Maltofer-IV 500 Injection - ePharma
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Maltofer-IV 500 Injection

Generic: Ferric Carboxymaltose INN

Type: Injection

Pack Size: 10ml

  • Maltofer-IV 500 Injection is a kind of iron replacement therapy. It is used to treat anemia, a condition in which your body produces fewer red blood cells due to a lack of iron. (iron-deficiency anemia). Iron is essential to build the red blood cells that transport oxygen around your body.
  • Maltofer-IV 500 Injection is administered by injection or infusion (saline drip) into a vein by your doctor or nurse. You will be observed closely to make sure you do not have an allergic response. It is normally administered in two doses separated by seven days. Your doctor will decide how much and how often you may need injections to improve your anemia. 
  • Eating a well-balanced diet rich in iron, vitamins, and minerals can assist in replenishing your iron reserves. Good sources of iron include meat, eggs, raisins, broccoli, and lentils.
  • The most frequent adverse effects are vomiting, headache, dizziness, elevated blood pressure, and soreness or irritation at the site of injection. Most of the symptoms normally go gone after a short period following the injection. If they trouble you or last for an extended period of time, consult your doctor or nurse. If your anemia is not caused by a shortage of iron, you should not use this medication.

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Description:

Maltofer-IV 500 Injection is a medication that replaces iron. It is used to treat a type of anemia in which your body produces fewer red blood cells as a result of a lack of iron (iron deficiency anemia). The red blood cells that carry oxygen throughout your body are made with the help of iron. Your doctor or nurse will administer Maltofer-IV 500 Injection by injection or infusion (saline drip) into a vein.

Safety Advices


Alcohol
CONSULT YOUR DOCTOR

It is not known whether it is safe to consume alcohol with Maltofer. Please consult your doctor.


Pregnancy
CONSULT YOUR DOCTOR

Maltofer may be unsafe to use during pregnancy. Although there are limited studies on humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing them to you. Please consult your doctor.


Breastfeeding
SAFE IF PRESCRIBED

Maltofer is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.


Driving
SAFE

Maltofer does not usually affect your ability to drive.


Kidney
SAFE IF PRESCRIBED

Maltofer is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Maltofer may not be needed in these patients. Please consult your doctor.


Liver
CAUTION

Maltofer should be used with caution in patients with liver disease. A dose adjustment of Maltofer may be needed. Please consult your doctor.

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Uses of Maltofer-IV 500 Injection
  • Treatment of Iron Deficiency Anemia
How to use Maltofer-IV 500 Injection

Your doctor or nurse will give you this medicine. Kindly do not self-administer.

How Maltofer-IV 500 Injection works

Maltofer is an anti-anemic medication. It replenishes the iron stores in your body. Iron is vital for the formation of new red blood cells and hemoglobin, a substance that gives these cells the ability to transport oxygen.

What if you forget to take Maltofer-IV 500 Injection?

If you miss a dose of Maltofer, please consult your doctor.

Side Effects of Maltofer-IV 500 Injection
  • Nausea
  • Flushing
  • Dizziness
  • High blood pressure
  • Low levels of phosphorus in the blood
  • Injection site reactions
Quick Suggestions:
  • Maltofer-IV 500 Injection is used for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.
  • Your doctor or nurse will administer it by injection. You will be observed for at least 30 minutes after each injection as it may cause an allergic reaction.
  • Your blood pressure and blood iron levels will be regularly monitored during treatment with this medication.
  • Inform your doctor if you are taking any iron-containing products by mouth.
  • It may cause your stools to become black or dark in color. This is normal and harmless.
Indications of Maltofer-IV 500 Injection

Maltofer-IV 500 Injection is a member of the class of anti-anemic drugs used to treat iron deficiency anemia in patients with chronic renal disease who are non-dialysis dependent, intolerant to oral iron preparations, or who need a rapid buildup of iron reserves. Iron deficiency anemia (lack of red blood cells caused by too little iron in the body) is a condition in which the body does not have enough red blood cells for carrying adequate oxygen to various body tissues.
Maltofer-IV 500 Injection 10ml contains ‘ferric carboxy maltose, which acts as a source of iron and helps in the transportation of oxygen throughout the body and the production of red blood cells. Thereby, Maltofer-IV 500 Injection 10ml helps in treating anemia. Maltofer-IV 500 Injection 10ml helps various vital processes in the body. 

Pharmacology

Non-dextran IV is a colloidal iron hydroxide complexed with carboxy maltose, a carbohydrate polymer that releases iron. It also replenishes the iron stores in hemoglobin, myoglobin, and enzymes. Hemoglobin aids in the transportation of oxygen. Macrophages consume FCM from blood and control the release of iron. Iron is carried to the liver, spleen, and bone marrow by transferrin, which binds to iron.

