MUCOFRIN 300 mg /3 Ml Инъекционный Раствор
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Инструкция по применению MUKOFRIN
Содержание инструкции
MUCOFRIN 300 mg/3 ml injectable solution and for nebulizer
N-acetylcysteine
Generic Medicine
Read this leaflet carefully before using this medicinebecause 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 pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any undesirable effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Mucofrin is and what it is used for
- 2. What you need to know before you use Mucofrin
- 3. How to use Mucofrin
- 4. Possible side effects
- 5. How to store Mucofrin
- 6. Contents of the pack and other information
1. WHAT IS MUCOFRIN AND WHAT IS IT USED FOR
Mucofrin contains the active ingredient N-Acetylcysteine, which belongs to a group of medicines
called mucolytics, used to facilitate the elimination of mucus from the respiratory tract and to a group
of medicines called antidotes used to counteract the toxic effect of certain substances.
Mucofrin is indicated in the treatment of diseases of the respiratory system characterized by an
increase in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:
- inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
- pathology of the pulmonary alveoli (pulmonary emphysema);
- cystic fibrosis (mucoviscidosis);
- dilations of the bronchi (bronchiectasis).
Mucofrin is used as an antidote in particular for:
- Accidental or intentional poisoning with paracetamol, a pain-relieving and antipyretic medicine.
- pathologies affecting the urinary tract (uropathies) caused by chemotherapeutic drugs such as iso and cyclophosphamide.
2. WHAT YOU NEED TO KNOW BEFORE USING MUCOFRIN
Do not take Mucofrin
if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in
section 6) unless used as an antidote in case of paracetamol poisoning;
- - if the patient is a child under 2 years of age, unless used as an antidote in case of paracetamol poisoning.
Warnings and precautions
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Consult your doctor or pharmacist before using Mucofrin. Take this medicine with caution
and always under the control of your doctor in the following cases:
- if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Immediately stop
taking Mucofrin if you experience bronchospasm (contraction of the bronchial muscles) - if you suffer from or have suffered from a problem with your stomach or intestines called a peptic ulcer, especially if you are taking other medicines that can cause stomach problems (gastrolesive drugs) together with Mucofrin.
- - If you have previously suffered from atopy and asthma as you may develop allergic reactions;
- - If you are intolerant to histamine as you may develop allergic reactions;
This medicine may increase the volume of bronchial mucus (bronchial secretions),
especially if administered by aerosol, at the beginning of treatment. Therefore, if this occurs and
you are unable to eliminate the bronchial secretions by coughing (expectorating), consult your doctor
who will indicate a method for eliminating the mucus (postural drainage or bronchoaspiration).
Allergic (hypersensitivity/anaphylactoid) reactions can occur with N-acetylcysteine. Monitoring
for signs of an allergic reaction may be necessary.
This medicine must be administered with particular caution and strictly following the
instructions given in the section “How to take Mucofrin”.
Keep in mind that:
- administration of Mucofrin to counteract the toxic effect of certain substances (antidotal treatment) has in very rare cases caused death;
- if Mucofrin is to be administered to counteract the toxic effect of certain substances (antidotal treatment) in people with a body weight of less than 40 Kg, an excessive administration of fluids may occur with consequent reduction of sodium in the blood (hyponatremia), convulsions and death;
- if Mucofrin is administered intravenously rapidly or in excessive quantities, it may increase the occurrence of undesirable effects.
This medicine may alter some blood parameters (reduction of prothrombin index,
increase of INR) when used as an antidote at the indicated dosage.
If you notice a sulfurous odor when opening the vial, or if the solution turns pink in the open vial
or when transferring the solution to the aerosol device, do not worry as this does not
indicate alteration of the medicine.
Laboratory tests:N-acetylcysteine may interfere with some blood and urine tests
(colorimetric dosage for the determination of salicylates and tests to determine ketones). Inform
your doctor that you are using this medicine before undergoing these tests.
Children
Mucofrin should not be administered to children under 2 years of age, as it may obstruct the
bronchi and prevent normal breathing.
The same warnings and precautions as for adults apply to children and adolescents.
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Other medicines and Mucofrin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take this medicine if you are taking cough medicines (antitussives), as
they may lead to an accumulation of mucus inside the bronchi.
Use this medicine with caution and consult your doctor if you are taking any of the following
medicines:
- nitroglycerin, used for some heart conditions. The use of this medicine together with Mucofrin may cause a reduction in blood pressure (hypotension) and headache;
- antibiotics, medicines used to treat infections. Do not mix these medicines with the solution containing Mucofrin.
You can use Mucofrin together with medicines for the treatment of asthma (see section
“Warnings and precautions”) and diseases of the bronchi and lungs (bronchodilators) or
medicines to increase blood pressure (vasoconstrictors).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
Take this medicine if you are pregnant only if strictly necessary and under the direct
control of your doctor.
Breastfeeding
The use of Mucofrin should be avoided if you are breastfeeding. Ask your doctor for advice before stopping
breastfeeding and/or starting/stopping therapy with Mucofrin.
Fertility
No data are available on the effect of Mucofrin on fertility.
Driving and operating machinery:
No information is available to establish the effect on the ability to drive vehicles or
operate machinery.
Mucofrin contains sodium
This medicine contains 40.62 mg (1.76 mmol) of sodium (the main component of table
salt) per vial. This is equivalent to 2% of the maximum recommended daily intake with the
diet of an adult. This should be taken into consideration in people with impaired renal function or who
are following a low-sodium diet.
