Forsteo 20micrograms80microlitres solution for injection 2.4ml pre-filled pen

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Teriparatide

Հասանելի է:

Eli Lilly and Company Ltd

ATC կոդը:

H05AA02

INN (Միջազգային անվանումը):

Teriparatide

Դոզան:

250microgram/1ml

Դեղագործական ձեւ:

Solution for injection

Կառավարման երթուղին:

Subcutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: ; GTIN: 5014602101343

Տեղեկատվական թերթիկ

PEN USER MANUAL
FORSTEO
FORSTEO 20 MICROGRAMS (ΜG)/ 80 MICROLITRES SOLUTION FOR INJECTION, IN
PRE-FILLED PEN
_ _
INSTRUCTIONS FOR USE
BEFORE YOU USE YOUR NEW PEN, PLEASE READ THE SECTION _INSTRUCTIONS FOR
USE _COMPLETELY. FOLLOW THE
DIRECTIONS CAREFULLY WHEN USING THE PEN.
ALSO READ THE PACKAGE LEAFLET PROVIDED.
DO NOT SHARE YOUR PEN OR YOUR NEEDLES AS THIS MAY RISK TRANSMISSION OF
INFECTIOUS AGENTS.
YOUR PEN CONTAINS 28 DAYS OF MEDICINE.
Forsteo parts*
* Needles not included.
Becton, Dickinson and
Company pen needles 29 to
31 gauge (diameter 0.25-0.33
mm) and 12.7, 8 or 5 mm
length can be used. Ask your
doctor or pharmacist which
needle gauge and length are
best for you.
Yellow Shaft
Black
Injection
button
Red Stripe Blue Body Medicine Cartridge White Cap
Paper Tab Needle Large Needle Cover
Small Needle Protector
ALWAYS WASH YOUR HANDS BEFORE EVERY INJECTION. PREPARE THE INJECTION
SITE AS DIRECTED BY YOUR
DOCTOR OR PHARMACIST.
1
PULL OFF WHITE CAP
2
ATTACH NEW
NEEDLE
Pull off paper
tab.
Push needle
STRAIGHT
onto medicine cartridge.
Screw on needle
until firmly attached.
Pull off large
needle cover
and
SAVE IT.
2
3
SET
DOSE
Red
stripe
Small
needle
protector
PULL
out black
injection
button
UNTIL IT STOPS.
If you cannot pull out
the black injection
button see
_ _
_Troubleshooting, _
_Problem E_
.
CHECK
to
make sure
red stripe
shows.
PULL
off small
needle
protector and throw
away.
4
INJECT DOSE
Gently hold a fold of skin from
thigh or
abdomen and insert needle straight
into skin.
PUSH IN
black injection button until
it stops. Hold it in and
COUNT TO 5
S-L-O-W-L-Y.
Then pull the needle
from skin. IMPORTANT
5
CONFIRM
DOSE
AFTER
COMPLETING THE
INJECTION
:
Once the needle
is removed from
the skin,
CHECK
to make sure the
black injection
button is all the
way in. If the
yellow shaft
does not show,
you have
completed the
injection steps
correctly.
You should
NOT
see any of
the yellow shaft. If you do
and have already injected, do
not inject yourself a second
time on the same day.
Instead,
YOU MUST RESET
FORSTEO
(see
Troub

Ապրանքի հատկությունները

OBJECT 1
FORSTEO 20 MICROGRAMS/80 MICROLITRES SOLUTION FOR
INJECTION IN PRE-FILLED PEN
Summary of Product Characteristics Updated 15-Dec-2017 | Eli Lilly and
Company Limited
1. Name of the medicinal product
FORSTEO 20 micrograms/80 microlitres solution for injection in
pre-filled pen.
2. Qualitative and quantitative composition
Each dose of 80 microlitres contains 20 micrograms of teriparatide*.
One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide
(corresponding to 250 micrograms
per mL).
*Teriparatide, rhPTH(1-34), produced in _E. coli_, using recombinant
DNA technology, is identical to the
34 N-terminal amino acid sequence of endogenous human parathyroid
hormone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Colourless, clear solution.
4. Clinical particulars
4.1 Therapeutic indications
Forsteo is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at
increased risk of fracture (see section
5.1). In postmenopausal women, a significant reduction in the
incidence of vertebral and non-vertebral
fractures but not hip fractures has been demonstrated.
Treatment of osteoporosis associated with sustained systemic
glucocorticoid therapy in women and men
at increased risk for fracture (see section 5.1).
4.2 Posology and method of administration
Posology
The recommended dose of Forsteo is 20 micrograms administered once
daily.
The maximum total duration of treatment with Forsteo should be 24
months (see section 4.4). The 24-
month course of Forsteo should not be repeated over a patient's
lifetime.
Patients should receive supplemental calcium and vitamin D supplements
if dietary intake is inadequate.
Following cessation of Forsteo therapy, patients may be continued on
other osteoporosis therapies.
Special populations
_Patients with renal impairment_
Forsteo must not be used in patients with severe renal impairment (see
section 4.3). In patients with
moderate renal impairment, Forsteo should be used with caution. No
special caut