bhpardo/ema_en · Datasets at Hugging Face

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Do not use Bondronat:
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
EXPIRY DATE
Keep out of the reach and sight of children.
Flushing
If you take more Circadin than you should If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Not all pack sizes may be marketed.
- pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance
In clinical studies, patients with creatinine clearance of ≥ 45 ml/ min required no dose adjustments other than those recommended for all patients.
Tel: +34 – 94 481 83 00
6.
Very common Common Very common Common
You will therefore need regular blood tests to determine the correct daily dose.
10.
- breathlessness
Based on this analysis there were no cases in the vaccine group and 20 cases in the control group (Efficacy 100%; 97.9% CI:
Common: alterations in some laboratory blood tests (including decreased red blood cell count and increased values of some liver and kidney tests Uncommon: high calcium
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
100 D-60318 Frankfurt/ Main Germany
1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
Powder for concentrate for solution for injection or infusion.
GENERAL CLASSIFICATION FOR SUPPLY
30-60
Therefore, pioglitazone should not be administered to breast-feeding women.
Rare
4.1 Therapeutic indications
For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Clinically significant laboratory abnormalities frequently (≥ 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Рачо Димчев 4 София 1000 тел.: + 359 2 9808482
Aranesp 300 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Before you use Cerezyme.
Medicinal product subject to medical prescription.
CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
APTIVUS soft capsules co-administered with low dose ritonavir should be taken with food (see section 5.2).
TRAY LID
Package size
These measures will help to protect the environment.
Medicinal product subject to medical prescription.
Store in a refrigerator (2°C to 8°C) For the convenience of the patient the product can be removed from such storage for one single period of maximum 1 month at room temperature (up to 25°C).
Luxembourg/ Luxemburg sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00 (Belgique/ Belgien)
CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin Germany info@ct-arzneimittel. de
6.1 List of excipients
4.2 Posology and method of administration
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Reproduction is authorised provided the source is acknowledged.
The studies measured the effectiveness of the treatment by looking at how the liver damage had evolved after 48 weeks treatment (using a liver biopsy, when a sample of liver tissue is taken and examined under a microscope) as well as measuring other signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA circulating in the blood of the patients.
The use of Cervarix should be in accordance with official recommendations.
level may become too high (hyperglycaemia).
There are no data in severe renal impairment.
OTHER SPECIAL WARNING(S), IF NECESSARY
The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.
16.
BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.
Κύπρος Takeda Global R & D Centre (Europe), Ηνω µένο Βασίλειο Τηλ: +44 (0)20 3116 8000
Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
Maintenance phase:
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for use in this patient population.
13.
In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/ green) was detected using the Farnsworth-Munsell 100-hue test.
167 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
How to take Aprovel 4.
Musculoskeletal and connective tissue disorders:
4 pre-filled syringes
32 Gastrointestinal disorders
Actraphane 50 Penfill
See section 4.4.
It may harm them, even
Chest pain
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 - 30 seconds, every three months.
ADENURIC 80 mg film-coated tablets
Once weekly
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
EXPIRY DATE
Bisphosphonates, ATC code:
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
AREA 6
Mention to your doctor, nurse or pharmacist anything you are taking which you bought over the counter, without a prescription.
- If you are already pregnant, or think that you might be, talk to a doctor as soon as you can.
SPECIAL STORAGE CONDITIONS
Each pre-filled pen contains 300 micrograms of darbepoetin alfa in 0.6 ml (500 µg/ ml).
Each tablet contains:
9 (9) Common:
Immune system disorders
10 GLULISINE LISPRO GIR - mg/ kg/ min
3.
3.
Maintenance phase:
Treatment naïve patients The resistance profile in treatment-naïve patients has not been characterized.
12.
4.
No line listings are required – these can be provided in signal evaluation reports as necessary.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
99.26 -0.65
Batch:
4.5 Interaction with other medicinal products and other forms of interaction
Each capsule contains 40 mg duloxetine (as hydrochloride).
Store in a refrigerator.
From a microbiological point of view, the product should be used immediately after dilution.

Do not use Bondronat:

The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).

