Seretide 125 Evohaler

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Fluticasone propionate; Salmeterol xinafoate

제공처:

Pharmaram Ltd

ATC 코드:

R03AK06

INN (국제 이름):

Fluticasone propionate; Salmeterol xinafoate

복용량:

125microgram/1dose ; 25microgram/1dose

약제 형태:

Pressurised inhalation

관리 경로:

Inhalation

수업:

No Controlled Drug Status

처방전 유형:

Caution - AMP level prescribing advised

제품 요약:

BNF: 03020000; GTIN: 05060666560404

환자 정보 전단

RARE (AFFECTS LESS THAN 1 PERSON IN 1000)
•
BREATHING DIFFICULTIES OR WHEEZING THAT GET WORSE STRAIGHT AFTER
TAKING
SERETIDE. If this happens STOP USING YOUR SERETIDE INHALER. Use your
fast-acting ‘reliever’ inhaler to help your breathing and TELL
YOUR
DOCTOR STRAIGHT AWAY.
•
Seretide may affect the normal production of steroid hormones in the
body, particularly if you have taken high doses for long periods of
time. The effects include:
−
Slowing of growth in children and adolescents
−
Thinning of the bones
−
Glaucoma
−
Weight gain
−
Rounded (moon shaped) face (Cushing’s Syndrome)
Your doctor will check you regularly for any of these side effects and
make sure you are taking the lowest dose of Seretide to control your
asthma.
•
Behavioural changes, such as being unusually active and irritable
(these effects mainly occur in children).
•
Uneven heart beat or heart gives an extra beat (arrhythmias). Tell
your
doctor, but do not stop taking Seretide unless the doctor tells you to
stop.
•
A fungal infection in the oesophagus (gullet), which might cause
difficulties in swallowing.
FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR:
•
Depression or aggression. These effects are more likely to occur in
children.
•
Blurred vision.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects you can help
provide more information on the safety of this medicine.
5 HOW TO STORE SERETIDE
•
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
•
Straight after use, replace the mouthpiece cover firmly and click it
into
position. Do not use excessive force.
•
Do not store above 25°C.
•
The metal canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C, protect from direct sunlight. Do not
pier

제품 특성 요약

OBJECT 1
SERETIDE 125 EVOHALER
Summary of Product Characteristics Updated 29-Nov-2019 |
GlaxoSmithKline UK
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Seretide Evohaler 25 microgram/50 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/125 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/250 microgram per metered dose
pressurised inhalation, suspension.
2. Qualitative and quantitative composition
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or
250 micrograms of fluticasone
propionate. This is equivalent to a delivered dose (ex actuator) of 21
micrograms of salmeterol and 44, 110 or
220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, suspension.
The canister contains a white to off white suspension.
The canisters are fitted into purple p