Fer-Rompharm (Solution) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

B03AC (Parenteral preparations of trivalent iron)

Active Substance

Iron polymaltose (BP British Pharmacopoeia)

Dosage Form

Fer-Rompharm

Solution for intramuscular administration 100 mg/2 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration brown in color, opaque.

Excipients : 1M sodium hydroxide solution or 1M hydrochloric acid solution – q.s. (to pH 5.7-6.5), water for injections – up to 1 ml.

2 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard boxes.
2 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Iron preparation

Pharmacological Action

Anemia treatment agent. The polynuclear centers of Fe3+ hydroxide are externally surrounded by many non-covalently bound polymaltose molecules, forming a complex with a total molecular weight of 50 kDa, which is so large that its diffusion through the intestinal mucosa membranes is approximately 40 times less than that of Fe2+ hexahydrate.

This macromolecular complex is stable, does not release iron in the form of free ions, and is similar in structure to the natural compound of iron and ferritin. Due to this similarity, Fe3+ ions from the intestine enter the bloodstream only through active absorption, which explains the impossibility of overdose (and intoxication) unlike simple iron salts, the absorption of which occurs along a concentration gradient.

The absorbed iron is deposited in a ferritin-bound form, mainly in the liver. Later, in the bone marrow, it is incorporated into hemoglobin. The iron that is part of the Fe3+-hydroxide polymaltose complex does not possess pro-oxidant properties (which are inherent in simple Fe2+ salts), which leads to a reduction in the oxidation of LDL and VLDL.

It rapidly replenishes iron deficiency in the body, stimulates erythropoiesis, and restores hemoglobin.

Pharmacokinetics

The degree of absorption after oral administration depends on the degree of iron deficiency (the greater the deficiency, the higher the absorption) and on the magnitude of the drug dose (the higher the dose, the worse the absorption). It is absorbed primarily in the duodenum and small intestine. The unabsorbed portion is excreted in the feces.

After intramuscular administration, it enters the bloodstream through the lymphatic system. The time to reach C_max is 24 hours. In the reticuloendothelial system (RES), the complex is broken down into iron (III) hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, in tissues it is deposited as part of ferritin, in the bone marrow it is incorporated into hemoglobin and used in the process of erythropoiesis.

Indications

For oral administration: treatment of iron deficiency anemia of various origins and latent iron deficiency in infants and young children; increased need for iron (pregnancy, lactation period, blood donation, period of intensive growth, vegetarianism, old age).

For parenteral administration: treatment of iron deficiency anemia in case of ineffectiveness or impossibility of taking oral iron-containing medicines (including in patients with gastrointestinal diseases, with malabsorption syndrome).

ICD codes

Dosage Regimen

Determine the dosage individually based on the degree of iron deficiency, patient weight, and hemoglobin levels.

For intramuscular injection only. Administer deep into the gluteal muscle. Use the Z-track technique to minimize skin staining.

Calculate the total cumulative dose using the formula: Total Iron Dose (mg) = Body Weight (kg) x (Target Hb – Actual Hb) (g/L) x 0.24 + 500 mg (for iron stores).

For adults and children over 14 years of age, administer a test dose of 1/4 to 1/2 ampoule (25-50 mg iron) initially. Monitor for hypersensitivity reactions for at least 30 minutes.

If the test dose is tolerated, administer subsequent doses not exceeding 100 mg (one 2 ml ampoule) per day. Do not exceed a single daily dose of 100 mg iron.

For children aged 4 months to 14 years, calculate the dose strictly by body weight: 0.12 ml of solution (6 mg iron) per kg body weight per day. The maximum single dose for a child must not exceed 2 ml (100 mg iron).

Continue treatment until the total cumulative dose is reached to replenish hemoglobin and iron stores.

Adverse Reactions

When taken orally : dyspepsia (feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea), dark coloration of stools (due to the excretion of unabsorbed iron and has no clinical significance).

With intramuscular injection : in rare cases – arthralgia, lymph node enlargement, fever, headache, malaise, dyspepsia (nausea, vomiting); extremely rarely – allergic reactions. Local reactions (with incorrect injection technique): skin staining, pain, inflammation.

Contraindications

Excess iron in the body (hemochromatosis, hemosiderosis); anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by cyanocobalamin deficiency, aplastic anemia); impaired mechanisms of iron utilization (lead anemia, sideroblastic anemia, thalassemia, cutaneous porphyria tarda); hypersensitivity to the active substance.

For intramuscular administration only (additionally): Rendu-Osler-Weber disease; chronic polyarthritis; acute stage of infectious kidney diseases; uncontrolled hyperparathyroidism; decompensated liver cirrhosis; infectious hepatitis; children under 4 months of age; first trimester of pregnancy.

Use in Pregnancy and Lactation

No negative effect on the fetus has been established when using oral forms during pregnancy (including in the first trimester).

Intramuscular administration is contraindicated in the first trimester of pregnancy.

In small amounts, unchanged iron from the polymaltose complex can be excreted in breast milk; however, the occurrence of adverse effects in breastfed children is unlikely.

Pediatric Use

Contraindicated for use in children under 4 months of age.

Special Precautions

Iron medication intake must be continued even after hemoglobin normalization.

Does not cause staining of tooth enamel.

Iron preparations for parenteral administration can cause allergic and anaphylactic reactions. In case of moderately severe allergic reactions, antihistamines should be prescribed; if a severe anaphylactic reaction develops, immediate administration of epinephrine is necessary. Cardiopulmonary resuscitation equipment should be available. Caution should be exercised when administering iron preparations to patients with allergies, as well as hepatic and renal insufficiency. Side effects occurring in patients with cardiovascular diseases may exacerbate the course of the underlying disease. Patients with bronchial asthma or those with low serum iron-binding capacity and/or folic acid deficiency are at high risk of developing allergic or anaphylactic reactions.

In children, iron preparations with parenteral use may adversely affect the course of an infectious process.

Drug Interactions

Oral forms : no interactions with other medicinal products have been detected.

Solution for injection ACE inhibitors enhance systemic effects. Should not be used concurrently

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.