Depo-Provera 150mg/1ml suspension for injection pre-filled syringes

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Medroxyprogesterone acetate

から入手可能:

Pfizer Ltd

ATCコード:

G03AC06

INN（国際名）:

Medroxyprogesterone acetate

投薬量:

150mg/1ml

医薬品形態:

Suspension for injection

投与経路:

Intramuscular

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 07030202; GTIN: 5012882002381

情報リーフレット

DP 9_0
Page 1 of 20
Pfleet no: 2015-0011402
PFIZER
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPO-PROVERA
® 150 MG/ML
STERILE SUSPENSION FOR INJECTION
Medroxyprogesterone acetate
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor, nurse or
healthcare provider.
This includes any possible side effects not listed in this leaflet.
See section 4.
IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT DEPO-PROVERA
DEPO-PROVERA IS A VERY EFFECTIVE INJECTABLE CONTRACEPTIVE WHICH GIVES
12 WEEKS
CONTINUOUS CONTRACEPTION WITH EACH INJECTION. THE EFFECT IS NOT
REVERSIBLE ONCE THE
INJECTION IS GIVEN.

You must have injections of this contraceptive regularly every 12
weeks; otherwise
you may risk becoming pregnant (see section 3).

Depo-Provera may not be suitable for every woman. You will need to
discuss with
your doctor or healthcare professional providing your contraception on
whether it is
suitable for you, especially if you wish to use it for more than 2
years (See section 1).

Depo-Provera may not be suitable for you if you have a history of
certain medical
conditions (see section 2) or if you are taking a medicine called
aminoglutethiamide
that thins the blood (see section 2). Your doctor or nurse should take
a full medical
history before prescribing Depo-Provera.

Regular use of Depo-Provera causes a gradual loss of bone mineral
density (see
section 4). For a small number of patients that were followed-up, the
average bone
mineral density returned to average 1-3 years after they stopped using
Depo-Provera.
Teenagers who are rapidly developing their bones may be at particular
risk and
should only use

製品の特徴

OBJECT 1
DEPO-PROVERA 150MG/ML INJECTION
Summary of Product Characteristics Updated 14-Dec-2016 | Pfizer
Limited
1. Name of the medicinal product
Depo-Provera 150 mg/ml
2. Qualitative and quantitative composition
Each ml of suspension contains 150 mg medroxyprogesterone acetate
Excipients with known effect:
Methylparaben (E218) – 1.35mg
Propylparaben (E216) – 0.15mg
Sodium chloride – 3.38mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile suspension for injection.
4. Clinical particulars
4.1 Therapeutic indications
Progestogen: for contraception.
Depo-Provera is a long-term contraceptive agent suitable for use in
women who have been appropriately
counselled concerning the likelihood of menstrual disturbance and the
potential for a delay in return to
full fertility.
Depo-Provera may also be used for short-term contraception in the
following circumstances:
1) For partners of men undergoing vasectomy, for protection until the
vasectomy becomes effective.
2) In women who are being immunised against rubella, to prevent
pregnancy during the period of activity
of the virus.
3) In women awaiting sterilisation.
Since loss of bone mineral density (BMD) may occur in females of all
ages who use Depo-Provera
injection long-term (see section 4.4), a risk/benefit assessment,
which also takes into consideration the
decrease in BMD that occurs during pregnancy and/or lactation, should
be considered before giving the
injection of Depo-Provera.
Paediatric population (12-18 years)
In adolescents, Depo-Provera may be used, but ONLY after other methods
of contraception have been
discussed with the patient and considered unsuitable or unacceptable.
It is of the greatest importance that adequate explanations of the
long-term nature of the product, of its
possible side-effects and of the impossibility of immediately
reversing the effects of each injection are
given to potential users and that every effort is made to ensure that
each patient receives such counselling
as to enable her to fully understan