3. HOW TO TAKE MUCOFRIN
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Open the MUCOFRIN vial at the time of use. Use open vials only if stored in
the refrigerator and for a maximum of 24 hours. Do not use vials stored open for
intravenous administration.
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If MUCOFRIN is mixed with medicines for the treatment of asthma and lung diseases (bronchodilators) or other medicines, use the solution quickly and do not
store it. The dose, duration of treatment and method of administration will be established by
the doctor based on your condition.
This medicine will be administered by a doctor or nurse in the case of intravenous
injection (intravenous administration).
Administration via injection (intravenous):
Treatment of accidental or intentional paracetamol poisoning:
Mucofrin will be administered to you slowly into a vein via intravenous infusion. The medicine
will be administered to you in a hospital setting by a doctor or nurse who will prepare
the infusion. If you have any doubts, consult your doctor or nurse.
Administration via aerosol
The recommended dose is 1 vial to be nebulized, 1-2 times a day. The duration of treatment is
5-10 days.
The dose and frequency of the medicine may be modified by the doctor.
Use a glass or plastic nebulizer and for devices that have metal or
rubber parts, it is necessary to wash the devices with water immediately after use.
Administration into the bronchi
The recommended dose is 1 vial at a time 1-2 times a day or as needed to be administered using the chosen methods (permanent catheters, bronchoscope, etc.).
Administration or ear washes or of other body cavities
The recommended dose is half or 1 vial at a time.
How to open the vial:
Hold the lower part of the vial firmly with one hand and place the index finger of the other hand
in the indentation of the vial, applying pressure with the thumb.
If you use more Mucofrin than you should
The symptoms of an overdose following an intravenous injection of an excessive dose are similar, but
more serious, to the undesirable effects listed in the “Possible side effects” section. No cases of
overdose have been reported instead when this medicine is administered by
aerosol or bronchial route. However, following the administration of an excessive dose of this
medicine, an accumulation of mucus in the bronchi may occur, especially if the patient is unable
to eliminate it by coughing (expectorating). Immediately consult your doctor who will indicate a
method to eliminate the mucus (bronchoaspiration).
In case of ingestion/taking an excessive dose of this medicine, immediately warn
your doctor or go to the nearest hospital.
If you forget to use Mucofrin:
Do not use a double dose to make up for a missed dose.
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If you have any doubts about the use of this medicine, consult your doctor, pharmacist 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 when MUCOFRIN is administered by
aerosol (inhalation use) or via endotracheobronchial route:
Frequency not known(the frequency of which cannot be estimated based on available data)
- urticaria;
- skin rash;
- pruritus;
- bronchial muscle contraction (bronchospasm);
- vomiting;
- nausea;
- allergic reactions (hypersensitivity);
- runny nose (rhinorrhea);
- inflammation of the mouth (stomatitis);
- bronchial obstruction.
The following side effects may occur when MUCOFRIN is administered
intravenously (parenteral use):
Frequency not known(the frequency of which cannot be estimated based on available data)
- severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
- allergic reactions (hypersensitivity);
- fast heartbeat (tachycardia);
- bronchial muscle contraction (bronchospasm);
- difficulty breathing (dyspnea);
- vomiting;
- nausea;
- swelling due to fluid retention around the mouth and eyes (angioedema);
- urticaria;
- skin rash;
- pruritus;
- redness;
- swelling (edema) of the face;
- decreased blood pressure;
- increased time required for blood to clot (prothrombin time).
In very rare cases, severe skin reactions (Stevens Johnson syndrome or
Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking
the medicine and consult your doctor. Furthermore, a reduction in platelet aggregation
(prolongation
of bleeding time) is possible.
Reporting of side effects
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If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at.
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 MUCOFRIN
Keep this medicine out of the sight and reach of children.
It is recommended to open the vials at the time of use. Opened vials can only be used if
stored in a refrigerator and for a maximum of 24 hours. Opened and stored vials must not be
used for injection.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
The active ingredient is N-Acetylcysteine: 1 vial of 3 ml contains 300 mg of N-Acetylcysteine.
The other components are: sodium hydroxide, sodium edetate, water for injectable preparations.
Description of the appearance of MUCOFRIN and contents of the pack
. Box of 5 vials of 3 ml.
Marketing Authorisation Holder
MavenPharmaS.r.l Via Stefano Jacini, 68 - 00191 Rome
MANUFACTURER
Esseti Farmaceuti S.r.l.
Via Campobello, 15
00071 Pomezia (Rome)
This leaflet was last approved
6/5
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- Страна регистрации
- Форма выпускаInjectable solution, 300 MG/3 ML
- Код АТХR05CB01
- 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 MUKOFRINФорма выпуска: Injectable solution, 300 MG/3 MLДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for oral solution, 100 MGДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается без рецептаФорма выпуска: Oral solution powder, 600 MGДействующее вещество: АцетилцистеинПроизводитель: HEXAL A/SОтпускается по рецепту
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Действующее вещество MUKOFRIN — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
MUKOFRIN производится компанией MAVEN PHARMA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения MUKOFRIN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить MUKOFRIN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Ацетилцистеин) включают AKK FLUIDIFIKANTE E ANTIDOTO, AKK, AKKFLUBUST. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
