MAGNESIO 1 Г/10 МЛ Концентрат для инфузионного раствора
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Инструкция по применению MANYESIO SOLFATO MONIKO
Содержание инструкции
MAGNESIO SOLFATO MONICO
1 g/10 ml concentrate for solution for infusion
2 g/10 ml concentrate for solution for infusion
2,5 g/10 ml concentrate for solution for infusion
2 mEq/ml concentrate for solution for infusion
Magnesio solfato
Equivalent medicinal product
Read this leaflet carefully before using 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 or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What MAGNESIO SOLFATO MONICO is and what it is used for
- 2. What you need to know before you use MAGNESIO SOLFATO MONICO
- 3. How to use MAGNESIO SOLFATO MONICO
- 4. Possible side effects
- 5. How to store MAGNESIO SOLFATO MONICO
- 6. Contents of the pack and other information
1. What is MAGNESIO SOLFATO MONICO and what is it used for
MAGNESIO SOLFATO MONICO contains the active ingredient magnesium sulfate, which is a salt
of magnesium. Magnesium has an essential role in the transmission of nerve impulses and
in muscle contraction.
This medicine is indicated for:
- the prevention and control of convulsions that may occur during pregnancy if you suffer from a condition called pregnancy toxemia (pre-eclampsia, eclampsia), characterized by high blood pressure, swelling due to fluid retention (edema) and the presence of protein in the urine;
- providing the body with magnesium in cases where it is deficient and reaches low levels in the blood (acute hypomagnesemia), particularly if you suffer from a condition characterized by cramps and muscle spasms (tetany);
- the prevention and treatment of low magnesium levels in the blood (hypomagnesemia), during the direct intravenous administration of nutrients (total parenteral nutrition).
2. What you need to know before using MAGNESIO SOLFATO MONICO
Do not use MAGNESIO SOLFATO MONICO
- if you are allergic to magnesium sulfate or any of the other ingredients of this medicine (listed in section 6);
- if you have heart problems (myocardial damage) or irregular heartbeat (cardiac arrhythmias);
- if you have severe kidney problems (severe renal impairment) (See section “Warnings and precautions”).
Warnings and precautions
Talk to your doctor or nurse before using MAGNESIO SOLFATO MONICO.
MAGNESIO SOLFATO MONICO should only be administered to you if the vial or
bottle is undamaged and the solution is clear. The medicine must be
injected through a single, uninterrupted administration, at a controlled rate,
after appropriate dilution. Any remaining medicine must be discarded (See the
section “How to use MAGNESIO SOLFATO MONICO”).
During treatment with MAGNESIO SOLFATO MONICO, your doctor must periodically check
magnesium levels in your blood to prevent them from increasing excessively.
MAGNESIO SOLFATO MONICO should be administered to you with particular caution if:
- you have kidney problems (renal impairment of a less severe degree);
- you suffer from a severe muscle disease (myasthenia gravis).
This medicine should not be administered to you if you have severe kidney problems
(renal failure), as excessive levels of magnesium in the blood
(magnesium intoxication) may occur following administration directly into a vein
(intravenously) (See section “Do not use MAGNESIO SOLFATO
MONICO”).
If you are pregnant and suffering from eclampsia, the medicine will only be administered to you
directly into a vein to control seizures that may be fatal
(See section “Pregnancy and breastfeeding”).
Other medicines and MAGNESIO SOLFATO MONICO
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.
Be particularly careful and talk to your doctor if you are taking:
- medicines that reduce brain activity (such as barbiturates, narcotics, other hypnotics, systemic anesthetics), as the dose of MAGNESIO SOLFATO MONICO to be administered may need to be adjusted to avoid a further reduction in brain activity;
- medicines used for some heart problems (cardiac glycosides such as digitalis), as serious heart rhythm disturbances (cardiac conduction disturbances) may occur;
- medicines that reduce muscle contraction (competitive and depolarizing neuromuscular blocking agents), used before surgery, as magnesium sulfate may potentiate their effects;
- certain medicines used to treat bacterial infections (aminoglycoside antibiotics), as they may potentiate muscle relaxation (neuromuscular block) induced by magnesium;
- eltrombopag used for circulatory disorders, as magnesium sulfate may reduce its concentration in the blood, and therefore its effects;
- rocuronium used for anesthesia during surgery, as it may cause excessive reduction of voluntary muscle contraction (neuromuscular block) and severe breathing difficulties (respiratory depression, apnea);
- labetalol used for heart rhythm disorders, as reduced heart activity (bradycardia) and reduced blood volume pumped by the heart (cardiac output) may occur, resulting in shortness of breath, dizziness and temporary loss of consciousness (fainting);
- medicines used to treat high blood pressure (calcium antagonists such as isradipine, felodipine, nicardipine and nifedipine), as excessive lowering of blood pressure (hypotension) may occur.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor for advice before this
medicine is administered to you.
Pregnancy
If you are pregnant, this medicine should only be administered to you in cases of
absolute necessity and under the direct supervision of your doctor, who must monitor your baby’s heart rate
(fetal heart rate) (See section “Warnings and
precautions”).
If you suffer from a condition called pregnancy toxemia and this medicine is
administered to you to control seizures before delivery, your baby may experience
serious muscle and breathing problems (neuromuscular and respiratory depression).
If used repeatedly during pregnancy, your doctor may recommend monitoring
mineral levels, as the baby may experience adverse effects on skeletal loading.
MAGNESIO SOLFATO MONICO should not be administered 2 hours before delivery.
Breastfeeding
If you are breastfeeding, this medicine should be administered under the direct
supervision of your doctor.
Driving and using machines
There is no data available regarding the ability to drive vehicles and operate machinery.
