bhpardo/ema_en · Datasets at Hugging Face

english stringlengths 2 1.37k
This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for N- acetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
For a full list of excipients, see section 6.1.
4.
The potential risk for humans is unknown.
AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles.
However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
2.
(from one 50 mg vial) at reduced volume
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
14.
12.
Nederland Baxter B.V.
The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
EU/ 1/ 06/ 343/ 002
Blister (PVC/ PVDC/ alu)
St John’ s wort (Hypericum perforatum):
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil
The cause and long-term health effects of these conditions are not known at this time.
The solution also contains potassium sorbate and sorbitol E420.
Overall, the proportions of pregnant subjects who experienced specific outcomes (e. g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
How is Advagraf used?
It is best to use your thumb rather than your nail as it could break.
5.1 Pharmacodynamic properties
WHAT ACTOS IS AND WHAT IT IS USED FOR
If signs of toxicity are noted (e. g. pronounced adverse reactions - see section 4.8) the dose of Advagraf may need to be reduced.
Read the package leaflet before use.
• The diluted solution must be mixed thoroughly by inverting several times
4.
Bondronat should not be mixed with calcium containing solutions.
Very rare Very rare
After administration of epoetin alfa, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
INFORMATION IN BRAILLE
4.
Date: ____ WEEK 4.
J07BM02
If you have any further questions on the use of this product ask your doctor.
Further information
6.2 Incompatibilities 25 Not applicable.
In addition the majority of participants had mutations associated with both NRTI and NNRTI resistance.
Not applicable
Data with AVANDAMET is also consistent with this combined adverse reaction profile.
4.6 Pregnancy and lactation
MARKETING AUTHORISATION NUMBER(S)
4.7 Effects on ability to drive and use machines
Actraphane is a dual-acting insulin.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
3.
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).
85 8.
5.3 Preclinical safety data
No animal studies have been conducted with the combined products in AVANDAMET.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.
The clinical relevance of this decrease is unknown.
1000
8.
Difference between Atripla and original treatment regimen
Lot Pot.
► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients.
HPV-16 and/ or HPV-18 DNA positive) of which only 0.5% were DNA positive for both types.
Wk 9-52 23.0% 15.0% 10.3% 2.66
However, significant liver toxicity has not been observed in patients treated in clinical studies, either during administration of Agenerase or after discontinuation.
2 Patients with hepatic impairment:
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
4.1 Therapeutic indications
DATE OF REVISION OF THE TEXT
Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: +357-22 757188
In general, women infected with HIV should not breast-feed because the virus may be transmitted through the breast milk.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown:
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Cardiac disorders:
OTHER SPECIAL WARNING(S), IF NECESSARY
KG Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
In this leaflet:
Suomi/Finland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Saksa Puh/ Tel: +49 (0)69 1503 – 1
4.7 Effects on ability to drive and use machines
Adverse Reactions, Probably or Possibly Related to CellCept, Reported in Patients Treated with CellCept in Renal, Cardiac and Hepatic Clinical Trials when Used in Combination with Ciclosporin and Corticosteroids
Listed below are the most common medicines which may affect your insulin treatment.
6.
Gastrointestinal disorders
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Special care before injection
between the study arms in at least one clinical trial)
EU/ 1/ 00/ 148/ 001
DATE OF REVISION OF THE TEXT
Pharmaceutical Form
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also “ Take special care with BeneFIX ”).
The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/ min (see sections 4.4 and 5.2).
more than 1 user in 10 1 to 10 users in 100 1 to 10 users in 1,000 1 to 10 users in 10,000 less than 1 user in 10,000 frequency cannot be estimated from the available data.
Draw air into the syringe, in the same amount as the dose of insulin you need 3.
Rarely, inhibitors may develop after the first 100 exposure days.
Do not use ADVATE if the solution is not fully clear or not completely dissolved.

This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for N- acetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.

For a full list of excipients, see section 6.1.

4.

