bhpardo/ema_en · Datasets at Hugging Face

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Consequently:
The most frequent adverse reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Antiviral activity: entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
This summary was last updated in 01-2009.
Qchs.mi@quintiles.com
Amgen Europe B. V.
INSTRUCTIONS ON USE
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
INFORMATION FOR THE USER
8.
6.
4.
For intravenous or subcutaneous use Read the package leaflet before use.
Dizziness, fatigue and somnolence are common side effects which may impair your ability to drive and use machines.
oral lyophilisate, or to loratadine.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
6.1 List of excipients
Avastin 10 mg/ kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Oral use
Taś mowa 7 PL-02-677 Warszawa Tel.: + 48-(0)22 478 41 50
Discard unused contents appropriately.
Psychiatric disorders Nervous system disorders
Common Rash** Uncommon Dermatitis, urticaria, pruritus
If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and then reinstitute epoetin alfa therapy at a dose 25% below the previous level.
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
1/ 1
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Neutropenia, anaemia, leukopenia, thrombocytopenia,
MARKETING AUTHORISATION HOLDER
- difficulty sleeping
Even at very high serum levels, no symptoms of overdose have been observed.
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.
Try to take the ABILIFY tablet at the same time each day.
The Committee recommended that Angiox be given marketing authorisation.
One patient in the APTIVUS arm had four mutations.
Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.
35 Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Ask your pharmacist how to dispose of medicines no longer required.
Summary of Product Characterisitics, Section 4.2).
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
BATCH NUMBER
2.
Subcutaneous route
20 PACKAGE LEAFLET:
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Push- button
This medicinal product does not require any special storage conditions.
PHARMACEUTICAL FORM
België/ Belgique/ Belgien/ Luxembourg/ Luxemburg Genzyme Belgium nv/ sa (Belgique/ Belgien), Tél/ Tel: + 32 2 714 17 11
Treatment of patients with chemotherapy induced anaemia:
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in order to minimise the potential risk of thromboembolic events.
See Commonly Asked Questions, number 4, in Section 4 of this user manual.
26.5
The use of Agenerase concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Fig. d
Upon discontinuation of the CYP2D6 or 3A4 inhibitor, the dosage of ABILIFY should be increased to the level prior to the initiation of the concomitant therapy.
2.
Contrada Fontana del Ceraso I-03012 Anagni-Frosinone - Italy
Wound infection Common:
Dose (IU/ kg given 3x / week)
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
A homogeneous solution will be obtained by shaking gently.
previous Grade 3 or
212 Information on how to use Actraphane 30 NovoLet
Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
4.
5.6
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
However the terminal half-life was not significantly altered.
The therapeutic margin of epoetin alfa is very wide.
6.
In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100mg QD.
- lithium salts (used to treat psychiatric disorders).
8.
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
3.
Most minor reactions to insulins usually resolve in a few days to a few weeks.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
EXPIRY DATE
Not all pack sizes may be marketed.
EXPIRY DATE
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development because of limited exposure.
Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Nucleoside-naive:
EU/ 1/ 02/ 230/ 002 Actrapid
29/ 30).
Solution for injection 1 x 10 ml 5 x 10 ml
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (≤ 0.01%).
AZOPT 10 mg/ ml eye drops, suspension.
EXP:
5.
5.
lactose monohydrate
Baseline ALT levels ≥ 2 x ULN and baseline HBV DNA ≤ 9.0 log10 copies/ ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ ml) in nucleoside-naive HBeAg-positive patients.
25%; return to
Therefore your haemoglobin-levels and your blood pressure should

Consequently:

The most frequent adverse reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.

Antiviral activity: entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.

This summary was last updated in 01-2009.

Qchs.mi@quintiles.com

Amgen Europe B. V.

INSTRUCTIONS ON USE

This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.

INFORMATION FOR THE USER

8.

6.

4.

For intravenous or subcutaneous use Read the package leaflet before use.

Dizziness, fatigue and somnolence are common side effects which may impair your ability to drive and use machines.

oral lyophilisate, or to loratadine.

This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).

6.1 List of excipients

Avastin 10 mg/ kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).

Oral use

Taś mowa 7 PL-02-677 Warszawa Tel.: + 48-(0)22 478 41 50

Discard unused contents appropriately.

Psychiatric disorders Nervous system disorders

Common Rash** Uncommon Dermatitis, urticaria, pruritus

If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and then reinstitute epoetin alfa therapy at a dose 25% below the previous level.

The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.

1/ 1

In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.

Neutropenia, anaemia, leukopenia, thrombocytopenia,

MARKETING AUTHORISATION HOLDER

- difficulty sleeping

Even at very high serum levels, no symptoms of overdose have been observed.

Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.

Try to take the ABILIFY tablet at the same time each day.

The Committee recommended that Angiox be given marketing authorisation.

One patient in the APTIVUS arm had four mutations.

Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.

35 Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.

Ask your pharmacist how to dispose of medicines no longer required.

Summary of Product Characterisitics, Section 4.2).

This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.

BATCH NUMBER

2.

Subcutaneous route

20 PACKAGE LEAFLET:

Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.

Push- button

This medicinal product does not require any special storage conditions.

PHARMACEUTICAL FORM

België/ Belgique/ Belgien/ Luxembourg/ Luxemburg Genzyme Belgium nv/ sa (Belgique/ Belgien), Tél/ Tel: + 32 2 714 17 11

Treatment of patients with chemotherapy induced anaemia:

In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in order to minimise the potential risk of thromboembolic events.

See Commonly Asked Questions, number 4, in Section 4 of this user manual.

26.5

The use of Agenerase concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).

Fig. d

Upon discontinuation of the CYP2D6 or 3A4 inhibitor, the dosage of ABILIFY should be increased to the level prior to the initiation of the concomitant therapy.

2.

Contrada Fontana del Ceraso I-03012 Anagni-Frosinone - Italy

Wound infection Common:

Dose (IU/ kg given 3x / week)

The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.

A homogeneous solution will be obtained by shaking gently.

previous Grade 3 or

212 Information on how to use Actraphane 30 NovoLet

Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis

4.

5.6

It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.

However the terminal half-life was not significantly altered.

The therapeutic margin of epoetin alfa is very wide.

6.

In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.

Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.

Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).

Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.

For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100mg QD.

- lithium salts (used to treat psychiatric disorders).

8.

There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.

3.

Most minor reactions to insulins usually resolve in a few days to a few weeks.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant.

EXPIRY DATE

Not all pack sizes may be marketed.

EXPIRY DATE

Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development because of limited exposure.

Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:

Nucleoside-naive:

EU/ 1/ 02/ 230/ 002 Actrapid

29/ 30).

Solution for injection 1 x 10 ml 5 x 10 ml

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (≤ 0.01%).

AZOPT 10 mg/ ml eye drops, suspension.

EXP:

5.

lactose monohydrate

Baseline ALT levels ≥ 2 x ULN and baseline HBV DNA ≤ 9.0 log10 copies/ ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ ml) in nucleoside-naive HBeAg-positive patients.

25%; return to

Therefore your haemoglobin-levels and your blood pressure should