КАРБОССИМАЛЬТОЗИО 50 мг/мл Инъекционная/инфузионная дисперсия

Содержание инструкции

1. CARBOSSIMALTOSIO FERRICO TEVA 50 mg iron/mL injectable dispersion/for infusion
   1. What is CARBOSSIMALTOSIO FERRICO TEVA and what is it used for
   2. What you need to know before you are given CARBOSSIMALTOSIO FERRICO
   3. How CARBOSSIMALTOSIO FERRICO TEVA is administered
   4. Possible side effects
   5. How to store CARBOSSIMALTOSIO FERRICO TEVA
   6. Package contents and other information
2. CARBOSSIMALTOSIO FERRICO TEVA must be administered only when
3. CARBOSSIMALTOSIO FERRICO TEVA, to ensure adequate time for erythropoiesis and
4. CARBOSSIMALTOSIO FERRICO TEVA can be administered by intravenous infusion,

CARBOSSIMALTOSIO FERRICO TEVA 50 mg iron/mL injectable dispersion/for infusion

iron as ferri-carboxymaltose
Generic medicine

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

• 1. What CARBOSSIMALTOSIO FERRICO TEVA is and what it is used for
• 2. What you need to know before you are given CARBOSSIMALTOSIO FERRICO TEVA
• 3. How CARBOSSIMALTOSIO FERRICO TEVA is given
• 4. Possible side effects
• 5. How to store CARBOSSIMALTOSIO FERRICO TEVA
• 6. Contents of the pack and other information

1. What is CARBOSSIMALTOSIO FERRICO TEVA and what is it used for

CARBOSSIMALTOSIO FERRICO TEVA is a medicine that contains iron.
Medicines that contain iron are used when there is not enough iron present in the body.
This condition is called iron deficiency.
CARBOSSIMALTOSIO FERRICO TEVA is used for the treatment of iron deficiency
when:

• oral iron is not sufficiently effective;
• you cannot tolerate iron administered orally;
• the doctor decides that you need iron very quickly to replenish iron stores.

The doctor will determine if you have an iron deficiency by performing a blood test.

2. What you need to know before you are given CARBOSSIMALTOSIO FERRICO

TEVA
You must not be given CARBOSSIMALTOSIO FERRICO TEVA

• if you are allergic (hypersensitive) to carbossimaltosio ferrico or to any of the other ingredients of this medicine (listed in section 6);
• if you have had severe allergic (hypersensitivity) reactions to other injectable iron-based preparations;
• if you have anaemia notcaused by iron deficiency;
• if you have iron overload (excess iron in the body) or disorders of iron utilisation.

Warnings and precautions
Talk to your doctor or nurse before you are given CARBOSSIMALTOSIO
FERRICO TEVA:

• if you have previously had allergies to medicines;
• if you suffer from systemic lupus erythematosus;
• if you suffer from rheumatoid arthritis;
• if you suffer from severe asthma, eczema or other allergies;
• if you have an infection;
• if you have liver problems;
• if you have or have had low levels of phosphate in the blood.

Incorrect administration of CARBOSSIMALTOSIO FERRICO TEVA may cause product leakage at the administration site, which may lead to skin irritation and potentially permanent brown discolouration at the administration site. Administration must be stopped immediately when this occurs.

Children
CARBOSSIMALTOSIO FERRICO TEVA must not be given to children under 1 year of age.

Other medicines and CARBOSSIMALTOSIO FERRICO TEVA
Tell your doctor if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines. If CARBOSSIMALTOSIO FERRICO TEVA
is given together with oral iron preparations, these oral preparations may
be less effective.

Pregnancy
Data relating to the use of carbossimaltosio ferrico in pregnant women are limited. It is important
to inform your doctor if you are pregnant, suspect you may be pregnant or are planning a pregnancy.
If you become pregnant during treatment, you should ask your doctor for advice. The doctor will decide
whether or not you should be given this medicine.

