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AKIS is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Akis Solution for Injection is effective in acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures, and post-operative pain (see section 4.3 and 4.4). Akis is indicated in adults. Use in children and adolescents is not…
Verbatim from this product's MHRA label. Tap a section to expand.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section
Clinical trials The most common undesirable effects observed during clinical trials with AKIS are gastrointestinal in nature or injection site reactions which are generally mild and transitory. Clinical trial data suggest that the use of diclofenac injectable solution is associated with injection site reactions, such as: pain and haematoma.
The frequency of injection site adverse events was significantly lower at the 25 and 50 mg dose than at the 75 mg dose. After administering diclofenac the following have also been reported: nausea, vomiting, diarrhoea and constipation.
The undesirable effects are presented below according to MedDRA System Organ Class classification (SOC) and frequency of observation, in accordance with the following convention: very common (≥1/10); common (≥1/100 - <1/10); uncommon (≥1/1000 - <1/100); rare (≥1/10000 - <1/1000); very rare (<1/10000), not known (cannot be estimated from the data available).
Body system Frequency Adverse Drug Reaction Infection and infestations Not known Injection site necrosis Nervous system disorders Uncommon Dizziness Headache Gastrointestinal disorders Common Uncommon Not known Nausea Diarrhoea Vomiting Constipation Gastritis Ischaemic colitis Hepatobiliary disorders Uncommon Hepatic enzymes increase Skin and subcutaneous tissue disorders Uncommon Pruritus General disorders and administration site conditions Very common Injection site reactions The most appropriate MedDRA term is listed to describe a certain reaction.
Synonyms or related conditions are not listed, but should be taken into consideration as well. Class effects Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.
4 Special warning sand precautions for use). Posology Adults AKIS Solution for Injection can be administered intramuscularly or subcutaneously. AKIS is for short-term treatment only and should not be given for more than two days. For mild and moderate grades of pain a lower dose may be sufficient.
A dose of 75 mg may be needed for severe pain such as renal colic. Exceptionally and in severe cases a second dose of 75 mg can be administered after 6 hours. A dose of 150 mg must not be exceeded within any 24 hour period. If more than one daily injection of AKIS is required, (up to a maximum, daily dose of 150 mg) it is advisable to change the injection area for subsequent injections.
If necessary, one injection of AKIS can be used with other dosage forms of diclofenac up to the maximum daily dosage of 150mg. 2). If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.
The patient should be monitored regularly for GI bleeding during NSAID therapy. The recommended maximum daily dose of AKIS Solution for Injection is 150 mg. Patients with renal impairment Hydroxypropyl-β-cyclodextrin (HPβCD), an excipient in AKIS Solution for Injection, is mainly eliminated through glomerular filtration.
Therefore, patients with severe renal impairment (defined as creatinine clearance below 30 ml/min) should not be treated with AKIS Solution for Injection. 2). In patients with renal impairment the lowest effective dose should be used.
Paediatric population The safety and efficacy of AKIS Solution for Injection in children aged 0-18 years has not been established. Method of administration AKIS Solution for Injection should only be administered by a healthcare professional.
It can be administered intramuscularly or subcutaneously into clean healthy tissue. g. a single 75 mg injection rather than a 25mg and a 50 mg injection or a 50mg injection rather than two 25 mg injections. Intramuscularly The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve or other tissue at the injection site.
• Known hypersensitivity to the active substance or to any of the excipients. • Active gastric or intestinal ulcer, bleeding or perforation • History of gastrointestinal bleeding or perforation related to previous NSAID therapy. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
4). • Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs. • Haemostasis disorders or current anticoagulant treatment (for intramuscular route of administration only).
• Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The following undesirable effects include those reported with either short-term or long-term use. Table 1 Blood and lymphatic system disorders Very rare Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), Agranulocytosis.
Immune system disorders Rare Very rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Angioneurotic oedema (including face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders Common Rare Very rare Headache, dizziness. Somnolence. Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident. Eye disorders Very rare Visual disturbance, vision blurred, diplopia.
Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired. Cardiac disorders Very rare Palpitations, chest pain, cardiac failure, myocardial infarction. Vascular disorders Very rare Hypertension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare Very rare Asthma (including dyspnoea).
Pneumonitis. Gastrointestinal disorders Common Rare Very rare Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer (with or without bleeding or perforation).
Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, Stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary disorders Common Rare Very rare Transaminases increased. Hepatitis, jaundice, liver disorder. Fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders Common Rare Very rare Rash. Urticaria.
Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura , allergic purpura, pruritus.
Renal and urinary disorders Very rare Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. General disorders and administration site conditions Common Rare Injection site reaction, injection site pain, injection site induration Oedema Injection site necrosis.
Infections and infestations Very rare Injection site abscess. 4 for Contraindications and Special warnings and special precautions for use). 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. uk/yellowcard.
A deep intragluteal injection into the upper outer quadrant of the buttock must be administered. If two injections daily are required, it is advised that the alternative buttock be used for the second injection. The product should be injected slowly to minimise local tissue damage.
Subcutaneously The injection must be administered into the subcutaneous tissue, preferably in the upper part of the gluteus or in the upper part of the thigh. If two injections daily are required, it is advisable to rotate the injection area between the gluteus and the thigh.
The needle must be fully introduced into the thickness of the skin fold which forms between the thumb and the index finger. Care should be taken to ensure that a blood vessel has not been entered. The product should be injected slowly and at a steady rate.
Keep the skin folded between the fingers during injection. ) administration. 6 for instructions for use and handling. 3 Contraindications • Known hypersensitivity to the active substance or to any of the excipients. • Active gastric or intestinal ulcer, bleeding or perforation • History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). 4). • Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
• Haemostasis disorders or current anticoagulant treatment (for intramuscular route of administration only). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
2 and GI and cardiovascular risks below). The concomitant use of Diclofenac with systemic NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.
Caution is indicated in the elderly on the basis of medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug.
Like other NSAIDs, Diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties. The instructions for intramuscular injection should be strictly followed in order to avoid adverse events at the injection site, which may result in muscle weakness, muscle paralysis, hypoaesthesia and injection site necrosis.
Gastrointestinal effects Gastrointestinal bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving Diclofenac, the medicinal product should be withdrawn. As with all NSAIDs, including Diclofenac, […]