Examples of using Fablyn in English and their translations into German
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
What is Fablyn?
Fablyn is intended for long-term use.
How is Fablyn used?
What is the risk associated with Fablyn?
What is Fablyn used for?
FABLYN does not eliminate the risk of breast cancer see section 5.1.
What benefit has Fablyn shown during the studies?
Fablyn was more effective than placebo at reducing the number of new fractures.
No dose adjustment for FABLYN is necessary in elderly patients.
Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients.
Due to the chronic nature of the disease process, FABLYN is intended for long-term use see section 5.1.
What FABLYN contains• The active substance is lasofoxifene.
Your doctor may also advise you to take Calcium andVitamin D supplements while you are treated with FABLYN if your daily intakes are not considered sufficient.
How has Fablyn been studied?
Safety and efficacy of lasofoxifene have not been evaluated in patients with severe renal insufficiency;therefore, FABLYN should be used with caution in these patients.
Why has Fablyn been approved?
FABLYN has no effect on the risk of ER negative breast cancer or ER negative invasive breast cancers.
The most serious adverse reaction related to FABLYN was VTE deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis.
FABLYN may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with estrogen deficiency.
Over the 5 years of the PEARL study(involving 8,556 patients), FABLYN treatment compared to placebo reduced the risk of invasive breast cancer by 85% placebo.
Fablyn must not be used in people who are hypersensitive(allergic) to lasofoxifene or any of the other ingredients.
The Marketing Authorisation Holder(MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with“ Pfizer” on one side and“ OPR 05” on the other.
The Marketing Authorisation Holder(MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Therefore FABLYN is unlikely to alter the pharmacokinetics of medicinal products that are cleared by metabolism via these CYP isoforms, or are transported by MDR1 P-glycoprotein.
No dose adjustment for FABLYN is necessary for patients with mild or moderate hepatic insufficiency.
FABLYN increases risk of venous thromboembolism(VTE).• The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE.• FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Clinical data indicate that FABLYN has an estrogen-like agonist effect on bone as well as antagonistic effects on the breast.
There was no difference between FABLYN- and placebo-treated women in the incidences of endometrial carcinoma and endometrial hyperplasia.
The concurrent use of FABLYN and systemic estrogen or hormone therapy has not been studied and therefore concomitant use of FABLYN with systemic estrogens is not recommended.