Breastfeeding
If you are breastfeeding, ask your doctor for advice before you are given
CARBOSSIMALTOSIO FERRICO TEVA. It is unlikely that CARBOSSIMALTOSIO FERRICO
TEVA poses a risk to the infant.

Driving and using machines
It is unlikely that CARBOSSIMALTOSIO FERRICO TEVA will affect your ability to drive or
use machines.

CARBOSSIMALTOSIO FERRICO TEVA contains sodium
2 mL vial of dispersion: this medicine contains less than 1 mmol (23 mg) of sodium per
vial, i.e. essentially “sodium-free”.
10 mL vial of dispersion: this medicine contains up to 46 mg of sodium (the main component of table salt) per vial. This is equivalent to 2.3% of the maximum recommended daily intake of sodium with the diet of an adult.
20 mL vial of dispersion: this medicine contains up to 92 mg of sodium (the main component of table salt) per vial. This is equivalent to 4.6% of the maximum recommended daily intake of sodium with the diet of an adult.

3. How CARBOSSIMALTOSIO FERRICO TEVA is administered

The doctor will decide the amount of CARBOSSIMALTOSIO FERRICO TEVA to be administered to you, the
frequency and duration of administration.
The doctor will perform a blood test to determine the necessary dose.

Adults and adolescents aged 14 years or older
The doctor or nurse will administer CARBOSSIMALTOSIO FERRICO TEVA undiluted
by injection, diluted by infusion or during dialysis:

• by injection, up to 20 mL of CARBOSSIMALTOSIO FERRICO TEVA, corresponding to 1,000 mg of iron, may be administered to you once a week directly into a vein;
• by infusion, up to 20 mL of CARBOSSIMALTOSIO FERRICO TEVA, corresponding to 1,000 mg of iron, may be administered to you once a week directly into a vein. Since CARBOSSIMALTOSIO FERRICO TEVA is diluted with a sodium chloride solution for infusion, it may have a volume of up to 250 mL and appear as a brown-colored solution;
• if you are undergoing dialysis, CARBOSSIMALTOSIO FERRICO TEVA may be administered to you during a hemodialysis session through the dialyzer.

Children and adolescents aged between 1 and 13 years
The doctor or nurse will administer CARBOSSIMALTOSIO FERRICO TEVA undiluted for
injection or diluted for infusion:

• your child will be administered CARBOSSIMALTOSIO FERRICO TEVA directly into a vein. The medicine will appear as a brown-colored solution;
• if your child is undergoing dialysis, CARBOSSIMALTOSIO FERRICO TEVA should not be administered.

CARBOSSIMALTOSIO FERRICO TEVA will be administered in a facility where immune-allergic events
can be treated promptly and appropriately. After each administration,
the doctor or nurse will observe you for at least 30 minutes.

If you are given more CARBOSSIMALTOSIO FERRICO TEVA than you should
Since this medicine will be administered by qualified medical personnel, it is unlikely that
you will receive an excessive amount.
Overdosage may cause an accumulation of iron in the body. The doctor will monitor the iron
parameters to prevent its accumulation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:
Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate
a serious allergic reaction: skin rash (e.g. hives), itching, difficulty breathing,
wheezing and/or swelling of the lips, tongue, throat or body, and chest pain, which
may be a sign of a potentially serious allergic reaction called Kounis syndrome.
In some patients, these allergic reactions (affecting less than 1 in 1,000 people) may
become serious or life-threatening (anaphylactic reactions) and may be associated with
cardiac and circulatory problems and loss of consciousness.
Tell your doctor if you experience worsening fatigue or muscle or bone pain
(pain in the arms or legs, joints or back). This may be a sign of a
decrease in phosphorus in the blood, which could make the bones soft (osteomalacia). This
condition can sometimes cause bone fractures. Your doctor may also check phosphate levels
in the blood, especially if you need several treatments with iron over time.
Your doctor is aware of these possible side effects and will monitor you during and after
the administration of CARBOSSIMALTOSIO FERRICO TEVA.

