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Material No. Preparation Date

34FS503 16 JAN 12page 1 of 1 Issue No. 1

MARKETINGTEXT & DESIGN LAYOUT

491S426A

Prepared by :

Fahad Al Wohipi _____________________Position : DesignerDate : 16 January 12

Checked by :

Iyad Eqtefan ________________________________Position : Medical & PV ManagerDate : 16 January 12

Approved by :

Ahmed El Shaarawy _________________________Position : Marketing DirectorDate : 16 January 12

Checked by :

Mohammed Barhoumi _____________________Position : Creative ManagerDate : 16 January 12

Dimension: 148 * 210 mm

Composition:Standardized aqueous alkaline solution of Iron (III) Hydroxide Saccharate Complex (Iron Saccharate).One ampoule of 5 ml contains 100 mg trivalent iron.Action:The polynuclear Ferric-Hydroxide is partly stored as ferritin (depot iron) after complex-formation with the protein ligand apoferritin of the mitochondria of the liver.Iron is transported in the blood plasma bound to a b-globulin, transferrin. This protein reacts with two atoms of iron per protein molecule, with the formation of a pink-coloured complex. The major function of transferrin is to act as the carrier of iron through the body (transportation to the sites of hemoglobin and myoglobin-synthesis as well as to the cells, producing iron containing enzymes). In doing this, it plays a vital and central role in iron metabolism. Transferrin also has a second important function, that of participating in the bodys defence mechanism against infection.The hemoglobin level increases quicker and with more certainty than after oral therapy with ferrous salts, although the kinetics of the iron incorporation is independent on the way of iron administration.Indications:All cases of iron deficiency in which rapid and reliable substitution of iron is required, more particularly for the following: Severe iron deficiency, e.g. after haemorrhages. Disturbances in iron absorption in the gastrointestinal tract. Marked incompatibility of oral iron preparations. Iron deficiency resistant to treatment, when the patient cannot be relied on to take the tablets, and contact

between doctor and patient at irregular intervals.Dosage and administration:Children: The use of Ferosac has not been adequately studied in children and, therefore, Ferosac is not recommended for use in children.1st day : 2.5 ml = 50 mg Fe (III).2nd day : 5.0 ml = 100 mg Fe (III).3rd day : 10.0 ml = 200 mg Fe (III).To be followed with 10 ml two times a week depending on hemoglobin level.In the average, administration of 100mg Fe (III) (=1 ampoule of 5 ml) results in an increase of the hemoglobin level of 23% and 2% during pregnancy respectively.In order to avoid overdosage the maximum dose may be determined with the following formula or according to the following table.Total iron deficiency in mg = Hb-iron deficiency + depot ironHb-iron deficiency (in mg) = body weight (kg) x (normal Hb actual Hb in g/I) x 0.24*This calculation is based on : A normal Hb 150 g/I for body weights higher than 35 kg and 130 g/I up to 34 kg body weight respectively. The iron-content of hemoglobin (0.34%). The blood volume (approx. 7% of the body weight) and the requirements of depot iron 500 mg for body weights

higher than 34 kg and (approx. 15 mg per kg up to a weight of about 34 kg).* Factor 0.24 = 0.0034 x 0.07 x 1000Example: Patient weighing 70 kgnormal Hb : 150 g/Iactual Hb : 80 g/IHb-Fe deficit: 70 x (150 80) x 0.24 =1176 mg FeNeed for depot iron =500 mg Fe Total dosage =1676 mg FeTherefore this patient requires 1700 mg iron or 17 ampoules during treatment.For IV use only either by slow injection or by infusion. Before administering the first dose to a new patient, a test dose of Ferosac should be given. Ferosac must not be used for intramuscular injection.

FEROSAC Intravenous

Manufactured by SPIMACOAl-Qassim Pharmaceutical Plant,Saudi Pharmaceutical Industries & Medical Appliances Corporation,Saudi Arabia.

Revision date: April 2011.FEROSAC is a trade mark

34FS503

This is a medicament

A medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.Follow strictly the doctors prescription, the method of use and the instructions of the pharmacists who sold the medicament.The doctor and the pharmacists are experts in medicine, its benefits and risks.Do not by yourself interrupt the period of treatment prescribed for you.Do not repeat the same prescription without consulting your doctor.

Keep medicaments out of the reach of childrenCouncil of Arab Health MinistersUnion of Arab Pharmacists

Intravenous injection: Ferosac may be administered by slow intravenous injection (over 2- 5 minutes per ampoule) and not exceeding 2 ampoules Ferosac (200 mg iron) per injection.Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given.Intravenous drip infusion: Ferosac must be diluted only in sterile 0.9% m/V sodium chloride solution (NS):- Intravenous infusion for a 100 mg dose (5 ml Ferosac), dilute to a maximum of 100 ml in NS and infuse over at

least 15 minutes.- Intravenous infusion for a 200 mg dose (10 ml Ferosac), dilute to a maximum of 200 ml in NS and infuse over at

least 30 minutes.For stability reasons, dilutions to lower Ferosac concentrations are not permissible.Dilution must take place immediately prior to infusion and the solution should be administered as follows:The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 50 ml in 15 minutes.Injection into dialyser: Ferosac may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.Daily maximum doses: - Adults: 10 ml ( 2 ampoules).Pregnancy and lactation:FDA Pregnancy Category B. Pregnancy first trimester: see contra-indications.Ferosac is unlikely to pass into the mothers milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.Side effects: In rare cases anaphylactoid reactions have been observed. The counter - measures to be taken are the same as with any anaphylaxis.Precautions :Store below 25 C.Do not freeze. Only homogenous solution to be used.Do not mix Ferosac i.v. with any other medicament.Contraindications :All cases of iron overload or disturbances in utilization of iron.Pregnancy first trimester.Presentation :Boxes of 5 X 5 ml Ampoules.

Body weightsHemoglobin level 30kg 35kg 40kg 45kg 50kg 55kg 60kg 65kg 70kg 75kg 80kg 85kg 90kg

Hb =60g/l AMP 9.5 12.5 13.5 15 16 17 18 19 20 21 22.5 23.5 24.5Hb =75g/l AMP 8.5 11.5 12 13 14 15 16 16.5 17.5 18.5 19.5 20.5 21.5Hb =90g/l AMP 7.5 10 11 11.5 12 13 13.5 14.5 15 16 16.5 17 18

Hb =105g/l AMP 6.5 9 9.5 10 10.5 11 11.5 12 12.5 13 13.5 14 14.5

34FS503 LEAFLET FEROSAC INJECTION