Gembag

 

1.     International nonproprietary name

Ferric hydroxide polymaltose complex

 

2.     Pharmaceutical form

Solution for injections.

 

3.     Qualitative and quantitative composition

 

1 ampoule contains:

 

Active substances:

                                                                                             

Iron (III) hydroxide polymaltose complex expressed as elemental iron 100 mg

 

Excipients:

 

Water for injections.                                                           

 

4.     Clinical data

 

4.1.   Therapeutic indications

Gembag is administered in iron-deficient conditions as:

- severe posthemorrhagic anemia;

- iron-deficient anemia of various genesis in adults and children, if administration of oral iron-containing preparations is ineffective or impossible (including in patients with GIT diseases and malabsorption syndrome).

Gembag is applied only in iron-deficient conditions confirmed by respective laboratory studies.

 

4.2.  Method of administration and dosage

The drug is intended only for deep intramuscular administration.

Injection technique is of crucial significance. As a result of inadequate administration painful sensations and skin staining may develop at the injection site. The method of ventrogluteal injection described below is recommended instead of the generally accepted one (injection is made into the upper outer quadrant of the gluteus maximus muscle):

- The needle must not be shorter than 5-6 cm. Needle lumen should not be too wide. Use shorter and thinner needles for children and for adults with low body weight.

- Injection site is defined as follows: fix point A along the vertebral column at the level corresponding to the lumbo-iliac juncture. If the patient is lying on the right side, place the middle finger of the left hand at point A. Set the index finger aside from the middle one so that it is placed under the line of the iliac crest at point B. The triangle between proximal phalanges, the middle and the index fingers is the injection site.

- Before introduction of the needle shift the skin for approximately 2 cm in order to close the puncture hole well after removal of the needle. This prevents penetration of the injected solution into subcutaneous tissues and skin staining.

- Place the needle vertically against skin surface at a greater angle to the point of the iliac juncture than to that of the femoral joint.

- After injection remove the needle immediately and press with the finger the skin area adjacent to the injection site for about 5 minutes.

- After injection the patient must move around for a while.

 

The daily dose for the adults is 1 ampoule (100 mg).

Lower doses are recommended for children depending on their age and body weight.

Duration of parenteral iron therapy is determined by the attending doctor with regard to hemoglobin level.

 

Maximum daily doses:

 

Children with body weight under 5 kg	0.5 ml (1/4 of an ampoule, 25 mg of elemental iron)
Children with body weight of 5 - 10 kg	1.0 ml (1/2 of an ampoule, 50 mg of elemental iron)
Adults	4.0 ml (2 ampoules, 200 mg of elemental iron)

 

Daily demand for iron is indicated in the table below:

Age group	Iron (mg/day)	Age group	Iron (mg/day)
0- 6 months	0,27	31- 50 years
7- 12 months	11	males	8
1- 3 years	7	females	18
4- 8 years	10	50- 70 years
9-13 years	8	males	8
14- 18 years		females	8
boys	11	> 70 years
girls	15	males	8
19- 30 years		females	8
males	8
females	18

 

Pregnancy: 27 mg/day. Lactation: under 18 years - 10 mg/day; over 18 years - 9 mg/day.

 

4.3.  Contraindications

- hypersensitivity;

- anemias, not related to iron deficit (hemolytic, megaloblastic anemias associated with vitamin B₁₂ deficiency);

- erythropoiesis disorders, bone marrow hypoplasia;

- excess of iron in the body (hemochromatosis, hemosiderosis);

- iron utilization disturbances (sideroachrestic anemia, thalassemia, lead anemia, late skin porphyria);

- Osler-Weber-Rendu syndrome;

- chronic polyarthritis;

- bronchial asthma;

- acute infectious renal diseases;

- uncontrolled hyperparathyreosis;

- decompensated cirrhosis of the liver;

- early childhood (under 4 months);

- pregnancy (1^st trimester);

- infectious hepatitis (as the drug accumulates in the RES).

With caution: renal and/or hepatic failure, cardiovascular and allergic diseases.

 

4.4.  Drug interactions

ACE inhibitors enhance systemic effects. The drug should not be used simultaneously with oral iron-containing preparations (GIT iron absorption decreases); thus treatment with oral iron preparations may be started at least 1 week after the last injection.

 

4.5.  Use during pregnancy and lactation

Contraindicated in the 1^st trimester of pregnancy. Administration of the drug in the 2^nd and the 3^rd trimesters is possible only in cases when the result of treatment outweighs potential risk for the fetus.

Small doses of unchanged iron from the polymaltose complex may penetrate into breast milk, but development of adverse effects in nursing children is unlikely.

 

4.6.  Side effects

Rare: arthralgia, enlargement of lymph nodes, fever, headache, ailment, dyspepsia (nausea, vomiting), metallic aftertaste; very rare: allergic reactions.

Local reactions (in case of incorrect injection technique): skin staining, soreness, inflammation.

 

           5.7. Overdose

No data on overdose are available. Overdose may lead to acute iron hypersaturation manifested by symptoms of hemosiderosis. Chronic excess of iron induces hemochromatosis. This may occur in case of wrong diagnosis of iron-deficiency anemia in the event of treatment-resistant anemia. Hemochromatosis should be treated as thalassemia (by intravenous administration of deferoxamine).

In case of administration of Gembag in excessive doses the complex cannot be eliminated from the body by hemodialysis due to its high molecular mass.

Treatment of overdose is symptomatic. Chelating agent deferoxamine is the antidote specific to iron.

Regular control of serum ferritin is recommended for timely detection of progressing iron accumulation.

 

5.     Pharmacological data

 

5.1.   Pharmacotherapeutic group

Hemopoiesis stimulators. Iron (trivalent) preparations for parenteral administration.

 

6.     Pharmaceutical data

 

6.1.   Shelf life

3 years from the manufacture date.

Do not use after expiry date.

 

6.2.   Storage conditions

Store in a protected from light place at temperature not exceeding 25ºС.

Keep out of reach of children!

 

 

6.3.   Package

Solution for injection in 2 ml amber glass ampoules.

5 ampoules in a contour tray.

1 contour tray together with a leaflet in carton box.

 

7.     Manufacturer

The holder of trade mark and Marketing Authorization is

“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY

Manufactured by

“PharmaVision Sanayi ve Ticaret A.Ş.”, Turkey

(Davutpaşa Caddesi No.145, Topkapı, İstanbul).