FREQUENTLY ASKED QUESTIONS

1- What is the mechanism of action, absorption site iron when using ?

Using the model of Caco-2 cells in vitro, it has been shown that some fish glycosaminoglycans, which are a source of a special type of oligosaccharides, are able to make the intestine to absorb 3 to 5 times more iron in comparison to the “meat factor”.

This increase, that relates predominantly to non-heme iron, is particularly important since this is the fraction less easy to absorb.

Kabtafer-plus formula is rich in a particular type of oligosaccharides (a fraction of low molecular weight carbohydrates), which produces a significant increase in the intestinal (duodenum) absorption of iron contained in foods.

2- What is the mechanism of action, absorption site iron when using ?

Using the model of Caco-2 cells in vitro, it has been shown that some fish glycosaminoglycans, which are a source of a special type of oligosaccharides, are able to make the intestine to absorb 3 to 5 times more iron in comparison to the “meat factor”.

This increase, that relates predominantly to non-heme iron, is particularly important since this is the fraction less easy to absorb.

Kabtafer-plus formula is rich in a particular type of oligosaccharides (a fraction of low molecular weight carbohydrates), which produces a significant increase in the intestinal (duodenum) absorption of iron contained in foods.

3- Is it possible for a pregnant woman that relies on Kabtafer-plus to be treated with it instead of iron ?

Look at answer to Q2.

In addition it has to be pointed out that in pregnancy, situation which can determine, quite often, nausea and vomiting, the availability of a well-tolerated alternative to oral iron treatment could be of extreme value to the patients.

Based on WHO, 50% of pregnant women suffer from Iron Deficiency Anemia & requires medical treatment. However in case of prophylaxis in pregnancy it is recommended to take Kabtafer-plus  tablet once daily during pregnancy & lactating period.

In case of anemia, it is recommended to take Kabtafer-plus  twice daily before / during the main meal.

In case of significant anemia, Kabtafer-plus can be associated with iron salts to boost the absorption. This association allows a reduction in the quantity of iron to be administered to 5-10mg/day.

4- Are there any studies carried out with Kabtafer-plus during the first three months of pregnancy ?

No study is available in women during the 1st three months of pregnancy. It has to be underlined that no Ethical Committee would approve a clinical trial in such a type of patients. This is a rule also for the so called “Ethical Drug” and data in pregnant women are often, not to say always, anecdotical, happened by misuse of drugs, assumed when woman was not yet aware of her status of pregnancy.

Anyway, we know that kabtafer plus has been so far used by many women during the first month of pregnancy.

Look also at answer to Q2.

5- Is Kabtafer-plus r effective in case of gastroileostomy or removal of a part of the intestine ?

Since Kabtafer-plus  is absorbed at intestinal level (duodenum and jejunum), it is possible that in the case of removal of part of the intestine the absorption could be incomplete.

Nevertheless, an attempt with Kabtafer-plus  could be done without any risk, with the only recommendation to monitor “iron parameters” (syderemia and ferritin Emia) at weekly intervals.

In these cases we suggest to associate the administration with lemon or orange juice to ensure a more acidic environment and to couple the action of vitamin C, which is known to Favour iron absorption.

If after 1 month no change in the abovementioned values is observed, You should consult a doctor.

6- Can Kabtafer-plus be used by vegetarians ?

No doubt that people who give up eating meat (vegetarians) and also animal products such as milk, cheese and eggs (vegans) may increase the risk of anemia. In these individuals, anemia can also be caused by vitamin B12 deficiency.

It is well known that iron is available in two forms: heme and non-heme. Heme iron is the most easily absorbed and used by our body and is found in meat, poultry and fish. Non-heme iron is found predominantly in vegetables, fruit, eggs, milk and dairy products; our body can use it, even if not as easily.

It is recommended to combine iron-rich foods with foods high in vitamin C because it helps our body use iron.

Example of morning diet: spinach salad with grapefruit juice or orange juice together with fortified cereal.

Kabtafer-plus  is the right choice because facilitates the absorption of non- heme iron contained in vegetarian and vegan diet both for its content in oligosaccharides and also vitamin C. In vegans, a supplementary intake of vitamin B12 should be considered .

7- What is the duration of action of one tablet of Kabtafer-plus ?

The exact duration of action of  kabtafer-plus  is not known since a valid method of detection of the active ingredient (oligosaccharides) has not yet been developed. This because, also using

radiolabelled oligosaccharides, it is impossible to follow its metabolic fate.

Nevertheless, considering the positive results obtained in clinical experience with intake of

Kabtafer-plus  concomitantly to meal, it is possible to say that the duration of action is long enough to allow a complete absorption of dietary iron from the intestine during the digestion process.

8- After the desired results have been obtained, should we stop or continue the treatment with Kabtafer-plus ?

Continuing or stopping Kabtafer-plus  treatment depends, obviously, from the underlying disease or reason which determined anemia.

Just for example, in a patient suffering from Chron’s disease or chronic ulcerative colitis, the treatment being effective, it should not be interrupted, whilst this could be possible in case the anemia is temporary, e.g. determined by intestinal bleeding surgically cured or in case of a period of unbalanced diet.

9- Is a treatment with Kabtafer-plus sufficient to treat anemia on its own without the use of iron?

As a general concept iron is contained in all foods in an average quantity of 7mg/1000 Kcal. In those cases when a strong anemia needs to be treated rapidly (a few days) it is possible to associate Kabtafer-plus with small quantities of iron salts.

Look also at answer to Q3.

Is Kabtafer-plus   maintains safe level of iron?

For people with iron deficiency or increased iron demand, Kabtafer-plus   will lessen the severity of the anemia, until the iron deficiency is corrected without causing iron overload.

10- Is Kabtafer – plus use in hemolytic anemia safe ?

Iron and hemolytic anemia are often confused; therefore a differential diagnosis is mandatory before starting any therapy.

Kabtafer – plus   facilitate iron absorption from diet when the body is in high demand for iron so no iron overload is caused by Kabtafer-plus 

To come to an answer to the question; it is possible to say that in the presence of iron loss, Kabtafer-plus   use is completely safe.

11- Is there any known food or drug interaction with Kabtafer-plus ?

Kabtafer  is active in acid environment (pH 2 or lower); therefore, if a drug which increases gastric pH (classical antacids, PPIs (Proton Pump Inhibitors), H2-receptors Inhibitors) is concomitantly administered, it could lose part of its efficacy. In this case an increased dose could compensate the reduction.

of Kabtafer-plus  in those patients

12- Can Kabtafer-plus be used by people who suffer from hypersensitivity to fish ?

The process of extraction and purification developed by Medestea concerning the fraction of oligosaccharides which exerts the pharmacological effect of the product usually makes Kabtafer-plus   free from the presence of fish proteins, even in very low quantities, potentially determining hypersensitivity phenomena.

Anyway we cannot guarantee, at this stage, an absolute lack of fish proteins so we cannot recommend the use of Kabtafer-plus  in those patients

13- From which age is Kabtafer-plus  indicated ?

Kabtafer-plus   is a food supplement intended for administration in adult people.

The content of Vitamins and Mineral salts is in compliance with EU RDA - which, in any case, does not refer to age groups. On the contrary, according to the Italian regulation, the above mentioned dosages in Kabtafer-plus  , exceed the ones foreseen for children under 11 years of age.

In addition to that, the stage of development of the swallowing capability is to be considered since the tablet is quite big.

Provided the above and depending on the local regulations, Kabtafer-plus   could be used also for children if it was in granular form or smaller tablets.