RECREOL Cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
RECREOL 50 mg/g cream.
Qualitative and quantitative composition
1 g cream contains 50 mg of dexpanthenol (Dexpanthenolum). Excipient(s) with known effect: 15 mg propylene glycol, 13 mg wool fat, 24 mg cetyl alcohol and 16 mg stearyl alcohol. For the full list of excipients, ...
Pharmaceutical form
Cream. Homogenous white or yellowish cream with specific odour.
Therapeutic indications
Supportive treatment of superficial skin lesion (such as small burns and lacerations, skin abrasions and cracking), skin inflammation (resulting from exposure of radiation therapy, phototherapy or ultraviolet ...
Posology and method of administration
Posology Dexpanthenol should be applied topically one to several times a day. Paediatric population Dexpanthenol can be used in pediatric population. Patients with renal and hepatic impairment No studies ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Dexpanthenol is contraindicated on wounds in patients with haemophilia because of risk of severe bleeding. ...
Special warnings and precautions for use
Accidental contact of dexpanthenol with the eyes should be avoided. Dexpanthenol should be discontinued if signs of hypersensitivity occur during use. Patients should be instructed to consult a doctor ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have not been performed with dexpanthenol. There are no known interactions. There is no evidence that topical dexpanthenol interacts with any medicine.
Fertility, pregnancy and lactation
Pregnancy The possible effect of dexpanthenol on reproduction was not studied. There is no data on the use of dexpanthenol in pregnant women. Animal studies do not indicate direct or indirect harmful effects ...
Effects on ability to drive and use machines
Dexpanthenol has no effects on ability to drive and use machines.
Undesirable effects
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), ...
Overdose
No data concerning overdose in humans are available. Even in case of unconventional use of excessive dexpanthenol amounts it has low systemic toxicity and causes no undesirable effects that would be dangerous ...
Pharmacodynamic properties
Pharmacotherapeutic group: preparations for treatment of wounds and ulcers, other cicatrizants ATC code: D03AX03 Dexpanthenol is converted in tissues to pantothenic acid, a component of coenzyme A (CoA) ...
Pharmacokinetic properties
Absorption Dexpanthenol rapidly absorbed into the skin, is immediately converted to pantothenic acid, which is widely distributed into body tissues, mainly as coenzyme A. Distribution After topical applications ...
Preclinical safety data
Single-dose toxicity In animals, young rats fed 50mg=day as calcium pantothenate for 190 days had no adverse effects. When bred, their offspring were maintained using the same diets with no signs of abnormal ...
List of excipients
DL-pantolactone Phenoxyethanol Potassium cetyl phosphate Wool fat Propylene glycol Stearyl alcohol Cetyl alcohol Isopropyl myristate Purified water
Incompatibilities
There is no information regarding possible incompatibilities.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions. Do not freeze.
Nature and contents of container
30 g or 50 g of cream in aluminium tube, interior lacquered with epoxy phenolic coating, and with sealing compound in the fold. Tube is closed with an aluminium membrane and fitted with a white HDPE screw ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
AS GRINDEKS., Krustpils iela 53, Rīga, LV-1057, Latvia, Tel.: +371 67083205, Fax: +371 67083505, E-mail: grindeks@grindeks.lv
Date of revision of the text
02/2017
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