8
» Benign gestational trophoblastic disease (
proliferative disorders of the
reproductive system, non-cancerous diseases
),
» The period following childbirth (between 48 hours and 4 weeks),
» Ovarian cancer,
» High probability of exposure to infectious diseases such as AIDS,
gonorrhoea or chlamydia.
6.3. Relative contraindications
The use of the MelbeaGold product must be should be carefully considered
in the following cases:
» Heart valve diseases,
» Anemia, coagulation disorders (including the taking of anticoagulant
medication),
» Significant hyper- or dysmenorrhea (prolonged or painful menstruation),
» Cervical stenosis caused by scar tissue that renders insertion impossible,
» Bradycardia (cardiac arrhythmia associated with a low pulse), circulatory
disorders, vasovagal syncope (loss of consciousness due to hypotension
or heart failure),
» Undergoing treatment with an anti-inflammatory preparation,
» Wilson disease (a rare genetic disorder of the copper metabolism),
» Frequent change of sexual partners (either the patient or the patient’s
partner has multiple sexual partners),
» Conditions associated with increased susceptibility to pelvic infections,
» Women of childbearing potential who have not yet given birth (including
virgin women).
Taking the above into account, please inform your gynaecologist or
healthcare service provider if any one of the above health conditions
applies to you and if you have recently given birth or you are currently
breastfeeding.
7. WHAT WARNINGS SHOULD BE TAKEN INTO ACCOUNT WHILE
USING MELBEAGOLD?
– Your gynaecologist or health care service provider will give you a guide
titled “Information for women”.
Please carefully read and understand this guide.
– Please retain the “Information for women” guide and the “Patient Card”
filled out by your gynaecologist or health care service provider.
After you are given this card, please verify that all fields have been filled
out before leaving the medical facility.
– Medical devices are sometimes used for purposes not listed on the
information leaflet among the indications of the manufacturer or used
in spite of the existence of a relative contraindicated condition.
Please request further information from your gynaecologist or healthcare
service provider regarding the product details included in the user
instructions intended for medical professionals.
– MelbeaGold is a single-use device which comes in a sterile packaging;
the device must not be reused!
– The insertion and removal procedures may cause slight pain or bleeding.
The procedures may trigger fainting in the case of patients suffering
from circulatory disorders and seizures in the case of patients suffering
from epilepsy.
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