Glamin
ItalyTable of Contents
Package leaflet: Information for the user
Glamin infusion solution
Read this leaflet carefully before you start taking this medicine because it contains important information for you
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Glamin is and what it is used for
- What you need to know before you take Glamin
- How to take Glamin
- Possible side effects
- How to store Glamin
- Contents of the pack and other information
1. What Glamin is and what it is used for
Glamin is a medicine containing the active substance N-Acetylcysteine. It belongs to a group of medicines called expectorants, which help loosen mucus in the airways. Glamin is used to treat respiratory conditions associated with thick mucus, such as bronchitis, chronic obstructive pulmonary disease (COPD), and other respiratory tract infections. It works by breaking down the mucus, making it easier to cough up and clear from the lungs.
| Glamin provides nourishment directly into the bloodstream when you are unable to eat normally, | |
| such as after surgery or illness. It provides amino acids, which your body uses to | |
| produce proteins (to build and repair muscles, organs, and other tissues). | |
| It is generally used as part of a balanced intravenous diet, including fats, carbohydrates, | |
| salt and vitamins. | |
2. What you need to know before taking Glamin
Do not take Glamin:
- if you suffer from a rare inherited disease that causes your body to not properly metabolize amino acids (e.g. phenylketonuria)
- if you have hepatic or renal insufficiency
- if you have very serious circulatory problems
- if you are in a state of shock
- if you suffer from metabolic acidosis – a condition in which the pH of your blood is low
- if you have oxygen deficiency in the body
- if you have a condition known as fluid overload, when you have too much water in your body
- if you have low sodium levels (hyponatremia)
- if you have low potassium levels (hypokalemia)
- if you suffer from high levels of lactic acid in your body (hyperlactatemia)
- if you have changes in your blood profile
- if you have fluid accumulation in your lungs (pulmonary edema)
- if you suffer from a heart condition known as decompensated heart failure, in which your heart is not strong enough to pump blood effectively throughout the body
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Your doctor or nurse will check for these conditions before you are given Glamin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Glamin.
Your doctor may ask you to have blood tests to monitor your health status.
Your doctor or nurse will check that the solution is free from particles before use.
Children
Glamin is not recommended for use in children.
Other medicines and Glamin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
There is no experience with the use of Glamin during pregnancy or breastfeeding. Your doctor will carefully evaluate the potential risks and benefits before prescribing Glamin to you.
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can be given Glamin.
Driving and using machines
Not applicable, as this medicine is administered in a hospital setting.
3. How to take Glamin
You will receive this medicine by infusion (a slow intravenous infusion drop by drop).
Your doctor will decide the correct dose for you based on your individual needs.
The usual dose of Glamin for adults is 7-14 ml per kg of body weight/day and may be adjusted if
you have liver or kidney problems.
Use in children
Glamin is not recommended for use in children.
If you receive more Glamin than you should
It is very unlikely that you will receive too much infusion, as your doctor or nurse will monitor you during treatment. However, if you think you have received too much Glamin, inform your doctor or nurse immediately.
The following undesirable effects have been observed when Glamin has been administered too rapidly:
- feeling unwell (nausea and vomiting)
- sweating
- flushing.
If you have any doubts about the use of Glamin, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If the solution is administered correctly, no side effects are expected.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse.
You can also report side effects directly via 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 Glamin
Keep this medicine out of the sight and reach of children.
The doctor or hospital pharmacist is responsible for the correct storage, proper use, and disposal of Glamin.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label.
The solution must not be used if it is not particle-free.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Glamin contains
- The active substances are
1000 ml of Glamin contain:
Amino acids Quantity
Alanine 16 g
Arginine 11.3 g
Aspartic acid 3.4 g
Glutamic acid 5.6 g
Glycyl-glutamine H2O 30.27 g (equivalent to glycine 10.27 g and glutamine 20 g)
Glycyl-tyrosine 2H2O 3.45 g (equivalent to glycine 0.94 g and tyrosine 2.28 g)
Histidine 6.8 g
Isoleucine 5.6 g
Leucine 7.9 g
Lysine acetate 12.7 g (equivalent to lysine 9.0 g)
Methionine 5.6 g
Phenylalanine 5.85 g
Proline 6.8 g
Serine 4.5 g
Threonine 5.6 g
Tryptophan 1.9 g
Valine 7.3 g
- The other components are citric acid, water for injections.
Description of the appearance of Glamin and contents of the pack
Glamin is a clear, colourless to slightly yellow solution of amino acids and dipeptides. It is available in
glass bottles with rubber stoppers containing 250 ml, 500 ml and 1000 ml of solution, and in infusion bags
containing 250 ml, 500 ml, 750 ml or 1000 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (VR)
Italy
Manufacturer:
Glamin in glass bottles:
Fresenius Kabi Austria GmbH
Haffnerstrasse 36
A-8055 Graz
Austria
Glamin in infusion bags:
Fresenius Kabi AB
751 74 Uppsala
Sweden
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
| Country | Name | |-------------|----------| | Austria | Glavamin Infusionslösung | | Belgium | Glavamin infusionlösung | | Belgium | Glavamin oplossing voor infusie | | Belgium | Glavamin solution pour perfusion | | Denmark | Glavamin | | Finland | Glavamin | | Germany | Glamin | | Germany | Glavamin | | Italy | Glamin | | Luxembourg | Glavamin | | Netherlands | Glamin | | Norway | Glavamin 22.4 g N/l infusjonsvæske, oppløsning | | Portugal | Glamin, solução para perfusão | | Slovenia | Glamin 134 mg/ml raztopina za infundiranje | | Spain | GLAMIN Solución para perfusión | | Sweden | Glavamin, infusionsvätska, lösning |