Other side effects that must be reported to your doctor if they become serious:
Common(may affect up to 1 in 10 people):
headache, dizziness, feeling of warmth (flushing), high blood pressure, nausea and reactions at the
injection/infusion site (see also section 2).

Uncommon(may affect up to 1 in 100 people):
numbness, tingling or pins and needles on the skin, altered sense of taste,
fast heartbeat, low blood pressure, difficulty breathing, vomiting, indigestion,
stomach pain, constipation, diarrhea, itching, hives, skin redness, rash,
muscle, joint and/or back pain, arm or leg pain, muscle spasms,
fever, fatigue, chest pain, swelling of the hands and/or feet, chills and general feeling of discomfort.

Rare(may affect up to 1 in 1,000 people):
inflammation of a vein, anxiety, fainting, feeling of fainting, wheezing, excessive
intestinal gas (flatulence), rapid swelling of the face, mouth, tongue or throat that
can cause difficulty breathing, paleness and changes in skin color in areas of the body other
than the administration site.

Not known(frequency cannot be estimated from available data):
loss of consciousness and facial swelling.
A flu-like illness (may affect up to 1 in 1,000 people) may occur a few
hours to several days after the injection, usually characterized by symptoms such as high temperature
and muscle and joint pain.
Some blood parameters may be temporarily altered, as can be detected in laboratory tests.
The following alteration of blood parameters is common: decrease in phosphorus in the blood.
The following alterations of blood parameters are uncommon: increase in some liver enzymes
called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and alkaline
phosphatase, and increase in an enzyme called lactate dehydrogenase.
For more information, ask your doctor.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system reported at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store CARBOSSIMALTOSIO FERRICO TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Do not store at a temperature above 30°C. For storage conditions after dilution
or the first opening of the medicine, see paragraph “The following information is intended
exclusively for healthcare professionals”.
As a rule, CARBOSSIMALTOSIO FERRICO TEVA is stored for you by the doctor or
the hospital.

6. Package contents and other information

What CARBOSSIMALTOSIO FERRICO TEVA contains
The active ingredient is ferric carboxymaltose, an iron-carbohydrate compound.
The concentration of iron present in the product is 50 mg per millilitre.
Each 2 mL vial contains 100 mg of iron (as ferric carboxymaltose).
Each 10 mL vial contains 500 mg of iron (as ferric carboxymaltose).
Each 20 mL vial contains 1,000 mg of iron (as ferric carboxymaltose).
The other components are sodium hydroxide (for pH adjustment), hydrochloric acid (for
pH adjustment) and water for injections.

Description of the appearance of CARBOSSIMALTOSIO FERRICO TEVA and contents of the
pack
CARBOSSIMALTOSIO FERRICO TEVA is a non-transparent injectable/infusion dispersion,
of a dark brown colour.
CARBOSSIMALTOSIO FERRICO TEVA is supplied in glass vials containing:

• 2 mL of dispersion. Available in packs of 1, 2 and 5 vials.
• 10 mL of dispersion. Available in packs of 1, 2 and 5 vials.
• 20 mL of dispersion. Available in packs of 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

and manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Eisen-Carboxymaltose TEVA 50 mg Eisen/ml Dispersion zur Injektion/Infusion
Bulgaria: Максифер 50 mg/ml инжекционна/инфузионна дисперсия; Maxifer 50 mg/ml
dispersion for injection/infusion
Czech Republic: Ferric carboxymaltose Teva
Germany: Eisen(III)-Carboxymaltose AbZ
Denmark: Feriliva
Greece: Ferric carboxymaltose/Teva
Spain: CARBOXIMALTOSA FERRICA TEVA 50 MG/ML DISPERSION
INYECTABLE Y PARA PERFUSIÓN EFG
France: CARBOXYMALTOSE FERRIQUE TEVA 50 mg/mL, dispersion injectable/pour
perfusion
Croatia: Friona 50 mg/ml disperzija za injekciju/infuziju
Hungary: Vas (III)-karboximaltóz Teva 50 mg/ml diszperziós injekció vagy infúzió
Ireland: Ferric carboxymaltose Teva 50 mg iron/ml dispersion for injection/infusion
Italy: CARBOSSIMALTOSIO FERRICO TEVA
Netherlands: IJzer(III)carboxymaltose Teva 50 mg/ml, dispersie voor injectie/infusie
Norway: Feriliva
Portugal: Carboximaltose férrica Teva
Romania: Carboximaltoză ferică Teva 50 mg/ml dispersie injectabilă/perfuzabilă
Sweden: Feriliva
Slovenia: Friona 50 mg/ml disperzija za injiciranje/infundiranje
Slovakia: Ferric carboxymaltose Teva 50 mg/ml
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The following information is intended for healthcare professionals only:
Carefully monitor patients for signs and symptoms of hypersensitivity reactions during and
after each administration of CARBOSSIMALTOSIO FERRICO TEVA.

CARBOSSIMALTOSIO FERRICO TEVA must be administered only when

immediately available qualified personnel to assess and manage anaphylactic reactions are present, in a
facility where complete resuscitation equipment can be guaranteed. The patient must
be kept under observation to monitor for adverse reactions for at least 30 minutes after each
administration of CARBOSSIMALTOSIO FERRICO TEVA.
The dosage of CARBOSSIMALTOSIO FERRICO TEVA follows a gradual approach:
Phase 1: Determination of iron requirement
The individual iron requirement to be supplemented with CARBOSSIMALTOSIO FERRICO TEVA is
determined based on the patient's body weight and hemoglobin (Hb) level. Refer to Table 1 for
determining the total iron requirement. 2
doses may be necessary to supplement the total iron requirement; see Phase 2 for individual maximum iron
doses.
Iron deficiency must be confirmed by laboratory tests.

Table 1: Determination of total iron requirement

Phase 2: Calculation and administration of the maximum individual iron dose(s)
Based on the determined total iron requirement, the appropriate dose(s) of
CARBOSSIMALTOSIO FERRICO TEVA must be administered taking into account the
following:

Adults and adolescents aged 14 years and over
A single administration of CARBOSSIMALTOSIO FERRICO TEVA must not exceed:

• 15 mg of iron/kg of body weight (for administration by intravenous injection) or 20 mg of iron/kg of body weight (for administration by intravenous infusion);
• 1,000 mg of iron (20 mL of CARBOSSIMALTOSIO FERRICO TEVA).

The recommended maximum cumulative dose of CARBOSSIMALTOSIO FERRICO TEVA is 1,000 mg
of iron (20 mL of CARBOSSIMALTOSIO FERRICO TEVA) per week. If the total iron
requirement is greater, the administration of an additional dose must occur at least 7 days after the
first dose.

Children and adolescents aged between 1 and 13 years
A single administration of CARBOSSIMALTOSIO FERRICO TEVA must not exceed:

• 15 mg of iron/kg of body weight;
• 750 mg of iron (15 mL of CARBOSSIMALTOSIO FERRICO TEVA).

The recommended maximum cumulative dose of CARBOSSIMALTOSIO FERRICO TEVA is 750 mg of
iron (15 mL of CARBOSSIMALTOSIO FERRICO TEVA) per week. If the total iron
requirement is greater, the administration of an additional dose must occur at least 7 days after the
first dose.
Phase 3: Evaluation after iron supplementation
The physician must perform a re-evaluation based on the individual patient's condition. The Hb level
must be re-evaluated no earlier than 4 weeks after the last administration of

CARBOSSIMALTOSIO FERRICO TEVA, to ensure adequate time for erythropoiesis and

iron utilization. If the patient requires further iron supplementation, it is necessary to recalculate
the iron requirement (see Step 1).

Children under 1 year of age
CARBOSSIMALTOSIO FERRICO TEVA is not recommended in children under 1 year of age.

