Morphine Sul 10mg/ml Inj, 1ml

Manufacturer HOSPIRA Active Ingredient Morphine Injection(MOR feen) Pronunciation MOR-feen
WARNING: For all injections:This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug. Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing.Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Do not take more than what your doctor told you to take. Do not take more often or for longer than you were told. Doing any of these things may raise the chance of severe side effects.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Injection (if given into the spine):You will be watched closely for breathing problems and other severe effects for at least 24 hours after getting this drug. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid analgesic
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Pharmacologic Class
Opioid agonist
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Pregnancy Category
Not available
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FDA Approved
Jan 1970
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Morphine is a strong pain medicine that belongs to a group of drugs called opioids. It works in your brain and spinal cord to change how your body feels and responds to pain. It is given as an injection, usually in a hospital setting, to help manage severe pain.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid alcohol and other sedatives while receiving morphine, as this can dangerously slow your breathing and heart rate.
  • Do not drive or operate heavy machinery until you know how morphine affects you, as it can cause drowsiness and dizziness.
  • Report any difficulty breathing, extreme drowsiness, or feeling faint immediately to your healthcare provider.
  • To prevent constipation, which is a common side effect, your doctor may recommend stool softeners or laxatives. Drink plenty of fluids and eat fiber-rich foods if possible.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on patient's pain severity, prior opioid exposure, and response. Typical initial IV dose: 2-10 mg every 3-4 hours as needed.
Dose Range: 2 - 10 mg

Condition-Specific Dosing:

acutePain_IV: 2-10 mg IV every 3-4 hours as needed, titrated to effect.
acutePain_IM_SC: 5-20 mg IM or SC every 3-4 hours as needed.
epidural: 2-5 mg once daily, may be repeated with caution.
intrathecal: 0.1-0.3 mg once daily.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used (e.g., 0.03-0.05 mg/kg/dose IV/IM/SC every 4-6 hours).
Infant: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 15 mg/dose).
Child: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 15 mg/dose).
Adolescent: Similar to adult dosing, individualized.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Morphine and its active metabolite (M6G) are dialyzable. Administer after dialysis. Significant dose reduction required (e.g., 25% of normal dose).

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor closely.
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible. Monitor closely.
Confidence: Medium

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS), peripheral nervous system, and gastrointestinal tract. Activation of these receptors leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, respiratory depression, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM/SC. Oral bioavailability is low (20-40%) due to significant first-pass metabolism.
Tmax: IV: 10-20 minutes; IM: 30-60 minutes; SC: 60-90 minutes.
FoodEffect: Not applicable for injection.

Distribution:

Vd: 3-4 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 2-4 hours (parent drug); M6G has a longer half-life (3-7 hours) and accumulates in renal impairment.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates, ~90%), small amount in feces/bile.
Unchanged: <10% (renal)
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Pharmacodynamics

OnsetOfAction: IV: 5-10 minutes; IM: 10-30 minutes; SC: 15-60 minutes.
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes.
DurationOfAction: 3-5 hours (variable, depending on dose and route).

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Morphine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking, fast heartbeat, confusion, hunger, or sweating
Severe dizziness or fainting
Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing or breathing problems during sleep (sleep apnea)
Seizures
Severe constipation or stomach pain, which may indicate a bowel problem
Depression or other mood changes
Swelling in the arms or legs
Fever, chills, or sore throat
Painful urination
Abnormal sensations, such as burning, numbness, or tingling
Serotonin syndrome, a potentially life-threatening condition, characterized by:
+ Agitation or changes in balance
+ Confusion, hallucinations, or fever
+ Rapid or abnormal heartbeat, flushing, or muscle twitching or stiffness
+ Seizures, shivering or shaking, or excessive sweating
+ Severe diarrhea, nausea, vomiting, or headache

If you experience any of these symptoms, contact your doctor immediately.

Additional Rare but Serious Side Effects

Adrenal gland problems, which may cause:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Nausea, vomiting, or decreased appetite
Lower sex hormone levels, which may lead to:
+ Decreased libido
+ Fertility problems
+ Irregular menstrual periods or ejaculation problems

Injection-Specific Side Effects (if administered into the spine)

Loss of motor function
Muscle spasms
Difficulty controlling body movements
Urination problems

Common Side Effects

While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Common side effects include:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating

If you experience any of these side effects or have concerns about others, contact your doctor for guidance.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide medical advice and support regarding side effects.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness
  • Confusion
  • Pinpoint pupils
  • Blue lips or fingernails
  • Severe constipation
  • Hives or rash (signs of allergic reaction)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

To ensure safe treatment, inform your doctor about the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reactions you've experienced.
Existing health conditions, such as:
+ Respiratory issues like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Additional Considerations for Spinal Injection:

Presence of an infection at the intended injection site
Bleeding disorders
* Use of blood thinners

This list is not exhaustive. It is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to verify the safety of taking this medication with your other treatments. Never initiate, cease, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.

