国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Liquid paraffin
Pinewood Healthcare
A06AA01
Liquid paraffin
1ml/1ml
Oral liquid
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060300
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 557482 11927 Addition of "reporting of side effects" statement. MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Landscape peelable label 150ml 21590007 42mm x 150mm 2 16.02.2015 Process Cyan Process Magenta Process Yellow Process Black Keylines (Does not print) Text Free Area (Does not print) Braille Liquid Paraffin Care Outlined _Data Matrix:_ _21590007_ Braille reads: Braille Warning! MPS cannot accept responsibility for any errors in this proof after approval by the customer. Whilst extreme care is taken in the setting of Braille, the customer must take the final responsibility for its accuracy. There is no single European Braille authority and there are many different Braille formats in existence, with country specific characters. This Braille is set to the Marburg Medium format unless you have requested otherwise. When you sign this proof you are signifying full approval of the Braille text and specification. 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Liquid Paraffin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Liquid Paraffin 100% v/v. 3. PHARMACEUTICAL FORM Liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the temporary relief of constipation. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral Recommended doses and dosage schedules: Adults including the elderly: 10-30ml when required. Children over 3 years: 5-20ml when required. Children under 3 years: not recommended. 4.3. CONTRA-INDICATIONS Use is contraindicated in children under 3 years of age. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Avoid prolonged use. Consult your doctor if laxatives are needed every day, if you have persistent abdominal pain or have a condition which makes swallowing difficult. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION There may be interference with the absorption of fat soluble vitamins. 4.6. PREGNANCY AND LACTATION As with all medicines avoid during early pregnancy and lactation. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS Anal seepage of paraffin with consequent anal irritation after prolonged use. Granulomatous reaction caused by absorption of small quantities of liquid paraffin. Lipoid pneumonia (by accidental inhalation) may occur, therefore caution is required in patients with swallowing difficulty. 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 If large doses are ingested withdraw medication. Supportive treatment may be required. 5. PHARMACOLOGICAL PROPERTIES 5.1. PHARMACODYNAMIC PROPERTIES Liquid paraffin acts as a lubricant and penetrates and softens the stools. 5.2. PHARMACOKINETIC PROPERTIES 阅读完整的文件