Therefore, consult your doctor if you need to drive vehicles or operate
machinery.
3. How to use MAGNESIO SOLFATO MONICO
This medicine will be administered to you by a doctor or specialized personnel, after
appropriate dilution (with 5% glucose solution or 0.9% sodium chloride solution).
Due to the possible formation of precipitates, magnesium sulfate must not be mixed with
solutions containing: high concentrations of alcohol, heavy metals, carbonates and bicarbonates,
sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate,
clindamycin phosphate, tartrates. Potential incompatibility is often influenced
by the modification of the concentration of reagents and the pH of the solutions.
The medicine must be administered to you through a single and uninterrupted
administration and any residue must be discarded.
Prevention and control of convulsions in case of severe pregnancy toxemia
Treatment of magnesium deficiency, especially if accompanied by tetany
In these cases, at the beginning of treatment, the total dose is 10-14 g of magnesium sulfate.
To control convulsions, it is necessary to reach a certain amount of magnesium
in the blood (6 mg/100 ml).
No more than 30-40 g should be administered to you in a day (24 hours).
Prevention and treatment of magnesium deficiency in people receiving total
parenteral nutrition
The recommended dose ranges from 1 g to 3 g (8-24 mEq) of magnesium sulfate per day (24 hours).
Use in people with kidney problems
If you suffer from kidney function problems (severe renal insufficiency), the maximum dose of
magnesium sulfate is 20 g every 2 days (48 hours).
If you use more MAGNESIO SOLFATO MONICO than you should
This medicine will be administered to you by a doctor or specialized personnel, therefore
it is unlikely that you will be injected with an excessive dose. However, if you think that you have been
administered an excessive dose of MAGNESIO SOLFATO MONICO, inform
your doctor or another healthcare professional immediately.
Following the administration of an excessive dose of this medicine, signs of toxicity may occur such as: excessive increase in blood pressure (blood pressure peak) and respiratory arrest (respiratory paralysis).
If you have any doubts about the use of MAGNESIO SOLFATO MONICO, ask your doctor or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
- intestinal disorders (paralytic ileus, delayed intestinal transit);
- allergic reactions (hypersensitivity reactions such as urticaria);
- increased levels of acidic substances in the blood (metabolic acidosis) or reduced levels of calcium in the blood (hypocalcemia);
- sudden feeling of heat (hot flushes), sweating, low blood pressure (hypotension), loss of voluntary movement (flaccid paralysis), decreased body temperature (hypothermia), serious problems of the heart, circulation and brain (circulatory collapse, cardiac and central nervous system depression) and, in the most severe cases, respiratory arrest (respiratory paralysis).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store MAGNESIO SOLFATO MONICO
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 packaging after
“EXP.”. The expiry date refers to the last day of that month and the product in
intact packaging and correctly stored.
Store this medicine in the original packaging.
No particular storage temperatures are required.
The medicine must be administered immediately after opening the
vial/bottle through a single and uninterrupted administration and only if the solution is
clear, colourless and free of particles. Any residual medicine must be
discarded.
Do not dispose of any medicine in wastewater or household waste. 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 MAGNESIO SOLFATO MONICO contains
MAGNESIO SOLFATO MONICO 1 g/10 ml concentrate for solution for infusion
- The active ingredient is magnesium sulfate heptahydrate. 10 ml of solution contains 1000 mg of magnesium sulfate heptahydrate. Each liter of solution contains 811 mEq of magnesium. pH: 5.5 ÷ 7.0.
- The other component is water for injections.
MAGNESIO SOLFATO MONICO 2 g/10 ml concentrate for solution for infusion
- The active ingredient is magnesium sulfate heptahydrate. 10 ml of solution contains 2000 mg of magnesium sulfate heptahydrate. Each liter of solution contains 1623 mEq of magnesium. pH: 5.5 ÷ 7.0.
- The other component is water for injections.
MAGNESIO SOLFATO MONICO 2.5 g/10 ml concentrate for solution for infusion
- The active ingredient is magnesium sulfate heptahydrate. 10 ml of solution contains 2500 mg of magnesium sulfate heptahydrate. Each liter of solution contains 2028 mEq of magnesium. pH: 5.5 ÷ 7.0.
- The other component is water for injections.
MAGNESIO SOLFATO MONICO 2 mEq/ml concentrate for solution for infusion
- The active ingredient is magnesium sulfate heptahydrate. 30 ml of solution contains 7390 mg of magnesium sulfate heptahydrate. Each liter of solution contains 2000 mEq of magnesium. pH: 5.5 ÷ 7.0.
- The other component is water for injections.
Description of the appearance of MAGNESIO SOLFATO MONICO and package contents
MAGNESIO SOLFATO MONICO 1 g/10 ml, 2 g/10 ml and 2.5 g/10 ml concentrate for
solution for infusion
Pack containing 5 or 10 glass vials of 10 ml.
MAGNESIO SOLFATO MONICO 2 mEq/ml concentrate for solution for infusion
Package containing 10 glass ampoules of 30 ml.
Marketing Authorisation Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy
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- Страна регистрации
- Форма выпускаConcentrate for infusion solution, 1 G/10 ML
- Код АТХB05XA05
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги MANYESIO SOLFATO MONIKOФорма выпуска: Concentrate for infusion solution, 2 MEQ/MLДействующее вещество: Сульфат магнияПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 1 G/10 MLДействующее вещество: Сульфат магнияПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается по рецептуФорма выпуска: Concentrate for infusion solution, 1 G/10 MLДействующее вещество: Сульфат магнияПроизводитель: S.A.L.F. SPA LABORATORIO FARMACOLOGICOОтпускается по рецепту
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