CALCIO 500 mg /5 Ml Roztwór Do Wstrzykiwań
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BIOINDUSTRIALaboratorio Italiano Medicinali S.p.A.
Calcium gluconate Bioindustria L.I.M. 500 mg/5 ml solution for infusion, 1000 mg/10 ml solution for infusion
PHARMACOTHERAPEUTIC CATEGORY
Mineral supplements
THERAPEUTIC INDICATIONS
Treatment of hypocalcemia conditions
Adjuvant in antianaphylactic treatment, for controlling increased capillary permeability
in allergic conditions and in cases of non-thrombocytopenic purpura.
CONTRAINDICATIONS
- Hypersensitivity to the active ingredient or to any of the excipients;
- diseases and/or conditions involving hypercalcemia (e.g. hyperparathyroidism, vitamin D hypervitaminosis, neoplastic disease with bone decalcification);
- severe hypercalciuria;
- severe renal insufficiency;
- ventricular fibrillation;
- patients taking cardioactive glycosides;
- concomitant treatment with ceftriaxone in neonates (≤28 days of age), even in case of use of separate infusion lines. See paragraphs Interactions, Undesirable effects, Dosage, method and time of administration.
PRECAUTIONS FOR USE
Subcutaneous and intramuscular administration should be avoided, as calcium salts are
irritating and can locally cause abscesses and necrosis. Patients should therefore be
regularly monitored at the infusion site to prevent local leakage of the
solution.
Serum calcium levels and urinary excretion should be monitored, particularly in
children, in cases of chronic renal insufficiency or in the presence of stones in the urinary tract.
If the calcium level in plasma exceeds 2.75 mmol/l or if the urinary calcium excretion
in 24 hours exceeds 5 mg/kg, treatment should be discontinued immediately as
cardiac arrhythmias may occur.
Calcium salts should be administered with caution in patients with altered renal function,
in the presence of nephrocalcinosis, as well as in patients with heart disease.
Calcium gluconate is physically incompatible with various substances (see Dosage, method and time of
administration). Avoid mixing, in the same infusion set, calcium gluconate solutions
with incompatible drugs or even administering them separately in succession.
Following the simultaneous administration of physically incompatible solutions or of
total parenteral nutrition solutions containing calcium and phosphate, serious, even fatal,
complications may occur due to the microcrystallization of insoluble calcium salts
in the body.
Concomitant use of calcium gluconate and ceftriaxone should be avoided, as
formation of ceftriaxone-calcium precipitates may occur.
BIOINDUSTRIALaboratorio Italiano Medicinali S.p.A.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
Cardioactive glycosides/digitalis: potentiation of effects. The association puts the subject at
risk of digitalis intoxication.
Verapamil: concomitant systemic use of verapamil and calcium gluconate may
determine reversal of the hypotensive effect.
Thiazide diuretics: concomitant use of thiazide diuretics with calcium gluconate increases the risk
of hypercalcemia.
Laboratory tests
Calcium gluconate may determine, for laboratory analyses, false negatives for
serum and urinary magnesium values. The mechanism of this interaction is unknown.
Physical incompatibilities
See Precautions for use and Dosage, method and time of administration.
As with other solutions containing calcium, concomitant treatment with ceftriaxone is
contraindicated in neonates (≤28 days of age), even in case of use of separate infusion lines
(risk of fatal precipitation of ceftriaxone-calcium salt in the newborn's bloodstream,
see paragraph Undesirable effects)
In patients over 28 days of age (including adults), ceftriaxone should not be
administered concurrently with intravenous solutions containing calcium, including Calcium
gluconate Bioindustria L.I.M., through the same infusion line (e.g. through a Y-connector).
If the same line is used for sequential administrations, the line must be flushed with
a compatible liquid between infusions.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Calcium gluconate should be used during pregnancy only if considered
essential by the doctor.
Calcium is secreted in breast milk. This should be taken into consideration when prescribing
calcium to breastfeeding women.
Effects on ability to drive and operate machinery
Calcium gluconate does not impair the ability to drive vehicles or operate machinery.
