1. Name Of The Medicinal Product
Balneum Plus Cream
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Cream.
A white smooth cream.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.
4.2 Posology And Method Of Administration
Adults, the elderly and children: Balneum Plus Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response. For external use only.
4.3 Contraindications
Patients with known hypersensitivity to any of the ingredients. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.
4.4 Special Warnings And Precautions For Use
Balneum Plus Cream may cause irritation if applied to broken or inflamed skin.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
For Balneum Plus Cream no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
Balneum Plus Cream has been reported to cause a burning sensation, erythema, pruritus or the formation of pustules, aggravation of eczema if applied to inflamed skin areas. Contact allergy has also been reported.
4.9 Overdose
Not applicable
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Antipruritics incl. antihistamines, anaesthetics etc.
ATC code: D 04 AX
Urea is a physiological product derived from human protein metabolism. It is found naturally in the skin and when applied topically it can increase the horny layer's capacity to retain water. Balneum Plus Cream has been shown to increase skin hydration and when used as recommended provides hydration for 24 hours.
Patients with eczema and psoriasis have been shown to have decreased levels of urea in their skin. Urea is not allergenic and is well-tolerated at a concentration of 5%.
Lauromacrogols have the properties of a topical anaesthetic and have an antipruritic effect. The local tolerability of lauromacrogols is good.
Balneum Plus Cream has also been shown to increase the lipid content of the epidermis thus soothing and smoothing the skin.
After twice-daily application for 4 weeks to non-infected eczematous lesions, in addition to an improvement in the clinical condition, use of Balneum Plus Cream was associated with a significant reduction in total bacteria and Staph. aureus counts. A reduction in Staph. aureus count (p2) to Day 29 (11.8 organisms/cm2). However, no bactericidal or bacteriostatic effects have been tested for.
5.2 Pharmacokinetic Properties
Little urea is absorbed after topical application. It is mainly excreted in the urine, and to a lesser extent in perspiration.
There is no evidence of systemic availability of lauromacrogols after topical administration.
5.3 Preclinical Safety Data
No specific studies have been performed with Balneum Plus Cream. Urea and lauromacrogols have been used therapeutically for many years in humans. Information from animal studies are unlikely to provide any further relevant information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Dimethicone
Phenyl dimeticone
Liquid paraffin
Cetylpalmitate
Stearic palmitic acid
Octyldodecanol
Glycerol 85%
Polvsorbate
Carbomer
Trometamol
Benzyl alcohol
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Aluminium tubes with double internal lacquer of epoxy phenol resin and closure made of polyethylene. Content: 10g, 35g, 50g, 75g and 100g.
Plastic pump dispensers. Content: 175g, 180g, 185g, 190g, 200g and 500g.
6.6 Special Precautions For Disposal And Other Handling
No special requirements
7. Marketing Authorisation Holder
Almirall Hermal GmbH
Scholtzstrasse 3
Postfach 1228 Reinbek
Hamburg
D-21465
Germany
8. Marketing Authorisation Number(S)
PL 33016/0010
9. Date Of First Authorisation/Renewal Of The Authorisation
31st July 1998
10. Date Of Revision Of The Text
06th October 2010
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