CALCIO 10 % Roztwór do wstrzykiwań

Treść ulotki

1. Calcio gluconato 10% B. Braun injectable solution
   1. What is Calcio gluconato 10% B. Braun and what is it used for
   2. What you need to know before using Calcio gluconato 10% B. Braun
   3. How to use Calcio gluconato 10% B. Braun
   4. Possible side effects
   5. How to store Calcio gluconato 10% B. Braun
   6. Package Contents and Other Information

Calcio gluconato 10% B. Braun injectable solution

Calcio gluconato

Read this leaflet carefully before you start to use this medicine as 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 get worse or if you notice any side effects not listed in this leaflet, tell your doctor. See section 4. Contents of this leaflet:
• 1. What Calcio gluconato 10% B. Braun is and what it is used for.
• 2. What you need to know before you use Calcio gluconato 10% B. Braun.
• 3. How to use Calcio gluconato 10% B. Braun.
• 4. Possible side effects.
• 5. How to store Calcio gluconato 10% B. Braun.
• 6. Contents of the pack and other information.

1. What is Calcio gluconato 10% B. Braun and what is it used for

Calcio gluconato 10% B. Braun is a solution for calcium supplementation.
It is used for the administration of calcium in patients with extremely low blood calcium levels (hypocalcemia) and
who present with acute symptoms, such as impaired skin sensations (numbness, itching, burning), spasmodic muscle rigidity (tetany), cramps in the hands and feet, colic, muscle weakness, confusion, which
could lead to convulsions and cardiac symptoms (irregular heartbeat and even acute heart failure).

2. What you need to know before using Calcio gluconato 10% B. Braun

Do not use Calcio gluconato 10% B. Braun

• If you are allergic to calcium gluconate or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (e.g. in patients with hyperactive parathyroid glands, high levels of vitamin D in the blood, cancers associated with bone breakdown, impaired kidney function, osteoporosis due to immobility, sarcoidosis and the so-called milk-alkali syndrome).
• In case of excessive elimination of calcium in the urine.
• In case of poisoning with digitalis medicines (a type of heart medicine).
• During treatment with digitalis medicines, unless you have extremely low blood calcium levels with potentially life-threatening symptoms, which can only be treated with an immediate calcium injection.
• The antibiotic ceftriaxone must not be used in premature babies and newborns (≤ 28 days of life) if they are receiving (or will receive) calcium-containing products that are to be administered intravenously. Warnings and precautions.Talk to your doctor before using Calcio gluconato 10% B. Braun. If you are regularly taking digitalis preparations and, exceptionally, urgently need a calcium injection (see above), your doctor will carefully monitor heart function. The

monitoring ensures that any worsening of heart function, for example, a severe arrhythmia
(irregular heartbeat) can be treated immediately.
Your doctor will carefully consider whether this medicine is suitable for you if you suffer from:

• calcium deposits in the kidneys (nephrocalcinosis);
• heart disease;
• sarcoidosis. In these cases, you will only be given calcium injections if absolutely necessary. The same applies if you are undergoing treatment with adrenaline (see “Other medicines and Calcio gluconato 10% B. Braun”) or if you are elderly. Impaired kidney function (renal impairment) may be accompanied by increased levels of calcium in the blood and hyperactivity of the parathyroid glands. If you have kidney impairment, you will only receive calcium injections if strictly necessary. Calcium and phosphate balance must be monitored. Your doctor will pay particular attention if you are receiving the antibiotic ceftriaxone. They will not administer it at the same time as calcium gluconate, even via different infusion lines or different infusion sites. Calcium must be injected slowly to prevent, if possible, vasodilation or compromise of heart function. Heart function or ECG should be monitored when this medicine is injected intravenously (intravenous injection). During treatment with calcium salts, you will be carefully monitored to ensure a normal calcium balance (calcium intake versus calcium elimination) and to prevent calcium deposits in the tissues. Calcium levels in the blood and the amount of calcium excreted in the urine will be monitored, especially when calcium is injected at high doses. Calcium is insoluble in fatty tissues and can cause inflammatory reactions followed by abscess formation, tissue hardening and tissue destruction (necrosis) if inadvertently injected into these areas. If the solution is inadvertently injected near a blood vessel or not sufficiently deep into a muscle, this can cause local tissue irritation that may be followed by skin peeling or even necrosis (see section 4). The doctor will ensure that the solution does not end up in the tissue around the blood vessel and will carefully observe the injection site. High doses of vitamin D should be avoided. Children and adolescentsIn children (<18 years) calcio gluconato 10% b. braun must be injected only into a muscle, not vein.< li>

