of an allergy are, for example, swelling of the face, lips, tongue, throat, causing breathing or swallowing difficulties. Such symptoms are rare (less than 1 in 1,000 patients) after intravenous administration of morphine.
• severe skin reaction with blisters, widespread skin peeling, pustular rash with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).
• breathing difficulties leading to loss of consciousness, usually after taking a higher dose of the medicine than recommended (see above subsection "Using a higher dose of Morphini sulfas WZF than recommended").
• withdrawal symptoms or dependence (symptoms are described in section 3, subsection: "Stopping the use of Morphini sulfas WZF").

Consult a doctor if the patient experiences side effects whose frequency is unknown (cannot be estimated from the available data), such as:

• deep changes in consciousness (confusion);
• development of tolerance to the medicine (which means that the medicine becomes less effective over time, requiring an increase in dose).
• difficulty urinating, ureteral spasm, and decreased urine output;
• bile duct spasm (severe pain on the right side under the ribs);
• slow heart rate, palpitations, sudden drops in blood pressure when changing position from lying to standing;
• headache, impaired consciousness and balance, vision disturbances (may be symptoms of increased intracranial pressure);
• anxiety, mood disorders, hallucinations;
• nausea, vomiting;
• constipation;
• drowsiness;
• dry mouth;
• sweating;
• flushing;
• dizziness;
• lowering of body temperature;
• pupil constriction.
• increased sensitivity to pain;
• headache, impaired consciousness and balance, vision disturbances (may be symptoms of increased intracranial pressure);
• muscle stiffness (after administration of high doses of morphine);
• hives, itching;
• low blood pressure;
• contact dermatitis (a type of allergy);
• sleep apnea (pauses in breathing during sleep);
• symptoms related to pancreatitis and bile duct disease, e.g. severe abdominal pain radiating to the back, nausea, vomiting, or fever;
• pain and irritation at the injection site.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. 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 the medicine.

5. How to store Morphini sulfas WZF

Store in a temperature below 25°C. Protect from light. Do not freeze.
Keep the medicine out of the 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 packaging and ampoule. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What does Morphini sulfas WZF 10 mg/ml contain

• The active substance of the medicine is morphine sulfate 2.5-hydrate. Each 1 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 does Morphini sulfas WZF 20 mg/ml contain

• The active substance of the medicine is morphine sulfate 2.5-hydrate. Each 1 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 does Morphini sulfas WZF look like and what does the packaging contain

Morphini sulfas WZF is a colorless or light yellow transparent liquid.
Packaging: cardboard boxes containing 10 ampoules of 1 ml each.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Date of last revision of the leaflet:

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS

MORPHINI SULFAS WZF, 10 mg/ml, solution for injection

MORPHINI SULFAS WZF, 20 mg/ml, solution for injection

Morphine hemisulfate 2.5-hydrate

Read the current Summary of Product Characteristics for Morphini sulfas WZF

Method of administration of Morphini sulfas WZF

• The dose is determined by the doctor individually for each patient. The medicine is administered subcutaneously, intramuscularly, or intravenously (see below "Dosage").
• After opening the ampoule, the contents should be used immediately.
• Morphini sulfas WZF can be administered undiluted or after dilution:
• in 0.9% sodium chloride solution for injection
• in water for injection in a ratio of 1:10. The concentration of morphine sulfate in the resulting solution is 1 mg/ml (Morphini sulfas WZF, 10 mg/ml) and 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 point of view, the prepared solution should be used immediately. If not used immediately, the user is responsible for the conditions and storage time. If necessary, the prepared solution can be stored for a maximum of 24 hours at 25°C, provided that the dilution is prepared in controlled and validated aseptic conditions. Unused solution should be discarded within 24 hours.
• The doctor may recommend diluting the contents of the ampoule with water and taking it orally. It is not recommended to administer morphine orally to children.
• In the case of administration to newborns or infants, constant medical supervision is recommended.
• The medicine should be used systematically.

Administration of Morphini sulfas WZF is not recommended:

• subarachnoid or epidural;
• subcutaneously in patients with poor local skin condition (skin damage, local inflammation, lymphedema) due to the risk of infection and impaired absorption of the medicine.

Morphine forms insoluble compounds with heparin. Do not mix morphine and heparin solutions in the same syringe.

A physical and chemical incompatibility (precipitation) has been demonstrated between morphine sulfate solutions and 5-fluorouracil.

Instructions for opening the ampoule

Before opening the ampoule, make sure that the entire solution is in the lower part of the ampoule.
You can gently shake the ampoule or tap it with your finger to help the solution flow down. Each ampoule has a colored dot (see Figure 1) as a mark indicating the break point below it.

• To open the ampoule, hold it vertically, with the colored dot facing upwards, as shown in Figure 2. The upper part of the ampoule should be grasped so that the thumb is above the colored dot.
• Press in the direction of the arrow shown in Figure 3. The ampoules are for single use only and should be opened immediately before use. Any remaining product should be disposed of in accordance with applicable regulations.

Figure 1.

Figure 2.

Figure 3.

