Product & Indication | Link to SmPC | Link to PIL |
Actos® and Competact® pioglitazone hydrochloride/metformin hydrochloride |
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Actos® (pioglitazone) is indicated as second or third line treatment of type 2 diabetes mellitus as described below:(1) as monotherapy as dual oral therapy in combination with: - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent rountine reviews that the benefit of pioglitazone is maintained. |
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Competact® (pioglitazone/metformin) is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.(2) After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.(2) |
Competact® 15 mg/850 mg film-coated tablets SmPC | Competact® 15 mg/850 mg film-coated tablets PIL |
Adcetris®▼ brentuximab vedotin |
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Adcetris® is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(3) Adcetris® is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT)(3) Adcetris® is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):(3) - following ASCT, or - following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option Adcetris® is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL)(3) Adcetris® is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy(3) |
Adcetris® 50 mg powder for concentrate for solution for infusion SmPC | Adcetris® 50 mg powder for concentrate for solution for infusion PIL |
Alofisel®▼ |
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Alofisel® is indicated for the treatment of complex perinal fistulae in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.(4) (Alofisel is marketed by Takeda UK under license from TiGenix)
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Alofisel® 5 million cells/mL suspension for injection SmPC | Alofisel® 5 million cells/mL suspension for injection PIL |
Alunbrig®▼ |
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Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. (5) |
Alunbrig ® tablets PIL | |
Amias® |
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Amias® is indicated for the:(6) - Treatment of essential hypertension in adults - Treatment of hypertension in children and adolescents aged 6 to <18 years - Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) when Angiotensin Converting Enzyme (ACE) inhibitors are not tolerated or as add-on therapy to ACE inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated
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Amias® tablets SmPC | Amias® tablets PIL |
Calcichew® & Calcichew® D3 |
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Calcichew® 500 mg Chewable Tablets are to be chewed as a supplement source of calcium in the correction of dietary deficiencies or when normal requirements are high. Calichew® 500 mg Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoorosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.(7) |
Calcichew®-500 mg chewable tablets SmPC | Calcichew®-500 mg chewable tablets PIL |
Calcichew® D3 Chewable Tablets should be used only as a therapeutic and not as a food supplement when the diet is deficient or when normal requirement of both components is increased. Calcichew® D3 Chewable Tablets may be used as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, in pregnant patients at high risk of needing such a therapeutic supplementation or in malnutrition when dietary intake is less than that required.(8) |
Calcichew® D3 chewable tablets SmPC | Calcichew® D3 chewable tablets PIL |
Calcichew® Forte Chewable Tablets are to be chewed as a supplement source of calcium in the correction of dietary deficiencies or when normal requirements are high. Calcichew® Forte Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.(9) |
Calcichew® Forte chewable tablets SmPC | Calcichew® Forte chewable tablets PIL |
Calcichew®-D3 1000 mg/800 IU Once Daily chewable tablets are indicated for: - Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.(10) |
Calcichew®-D3 1000 mg/800 IU once daily chewable tablets SmPC | Calcichew®-D3 1000 mg/800 IU once daily chewable tablets PIL |
Calcichew®-D3 500 mg/400 IU Film-coated Tablets are indicated for: - Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.(11) |
Calcichew®-D3 500 mg/400 IU cfilm-coated tablets SmPC | Calcichew®-D3 500 mg/400 IU film-coated tablets PIL |
Calcichew®-D3 Forte 500 mg/400 IU Chewable Tablets are indicated for: - The supplementation of Viatmin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia, and in other situations requiring therapeutic supplmentation of malnutrition.(12) |
Calcichew®-D3 Forte 500 mg / 400 IU chewable tablets SmPC | Calcichew®-D3 Forte 500 mg / 400 IU chewable tablets PIL |
Condyline® podophyllotoxin cutaneous solution |
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Condyline® cutaneous solution is indicated for the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.(13) |
Condyline® SmPC | Condyline® PIL |
Edarbi® azilsartan medoxomil potassium |
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Edarbi® is indicated for the treatment of essential hypertension in adults.(14)
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Edarbi® tablets SmPC | Edarbi® tablets PIL |
Entyvio® vedolizumab |
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Entyvio® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis or moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.(15) |
Entyvio® 300 mg powder for concentrate for solution for infusion SmPC | Entyvio® 300 mg powder for concentrate for solution for infusion PIL |
Instanyl® fentanyl citrate nasal spray |
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Instanyl® is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.(16)
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Instanyl® 50 mcg/dose nasal spray, solution in single-dose container SmPC Instanyl® 100 mcg/dose nasal spray, in single solution container SmPC Instanyl® 200 mcg/dose nasal spray, in single solution container SmPC |
Instanyl® 50 mcg/dose nasal spray PIL |
Matrifen® fentanyl transdermal patches |
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Matrifen® transdermal patches are indicated in adults for:(17) - Severe chronic pain that requires continuous long term opioid administration And in children for:(17) |
Matrifen® SmPC | Matrifen® PIL |
Mepact® mifamurtide |
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Mepact® is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.(18) |
Mepact® 4 mg powder for suspension for infusion SmPC | Mepact® 4 mg powder for suspension for infusion PIL |
Ninlaro®▼ |
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Ninlaro® in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.(19) |
Ninlaro® 2.3 mg hard capsules SmPC |
Ninlaro® 2.3 mg hard capsules PIL Ninlaro® 3 mg hard capsules PIL Ninlaro® 4 mg hard capsules PIL
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Protium® IV & Pantoprazole gastro-resistant tablets pantoprazole sodium sesquihydrate |
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Pantoprazole 20 mg gastro-resistant tablets are indicated in adults and adolescents 12 years of age and above for the treatment of:(20) - Symptomatic gastro-oesophageal reflux disease And in adults for the:(20) - Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment |
Pantoprazole® 20 mg gastro-resistant tablets SmPC | Pantoprazole® 20 mg gastro-resistant tablets PIL |
Pantoprazole 40 mg gastro-resistant tablets are indicated in adults and adolescents 12 years of age and above for the treatment of:(21) And in adults for the: - Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers |
Pantoprazole® 40 mg gastro-resistant tablets SmPC | Pantoprazole® 40 mg gastro-resistant tablets PIL |
Protium® i.v. 40 mg powder for solution for injesction is indicated for adults for the treatment of: (22) - Reflux oesophagitis |
Protium® 40 mg i.v. powder for solution for injection SmPC | Protium® 40 mg i.v. powder for solution for injection PIL |
Prostap® SR DCS and Prostap® 3 DCS leuprorelin acetate |
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Prostap® SR DCS and Prostap® 3 DCS are indicated for:(23) - Metastatic prostate cancer - As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer - As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression - As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer - Management of endometriosis, including pain relief and reduction of endometriotic lesions - Treatment of central precocious puberty in girls under 9 years of age and boys under 10 years of age |
Prostap® 3 DCS SmPC | Prostap® 3 DCS PIL |
In addition, Prostap® SR DCS is also indicated for:(24) - Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection - Preoperative management of uterine fibroids to reduce their size and associated bleeding |
Prostap® SR DCS SmPC | Prostap® SR DCS PIL |
TachoSil® sealant matrix human fibrinogen and human thrombin medicated sponge |
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TachoSil® is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.(25) |
TachoSil® sealant matrix SmPC | TachoSil® sealant matrix PIL |
Vipdomet® alogliptin benzoate and metformin hydrochloride |
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Vipdomet® is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus: - In combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone - In combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control(26) |
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Vipidia® |
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Vipidia® is indicated in adullts aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.(27)
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Vipidia® 6.25mg film-coated tablets SmPC |
Vipidia® 6.25mg film-coated tablets PIL |
Please refer to the Summary of Product Characteristics for details on the full side-effect profile and drug interactions of the medicines refered to above. Adverse events should be reported. Reporting forms and information can be found at https:yellowcard.mhra.gov.uk/ |
"The black triangle denotes that additional monitoring is required in relation to adverse reactions. This allows quick identification of new safety information."
References
1. Actos® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
2. Competact® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
3. Adcetris®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
4. Alofisel®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
5. Alunbrig®▼Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
6. Amias® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
7. Calcichew® 500 mg Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
8. Calcichew® D3 Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
9. Calcichew® Forte Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
10. Calcichew® D3 1000 mg/800 IU Once Daily chewable tablets Summary of Product Characteristics, Takeda UK Limited . Available from www.medicines.org.uk. Last accessed May 2019
11. Calcichew® D3 500 mg/400 IU film-coated tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
12. Calcichew® D3 Forte Chewable Tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
13. Condyline® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
14. Edarbi® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
15. Entyvio® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019
16. Instanyl® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
17. Matrifen® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
18. Mepact® Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
19. Ninlaro®▼ Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019
20. Pantoprazole 20 mg gastro-resistant tablets Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
21. Pantoprazole 40 mg gastro-resistant tablets Summary of Product Characteristics, Takeda UK Limited. Available www.medicines.org.uk. Last accessed May 2019
22. Protium® IV Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk.
Last accessed May 2019
23. Prostap® SR DCS Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
24. Prostap® 3 DCS Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
25. TachoSil® sealant matrix Summary of Product Characteristics, Takeda UK Limited. Available from www.medicines.org.uk. Last accessed May 2019
26. Vipdomet® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019
27. Vipidia® Summary of Product Characteristics, Takeda UK Ltd. Available from www.medicines.org.uk. Last accessed May 2019
UK/WBC/1707/0007c(3) Date of Preparation: May 2019