bhpardo/ema_en · Datasets at Hugging Face

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5.4 0.0
Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Hence, the CHMP recommended that Alpheon be refused marketing authorisation.
- Measure antithrombin levels daily, in order to adjust the individual dose.
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
GlaxoSmithKline Biologicals SA Parc de la Noire Epine rue Flemming 20-1300 Wavre Belgium
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Tel: + 421 2 59298411
Bone is a living tissue that is constantly renewed by a process that erodes old bone and replaces it with new bone at the same rate.
Subcutaneous use
OUTER CARTON
The alendronate component in the ADROVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
H
Package containing one or four pre-filled syringe(s) of a 100 µg Aranesp solution for injection in 0.5 ml (200 µg/ ml).
Pregnancy: there are no adequate data from the use of amprenavir in pregnant women.
9.
432 BACK- Aranesp getting started guide:
12 purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.
Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.
Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
1.
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese
Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p < 0.0001).
Baraclude 0.05 mg/ ml oral solution is supplied in a bottle containing 210 ml oral solution.
15 ANNEX II
System organ class
Fatigue
EU/ 1/ 02/ 206/ 024
Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
NAME OF THE MEDICINAL PRODUCT
Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
As soon as you are able to tolerate oral medication your doctor will switch you to CellCept capsules, tablets or oral suspension.
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany.
50 IU/ kg 3 times per week by the intravenous route.
Before you are given ALIMTA 3.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
HOW TO USE ALDURAZYME
Common
15.
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
OTHER SPECIAL WARNING(S), IF NECESSARY
Aranesp works in exactly the same way as the natural hormone erythropoietin.
System organ class
Immunogenicity data for subcutaneous use of Abseamed in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.
5.8
EXP {month/ year}
Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
4.
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
Alcohol should be avoided when taking ABILIFY.
(CV)
Outcome
This should be taken into consideration when treating infections such as active tuberculosis and invasive fungal infections.
Fig. a
Aranesp
10.95
Keep the bottle tightly closed.
Cmax (mg/ l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
Beromun must not be administered systemically.
1.
EXPIRY DATE
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
It may harm them, even
6.8
6.4 Special precautions for storage
1 1.
Aranesp is a sterile but unpreserved product.
Musculoskeletal, connective tissue and bone disorders:
This leaflet was last approved on
For subcutaneous and intravenous use.
EU/ 1/ 01/ 196/ 001
In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
HOW TO STORE ACTRAPHANE
Pemetrexed N = 265
ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Batch:
BOTTLE LABEL LEAFLET
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Adverse Experience Rate
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
One hundred and sixty-three (163) patients with virus sensitive to Agenerase, at least one other PI, and at least one NRTI were included in PRO30017 substudy A.
NAME OF THE MEDICINAL PRODUCT
Other phenotypic and genotypic assays are currently being evaluated.
Amprenavir is 14% less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Do not store above 25°C.
Uncommon:
186 B.
11.
OTHER SPECIAL WARNING(S), IF NECESSARY
Actraphane is for injection under the skin (subcutaneously).
Cartridge (glass) in pre-filled pen
Solution for injection

5.4 0.0

Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.

The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.

Hence, the CHMP recommended that Alpheon be refused marketing authorisation.

- Measure antithrombin levels daily, in order to adjust the individual dose.

Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.

GlaxoSmithKline Biologicals SA Parc de la Noire Epine rue Flemming 20-1300 Wavre Belgium

DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

Tel: + 421 2 59298411

Bone is a living tissue that is constantly renewed by a process that erodes old bone and replaces it with new bone at the same rate.

Subcutaneous use

OUTER CARTON

The alendronate component in the ADROVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.

Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.

H

Package containing one or four pre-filled syringe(s) of a 100 µg Aranesp solution for injection in 0.5 ml (200 µg/ ml).

Pregnancy: there are no adequate data from the use of amprenavir in pregnant women.

9.

432 BACK- Aranesp getting started guide:

12 purified water, sucrose, natural and artificial flavour (bubblegum), orange colour E110.

Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.

Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).

1.

In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese

Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p < 0.0001).

Baraclude 0.05 mg/ ml oral solution is supplied in a bottle containing 210 ml oral solution.

15 ANNEX II

System organ class

Fatigue

EU/ 1/ 02/ 206/ 024

Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.

NAME OF THE MEDICINAL PRODUCT

Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.

In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.

As soon as you are able to tolerate oral medication your doctor will switch you to CellCept capsules, tablets or oral suspension.

Deutschland Roche Pharma AG Tel: +49 (0) 7624 140

Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany.

50 IU/ kg 3 times per week by the intravenous route.

Before you are given ALIMTA 3.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

HOW TO USE ALDURAZYME

Common

15.

Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.

In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.

Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.

OTHER SPECIAL WARNING(S), IF NECESSARY

Aranesp works in exactly the same way as the natural hormone erythropoietin.

System organ class

Immunogenicity data for subcutaneous use of Abseamed in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.

5.8

EXP {month/ year}

Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.

4.

AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:

General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.

Alcohol should be avoided when taking ABILIFY.

(CV)

Outcome

This should be taken into consideration when treating infections such as active tuberculosis and invasive fungal infections.

Fig. a

Aranesp

10.95

Keep the bottle tightly closed.

Cmax (mg/ l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).

Beromun must not be administered systemically.

1.

EXPIRY DATE

If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.

It may harm them, even

6.8

6.4 Special precautions for storage

1 1.

Aranesp is a sterile but unpreserved product.

Musculoskeletal, connective tissue and bone disorders:

This leaflet was last approved on

For subcutaneous and intravenous use.

EU/ 1/ 01/ 196/ 001

In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).

HOW TO STORE ACTRAPHANE

Pemetrexed N = 265

ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion

Batch:

BOTTLE LABEL LEAFLET

It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).

Adverse Experience Rate

If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.

One hundred and sixty-three (163) patients with virus sensitive to Agenerase, at least one other PI, and at least one NRTI were included in PRO30017 substudy A.

NAME OF THE MEDICINAL PRODUCT

Other phenotypic and genotypic assays are currently being evaluated.

Amprenavir is 14% less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).

Do not store above 25°C.

Uncommon:

186 B.

11.

OTHER SPECIAL WARNING(S), IF NECESSARY

Actraphane is for injection under the skin (subcutaneously).

Cartridge (glass) in pre-filled pen

Solution for injection