Examples of using Oracea in English and their translations into Swedish
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Medicine
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Official/political
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Computer
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Political
ORACEA 40 mg modified-release hard capsules.
Should not be taken until at least 2 hours after ORACEA.
Take special care with ORACEA Inform your physician.
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea.
ORACEA may make certain antibiotics,
These medicines may reduce the effectiveness of ORACEA if taken at the same time.
ORACEA and certain other medications may not work properly when taken together.
heartburn may also reduce the effectiveness of ORACEA and.
ORACEA is indicated to reduce papulopustular lesions in adult patients with facial rosacea.
Important information about some of the ingredients of ORACEA ORACEA contains sugar sucrose.
active treatments were not practical or warranted, in the case of Oracea.
If these manifestations appear during the course of the treatment Oracea should be discontinued and the patient should be referred to an ophthalmologist.
Oracea, 40 mg, modified release capsules is an antibiotic(doxycycline),
Consequently, the CHMP considered the clinical efficacy of Oracea to be sufficiently demonstrated in the two placebo-controlled phase 3 studies
positive effect on erythema, there are no indications of any risk of worsening of erythema during Oracea therapy.
However, it can not be excluded that long-term use of Oracea can lead to emergence of resistant intestinal bacteria such as Enterobacteriaceae and enterococci, as well as to enrichment of resistance genes.
the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio.
The Applicant was also requested to revise the SPC for Oracea, in sections 4.4 and 5.1 due to the lack
the fact that all Phase 3 studies indicate that Oracea is well tolerated
In addition, the preliminary results of a study comparing Oracea(40 mg doxycycline) to 100 mg doxycycline daily, both in conjunction with topical metronidazole, support the non-inferiority hypothesis of the Oracea dosing regimen.
upper respiratory microflora associated with the long- term use of Oracea.
The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006.
for doxycycline(100 mg daily), which would present additional challenges studying two unapproved drugs(100 mg doxycycline and Oracea) in one clinical trial.
Thus, the CHMP considers that the benefits of marketing a systemic drug such as Oracea in the present indication outweighs the risk for potential harmful effects related to resistance development and therefore consider the
upper respiratory microflora associated with the long-term use of Oracea, and commit to submitting a study protocol within 3 months of approval.
pharmacokinetic data indicate that Oracea(40 mg doxycycline daily)
than the proposed dosage for Oracea 40 mg daily.
Finally, the CHMP also acknowledged the difficulty in breaking down the different subgroups of rosacea since symptoms often overlap between the different subtypes and recognised that Oracea is aimed towards the treatment of papules
showing that Oracea, given as an adjunct to metronidazole,
was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics,