Orofer Fcm Injection 10ml Allschoolabs -

Specification

INTRODUCTION
OROFER FCM contains Ferric carboxymaltose which belongs to the group of medicines called Iron replacement medicines. It is used to treat iron deficiency anaemia (IDA) in adults and in children (above 14 years of age), who are unable to take iron supplements orally, have an intolerance to oral iron supplements, need a rapid iron supplement in the body, have non-dialysis dependent chronic kidney disease. Iron deficiency anaemia is a condition in which the body lacks enough amount of iron, which is essential for the production of red blood cells and transport of oxygen in the body.
Your doctor may advise you to take relevant tests to understand your existing condition. Before receiving OROFER FCM inform your doctor if you are pregnant or planning to get pregnant or breast-feeding. OROFER FCM is not recommended for use in children and adolescents (under 14 years of age) and it should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving OROFER FCM.
The most common side effects of receiving OROFER FCM may include headache, dizziness, flushing, high blood pressure, nausea and injection or infusion site reactions. Consult your physician if any of the symptom worsens. ???????
USES OF OROFER FCM

Treats iron deficiency anaemia ??

HOW OROFER FCM WORKS
OROFER FCM contains iron (III) hydroxide complexed with a carbohydrate polymer called carboxymaltose, which is capable of releasing iron. The iron released from the complex helps in the synthesis of haemoglobin and increases red blood cell count. As a result, it treats iron deficiency anaemia. ????
DIRECTIONS FOR USE
OROFER FCM will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your physician will decide the correct dose and duration for you depending upon your age, body weight and severity of the condition.
SIDE EFFECTS OF OROFER FCM

COMMON

Headache

Dizziness

Flushing

High blood pressure

Nausea

Injection/infusion site reactions

Low levels of phosphorous in the blood

UNCOMMON

Numbness

Prickling or tingling sensation of the skin

Change in taste sensation

Increased heart rate

Low blood pressure

Difficulty in breathing

Vomiting

Indigestion

Stomach pain

Constipation

Diarrhoea

Itching

Redness of the skin

Skin rash

Muscle or joint pain

Back pain

Pain in the arms or the legs

Muscle spasms

Fever

Tiredness

Chest pain

Swelling of the hands and feet, and chills

RARE

Inflammation of the vein

General feeling of discomfort

Anxiety

Fainting or feeling faint

Wheezing

Flatulence

Rapid swelling of the face, mouth, tongue or throat which may cause difficulty in breathing

Paleness and discoloration of the skin in other areas of the body than the injected site
Contact your doctor immediately if you experience any of the following side effects:
Symptoms of serious allergic reaction or kounis syndrome (such as rashes, itching, swelling of the face, lips, mouth, tongue, throat or body causing difficulty in breathing or wheezing and chest pain)

Severe or life-threatening allergic reactions called anaphylactic reactions which can be associated with heart, circulation problems (low blood pressure) and loss of consciousness

Sign of a decrease in blood phosphorus causing softening of bones (osteomalacia) symptoms include worsening of tiredness, muscle or bone pain (pain in arms or legs, joints or back) and may lead to fractures

Signs of high blood pressure (such as facial flushing, dizziness or nausea)

Skin irritation and brownish discolouration of the skin at the injected site

HOW TO MANAGE SIDE EFFECTS
Headache:
Take rest and relax. Drink plenty of fluids such as water. Apply a pain-relieving balm on the forehead if necessary. Consult your doctor if your headache does not improve.
Nausea or vomiting:
Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Stomach pain:
Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.
Diarrhoea:
Drink lot of fluids, such as water or fruit juices to keep yourself hydrated. Avoid eating high-fat or spicy foods. If the symptom does not improve, consult your doctor.
Constipation:
Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS

