Unifer  Injection:   Each  5  ml  ampoule  contains  100  mg  elemental  Iron  as  Iron  Sucrose  USP.
 

Intravenous  Iron  Sucrose  is  more  effective  and  well  tolerated  in  comparison  with  oral  Iron  preparations  and  it  is  the  treatment  of  choice  for  anemia  due  to  Iron  deficiency.  Administration  of  Iron Sucrose replenishes tissue Iron stores, reverses Iron depletion and Iron-deficient erythropoiesis and corrects or prevents Iron deficiency anemia.

Iron Sucrose is indicated for the treatment of Iron deficiency in the following indications:

• Treatment of Iron deficiency anemia (IDA)
• In  non-dialysis  dependent  chronic  kidney  disease  (CKD)  patients  either  receiving  or  not  receiving an erythropoietin
• Hemodialysis dependent CKD patients receiving an erythropoietin
• Peritoneal dialysis dependent CKD patients receiving an erythropoietin.

Adults and Elderly:  Iron Sucrose has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyser. Iron Sucrose must not be used for intramuscular injection. As Injection:  Iron Sucrose can also be administered undiluted by slow IV injection at a rate of 1 ml Iron Sucrose (20 mg Iron) in at least 1 minute. A maximum of 10 ml Iron Sucrose (200 mg Iron) can be administered per injection in at least 10 minutes. As Infusion: Iron Sucrose should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Iron Sucrose in maximum 20 ml 0.9% NaCl etc up to 25 ml Iron Sucrose in maximum 500 ml 0.9% NaCl. Dilution must take place immediately prior to infusion and solution must be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes, ete. Normal posology is to use 5-10 ml Iron Sucrose 1-3 times a week depending on the Hemoglobin level. For the administration of the maximum tolerable dose of 7 mg Iron/kg body weight an infusion time of at least 3.5 hours has to be respected, independently of the total dose. Chronic  Kidney  Disease  Patients  not  on  Dialysis:   Unifer  is  administered  as  a  total  cumulative   dose of 1000 mg over a 14 day period, or as an infusion of 500 mg of Unifer over a period of 4 hours on day 1 and day 14. Patients weighing less than 70 kg may require longer infusion times. Hemodialysis  Patients:  Unifer  is  administered  as  a  100  mg  slow  intravenous  injection  or  as  an   infusion  of  100  mg  per  consecutive  hemodialysis  session  for  a  total  cunulative  dose  of  1000  mg. Peritoneal  Dialysis  Patients:   Unifer  is  administered  as  a  total  cumulative  dose  of  1000  mg  in  3   divided doses within a 28 day period. 2 infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Children:  There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose (3 mg Iron) per kg body weight 1-3 times a week  depending on the hemoglobin level.

Iron Sucrose should be administered with caution in patients with asthma, eczema, other atopic allergies  or  allergic  reaction  to  other  parenteral  Iron  preparations,  low  binding  capacity  and/or   folic acid deficiency, liver dysfunction, acute or chronic infection. Blood Pressure:
 Monitor Blood Pressure during infusion. If  hypotension occurs, slow the rate of infusion. If hypotension continues, discontinue infusion and be prepared to treat appropriately.

•     Discontinue oral Iron preparations before administering parenteral Iron products. Co-administration of parenteral Iron preparations may reduce absorption of oral Iron.
•     The dose will be in terms of elemental Iron.
•     For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial  administration.
•     Medication is administered 1 to 3 times/ week. Do not administer more than 3  times/week.
•     Discard any unused diluted solution. Do not save unused solution for future use.
•     Do not administer if particulate matter or discoloration noted.

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron preparations or any components preparation, in patients with anemia not caused by Iron deficiency.

  Each  box  contains  5  ml  Ampoule  in  blister  pack,  100  ml  of  Salnor  (Sodium  Chloride 0.9% w/v) Intravenous Infusion BP in glass bottle, one 5 ml sterile Disposable Syringe, one Infusion Set, one Alcohol Pad & one First Aid Band.  

Pregnant  women: FDA  pregnancy  category  B.  Lactating  mothers: It  is  not  known  whether  this  drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman