CALCIO 1000 mg /10 Ml Injectable Solution
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Інструкція із застосування KALKIO LUKONATO GALENIKA SENESE
Зміст інструкції
Calcium gluconate Galenica Senese 500 mg/5 ml solution for infusion, 1000 mg/10 ml solution for infusion
PHARMACOTHERAPEUTIC CATEGORY
Mineral supplements
THERAPEUTIC INDICATIONS
Treatment of hypocalcemia.
Adjunct in the treatment of anaphylaxis, 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 excess, 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 using separate infusion lines. See paragraphs Interactions, Undesirable effects and 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 extravasation 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 urinary calcium excretion
exceeds 5 mg/kg in 24 hours, treatment should be discontinued immediately as
cardiac arrhythmias may occur.
Calcium salts should be administered with caution in patients with impaired 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.
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
cause 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 not known.
Physical Incompatibility
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 using 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 Galenica Senese 500 mg/5 ml solution for infusion and Calcium gluconate Galenica
Senese 1000 mg/10 ml solution for infusion 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 women during breastfeeding.
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 reported.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
The normal calcium concentration in plasma is generally 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 carefully monitored.
Calcium gluconate should not be administered subcutaneously or intramuscularly (see
Precautions for Use). Calcio gluconato Galenica Senese is a hypertonic solution to be used with
caution and at a controlled infusion rate. Administration should be by very slow intravenous infusion. It is recommended not to exceed an infusion rate of 1.5 ml per minute.
As a guide, the following dosages of calcium gluconate are suggested:
Adults
500 mg – 2000 mg (5-20 ml of solution).
Children
- 200 – 500 mg (2-5 ml of solution). Infantsnot more than 200 mg (not more than 2 ml of solution). Elderly patientsAlthough there is no evidence that tolerance to calcium gluconate is directly affected by advanced age, there are some factors or clinical situations, such as a poor diet and impaired renal function, which may negatively affect tolerance to the drug and consequently require a dose reduction.
Do not use if the solution is not clear; any precipitate may be redissolved with
slight heating 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,
bicarbonates, phosphates, tartrates and sulphates.
They are also incompatible with ceftriaxone (see Precautions for Use), amphotericin,
cephalothin 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 emulsified nutritional solutions for intravenous use.
Calcium salts can form complexes with many drugs and this may lead to the formation
of precipitates.
Physical incompatibility has been reported with ceftriaxone (see paragraphs Contraindications,
Interactions and Undesirable effects).
OVERDOSAGE
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 Overdosage
Severe hypercalcemia is treated with infusion of sodium chloride solution to increase
extracellular fluid volume. Furosemide may then be used, simultaneously or
subsequently, to further increase calcium excretion. If treatment is ineffective, other drugs such as calcitonin, bisphosphonates, disodium
edetate and phosphates may be used.
Hemodialysis may be considered as a last possible treatment.
During the treatment of overdosage, the amount of electrolytes in the serum must be
carefully monitored.
In case of accidental ingestion/intake of an excessive dose of calcium gluconate Galenica
Senese, immediately inform the doctor or go to the nearest hospital.
If you have any doubts about the use of calcium gluconate Galenica Senese, consult your doctor or
pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, calcium gluconate can cause side effects, although not everyone
experiences them.
The following are reported undesirable effects of calcium gluconate. There is insufficient data
to establish the frequency of individual effects listed.
Many of the undesirable effects are consequent to a high infusion rate. This may
cause vasodilation, with sweating, nausea, vomiting, hot flushes, hypotension,
bradycardia, arrhythmias, as well as syncope and vasomotor collapse, even fatal.
Local extravasation of the solution may lead to 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
Serious adverse reactions, and in some cases fatal, have been rarely reported in premature infants and
in term infants (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 Contraindications and 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.
Precipitation of ceftriaxone-calcium salt has been observed in the gallbladder, mainly in
patients treated with doses higher than the standard recommended dose. In children, prospective
studies have shown a variable incidence of precipitation with intravenous administration; in some studies the incidence has been greater than 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. Symptomatic treatment is recommended in these cases. The
precipitation is generally reversible with discontinuation of administration.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet
tell your doctor or pharmacist. Adverse reactions can also be reported directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting of adverse reactions helps
to provide more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the medicine in intact packaging, correctly
stored.
Caution: do not use the medicine after the expiry date printed on the packaging.
Storage conditions
Store in the original packaging. Do not freeze.
After first opening the packaging, the medicine must be used immediately for
a single and uninterrupted administration.
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 Galenica Senese 500 mg/5 ml solution for infusion
1 vial contains:
Active ingredient: Calcium gluconate 475 mg
(Ca mEq/l 446)
Excipients: Water for injections q.s. to 5 ml and calcium saccharate 18 mg.
pH: from 6.0 to 8.2.
Calcium gluconate Galenica Senese 1000 mg/10 ml solution for infusion
1 vial contains:
Active ingredient: Calcium gluconate 950 mg
(Ca mEq/l 446)
Excipients: Water for injections q.s. to 10 ml and calcium saccharate 36 mg.
pH: from 6.0 to 8.2.
PHARMACEUTICAL FORM AND CONTENT
Solution for infusion
Calcio gluconato Galenica Senese 500mg/5ml solution for infusion:
Glass vial of 5 ml
5 glass vials of 5 ml
10 glass vials of 5 ml
Calcio gluconato Galenica Senese 1000mg/10ml solution for infusion:
Glass vial of 10 ml
5 glass vials of 10 ml
10 glass vials of 10 ml
MARKETING AUTHORISATION HOLDER
Industria Farmaceutica Galenica Senese S.r.l.
MANUFACTURER
Industria Farmaceutica Galenica Senese S.r.l.
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- Країна реєстрації
- Лікарська формаInjectable solution, 1000 MG/10 ML
- Код АТХA12AA03
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до KALKIO LUKONATO GALENIKA SENESEЛікарська форма: Injectable solution, 10 %Діюча речовина: глюконат кальцияВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Injectable solution, 500 MG/5 MLДіюча речовина: глюконат кальцияПотрібен рецептЛікарська форма: Injectable solution, 500 MG/5 MLДіюча речовина: глюконат кальцияВиробник: MONICO S.P.A.Потрібен рецепт
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Діюча речовина у KALKIO LUKONATO GALENIKA SENESE — глюконат кальция. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
KALKIO LUKONATO GALENIKA SENESE виробляється компанією INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування KALKIO LUKONATO GALENIKA SENESE з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
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Інші препарати з тією самою діючою речовиною (глюконат кальция) включають KALKIO LUKONATO B. BRAUN, KALKIO LUKONATO BIOINDUSTRIA L.I.M., KALKIO LUKONATO MONIKO. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