EXPIRY DATE

Keep out of the reach and sight of children.

Flushing

If you take more Circadin than you should If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.

Not all pack sizes may be marketed.

- pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance

In clinical studies, patients with creatinine clearance of ≥ 45 ml/ min required no dose adjustments other than those recommended for all patients.

Tel: +34 – 94 481 83 00

6.

Very common Common Very common Common

You will therefore need regular blood tests to determine the correct daily dose.

10.

- breathlessness

Based on this analysis there were no cases in the vaccine group and 20 cases in the control group (Efficacy 100%; 97.9% CI:

Common: alterations in some laboratory blood tests (including decreased red blood cell count and increased values of some liver and kidney tests Uncommon: high calcium

Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.

100 D-60318 Frankfurt/ Main Germany

1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.

Powder for concentrate for solution for injection or infusion.

GENERAL CLASSIFICATION FOR SUPPLY

30-60

Therefore, pioglitazone should not be administered to breast-feeding women.

Rare

4.1 Therapeutic indications

For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).

Clinically significant laboratory abnormalities frequently (≥ 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.

Рачо Димчев 4 София 1000 тел.: + 359 2 9808482

Aranesp 300 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa

Before you use Cerezyme.

Medicinal product subject to medical prescription.

CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

APTIVUS soft capsules co-administered with low dose ritonavir should be taken with food (see section 5.2).

TRAY LID

Package size

These measures will help to protect the environment.

Medicinal product subject to medical prescription.

Store in a refrigerator (2°C to 8°C) For the convenience of the patient the product can be removed from such storage for one single period of maximum 1 month at room temperature (up to 25°C).

Luxembourg/ Luxemburg sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00 (Belgique/ Belgien)

CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin Germany info@ct-arzneimittel. de

6.1 List of excipients

4.2 Posology and method of administration

A causal relationship has been evoked, although the mechanism of action has not been elucidated.

HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).

Reproduction is authorised provided the source is acknowledged.

The studies measured the effectiveness of the treatment by looking at how the liver damage had evolved after 48 weeks treatment (using a liver biopsy, when a sample of liver tissue is taken and examined under a microscope) as well as measuring other signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA circulating in the blood of the patients.

The use of Cervarix should be in accordance with official recommendations.

level may become too high (hyperglycaemia).

There are no data in severe renal impairment.

OTHER SPECIAL WARNING(S), IF NECESSARY

The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.

16.

BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.

Κύπρος Takeda Global R & D Centre (Europe), Ηνω µένο Βασίλειο Τηλ: +44 (0)20 3116 8000

Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.

Maintenance phase:

• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for use in this patient population.

13.

In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/ green) was detected using the Farnsworth-Munsell 100-hue test.

167 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.

How to take Aprovel 4.

Musculoskeletal and connective tissue disorders:

4 pre-filled syringes

32 Gastrointestinal disorders

Actraphane 50 Penfill

See section 4.4.

It may harm them, even

Chest pain

The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 - 30 seconds, every three months.

ADENURIC 80 mg film-coated tablets

Once weekly

In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.

EXPIRY DATE

Bisphosphonates, ATC code:

patients with active malignant disease receiving neither chemotherapy nor radiation therapy.

AREA 6

Mention to your doctor, nurse or pharmacist anything you are taking which you bought over the counter, without a prescription.

- If you are already pregnant, or think that you might be, talk to a doctor as soon as you can.

SPECIAL STORAGE CONDITIONS

Each pre-filled pen contains 300 micrograms of darbepoetin alfa in 0.6 ml (500 µg/ ml).

Each tablet contains:

9 (9) Common:

Immune system disorders

10 GLULISINE LISPRO GIR - mg/ kg/ min

3.

Maintenance phase:

Treatment naïve patients The resistance profile in treatment-naïve patients has not been characterized.

12.

4.

No line listings are required – these can be provided in signal evaluation reports as necessary.

Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).

Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.

99.26 -0.65

Batch:

4.5 Interaction with other medicinal products and other forms of interaction

Each capsule contains 40 mg duloxetine (as hydrochloride).

Store in a refrigerator.

From a microbiological point of view, the product should be used immediately after dilution.