Other medicines and Calcio gluconato 10% B. BraunTell your doctor if you are taking, have recently taken or might take any other medicines. The effect of heart medicines, such as digoxinand other digitalisdrugs can be increased by calcium up to causing digitalis poisoning. Therefore, if you are taking digitalisdrugs, you will only be given an intravenous calcium injection for the treatment of severe, life-threatening symptoms associated with very low blood calcium levels. The administration of calcium together with adrenalineafter heart surgery weakens the effects of adrenaline on the heart and circulation. Calcium and magnesiummutually inhibit their effects. Calcium can reduce the effects of certain medicines used to regulate heart function( calciumantagonists). The simultaneous administration of calcium with certain medicines that increase urine formation andelimination( thiazide diuretics) can lead to excessively high levels of calcium in the blood (hypercalcemia), as these medicines reduce the excretion of calcium through the kidneys. The simultaneous administration of calcium with ceftriaxone can lead to the formation of aggregates.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Calcium passes through the placenta into the fetal circulation and reaches higher levels in the fetal blood than in the mother's blood.
Pregnant women should therefore only receive calcium injections if absolutely necessary. The
dose should therefore be calculated carefully and calcium levels in the blood should be checked regularly to
avoid reaching levels that could be harmful to the fetus.

Breastfeeding
Calcium is excreted in breast milk. Your doctor will take this into account when administering calcium to you if you are
breastfeeding your baby.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use Calcio gluconato 10% B. Braun

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.
The recommended dose will be established by the doctor in order to increase the blood calcium level/the blood calcium level of your child until it reaches normal values.
Adults
The usual initial dose is 10 ml, i.e. one vial of Calcio gluconato 10 % B. Braun. If necessary, the dose may be repeated. Subsequent doses will be modified according to current blood calcium values.
Use in infants, toddlers, children and adolescents
The doctor will decide the dosage and method of administration based on the blood calcium level and the severity of the symptoms. In case of mild symptoms affecting the nerves and muscles, preference will be given to oral calcium preparations.
The following table shows the values of the usual initial dose:

In cases of exceptionally low blood calcium levels in neonates and infants with, for example, impaired cardiac function, higher initial doses may be required to quickly increase blood calcium levels (up to 2 ml per kg of body weight).
Calcium administration may be repeated if required. The concentration of subsequent doses will depend on the existing blood calcium level. After intravenous therapy, treatment with oral calcium preparations may be necessary, for example in case of vitamin D deficiency.
Elderly patients
Some disorders that are sometimes associated with advanced age, such as impaired renal function and malnutrition, can affect the tolerance of calcium gluconate. Therefore, a lower dose is required.

Method of administration
Calcio gluconato 10% B. Braun will be given to you by a slow injection into a vein, or deep into a large muscle. You will be given it lying down and, in particular, cardiac function will be carefully monitored during the injection.
Injections into the muscle (intramuscular injections) must be made if the injection is not possible due to the risk of local tissue irritation. The doctor will carefully ensure that intramuscular injections are administered sufficiently deeply, preferably into the buttock muscle.
The rate of infusion or intravenous injection must be sufficiently slow.
Infants, toddlers, children and adolescents
For intravenous administration (into a vein) as a slow injection or slow intravenous infusion (drip administration) both after dilution.
In children, this medicine should not be injected into muscle or under the skin.

