natgillin/translations-raw huggingface dataset:
, -
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
, - 1 & $/ Penfill, -
If your blood sugar gets too high
Protaphane) 5
Your blood sugar may get too high (this is called hyperglycaemia).
Protaphane Penfill.
The warning signs appear gradually.
NovoFine.
Then seek medical advice straight away.
Protaphane Penfill%,
If you don’ t treat it, this could lead to diabetic coma and death.
Penfill,.
Causes of hyperglycaemia
- '-
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
94
94 5.
• & • •
POSSIBLE SIDE EFFECTS
. "). &. (
Changes at the injection site (Lipodystrophy).
+ ". #
Signs of allergy.
2
See also warning in 2 Before you use Protaphane.
$&
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Protaphane.
Ask your doctor about this.
% "). -
Swollen joints.
Protaphane!
This soon disappears.
)
Side effects reported very rarely (in less than 1 patient in 10,000)
).
Vision problems.
(
When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.
(
Painful neuropathy (nerve related pain).
(2°C - 8°C).
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
-! #!
95 temperature before resuspending the insulin as instructed for the first time use.
Protaphane
Protaphane should not be disposed of via wastewater or household waste.
- 1 & $Protaphane 1
What Protaphane contains
Protaphane. 1
– The active substance is insulin human made by recombinant biotechnology.
(NPH).
Protaphane is an isophane insulin suspension (NPH).
1 ml 300 IU.
1 ml contains 100 IU of insulin human.
100 IU
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd,
The suspension for injection comes as a cloudy, white, aqueous suspension.
W5, S6, P5, K7
Not all packs may be marketed.
Novo Nordisk A/ S,
Marketing Authorisation Holder and Manufacturer
Novo Allé, DK- 2880 Bagsværd,
Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
Protaphane NovoLet 100 IU/ ml
Now turn over for information on how to use your NovoLet.
) (Insulin human (rDNA))
This leaflet was last approved in
Protaphane
96 Information on how to use Protaphane NovoLet
Protaphane
Please read the following instructions carefully before using your Protaphane NovoLet.
2 - 1 - "" 5.
Introduction
Protaphane
Protaphane NovoLet is a simple, compact pre-filled pen.
2
You can dial doses from 2 to 78 units in increments of 2 units.
1½ Protaphane
NovoLet ®
PROTAPHANE
NovoFine® needle
! #!, Protaphane
Big outer needle cap
1 * '- (
Protective tab
Protaphane
Inner Pen cap needle cap
(() -;
Cap scale
#) (- #
Needle
PROTAPHANE
Rubber membrane
Protaphane
Insulin level indicator
! #!, Protaphane
Insulin cartridge
NovoLet! '- - 1 * "
Glass ball
Protaphane) 100 5
Dosage indicator
Protaphane%
Colour coding
• •
Push button scale
• •
Push button
, Protaphane
97 Getting started
Protaphane
Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin.
. "). &. (
Take off the pen cap.
(
If there are less than 12 units left, use a new Protaphane NovoLet • Move the pen up and down between positions a and b and back (picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times.
Protaphane.
Repeat this movement at least 10 times before each injection.
Protaphane!
Do not discard the big outer needle cap.
,
A
%
a
-
B
,
b
PROTAPHANE
Priming to expel air
(2°C - 8°C).
Small amounts of air may collect in the needle and cartridge during normal use.
Protaphane. #
If not, change the needle and repeat the procedure no more than 6 times.
6
If a drop of insulin still does not appear, the device is defective and must not be used.
% -.
98
.
D
Protaphane
Setting the dose
. 0
• Put the cap back on the pen, with 0 next to the dosage indicator (picture E) • Check that the push-button is fully down.
Protaphane NovoLet
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Protaphane NovoLet horizontally.
2
For every click you feel when you turn the cap, you set 2 units more.
20
Every time you fully turn the cap, you set 20 units.
1
E
,
F
2 "Protaphane NovoLet *! -
Dosage examples To set 8 units:
0, 2, 4, 6, 8, 10, 12, 14, 16,,!
Turn the cap until 8 is opposite the dosage indicator; four clicks To select 26 units:
&. 0
Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again.
20
You’ ve now set 20 units.
20
Add the 6 from the dosage indicator to the 20 on the push-button scale.
26 &
There, you’ ve set 26 units (picture G).
20 -
99 G
. 0
To check a dose you set • Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
78 &
The maximum dose is 78 units • Don’ t try to set a dose higher than 78 units.
78 &
Turn the cap back as far as you can.
0 &
Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator.
.), 78
Remember that 78 units is the maximum dose • After the dose is set, remove the cap to inject the insulin.
) # &!, - #
Injecting the insulin
,! &.
This will ensure that the full dose has been delivered.
