Morphini sulfas Vzf

Leaflet attached to 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 or 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 postoperative 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 opioid medicines, 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 medicine. 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 must take the medicine for a longer period than prescribed by the doctor;
• the patient must 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 experiences improvement in well-being when taking 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 treatment and how it can be safely discontinued (see section 3 "Discontinuation of Morphini sulfas WZF").

Warnings and precautions

Before starting treatment with Morphini sulfas WZF, consult a doctor or 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. The patient should tell their doctor if they have ever had a severe skin rash or skin peeling after taking Morphini sulfas WZF or other opioids, or if they have had blisters and (or) ulcers in the mouth. The patient should discontinue Morphini sulfas WZF and seek medical attention immediately if they 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 maintaining sleep, 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.
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 disease.
If any of the following symptoms occur during treatment with Morphini sulfas WZF, the patient should consult their doctor:

• Increased sensitivity to pain, despite increased dose of the medicine (hyperalgesia). The doctor will decide whether a change in dosage 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, amenorrhea. This may be due to decreased production of sex hormones.
• If the patient has a history of drug or alcohol dependence. The patient should also tell their doctor if they notice that they are becoming dependent on Morphini sulfas WZF during its use. 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 prostate enlargement or difficulty urinating;
• with low blood pressure;
• in shock (sudden drop in blood pressure and reduced blood flow to body tissues);
• with inflammatory bowel disease or impaired bowel patency;
• with muscle weakness (myasthenia);
• abusing drugs;
• weakened or exhausted by disease;
• with bile duct disorders (morphine may worsen pain);
• with liver function disorders;
• with kidney function disorders;
• in old 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 a doctor.

Morphini sulfas WZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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 sedative medicines, e.g. benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available. However, if Morphini sulfas WZF is used with sedative medicines, the doctor should limit the dose and duration of concomitant use. The patient should tell their doctor about all sedative medicines they are taking and strictly follow the prescribed dose.

Morphini sulfas WZF may interact with:

• inhibitors of monoamine oxidase (antidepressant medicines), e.g. moclobemide, especially if the patient has taken these medicines within the last 2 weeks. Medicines from this group should not be used with morphine - see section 2, subsection: "When not to use Morphini sulfas WZF";
• tricyclic antidepressant medicines, e.g. amitriptyline;
• sleeping medicines, e.g. phenobarbital;
• sedative, anxiolytic medicines, e.g. diazepam;
• medicines from the phenothiazine derivative group, e.g. promazine, chlorpromazine;
• blood pressure lowering medicines;
• smooth muscle relaxants and heart rate regulators, e.g. atropine;
• ciprofloxacin (a medicine used to treat bacterial infections);
• 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 been given such medicines or has had surgery, they should tell their doctor.

Morphini sulfas WZF with alcohol

Alcohol should be avoided during treatment with 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 used during pregnancy for a long time, 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: "Discontinuation of Morphini sulfas WZF".

Driving and using machines

Morphine can cause drowsiness and impair psychophysical performance. During treatment with the medicine, the patient should not drive vehicles or operate machinery.

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

The medicine contains sodium metabisulfite (E 223), which may rarely cause severe hypersensitivity reactions and bronchospasm (symptoms: shortness of breath, wheezing, cough).
Patients who have had allergic reactions in the past 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 treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Morphini sulfas WZF, when and how long to take it, when to consult a doctor, and when to discontinue treatment (see also "Discontinuation of Morphini sulfas WZF" in this section).

• The dosage 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, aspiration pneumonia may occur, caused by inhalation 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 severe narrowing of the 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

A double dose should not be taken to make up for a missed dose.

Discontinuation of Morphini sulfas WZF

In case of sudden discontinuation of morphine, especially in individuals who are dependent, withdrawal symptoms occur.
Morphini sulfas WZF should not be discontinued unless the doctor recommends it. To discontinue Morphini sulfas WZF, the patient should consult their 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.

The patient should stop using the medicine and contact their doctor immediately if they experience:

• severe allergic reactions causing breathing difficulties or dizziness. The first symptoms of an allergic reaction 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 reactions 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 "Discontinuation of Morphini sulfas WZF").

The patient should consult their doctor if they experience 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 (moments of breathing cessation 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 or 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. By reporting side effects, more information can be collected 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.
The medicine should be stored 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 specified 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 Morphini sulfas WZF looks like and what the packaging contains

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

Polpharma S.A.
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 dosage is determined by the doctor individually for each patient. The medicine is administered subcutaneously, intramuscularly, or intravenously (see below, section: "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); 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 diluted product should be used immediately. If not used immediately, the user is responsible for the conditions and duration of storage. If necessary, the prepared solution can be stored for a maximum of 24 hours at 25°C, provided that the dilution is prepared under controlled and validated aseptic conditions. Unused solution should be discarded after 24 hours.
• The doctor may recommend diluting the contents of the ampoule with water and taking it orally. Oral administration of morphine is not recommended for children.
• In the case of administration to newborns or infants, constant medical supervision is recommended.
• The medicine should be used systematically.

Subcutaneous administration of the medicine is not recommended for 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. Solutions of morphine and heparin should not be mixed in the same syringe.
• A physicochemical 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.
Shake the ampoule gently or tap it with your finger to facilitate the flow of the solution. 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 you (see Figure 2). Hold the upper part of the ampoule so that your thumb is above the colored dot.
• Press in the direction of the arrow shown in Figure 3. The ampoules are intended 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, prostate enlargement, hypotension, shock, inflammatory bowel disease, or impaired bowel patency, as well as to patients who abuse drugs.
• 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 worsen pain.
• When administering morphine to patients with liver function disorders, caution is advised, 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, the doctor should 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, caution is advised due to their small body weight, as these patient groups may be more sensitive to opioids.
Constant medical supervision is recommended when administering the medicine to newborns or infants.
Subcutaneous or intramuscular administration

• usually administered subcutaneously or intramuscularly at a dose of 0.1 to 0.2 mg/kg (100 to 200 micrograms/kg), if necessary, every 4 hours; the dose should not exceed 15 mg;
• 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 of age: 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 12 months of age: 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 of age and adolescents up to 18 years of age: 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 can be administered at 0.005-0.02 mg/kg/h (5-20 micrograms/kg/h).
Liver function disorders
When administering morphine to patients with liver function disorders, caution is advised, as morphine metabolism occurs in the liver.
Kidney function disorders
A reduced maintenance dose may be necessary in case of 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 m² and 50% if it is less than 10 ml/min/1.73 m².

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 data on age 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, a conversion should be made.

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.