The potential risk for humans is unknown.

AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles.

However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.

2.

(from one 50 mg vial) at reduced volume

A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.

14.

12.

Nederland Baxter B.V.

The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.

EU/ 1/ 06/ 343/ 002

Blister (PVC/ PVDC/ alu)

St John’ s wort (Hypericum perforatum):

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil

The cause and long-term health effects of these conditions are not known at this time.

The solution also contains potassium sorbate and sorbitol E420.

Overall, the proportions of pregnant subjects who experienced specific outcomes (e. g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.

In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

How is Advagraf used?

It is best to use your thumb rather than your nail as it could break.

5.1 Pharmacodynamic properties

WHAT ACTOS IS AND WHAT IT IS USED FOR

If signs of toxicity are noted (e. g. pronounced adverse reactions - see section 4.8) the dose of Advagraf may need to be reduced.

Read the package leaflet before use.

• The diluted solution must be mixed thoroughly by inverting several times

4.

Bondronat should not be mixed with calcium containing solutions.

Very rare Very rare

After administration of epoetin alfa, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.

INFORMATION IN BRAILLE

4.

Date: ____ WEEK 4.

J07BM02

If you have any further questions on the use of this product ask your doctor.

Further information

6.2 Incompatibilities 25 Not applicable.

In addition the majority of participants had mutations associated with both NRTI and NNRTI resistance.

Not applicable

Data with AVANDAMET is also consistent with this combined adverse reaction profile.

4.6 Pregnancy and lactation

MARKETING AUTHORISATION NUMBER(S)

4.7 Effects on ability to drive and use machines

Actraphane is a dual-acting insulin.

Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.

3.

No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.

If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).

85 8.

5.3 Preclinical safety data

No animal studies have been conducted with the combined products in AVANDAMET.

Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.

The clinical relevance of this decrease is unknown.

1000

8.

Difference between Atripla and original treatment regimen

Lot Pot.

► If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).

Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.

Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients.

HPV-16 and/ or HPV-18 DNA positive) of which only 0.5% were DNA positive for both types.

Wk 9-52 23.0% 15.0% 10.3% 2.66

However, significant liver toxicity has not been observed in patients treated in clinical studies, either during administration of Agenerase or after discontinuation.

2 Patients with hepatic impairment:

They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

4.1 Therapeutic indications

DATE OF REVISION OF THE TEXT

Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: +357-22 757188

In general, women infected with HIV should not breast-feed because the virus may be transmitted through the breast milk.

In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown:

Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.

Cardiac disorders:

OTHER SPECIAL WARNING(S), IF NECESSARY

KG Binger Strasse 173 D-55216 Ingelheim am Rhein Germany

Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06

In this leaflet:

Suomi/Finland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Saksa Puh/ Tel: +49 (0)69 1503 – 1

4.7 Effects on ability to drive and use machines

Adverse Reactions, Probably or Possibly Related to CellCept, Reported in Patients Treated with CellCept in Renal, Cardiac and Hepatic Clinical Trials when Used in Combination with Ciclosporin and Corticosteroids

Listed below are the most common medicines which may affect your insulin treatment.

6.

Gastrointestinal disorders

If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).

Special care before injection

between the study arms in at least one clinical trial)

EU/ 1/ 00/ 148/ 001

DATE OF REVISION OF THE TEXT

Pharmaceutical Form

This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.

Aripiprazole is the predominant medicinal product moiety in systemic circulation.

Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also “ Take special care with BeneFIX ”).

The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/ min (see sections 4.4 and 5.2).

more than 1 user in 10 1 to 10 users in 100 1 to 10 users in 1,000 1 to 10 users in 10,000 less than 1 user in 10,000 frequency cannot be estimated from the available data.

Draw air into the syringe, in the same amount as the dose of insulin you need 3.

Rarely, inhibitors may develop after the first 100 exposure days.

Do not use ADVATE if the solution is not fully clear or not completely dissolved.