Glandosanes neutral spray, 1x50 ml

Upute za korištenje Glandosanes neutral spray, 1x50 ml

Important notes (compulsory information):

Glandosane. Spray for use in the oral cavity. Applications: For oral dryness of every genesis, especially in the radius of sialadenitis and oral care in the intensive care unit.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

1. Designation of the medicinal product

Glandosan
Glandosanes aromatized

2. Qualitative and quantitative composition

50 ml spray included:
Carmelose sodium 0,5075 g, sorbitol (pH. EUR.) 1.5225 g, potassium chloride 0.0609 g, sodium chloride 0.0428 g, potassium monohydrogen phosphate (ph. EUR.) 0.0174 g, calcium chloride dihydrate 0.0074 G, magnesium chloride hexahydrate 0.0026 g

Other ingredients:
Sodium benzoate and sorbic acid (Ph.eur.). The full listing of other ingredients see section 6.1

3rd dosage form
Spray for use in the oral cavity

4. Clinical information

4.1 Applications
Mouth dryer of every genesis, especially in the radios of sialadenitis. For oral care in the intensive care unit.

4.2 Dosage,
Type and duration of the application unless otherwise prescribed, if necessary spray oral and throat mucosa. For use in the oral cavity. The application time of glandosanes is not limited.

4.3 Contraindications
Hypersensitivity to one of the active ingredients or any other ingredients of glandosanes.

4.4 Special warnings and precautions for the application
Sodium benzoate can cause light irritation to skin, eyes and mucous membranes. Sorbic acid can cause localized skin irritation (e.g., contact dermatitis.

4.5 Interactions with other medicines and other interactions
Have not been observed so far.

4.6 Fertility, pregnancy and lactation
Glandosanes can be used in pregnancy and lactation when used in pregnancy.

4.7 Impact on ability to drive and the ability to serve machinery
When used as intended.

4.8 side effects
The evaluation of side effects is based on the following frequencies: very often (> 1/10), often (> 1/100 to < 1/10), occasionally (> 1 / 1,000 to < 1/100), rare (> 1/10,000 to < 1 / 1,000), very rare (< 1 / 10,000), unknown (frequency based on the available data not estimable).

Experiences after the market launch (spontaneous reports), frequency not known:
Diseases of the gastrointestinal tract Local complaints in the mouth and neck Message of suspicion of side effects The notification of suspicion of side effects after approval is of great importance. It enables continuous monitoring of the benefit risk ratio of the medicine. Relatives of health professions are invited to any suspicion of a side effect of the
Federal Institute for Medicines and
Medicine
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
to display.

4.9 overdose
Not applicable.

5. Pharmacological properties

5.1 Pharmacodynamic properties
ATC Code: A01A D69
Pharmacotherapeutic group: mouth
Rach therapy

5.2 Pharmacokinetic properties
Information for this is not available in this orally used medicinal product.

5.3 Preclinical safety data
Based on the results of preclinical studies on acute and chronic toxicity, reproductive toxicology, carcinogenicity and mutagenicity, no risk to humans is expected for intended use.

6. Pharmaceutical information

6.1 List of other ingredients
Carbon dioxide, sorbic acid (pH. EUR.), Sodium benzoate, purified water, hydrochloric acid, sodium hydroxide
Glandosanes aromatized:
Additionally lemon liqueur aroma

6.2 Incompatibilities
Not applicable.

6.3 Duration of durability
2 years

6.4 Special precautions for storage
Not over 50 ° C heat.
Protect from direct sunlight.

6.5 Type and content of the container
Pack of 1 or 12 spray can (s) with 50 ml
Pack of 1 or 12 spray can (N) with 100 ml

6.6 Special precautions for elimination and other
Notes for handling do not spray into the eyes. Hold spray can with use perpendicular. Container is under pressure! Do not crack open or set fire to after using. Do not spray against flame or on glowing object. Keep away from sources of ignition - do not smoke.

7. owner of the authorization

cell pharm GmbH
Theodor Heuss-Str. 52
61118 Bad Vilbel
Telephone: 0 61 01/30 42-0
Fax: 0 61 01/30 42-11

8. Registration number

Glandosane: 6072896.00.00
Glandosanes aromatized: 6666733.00.00

9. Date of granting the approval / extension of the approval
July 28, 2003

10. Stand of information
This leaflet was recently revised in February 2014

11. Sales limited
Pharmacy

Source: Information of the leaflet
Status: 03/2017