If you use more Calcio gluconato 10% B. Braun than you should
Symptoms related to high blood calcium levels (hypercalcemia) include: loss of appetite, feeling unwell, malaise (vomiting), constipation, stomach pain, abundant urine, increased thirst, fluid loss, muscle weakness, calcium deposition in the kidneys, fatigue, confusion, high blood pressure (hypertension) and, in severe cases, irregular heartbeat, which can turn into a heart attack and loss of consciousness.
Symptoms of high blood calcium levels (hypercalcemia) and a chalky taste, hot flashes and a drop in blood pressure may occur if the intravenous injection is performed too quickly.
Treatment aims to lower high blood calcium levels.
The doctor will decide the treatment to be administered, which may include the administration of fluids or specific medicines to lower the blood calcium level. In severe cases, dialysis may be necessary.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is expressed below:
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 1,000 people.
Rare: may affect up to 1 in 10,000 people.
Very rare: may affect less than 1 in 10,000 people.
Not known: the frequency cannot be estimated from the available data.
Side effects affecting the heart, circulation or other functions of the body may occur
as symptoms of excessively high blood calcium levels, following overdose or too rapid injection into a
vein. The presence and frequency of these symptoms depend directly on the speed
of the injection and the dose administered.

The following side effects may be serious. If any of the side effects reported below occur, seek medical attention immediately and stop taking this medicine:
Not known (the frequency cannot be estimated from the available data):

• slow or irregular heartbeat,
• low blood pressure (hypotension),
• circulatory collapse (potentially fatal). Rare (may affect up to 1 in 10,000 people): serious adverse reactions, and in some cases fatal, have been reported in premature and term newborns (age < 28 days) who have been treated with intravenous ceftriaxone and calcium. Ceftriaxone-calcium salt precipitates have been observed in the lung and kidneys post mortem. Other side effects include:Not known (the frequency cannot be estimated from the available data):
• blood vessel dilation,
• hot flushes, mainly after an injection that has been administered too quickly,
• feeling unwell or sick (vomiting),
• feeling of warmth,
• sweating,
• injections into muscles may be accompanied by pain and redness. Side effects that occur when the medicine is not used correctly
• If the injection is not performed deep enough into the muscle, the solution may penetrate the fatty tissue and it is possible that inflammation, hardening and destruction (necrosis) of the tissue may occur.
• It has been reported that following leakage of the solution from the vein into the surrounding tissue, calcium deposits can occur in the soft tissues. This may be followed by scaling and destruction of the skin.
• Redness of the skin and a burning or painful sensation during intravenous injection may indicate an involuntary injection next to the blood vessel, which may cause tissue destruction. Reporting of side effectsIf any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calcio gluconato 10% B. Braun

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container and the carton.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The solution must be used immediately after the vial has been opened.
After dilution, the ready-to-use solution must be administered as soon as possible, but must not
be stored for more than 24 hours at 2-8 °C.
Do not use this medicine if you notice the following changes:

• damage to the vial, discoloration or cloudiness (turbidity) of the solution, visible particles in the solution. Do not dispose of any medicine in the wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Calcio gluconato 10% B. Braun contains