$
Don’ t use this to set or check your dose; it may not be accurate • You can’ t set a dose higher than the number of units left in the cartridge • You can use the insulin level indicator to estimate how much is left, but you can’ t use it to set or select your dose.
$) '- &, - # & $
Removing the needle
, &
• Replace the big outer needle cap and unscrew the needle.
$. "
Dispose of it carefully.
6
100 Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
. 0
Close your Protaphane NovoLet fully with 0 next to the dosage indicator.
Protaphane NovoLet 0 Protaphane NovoLet
Dispose of your used Protaphane NovoLet carefully without the needle attached.
& 1$ &
Maintenance
Protaphane
Your Protaphane NovoLet is designed to work accurately and safely.
NovoLet.
It must be handled with care.
Protaphane NovoLet.
Do not refill Protaphane NovoLet.
Protaphane NovoLet,
You can clean the exterior of your Protaphane NovoLet by wiping it with a medicinal swab.
,.
Do not soak it, wash or lubricate it.
.
INFORMATION FOR THE USER
Protaphane InnoLet 100 IU/ ml
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
$%
You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you.
) (Insulin human (rDNA))
Do not pass it on to others.
% "#. #
This side of the leaflet:
# "Protaphane
What Protaphane is and what it is used for 2.
Protaphane
Before you use Protaphane 3.
1! $
What to do in an emergency 5.
& - 1 * "
Possible side effects 6.
Protaphane
How to store Protaphane 7.
(% "
Further information
& '+
Overleaf:
InnoLet
How to use your InnoLet
(# ('-
Driving and using machines
);
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
-
Injecting insulin
. 0
See overleaf for detailed instructions.
5
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.
5
In insulin infusion pumps If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Protaphane) 111 5
Protaphane is for injection under the skin (subcutaneously).
Protaphane%
WHAT TO DO IN AN EMERGENCY
•
If you get a hypo
. 0.;
A hypo means your blood sugar level is too low.
:
The amount or timing of insulin, food or exercise may need to be adjusted.
1!
Using glucagon
*
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
# "
If your blood sugar gets too high
,
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
.
104 Side effects reported uncommonly (in less than 1 patient in 100)
(113
Painful neuropathy (nerve related pain).
(2°C - 8°C).
The expiry date refers to the last day of that month.
InnoLet
The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
! #!,.)%
Do not freeze.
Protaphane
105 Protaphane should not be disposed of via wastewater or household waste.
1 ml 3 ml,
Protaphane is an isophane insulin suspension (NPH).
- 1 -,.
1 ml contains 100 IU of insulin human.
-,
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
+
It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml.
3 ml.
Not all packs may be marketed.
$
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd,
Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
2 "InnoLet.
Now turn over for information on how to use your InnoLet.
- #
This leaflet was last approved in
Protaphane InnoLet
106 Information on how to use Protaphane InnoLet
Protaphane InnoLet.
Please read the following instructions carefully before using your Protaphane InnoLet.
1 &
Introduction
Protaphane InnoLet 1 50
Protaphane InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Protaphane InnoLet S
Protaphane InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
NovoFine S.
Look for an S on the needle box.
InnoLet
Push- button
.
Dose selector dial Residual scale Dose scale Insulin
Protaphane InnoLet
Compartment for needles
Protaphane InnoLet •
cartridge Glass ball
1A),
Rubber membrane
- '-
Needle
1 # -
Inner
- # & / - 1
Pen cap
%, + ('
Protective tab
• •
needle cap
! #!,! / "
Big outer needle cap
NovoFine S
Preparing for injection
Protaphane InnoLet (
Check the label to make sure that your Protaphane InnoLet contains the correct type of insulin.
•! 1
Suspending the insulin
&
The movement must always be repeated, until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay.
1! '& *
107 1A
:
A
)
B
• Protaphane InnoLet - +
Attaching the needle
1$
You may want to store the big outer needle cap in the compartment.
) '
1B
117 •
Priming to expel air
1 *
If not, change the needle and repeat the procedure no more than 6 times.
+ #
108 If a drop of insulin still does not appear, the device is defective and must not be used.
- &
1C
, & # - # 1
Setting the dose
&%, 2).
• Always check that the push-button is fully depressed and the dose selector is set at zero • Dial the number of units required by turning the dose selector clockwise (picture 2).
-
You cannot set a dose larger than the number of units left in the cartridge.
, &!,%
Injecting the insulin
-
• Insert the needle into your skin.
3).
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button fully down (picture 3).
6
You will hear clicks as the dose selector returns to zero • After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button • Remove the needle after each injection.
1 #
Removing the needle
4).
• Replace the big outer needle cap and unscrew the needle (picture 4).
InnoLet
Dispose of it carefully.
