Active ingredients: Sobrerol
Sobrefluid 60 mg / 4 ml solution for injection for intramuscular use in adults
Sobrefluid package inserts are available for pack sizes:- Sobrefluid 60 mg / 4 ml solution for injection for intramuscular use in adults
- Sobrefluid adults 200 mg suppositories
- Sobrefluid 40mg / 3ml solution to be sprayed
- Sobrefluid children 100 mg suppositories
Indications Why is Sobrefluid used? What is it for?
The active ingredient in Sobrefluid is sobrerol, a mucolytic.
This medicine is indicated to facilitate the removal of excess mucus in acute and chronic diseases of the respiratory tract.
Contraindications When Sobrefluid should not be used
Do not use Sobrefluid
- if you are allergic to sobrerol or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
- in children under 2 years of age.
Important: This formulation of the medicine, solution for injection for intramuscular use, is for use in adults only.
Precautions for use What you need to know before taking Sobrefluid
Talk to your doctor or pharmacist before using Sobrefluid.
Children
The product should not be used in children under 2 years of age, as mucolytics can induce bronchial occlusion (the ability to eliminate bronchial mucus in children under 2 years of age is limited due to the characteristics of their respiratory tract)
Interactions Which drugs or foods can modify the effect of Sobrefluid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will prescribe Sobrefluid only in case of absolute necessity and only after a "careful evaluation of the potential risks and benefits.
Driving and using machines
Sobrefluid does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Sobrefluid: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1-2 ampoules per day for intramuscular injection.
Overdose What to do if you have taken too much Sobrefluid
No cases of overdose have been reported. In case of accidental ingestion / administration of an overdose of Sobrefluid, notify your doctor immediately or go to the nearest hospital. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Sobrefluid
Like all medicines, this medicine can cause side effects, although not everybody gets them
. Undesirable effects with frequency not known (frequency cannot be estimated from the available data):
- bronchial obstruction (temporary narrowing of the upper respiratory tract);
- gastric (stomach) discomfort;
- nausea.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: https://www.aifa.gov. it / content / reports-adverse-reactions
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Sobrefluid contains
- The active ingredient is sobrerol. One 4 ml ampoule contains 60 mg of sobrerol.
- The other ingredients are: sodium benzoate, benzoic acid, water for injections.
What Sobrefluid looks like and contents of the pack
Sobrefluid comes in the form of solution ampoules for intramuscular injection.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SOBREFLUID
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sobrefluid 60 MG / 4 ML solution for injection adults.
One 4 ml ampoule contains: 60 mg sobrerol.
Sobrefluid adults 200 mg suppositories.
One suppository contains: sobrerol 200 mg.
Sobrefluid children 100 mg suppositories.
One suppository contains: sobrerol 100 mg.
Sobrefluid 40 mg / 3 ml solution for nebulisation.
A 3 ml ampoule contains: sobrerol 40 mg.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
• Solution for injection for intramuscular use.
• Suppositories for rectal use.
• Nebuliser solution for inhalation use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Mucolytic, fluidifying in acute and chronic diseases of the respiratory system.
04.2 Posology and method of administration
60 MG / 4 ML adult solution for injection: 1-2 ampoules per day intramuscularly.
Adults 200 mg suppositories: 1-2 suppositories per day.
Children 100 mg suppositories: 1-2 suppositories per day.
40 mg / 3 ml solution to be nebulized: 1 vial for each inhalation or aerosolized tubal catheterization for 1 or 2 applications per day.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Generally contraindicated in pregnancy and lactation (see 4.6 Pregnancy and lactation).
The drug is contraindicated in children under 2 years of age.
04.4 Special warnings and appropriate precautions for use
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (see section 4.3).
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions of sobrerol with other drugs.
04.6 Pregnancy and lactation
In pregnancy and breastfeeding, the safety of sobrerol is not sufficiently demonstrated; therefore Sobrefluid should only be administered when, in the judgment of the physician, the potential benefits outweigh the possible risks.
04.7 Effects on ability to drive and use machines
No effects have ever been reported that cause danger to those who drive or use dangerous machinery.
04.8 Undesirable effects
Bronchial obstruction: frequency unknown Gastric upset and nausea may occur.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
No reports of overdose. If necessary, implement the usual measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: mucolytic.
ATC code: R05CB07.
Sobrerol, through a hydration mechanism, increases the volume of bronchial secretions thus acting as a fluidifying agent.
It also modifies the biochemical and cellular component of mucus and increases the speed of the ciliary beat. These actions, together, favor the airway purification mechanisms which are reflected in an improvement in respiratory function.
05.2 "Pharmacokinetic properties
Sobrerol is rapidly absorbed by the first tracts of the "gastrointestinal tract. Maximum at 60". Sobrerol is rapidly distributed. The rapid distribution is confirmed by elevated sobrerol levels found in bronchial mucus as early as one hour after administration.
In humans, the plasma half-life of sobrerol is 2.39 hours and 2.98 hours in bronchial mucus.
The biotransformation of sobrerol in humans has two types of reaction: that in phase I in which the passage of sobrerol to carvone takes place. The one in phase II constituted by conjugation with glucuronic acid.
A total of 9 metabolites have been identified in humans and animals.
In humans, sobrerol is eliminated almost exclusively via the kidneys in the form of free sobrerol, glucurono-conjugated sobrerol, carvone.
05.3 Preclinical safety data
The LD50 of sobrerol was 4240 mg / kg orally and 885 mg / kg intravenously in the rat.
The oral LD50 in mice was 2560 mg / kg and intravenously 1100 mg / kg.
The oral LD50 in dogs was 2500 mg / kg and intravenous 40 mg / kg.
In the chronic toxicity tests in all treated animal species, no signs of intolerance and no specific lesions were found in autopsy studies.
Studies on gestation, embryo-fetal development and peri and postnatal toxicity did not show substantial changes compared to controls.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sobrefluid 60 MG / 4 ML solution for injection adults,
Sobrefluid 40 mg / 3 ml solution for nebulisation:
sodium benzoate, benzoic acid, water for injections.
Sobrefluid adults suppositories, Sobrefluid children suppositories:
solid semisynthetic glycerides.
06.2 Incompatibility
None known.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C:
Suppositories adults, children
No particular storage conditions
Adult solution for injection
Solution to be sprayed 40 mg / 3 ml
06.5 Nature of the immediate packaging and contents of the package
Sobrefluid 60 MG / 4 ML solution for injection adults,
Sobrefluid 40 mg / 3 ml solution for nebulisation
Type I colorless glass vials.
Sobrefluid adults suppositories, Sobrefluid children suppositories
PVC / PE valves.
Not all pack sizes may be marketed
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A - Viale Certosa 130 - 20156 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
"60 MG / 4 ML adult solution for injection" 10 ampoules of 4 ml i.m. AIC n ° 039427012
"adult suppositories" 10 suppositories AIC n ° 039427024
"children suppositories" 10 suppositories AIC n ° 039427036
"40 mg / 3 ml solution for nebulization" 10 ampoules of 3 ml AIC n ° 039427063
Not all pack sizes may be marketed
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
July 2015