Patients with chronic kidney disease dependent on hemodialysis
For adults and adolescents aged 14 years and over, a single maximum daily dose of 200 mg of iron should not be exceeded in patients with chronic kidney disease dependent on hemodialysis.
CARBOSSIMALTOSIO FERRICO TEVA is not recommended in children between 1 and
13 years of age with chronic kidney disease who require hemodialysis.
Route of administration
Before use, visually inspect the vials for damage and sediment. Use only
vials that contain a homogeneous dispersion free of sediment. Each vial of
CARBOSSIMALTOSIO FERRICO TEVA is for single use only.
CARBOSSIMALTOSIO FERRICO TEVA must be administered exclusively by
intravenous route:

• by injection, or
• by infusion, or
• during a hemodialysis session, not diluted directly into the venous inlet of the dialyzer.

CARBOSSIMALTOSIO FERRICO TEVA must not be administered by subcutaneous or
intramuscular route.
During the administration of CARBOSSIMALTOSIO FERRICO TEVA, caution must be exercised to avoid paravenous leakage. Paravenous leakage of CARBOSSIMALTOSIO
FERRICO TEVA at the administration site can cause skin irritation and potentially long-lasting browning
of the skin at the administration site. In case of paravenous leakage,
the administration of CARBOSSIMALTOSIO FERRICO TEVA must be stopped
immediately.

Intravenous injection
CARBOSSIMALTOSIO FERRICO TEVA can be administered by intravenous injection
using an undiluted dispersion. In adults and adolescents aged 14 years and over, the
single maximum dose is 15 mg of iron/kg of body weight, but it must not exceed 1,000 mg of iron.
In children between 1 and 13 years of age, the single maximum dose is 15 mg of iron/kg of body
weight, but it must not exceed 750 mg of iron. The administration rates are reported in
Table 2:

Table 2: Administration rate of CARBOSSIMALTOSIO FERRICO TEVA for
intravenous injection

Intravenous infusion

CARBOSSIMALTOSIO FERRICO TEVA can be administered by intravenous infusion,

in which case it must be diluted. In adults and adolescents aged 14 years or older, the maximum single dose is 20 mg of iron/kg of body weight, but it must not exceed 1000 mg of iron.
In children aged between 1 and 13 years, the maximum single dose is 15 mg of iron/kg of body weight, but it must not exceed 750 mg of iron.
For infusion, CARBOSSIMALTOSIO FERRICO TEVA must be diluted exclusively in a sterile 0.9% m/V sodium chloride solution, as shown in Table 3. Note: for stability reasons, CARBOSSIMALTOSIO FERRICO TEVA must not be diluted to concentrations lower than 2 mg of iron/mL (excluding the volume of the iron carbomaltose dispersion).

Table 3: Dilution plan for CARBOSSIMALTOSIO FERRICO TEVA for intravenous infusion
Incompatibilities
Oral iron absorption is reduced in case of concomitant administration of parenteral iron preparations. Therefore, if necessary, oral iron therapy should not be started for at least 5 days after the last administration of CARBOSSIMALTOSIO
FERRICO TEVA.
Overdose
Administration of CARBOSSIMALTOSIO FERRICO TEVA in quantities greater than those necessary to correct iron deficiency at the time of administration can lead to iron accumulation in storage sites, eventually leading to hemosiderosis. Monitoring iron parameters, such as serum ferritin and transferrin saturation, may be useful in identifying iron accumulation. If iron accumulation occurs, treat according to standard medical practice, for example by considering the use of an iron chelator.

Stability in use

Shelf life after first opening of the container:
From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, the storage times and conditions in use are the responsibility of the user.

Shelf life after dilution with a sterile 0.9% m/V sodium chloride solution:
Chemical-physical stability in use has been demonstrated for 24 hours at 15-25°C.
From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and generally should not exceed 24 hours at 15-25°C, unless the dilution has taken place under controlled and validated aseptic conditions.