.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
Protaphane InnoLet
Dispose of your used Protaphane InnoLet carefully without the needle attached.
119 -
Maintenance
Protaphane
Your Protaphane InnoLet is designed to work accurately and safely.
InnoLet.
Do not refill Protaphane InnoLet.
Protaphane InnoLet.
You can clean your Protaphane InnoLet by wiping it with a medicinal swab.
- Protaphane InnoLet,
Do not soak it, wash or lubricate it.
,
INFORMATION FOR THE USER
Protaphane FlexPen 100 IU/ ml
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
$%
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
5
In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Protaphane) 122 5
Protaphane is for injection under the skin (subcutaneously).
.
113 Side effects reported uncommonly (in less than 1 patient in 100)
$Protaphane.
Ask your doctor about this.
(124
Painful neuropathy (nerve related pain).
,
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Protaphane
Do not use Protaphane the expiry date which is stated on the label and the carton.
FlexPen
The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
! #!%
Do not freeze.
Protaphane
114 Protaphane should not be disposed of via wastewater or household waste.
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd,
Marketing Authorisation Holder Novo Nordisk A/ S Novo Allé, DK-2880 Bagsværd, Denmark
125 &
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
2 "FlexPen.
Now turn over for information on how to use your FlexPen.
(# - # & - '%, & &! #!
This leaflet was last approved in
# ", (#
115 Introduction
Protaphane FlexPen.
Please read the following instructions carefully before using your Protaphane FlexPen.
1
The colour of the pen in the illustrations differs from your FlexPen.
FlexPen
Protaphane FlexPen Pen cap
. #
Rubber
NovoFine
12 units Glass
NovoTwist
Cartridge
8 mm.
Residual
FlexPen
Pointer
-
Dose
FlexPen.
Push-
Protaphane FlexPen
membrane
3
ball
12
scale
&)))
selector
+ (
button
()
Needle (example)
3
Big outer
!
Inner
& 1$ &
Needle
FlexPen. (
Protective
,
needle cap needle cap
.)
tab
FlexPen,
Maintenance
,
Your FlexPen is designed to work accurately and safely.
%. 0
It must be handled with care.
-
Do not soak it, wash or lubricate it as it may damage the pen.
FlexPen.
Do not refill your FlexPen.
Protaphane FlexPen
Preparing your Protaphane FlexPen
,! & - ',
Before your first injection with a new FlexPen you must resuspend the insulin:
2 "FlexPen - 1 & $
This makes it easier to resuspend.
FlexPen, ") & - '- &
116 Pull off the pen cap.
127 '0
Repeat until the liquid appears uniformly white and cloudy.
.
For every following injection move the pen up and down between position 1 and 2 at least ten times until the liquid appears uniformly white and cloudy.
%
After you have resuspended the insulin, complete all the following steps of injection without delay.
,
B
)
Attaching a needle
.
Disinfect the rubber membrane with a medicinal swab.
A
C Remove the protective tab from a new disposable needle.
0 /
Screw the needle straight and tightly onto your FlexPen.
-
C
.
D Pull off the big outer needle cap and keep it for later.
2,
117 D
. &
E Pull off the inner needle cap and dispose of it.
%
E
,,
• Always use a new needle for each injection to prevent contamination.
6
• Be careful not to bend or damage the needle before use.
- "
• To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.
- # & /
Checking the insulin flow
$
To avoid injection of air and ensure proper dosing:
2
F Turn the dose selector to select 2 units.
2
2 units- selected
.
G Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
129 6
118 G
%
The dose selector returns to 0.
“ 0 ”.
A drop of insulin should appear at the needle tip.
.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
1
H
,
Check that the dose selector is set at 0.
,
I Turn the dose selector to select the number of units you need to inject.
.
When turning the dose selector be careful not to push the push- button as insulin will come out.
,
You cannot select a dose larger than the number of units left in the cartridge.
-,
119 I
130 5 $
5 units selected
24 $
24 units selected
$.! #!, *
Making the injection
, + # & $.! #!, * $,
Insert the needle into your skin.
„ 0 ”
J Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
!
Turning the dose selector will not inject insulin.
.
J
"
K
%
120 Dispose of it carefully and put the pen cap back on.
,
L
. 0
Otherwise, the liquid may leak out which can cause inaccurate dosing.
!
• Caregivers should be most careful when handling used needles to avoid needle sticks.
FlexPen
• Do not share your FlexPen with anyone else.
EMEA/ H/ C/ 560
EMEA/ H/ C/ 560
PROTELOS
PROTELOS
Какво представлява PROTELOS?
What is PROTELOS?
PROTELOS е лекарство, съдържащо активното вещество стронциев ранелат.
PROTELOS is a medicine containing the active substance strontium ranelate.
За какво се използва PROTELOS?
