Protect from light. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. /NonFullScreenPageMode /UseNone C, Is likely to be glutathione depleted e.g. It is excreted in the urine, mainly as the glucuronide and sulfate conjugates. Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available. 1 0 obj Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). %PDF-1.7 "���MG�(g�2�7��{�X!�[hq 4�]���D��")t�c-`�t�"��ɸ����ܟ{�j�p����4�����*2@� (\ߗX��ԫs��1y�&���[y�A��4/�2ni=�*��� ʉp� WB4����*#z��FJ���Ȋ����}0 [�6��DŽE_7��bo�_�3��Y�N�ed����E{�J�dց�g�� ����M4���vP/�s�!a�T )�=�����_�N8jx#s� ��e�Xi`� When suggestions are available use up and down arrows to review and ENTER to select. /PageMode /UseNone PE tablet container with a child-resistant PP closure. 0000010204 00000 n
Store below 25°C in a dry place. /Type /Catalog �zWk :a��{ߦ�L���v:
�@���4����j5��� �ah�.�B��8D�m��8��Qٙ},ZQ��fZrB�)?�5q�e�Y ?C��{��K�(HEs:f�0��ru?y0�L���l��'m]s)E.q��ԑ �W}�ap�D�_Rʑ�� Date of first authorisation/renewal of the authorisation. Safety Data Sheets (SDSs) containing safety information for the complete catalog of USP Reference Standards are available from this online searchable index. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. 0000008056 00000 n
/ViewerPreferences << Keep out of the reach and sight of children. 4.8 Undesirable effects. • Anticoagulants - the effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. No. trailer
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Immediate treatment is essential in the management of paracetamol overdose. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. {�4��U
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SAFETY DATA SHEET PROTECTIVE EQUIPMENT AND Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Immediate medical advice should be sought in the event of an overdose, even if you feel well. 5 0 obj 0000001544 00000 n
PARACETAMOL This substance was considered by a previous working group, in 1989 (IARC, 1990). If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. 0000003593 00000 n
Do not take with any other paracetamol-containing products. 0000004646 00000 n
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Care is advised in the administration of paracetamol to patients with alcohol dependency (see section 4.9), severe renal or severe hepatic impairment. There have been reports of blood dyscrasias including thrombocytopenia, neutropenia, pancytopenia, leukopenia and agranulocytosis but these were not necessarily causality related to Paracetamol. Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. The effectiveness of the antidote decines sharply after this time. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg. /Filter [ /FlateDecode ] Last Revision: 11/2018 IBUPROFEN, USP Page 2 of 8. >> When you use these standards together, you know you’re gaining value beyond the vial. This information is intended for use by health professionals. Cardiac arrhythmias and pancreatitis have been reported. Paracetamol has analgesic and antipyretic actions similar to those of aspirin and hence is a suitable alternative for patients sensitive to aspirin. 0000009709 00000 n
0000002280 00000 n
• Imatinib - restriction or avoidance of concomitant regular paracetamol use should be taken with imatinib. Latest Standards Updates. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. 0000004978 00000 n
Management should be in accordance with established treatment guidelines, see BNF overdose section. <]>>
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause tissue damage. x��X[s�}�W�#S�-����&a�>�L6[yQ@����lfR�?~[6&`9�RS��>}t�ݒl����s\���C���_V7=cC����0t����K{? 0000004379 00000 n
Abnormalities of glucose metabolism and metabolic acidosis may occur. Exposure Data 1.1 Chemical and physical data 1.1.1 Nomenclature Chem. 1.
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Liver damage is possible in adults who have taken 10g or more of Paracetamol. /Length 2110 �o�� �e�qh�T���^���»�V�OQ>� G��u��8��L?����Ad%=k�K�C�n �ď�]C�b2��c�?��M�J�oIT"~�B4�Z����2�煉�?�`�������r>��.S�a���h���S14.��� In severe poisioning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death.
Mallinckrodt also offers a line of direct compression Acetaminophen products, known as Compap™, that offer a unique particle size advantage to facilitate blending with other active pharmaceutical ingredients. 1) For the relief of mild to moderate pain and febrile conditions, eg headache, toothache, colds, influenza, rheumatic pain and dysmenorrhoea. Liver damage may become apparent 12 to 48 hours after ingestion. To email a medicine you must sign up and log in. Safety Data Sheets (SDSs) for pharmaceutical products can be accessed by utilizing our pharmaceutical product listing tool and clicking on the product page for which you are interested in obtaining a Safety Data Sheet (SDS). Important alcohol-based hand sanitizer information. 0000004901 00000 n
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Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. Abstr. Adults including the elderly and children over 16 years: One to two tablets every 4-6 hours as required, to a maximum of 8 tablets daily in divided doses. Compliant with BS8404. Pharmacotherapeutic group: Other analgesics and antipyretics, Anilides. _]�>L����K�F�����^�$3{^�����rDl�|�ѝe���O�"/g[�C%O����]��ڢ :Jn�\�Mh�Uγ�Ӎ�Lxx����_������7���&)�J�k�,�����J�}l��¯X�5��ho0ҽ@H��1?
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/Pages 2 0 R B, Regularly consumes ethanol in excess of recommended amounts. /PageLayout /SinglePage Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with our primary reference standards. 0000002794 00000 n
0000001680 00000 n
PRECAUTIONS FOR FIREFIGHTERS Dust explosion properties: Kst: 200 - 300 bar.m/s St class: 2 Minimum ignition energy (MIE) – dust cloud : 3 - 5 mJ NOTES SECTION 6: ACCIDENTAL RELEASE …
Children under 10 years: Not recommended for children under 10 years of age. Paracetamol has analgesic and antipyretic properties but it has no useful anti-inflammatory properties. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit. 0000000795 00000 n
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It allows continued monitoring of the benefit/risk balance of the medicinal product. << 4.7 Effects on ability to drive and use machines. To bookmark a medicine you must sign up and log in. �8V�#�nl��UB �a(!�
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If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. 0000002013 00000 n
(Product Licence of Right issued: Pre 1974), Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK.
0000010423 00000 n
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. %%EOF
It is metabolised in the liver. 0000000016 00000 n
Product may also be supplied in bulk hospital packs for reassembly, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Continue, 2. Available published data do not contraindicate breast feeding. 0000007041 00000 n
Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. Paracetamol is readily absorbed from the gastrointestinal tract. The elimination half-life varies from about 1 to 4 hours. • Metoclopramide – may increase speed of absorption of paracetamol. Ingestion of 5g or more of Paracetamol may lead to liver damage if the patient has risk factors (see below). Compliant with ISO8317. eating disorders, cystic fibrosis, HIV, starvation, cachexia. Paracetamol is excreted in breast milk but not in a clinically significant amount.
Available published data do not contraindicate breast feeding.
None known. In such cases, the use of analgesics should be discontinued in consultation with the doctor. Child-resistant blister pack: (i) 250µm white rigid PVC (ii) 9µm soft aluminium / 35g/m2 glassine paper. stream 0000002146 00000 n
Paracetamol's effects are thought to be related to inhibition of prostaglandin synthesis. Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 0
Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Since that time, new data have become available, and these have been incorporated into the monograph and taken into consideration in the present evaluation. USP–NF 2021, Issue 1 Commentary (posted 02–Nov–2020) Five New Revision Bulletins((posted 30–Oct–2020) One New General Chapter Prospectus (posted 25–Sep–2020) One New Publication Announcement (posted … Paracetamol is distributed into most body tissues. Read more.