Dosage & Administration of Maltofer-IV 500 Injection
  • Give Ferric Carboxy Maltose in two doses separated by at least seven days for patients weighing 50 kg or more. Each dose should contain 750 mg, with a maximum cumulative dose of 1500 mg per course.
  • Ferric Carboxy Maltose dosage is specified in milligrams of elemental iron. 50 mg of elemental iron are present in each mL of ferric carboxy maltose. If iron deficiency anemia reappears, the ferric carboxy maltose treatment can be repeated.
  • Use an intravenous infusion or a slow, undiluted intravenous push to administer ferric carboxy maltose. Give at a rate of about 100 mg (2 mL) per minute when given as a slow intravenous push. When given as an infusion, dilute up to 750 mg of iron in a maximum of 250 mL of sterile 0.9% sodium chloride injection, USP, so that the infusion's iron concentration is at least 2 mg per mL. This should be done over a minimum of 15 minutes.
  • Ferric Carboxy Maltose Solution is physically and chemically stable for 72 hours when kept at room temperature when added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL. Do not dilute to concentrations lower than 2 mg iron/mL in order to maintain stability. Ferric Carboxy Maltose Solution is physically and chemically stable for 72 hours when kept at room temperature when added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL. Do not dilute to concentrations lower than 2 mg iron/mL in order to maintain stability.
  • Prior to administration, visually check parenteral drug products for impurities and discoloration. There are no preservatives in the product. Ferric Carboxy Maltose is only meant for a single use per vial. Following injection, any unused medication must be thrown away.
  • Avoid extravasating ferric carboxy Maltose because the extravasation site may develop a permanent brown discoloration. Keep an eye out for invasion. If extravasation happens, stop administering ferric carboxy Maltose there.
  • Prior to administration, visually check parenteral drug products for impurities and discoloration. There are no preservatives in the product. Ferric Carboxy Maltose is only meant for a single use per vial. Following injection, any unused medication must be thrown away.
  • Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long-lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
Interaction of Maltofer-IV 500

There are no known or well-documented medication interactions.

Contraindications

Any of its constituents can cause hypersensitivity.

Pregnancy & Lactation

Pregnancy Type C. Animal reproduction studies have revealed a detrimental impact on the fetus, and there have been no appropriate and well-controlled human trials, although possible advantages may justify the drug's usage in pregnant women despite potential dangers.

Precautions & Warnings
  • Patients taking ferric Carboxy Maltose have experienced severe hypersensitivity reactions, including anaphylactic-type reactions, some of which have been fatal. 
  • Patients may experience shock, clinically severe hypotension, unconsciousness, and/or collapse. After receiving ferric carboxy Maltose, patients should continue to be watched for signs and symptoms of hypersensitivity for at least 30 minutes or until they reach a clinically stable state. 
  • Use ferric Carboxy Maltose only in situations where it is possible to quickly access medical personnel and treatments for severe hypersensitivity reactions. 
  • In addition to wheezing and hypotension, other acute or severe adverse reactions that can result from hypersensitivity include pruritus, rash, urticaria, and urticaria.
  • Transient increases in systolic blood pressure were reported, occasionally accompanied by face flushing, dizziness, or nausea. 
  • These increases were often observed shortly upon dosage and disappeared within 30 minutes. 
  • Following each Ferric Carboxy Maltose dose, check patients for signs and symptoms of hypertension.
  • Regular monitoring of blood pressure and phosphorus levels whilst on treatment with Maltofer-IV 500 Injection 10ml is advised.
  • Maltofer-IV 500 Injection 10ml might cause blackening/darkening of the stools and can interfere with test results. Inform the person doing the tests that you are taking Maltofer-IV 500 Injection 10ml if you are having tests on your stools.
  • Regular blood tests while taking Maltofer-IV 500 Injection 10ml are advised.
Storage Condition

Ferium Injection vials should be stored at 20°C to 25°C (68°F to 77°F). Remember, these should not be frozen. The temperature should not deviate more than 15°C to 30°C (59°F to 86°F).

Frequently Asked Questions (FAQ)

Ferric Carboxymaltose Injection should be administered by staff that is trained in dealing with serious allergic reactions (anaphylactic reaction). Ferium Injection can be administered as an undiluted injection, directly into the vein or via a dialyzer if the patient is on dialysis. It can also be diluted with sodium chloride and given as infusion directly into the vein. The patient should be monitored for at least 30 minutes after each injection. Also, the injection should not be given below the skin (subcutaneous route) or in the muscle (intramuscular route).

Yes, Ferric Carboxymaltose Injection may cause a temporary increase in blood pressure accompanied with facial flushing, dizziness, and nausea. This may occur immediately after you take the medicine and generally disappears within 30 minutes.

Usually, two doses of this medicine are given 7 days apart. The hemoglobin is then assessed at least 4 weeks after the final injection to allow time for the RBCs to form. If the reports still show deficiency of iron, it can be re-administered depending on individual need.

Maltofer-IV 500 Injection 10 ml acts as a source of iron and helps in the transportation of oxygen throughout the body and the production of red blood cells. Thereby, Orofer FCM Injection 10 ml helps in treating anaemia.

Oral iron preparations will be less effective when taken along with Maltofer-IV 500 Injection 10ml. Inform your doctor if you are taking oral iron preparations or any supplements.

Maltofer-IV 500 Injection 10ml might cause hypophosphatemia (low phosphorus levels). Inform your doctor if you experience symptoms such as severe tiredness, bone or muscle pain, as these could be a sign of low phosphorus levels. Regular monitoring of phosphorus levels whilst on treatment with Orofer FCM Injection 10 ml is advised.

There is limited data on the use of Ferium Injection in pregnancy. It is important to tell your doctor if you are pregnant or are planning to have a baby. Consult your doctor if you become pregnant during treatment with Ferium Injection. Your doctor will decide whether you need to continue treatment or discontinue it.
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ePharma sole intention is to ensure that its consumers get proper information as musch as possible. Although we do not guarantee the accuracy and the completeness of the information that provided and here information is for informational purposes only. The information contained herein should NOT be used as a substitute for the advice of a qualified physician. This may not cover everything about particular health conditions, lab tests, medicines, all possible side effects, drug interactions, warnings, alerts, etc. Please consult your healthcare professional and discuss all your queries related to any disease or medicine. We intend to support, not replace, the doctor-patient relationship.

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