What is PROTELOS used for?
PROTELOS се използва за лечение на остеопороза (заболяване, което прави костите чупливи) след менопауза при жени, за да се намали рискът от фрактури на прешлени (на гръбначния стълб) и на бедрената кост.
PROTELOS is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
Как да използвате PROTELOS?
How is PROTELOS used?
PROTELOS се приема по една сашета на ден.
PROTELOS is taken as one sachet once a day.
PROTELOS трябва да се приема поне два часа след хранене, прием на мляко, млечни продукти или калциеви добавки, за предпочитане преди лягане.
PROTELOS should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
PROTELOS е предназначен за продължителна употреба.
PROTELOS is intended for long-term use.
Пациентките трябва да приемат добавки от калций или витамин D, ако не приемат достатъчно от тях с храната.
Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.
Как действа PROTELOS?
How does PROTELOS work?
Постепенно костите изтъняват, стават чупливи и податливи на фрактури.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Активното вещество в PROTELOS, стронциев ранелат, действа върху костната структура.
The active substance in PROTELOS, strontium ranelate, acts on the bone structure.
Как е проучен PROTELOS?
How has PROTELOS been studied?
PROTELOS е проучен при около 7000 възрастни жени след менопауза в две големи проучвания.
Nearly a quarter of the patients were over 80 years of age.
Почти една четвърт от пациентките са над 80- годишна възраст.
The first study included 1,649 women with osteoporosis who already had vertebral fractures and the second included over 5,000 women whose osteoporosis affected the hip region in the thighbone.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged проучвания ефектите на PROTELOS са сравнени с тези на плацебо (сляпо лечение).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has PROTELOS shown during the studies?
Какви ползи от PROTELOS са установени в проучванията?
In the first study, PROTELOS was more effective than placebo in reducing the risk of new vertebral fractures.
Рискът е намален с 41% за период от три години, като 21% от 719 жени, приемали OSSEOR, получават нова фрактура на прешлен, в сравнение с 33% от 723 пациентки, приемали плацебо.
The risk was reduced by 41% over three years, with 21% of the 719 women who took PROTELOS developing a new vertebral fracture, compared with 33% of those 723 who took placebo.
Като цяло резултатите от второто проучване, взети самостоятелно, са недостатъчни, за да се докаже ползата от PROTELOS за предотвратяване на периферни фрактури.
Overall, he results of the second study taken alone were insufficient to demonstrate a benefit of PROTELOS in preventing peripheral fractures.
Когато се вземат предвид само жените на възраст 74 и повече години с особено крехки бедрени кости, резултатите сочат за намаляване на риска от бедрени фрактури при употреба на PROTELOS.
When looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of hip fractures with PROTELOS.
При оценката на резултатите от двете проучвания, взети заедно, по- малко жени в групата на лекуваните с PROTELOS развиват периферни фрактури в която и да е зона (включително бедрото), отколкото плацебо групата (331 от 3295, приемащи PROTELOS, спрямо 389 от 3256, приемащи плацебо).
When looking at results of the two studies taken together, fewer women in the PROTELOS group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with PROTELOS compared with 389 out of 3,256 for placebo).
Какви са рисковете, свързани с PROTELOS?
What is the risk associated with PROTELOS?
Най- честите нежелани реакции, свързани с PROTELOS (наблюдавани при 1 до 10 пациенти от 100), са главоболие, гадене (повдигане), диария, редки фекалии, дерматити (кожни реакции) и екзема (люспест кожен обрив).
The most common side effects with PROTELOS (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), diarrhoea, loose stools, dermatitis (skin reactions) and eczema (flaky skin rash).
За пълния списък с всички наблюдавани при PROTELOS нежелани реакции – вижте листовката.
For the full list of all side effects reported with PROTELOS, see the Package Leaflet.
PROTELOS е противопоказен за пациентки, които биха могли да проявят свръхчувствителност (алергични реакции) към стронциев ранелат или някоя от другите съставки.
PROTELOS should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
Основания за одобряване на PROTELOS?
Why has PROTELOS been approved?
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от PROTELOS надвишават рисковете при лечение на остеопороза след менопауза с цел намаляване на риска от фактури на прешлени и бедрена кост.
The Committee for Medicinal Products for Human Use (CHMP) decided that PROTELOS’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
Комитетът препоръчва на PROTELOS да бъде издадено разрешение за употреба.
The Committee recommended that PROTELOS be given marketing authorisation.
Допълнителна информация за PROTELOS:
Other information about PROTELOS:
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за PROTELOS на LES LABORATORIES SERVIER на 21 септември 2004 г.
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for PROTELOS on 21 September 2004.
Пълният текст на EPAR относно PROTELOS може да се намери тук.
The full EPAR for PROTELOS is available here.