Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium sulfate dried; Glycerol; Phenol
KL Pharmaceutical Ltd
D11AX05
Magnesium sulfate dried; Glycerol; Phenol
450mg/1gram ; 550mg/1gram ; 5mg/1gram
Cutaneous paste
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100500
PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 632344 12729 Change spelling of "sulphate" to "sulfate" at request of licence holder. MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Landscape peelable label 50g 21566809 35mm x 110mm 2 10.02.2016 Process Cyan Process Magenta Process Yellow Process Black Keyline (non-printing) Braille Text free area (non-printing) Magnesium Sulfate Paste BP Helvetica OCRB Print free area (non-printing) FRONT PLY FRONT REVERSE PLY BOTTOM PLY MAGNESIUM SULFATE PASTE BP (MAGNESIUM SULFATE, PHENOL) A DRAWING PASTE TO HELP TREAT MINOR SKIN INFECTIONS, INCLUDING BOILS AND REDUCE SWELLING READ ALL THE LEAFLET BEFORE USE. PEEL WHERE SHOWN. Stir paste well before use. Apply it to the skin. ADULTS, ELDERLY AND CHILDREN: Apply liberally to the affected area and cover with a clean dressing. Do not use repeatedly. If symptoms persist talk to your doctor. FOR EXTERNAL USE ONLY. PEEL WHERE SHOWN FOR PRECAUTIONS. ACTIVE INGREDIENTS: Dried Magnesium Sulfate 47.76% w/w, Phenol 0.49% w/w. ALSO CONTAINS: glycerol (E422). MA holder and manufacturer: KL Pharmaceutical Ltd., Irvine, Ayrshire KA11 4HP. Distributor: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. Do not store above 25˚C. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. PL 03436/0002 21566809 The ingredients in Magnesium Sulfate Paste help to draw puss from minor skin infections including boils and so reduce swelling. 1. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU HAVE…. • An ALLERGY to any of the ingredients listed on the front. PREGNANT OR BREASTFEEDING…. Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. 2. POSSIBLE SIDE EFFECTS There are no known side effects from using this medicine as directed. If you notice any side effects, stop use and tell your doctor or pharmacist. They will te Preberite celoten dokument
1. TRADE NAME OF THE MEDICINAL PRODUCT Magnesium Sulfate Paste BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Name of ingredient Quantity Dried Magnesium Sulfate 47. 762g Phenol 0.497g For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Paste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct to the management of superficial skin infections, including boils. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, elderly and children Apply to the affected area as required. There is no difference in the quantity required for affected areas or for children, adults or the elderly. Stir well before use and apply liberally to the affected area. Cover with a dressing. Method of Administration For topical application 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Do not use repeatedly. 4.5. INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION No significant clinical interactions known. 4.6 FERTILITY, PREGNANCY AND LACTATION As with all medicines it may be used during this period if the benefits outweigh the risks. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 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 Should accidental ingestion occur, treat symptomatically. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic Group: Other Dermatologicals, Magnesium Sulfate ATC code: D11A X05 Topical application of the ingredients of the paste help to draw infected wounds and reduce inflammation. 5.2. PHARMACOKINETIC PROPERTIES Not applicable. 5.3. PRE Preberite celoten dokument