• The active ingredient is calcium gluconate.
• 1 ml of solution contains 94 mg of calcium gluconate, equivalent to 0.21 mmol of calcium.
• 10 ml contain 940 mg of calcium gluconate, equivalent to 2.10 mmol of calcium. Excipients:The product also contains an amount of the excipient calcium D-saccharate tetrahydrate equivalent to 0.02 mmol of calcium per ml (or 0.15 mmol of calcium per 10 ml). The other component is water for injections. Total calcium content: 0.23 mmol per ml (2.25 mmol per 10 ml). Description of the appearance of Calcio gluconato 10% B. Braun and contents of the packCalcio gluconato 10% B. Braun is an injectable solution (a solution that is administered with a syringe). It is a transparent solution from colorless to brownish. Calcio gluconato 10% B. Braun is contained in 10 ml polyethylene vials. Available in packs of 20 x 10 ml. Marketing Authorisation Holder
• B. Braun Melsungen AG Carl-Braun Strasse, 1 34212-Melsungen Germany Manufacturer
• B. Braun Melsungen AG, Carl Braun Strasse 1, D-34212, Melsungen (Germany), manufacturing site located in Mistelweg 2, D-12357, Berlin (Germany), This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:Austria: Calciumgluconat 10% B.BRAUN Injektionslösung Belgium: Calcium Gluconate 10 % B. Braun solution for injection Denmark: Calciumgluconat B. Braun 100 mg/ml Finland: Calciumgluconat B. Braun 100 mg/ml France: Gluconate de Calcium 10 % B.Braun, solution pour perfusion Italy: Calcio gluconato 10% B.Braun injectable solution Netherlands: Calcium Gluconaat 10 % B.Braun, oplossing voor injectie 10 % Portugal: Gluconato de cálcio 10 % B.Braun Czech Republic: Calcium Gluconicum 10 % B.Braun Slovakia: Calcium Gluconicum 10% B.Braun United Kingdom: Calcium Gluconate 10 % w/v Injection BP

The following information is intended exclusively for healthcare professionals:
Method of administration
In the case of obese patients, a longer needle should be used to ensure placement
of the injection into the muscle and not into the adipose tissue.
If repeated injections are necessary, the injection site should be changed each time.

Paediatric patients (<18 years)
Only slow intravenous injection or intravenous infusion (both after dilution) in order to obtain
sufficiently low administration rates and to avoid irritation/necrosis in case of accidental extravasation.
The rate of intravenous administration should not exceed 5 ml of a 1:10 dilution per
minute of Calcio gluconato 10% B. Braun in children and adolescents.

Special warnings and precautions for use
In patients of all ages, ceftriaxone should not be mixed with or administered simultaneously with
any intravenous solution containing calcium, even through different infusion lines or different infusion sites.
Cases of fatal reactions with ceftriaxone-calcium precipitates in the lungs and kidneys have been described in premature infants and full-term infants less than one month of age.
However, in patients over 28 days of age, ceftriaxone and solutions containing calcium can be
administered sequentially, one after the other, if different infusion lines are used or if the
infusion lines are replaced or thoroughly flushed between infusions with saline solution to
avoid precipitates.
Sequential infusions of ceftriaxone and calcium-containing products should be avoided in case of
hypovolemia.

Incompatibilities
Calcium salts can form complexes with many drugs, and this can lead to a precipitate.
Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates, bicarbonates, oxalates, phosphates,
tartrates and sulphates.
Physical incompatibility has been reported with amphotericin, sodium cephalothin, ceftriaxone (see “Warnings and
precautions”), sodium cefazolin, cefamandole nafate, sodium novobiocin, dobutamine hydrochloride,
prochlorperazine and tetracyclines.
This medicinal product should not be mixed with other medicinal products except those mentioned
in the “Dilutions” paragraph or unless compatibility has been sufficiently demonstrated.

Dilution
For intravenous infusions, Calcio gluconato 10% B. Braun can be diluted 1:10 to a concentration of 10
mg/ml with the following two infusion solutions: sodium chloride 9 mg/ml (0.9%) solution for injection or glucose
50 mg/ml (5%) solution for injection. When diluted with these recommended infusion solutions, the resulting
solutions are intended for immediate single use.
Dilution must be carried out under aseptic, controlled and validated conditions. After mixing, the
container should be gently shaken to ensure homogeneity.

Overdose treatment
Initial management should include rehydration and, in case of severe hypercalcemia, it may be necessary to
administer isotonic sodium chloride solution via intravenous infusion in order to increase the
extracellular fluid. Calcitonin can be given to lower the high calcium concentration in the serum.
Furosemide can be administered to increase calcium excretion, but thiazide diuretics should be avoided as these can increase renal calcium absorption.
Serum electrolytes should be carefully monitored during overdose treatment.