PREGNANCY
OROFER FCM should be used with caution in pregnant women only if considered clearly necessary. Inform your doctor if you are pregnant, think you may be pregnant, or planning to have a baby. Consult your doctor before receiving OROFER FCM. ?????
BREASTFEEDING
If you are breastfeeding, consult your doctor for advice before receiving OROFER FCM. It is unlikely that OROFER FCM represents a risk to the breast-fed child. ??
DRIVING AND USING MACHINES
OROFER FCM is unlikely to impair the ability to drive or operate machines.
KIDNEY
OROFER FCM should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving OROFER FCM. ?
LIVER
OROFER FCM should be used with caution in patients with liver disease. Consult your doctor before receiving OROFER FCM. ????????????????????
ALLERGY
Do not receive OROFER FCM if you are allergic to ferric carboxymaltose or any of the other ingredients of this medicine or if you have experienced serious allergic reactions to other injectable iron preparations. ??
LUNGS
OROFER FCM should be used with caution in patients with severe asthma. Consult your doctor before receiving OROFER FCM.
OTHERS
OROFER FCM is not recommended for use if you have:
Anaemia not caused by iron deficiency

Iron overload (too much iron in your body) or disturbances in the utilisation of iron
Before receiving OROFER FCM inform your doctor if you have:
Systemic lupus erythematosus

Rheumatoid arthritis

Eczema or other allergies

An infection

Low levels of phosphate in the blood

High blood pressure
Use in paediatrics:
OROFER FCM is not recommended for use in children (under 14 years of age). Consult child?s doctor for advice to treat the condition.
Use in geriatrics:
OROFER FCM should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before receiving OROFER FCM.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving OROFER FCM, inform your doctor if you are using or have recently taken any other medicines including prescription, non-prescription medicines and vitamins or herbal supplements. ?
Oral iron preparations such as ferrous ascorbate, ferrous sulphate, ferric citrate (used to prevent or treat low levels of iron in the body)
Overdosage:
OROFER FCM will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms. ?
SYNOPSIS

Drug :?? Ferric carboxymaltose

Pharmacological Category :?? Iron replacement medicines

Therapeutic Indication :??
Iron Deficiency Anemia (IDA)
Dosage Forms :??
Injection
MORE INFORMATION

Keep OROFER FCM out of reach in children

Store at room temperature

FAQs ABOUT OROFER FCM
How does OROFER FCM work?
OROFER FCM contains iron (III) hydroxide complexed with a carbohydrate polymer called carboxymaltose, which is capable of releasing iron. The iron released from the complex helps in the synthesis of haemoglobin and increases red blood cell count. As a result, it treats iron deficiency anaemia.? ?
Is OROFER FCM safe to use in patients with kidney problems?
OROFER FCM should be used with caution in patients with chronic kidney disease who are dependent of haemodialysis treatment. Consult your doctor before receiving OROFER FCM.?
Who should avoid receiving OROFER FCM?
OROFER FCM is not recommended for use in patients with evidence of iron overload or disturbances in the utilisation of iron, anaemia not attributed to iron deficiency (microcytic anaemia) and with known allergic to ferric carboxymaltose or serious allergic to other parenteral iron products.
Is OROFER FCM safe to use in elderly patients?
OROFER FCM should be used with caution in elderly patients (aged 65 years or above). Your doctor may monitor you carefully during administration and certain time after administration of OROFER FCM. Consult your doctor before receiving OROFER FCM.?
Can OROFER FCM be used during pregnancy?
OROFER FCM should be used with caution in pregnant women only if clearly advised by your doctor. Inform your doctor if you are pregnant, think you may be pregnant, or planning to have a baby. Consult your doctor before receiving OROFER FCM.?????
REFERENCES
1. KD. Tripathi. Haematinics and Erythropoietin. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 605.
2. Joao Ricardo Friedrischa and Rodolfo Delfini Cancadob. Intravenous ferric carboxymaltose for the treatment of iron deficiency anemia. NIH. National Library of Medicine, National Center for Biotechnology Information. PMC PubMed Central. October 2015. [Accessed on 1st July 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678908/
3. American Regent, Inc. Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia. NIH. U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in February 2018] [Accessed on 1st July 2022]?https://clinicaltrials.gov/ct2/show/NCT00703937
4. Vifor France. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 1st July 2022]?https://www.medicines.org.uk/emc/files/pil.5910.pdf
5. Vifor (International) Inc. U.S. Food & Drug Administration. [Revised in April 2021] [Accessed on 1st July 2022]?https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565s014lbl.pdf
USEFUL DIAGNOSTIC TESTS