Do not combine this medication with other strong pain relievers or use it with a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be required to achieve the same pain relief. If you find that this medication is no longer working as well as it did initially, consult your doctor. Do not increase your dose without medical guidance.

Prolonged or regular use of opioid medications like this one can result in dependence. If you need to reduce your dose or stop taking this medication, consult your doctor first, as abruptly lowering the dose or discontinuing the medication can increase the risk of withdrawal or other severe complications. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

If you have a sulfite allergy, discuss this with your doctor, as some formulations of this medication may contain sulfites. Avoid consuming alcohol or using products that contain alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

This medication may increase the risk of seizures in certain individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek immediate medical attention if your baby appears excessively sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Slowed heart rate
  • Low blood pressure

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone (Narcan) if trained to do so and if opioid overdose is suspected. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with reduced doses and close monitoring)
  • Concomitant use with alcohol
  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome or severe respiratory depression)
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Major Interactions

  • Other CNS depressants (e.g., sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, other opioids, gabapentinoids): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, butorphanol, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Diuretics: Reduced efficacy of diuretics due to ADH release.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, TCAs, antihistamines): Increased risk of urinary retention and severe constipation.
  • Antihypertensives: Additive hypotensive effects.
  • Cimetidine: May increase morphine levels (inhibition of glucuronidation).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to initiation of therapy.

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to initiation of therapy.

Level of consciousness/sedation

Rationale: To assess baseline mental status and identify risk for excessive sedation.

Timing: Prior to initiation of therapy.

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to initiation of therapy.

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify impairment that may require dose adjustment.

Timing: Prior to initiation of therapy, especially in elderly or those with comorbidities.

History of substance abuse or mental health disorders

Rationale: To assess risk for addiction, abuse, and misuse.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Pain assessment

Frequency: Regularly, based on patient's condition and dosing schedule (e.g., every 1-2 hours initially, then every 4 hours or as needed).

Target: Acceptable pain level as defined by patient.

Action Threshold: Uncontrolled pain or adverse effects requiring dose adjustment.

Respiratory rate and depth

Frequency: Frequently, especially after initial doses or dose increases (e.g., every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours).

Target: >10-12 breaths/min (adults), regular rhythm.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, hypoventilation, or signs of hypoxia.

Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Frequently, especially after initial doses or dose increases (e.g., every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours).

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable.

Blood pressure and heart rate

Frequency: Periodically, especially with initial doses or dose increases.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements.

Action Threshold: Constipation (no bowel movement for >2-3 days).

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Pinpoint pupils
  • Dizziness
  • Nausea and vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion
  • Hypotension

Special Patient Groups

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Pregnancy

Prolonged use of morphine during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS) in the newborn, which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Monitor neonates for signs of withdrawal.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out with chronic use.
Second Trimester: Risk of NOWS increases with prolonged use.
Third Trimester: High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

Morphine is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. A single dose is generally considered compatible with breastfeeding, but chronic use is not recommended. Consider alternative analgesics or pump and dump if chronic use is necessary.

Infant Risk: L3 (Moderately Safe) - Monitor infant for drowsiness, difficulty breathing, or feeding difficulties.
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Pediatric Use

Use with extreme caution. Pediatric patients, especially neonates and infants, are more sensitive to the respiratory depressant effects of opioids. Dosing must be individualized and carefully titrated. Close monitoring for respiratory depression and sedation is essential.

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Geriatric Use

Elderly patients are generally more sensitive to the adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression, and consider age-related decline in renal and hepatic function.

Clinical Information

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Clinical Pearls

  • Morphine is a potent opioid; always start with the lowest effective dose and titrate slowly to effect, especially in opioid-naive patients.
  • Respiratory depression is the most serious adverse effect; monitor respiratory rate and sedation level closely, especially during initiation and dose escalation.
  • Naloxone should be readily available when administering morphine, particularly in higher doses or to at-risk patients.
  • Opioid-induced constipation is common and often requires prophylactic treatment (e.g., stool softeners, laxatives).
  • Patients with renal impairment are at increased risk of M6G accumulation, leading to prolonged and enhanced opioid effects; significant dose reduction is necessary.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients to avoid withdrawal symptoms.
  • Educate patients and caregivers about the risks of addiction, abuse, and accidental ingestion, and safe storage of opioids.
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Alternative Therapies

  • Fentanyl (IV)
  • Hydromorphone (IV)
  • Oxycodone (oral)
  • Hydrocodone (oral)
  • Tramadol (oral)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.
  • Regional anesthesia/nerve blocks
  • Epidural analgesia (with other agents)
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Cost & Coverage

Average Cost: Varies widely, typically low for generic injectable per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which provides crucial information for safe use. Read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Consult your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred, to ensure prompt and effective treatment.