Cetomacrogol cream (Formula A)

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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PIL PIL (PIL)
07-06-2018
SPC SPC (SPC)
07-06-2018

active_ingredient:

White soft paraffin; Cetostearyl alcohol; Macrogol cetostearyl ether 22; Liquid paraffin; Chlorocresol; Purified water

MAH:

Formula A) (Thornton & Ross Ltd

ATC_code:

n/a

INN:

White soft paraffin; Cetostearyl alcohol; Macrogol cetostearyl ether 22; Liquid paraffin; Chlorocresol; Purified water

dosage:

150mg/1gram ; 72mg/1gram ; 18mg/1gram ; 60mg/1gram ; 1mg/1gram ; 699mg/1gram

pharmaceutical_form:

Cutaneous cream

administration_route:

Cutaneous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 13010100; GTIN: 5011309140514

PIL

                                CETOMACROGOL CREAM BP 1988 FORMULA A
                                
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SPC

                                OBJECT 1
CETOMACROGOL CREAM BP 1988 FORMULA A
Summary of Product Characteristics Updated 03-Dec-2014 | Thornton &
Ross Ltd
1. Name of the medicinal product
Cetomacrogol Cream BP 1988 Formula A
2. Qualitative and quantitative composition
Macrogol Cetostearyl Ether 22 1.8% w/w
3. Pharmaceutical form
Cream.
4. Clinical particulars
4.1 Therapeutic indications
For external application for use as an emollient, and for use as a
diluent in medicinal external
preparations.
4.2 Posology and method of administration
Topical
Recommended dose and dosage schedule
To be used as prescribed by a registered medical practitioner or
counter prescribed by a registered
pharmacist.
The product is suitable for use by adults, children and the elderly.
Dosage: as prescribed by the medical practitioner or pharmacist.
4.3 Contraindications
Sensitivity to chlorocresol.
4.4 Special warnings and precautions for use
For external use only.
Keep all medicines away from children.
Store below 25°C. Do not allow to freeze.
The diluted cream should be used within 2 weeks of preparation.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Fertility, pregnancy and lactation
No special precautions regarding this vehicle.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard.
4.9 Overdose
Not applicable.
5. Pharmacological properties
5.1 Pharmacodynamic properties
The product has an emollient effect.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None.
6. Pharmaceutical particulars
6.1 List of excipients
Cetostearyl Alcohol
Chlorocresol
Liquid Paraffin
Paraffin White Soft
Water Purified
6.2 I
                                
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