Important information on some excipients: None
DOSAGE, METHOD AND TIME OF ADMINISTRATION
The normal calcium concentration in plasma generally ranges between 2.25-2.75 mmol
or 4.5-5.5 mEq/l. Treatment with calcium gluconate is aimed at restoring or maintaining these levels.
It should be noted, however, that the absolute amount of Calcium required in certain clinical situations is
difficult to determine and may vary within a very wide range. During therapy,
therefore, calcium levels in the serum must be monitored very carefully.
Calcium gluconate should not be administered subcutaneously or intramuscularly (see
Precautions for use).
Calcium gluconate Bioindustria L.I.M. is a hypertonic solution to be used with caution and at a
controlled infusion rate. Administration should be by slow intravenous infusion.
It is recommended not to exceed an infusion rate of 1.5 ml per minute.
BIOINDUSTRIALaboratorio Italiano Medicinali S.p.A.
As a guide, the following dosages of calcium gluconate are suggested:
Adults
500 mg – 2000 mg (5 – 20 ml of solution)
Children
200 mg – 500 mg (2 – 5 ml of solution)
Infants
Not more than 200 mg (not more than 2 ml of solution)
Elderly patients
Although there is no evidence that the tolerability to calcium gluconate is directly affected
by advanced age, there are some factors or clinical situations, such as a poor diet and a
altered renal function, which may negatively affect the tolerability to the drug and consequently require a reduction in dosage.
Do not use if the solution is not clear; any precipitate may be redissolved with
gentle warming in warm water.
Calcium gluconate for intravenous use may be diluted with 5% glucose solutions or 0.9% sodium
chloride. Dilution in solutions containing bicarbonates, phosphates or sulphates should be
avoided.
Calcium salts can form complexes with many substances leading to the formation of
precipitates. Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates,
bicarbonate, phosphates, tartrates and sulphates.
They are also incompatible with ceftriaxone (see Precautions for use), amphotericin,
cephalotin sodium, cefazolin sodium, cefamandole nafate, novobiocin sodium, dobutamine
hydrochloride, prochlorperazine, tetracyclines, methylprednisolone sodium succinate, prochlorperazine
edisylate, metoclopramide hydrochloride, fluconazole, indometacin, meropenem.
The medicine should also not be mixed with nutrient emulsions for intravenous use.
Calcium salts can form complexes with many drugs and this can lead to the formation of
precipitates. Physical incompatibility has been reported with ceftriaxone (see paragraphs
Contraindications, Interactions and Undesirable effects).
OVERDOSE
Excessive administration of calcium salts causes hypercalcemia. Symptoms
of hypercalcemia may include: anorexia, nausea, vomiting, constipation, abdominal pain,
muscle weakness, polydipsia, polyuria, mental disorders, bone pain, nephrocalcinosis, kidney stones and, if severe, cardiac arrhythmias and coma.
Treatment of overdose
Severe hypercalcemia is treated with infusion of a sodium chloride solution to increase
the volume of extracellular fluid. Furosemide may then be used, simultaneously or
subsequently, to further increase calcium excretion. If treatment
is ineffective, other drugs such as calcitonin, bisphosphonates,
sodium edetate and phosphates may be used.
Hemodialysis may be considered as a last possible treatment.
During the treatment of overdose, the amount of electrolytes in the serum must be carefully
monitored.
In case of accidental ingestion/intake of an excessive dose of calcium gluconate Bioindustria
L.I.M., immediately warn the doctor or go to the nearest hospital.
If you have any doubts about the use of calcium gluconate Bioindustria L.I.M., ask your doctor or
pharmacist.
BIOINDUSTRIALaboratorio Italiano Medicinali S.p.A.
UNDESIRABLE EFFECTS
Like all medicines, calcium gluconate Bioindustria L.I.M. can cause side effects
although not everyone experiences them.
The following are the undesirable effects of calcium gluconate. Sufficient data are not available
to establish the frequency of individual listed effects.
Many of the undesirable effects are consequent to a high infusion rate. This may
determine vasodilation, with sweating, nausea, vomiting, hot flushes, hypotension,
bradycardia, arrhythmias, as well as syncope and vasomotor collapse, even fatal.
Local leakage of the solution may result in calcification of soft tissues, abscess formation and necrosis.
Some undesirable effects are possible consequences of an overdose, including nephrolithiasis from
hypercalcemia and hypercalciuria.
Ceftriaxone-calcium salt precipitation
Rarely, serious, and in some cases fatal, adverse reactions have been reported in preterm and
full-term neonates (age < 28 days) who had been treated with ceftriaxone and calcium intravenously.
The presence of ceftriaxone-calcium salt precipitation has been detected post mortem
in the lungs and kidneys. The high risk of precipitation in neonates is a consequence of their
low blood volume and the longer half-life of ceftriaxone compared to adults (see paragraphs
Contraindicationsand Interactions).
Cases of renal precipitation have been reported, mainly in children over 3 years of age
treated with high daily doses (e.g. ≥ 80 mg/kg/day) or with total doses greater than 10 grams and
who presented other risk factors (e.g. fluid restriction, bedridden patients). The risk
of precipitate formation increases in immobilized or dehydrated patients. This event may
be symptomatic or asymptomatic, may cause renal failure and anuria and is reversible with
discontinuation of administration.
Ceftriaxone-calcium salt precipitation has been observed in the gallbladder, mainly in
patients treated with doses higher than the standard recommended dose. In children, prospective
studies have demonstrated a variable incidence of precipitation with intravenous administration; in some studies the incidence has resulted in over 30%. This incidence appears to be
lower when infusions are administered slowly (20-30 minutes). This effect is generally
asymptomatic, but in rare cases precipitations have been accompanied by clinical symptoms, such as
pain, nausea and vomiting. In these cases, symptomatic treatment is recommended. The precipitation
is generally reversible with discontinuation of administration.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
SHELF LIFE AND STORAGE
Expiry date: see the expiry date indicated on the packaging
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date indicated on the packaging.
Storage conditions
Store in the original packaging. Do not freeze
Do not use if the solution is not clear; any precipitate may be redissolved with
gentle warming in warm water.
BIOINDUSTRIALaboratorio Italiano Medicinali S.p.A.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
Calcium gluconate Bioindustria L.I.M.500 mg/5 ml solution for infusion
1 vial contains:
Active ingredient:calcium gluconate 475 mg
Excipient: calcium D-saccharate 18 mg
(equivalent to mEq/l Ca 446)
Excipients:calcium D-saccharate, water for injections
Calcium gluconate Bioindustria L.I.M.1000 mg/10 ml solution for infusion
1 vial contains:
Active ingredient: calcium gluconate 950 mg
Excipient: calcium D-saccharate 36 mg
(equivalent to mEq/l Ca 446)
Excipients:calcium D-saccharate, water for injections
PHARMACEUTICAL FORM AND CONTENT
Solution for infusion
10 vials of 5 ml and 10 vials of 10 ml.
MARKETING AUTHORISATION HOLDER
BIOINDUSTRIA Laboratorio Italiano MedicinaliS.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano MedicinaliS.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 500 MG/5 ML
- Kod ATCA12AA03
- Substancja czynna
- Wymaga receptyTak
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- Zamienniki KALKIO LUKONATO BIOINDUSTRIA L.I.M.Postać farmaceutyczna: Injectable solution, 10 %Substancja czynna: calcium gluconateProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Injectable solution, 1000 MG/10 MLSubstancja czynna: calcium gluconateWymaga receptyPostać farmaceutyczna: Injectable solution, 500 MG/5 MLSubstancja czynna: calcium gluconateProducent: MONICO S.P.A.Wymaga recepty
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Substancją czynną w KALKIO LUKONATO BIOINDUSTRIA L.I.M. jest calcium gluconate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KALKIO LUKONATO BIOINDUSTRIA L.I.M. jest produkowany przez BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
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Inne leki zawierające tę samą substancję czynną (calcium gluconate) to m.in. KALKIO LUKONATO B. BRAUN, KALKIO LUKONATO GALENIKA SENESE, KALKIO LUKONATO MONIKO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
