Active ingredients: Polymaltose Iron Complex
Intrafer 50 mg / ml oral drops, solution
Intrafer package inserts are available for pack sizes:- Intrafer 50 mg / ml oral drops, solution
- Intrafer 100 mg oral solution
Indications Why is Intrafer used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antianemics based on trivalent iron.
THERAPEUTIC INDICATIONS
Therapy of latent states or manifestations of iron deficiency. In particular: iron deficiency anemia or increased need for iron, especially in pregnancy and lactation, in premature babies, infants, young children and after bleeding
Contraindications When Intrafer should not be used
Hypersensitivity to the active substance or to any of the excipients. Hemosiderosis, hemochromatosis. Aplastic, haemolytic, sideroacrestic anemias. Chronic pancreatitis. Cirrhosis of the liver.
Precautions for use What you need to know before taking Intrafer
Iron derivatives can reduce the absorption of tetracyclines, the simultaneous administration of which must therefore be avoided.
Interactions Which drugs or foods may change the effect of Intrafer
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Any dark discolouration of the stool is of no clinical significance
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. However, the preparation is indicated in the presence of iron found in these particular phases of women's life.
Dosage and method of use How to use Intrafer: Dosage
Unless otherwise prescribed by the doctor:
Premature babies: 1 drop (2.5 mg per kg) per day.
Children up to 1 year: start with 6 drops, increasing up to 20 drops / day with fractional administration.
Children from 1 to 12 years: 20 drops 1 or 2 times a day (50-100 mg).
Children over 12 years: 20 drops 2 times a day (100 mg).
Adults: 40 drops 1 or 2 times a day (100-200 mg), before, during or after meals.
After reaching the normal parameters (Hb, Ht, Erythrocytes) the therapy should be continued to allow the iron deposits to be restored.
Instructions for Use:
Instructions for opening the bottle: to open the bottle press the cap and unscrew.
To facilitate the exit of the first drop, place the bottle in a vertical position after its opening, and shake it vertically, until dispensing begins.
Intrafer can be mixed with fruit or vegetable juices.
Overdose What to do if you have taken too much Intrafer
In case of accidental ingestion / intake of an excessive dose of Intrafer, notify your doctor or go to the nearest hospital.
FOR ANY DOUBT OR CLARIFICATION ABOUT THE USE OF THE PRODUCT, PLEASE CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Intrafer
Like all medicines, Intrafer? it can cause side effects, although not everybody gets them.
Occasionally, particularly with too high dosages, gastrointestinal disturbances such as feelings of fullness, abdominal tension, nausea, constipation and diarrhea may occur, which regress upon discontinuation of treatment or dose reduction.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: check the expiration date indicated on the package.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
After first opening the medicine is valid for 60 days.
The product can be stored in normal environmental conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
1 ml of solution contains: Polymaltose iron complex mg 178.5, equal to Fe (III) mg 50. Excipients: Sucrose, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Lemon essence, Ethanol, Polysorbate 80, Purified water.
PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE
Oral drops, solution - 30 ml bottle
Oral drops, solution - bottle of 50 ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
INTRAFER drops
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
Active ingredient: polymaltose iron complex 178.5 mg equal to 50 mg of Fe (III).
03.0 PHARMACEUTICAL FORM
Drops for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Therapy of latent states or manifestations of iron deficiency. In particular: iron deficiency anemia or increased need for iron, especially in pregnancy and breastfeeding, in premature babies, infants, young children and after bleeding.
04.2 Posology and method of administration
Premature babies: 1 drop (2.5 mg) per kg / day.
Children up to 1 year: start with 5 drops, increasing up to 20 drops / day with fractional administration.
Children from 1 to 12 years: 20 drops 1 or 2 times a day (50-100 mg).
Children over 12 years: 20 drops 2 times a day (100 mg).
Adults: 40 drops 1 or 2 times a day (100-200 mg), before, during or after meals.
04.3 Contraindications
Known hypersensitivity to the product. Hemosiderosis, hemochromatosis. Aplastic, haemolytic, sideroacrestic anemias. Chronic pancreatitis. Cirrhosis of the liver.
04.4 Special warnings and appropriate precautions for use
Any dark discolouration of the stool is of no clinical significance.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Iron derivatives can reduce the absorption of tetracyclines, the simultaneous administration of which must therefore be avoided.
04.6 Pregnancy and lactation
The preparation finds elective indication in the iron deficiency found in these particular phases of women's life.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
Occasionally, particularly with too high dosages, gastrointestinal disturbances such as feeling of fullness, abdominal tension, nausea, constipation and diarrhea may occur, which regress upon discontinuation of treatment or reduction of doses.
04.9 Overdose
In case of overdose with gastrointestinal disturbances and circulatory collapse, vomiting is caused and gastric lavage is performed, thus administering bicarbonate and milk.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacological studies have shown that the product exerts an appreciable curative and preventive activity against iron deficiency anemia.
05.2 "Pharmacokinetic properties
Polymaltose iron is a macromolecular complex analogous to ferritin, in which the metal is bound to a carbohydrate, polymaltose.
Fe is present in a non-ionic form and, after absorption, is able to detach itself from the polysaccharide support, making itself available as Fe (III) for its own biological activity.
05.3 Preclinical safety data
Intrafer Gocce is free from toxicity and teratogenic and carcinogenic properties. It is also well tolerated at the gastrointestinal level, even for doses considerably higher than those used in man and for prolonged treatments.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients: sucrose, methyl p-hydroxybenzoate, lemon essence, propyl p-hydroxybenzoate, ethanol, polysorbate 80, purified water.
06.2 Incompatibility
None.
06.3 Period of validity
5 years in intact and properly stored packaging.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Bottle of 30 ml of dark glass equipped with a dropper valve and closed with a safety cap.
06.6 Instructions for use and handling
Intrafer drops can be mixed with fruit or vegetable juices.
07.0 MARKETING AUTHORIZATION HOLDER
GEYMONAT S.p.A.
Via S. Anna, 2 - 03012 Anagni (FR)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 016747026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization:
11 August 1988 / Renewal date: 1 June 2000.
10.0 DATE OF REVISION OF THE TEXT
01.06.2000
