Medication info

One Blue 5 Weeks

Prescription medicationInjections정맥Approval withdrawn
Ingredient · strength
Zinc Sulfate Hydrate›4.39mg / 1mLCopper Sulfate›1.57mg / 1mLManganese Sulfate›0.308mg / 1mLChromic Chloride Hydrate›20.5μg / 1mLSelenious Acid›32.7μg / 1mL
Manufacturer / importer
대원제약(주)
Appearance
A colorless and transparent vial injection containing a colorless and transparent liquid that is odorless, colorless, or light blue.
Packaging
10mL/vial × 10
Approval status
Approval withdrawn

MFDS item code 201607064 · Notified 2016.12.13

This product's status changed to Approval withdrawn on 2024.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of nutritional status through trace element supply
Who receives it
Adults · Children
Adult administration
Use according to doctor's prescription, adjusting dosage based on plasma trace element levels. For metabolically stable parenteral nutrition patients: - Zinc: 2.5 to 4mg per day - Copper: 0.5 to 1.5mg per day - Manganese: 0.15 to 0.8mg per day - Chromium: 10 to 15μg per day - Selenium: 20 to 40μg per day Others - For metabolically stable small bowel fluid loss patients: additional 12.2mg/L (
Child administration
For pediatric patients - Under 5 years: - Zinc: 100μg per kg of body weight per day - Copper: 20μg per kg of body weight per day - Manganese: 2 to 10μg per kg of body weight per day - Chromium: 0 per kg of body weight per day

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement of nutritional status through trace element supply

View approved original text

When trace elements such as zinc, copper, manganese, selenium, and chromium are supplied together during parenteral nutrition, they help improve nutritional status. These trace elements play an important role in physiological functions in the body, strengthen immune function, and promote wound healing. Additionally, they are essential for maintaining normal metabolism and cellular functions, positively impacting the patient's recovery process. Therefore, appropriate supply of these trace elements during parenteral nutrition is used to assist in the recovery of the patient's health.

How it is given

Adult administration

Use according to doctor's prescription, adjusting dosage based on plasma trace element levels. For metabolically stable parenteral nutrition patients: - Zinc: 2.5 to 4mg per day - Copper: 0.5 to 1.5mg per day - Manganese: 0.15 to 0.8mg per day - Chromium: 10 to 15μg per day - Selenium: 20 to 40μg per day Others - For metabolically stable small bowel fluid loss patients: additional 12.2mg/L (

Child administration

For pediatric patients - Under 5 years: - Zinc: 100μg per kg of body weight per day - Copper: 20μg per kg of body weight per day - Manganese: 2 to 10μg per kg of body weight per day - Chromium: 0 per kg of body weight per day

Precautions

This drug contains benzylic alcohol, which can cause serious respiratory problems in neonates and premature infants, so it should not be used. This drug should be diluted and then injected to prevent the risk of vascular inflammation when injected directly into the vein. This drug is a hypotonic solution and should only be used for injection when mixed with other drugs. If any component shows toxic symptoms during administration, the treatment must be discontinued immediately. The aluminum component included in parenteral nutrition solutions can cause toxicity when administered for an extended period to patients with impaired renal function, especially premature infants. Although zinc, copper, manganese, chromium, and selenium in this drug are present in small amounts, patients with impaired kidney or liver function should be cautious of the accumulation of these trace elements in the body. In particular, patients with renal failure can accumulate zinc, and patients with biliary obstruction are at risk for accumulation of copper and manganese. Diabetic patients should confirm the diabetes treatment as chromium components can affect blood sugar control. The safety of this drug has not been established for pregnant women or women of childbearing potential; it should only be administered cautiously if the benefits outweigh the risks. Excessive administration may lead to toxic symptoms from zinc, copper, chromium, selenium, etc., and in severe cases may result in hypotension, pulmonary edema, neurological abnormalities, so strict dose control is necessary. This drug must be used according to a doctor's prescription, and sterile conditions should be maintained to reduce the risk of infection when added to parenteral nutrition. Before administration, ensure that the solution is not discolored or contaminated with foreign substances. During storage, keep it in a sealed container to prevent exposure to air or moisture, storing in a dry and cool place, and keep it out of reach of children, avoiding transfer to other containers that may lead to quality degradation or accidents.

Side effects and when to seek care immediately

Serious side effects

  • Pulmonary edema
  • hypotension
  • jaundice
  • decreased urine output
  • coma
  • death

Mild side effects

  • Sweating
  • tachycardia
  • hypothermia
  • nausea
  • vomiting
  • ulcers
  • gastrointestinal disturbances
  • irritability
  • depression
  • metallic taste
Show 12 more
  • sweating
  • garlic odor
  • hair loss
  • nail weakening
  • dermatitis
  • tooth damage
  • diarrhea
  • behavioral changes
  • exhaustion
  • progressive wasting syndrome
  • glare
  • peripheral edema

Not everyone experiences these, and they can vary from person to person.

Storage

This drug must be stored in a sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 15 to 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance and packaging

Appearance

A colorless and transparent vial injection containing a colorless and transparent liquid that is odorless, colorless, or light blue.

Package unit

10mL/vial × 10

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.