Precautions for the use of Morphini sulfas WZF

• Opioid pain relievers should be administered with caution or in reduced doses to patients with hypothyroidism, adrenal insufficiency, asthma, reduced respiratory reserve, enlarged prostate, hypotension, shock, inflammatory bowel disease, or impaired bowel patency, myasthenia, drug abuse, or weakened by disease.
• In the case of concomitant use of midazolam and opioids, the risk of respiratory depression increases, so such cases require monitoring.
• Morphine may cause liver dysfunction and spasm of the sphincter of Oddi, leading to increased pressure in the bile ducts. Therefore, in patients with biliary colic or other bile duct disorders, morphine may exacerbate pain.
• When administering morphine to patients with liver dysfunction, caution is recommended, as morphine metabolism occurs in the liver.
• In patients with renal impairment, prolonged respiratory depression has been observed after morphine administration.
• Opioids may cause sleep apnea, including central sleep apnea (CSA), and hypoxemia. The risk of CSA increases with the dose of opioids. In patients with CSA, it is recommended to consider reducing the total dose of opioids.
• Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphini sulfas WZF treatment, which can be life-threatening or fatal. Most of these reactions occurred within the first 10 days of treatment.
• In elderly and weakened patients, the dose of morphine should be reduced.

Dosage

Adults

• in acute pain, usually: 10 mg to 15 mg (0.1 to 0.15 mg/kg) subcutaneously or intramuscularly, or 2 mg to 8 mg intravenously (at a rate of 2 mg/min). If necessary, doses can be repeated every 4 hours.
• in chronic pain: 5 mg to 20 mg orally, subcutaneously, or intramuscularly every 4 hours. Elderly patients are usually given half the dose intended for younger adults.

Children and adolescents:

Oral administration of morphine is not recommended.
In the case of administration of morphine to newborns and small children, due to their small body weight, caution is recommended, as these patient groups may be more sensitive to opioids.
When administering the medicine to newborns or infants, constant medical supervision is recommended.
Subcutaneous or intramuscular administration

• usually, 0.1 to 0.2 mg/kg (100 to 200 micrograms/kg) is administered subcutaneously or intramuscularly, if necessary, every 4 hours; do not exceed 15 mg per dose;
• in newborns, the recommended dose is 0.1 mg/kg (100 micrograms/kg) subcutaneously, if necessary, every 4 to 6 hours.

Intravenous administration
Due to the increased risk of respiratory depression during continuous intravenous infusions of morphine in children, it is recommended to monitor heart rate, breathing rate, and blood saturation.

• Premature newborns: 0.025 mg/kg (25 micrograms/kg) intravenously in a slow 30-minute infusion. Subsequent doses can be administered at 8-hour intervals. In children with extreme prematurity, the dose can be repeated every 12 hours, proposed continuous infusion 0.01-0.02 mg/kg/h (10-20 micrograms/kg/h).
• Full-term newborns: 0.025-0.05 mg/kg (25-50 micrograms/kg) intravenously every 6 hours or continuous infusion 0.01-0.03 mg/kg/h (10-30 micrograms/kg/h).
• Infants up to 6 months: 0.05 mg/kg (50 micrograms/kg) intravenously every 4-6 hours or continuous infusion 0.01-0.03 mg/kg/h (10-30 micrograms/kg/h).
• Infants over 6 months to 1 year: 0.05-0.1 mg/kg (50-100 micrograms/kg) every 4 hours or continuous infusion 0.01-0.04 mg/kg/h (10-40 micrograms/kg/h).
• Children over 1 year and adolescents up to 18 years: 0.05-0.1 mg/kg (50-100 micrograms/kg) intravenously every 2-4 hours or continuous infusion 0.01-0.04 mg/kg/h (10-40 micrograms/kg/h).

Patient-controlled analgesia (PCA) can be used in children from 6 years of age: intravenous bolus injections are 0.015-0.02 mg/kg (15-20 micrograms/kg), followed by a lockout period of 10-15 minutes. A continuous infusion of 0.005-0.02 mg/kg/h (5-20 micrograms/kg/h) can be administered.
Liver function disorders
When administering morphine to patients with liver function disorders, caution is recommended, as morphine metabolism occurs in the liver.
Kidney function disorders
A reduced maintenance dose may be necessary in patients with moderate to severe kidney function disorders. In children, 75% of the dose is recommended if the creatinine clearance is

• 10-50 ml/min/1.73 m and 50% if it is less than 10 ml/min/1.73 m.

Since the dose administered to a child under 12 years of age is often based on their body weight, the following table is provided to allow verification of the calculated dose. The table uses age-based data based on average body weight values.

NOTE: The calculated data refer to a concentration of 10 mg/ml; when using a concentration of 20 mg/ml, recalculation is necessary.

Dose (in milligrams per kilogram of body weight)

Age Body weight Dose in milligrams (mg)

Dose

Volume in milliliters (ml)

(approximate)
of the
patient
and
(in
kilograms)
(in micrograms/kg)
1 year
10
0.5-1 mg
0.05-0.1 ml
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
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
0.05-0.1 mg/kg (50-100 micrograms/kg)
Doses and volumes for children must be calculated, measured, and carefully verified by competent medical personnel to avoid errors. Particular care should be taken when measuring very small volumes.
After calculation, the data in the above tables should be used to verify that the dose and volume are appropriate for the child's age and weight.
The medicine should be used systematically. If necessary, the doctor may make changes to the dosage.