Tot'hema Oral Solution in ampoules

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

COPPER, IRON, MANGANESE

Dostupné s:

Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France

ATC kód:

B03AE10

INN (Mezinárodní Name):

COPPER 0.7 mg IRON 50 mg MANGANESE 1.33 mg

Léková forma:

ORAL SOLUTION

Složení:

COPPER 0.7 mg IRON 50 mg MANGANESE 1.33 mg

Druh předpisu:

OTC

Terapeutické oblasti:

ANTIANEMIC PREPARATIONS

Stav Autorizace:

Authorised

Datum autorizace:

2006-11-03

Informace pro uživatele

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ANNEX IIIB
PACKAGE LEAFLET
TOT’HÉMA
, oral solution in ampoule
Iron/ manganese/ copper
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 4 weeks.
WHAT IS IN THIS LEAFLET
1. What TOT’HEMA, oral solution in ampoule is and what it is used
for
2. What you need to know before you take TOT'HEMA, oral solution in
ampoule
3. How to take TOT’HEMA, oral solution in ampoule
4. Possible side effects
5. How to store TOT’HEMA, oral solution in ampoule
6. Contents of the pack and other information.
1.
WHAT TOT’HEMA, ORAL SOLUTION IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: ANTIANEMIC PREPARATIONS - ATC code:
B03AE10.
This medicine is an iron supplement. It is indicated for:
• the curative treatment of iron deficiency anaemia in adults,
children and infants
• the preventive or curative treatment of iron deficiency in
pregnant women, infants and
children when the dietary intake of iron is inadequate.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOT’HEMA, ORAL SOLUTION IN
AMPOULE
Do not take TOT’HEMA, oral solution in ampoule
•
if you are allergic to iron, manganese or copper or any of the other
ingredients of this
medicine, listed in section 6,
•
if you have iron overload in your body (due to haemochromatosis,
thalassemia, refractory
anaemia, anaemia due to medullary insufficiency or due to repeated or
chronic blood
transfusions),
•
if
you
have
non-iron
deficiency
anaemia
(e.g.,
haemolytic
anaemia,
megaloblastic
anaemia, anaemia of inflammation),
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Charakteristika produktu

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
TOT’HEMA,
oral solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Iron………………………………………………………………….…………………50.00
mg
Corresponding to ferrous gluconate
hydrate…………………………………………399.73 mg
Manganese……………………………………………………………………………...1.33
mg
Corresponding to manganese
gluconate………………………………………………10.78
mg
Copper…………………………………………………………………………………..0.70
mg
Corresponding to copper
gluconate…………………………………………………….5.00
mg
For a 10 ml ampoule.
Excipients with known effect: glucose (99 mg/10 ml), sucrose (3000
mg/10 ml), ethanol (108
mg/10 ml), sodium benzoate (20 mg/10 ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution in ampoule.
TOT’HEMA is a clear dark brown liquid. The presence of a fine
precipitate is possible.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Curative treatment of iron deficiency anaemia in adults, children and
infants.
Preventive and curative treatment of iron deficiency in pregnant
women, premature infants,
twins or babies born to a mother with iron deficiency, when dietary
iron intake is inadequate.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One ampoule contains 50 mg of elemental iron.
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CURATIVE TREATMENT OF IRON DEFICIENCY ANAEMIA:
_For infants from 1 month and children:_
3 mg of elemental iron/kg/day, without exceeding 60
mg.
_For adults:_
100 to 150 mg of elemental iron per day, i.e. 2 to 3 ampoules per day,
in a single
or divided dose.
_For patients with renal impairment:_
No dosage adjustment is generally necessary in patients
with renal impairment (see section 4.4).
_ _
_For patients with hepatic impairment:_
No dosage adjustment is generally necessary