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ESTRING Vaginal delivery system (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Estring 7.5 microgram/24 hours, vaginal delivery system.

Qualitative and quantitative composition

Each vaginal ring contains: Estradiol Hemihydrate 2.0 mg, corresponding to 1.94 mg estradiol. Each ring releases estradiol at an average amount of 7.5 microgram per 24 hours, over a period of 90 days. ...

Pharmaceutical form

Vaginal delivery system. A slightly opaque ring, made of a silicone elastomer, with a whitish core, containing a drug reservoir of Estradiol Hemihydrate. The product has the following dimensions. Outer ...

Therapeutic indications

Treatment for atrophic vaginitis, (due to oestrogen deficiency) in postmenopausal women.

Posology and method of administration

ESTRING vaginal delivery system is an oestrogen-only product for vaginal use. Adults including elderly people (≥65 years old) One ring to be inserted into the upper third of the vagina. Once inserted it ...

Contraindications

Known, past or suspected breast cancer. Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or ...

Special warnings and precautions for use

For the treatment of postmenopausal symptoms, Hormone Replacement Therapy (HRT) should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks ...

Interaction with other medicinal products and other forms of interaction

As the oestrogen is administered within the vagina and due to the low levels released, it is unlikely that any clinically relevant drug interactions will occur with ESTRING vaginal delivery system. However, ...

Pregnancy and lactation

Pregnancy ESTRING is not recommended during pregnancy and in women of childbearing potential. If pregnancy occurs during medication with ESTRING vaginal delivery system treatment should be withdrawn immediately. ...

Effects on ability to drive and use machines

ESTRING has no or negligible influence on the ability to drive and use machines.

Undesirable effects

See also section 4.4. Adverse reactions due to local therapy with ESTRING which were reported in ESTRING clinical trials with a frequency of 1/1000 or more, or were reported as post-marketing experience ...

Overdose

ESTRING is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.

Pharmacodynamic properties

Pharmacotherapeutic group: Natural and semisynthetic oestrogens, plain ATC Code: G03CA03 Treatment of vaginal oestrogen deficiency symptoms Vaginally applied oestrogen alleviates the symptoms of vaginal ...

Pharmacokinetic properties

The pharmacokinetic properties of estradiol in humans are well known and depend, in large part, on the extent to which estradiol is taken up by the systemic circulation. The clinical effects of ESTRING ...

Preclinical safety data

The toxicity profile of estradiol is well known. There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC Studies on the silicone ...

List of excipients

Silicone elastomer Q7-4735 A Silicone elastomer Q7-4735 B Silicone fluid Barium sulfate

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Each ring is individually packed in a heat-sealed rectangular pouch consisting of, from outside to inside: Polyester/Aluminium foil/Low density Poly-ethylene. Each pouch is provided with a tear-off notch ...

Special precautions for disposal and other handling

After use the ring still contains some of the active hormonal ingredient, which may be harmful to the environment. Therefore, the used ring should be placed within the original pouch or a plastic bag, ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/1424

Date of first authorization / renewal of the authorization

29/07/2013 / 10/07/2018

Date of revision of the text

02/2019

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